Victrelis - patient leaflet, side effects, dosage

What Victrelis is and what it is used for

What Victrelis is used for

Victrelis, in combination with peginterferon alfa and ribavirin, is used for chronic hepatitis C virus infection in adults (also called HCV infection).

Victrelis may be used in adults who are previously untreated for HCV infection or who have previously used medicines called ‘interferons’ and ‘pegylated interferons’.

Do not take Victrelis if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Victrelis.

Reminder: Please also read the “Do not use” section of the Package Leaflets for peginterferon alfa and ribavirin before you start taking Victrelis.

Warnings and precautions

Talk to your doctor or pharmacist before taking your medicine if you:

have ever had a blood problem such as anaemia (when you lack enough healthy red blood cells, which transport oxygen around your body)

have ever had a blood problem such as neutropenia (lack of a certain type of white blood cells).

Neutropenia affects the body's ability to fight off infections

have ever had a blood problem such as pancytopenia (a combination of low platelet, red and white blood cell counts)

have a current or previous infection with the hepatitis B virus, since your doctor ma monitor you more closely have liver failure

have another liver problem in addition to hepatitis C infection

have HIV (human immunodeficiency virus) or have ever had any other immune system

were an organ transplant recipient

have hepatitis C other than genotype 1

were a patient who has previously failed treatment with an HCV protease inhibitor

have or anyone in your family has an irregular heartbeat, especially a condition called “QT prolongation”

have low blood potassium (hypokalaemia)

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Victrelis.

While taking the combination of Victrelis with ribavirin and peginterferon alpha, serious allergic reactions have been reported. Please see „Possible side effects“ for more information.

gularly. These blood tests are done for a number of reasons:

• so your doctor knows if the treatment is working for you
• to help your doctor decide how long you will be treated with Victrelis.
• to check for side effects.

Other medicines and Victrelis

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription and herbal medicines.

In particular, do not take Victrelis if you are taking any of the following medicines:

alfuzosin and silodosin – used to treat symptoms of an enlarged prostate bepridil – used for heart problems

pimozide or lurasidone – used for mental health problems

oral midazolam or oral triazolam – a sedative, given by mouth

statins – simvastatin or lovastatin

• ‘ergot’ type medicines, such as dihydro-ergotamine, ergonovine, ergotamine or

methylergonovine – used for migraine and cluster headaches

• lumefantrine and halofantrine – anti-malaria medicines
• quetiapine – used to treat schizophrenia, bipolar disorder and major depressive disorder
• tyrosine kinase inhibitors – used as anti-cancer medicines

Do not take Victrelis if you are taking any of the medicines above. If you are not sure, talk to your doctor or pharmacist before taking Victrelis.

Also, tell your doctor or pharmacist if you are taking any of the following:

birth control medicines – drospirenone

CYP3A4 inducer medicines (such as antibiotic medicine – rifampicin, and anticonvulsant medicines – carbamazepine, phenobarbital, phenytoin) antiarrhythmic medicines- amiodarone, quinidine antimicrobial medicine – pentamidine some neuroleptics antifungal medicines – ketaconazole, itraconazole, posaconazole, voriconazole HIV non-nucleoside reverse transcriptase inhibitor – efavirenz, etravirine HIV protease inhibitors – atazanavir, darunavir, lopinavir, ritonavir intravenous sedatives – benzodiazepines (e.g., alprazolam, midazolam, triazolam immunosuppressants – tacrolimus, sirolimus, cyclosporine select statins – atorvastatin or pravastatin methadone hormonal replacement therapy – oestrogen-based medicines

medicine used to decrease blood pressure – calcium channel blockers (e.g., amlodipine, diltiazem, felodipine, nicardipine, nifedipine, nisoldipine, verapamil)

medicine used to treat symptoms of an enlarged prostate – doxazosin and tamsulosin

warfarin and other similar medicines called vitamin K antagonists used to thin the blood. Your doctor may need to increase the frequency of your blood tests to check how well your blood can clot.

Pregnancy and breast-feeding

Pregnancy must be avoided due to the use of Victrelis with ribavirin. 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 woman of childbearing age who is taking ribavirin:

you must have a negative pregnancy test before treatment, each month during treatment, and for the 4 months after treatment is stopped. You must use an effective birth control during the time you are 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. This will lessen the possibility for ribavirin to be left in the woman's body. If your female partner is not pregnant but is of childbearing age, she must be tested for pregnancy each month during treatment 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.

ible that boceprevir is excreted in human milk. If you are breast-feeding, your doctor will e you to discontinue breast-feeding or to discontinue Victrelis while breast-feeding.

Reminder: Please also read the “Pregnancy and breast-feeding” section of the Package Leaflets for peginterferon alfa and ribavirin before you start taking Victrelis.

Driving and using machines

Victrelis does not affect your ability to drive or use tools or machines. However, the combination therapy of Victrelis, peginterferon alfa and ribavirin may make you feel tired, faint, a sensation of your head spinning, changes in blood pressure, confused or difficulty seeing clearly. If this happens, do not drive or use any tools or machines.

3. How to take Victrelis

How to take this medicine

Peel back the tab to get to the capsule – do not push the capsule through the blist pushing the capsule through the package may break the capsule.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine:

Stop taking Victrelis and see a doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:

• difficulty breathing or swallowing, wheezing, hives, itching, swelling of your face, eyes, lips,

tongue or throat – these are signs of an allergic reaction.

Other side effects include:

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

General: headache; chills, fever; feeling sick (nausea); flu-like symptoms; feeling dizzy, low energy; not being able to sleep; low appetite, weight loss; shortness of breath

Mouth, nose or throat: cough; dry mouth; funny taste

Skin and hair: dry skin, itching, rash; hair loss or thinning of hair

Joints and muscles: unusual weakness; painful, swollen joints; muscle ache not caused by

exercise

Stomach and gut: diarrhoea; being sick (vomiting)

Mental illness: feeling anxious; feeling of deep sadness or of being worthless (depression); feeling irritable, tense and restless

Blood: low red blood cell count (anaemia), drop in the number of red blood cells – the sign may include feeling tired, headaches, being short of breath when exercising; low neutrophil count (neutropenia), low number of white blood cells – the signs may include getting more infections than usual – including fever, severe chills, a sore throat or mouth ulcers

Common (may affect up to 1 in 10 people)

General: shaking; fainting; difficulty breathing; feeling thirsty; trouble

headache; generally feeling unwell; feeling like you are spinning Eyes or ears: dry eyes; ringing in the ears; changes in your vision Mouth, nose or throat: mouth pain, tooth ache; pain when swallowing; nose bleed, stuffy nose; a change in how things smell; sore and raised patches in the mouth; feeling very thirsty with a dry mouth or dry skin; swelling of the thyroid gland, neck or voicebox; underactive thyroid gland; sores or swelling in the mouth, burning feeling on the tongue; feeling of tension or fullness in the nose, cheeks and behind the eyes – times with a throbbing ache, fever or

stuffy nose (sinusitis)

Skin and hair: cold sores, tingling or numbness of the skin; reduced feeling or sense of touch; skin rash, patchy skin rash, red skin; red raised skin rash sometimes with pus-filled blisters; hot, tender and red skin, sometimes with fever and chills; increased sweating; skin disease with thick patches of red skin – often with silvery scales

Joints and muscles: muscle spasm; feeling tired, muscle weakness, feeling cold; back pain, neck pain, pain in the arms or legs

Stomach and gut: pain in stomach and in the upper right side of the stomach or back; a burning feeling in the stomach, upset stomach; feeling bloated, burping (belching) Anus: wind (flatulence); piles (haemorrhoids); difficulty passing stools (constipation) Urinary: going to the toilet to urinate more often than usual

Sexual: a decrease in sex drive; difficulty getting or keeping an erection

Mental illness: changes in mood, feeling agitated; memory loss, trouble concentrating Chest: difficulty breathing; chest discomfort, chest pain; heavy feeling in the chest, with difficulty breathing or wheezing

Heart or circulation: fast or uneven heart-beat; high or low blood pressure

Blood: drop in the number of blood platelets -the signs may include bleeding or bruising more easily than usual; high sugar (glucose) levels in the blood; high triglycerides levels in the blood; high uric acid levels in the blood; a combination of low platelet, red and white blood cell counts (pancytopenia); a severe drop of neutrophil count (agranulocytosis)

ncommon (may affect up to 1 in 100 people)

General: light-headedness, arthritis; increased tendency to bleed; swollen glands in neck or armpit or groin; intense burning or stabbing pain; increased sensitivity to light, sound, what is felt, or food one tastes; diabetes

Eyes or ears: pink eye; eye pain; deafness; trouble hearing; swelling around the eyelid; increased tearing; fluid draining from the ear or eye; abnormal feeling around the eye, red patch on the white of the eye; yellowing of the white part of the eyes or of the skin

Mouth, nose or throat: hoarseness, dry throat or lips; painful or bleeding gums; sensitive tooth or toothache; tongue swollen, discoloured, or has sores; blistering by the tongue; severe pain when swallowing; chest pain close to the lungs; chest pain worsens when taking a deep breath; uncontrolled salivating; overactive thyroid gland

Skin and hair: hives; open sore; intolerance to heat; markedly red face; pale face; yellow skin; rash due to sunlight; wound not healing normally

Feet or hands or legs or arms: sensation of pain, numbness, tingling or prickling; blood clot in a vein; feeling cold in an arm or leg; painful inflammation of the joints most commonly in the foot (gout)

Stomach and gut: lower stomach pain; pancreatitis

Urinary: painful when urinating; burning feeling or difficulty urinating; get up several times during the night to urinate

Rectum or anus: anal itching; inability to pass stools or discoloured stools; more frequen bowel movements; bleeding from anus

Sexual: missing menstrual period; heavy or prolonged menstrual period; uterine bleeding prolonged >7 days or excessive bleeding at irregular or more frequent than normal intervals, bleeding occurring in menopausal women at least 6 months to 1 year after cessation of cycles) Mental illness: anger; hostile attitude or behaviour; threatening behaviour; substance abuse problems, abnormal behaviour; feeling of confusion; thoughts of suicide; sudden intense fear or apprehension; feeling you are being persecuted; difficulty solving problems

Muscles: pain in your bones; local or widespread pain

Chest: pneumonia

Heart or circulation: abnormal or rapid heart rate; heart disea the heart

Blood: low potassium levels in your blood; high calcium levels in the blood

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

General: difficult breathing and swallowing; tum

swelling or lumps in organs of the body; disease which leads to increasing muscle paralysis; disease of the brain – signs may include headache and fever, paralysis of a part of the body, a stiff neck or being sensitive to light

Eyes or ears: ear ache

Skin and hair: reddening of the skin; bacterial skin infection

Stomach and gut: problems digesting food; vomiting blood; vomiting, diarrhoea, and severe right upper corner stomach (abdominal) pain

Sexual: drop in levels of sperm

Mental illness: changes in mood; feeling like your life is falling apart; seeing, feeling or hearing things that are not real (hallucinations); thoughts of killing yourself (suicide), trying to kill yourself; feeling of great happiness (mania) and then a feeling of deep sadness or not being worthy

Chest: being short of breath when lying flat; serious lung infection like pneumonia; sharp chest pains which are worse when breathing; pain behind breast bone which can spread to neck and shoulders

Heart or circulation: heart attack; stopping breathing; blood clot in the leg or arm; decreased blood flow to parts of the brain (e.g., dizziness, double vision, or weakness on both sides of the body)

known (frequency cannot be estimated from the available data)

Skin and hair: Severe rash, which may be accompanied by fever, fatigue, swelling of the face or lymph glands, increase of eosinophils (type of white blood cells), effects on liver, kidney or lung (a reaction called DRESS); serious skin reaction, including blistering or peeling of the skin (a reaction called Stevens-Johnson syndrome)

Kidney: renal impairment (generally reversible after conclusion of treatment)

Reporting of side effects

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

5. How to store Victrelis

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 and blisterfoil after EXP. The expiry date refers to the last day of that month.

Storage by the pharmacist

Store in a refrigerator (2°C – 8°C).

Storage by the patient

• Store in a refrigerator (2°C – 8°C) until expiry.

OR

• Store outside of the refrigerator at or below 30°C for a period of not more than 3 months until

expiry. After this period, the medicinal product should be disposed.

Store in the original blister in order to protect from moisture.

Do not throw away any medicine 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 Victrelis contains The active substance is boceprevir. Each hard capsule contains 200 mg of boceprevir.

• The other ingredients are sodium lauryl sulfate, microcrystalline cellulose, lactose

What Victrelis looks like and contents of the pack

The hard capsules have a yellowish-brown cap with the „MSD“ logo printed in red ink and an off-white body with „314“ printed in red ink.

Peelable blisters containing 12 hard capsules (3×4 capsule blister strip).

Pack sizes: carton of 84 hard capsules and multipack containing 336 (4 packs of 84) hard capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon Hertfordshire

EN11 9BU

United Kingdom

Ireland

Merck Sharp & Dohme Ireland (Human Health)

Limited

Tel: +353 (0)1 299 8700

Slovenija

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

Tel: + 386 1 5204 201

Ísland

Vistor hf.

Sími: +354 535 7000

Italia

MSD Italia S.r.l.

Tel: +39 06 361911

Kvnpog

Merck Sharp & Dohme Cyprus Limited

Tql: 800 00 673 (+357 22866700)

Slovenská republika

Merck Sharp & Dohme, s. r. o.

Tel.: +421 2 58282010

Sverige

Merck Sharp & Dohme (Sweden) AB

Tel: +46 77 570048

Latvija

SIA Merck Sharp & Dohme Latvija

Tel: +371 67364224

.

Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272

This leaflet was last revised in {MM/YYYY}

the European Medicines Agency web site:

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In clinical trials, HCV-RNA in plasma was measured with a Roche COBAS Taqman assay with a limit of detection of 9.3 IU/mL and a limit of quantification of 25 IU/mL.

In clinical trials, HCV-RNA in plasma was measured with a Roche COBAS Taqman assay with a limit of detection of 9.3 IU/mL and a limit of quantification of 25 IU/mL.

In clinical trials, HCV-RNA in plasma was measured with a Roche COBAS Taqman assay with a limit of detection of 9.3 IU/mL and a limit of quantification of 25 IU/mL.

In clinical trials, HCV-RNA in plasma was measured with a Roche COBAS Taqman assay with a limit of detection of 9.3 IU/mL and a limit of quantification of 25 IU/mL.

1

In clinical trials, HCV-RNA in plasma was measured with a Roche COBAS Taqman assay with a limit of detection of 9.3 IU/mL and a limit of quantification of 25 IU/mL.

In clinical trials, HCV-RNA in plasma was measured with a Roche COBAS Taqman assay with a limit of detection of 9.3 IU/mL and a limit of quantification of 25 IU/mL.