SIMPONI 50 mg Инъекционный Раствор

Наталья Бессолицына

Наталья Бессолицына — врач-ревматолог высшей категории. Проводит онлайн-консультации по диагностике, лечению и сопровождению пациентов с заболеваниями суставов и системными болезнями соединительной ткани. В работе опирается на международные клинические рекомендации и методы доказательной медицины.

С какими симптомами и диагнозами можно обратиться:

Боли в суставах — острая, хроническая, рецидивирующая боль.
Артриты: ревматоидный артрит, псориатический артрит, полиартрит, подагрический артрит.
Артрозы: остеоартроз, коксартроз, гонартроз, узелковый полиостеоартроз.
Плечелопаточный периартрит и спондилоартриты.
Хронические воспалительные заболевания позвоночника — болезнь Бехтерева.
Системные аутоиммунные заболевания: системная красная волчанка, склеродермия, системные васкулиты.
Остеопороз и нарушение плотности костей.

Наталья Бессолицына помогает разобраться в причинах болей, назначает необходимые обследования и подбирает индивидуальное лечение с учётом состояния пациента, образа жизни и риска прогрессирования болезни. Основной акцент — на раннюю диагностику, профилактику осложнений и улучшение качества жизни.

Онлайн-формат позволяет получить квалифицированную ревматологическую помощь независимо от региона проживания.

Записаться на онлайн-консультацию

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Больше времени

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Инструкция по применению SIMPONI

Содержание инструкции

Simponi 45 mg/0.45 mL injectable solution in pre-filled pen
Simponi 45 mg/0.45 mL
Simponi 50 mg solution for injection in pre-filled pen
Simponi 50 mg injectable solution in pre-filled syringe
Simponi 100 mg injectable solution in pre-filled pen
1. What is Simponi and what is it used for
2. What you need to know before you use Simponi
Simponi should be used during pregnancy only if strictly necessary for you.
Simponi before the child receives any vaccine (for more information see the
Simponi 100 mg injectable solution in pre-filled syringe
1. What is Simponi and what is it used for
2. What you need to know before you use Simponi
Simponi should be used during pregnancy only if strictly necessary for you.
Simponi before the baby receives any vaccine (for more information see the

Simponi 45 mg/0.45 mL injectable solution in pre-filled pen

For pediatric patients with a weight less than 40 kg
golimumab

Read this leaflet carefully before taking this medicine as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Your doctor will provide you with a Patient Reminder Card, which contains important information
about safety, of which you should be aware before and during therapy with Simponi.

Contents of this leaflet

1. What Simponi is and what it is used for
2. What you need to know before you use Simponi
3. How to use Simponi
4. Possible side effects
5. How to store Simponi
6. Contents of the pack and other information

1. What is Simponi and what is it used for

Simponi contains an active substance called golimumab.
Simponi belongs to a group of medicines called “TNF blockers”. It is used in children
aged 2 years and older for the treatment of polyarticular juvenile idiopathic arthritis.
Simponi works by blocking the action of a protein called “tumour necrosis factor alpha” (TNF-
α). This protein is involved in the inflammatory processes of the body and by blocking it, it is possible
to reduce inflammation in the body.

Polyarticular juvenile idiopathic arthritis
Polyarticular juvenile idiopathic arthritis is an inflammatory disease that causes pain and swelling
in the joints of children. If you have polyarticular juvenile idiopathic arthritis, you will first be given
other medicines. If you do not respond adequately to these medicines, you will be given Simponi
in association with methotrexate to treat the disease.

2. Cosa deve sapere prima di usare Simponi

Non usi Simponi

Se è allergico (ipersensibile) a golimumab o ad uno qualsiasi degli altri componenti di questo medicinale (elencati al paragrafo 6).
Se ha la tubercolosi (TB) o qualsiasi altra infezione grave.
Se ha un’insufficienza cardiaca moderata o grave.

Se non è sicuro che una qualsiasi delle condizioni citate in precedenza possano riguardarla, ne parli
con il medico, con il farmacista o con l’infermiere prima di usare Simponi.

Avvertenze e precauzioni
Si rivolga al medico, al farmacista o all’infermiere prima di usare Simponi.
Infezioni
Informi subito il medico se ha già avuto o se presenta sintomi di infezione durante o dopo il
trattamento con Simponi. I sintomi dell’infezione comprendono febbre, tosse, respiro corto, sintomi
simili all’influenza, diarrea, ferite, problemi ai denti o sensazione di bruciore quando urina.

Può contrarre infezioni più facilmente quando usa Simponi.
Le infezioni possono progredire più rapidamente ed essere più gravi. Inoltre, possono ripresentarsi infezioni contratte in passato.

Tubercolosi (TB)
Informi subito il medico se nota sintomi di TB durante il trattamento. I sintomi della TB
comprendono tosse persistente, perdita di peso, sensazione di stanchezza, febbre o sudorazione
notturna.

Sono stati segnalati alcuni casi di TB in pazienti trattati con Simponi, in rare occasioni perfino in pazienti che sono stati trattati con medicinali per la TB. Il medico eseguirà degli esami per valutare se ha la TB. Il medico registrerà questi esami sulla Scheda di Promemoria per il Paziente.
È molto importante che riferisca al medico se in passato ha avuto la TB, o se è venuto in stretto contatto con qualcuno che ha o ha avuto la TB.
Se il medico ritiene che lei sia a rischio di TB, è possibile che venga trattato con medicinali per la TB prima che le sia somministrato Simponi.

Virus dell’epatite B (HBV)

Informi il medico se è un portatore o ha o ha avuto l’epatite B, prima che le sia somministrato Simponi.
Informi il medico se crede di poter essere a rischio di contrarre l’epatite B
Il medico deve eseguire degli esami per valutare se ha l’epatite B
Il trattamento con i bloccanti del TNF come Simponi può causare la riattivazione del virus dell’epatite B nei pazienti portatori di questo virus, che in alcuni casi può causare la morte.

Infezioni invasive da funghi
Informi immediatamente il medico se ha vissuto o viaggiato in un’area dove sono comuni le
infezioni causate da specifici tipi di funghi che possono colpire i polmoni o altre parti del corpo
(chiamate istoplasmosi, coccidioidomicosi o blastomicosi). Chieda al medico se non sa se
queste infezioni fungine sono comuni nell’area in cui ha vissuto o viaggiato.
Tumore e linfoma
Informi il medico se ha o ha mai avuto un linfoma (un tipo di tumore del sangue) o altri tipi di tumore,
prima che le sia somministrato Simponi.

Se usa Simponi o altri bloccanti del TNF può aumentare il rischio di sviluppo di un linfoma o di un altro tipo di tumore.
I pazienti con artrite reumatoide grave o altre malattie infiammatorie, che hanno sofferto di questa malattia per molto tempo, possono presentare un rischio di sviluppo di linfoma maggiore della media.
Nei pazienti bambini e adolescenti che hanno assunto medicinali bloccanti del TNF, sono stati segnalati casi di tumori, compresi quelli di tipo inusuale, qualche volta mortali.
In rare occasioni, uno specifico e grave tipo di linfoma chiamato linfoma epatosplenico a cellule T è stato osservato in pazienti che assumevano altri bloccanti del TNF. La maggior parte di questi pazienti erano adolescenti o giovani adulti di sesso maschile. Questo tipo di tumore ha portato solitamente alla morte. Quasi tutti questi pazienti avevano ricevuto anche medicinali conosciuti come azatioprina o 6-mercaptopurina. Informi il medico se sta prendendo azatioprina o 6-mercaptopurina con Simponi.
Pazienti con grave asma persistente, malattia polmonare cronica ostruttiva (BPCO) o assidui fumatori possono avere un aumentato rischio di cancro con il trattamento con Simponi. Se ha asma grave persistente, BPCO o è un assiduo fumatore, deve discutere con il medico se il trattamento con un bloccante del TNF è appropriato.
Alcuni pazienti trattati con golimumab hanno sviluppato alcuni tipi di cancro della pelle. Se si manifesta qualsiasi tipo di variazione di aspetto della pelle o escrescenze sulla pelle durante o dopo la terapia, informi il medico.

Insufficienza cardiaca
Informi immediatamente il medico se nota nuovi sintomi di insufficienza cardiaca o un loro
peggioramento. I sintomi dell’insufficienza cardiaca comprendono respiro corto o gonfiore dei piedi.

Con i bloccanti del TNF, compreso Simponi, sono stati segnalati casi di insufficienza cardiaca congestizia di nuova insorgenza o un suo peggioramento. Alcuni di questi pazienti sono morti.
Se ha insufficienza cardiaca lieve ed è trattato con Simponi, il medico la terrà strettamente monitorato.

Malattia del sistema nervoso
Informi immediatamente il medico se le è mai stata diagnosticata o se sviluppa i sintomi di una
malattia demielinizzante, come la sclerosi multipla. I sintomi possono comprendere alterazioni della
vista, debolezza a braccia e gambe, torpore o formicolio in qualsiasi parte del corpo. Il medico
deciderà se è il caso che le sia somministrato Simponi.
Operazioni o procedure odontoiatriche

Informi il medico se dovrà essere sottoposto a eventuali operazioni o procedure odontoiatriche.
Informi il chirurgo o il dentista che esegue la procedura che è in trattamento con Simponi, mostrando la Scheda di Promemoria per il Paziente.

Malattie autoimmuni
Informi il medico se sviluppa i sintomi di una malattia chiamata lupus. I sintomi comprendono
eruzione cutanea persistente, febbre, dolore alle articolazioni e stanchezza.

In rare occasioni, le persone trattate con i bloccanti del TNF hanno sviluppato lupus.

Malattie del sangue
In alcuni pazienti il corpo può non produrre a sufficienza cellule del sangue che aiutano il corpo a
lottare contro le infezioni o aiutano a smettere di sanguinare. Se dovesse avere febbre persistente di cui
non capisce l’origine, lividi o sanguinare facilmente o essere molto pallido, chiami immediatamente il
medico. Il medico può decidere di interrompere il trattamento.
Se non è sicuro che una qualsiasi delle condizioni citate in precedenza possano riguardarla, ne parli
con il medico o il farmacista prima di usare Simponi.
Vaccinazioni
Informi il medico se è stato recentemente vaccinato o se ha in programma di essere vaccinato.

Non deve ricevere determinati vaccini (vivi) mentre è in trattamento con Simponi.
Alcune vaccinazioni possono causare infezioni. Se ha ricevuto Simponi mentre era in gravidanza, il bambino può avere un maggior rischio di contrarre tale infezione per approssimativamente sei mesi dopo l’ultima dose ricevuta durante la gravidanza. È importante dire al pediatra e agli altri operatori sanitari dell’uso di Simponi in modo che possano decidere quando il bambino debba ricevere qualsiasi vaccino.

Si rivolga al medico del bambino per quanto riguarda le vaccinazioni per il bambino. Se possibile, il
bambino deve essere in regola con tutte le vaccinazioni prima di usare Simponi.
Agenti infettivi terapeutici
Si rivolga al medico se ha recentemente assunto o ha in programma di assumere un trattamento con un
agente terapeutico infettivo (come l’instillazione di BCG usata per il trattamento del cancro).
Reazioni allergiche
Informi immediatamente il medico se sviluppa i sintomi di una reazione allergica dopo il trattamento
con Simponi. I sintomi di una reazione allergica possono comprendere gonfiore del viso, delle labbra,
della bocca o della gola che possono causare difficoltà nella deglutizione o nella respirazione, eruzione
cutanea, orticaria, gonfiore di mani, piedi e caviglie.

Alcune di queste reazioni possono essere gravi o, raramente, pericolose per la vita.
Alcune di queste reazioni si sono verificate dopo la prima somministrazione di Simponi.

Bambini
Simponi non è raccomandato per i bambini al di sotto dei 2 anni di età affetti da artrite idiopatica
giovanile poliarticolare poiché non è stato studiato in questa popolazione.

Altri medicinali e Simponi

Informi il medico o il farmacista se sta assumendo, ha recentemente assunto o potrebbe assumere qualsiasi altro medicinale, compreso qualsiasi altro medicinale per trattare l’artrite idiopatica giovanile poliarticolare.
Non deve assumere Simponi con medicinali contenenti il principio attivo anakinra o abatacept. Questi medicinali sono utilizzati per il trattamento di malattie reumatiche.
Informi il medico o il farmacista se sta assumendo qualsiasi altro medicinale che agisce sul sistema immunitario.
Non deve ricevere determinati vaccini (vivi) mentre è in trattamento con Simponi.

Se non è sicuro che una qualsiasi delle condizioni citate in precedenza possano riguardarla, ne parli
con il medico o il farmacista prima di usare Simponi.

Gravidanza e allattamento
Parli con il medico prima di usare Simponi se:

È in corso una gravidanza o sta pianificando una gravidanza durante l’uso di Simponi. Sono disponibili informazioni limitate sugli effetti di questo medicinale nelle donne in gravidanza. Se deve essere trattata con Simponi, deve evitare una gravidanza utilizzando un adeguato metodo contraccettivo durante il trattamento e per almeno 6 mesi dopo l’ultima iniezione di Simponi. Simponi deve essere usato durante la gravidanza solo se strettamente necessario per lei.
Prima di allattare al seno, l’ultimo trattamento con Simponi deve risalire ad almeno 6 mesi prima. Deve interrompere l’allattamento al seno se deve esserle somministrato Simponi.
Se ha ricevuto Simponi durante la gravidanza, il bambino può avere un maggior rischio di contrarre un’infezione. È importante dire al pediatra e agli altri operatori sanitari dell’uso di Simponi prima che il bambino riceva qualsiasi vaccino (per maggiori informazioni vedere il paragrafo sulle vaccinazioni). Se è in corso una gravidanza, se sospetta o sta pianificando una gravidanza, o se sta allattando con latte materno chieda consiglio al medico o al farmacista prima di prendere questo medicinale.

Guida di veicoli e utilizzo di macchinari
Simponi altera lievemente la capacità di andare in bicicletta e di guidare e di usare strumenti o
macchinari. Dopo l’uso di Simponi, tuttavia si possono verificare capogiri. In questo caso, non vada in
bicicletta, non guidi, né usi strumenti o macchinari.

Simponi contiene lattice e sorbitolo
Sensibilità al lattice
Una parte della penna preriempita, il cappuccio che copre l’ago, contiene lattice. Poiché il lattice può
causare reazioni allergiche gravi, informi il medico prima di usare Simponi, se lei o chi la assiste è
allergico al lattice.
Intolleranza al sorbitolo
Questo medicinale contiene 18,45 mg di sorbitolo (E420) in ciascuna penna preriempita. Ogni
0,05 mL di medicinale contiene 2,05 mg di sorbitolo (E420).

3. How to use Simponi

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any
doubts, consult your doctor or pharmacist.

How much Simponi is administered
Polyarticular juvenile idiopathic arthritis in children aged 2 years or older:

Children with a weight less than 40 kg: The recommended dose of Simponi in children weighing less than 40 kg depends on weight and height. Your doctor will tell you the correct dose to use. The dose should be administered once a month, on the same day each month.
Children with a weight of at least 40 kg: For children with a body weight of at least 40 kg, a prefilled pen or a prefilled fixed-dose syringe of 50 mg is available. For the 50 mg dose, see section 3 “How

prefilled.

Consult your doctor before taking the fourth dose. The doctor will decide whether you should continue treatment with Simponi.

How Simponi is administered

Simponi is administered by injection under the skin (subcutaneously).
Initially, the doctor or nurse will inject Simponi. However, you and your doctor can decide that you can inject Simponi yourself or that you can inject it into the child. In this case, you will be instructed on how to inject Simponi. Talk to your doctor if you have any questions about self-administration of an injection. At the end of

If you use more Simponi than you should
If you have used or have been given too much Simponi (injecting too much in a single
administration or using it too often), inform your doctor or pharmacist immediately. Bring

If you forget to use Simponi
If you forget to use Simponi on the scheduled day, inject the forgotten dose as soon as you
remember.
Do not use a double dose to make up for the forgotten dose.
When to inject the next dose:

If the delay is less than 2 weeks, inject the forgotten dose as soon as you remember and continue to follow the original schedule.
If the delay is more than 2 weeks, inject the forgotten dose as soon as you remember and inform your doctor or pharmacist and ask when you should take the next dose.

If you have any doubts about what to do, consult your doctor or pharmacist.

If you stop taking Simponi
If you are considering stopping treatment with Simponi, consult your doctor or
pharmacist first.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some patients may experience serious side effects that may require medical treatment. Side effects may also occur even several months after the last injection.
Tell your doctor immediately if you notice any of the following serious side effects of
Simponi, which include:

allergic reactions that can be severe, or rarely, potentially life-threatening (rare).Symptoms of an allergic reaction can include swelling of the face, lips, mouth or throat which can cause difficulty swallowing or breathing, skin rash, hives, swelling of hands, feet and ankles. Some of these reactions have occurred after the first administration of Simponi.
serious infections (including TB, bacterial infections including serious blood infections andpneumonia, serious fungal infections and other opportunistic infections) (common).Symptoms of an infection can include fever, fatigue, cough (persistent), shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhea, sores, dental problems and a burning sensation when urinating.
reactivation of hepatitis B virus if you are a carrier or have had hepatitis Bbefore (rare).Symptoms can include yellowing of the skin and eyes, dark brown urine, pain in the upper right abdomen, fever, feeling unwell, malaise and extreme fatigue.
disease of the nervous system such as multiple sclerosis (rare).Symptoms of the nervous system disease can include changes in vision, weakness of arms or legs, numbness or tingling in any part of the body.
cancer of the lymph nodes (lymphoma) (rare).Symptoms of lymphoma can include swollen lymph nodes, weight loss or fever.
heart failure (rare).Symptoms of heart failure can include shortness of breath or swelling of the feet.
signs of immune system disorders called:
lupus (rare).Symptoms can include joint pain or a rash on cheeks or arms that is sensitive to the sun.
sarcoidosis (rare).Symptoms can include a persistent cough, shortness of breath, chest pain, fever, swollen lymph nodes, weight loss, skin rashes and blurred vision.
swelling of small blood vessels (vasculitis) (rare).Symptoms can include fever, headache, weight loss, night sweats, rash and nerve problems such as numbness and tingling.
skin cancer (uncommon).Symptoms of skin cancer can include changes in the appearance of the skin or growths on the skin.
blood disease (common).Symptoms of blood disease can include a fever that does not go away, a tendency to bruise easily or bleeding or very pale appearance.
blood cancer (leukemia) (rare).Symptoms of leukemia can include fever, feeling tired, frequent infections, bruising and night sweats.

Tell your doctor immediately if you notice any of the symptoms listed above.

The following additional side effects have been observed with Simponi:
Very common side effects (may affect more than 1 in 10 people):

Upper respiratory tract infections, sore throat or hoarseness, common cold

Common side effects (may affect up to 1 in 10 people):

Abnormal liver tests (increased liver enzymes), found during blood tests performed by your doctor
Feeling dizzy
Headache
Feeling of numbness or tingling
Superficial fungal infections
Abscess
Bacterial infections (such as cellulitis)
Reduced red blood cells
Reduced white blood cells
Positive blood test for lupus
Allergic reactions
Indigestion
Stomach pain
Feeling sick (nausea)
Flu
Bronchitis
Sinus infection
Cold sores
High blood pressure
Fever
Asthma, shortness of breath, wheezing
Stomach and intestinal disorders including inflammation of the lining of the stomach and colon that can cause fever
Pain and ulcers in the mouth
Injection site reactions (including redness, hardening, pain, bruising, itching, tingling and irritation)
Hair loss
Skin rash and itchy skin
Difficulty sleeping
Depression
Feeling weak
Bone fractures
Chest pain

Uncommon side effects (may affect up to 1 in 100 people):

Kidney infection
Cancer, including skin cancer and non-cancerous tumors or small masses, including moles
Blisters
Serious infection throughout the body (sepsis), which sometimes includes low blood pressure (septic shock)
Psoriasis (including that of palms of hands and/or soles of feet and/or in the form of skin blisters)
Reduced platelets
Combined reduction of platelets, red blood cells and white blood cells
Thyroid disorders
Increased blood sugar levels
Increases in blood cholesterol levels
Balance disorders
Vision disorders
Inflamed eye (conjunctivitis)
Eye allergy
Feeling of irregular heartbeat
Narrowing of blood vessels in the heart
Blood clots
Flushing
Constipation
Chronic inflammation of the lungs
Acid reflux
Gallstones
Liver disorders
Breast disorders
Menstrual disorders

Rare side effects (may affect up to 1 in 1,000 people):

Inability of the bone marrow to produce blood cells
Severe reduction in the number of white blood cells
Infection of the joints or surrounding tissues
Difficulty healing
Inflammation of blood vessels in internal organs
Leukemia
Melanoma (a type of skin cancer)
Merkel cell carcinoma (a type of skin cancer)
Lichenoid reactions (itchy purple-reddish rash and/or whitish-gray filamentous lines on mucous membranes)
Skin peeling
Immune disorders that can affect the lungs, skin and lymph nodes (most commonly present as sarcoidosis)
Pain and discoloration in the fingers of the hand or foot
Taste disorders
Bladder disorders
Kidney disorders
Inflammation of the blood vessels in the skin causing rash

Side effects with unknown frequency:

A rare cancer of the blood that mainly affects young people (T-cell hepatosplenic lymphoma)
Kaposi’s sarcoma, a rare form of cancer related to human herpes virus 8 infection. Kaposi’s sarcoma most commonly manifests with purple lesions on the skin
Worsening of a condition called dermatomyositis (which manifests as a skin rash associated with muscle weakness)

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side
effects you can help provide more information on the safety of this medicine.

5. How to store Simponi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and on the packaging box after “Exp”. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C-8 °C). Do not freeze.
Keep the pre-filled pen in the outer packaging, to protect the medicine from light.
This medicine can also be stored outside the refrigerator at temperatures up to a maximum of 25 °C for a single period of up to 30 days, but not beyond the original expiry date printed on the packaging box. Write the new expiry date on the packaging box indicating day/month/year (no more than 30 days after the medicine has been removed from the refrigerator). Do not return this medicine to the refrigerator if it has reached room temperature.

Eliminate this medicine if not used by the new expiry date or by the
expiry date printed on the packaging box, if earlier.

Do not use this medicine if you notice that the liquid is not from clear to light yellow in colour, appears cloudy, or contains foreign particles.
Do not dispose of any medicine in wastewater or household waste. Ask your doctor or pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Simponi contains
The active ingredient is golimumab. One pre-filled pen of 0.45 mL contains 45 mg of golimumab.
1 mL contains 100 mg of golimumab.
The other ingredients are sorbitol (E420), histidine, histidine hydrochloride monohydrate, polysorbate 80 and
water for injections. For more information on sorbitol (E420), see paragraph 2.

Description of the appearance of Simponi and contents of the pack
Simponi is supplied as an injectable solution in a single-use pre-filled pen, VarioJect.
Simponi is available in packs containing 1 pre-filled pen.
The solution is from clear to slightly opalescent (pearlescent), from colourless to pale yellow
and may contain some small translucent or white protein particles. Do not use
Simponi if the solution has changed colour, is cloudy or if it contains visible foreign particles.

Marketing Authorisation Holder and Manufacturer
Janssen Biologics B.V.
Einsteinweg 101
2333 CB Leiden
Netherlands
For further information on this medicinal product, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
MSD Belgium
Tél/Tel: +32(0)27766211
[email protected]

Lietuva
UAB Merck Sharp & Dohme
Tel. + 370 5 278 02 47
[email protected]

България
Мерк Шарп и Доум България ЕООД
Тел.: +359 2 819 3737
[email protected]

Luxembourg/Luxemburg
MSD Belgium
Tél/Tel: (+32(0)27766211)
[email protected]

Česká republika
Merck Sharp & Dohme s.r.o.
Tel: +420 233 010 111
[email protected]

Magyarország
MSD Pharma Hungary Kft.
Tel.: +36 1 888 5300
[email protected]

Danmark
MSD Danmark ApS
Tlf: + 45 4482 4000
[email protected]

Malta
Merck Sharp & Dohme Cyprus Limited
Tel: 8007 4433 (+356 99917558)
[email protected]

Deutschland
MSD Sharp & Dohme GmbH
Tel: 0800 673 673 673 (+49 (0) 89 4561 0)
[email protected]

Nederland
Merck Sharp & Dohme B.V.
Tel: 0800 9999000
(+31 23 5153153)
[email protected]

Eesti
Merck Sharp & Dohme OÜ
Tel.: +372 6144 200
[email protected]

Norge
MSD (Norge) AS
Tlf: +47 32 20 73 00
[email protected]

Ελλάδα
MSD Α.Φ.Β.Ε.Ε.
Τηλ: +30 210 98 97 300
[email protected]

Österreich
Merck Sharp & Dohme Ges.m.b.H.
Tel: +43 (0) 1 26 044
[email protected]

España
Merck Sharp & Dohme de España, S.A.
Tel: +34 91 321 06 00
[email protected]

Polska
MSD Polska Sp. z o.o.
Tel: +48 22 549 51 00
[email protected]

France
MSD France
Tél: + 33 (0) 1 80 46 40 40

Portugal
Merck Sharp & Dohme, Lda
Tel: +351 21 4465700
[email protected]

Hrvatska
Merck Sharp & Dohme d.o.o.
Tel: + 385 1 6611 333
[email protected]

România
Merck Sharp & Dohme Romania S.R.L.
Tel: +40 21 529 29 00
[email protected]

Ireland
Merck Sharp & Dohme Ireland (Human Health)
Limited
Tel: +353 (0)1 2998700
[email protected]

Slovenija
Merck Sharp & Dohme, inovativna zdravila
d.o.o.
Tel: +386 1 5204 201
[email protected]

Ísland
Vistor hf.
Sími: + 354 535 7000

Slovenská republika
Merck Sharp & Dohme, s. r. o.
Tel: +421 2 58282010
[email protected]

Italia
MSD Italia S.r.l.
Tel: 800 23 99 89 (+39 06 361911)
[email protected]

Suomi/Finland
MSD Finland Oy
Puh/Tel: +358 (0)9 804 650
[email protected]

Κύπρος
Merck Sharp & Dohme Cyprus Limited
Τηλ.: 800 00 673 (+357 22866700)
[email protected]

Sverige
Merck Sharp & Dohme (Sweden) AB
Tel: +46 77 5700488
[email protected]

Latvija
SIA Merck Sharp & Dohme Latvija
Tel: + 371 67364224
[email protected]

United Kingdom (Northern Ireland)
Merck Sharp & Dohme Ireland (Human Health)
Limited
Tel: +35312998700
[email protected]
More detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu.

Instructions for use

Simponi 45 mg/0.45 mL

injectable solution in prefilled pen, VarioJect
For pediatric use

SINGLE USE

Blue and white injectable pen with dose indicator 0.45 and graduated scale from 0.1 ml

Know your dose
Write the prescribed dose in the space above.
If you are unsure of the dose, check with your doctor.

Important
If your doctor decides that Simponi injections can be administered at home by you or by someone
assisting you, you must be instructed on how to prepare and inject Simponi correctly.
Read these instructions for use before using the Simponi prefilled pen and each time you
receive a new prefilled pen. There may be new information.
the user”. These instructions do not replace a discussion with your doctor about your illness or your
treatment.
If you have not been instructed or if you have any questions, ask your doctor, nurse or pharmacist.

Stylized white thermometer on a blue background with temperature indication and graduated scale

Storage information
Store in a refrigerator at 2 °C – 8 °C.
It may be stored at room temperature (up to 25 °C) for a single period of up to 30 days,
but without exceeding the original expiration date. Write the new expiration date on the back
of the box indicating day/month/year (no more than 30 days after the medicine has been removed
from the refrigerator). Do not return this medicine to the refrigerator if it has reached
room temperature.

Keep the Simponi prefilled pen and all medicines out of the sight and reach of
children.
General information
The prefilled pen is a manualinjection pen that allows you to set a specific dose
prescribed. Each prefilled pen can deliver from 0.1 mL to 0.45 mL (corresponding to 10 mg - 45 mg
of golimumab) in increments of 0.05 mL.
Before starting to use this prefilled pen, you must have learned how to:

Remove air bubbles
Set the prescribed dose
Manually press the plungerto inject the contents, as with a syringe

The prefilled pen must be used only once. Dispose of the prefilled pen after use.

Do nottry to use any medicine remaining in the prefilled pen.

Do notshare the prefilled pen with others.

Do notshake it.

Stylized white telephone on a blue background with handset and support

Need help?
If you have any questions, ask your doctor, nurse or pharmacist. For further assistance,

Preliminary operations

Rectangular white package with light blue border, viewed in isometric perspective on a light gray background

Inspect the box
Check the expiration date (“Exp.”)printed or written on the back of the box.

Do not use the medicineif the expiration date has passed.

Do not administer the injectionif the perforations on the box are broken. Contact your doctor or pharmacist
to obtain a new prefilled pen.

Stylized clock with vertical hand indicating 12 o'clock on a light blue background and blue circle

Remove the prefilled pen from the box
Leave the prefilled pen at room temperature for at least 30 minutesand out of the reach of
children.

Do not heat itin any other way.

You will need:

1 alcohol swab
1 cotton ballor cotton gauze
1 bandage
1 sharps container(see point 3)

An overview of the pre-filled pen
An overview of the pre-filled pen

Blue and orange injectable pen with viewing window, loading orange band, dose lines, and tip

Orange
loading
band
Dose
lines
Viewing
window
Tip
Thin
needle
hidden

Pre-filled syringe with blue cap, protected orange needle and dose indicator, plunger visible and green text instructions

Cap*
Do notremove it before
indicated in the
instructions.

Orange
needle
guard
Dosage
selection
notchPlunger
IMPORTANT:
Do notpress on the orange needle guard before
the injection, otherwise it will lock and
the dose will not be delivered.

Do notlift the prefilled pen
from the skin during the injection
otherwise the orange needle guard will lock and not
the full dose will be delivered.
*CHOKING HAZARD! Keep out of reach of children.

1. Prepare the injection

Stylized human body with blue highlighting of subcutaneous injection areas on hips, abdomen and thighs

Choose an injection site
Choose one of the following areas for the injection:

Front of the thighs(recommended)
Lower abdomen Do notuse the area within 5 centimeters around the navel.
Outer area of the upper arm (if the injection is performed by someone assisting you) For each injection, choose a different area of the chosen area. Do notinject into areas where the skin is sore, bruised, red, scaly, hardened, or has scars.

Hand applying pressure to the injection site with a cotton swab while

Clean the injection site
Wash your hands thoroughly with soap and warm water.
Rub the injection site with an alcohol-soaked swab and let it dry.

Do nottouch, wave, or blow on the injection site after cleaning it.

White and blue injectable pen with transparent oval window showing the medicinal liquid

Inspect the liquid
Remove the prefilled pen from the box.
Check the liquid in the viewing window. It should appear from clear to slightly
opalescent (pearlescent) and from colorless to light yellow, and may contain some small
translucent or white protein particles. It is also possible that there are one or more air bubbles. This is
normal.

Do notinject if the liquid is the wrong color, cloudy, or if there are large
particles. If you have any doubts, contact your doctor or pharmacist for a new prefilled
pen.

Blue and white injection pen with finger pressing the drug release button

Tap to bring any air bubbles to the surface
Hold the prefilled pen upright with the blue cap facing up.
Gently tap the prefilled pen with your finger near the viewing window. This will cause the air bubbles to rise to the surface.

Hand screwing a blue and orange device onto a white pen injector with blue curved arrow and transparent bottom

Remove the cap
Continue to hold the prefilled pen upright, then rotate the cap to remove it.

IMPORTANT:Do notpress on the orange needle guard before the injection
otherwise it will lock and the dose will not be delivered.

Administer the injection within 5 minutes of removing the cap.
Do notreinsert the cap as it may damage the needle inside the prefilled pen.

Do notuse the prefilled pen if it has fallen without the cap.
Contact your doctor or pharmacist for a new prefilled pen.

Orange injectable pen with triggering band, blue arrow towards

Remove air bubbles*
Continue to hold the prefilled pen upright.
Gently press the plunger upwards with your thumb until it stops. Some liquid will come out. This is
normal.

The orange loading band will disappear.

*Removing air bubbles ensures that the correct dose is delivered.

Once the air bubbles have been removed, you may see a line inside the

viewing window. This is normal.

2. Inject Simponi using the pre-filled pen

Medical device with numerical dosage indications and a blue arrow indicating the direction of insertion

Prefilled syringe with a needle protected by a transparent safety cap

Set the prescribed dose
Rotate the plunger until the line corresponding to the prescribed dose aligns with the dosage selection mark. The pre-filled pen is now ready for use.

Dosage options:
0.1 mL
0.15 mL
0.2 mL
0.25 mL
0.3 mL
0.35 mL
0.4 mL
0.45 mL

Hand holding a self-injectable injection device with the needle pointing downwards and a close-up of the cutaneous injection site

Insert the needle and hold it in place
IMPORTANT:Do notlift the pre-filled pen from the skin during the injection, otherwise the orange needle guard will lock and the full dose will not be administered.

Do notpress the plunger while inserting the needle.
Push and hold the tip of the pre-filled pen against the skin so that the orange guard rises until it stops. You will see some orange.

Hand holding an injection pen with the needle pointing downwards and a close-up of the dosage mechanism

Inject Simponi
Continue to push the pre-filled pen against the skin.
Gently press the plunger until it stops.

If a low dose is set, the plunger will only move a little.
You can check the administered dose by checking the dosage selection mark.

Do notlift the pre-filled pen yet.

Hand holding a blue and white auto-injector pressing the button for

Continue to hold, then lift
Continue to push the pre-filled pen against the skin for about 5 seconds.
It is normal for some medicine to still be visible in the viewing window.
Lift the pre-filled pen from the skin.
The orange needle guard will extend and lock.

3. After the injection

Injection pen with needle near a red container for biological waste with symbol and space for safe disposal

Dispose of the pre-filled pen
Place the used pre-filled pen in a sharps container immediately after use. Ensure
you dispose of the container according to the instructions provided by your doctor or nurse when the
container is full.

Hand holding a cotton ball and pressing it on an injection site on the skin

Check the injection site
There may be a small amount of blood or fluid at the injection site.
Press a cotton ball or gauze pad on the skin until the bleeding stops.

Do notrub the injection site.
If necessary, you can cover the injection site with a bandage. The injection is complete!

Не уверены, подходит ли вам это лекарство?

Обсудите симптомы и варианты лечения с врачом онлайн.

Simponi 50 mg solution for injection in pre-filled pen

golimumab

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful.
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Your doctor will provide you with a Patient Reminder Card, which contains important information
about safety that you should be aware of before and during therapy with Simponi.

Contents of this leaflet

1. What Simponi is and what it is used for
2. What you need to know before you use Simponi
3. How to use Simponi
4. Possible side effects
5. How to store Simponi
6. Contents of the pack and other information

1. What is Simponi and what is it used for

Simponi contains an active substance called golimumab.
Simponi belongs to a group of medicines called “TNF blockers”. It is used in adults
for the treatment of the following inflammatory diseases:

Rheumatoid arthritis
Psoriatic arthritis
Axial spondyloarthritis, including ankylosing spondylitis and non-radiographic axial spondyloarthritis
Ulcerative colitis

In childrenaged 2 years and older, Simponi is used for the treatment of polyarticular juvenile idiopathic arthritis.
Simponi works by blocking the action of a protein called “tumor necrosis factor alpha”
(TNF-α). This protein is involved in the inflammatory processes of the body and by blocking it is
possible to reduce inflammation in the body.

Rheumatoid arthritis
Rheumatoid arthritis is an inflammatory disease of the joints. If you suffer from active rheumatoid arthritis,
you will initially be treated with other medicines. If you do not respond adequately to
these medicines, you will be treated with Simponi in combination with another medicine called
methotrexate for:

Reducing the signs and symptoms of the disease.
Slowing down damage to bones and joints.
Improving physical function.

Psoriatic arthritis
Psoriatic arthritis is an inflammatory disease of the joints, usually accompanied by
psoriasis, an inflammatory skin disease. If you suffer from active psoriatic arthritis, you will be treated first
with other medicines. If you do not respond adequately to these medicines, you will be treated with
Simponi for:

Reducing the signs and symptoms of the disease.
Slowing down damage to bones and joints.
Improving physical function.

Ankylosing spondylitis and non-radiographic axial spondyloarthritis
Ankylosing spondylitis and non-radiographic axial spondyloarthritis are inflammatory diseases
of the spine. If you suffer from ankylosing spondylitis or non-radiographic axial spondyloarthritis,
you will be treated first with other medicines. If you do not respond adequately to
these medicines, you will be treated with Simponi for:

Reducing the signs and symptoms of the disease.
Improving physical function.

Ulcerative Colitis
Ulcerative colitis is an inflammatory disease of the intestine. If you have ulcerative colitis, you will be
given other medicines first. If you do not respond adequately to these medicines, you will
be given Simponi to treat your disease.

Polyarticular juvenile idiopathic arthritis
Polyarticular juvenile idiopathic arthritis is an inflammatory disease that causes pain and swelling
in the joints in children. If you have polyarticular juvenile idiopathic arthritis, you will be given other
medicines first. If you do not respond adequately to these medicines, you will be given Simponi
in combination with methotrexate to treat the disease.

2. Cosa deve sapere prima di usare Simponi

Non usi Simponi

Se è allergico (ipersensibile) a golimumab o ad uno qualsiasi degli altri componenti di questo medicinale (elencati al paragrafo 6).
Se ha la tubercolosi (TB) o qualsiasi altra infezione grave.
Se ha un’insufficienza cardiaca moderata o grave.

Se non è sicuro che una qualsiasi delle condizioni citate in precedenza possano riguardarla, ne parli
con il medico, con il farmacista o con l’infermiere prima di usare Simponi.

Può contrarre infezioni più facilmente quando usa Simponi.
Le infezioni possono progredire più rapidamente ed essere più gravi. Inoltre, possono ripresentarsi infezioni contratte in passato.

Sono stati segnalati alcuni casi di TB in pazienti trattati con Simponi, in rare occasioni perfino in pazienti che sono stati trattati con medicinali per la TB. Il medico eseguirà degli esami per valutare se ha la TB. Il medico registrerà questi esami sulla Scheda di Promemoria per il Paziente.
È molto importante che riferisca al medico se in passato ha avuto la TB, o se è venuto in stretto contatto con qualcuno che ha o ha avuto la TB.
Se il medico ritiene che lei sia a rischio di TB, è possibile che venga trattato con medicinali per la TB prima che le sia somministrato Simponi.

Virus dell’epatite B (HBV)

Informi il medico se è un portatore o ha o ha avuto l’epatite B, prima che le sia somministrato Simponi
Informi il medico se crede di poter essere a rischio di contrarre l’epatite B
Il medico deve eseguire degli esami per valutare se ha l’epatite B
Il trattamento con i bloccanti del TNF come Simponi può causare la riattivazione del virus dell’epatite B nei pazienti portatori di questo virus, che in alcuni casi può causare la morte.

Infezioni invasive da funghi
Informi immediatamente il medico se ha vissuto o viaggiato in un’area dove sono comuni le
infezioni causate da specifici tipi di funghi che possono colpire i polmoni o altre parti del corpo
(chiamate istoplasmosi, coccidioidomicosi, o blastomicosi). Chieda al medico se non sa se
queste infezioni fungine sono comuni nell’area in cui ha vissuto o viaggiato.
Tumore e linfoma
Informi il medico se ha o ha mai avuto un linfoma (un tipo di tumore del sangue) o altri tipi di tumore,
prima che le sia somministrato Simponi.

Se usa Simponi o altri bloccanti del TNF può aumentare il rischio di sviluppo di un linfoma o di un altro tipo di tumore.
I pazienti con artrite reumatoide grave o altre malattie infiammatorie, che hanno sofferto di questa malattia per molto tempo, possono presentare un rischio di sviluppo di linfoma maggiore della media.
Nei pazienti bambini e adolescenti che hanno assunto medicinali bloccanti del TNF, sono stati segnalati casi di tumori, compresi quelli di tipo inusuale, qualche volta mortali.
In rare occasioni, uno specifico e grave tipo di linfoma chiamato linfoma epatosplenico a cellule T è stato osservato in pazienti che assumevano altri bloccanti del TNF. La maggior parte di questi pazienti erano adolescenti o giovani adulti di sesso maschile. Questo tipo di tumore ha portato solitamente alla morte. Quasi tutti questi pazienti avevano ricevuto anche medicinali conosciuti come azatioprina o 6-mercaptopurina. Informi il medico se sta prendendo azatioprina o 6-mercaptopurina con Simponi.
Pazienti con grave asma persistente, malattia polmonare cronica ostruttiva (BPCO), o assidui fumatori possono avere un aumentato rischio di cancro con il trattamento con Simponi. Se ha asma grave persistente, BPCO o è un assiduo fumatore, deve discutere con il medico se il trattamento con un bloccante del TNF è appropriato.
Alcuni pazienti trattati con golimumab hanno sviluppato alcuni tipi di cancro della pelle. Se si manifesta qualsiasi tipo di variazione di aspetto della pelle o escrescenze sulla pelle durante o dopo la terapia, informi il medico.

Con i bloccanti del TNF, compreso Simponi, sono stati segnalati casi di insufficienza cardiaca congestizia di nuova insorgenza o un suo peggioramento. Alcuni di questi pazienti sono morti.
Se ha insufficienza cardiaca lieve ed è trattato con Simponi, il medico la terrà strettamente monitorato.

Informi il medico se dovrà essere sottoposto a eventuali operazioni o procedure odontoiatriche.
Informi il chirurgo o il dentista che esegue la procedura che è in trattamento con Simponi, mostrando la Scheda di Promemoria per il Paziente.

Malattie autoimmuni
Informi il medico se sviluppa i sintomi di una malattia chiamata lupus. I sintomi comprendono
eruzione cutanea persistente, febbre, dolore alle articolazioni e stanchezza.

In rare occasioni, le persone trattate con i bloccanti del TNF hanno sviluppato lupus.

Non deve ricevere determinati vaccini (vivi) mentre è in trattamento con Simponi.
Alcune vaccinazioni possono causare infezioni. Se ha ricevuto Simponi mentre era in gravidanza, il bambino può avere un maggior rischio di contrarre tale infezione per approssimativamente sei mesi dopo l’ultima dose ricevuta durante la gravidanza. È importante dire al pediatra ed agli altri operatori sanitari dell’uso di Simponi in modo che possano decidere quando il bambino debba ricevere qualsiasi vaccino.

Alcune di queste reazioni possono essere gravi o, raramente, pericolose per la vita.
Alcune di queste reazioni si sono verificate dopo la prima somministrazione di Simponi.

Bambini
Simponi non è raccomandato per i bambini al di sotto dei 2 anni affetti da artrite idiopatica giovanile
poliarticolare poiché non è stato studiato in questa popolazione.

Altri medicinali e Simponi

Informi il medico o il farmacista se sta assumendo, ha recentemente assunto o potrebbe assumere qualsiasi altro medicinale, compreso qualsiasi altro medicinale per trattare l’artrite reumatoide, l’artrite idiopatica giovanile poliarticolare, l’artrite psoriasica, la spondilite anchilosante, la spondiloartrite assiale non radiografica o la colite ulcerosa.
Non deve assumere Simponi con medicinali contenenti il principio attivo anakinra o abatacept. Questi medicinali sono utilizzati per il trattamento di malattie reumatiche.
Informi il medico o il farmacista se sta assumendo qualsiasi altro medicinale che agisce sul sistema immunitario.
Non può essere trattato con certi vaccini (vivi) mentre usa Simponi.

Se non è sicuro che una qualsiasi delle condizioni citate in precedenza possano riguardarla, ne parli
con il medico o il farmacista prima di usare Simponi.

Gravidanza e allattamento
Parli con il medico prima di usare Simponi se:

È in corso una gravidanza o sta pianificando una gravidanza durante l’uso di Simponi. Sono disponibili informazioni limitate sugli effetti di questo medicinale nelle donne in gravidanza. Se deve essere trattata con Simponi, deve evitare una gravidanza utilizzando un adeguato metodo contraccettivo durante il trattamento e per almeno 6 mesi dopo l’ultima iniezione di Simponi. Simponi deve essere usato durante la gravidanza solo se strettamente necessario per lei.
Prima di allattare al seno, l’ultimo trattamento con Simponi deve risalire ad almeno 6 mesi prima. Deve interrompere l’allattamento al seno, se deve esserle somministrato Simponi.
Se ha ricevuto Simponi durante la gravidanza, il bambino può avere un maggior rischio di contrarre un’infezione. È importante dire al pediatra ed agli altri operatori sanitari dell’uso di Simponi prima che il bambino riceva qualsiasi vaccino (per maggiori informazioni vedere il paragrafo sulle vaccinazioni). Se è in corso una gravidanza, se sospetta o sta pianificando una gravidanza, o se sta allattando con latte materno chieda consiglio al medico o al farmacista prima di prendere questo medicinale.

Guida di veicoli e utilizzo di macchinari
Simponi altera lievemente la capacità di guidare e di usare strumenti o macchinari. Dopo l’uso di
Simponi, tuttavia si possono verificare dei capogiri. In questo caso, non guidi, né usi strumenti o
macchinari.

Simponi contiene lattice e sorbitolo
Sensibilità al lattice
Una parte della penna preriempita, il cappuccio che copre l’ago, contiene lattice. Poiché il lattice può
causare reazioni allergiche gravi, informi il medico prima di usare Simponi, se lei o chi la assiste è
allergico al lattice.
Intolleranza al sorbitolo
Questo medicinale contiene 20,5 mg di sorbitolo (E420) in ogni penna preriempita.

3. How to use Simponi

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.

How much Simponi is administered
Rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis, including ankylosing spondylitis and
non-radiographic axial spondyloarthritis:

The recommended dose is 50 mg (the content of 1 pre-filled pen) administered once a month, on the same day each month.
Consult your doctor before taking the fourth dose. Your doctor will decide whether you should continue treatment with Simponi. Or if you weigh more than 100 kg, the dose may be increased to 100 mg (the content of 2 pre-filled pens), administered once a month, always on the same day each month.

Juvenile idiopathic polyarticular arthritis in children aged 2 years or older:

For patients weighing at least 40 kg, the recommended dose is 50 mg administered once a month, on the same day each month. For patients weighing less than 40 kg, a

45 mg/0.45 mL pre-filled pen is available. Your doctor will tell you the correct dose to
use.

Consult your doctor before taking the fourth dose. Your doctor will decide whether you should continue treatment with Simponi.

Ulcerative colitis

The following table shows how you will generally use this medicine.

Initial treatment

m An initial dose of 200 mg (the content of 4 pre-filled pens) followed by 100 mg (the content of 2 pre-filled pens) after 2 weeks.

Maintenance treatment

In patients weighing less than 80 kg, 50 mg (the content of 1 pre-filled pen) 4 weeks after your last treatment, then subsequently every 4 weeks. The doctor may decide to prescribe 100 mg (the content of 2 pre-filled pens), based on the effect that Simponi has on you.
In patients weighing 80 kg or more, 100 mg (the content of 2 pre-filled pens) 4 weeks after your last treatment, then subsequently every 4 weeks.

How Simponi is administered

Simponi is administered by injection under the skin (subcutaneously).
Initially, the doctor or nurse will inject Simponi for you. However, you and your doctor may decide that you can inject Simponi yourself or that you can inject it into the child. In this case, you will be instructed on how to inject Simponi. Talk to your doctor if you have any questions about self-administration of an injection. At the end of

If you use more Simponi than you should
If you have used or have been given too much Simponi (injecting too much in a single
administration, or using it too often), inform your doctor or pharmacist immediately.

If you forget to use Simponi
If you forget to use Simponi on the scheduled day, inject the forgotten dose as soon as you
remember.
Do not use a double dose to make up for the missed dose.
When to inject the next dose:

If the delay is less than 2 weeks, inject the forgotten dose as soon as you remember and continue to follow the original schedule.
If the delay is more than 2 weeks, inject the forgotten dose as soon as you remember and inform your doctor or pharmacist and ask when you should take the next dose.

If you have any doubts about what to do, consult your doctor or pharmacist.

If you stop taking Simponi
If you are considering stopping treatment with Simponi, consult your
doctor or pharmacist first.
If you have any doubts about using this medicine, consult your doctor, pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Some patients may experience serious side effects that may require medical treatment. The risk of some side effects is higher with the dose of
100 mg compared to the dose of 50 mg. Side effects may also occur even after
several months after the last injection.
Tell your doctor immediately if you notice any of the following serious side effects of
Simponi, which include:

allergic reactions that can be severe, or rarely, potentially life-threatening (rare).Symptoms of an allergic reaction may include swelling of the face, lips, mouth or throat that can cause difficulty swallowing or breathing, rash, hives, swelling of hands, feet or ankles. Some of these reactions have occurred after the first administration of Simponi.
serious infections (including TB, bacterial infections including serious blood infections andpneumonia, serious fungal infections and other opportunistic infections) (common).Symptoms of an infection may include fever, fatigue, cough (persistent), shortness of breath, flu-like symptoms, weight loss, night sweats, diarrhea, wounds, dental problems and a burning sensation when urinating.
reactivation of the hepatitis B virus if you are a carrier or have had hepatitis Bbefore (rare).Symptoms may include yellowing of the skin and eyes, dark brown urine, pain in the right side of the abdomen, fever, feeling unwell, malaise and severe fatigue.
disease of the nervous system such as multiple sclerosis (rare).Symptoms of the nervous system disease may include changes in vision, weakness of arms or legs, numbness or tingling in any part of the body.
lymph node cancer (lymphoma) (rare).Symptoms of lymphoma may include swollen lymph nodes, weight loss, or fever.
heart failure (rare).Symptoms of heart failure may include shortness of breath or swelling of the feet.
signs of immune system disorders called:
lupus (rare).Symptoms may include joint pain or a rash on cheeks or arms that is sensitive to sunlight.
sarcoidosis (rare).Symptoms may include a persistent cough, shortness of breath, chest pain, fever, swollen lymph nodes, weight loss, skin rashes and blurred vision.
swelling of small blood vessels (vasculitis) (rare).Symptoms may include fever, headache, weight loss, night sweats, rash and nerve problems such as numbness and tingling.
skin cancer (uncommon).Symptoms of skin cancer may include changes in the appearance of the skin or growths on the skin.
blood disease (common).Symptoms of blood disease may include a fever that does not go away, a strong tendency to develop bruises or bleeding or a very pale appearance.
blood cancer (leukemia) (rare).Symptoms of leukemia may include fever, feeling tired, frequent infections, bruising and night sweats.

Tell your doctor immediately if you notice any of the symptoms listed above.

The following additional side effects have been observed with Simponi:
Very common side effects (may affect more than 1 in 10 people):

Upper respiratory tract infections, sore throat or hoarseness, common cold

Common side effects (may affect up to 1 in 10 people):

Abnormal liver tests (increased liver enzymes), found during blood tests performed by the doctor
Feeling dizzy
Headache
Feeling of numbness or tingling
Superficial fungal infections
Abscess
Bacterial infections (such as cellulitis)
Decreased red blood cells
Decreased white blood cells
Positive blood test for lupus
Allergic reactions
Indigestion
Stomach pain
Feeling sick (nausea)
Flu
Bronchitis
Sinus infection
Facial herpes
High blood pressure
Fever
Asthma, shortness of breath, wheezing
Stomach and intestinal disorders including inflammation of the inside of the stomach and colon that can cause fever
Pain and ulcers in the mouth
Injection site reactions (including redness, hardening, pain, bruising, itching, tingling and irritation)
Hair loss
Skin rash and itching
Difficulty sleeping
Depression
Feeling weak
Bone fractures
Chest pain

Uncommon side effects (may affect up to 1 in 100 people):

Kidney infection
Cancer, including skin cancer and non-cancerous tumors or small masses, including moles
Blisters on the skin
Severe infection throughout the body (sepsis), which sometimes includes low blood pressure (septic shock)
Psoriasis (including that of palms of hands and/or soles of feet and/or in the form of skin blisters)
Decreased platelets
Combined decrease of platelets, red blood cells and white blood cells
Thyroid disorders
Increased blood sugar levels
Increased blood cholesterol levels
Balance disorders
Vision disorders
Inflamed eye (conjunctivitis)
Eye allergy
Feeling of irregular heartbeat
Narrowing of blood vessels in the heart
Blood clots
Flushing
Constipation
Chronic inflammation of the lungs
Acid reflux
Gallstones
Liver disorders
Breast disorders
Menstrual disorders

Rare side effects (may affect up to 1 in 1,000 people):

Inability of the bone marrow to produce blood cells
Severe decrease in the number of white blood cells
Infection of the joints or surrounding tissues
Difficulty healing
Inflammation of blood vessels in internal organs
Leukemia
Melanoma (a type of skin cancer)
Merkel cell carcinoma (a type of skin cancer)
Lichenoid reactions (itchy purple-reddish rash and/or whitish-gray filamentous lines on mucous membranes)
Skin peeling
Immune disorders that can affect the lungs, skin and lymph nodes (most commonly present as sarcoidosis)
Pain and discoloration in the fingers of the hand or foot
Taste disorders
Bladder disorders
Kidney disorders
Inflammation of blood vessels in the skin causing rash

Side effects with unknown frequency:

A rare cancer of the blood that mainly affects young people (T-cell hepatosplenic lymphoma)
Kaposi's sarcoma, a rare form of cancer related to human herpes virus 8 infection. Kaposi's sarcoma most commonly manifests with purple lesions on the skin
Worsening of a condition called dermatomyositis (which manifests as a rash associated with muscle weakness)

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet. You can also report side effects directly
through the national reporting system listed in Annex V. By reporting side effects you can help
provide more information on the safety of this medicine.

5. How to store Simponi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and the packaging box after “Exp”. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C-8 °C). Do not freeze.
Keep the pre-filled pen in the outer packaging, to protect the medicine from light.
This medicine can also be stored outside the refrigerator at temperatures up to a maximum of 25 °C for a single period of up to 30 days, but not beyond the expiry date

originally printed on the packaging box. Write the new expiry date on the packaging box indicating
day/month/year (no more than 30 days after the medicine has been removed from the refrigerator).
Do not return this medicine to the refrigerator if it has reached room temperature.
Dispose of this medicine if not used by the new expiry date or by the
expiry date printed on the packaging box, if earlier.

Do not use this medicine if you notice that the liquid is not from clear to pale yellow in colour, appears cloudy, or contains foreign particles.
Do not dispose of any medicine in waste water or household waste. Ask your doctor or pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Simponi contains
The active ingredient is golimumab. A pre-filled pen from 0.5 mL contains 50 mg of golimumab.
The other ingredients are sorbitol (E420), histidine, histidine hydrochloride monohydrate, polysorbate 80 and
water for injections. For more information on sorbitol (E420), see paragraph 2.

Description of Simponi and contents of the pack
Simponi is supplied as an injectable solution in a single-use pre-filled pen. Simponi is
available in packs containing 1 pre-filled pen and multi-packs containing 3
(3 packs of 1) pre-filled pens. Not all pack sizes may be marketed.
The solution is from clear to slightly opalescent (pearlescent), from colourless to light yellow
and may contain some small translucent or white protein particles. Do not use
Simponi if the solution has changed colour, is cloudy or if it contains visible foreign particles.

Marketing authorisation holder and manufacturer
Janssen Biologics B.V.
Einsteinweg 101
2333 CB Leiden
Netherlands
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
MSD Belgium
Tél/Tel: +32(0)27766211
[email protected]

Lietuva
UAB Merck Sharp & Dohme
Tel. + 370 5 278 02 47
[email protected]

България
Мерк Шарп и Доум България ЕООД
Тел.: +359 2 819 3737
[email protected]

Luxembourg/Luxemburg
MSD Belgium
Tél/Tel: +32(0)27766211
[email protected]