XEPLION 25 mg Injectable Suspension

Зміст інструкції

1. Xeplion 25 mg prolonged-release injectable suspension, 50 mg prolonged-release injectable suspension, 75 mg prolonged-release injectable suspension, 100 mg prolonged-release injectable suspension, 150 mg prolonged-release injectable suspension
   1. What is Xeplion and what it is used for
   2. What you need to know before you use Xeplion
   3. How to use Xeplion
   4. Possible side effects
   5. How to store Xeplion
   6. Contents of the pack and other information

Xeplion 25 mg prolonged-release injectable suspension, 50 mg prolonged-release injectable suspension, 75 mg prolonged-release injectable suspension, 100 mg prolonged-release injectable suspension, 150 mg prolonged-release injectable suspension

Paliperidone

Read this leaflet carefully before you start to use 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.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What is Xeplion and what it is used for

Xeplion contains the active ingredient paliperidone, which belongs to the class of antipsychotic medicines
and is used as maintenance treatment for the symptoms of schizophrenia in adult patients
stabilized with paliperidone or risperidone.
If you have shown to respond to paliperidone or risperidone in the past and have mild to
moderate symptoms, your doctor may start treatment with Xeplion without prior stabilization with
paliperidone or risperidone.
Schizophrenia is an illness characterized by “positive” and “negative” symptoms. Positive symptoms refer
to an excess of symptoms that are not normally present. For example, a person with schizophrenia
may hear voices or see things that do not actually exist (called hallucinations), believe things that are not
true (called delusions) or be unusually suspicious of others. Negative symptoms refer to a lack of
behaviours or sensations that are normally present. For example, a person with schizophrenia may have a
tendency to isolate themselves and may not react emotionally or may have difficulty speaking clearly and
logically. People with this illness may also feel depressed, anxious, guilty or tense.
Xeplion can help to relieve the symptoms of your illness and prevent them from recurring.

2. What you need to know before you use Xeplion

Do not use Xeplion

• if you are allergic to paliperidone or to any of the other ingredients of this medicine (listed in section 6).
• if you are allergic to another antipsychotic medicine, including risperidone.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before you use Xeplion.
This medicine has not been studied in elderly patients with dementia. However, elderly patients
with dementia, treated with other similar medicines, may have an increased risk of stroke
or death (see section 4, possible side effects).
All medicines have side effects and some of the side effects of this medicine
can worsen the symptoms of other medical conditions. For this reason, it is important that you discuss
with your doctor any of the following conditions, which may potentially worsen during the
treatment with this medicine:

• if you have Parkinson’s disease
• if you have ever been diagnosed with an illness whose symptoms include high temperature and muscle stiffness (also known as Neuroleptic Malignant Syndrome)
• if you have ever had abnormal movements of the tongue or face (Tardive Dyskinesia)
• if you are aware that you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines)
• if you are diabetic or predisposed to diabetes
• if you have been diagnosed with breast cancer or a tumour of the pituitary gland in the brain
• if you have a heart condition or are taking treatment for a heart condition that tends to lower your blood pressure
• if you have low blood pressure when you stand up or go from a lying position to a sitting position suddenly
• if you suffer from epilepsy
• if you have kidney problems
• if you have liver problems
• if you have a prolonged and/or painful erection
• if you have difficulty controlling your internal body temperature or conditions of excessive heat
• if you have an abnormally high level of the hormone prolactin in your blood or if you have a possible prolactin-dependent tumour
• if you or someone in your family has a history of blood clots (thrombi), because antipsychotics have been associated with the formation of blood clots.

If you have any of these conditions, talk to your doctor so that they can assess whether it is
necessary to adjust the dose or monitor you carefully for a certain period.
Because a dangerously low number of a certain type of white blood cells needed to fight infections in the
blood has been observed very rarely in patients taking this medicine, your doctor may check your white blood cell count.
Even if you have previously tolerated oral paliperidone or oral risperidone, allergic reactions rarely occur
after receiving injections of Xeplion. Contact your doctor immediately if you
develop a rash, swelling of the throat, itching or breathing problems as these may be
signs of a serious allergic reaction.
This medicine can cause an increase in body weight. Significant weight gain
can negatively affect your health. Your doctor should weigh you regularly.
Because diabetes mellitus or worsening of pre-existing diabetes mellitus has been observed in patients who are taking this medicine, your doctor should check for high levels
of sugar in your blood. In patients with pre-existing diabetes mellitus, blood glucose levels should be monitored regularly.
Since this medicine may reduce the urge to vomit, there is a possibility that
it may mask the body's normal response to the ingestion of toxic substances or other medical conditions.
During an eye operation for cataracts (clouding of the lens), the pupil (the black circle in the
centre of your eye) may not increase in size as needed. In addition, the iris (the coloured part of the eye) may become floppy during surgery and this can cause damage
to the eye. If you are planning to have an eye operation, make sure to inform
your ophthalmologist that you are taking this medicine.

Children and adolescents
This medicine should not be used in children and adolescents under the age of 18 years.

Other medicines and Xeplion
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
Taking this medicine with carbamazepine (antiepileptic and mood stabilizer) may
require adjustment of the dose of this medicine.
Because this medicine acts mainly on the brain, interference with other medicines that
act on the brain, such as other psychiatric drugs, opioids, antihistamines and sleep disorder medications, can cause an exaggeration of side effects such as drowsiness or other effects on the
brain.
Because this medicine can lower blood pressure, be careful when
this medicine is used with other medicines that lower blood pressure.
This medicine can reduce the effect of medicines used to treat Parkinson’s disease and
restless legs syndrome (e.g., levodopa).
This medicine can cause an abnormality in the electrocardiogram (ECG), characterized by a
longer period for the progression of an electrical impulse through a certain part of the
heart (known as “QT prolongation”). Other medicines that have this effect
include some medicines used to treat heart rhythm or to treat infections and other
antipsychotics.
If you are prone to developing seizures, this medicine may increase the possibility of
experiencing them. Other medicines that have this effect include some medicines used
to treat depression or infections and other antipsychotics.
Xeplion must be used with caution with medicines that increase the activity of the central nervous
system (stimulants such as methylphenidate).

Xeplion and alcohol
Alcohol should be avoided.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. Do not
use this medicine during pregnancy unless you have already discussed this with your
doctor. The following symptoms may occur in newborns of mothers who have used paliperidone
in the last trimester (last three months of pregnancy): tremor, stiffness and/or muscle weakness,
drowsiness, agitation, breathing problems, and difficulty feeding. If the baby presents one
of these symptoms, you may need to contact your doctor.
This medicine can pass from the mother to the child through breast milk and may harm
the child. Therefore, do not breastfeed while using this medicine.

Driving and using machines
Dizziness, extreme fatigue and
vision problems (see section 4) may occur during treatment with this medicine. This should be taken into account in cases where complete
vigilance is required, e.g., when driving a car or using machines.

Xeplion contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose; in practice it is essentially
"sodium-free".

3. How to use Xeplion

This medicine is administered by your doctor or another healthcare professional. Your doctor will determine when you need your next injection. It is important not to miss your scheduled dose. If you believe you will not be able to attend your appointment with the doctor, contact them immediately to arrange a new appointment as soon as possible. You will be given a first injection (150 mg) and a second injection (100 mg) of this medicine in the upper arm approximately one week apart. Afterwards, you will receive an injection (which may vary from 25 mg to 150 mg) either in the upper arm or in the buttock once a month.
If your doctor switches you from long-acting risperidone to this medicine, you will receive the first injection of this medicine (which may vary from 25 mg to 150 mg) either in the upper arm or in the buttock on the date already scheduled for your next injection. Afterwards, you will receive an injection (which may vary from 25 mg to 150 mg) either in the upper arm or in the buttock once a month.
Depending on the symptoms, your doctor may increase or decrease the dose by one level of the medicine you receive at the time of the scheduled monthly injection.

Patients with kidney problems
Your doctor may adjust the dose of the medicine based on kidney function. If you have mild kidney problems, your doctor may prescribe a lower dose. If you have moderate to severe kidney problems, this medicine should not be used.

Elderly
Your doctor may reduce the dose of this medicine if kidney function is reduced.

If you take more Xeplion than you should
This medicine will be administered under medical supervision; therefore, it is unlikely that you will be given an excessive amount.
In patients who have received an overdose of paliperidone, the following symptoms may occur: drowsiness or sedation, increased heart rate, decreased blood pressure, abnormal electrocardiogram (tracing of the heart's electrical activity), or slow or abnormal movements of the face, body, arms or legs.

If you stop using Xeplion
If you stop receiving your injections, you will lose the effects of the medicine. Do not stop using this medicine unless your doctor has instructed you to do so, as your symptoms may return.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Tell your doctor immediately if:

• you think you have blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness in the legs), which can move along the blood vessels to the lungs, causing chest pain and difficulty breathing. If you notice any of these symptoms, consult your doctor immediately.
• you suffer from dementia and notice a sudden change in your mental state or a sudden weakness or numbness of the face, arms or legs, especially on one side, or if your speech is incomprehensible, even for a short period. These may be signs of a stroke.
• you have a fever, muscle stiffness, sweating or reduced level of consciousness (a condition called “Neuroleptic Malignant Syndrome”). Immediate medical treatment may be necessary.
• you are a male and have a prolonged or painful erection. This condition is called priapism. Immediate medical treatment may be necessary.
• you have involuntary rhythmic movements of the tongue, mouth and face. It may be necessary to stop paliperidone.
• you experience a severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, skin rash and sometimes a drop in blood pressure (corresponding to an ‘anaphylactic reaction’). Even if you have previously tolerated oral risperidone or oral paliperidone, allergic reactions rarely occur after receiving paliperidone injections.
• you are planning to undergo eye surgery, be sure to inform your ophthalmologist that you are taking this medicine. During eye surgery for cataract (clouding of the lens), the iris (the colored part of the eye) may become flaccid during the procedure (“iris floppy syndrome”), which can cause eye damage.
• you are aware that you have a dangerously low number of a certain type of white blood cells in your blood needed to fight infections.

The following side effects may occur:

Very common: may affect more than 1 in 10 people

• difficulty falling asleep or staying asleep.

Common: may affect up to 1 in 10 people

• common cold symptoms, urinary tract infection, feeling as if you have the flu
• Xeplion may increase the levels of a hormone called “prolactin” found in a blood test (which may or may not cause symptoms). When symptoms due to a high level of prolactin occur, these may include (in men) breast enlargement, difficulty having or maintaining erections or other sexual dysfunction; (in women) breast discomfort, leakage of milk from the breasts, loss of menstrual periods or other problems with the cycle
• high blood sugar level, weight gain, weight loss, decreased appetite
• agitation, depression, anxiety
• parkinsonism: this condition may include slow or abnormal movements, a feeling of stiffness or tension in the muscles (making movements jerky) and sometimes also a feeling of movement that stops and then restarts. Other signs of Parkinsonism include slow walking with shuffling feet, a resting tremor, increased saliva and/or loss of saliva, and a loss of facial expression
• restlessness, feeling sleepy or drowsy
• dystonia: this is a condition that involves a slow or prolonged involuntary muscle contraction. While it can involve any part of the body (resulting in an abnormal posture), dystonia often involves the muscles of the face, including abnormal movements of the eyes, mouth, tongue or jaw.
• dizziness
• dyskinesia: this is a condition that involves involuntary muscle movements and may include repetitive, jerky or twisting movements, or spasms.
• tremor
• headache
• rapid heart rate
• high blood pressure
• cough, stuffy nose
• abdominal pain, vomiting, nausea, constipation, diarrhea, indigestion, toothache
• increased liver transaminases in the blood
• bone or muscle pain, back pain, joint pain
• loss of menstrual cycle
• fever, weakness, fatigue (tiredness)
• a reaction at the injection site, including itching, pain or swelling.

Uncommon: may affect up to 1 in 100 people

• lung infection, chest infection (bronchitis), respiratory tract infection, sinusitis, bladder infection, ear infection, fungal nail infection, tonsillitis, skin infection
• decreased in white blood cell count, decreased in a certain type of white blood cells in the blood that help protect the body from infections, anemia
• allergic reaction
• diabetes or worsening of diabetes, increased insulin in the blood (a hormone that controls blood sugar levels)
• increased appetite
• loss of appetite with resulting malnutrition and low body weight
• increased triglycerides (a fat) in the blood, increased cholesterol in the blood
• sleep disorders, elevated mood (mania), decreased sexual drive, nervousness, nightmares
• tardive dyskinesia (spasms or jerky movements that you cannot control in the face, tongue or other parts of the body). Contact your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth and face. It may be necessary to discontinue this medicine.
• fainting, an urgent need to move a part of the body, dizziness when getting up, attention disorders, speech problems, loss or abnormal sense of taste, reduced sensitivity of the skin to pain and touch, a sensation of tingling, prickling or numbness of the skin
• blurred vision, eye infection or “slightly red” eye, dry eye
• sensation of spinning (vertigo), ringing in the ears, ear pain
• interruption of the conduction between the upper and lower parts of the heart, abnormal electrical conduction of the heart, prolongation of the QT interval of the heart, rapid heartbeat when getting up, slowed heartbeat, abnormal heart tracing (electrocardiogram or ECG), a sensation of a fast or pounding heartbeat (palpitations)
• low blood pressure, decrease in blood pressure when getting up (as a result, some people taking this medicine may feel faint, dizzy or may faint when getting up or sitting down suddenly)
• shortness of breath, sore throat, nosebleed
• abdominal discomfort, stomach or intestinal infection, difficulty swallowing, dry mouth
• excessive passing of gas or air
• increased GGT in the blood (a liver enzyme called gamma-glutamyltransferase), increased liver enzymes in the blood
• skin rash (or hives), itching, skin rash, hair loss, eczema, dry skin, reddened skin, acne, subcutaneous abscess
• an increase in CPK (creatine phosphokinase) in the blood, an enzyme that is sometimes released when there is muscle damage, muscle spasms, joint stiffness, muscle weakness
• urinary incontinence (loss of control) of urine, frequent urination, pain during urination
• erectile dysfunction, ejaculation disorders, absence of menstruation or other problems with the cycle (females), development of breast tissue in men, sexual dysfunction, breast pain, leakage of milk from the breasts
• swelling of the face, mouth, eyes or lips, swelling of the body, arms or legs
• increased body temperature
• a change in the way you walk
• chest pain, chest discomfort, feeling unwell
• hardening of the skin
• falls.

Rare: may affect up to 1 in 1,000 people

• eye infection
• skin inflammation caused by mites, scaling and itching of the scalp or skin
• increased eosinophils (a type of white blood cells) in your blood
• decreased platelets (blood cells that help stop bleeding)
• tremor of the head
• inappropriate secretion of a hormone that controls urine volume
• sugar in the urine
• complications leading to life-threatening diabetes
• low blood sugar
• excessive intake of water
• absence of movement or responses when awake (catatonia)
• confusion
• sleepwalking
• lack of emotion
• inability to reach orgasm
• neuroleptic malignant syndrome (confusion, reduction or loss of consciousness, high fever and severe muscle stiffness), brain vascular problems including sudden loss of blood supply to the brain (stroke or “mini” stroke), lack of response to stimuli, loss of consciousness, low level of consciousness, seizures (convulsions) balance disorders
• abnormal coordination
• glaucoma (increased pressure inside the eyeball)
• problems with eye movements, rolling of the eyes back in the head, hypersensitivity of the eyes to light, increased tearing, redness of the eyes
• atrial fibrillation (abnormal heart rhythm), irregular heartbeat
• blood clots in the lungs that can cause chest pain and difficulty breathing. If you notice any of these symptoms, contact your doctor immediately
• blood clots in the veins, particularly in the legs (symptoms include swelling, pain and redness in the legs. If you notice any of these symptoms, consult your doctor immediately.
• hot flashes
• sleep breathing problems (sleep apnea) congestion of the lungs, congestion of the airways
• crackling in the lungs, wheezing
• inflammation of the pancreas, swelling of the tongue, fecal incontinence, very hard stools
• blockage of the intestine
• chapped lips
• drug-related skin rash, thickening of the skin, dandruff
• breakage of muscle fibers and muscle pain (rhabdomyolysis)
• swollen joints
• inability to urinate
• breast discomfort, enlargement of the mammary glands, enlargement of the breasts
• vaginal discharge
• priapism (a prolonged erection of the penis that may require surgical treatment)
• very low body temperature, chills, thirst
• withdrawal symptoms from the drug
• accumulation of pus caused by an infection at the injection site, deep skin infection, a cyst at the injection site, bruising at the injection site.

Not known: frequency cannot be estimated from available data

• dangerous decrease in a certain type of white blood cells in the blood that help protect the body from infections
• severe allergic reaction characterized by fever, swelling of the mouth, face, lips or tongue, shortness of breath, itching, skin rash and sometimes a drop in blood pressure
• dangerous and excessive consumption of water
• eating disorder related to sleep
• coma due to uncontrolled diabetes
• decrease in oxygen in parts of your body (due to reduced blood flow)
• fast and shallow breathing, infection due to inhalation of food, voice disorder
• lack of intestinal muscle movement causing blockage
• yellowing of the skin and eyes (jaundice)
• severe and life-threatening skin rash with blisters and peeling of the skin that can start inside and around the mouth, nose, eyes and genitals and spread to other areas of the body (Stevens-Johnson syndrome / toxic epidermal necrolysis)
• severe allergic reaction with swelling that can affect the throat causing difficulty breathing
• skin discoloration
• abnormal posture
• babies born to mothers who have taken Xeplion during pregnancy may have experienced adverse drug events or withdrawal symptoms such as irritability, slow or prolonged muscle contractions, tremor, drowsiness, breathing or feeding problems
• a decrease in body temperature
• death of skin cells at the injection site and ulcer at the injection site

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 detailed in Annex V.
By reporting side effects you can help provide more information on the safety
of this medicine

5. How to store Xeplion

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 expiry date refers to the last day of the month.
Do not store at a temperature above 30°C.
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. Contents of the pack and other information

What Xeplion contains
The active ingredient is paliperidone.
Each pre-filled Xeplion 25 mg syringe contains 39 mg of paliperidone palmitate in 0.25 mL.
Each pre-filled Xeplion 50 mg syringe contains 78 mg of paliperidone palmitate in 0.5 mL.
Each pre-filled Xeplion 75 mg syringe contains 117 mg of paliperidone palmitate in 0.75 mL.
Each pre-filled Xeplion 100 mg syringe contains 156 mg of paliperidone palmitate in 1 mL.
Each pre-filled Xeplion 150 mg syringe contains 234 mg of paliperidone palmitate in 1.5 mL.
The other ingredients are:
Polysorbate 20
Polyethylene glycol 4000
Citric acid monohydrate
Disodium hydrogen phosphate anhydrous
Sodium dihydrogen phosphate monohydrate
Sodium hydroxide (for pH adjustment)
Water for injections

Description of Xeplion and contents of the pack
Xeplion is a white to off-white, prolonged-release suspension for injection in a
pre-filled syringe.
Each pack contains 1 pre-filled syringe and 2 needles.
Starter pack:
each pack contains 1 pack of Xeplion 150 mg and 1 pack of Xeplion 100 mg.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium

Manufacturer
Janssen Pharmaceutica N.V.
Turnhoutseweg 30
B-2340 Beerse
Belgium
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:
Authorisation Holder.

België/Belgique/Belgien
Janssen-Cilag NV
Tel/Tél: +32 14 64 94 11

Lietuva
UAB “JOHNSON & JOHNSON”
Tel: +370 5 278 68 88

България
”Джонсън & Джонсън България” ЕООД
Тел.:+359 2 489 94 00

Luxembourg/Luxemburg
Janssen-Cilag NV
Tél/Tel: +32 14 64 94 11

Česká republika
Janssen-Cilag s.r.o.
Tel:+420 227 012 227

Magyarország
Janssen-Cilag Kft.
Tel.:+36 1 884 2858

Danmark
Janssen-Cilag A/S
Tlf: +45 45 94 82 82

Malta
AM MANGION LTD.
Tel: +356 2397 6000

Deutschland
Janssen-Cilag GmbH
Tel: +49 2137-955-955

Nederland
Janssen-Cilag B.V.
Tel: +31 76 711 1111

Eesti
UAB “JOHNSON & JOHNSON” Eesti filiaal
Tel.: +372 617 7410

Norge
Janssen-Cilag AS
Tlf: +47 24 12 65 00

Ελλάδα
Janssen-Cilag Φαρμακευτική Α.Ε.Β.Ε
Tηλ: +30 210 80 90 000

Österreich
Janssen-Cilag Pharma GmbH
Tel: +43 1 610 300

España
Janssen-Cilag, S.A.
Tel: +34 91 722 81 00

Polska
Janssen-Cilag Polska Sp. z o.o.
Tel.: +48 22 237 60 00

France
Janssen-Cilag
Tel: 0 800 25 50 75 / +33 1 55 00 40 03

Portugal
Janssen-Cilag Farmacêutica, Lda.
Tel: +351 214 368 600

Hrvatska
Johnson & Johnson S.E. d.o.o.
Tel: +385 1 6610 700

România
Johnson & Johnson România SRL
Tel: +40 21 207 1800

Ireland
Janssen Sciences Ireland UC
Tel: 1 800 709 122
[email protected]

Slovenija
Johnson & Johnson d.o.o.
Tel: +386 1 401 18 00

Ísland
Janssen-Cilag AB
C/o Vistor hf
Sími: +354 535 7000

Slovenská republika
Johnson & Johnson s.r.o.
Tel: +421 232 408 400

Italia
Janssen-Cilag SpA
Tel: 800.688.777 / +39 02 2510 1

Suomi/Finland
Janssen-Cilag Oy
Puh/Tel: +358 207 531 300

Κύπρος
Βαρνάβας Χατζηπαναγής Λτδ
Tηλ: +357 22 207 700

Sverige
Janssen-Cilag AB
Tel: +46 8 626 50 00

Latvija
UAB “JOHNSON & JOHNSON” filiāle Latvijā
Tel: +371 6789 3561

United Kingdom (Northern Ireland)
Janssen Sciences Ireland UC
Tel: +44 1 494 567 444
[email protected]
Further detailed information on this medicinal product is available on the website of the European
Medicines Agency, http://www.ema.europa.eu/

The following information is intended exclusively for physicians or healthcare professionals and
must be read by physicians or healthcare professionals together with the complete prescribing
information (Summary of Product Characteristics):
The injectable suspension is for single use only. A visual inspection should be performed to
exclude the presence of particulate matter before administration. Do not use if the
syringe does not appear visually free of particulate matter.
The pack contains one pre-filled syringe and 2 safety needles (one 1 ½ inch, 22 G
[38.1 mm x 0.72 mm] and one 1 inch, 23 G [25.4 mm x 0.64 mm]) for
intramuscular injection. Xeplion is also available in a starter pack containing two pre-filled syringes (150 mg + 100mg) and 2 additional safety needles.

• (A) 22 G x 1 ” (Grey hub)
• (B) 23 G x 1” (Blue hub)
• (C) Pre-filled syringe
• (D) Hub
• (E) Tip cap
• 1. Shake the syringe vigorously for at least 10 seconds to ensure a homogenous suspension.

• 2. Select the appropriate needle. The first initiating dose of Xeplion (150 mg) must be administered on Day 1 into the DELTOID muscle using the needle for DELTOID injection. The second initiating dose of Xeplion

(100 mg) must also be administered into the DELTOID muscle one week later
(Day 8) using the needle for DELTOID injection.
If the patient is switching from long-acting risperidone to Xeplion, the
first Xeplion injection (which may range from 25 mg to 150 mg) may be administered either into the
DELTOID or GLUTEAL muscle at the time of the next scheduled injection
using the appropriate needle for the injection site.
Subsequently, monthly maintenance injections may be administered either into the
DELTOID or GLUTEAL muscle using the appropriate needle for the injection site.
For DELTOID injection, if the patient weighs < 90 kg, use the 1 inch, 23G
(25.4 mm x 0.64 mm) needle (the needle with the bluecoloured hub); if the patient weighs 90 kg,
use the 1 ½ inch, 22G (38.1 mm x 0.72 mm) needle (the needle with the coloured hub in

grey).
For GLUTEAL injection, use the 1½ inch, 22G (38.1 mm x 0.72 mm) needle (the needle
with the coloured hub in grey).

• 3. Holding the syringe with the tip cap facing upwards, remove the rubber tip cap with a slight twisting motion.

• 4. Open the blister pack of the safety needle halfway. Grip the needle cap using the open plastic wrapper. Hold the syringe with the tip facing upwards. Connect the safety needle to the syringe using a slight twisting motion to avoid breakage or damage to the needle connection. Always check for any signs of damage or leakage before administration.

• 5. Pull off the needle protection cap with a straight motion. Do not rotate the cap as the needle may loosen from the syringe.

• 6. Hold the syringe with the connected needle in a vertical position to eliminate air. Remove air from the syringe by carefully pushing the plunger forward.

• 7. Inject the entire contents slowly and deeply into the selected deltoid or gluteal muscle. Do not administer intravenously or subcutaneously.
• 8. Once the injection is complete, use your thumb or another finger (8a, 8b) or a flat surface (8c) to activate the needle protection system. The system is fully activated when a clicking sound is heard. Dispose of the syringe with the needle appropriately.

8a

8b

8c

Unused medicinal product and waste materials derived from such medicinal product should be disposed of in
accordance with local regulations.