PegIntron - patient leaflet, side effects, dosage

What PegIntron is and what it is used for

bavirin and boceprevir is recommended for use for some types of (also called HCV infection) in adults 18 years of age and older. It may been previously treated for HCV infection or who have previously used d pegylated interferons.

is medicine and ribavirin is recommended for adults 18 years of age and older who ly been treated with these medicines. This includes adults also infected with clinically uman Immunodeficiency Virus). The combination can also be used to treat adults who have

iled treatment with an interferon alpha or peginterferon alpha in combination with ribavirin or n alpha alone.

If you have a medical condition making use of ribavirin dangerous or if you already have had a problem taking it, your doctor will likely prescribe this medicine alone.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Children and adolescents

This medicine is used in combination with ribavirin in children 3 years of age and older and adolescents who have not been treated previously for chronic hepatitis C.

2. What you need to know before you use PegIntronDo not use PegIntronYou should tell your doctor before starting treatment if you, or the child you are caring for:

• – are allergic to peginterferon alfa-2b or any of the other ingredients of this medicine (listed in

• section 6).

• – are allergic to any interferon.

• – have had severe heart problems.

• – have heart disease that has not been well controlled during the past 6 months.

  ild you are

  
  

• – have severe medical conditions that leave you very weak.

• – have autoimmune hepatitis or any other problem with your immune system.

• – are taking medicine that suppresses (weakens) your immune system.

• – have advanced, uncontrolled liver disease (other than hepatitis C).

• – have thyroid disease that is not well controlled with medicines.

• – have epilepsy , a condition that causes convulsions (seizures, or “fits”).

• – are being treated with telbivudine (see section “Other medicines and PegIntron

  
  

You must not use PegIntron if any of the conditions above should caring for.

In addition, children and adolescents must not use this medicine if they have had serious nervous or mental problems, such as severe depression or thoughts of suicide.

Reminder: Please also read the “Do not take” section of the Pa boceprevir before using them in combination wit

Warnings and precautions

Seek medical help immediately in case of a severe wheezing, or hives).

Talk to your doctor before taking this medicine if you, or the child you are caring for:

have had a severe nervous or mental disorder or have a history of substance abuse (e.g. alcohol or drugs).

The use of this medicine inand adolescents with existence of or history of severe psychiatric conditions is ned (see section “Do not use PegIntron” above).

are being treated for a illness or had treatment in the past for any other nervous or mental

disorder, including depn (such as feelings of sadness, dejection) or suicidal or homicidal behaviour (see section 4 “Possible side effects”).

have ever had a heart attack or a heart problem.

have kidney disease , your doctor may prescribe a lower than usual dose and monitor your kidney blood values regularly during treatment. If this medicine is used in combination with ribavirin, your doctor should monitor you, or the child you are caring for more carefully for a decrease in red cell count.

ha rhosis or other liver problems (other than hepatitis C).

develop symptoms associated with a cold or other respiratory infection, such as fever , cough , or any difficulty in breathing.

are diabetic or have high blood pressure , your doctor may ask you, or the child you are caring for to have an eye examination.

have had any serious illness affecting breathing or blood.

have the skin disorders, psoriasis or sarcoidosis , which may become worse while you are using this medicine.

are planning to become pregnant , discuss this with your doctor before starting to use this medicine.

have received an organ transplant , either kidney or liver, interferon treatment may increase the risk of rejection. Be sure to discuss this with your doctor.

If you are also being treated for HIV (see section “Other medicines and PegIntron”). have a current or previous infection with the hepatitis B virus, since your doctor may want to monitor you more closely.

Reminder: Please read the “Warnings and precautions” section of the Package Leaflet for ribavirin before using it in combination with this medicine.

Teeth and mouth problems have been reported in patients receiving this medicine in combination with ribavirin. You may develop gum disease, which could lead to loss of teeth. You may develop a dry mouth or vomiting, both of which can damage your teeth. It is important to brush your teeth thoroughly twice a day, rinse your mouth out if you vomit, and have regular dental check-ups.

During treatment, some patients may experience eye problems, or loss of vision in rare instances. Your doctor should carry out an eye examination before starting your treatment. In case of any changes in vision, you must tell your doctor and have a prompt and complete eye examination. If have a medical condition that may lead to future eye problems (e.g. diabetes or high blood pressur you should receive regular eye exams during therapy. If your eye disorder becomes more severe o you develop new eye disorders, your treatment will be discontinued.

While being treated with PegIntron, your doctor may advise to drink extra fluids to blood pressure.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

In studies in pregnant animals, interferons have sometimes caused miscarriage. The effect of this medicine on human pregnancy is not known. Girls or women of childbearing potential need to use effective birth control during the treatment with this medicine.

Ribavirin can be very damaging to an unborn baby. Therefore, you and your partner must take special precautions in sexual activity if there is any chance for pregnancy to occur: – if you are a girl or a woman of childbearing age who is taking ribavirin:

you must have a negative pregnancy test before treatment, each month during treatment, and for t 4 months after treatment is stopped. You must use an effective birth control during the time you a taking ribavirin and for 4 months after stopping treatment. This should be discussed with your doctor. – if you are a man who is taking ribavirin:

do not have sex with a pregnant woman unless you use a condom. If your female pis not pregnant but is of childbearing age, she must be tested for pregnancy each month dreatment and for the 7 months after treatment has stopped. You or your partner must use an effective birth control during the time you are taking ribavirin and for 7 months after stopping treatment. This should be discussed with your doctor.

Breast-feeding

It is not known whether this medicine is present in human milk an infant if you are taking this medicine. Ask your doctor for

ine exactly as your doctor or pharmacist has told you. Check with your doctor e not sure.

formation about taking this medicine octor has determined the correct dose of this medicine based on how much you, or the child u are caring for weighs. If necessary, the dose may be changed during treatment.

This medicine is intended for subcutaneous use. This means that it is injected through a short injection needle into the fatty tissue just under the skin. If you are injecting this medicine yourself, you will be instructed how to prepare and give the injection. Detailed instructions for subcutaneous administration are provided at the end of this leaflet (see section “How to self-inject PegIntron”).

Water for injection and PegIntron powder are provided in separate ampoules. Prepare the dose by adding water for injection to PegIntron powder just before you intend to inject it and use it

Intron

of this medicine as soon as you remember, but only if within 1–2 days after very close to your next injection, do not double the dose to make up for the

but continue your treatment as usual.

tain, contact your doctor or pharmacist or the doctor or pharmacist of the child you are

Like all medicines, this medicine can cause side effects, although not everybody gets them. Although not all of these side effects may occur, they may need medical attention if they do. When this medicine is used alone, some of these effects are less likely to occur, and some have not occurred at all.

Psychiatric and central nervous system:

Some people get depressed when taking this medicine alone or in combination treatment with ribavirin, and in some cases people have had thoughts about threatening the life of others, suicidal thoughts or aggressive behaviour (sometimes directed against others). Some patients have actually committed suicide. Seek emergency care if you notice that you are becoming depressed or have suicidal thoughts or change in your behaviour. Ask a family member or close friend to help you stay alertto signs of depression or changes in your behaviour.

Children and adolescents are particularly prone to develop depression when being treated with this medicine and ribavirin. Immediately contact the doctor or seek emergency treatment if they display any unusual behavioural symptoms, feel depressed, or feel they want to harm themselves or others.

Growth and development (children and adolescents):

With up to one year of treatment with this medicine in combination with ribavirin, some children and adolescents did not grow or gain weight as much as expected. Some children did not reach their projected height within 1–5.5 years after completing treatment.

Unknown frequency side effects (frequency cannot be estimated from the available data): – Wanting to harm others.

;cts that have been reported in adults include:

mmon side effects (may affect more than 1 in 10 people):

feeling depressed, irritability, trouble falling asleep or staying asleep, feeling anxious or nervous, difficulty concentrating, mood swings,

headache, dizziness, tired feeling, shaking chills, fever, flu-like symptoms, virus infection, weakness,

difficult breathing, pharyngitis (sore throat), coughing,

stomach pain, vomiting, nausea, diarrhoea, loss of appetite, loss of weight, dry mouth, hair loss, itching, dry skin, rash, irritation or redness (and rarely, skin damage) at the site of injection,

decreases in the number of red blood cells (that may cause fatigue, shortness of breath, dizziness), decrease in certain white blood cells (that makes you more susceptible to different infections),

pain in joints and muscles, muscle and bone pain.

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

• – diabetic ketsis (medical emergency due to build-up of ketone bodies in the blood as a

result of out-of-control diabetes),

• – seizures (convulsions) and bipolar disorders (mood disorders characterized by alternating

eeypiesopdros of sadness and excitement),

blems including changes in vision, damage to the retina, obstruction of the retinal artery, ation of the optic nerve, swelling of the eye,

• – congestive heart failure, abnormal heart rhythm, pericarditis (inflammation of the lining of the

heart), inflammation and degeneration of muscle tissue and peripheral nerves, kidney problems,

• – sarcoidosis (a disease characterized by persistent fever, weight loss, joint pain and swelling,

skin lesions and swollen glands).

Very rare side effects (may affect up to 1 in 10,000 people):

• – aplastic anaemia, stroke (cerebrovascular events), toxic epidermal necrolysis/Stevens Johnson

Syndrome/erythema multiforme (a spectrum of rashes with varying degree of severity including death which may be associated with blisters in the mouth, nose, eyes and other mucosal membranes and sloughing of the affected area of the skin).

• – loss of consciousness has occurred very rarely with alpha interferons, mostly in elderly patients

treated at high doses.

Side effects of unknown frequency (frequency cannot be estimated from the available data):

• – pure red cell aplasia (a condition where the body stopped or reduced the production of red blood

cells). This causes severe anaemia, symptoms of which would include unusual tiredness and a

lack of energy.

facial palsy (weakness and slumping on one side to the face), severe allergic reactions such as angioedema (an allergic skin disease characterized by patches of swelling involving the skin and

its subcutaneous layers, the mucous membranes, and sometimes the internal organs), mania

(excessive or unreasonable enthusiasm), pericardial effusion (a fluid collection that develops between the pericardium (the lining of the heart) and the heart itself), Vogt-Koyanagi-Harada syndrome (an autoimmune inflammatory disorder affecting the eyes, skin and the membranes the ears, brain and spinal cord), change in colour of the tongue. thoughts about threatening the life of others. pulmonary fibrosis (scarring of the lungs).

pulmonary arterial hypertension – a disease of severe narrowing of the blood vessel

lungs resulting in high blood pressure in the blood vessels that carry blood from theo the lungs. This may occur in particular in patients with risk factors such as HIV infection or severe

liver problems (cirrhosis). The side effect may develop at various time points during treatment, typically several months after starting treatment with PegIntron.

hepatitis B reactivation in HCV/HBV co-infected patients (recurrence of hepatitis B disease).

If you are an HCV/HIV co-infected adult patient receiving HAART , the addition of this medicine and ribavirin may increase your risk of lactic acidosis, liver faievelopment of blood abnormalities (reduction in number of red blood cells which cn, certain white blood cells that fight infection, and blood clotting cells called platelets).

The following other side effects (not listed above) have occurred with the combination of this medicine and ribavirin capsules (adults) in HCV/HIV co-infected patients receiving HAART:

oral candidiasis (oral thrush), defective metabolism of fat, CD4 lymphocytes decreased, appetite decreased, back pain, hepatitis, limb pain, and various laboratory

Side effects in children and adolescents

The following effectshave^ccurred in children and adolescents:

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

• – lospetite, dizziness, headache, vomiting, nausea, stomach pain,

  
  

ry skin, pain in joints and muscles, redness at the site of injection, irritable, tired feeling, feeling unwell, pain, chills, fever, flu-like symptoms, weakness, se in rate of growth (height and weight for age), ses in red blood cells that may cause fatigue, shortness of breath, dizziness.

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

fungal infection, common cold, cold sores, pharyngitis (sore throat), sinusitis, ear infection, coughing, throat pain, feeling cold, eye pain,

decrease in blood clotting cells called platelets, that may result in easy bruising and spontaneous bleeding, swollen glands (swollen lymph nodes), blood thyroid tests abnormalities, decrease in thyroid gland activity, which may make you feel tired, depressed, increase your sensitivity to cold and other symptoms,

wanting or attempting to harm yourself aggressive behaviour, agitation, anger, mood changes, nervousness or restlessness, depression, feeling anxious, trouble falling asleep or staying asleep, emotional instability, poor quality sleep, feeling sleepy, disturbance in attention.

• – changes in taste, diarrhoea, stomach upset, oral pain,

• – fainting, palpitations (pounding heart beat), rapid heart rate, flushing, nosebleed,

• – sores in mouth, scaling lips and clefts in the corners of the mouth, rash, redness of skin, itching,

eczema (inflamed, red, itchy and dryness of the skin with possible oozing lesions), acne,

• – back pain, muscle and bone pain, limb pain, dryness, pain, rash, irritation or itching at the site of

injection.

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

• – painful or difficult urination, urinary frequency, the presence of excess protein in the urine,

painful menstruation,

• – itchy anal area (pinworms or ascarids), inflammation of the lining membrane of the stomach and

the intestines, inflamed gums, enlarged liver,

• – abnormal behaviour, emotional disorder, fear, nightmare, tremor, decreased sensitivity to touch,

numbness or tingling feeling, pain radiating along the course of one or more nerves, drowsiness,

• – bleeding of the mucous membrane that lines the inner surface of the eyelids, itchy eyes, eye

pain, blurred vision, intolerance to light,

• – low blood pressure, paleness, nasal discomfort, runny nose, wheezing, difficult breathing, chest

pain or discomfort,

• – redness, swelling, pain of skin, shingles, skin sensitive to sunlight, rash with raised spotted

lesions, skin discolouration, peeling of skin, shortening of muscle tissue, muscle twitching, facial pain, bruising.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. Thisjnciudes any possible side effects not listed in this leaflet. You can also report side effects directlyQia>i­e*nationai reporting system listed in By reporting side effects, you can also help provide more information on the safety of this medicine.

Reminder to adult patients prescribed combination therapy of this medicine, boceprevir and ribavirin: Please read the “Possible side effects” section of these Package Leaflets.

5. How to store PegIntron

Keep this medicine out of the si

expiry date which is stated on the carton, after EXP.

Store in a refrigerator (2°C^ 8°C)

Use the reconstituted solution (solution you prepared by adding water for injection to the PegIntron powder) immediately or within 24 hours when stored in a refrigerator (2°C – 8°C).

Do not use this medicine if you notice discolouration of the powder, which should be white.

The reconstituted solution should be clear and colourless. Do not use if it is discoloured or if bits of

are present. PegIntron vials are for single use only. Discard any unused material.

Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other informationWhat PegIntron contains- The active substance is peginterferon alfa-2b.

PegIntron 50 micrograms powder and solvent for solution for injection

Each vial contains 50 micrograms of peginterferon alfa-2b measured on a protein basis.

Each vial provides 50 micrograms/0­.5 ml of solution when reconstituted as recommended.

PegIntron 80 micrograms powder and solvent for solution for injection

Each vial contains 80 micrograms of peginterferon alfa-2b measured on a protein basis.

Each vial provides 80 micrograms/0­.5 ml of solution when reconstituted as recommended.

PegIntron 100 micrograms powder and solvent for solution for injection

Each vial contains 100 micrograms of peginterferon alfa-2b measured on a protein basis.

Each vial provides 100 microgram­s/0.5 ml of solution when reconstituted as recommended.

PegIntron 120 micrograms powder and solvent for solution for injection

Each vial contains 120 micrograms of peginterferon alfa-2b measured on a protein basis.

Each vial provides 120 microgram­s/0.5 ml of solution when reconstituted as recommended.

PegIntron 150 micrograms powder and solvent for solution for injection

Each vial contains 150 micrograms of peginterferon alfa-2b measured on a protein basis.

Each vial provides 150 microgram­s/0.5 ml of solution when reconstituted as recommended

The other ingredients are:

Powder: disodium phosphate; anhydrous, sodium dihydrogen phospKOte dihydrate; sucrose and polysorbate 80.

Solvent: water for injections.

What PegIntron looks like and contents of the pack

This medicine is a powder and solvent (liquid) for solution for injection.

The white powder is contained in a 2 ml glass vial and the clear and colourless solvent is presented in a 2 ml glass ampoule.

PegIntron is available in different pack sizes:

• – 1 vial of powder for solution for injection and 1 ampoule of solvent for injection;

• – 1 vial of powder for solution for injection, 1 ampoule of solvent for injection, 1 injection syringe,

2 injection needles and 1 cl

4 vials of powder for solution for injection and 4 ampoules of solvent for injection;

4 vials of powder for solution for injection, 4 ampoules of solvent for injection, 4 injection

edles and 4 cleansing swabs;

olution for injection and 6 ampoules of solvent for injection;

wder for solution for injection, 12 ampoules of solvent for injection, 12 injection njection needles and 12 cleansing swabs.

ay be marketed.

Authorisation Holder rp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

The Netherlands

Manufacturer

SP Labo N.V.

Industriepark, 30

B-2220 Heist-op-den-Berg

Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgiqu­e/Belgien

MSD Belgium BVBA/SPRL

Tel: 0800 38 693 (+32(0)27766211)

Efc^rapufl

MepK fflapn u ^ovm Etnrapua EOOfl

Ten.: +359 2 819 3737

Česká republika

Merck Sharp & Dohme s.r.o.

Tel: +420 233 010 111

Danmark

MSD Danmark ApS Tlf: + 45 4482 4000

Deutschland

MSD SHARP & DOHME GMBH

Tel: 0800 673 673 673 (+49 (0) 89 4561 2612)

Luxembourg/Lu­xemburg

MSD Belgium BVBA/SPRL

Tel: +32(0)27766211

Magyarorszag

MSD Pharma Hungary Kft.

Tel.: +36 1 888 5300

Malta

Merck Sharp & Dohme Cy Tel: 8007 4433 (+356 9991 e BV

(+31 23 5153153) erck.com

No

MSD (Norge) AS

Tlf: +47 32 20 73 00

Romania

Merck Sharp & Dohme Romania S.R.L.

Tel: +40 21 529 2900

Ireland

Merck Sharp & Dohme Ireland (Human Health)

Limited

Tel: +353 (0)1 2998700

Slovenija

Merck Sharp & Dohme, inovativna zdravila d.o.o.

Tel: +386 1 5204 201

Slovenská republika

Merck Sharp & Dohme, s. r. o.

Tel: +421 2 58282010

Suomi/Finland

MSD Italia S.r.l.

Tel: +39 06 361911

Kùnpoç

Merck Sharp & Dohme Cyprus Limited

TqX.: 800 00 673 (+357 22866700)

MSD Finland Oy

Puh/Tel: +358 (0)9 804 650

Sverige

Merck Sharp & Dohme (Sweden) AB

Tel: +46 77 5700488

How to self-inject PegIntron?

Your healthcare provider will instruct you how to self-inject this medicine. Do not attempt to inject yourself unless you are sure you understand the procedure and requirements of selfinjection. The following instructions explain how to inject this medicine yourself. Please read the instructions carefully and follow them step by step.

Preparation

Collect the necessary items before you begin:

– a vial of PegIntron powder for injection;

• – an ampoule of water for injections solvent to prepare PegIntron injection;

• – a 1 ml syringe;

• – a long needle (for example 0.8 × 40 mm [21 gauge 1.5 inch]) to be used to add water

injections to the PegIntron powder vial;

• – a short needle (for example 0.3 × 13 mm [30 gauge 0.5 inch]) for the subcutaneous

• – a cleansing swab.