CIBINQO 50 мг Фильм-coated таблетки

Содержание инструкции

1. Cibinqo 50 mg film-coated tablets, 100 mg film-coated tablets, 200 mg film-coated tablets
   1. What is Cibinqo and what is it used for
   2. What you need to know before taking Cibinqo
   3. How to take Cibinqo
   4. Possible side effects
   5. How to store Cibinqo
   6. Package contents and other information

Cibinqo 50 mg film-coated tablets, 100 mg film-coated tablets, 200 mg film-coated tablets

abrocitinib

Medicinal product subject to additional monitoring. This will allow the rapid identification of
new safety information. You can contribute by reporting any adverse effects
experienced during the use of this medicinal product. See the end of section 4 for
information on how to report adverse effects.

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 or pharmacist.
• 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 any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

information on safety that you need to be aware of. Keep this patient card with you.

Contents of this leaflet

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

1. What is Cibinqo and what is it used for

Cibinqo contains the active substance abrocitinib. It belongs to a group of medicines called
Janus kinase inhibitors, which help to reduce inflammation. It works by reducing the activity of an
enzyme in the body called “Janus kinase”, involved in inflammation.
Cibinqo is used for the treatment of adults and adolescents aged 12 years and over with moderate to severe atopic dermatitis, also known as atopic eczema. By reducing the activity of Janus
kinase enzymes, Cibinqo reduces itching and skin inflammation. This in turn can reduce
sleep disturbances and other consequences of atopic eczema such as anxiety or depression and improves
overall quality of life.

2. What you need to know before taking Cibinqo

Do not take Cibinqo

• if you are allergic to abrocitinib or any of the other ingredients of this medicine (listed in section 6).
• if you have a serious ongoing infection, including tuberculosis.
• if you have severe liver problems.
• if you are pregnant or breastfeeding (see section “Pregnancy, contraception, breastfeeding and fertility”).

Warnings and precautions
Talk to your doctor or pharmacist before and during treatment with Cibinqo if:

• you have an infection or get infections often. Tell your doctor if you develop symptoms such as fever, have sores, feel more tired than usual, or have dental problems, as these can be signs of infection. Cibinqo may reduce the body's ability to fight infections and may worsen an existing infection or increase your chances of getting a new infection. If you have diabetes or are 65 years of age or older, you may be more likely to get infections.
• you have or have had tuberculosis or have been in close contact with someone with tuberculosis. Your doctor will perform tests for tuberculosis before starting treatment with Cibinqo and may repeat the test during treatment.
• you have had a herpes infection (Herpes Zoster) before, as Cibinqo may cause it to reappear. Tell your doctor if you develop a painful rash with blisters, as this may be a sign of Herpes Zoster.
• you have had hepatitis B or hepatitis C before.
• you have recently had or are planning to have a vaccination (immunization); this is because some vaccines (live vaccines) are not recommended during the use of Cibinqo.
• you have previously had blood clots in the veins of your legs (deep vein thrombosis) or in your lungs (pulmonary embolism) or have an increased risk of developing them (for example, if you have recently had major surgery, if you are using hormonal contraceptives/hormone replacement therapy, if you or a close relative have been diagnosed with a blood clotting disorder). Your doctor will discuss with you whether Cibinqo is an appropriate therapy in your case. If you suddenly experience shortness of breath or difficulty breathing, chest pain or pain in the upper back, swelling of a leg or arm, pain or tenderness in the legs, or redness or discoloration of a leg or arm, see your doctor, as these may be signs of blood clots in the veins.
• you have or have had heart problems because your doctor will discuss with you whether Cibinqo is an appropriate therapy in your case.
• you have or have had cancer, smoke or have smoked in the past, because your doctor will discuss with you whether Cibinqo is an appropriate therapy in your case.
• non-melanoma skin cancer has been observed in patients taking Cibinqo. While taking Cibinqo, your doctor may recommend that you have regular skin checks. If new skin lesions appear during or after therapy or if existing lesions change in appearance, tell your doctor.

Further monitoring tests
Your doctor will perform blood tests before and during treatment with Cibinqo and, if necessary,
may modify it.

Children
This medicine is not approved for use in children under 12 years of age as the safety
and benefits of Cibinqo have not yet been established.

Other medicines and Cibinqo
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
In particular, tell your doctor or pharmacist before taking Cibinqo if you are taking
medicines for the treatment of:

• fungal infections (such as fluconazole), depression (such as fluoxetine or fluvoxamine), stroke (such as ticlopidine), as they may increase the side effects of Cibinqo.
• stomach acid reflux (such as antacids, famotidine or omeprazole), as they may reduce the amount of Cibinqo in the blood.
• depression (such as citalopram, clobazam or escitalopram), as Cibinqo may increase their effects.
• type 1 neurofibromatosis (such as selumetinib), as Cibinqo may increase its effects.
• heart failure (such as digoxin) or stroke (such as dabigatran), as Cibinqo may increase their effects.
• seizures (such as S-mefenitoin), as Cibinqo may increase their effects.
• stroke (such as clopidogrel), as Cibinqo may reduce its effects.
• asthma, rheumatoid arthritis or atopic dermatitis (such as biological antibody therapies, medicines that control the body's immune response such as cyclosporine, other Janus kinase inhibitors, such as baricitinib, upadacitinib), as they may increase the risk of side effects.

Your doctor may advise you to avoid using or stop taking Cibinqo if you are taking
medicines for the treatment of:

• tuberculosis (such as rifampicin), seizures or convulsions (such as phenytoin), prostate cancer (such as apalutamide, enzalutamide) or HIV infection (such as efavirenz), as they may reduce the effectiveness of Cibinqo.

If any of the above conditions apply to you or if you have any doubts, ask your doctor or pharmacist
before taking Cibinqo.

Pregnancy, contraception, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.
Contraception in women
If you are a woman of childbearing potential, you must use an effective method of contraception during
treatment with Cibinqo and for at least one month after the last dose of treatment. Your doctor can
advise you on appropriate contraceptive methods.
Pregnancy
Do not use Cibinqo if you are pregnant, think you might be pregnant or are planning to have a baby, as
it may harm the developing baby. Tell your doctor immediately if you become pregnant or
think you might be pregnant during treatment.
Breastfeeding
Do not use Cibinqo while breastfeeding, as it is not known whether this medicine is excreted
in breast milk and has effects on the infant. You and your doctor must decide whether you will breastfeed
or use this medicine.
Fertility
Cibinqo may cause a temporary decrease in fertility in women of childbearing potential. The effect is
reversible after stopping treatment.

Driving and using machines
Cibinqo does not affect the ability to drive vehicles or use machines.

Cibinqo contains lactose monohydrate and sodium
If your doctor has told you that you have an intolerance to some sugars, contact him before taking
this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially
“sodium-free”.
Elderly
Patients aged 65 years or older may be at increased risk of infections, heart attack and some types of cancer. Your doctor may decide that Cibinqo is not the right therapy for you.

3. How to take Cibinqo

Take this medicine exactly as your doctor has told you. If you have any doubts, ask your doctor or pharmacist.
Cibinqo is a tablet to be taken by mouth. It can be used in combination with other medicines
for eczema to be applied to the skin or it can be used alone.
The recommended starting dose for adults and adolescents (12 to 17 years) weighing 59 kg or more is
100 mg or 200 mg once a day, as prescribed by your doctor. Your doctor may
increase or decrease the dose based on the effectiveness of the medicine.
For some patients, a lower starting dose is necessary and your doctor may give you 100 mg once a
day if:

• you are 65 years of age or older;
• you have a certain medical history or condition;
• you are an adolescent (12 to 17 years) weighing between 25 kg and 58 kg. If you have moderate to severe kidney problems or if you are prescribed certain other medicines, the starting dose may be 50 mg or 100 mg once a day. You will receive a starting dose based on your needs, your medical history or your condition; therefore, you should always take this medicine exactly as your doctor has told you.

After starting treatment, your doctor may adjust the dose based on the effectiveness of the medicine
and any side effects. If the medicine is working correctly, the dose may be reduced.
In addition, treatment may be interrupted temporarily or permanently if blood tests
show a low white blood cell or platelet count.
If you have taken Cibinqo for 24 weeks and are not yet showing any signs of improvement, your doctor
may decide to stop treatment permanently.
The tablet must be swallowed whole with water. Do not split, crush or chew the
tablet before swallowing as this may change the amount of medicine that your
body absorbs.
The tablet can be taken independently of meals. If you feel unwell (nausea) during
taking this medicine, it may be helpful to take it with food. To help you remember to
take the medicine, we suggest you take it at the same time each day.

If you take more Cibinqo than you should
If you take more Cibinqo than you should, contact your doctor, as you may experience some of the
side effects described in section 4.

If you forget to take Cibinqo

• If you forget a dose, take it as soon as you remember, unless the next dose is due within 12 hours.
• If less than 12 hours remain until the next dose, do not take the missed dose but take the next dose as scheduled.
• Do not take a double dose to make up for a missed tablet.

If you stop taking Cibinqo
Do not stop taking Cibinqo without talking to your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects
Seek immediate medical attention if you experience signs of:

• Herpes zoster, a painful rash with blisters and fever
• Blood clots in the lungs, legs, or pelvis with symptoms such as a swollen, painful leg, chest pain, or shortness of breath

Other side effects
Very common(may affect more than 1 in 10 people)

• Feeling unwell (nausea)

Common(may affect up to 1 in 10 people)

• Cold sores and other types of herpes simplex infections
• Vomiting
• Stomach pain
• Headache
• Dizziness
• Acne
• Increase in an enzyme called creatine phosphokinase, visible from blood tests

Uncommon(may affect up to 1 in 100 people)

• Pneumonia (lung infection)
• Low platelet count visible from blood tests
• Decreased white blood cell count visible from blood tests (lymphocytes and neutrophils)
• Elevated levels of fats in the blood (cholesterol) visible from blood tests (see section 2 Warnings and precautions)

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

5. How to store Cibinqo

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 carton, the bottle and the
blister after Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Cibinqo contains
The active ingredient is abrocitinib.
Each 50 mg tablet contains 50 mg of abrocitinib.
Each 100 mg tablet contains 100 mg of abrocitinib.
Each 200 mg tablet contains 200 mg of abrocitinib.
The other ingredients are:
Tablet core: microcrystalline cellulose (E460i), anhydrous calcium hydrogen phosphate
(E341ii), sodium starch glycolate, magnesium stearate (E470b).
Film coating: hypromellose (E464), titanium dioxide (E171), lactose monohydrate,
macrogol (E1521), triacetin (E1518), red iron oxide (E172) (see section 2 Cibinqo
contains lactose and sodium).

Description of Cibinqo’s appearance and package contents
Cibinqo 50 mg tablets are oval, pink-colored tablets, approximately 11 mm long and 5 mm wide
with “PFE” imprinted on one side and “ABR 50” on the other.
Cibinqo 100 mg tablets are round, pink-colored tablets, approximately 9 mm in diameter
with “PFE” imprinted on one side and “ABR 100” on the other.
Cibinqo 200 mg tablets are oval, pink-colored tablets, approximately 18 mm long and 8 mm wide
with “PFE” imprinted on one side and “ABR 200” on the other.
The 50 mg, 100 mg and 200 mg tablets are available in polyvinylidene chloride (PVDC) blisters
with an aluminum foil covering or in high-density polyethylene (HDPE) bottles with
a polypropylene closure. Each blister contains 14, 28 or 91 tablets. Each bottle contains 14 or
30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Manufacturer
Pfizer Manufacturing Deutschland GmbH
Mooswaldallee 1
79108 Freiburg Im Breisgau
Germany
For further information on this medicine, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/ Belgien
Luxembourg/Luxemburg
Pfizer NV/SA
Tél/Tel: +32 (0)2 554 62 11

Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje
Tel: + 370 52 51 4000

България
Пфайзер Люксембург САРЛ, Клон България
Тел.: +359 2 970 4333

Magyarország
Pfizer Kft.
Tel.: +36-1-488-37-00

Česká republika
Pfizer, spol. s r.o.
Tel.: +420 283 004 111

Malta
Vivian Corporation Ltd.
Tel: +356 21344610

Danmark
Pfizer ApS
Tlf.: +45 44 20 11 00

Nederland
Pfizer bv
Tel: +31 (0)800 63 34 636

Deutschland
PFIZER PHARMA GmbH
Tel: +49 (0)30 550055-51000

Norge
Pfizer AS
Tlf: +47 67 52 61 00

Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel: +372 666 7500

Österreich
Pfizer Corporation Austria Ges.m.b.H.
Tel: +43 (0)1 521 15-0

Ελλάδα
Pfizer Ελλάς A.E.
Τηλ: +30 210 6785 800

Polska
Pfizer Polska Sp. z o.o.
Tel.:+48 22 335 61 00

España
Pfizer S.L.
Tel: +34 91 490 99 00

Portugal
Laboratórios Pfizer, Lda.
Tel: +351 21 423 5500

France
Pfizer
Tél: +33 (0)1 58 07 34 40

România
Pfizer Romania S.R.L.
Tel: +40 (0) 21 207 28 00

Hrvatska
Pfizer Croatia d.o.o.
Tel: +385 1 3908 777

Slovenija
Pfizer Luxembourg SARL
Pfizer, podružnica za svetovanje s področja
farmacevtske dejavnosti, Ljubljana
Tel: + 386 (0)1 52 11 400

Ireland
Pfizer Healthcare Ireland Unlimited Company
Tel: 1800 633 363 (toll free)
+44 (0)1304 616161

Slovenská republika
Pfizer Luxembourg SARL, organizačná zložka
Tel: + 421 2 3355 5500

Ísland
Icepharma hf.
Sími: +354 540 8000

Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 43 00 40

Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21

Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00

Kύπρος
Pfizer Ελλάς Α.Ε. (Cyprus Branch)
Τηλ: +357 22 817690

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel: + 371 670 35 775

Other sources of information
More detailed information on this medicine is available on the European Medicines Agency website,
https://www.ema.europa.eu .

ANNEX IV
SCIENTIFIC CONCLUSIONS AND JUSTIFICATION FOR VARIATION OF THE TERMS
OF THE MARKETING AUTHORISATION
Scientific conclusions
Taking into account the evaluation of the Pharmacovigilance and Risk Assessment Committee
(PRAC) of the Periodic Safety Update Report (PSUR) for abrocitinib, the PRAC’s scientific
conclusions are as follows:
In light of the available data on neutropenia, two reported cases with positive dechallenge and
rechallenge, as well as two further reports with positive dechallenge, together with data from
clinical studies and data from non-clinical studies in which an effect on neutrophil count was
observed in rats, and the potential class effect, the PRAC concluded that the product information
for abrocitinib should be amended accordingly.
Having examined the PRAC recommendation, the Committee for Human Medicinal Products
(CHMP) agrees with the related overall conclusions and with the justification for the recommendation.

Justification for variation of the terms of the marketing authorisation
Based on the scientific conclusions on abrocitinib, the CHMP considers that the benefit/risk
balance of the medicine(s) containing abrocitinib remains unchanged, subject to the proposed
changes to the product information.
The CHMP recommends the variation of the terms of the marketing authorisation.