Consumer medicine information

VICTRELIS® CAPSULES

Boceprevir

Consumer Medicine Information

What is in this leaflet?

This leaflet answers some common questions about VICTRELIS Capsules. It does not contain all of the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using VICTRELIS Capsules against the benefits they expect it will have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may want to read it again.

What VICTRELIS is used for?

VICTRELIS Capsules contain a medicine called boceprevir. VICTRELIS stops the multiplication of the hepatitis C virus. VICTRELIS works by lowering the amount of Hepatitis C Virus in your body.

VICTRELIS Capsules must only be used in combination with two other medicines (peginterferon alfa and ribavirin) for the treatment of chronic hepatitis C Type 1 virus infection in adults. Peginterferon alfa belongs to a group of medicines called interferons. Ribavirin is an antiviral agent.

Combination therapy with VICTRELIS Capsules is used for the treatment of chronic hepatitis C (a viral infection of the liver) Type 1 in patients (18 years or older) who have compensated liver disease and who either have not previously received, or have failed, interferon alfa treatment (pegylated or nonpegylated).

Before you use VICTRELIS Capsules

Since VICTRELIS must be taken in combination with peginterferon alfa and ribavirin, certain warning in this Consumer Medicine Information are detailed here because they relate to VICTRELIS or peginterferon alfa or ribavirin.

You must tell any doctor that is prescribing medicine to you about all the medicines you take, including VICTRELIS, other prescription and non-prescription medicines, vitamins and herbal supplements

Many prescription medicines, over the counter, and complementary medicines have the potential to interact with VICTRELIS. This can cause you to have too much or not enough VICTRELIS or your other medicines in your body, affecting the way VICTRELIS and your other medicines work, or causing side effects that can be serious or life-threatening. Do not start taking a new medicine without telling your healthcare provider or pharmacist.

When you must not use it:

Do not use VICTRELIS Capsules if you are allergic to boceprevir or any of the ingredients listed at the end of this leaflet.

VICTRELIS Capsules are not suitable for patients with certain other past or present serious illness.

You must mention any past or present serious illness to your doctor.

Do not use VICTRELIS Capsules in combination with peginterferon alfa and/or ribavirin if you are or your partner is pregnant or planning to become pregnant. This applies to both female patients and to partners of male patients using VICTRELIS Capsules in combination with peginterferon alfa and ribavirin.

It is very important that you or your partner avoid becoming pregnant during treatment and for 6 months after treatment. This is because ribavirin can affect the sperm as well as the unborn child.

Do not use VICTRELIS Capsules in combination with peginterferon alfa and/or ribavirin if you are breastfeeding. VICTRELIS Capsules in combination with peginterferon alfa and/or ribavirin are not recommended for use while breastfeeding. Ask your doctor about the risks and benefits involved.

Do not use VICTRELIS Capsules in combination with peginterferon alfa and ribavirin if you have any of these medical conditions:

serious liver problems other than chronic hepatitis C
autoimmune hepatitis or any other problem with your immune system

Do not use VICTRELIS Capsules in combination with peginterferon alfa and ribavirin if you are presently taking or have been treated recently with any of the following medications:

oral midazolam, oral triazolam (a sedative, when given by mouth)
amiodarone (used for heart-beat problems)
lurasidone (used for mental health problems)
‘ergot’ type medicines, such as dihydro-ergotamine mesylate or ergotamine tartrate
sildenafil, tadalafil (when used to treat pulmonary arterial hypertension)
alfuzosin, doxazosin, silodosin and tamsulosin (used to treat an enlarged prostate)
simvastatin, lovastatin (used to treat high cholesterol)
cisapride (used to treat stomach problems).

You must tell any doctor that is prescribing medicine to you about all the medicines you take, including VICTRELIS, other prescription and non-prescription medicines, vitamins and herbal supplements.

Tell your doctor if you are taking any of the following medicines since they may interact with VICTRELIS:

birth control medicines
medicines for tuberculosis (e.g. rifampicin)
medicines for epilepsy (such as phenytoin, phenobarbital, carbamazepine)
antimicrobial medicine – pentamidine
quinidine (used for heart-beat problems)
methadone
medicines for certain psychiatric problems (neuroleptics)
medicines for HIV infections
medicines used to decrease blood pressure – calcium channel blockers (e.g., amlodipine, diltiazem, felodipine, nicardipine, nifedipine, nisoldipine, verapamil)
medicines used to treat high cholesterol (statins)
immunosuppressants (cyclosporine, sirolimus, tacrolimus)

Do not use VICTRELIS Capsules if you have any of the following hereditary disorders:

Galactose intolerance (the body is unable to absorb galactose)
Lapp lactase deficiency (the body is unable to digest milk and milk products)
Glucose-galactose malabsorption (the small intestine is unable to transport and absorb glucose and galactose).

Do not use VICTRELIS Capsules:

if the packaging is torn or shows signs of tampering.
after the expiry date (EXP) printed on the packs has passed.
If you use it after the expiry date it may not work as well.

If you are not sure whether you should start using VICTRELIS Capsules, talk to your doctor.

Before you start to use it

It is very important that you or your partner have a negative pregnancy test before treatment with ribavirin starts. You or your partner must also have a negative pregnancy test each month during treatment and for the 6 months after treatment is stopped. Two effective forms of contraception must be used, one by each partner, male and female, during treatment with ribavirin and for the 6 months after treatment is completed. Ribavirin can cause harm to the unborn child if a pregnant woman takes ribavirin herself during pregnancy or has unprotected sex (sex without using a condom) with a man who is taking ribavirin. Ribavirin can damage the sperm and the embryo (unborn child).

Do not use VICTRELIS Capsules in combination with peginterferon alpha and ribavirin if you are breastfeeding. VICTRELIS Capsules in combination with peginterferon alpha and ribavirin are not recommended for use while breastfeeding. Ask your doctor about the risks and benefits involved.

You must tell your doctor before starting treatment with VICTRELIS Capsules in combination with peginterferon alfa and ribavirin:

if you are allergic to any other medicines or any food, dyes or preservatives.
if you have any liver problems (besides hepatitis C)
if you are taking any medicines, including certain birth control medicines and medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.

Please read the Consumer Medicine Information for peginterferon alpha and ribavirin for other things to be careful of when VICTRELIS Capsules are used in combination with peginterferon and ribavirin.

Use in Children

VICTRELIS Capsules are not recommended for use in patients under 18 years of age.

How to use VICTRELIS Capsules

Use VICTRELIS Capsules exactly as your doctor has directed.

Routine blood tests will help your doctor to monitor your response to treatment.

Do not exceed the recommended dosage.

How many VICTRELIS Capsules to take

The usual dose is four capsules orally, three times a day. However, your doctor may prescribe a different dose.

How to take the capsules

Peel the back of the tab to remove the capsule. Do not push the capsule through the blister.

VICTRELIS Capsules should be taken in the morning, the afternoon and the evening with food.

Swallow the capsules whole with water.

How long to use VICTRELIS Capsules

Do not stop using this medicine without first checking with your doctor. Your doctor will determine when your treatment should be stopped.

If you forget to use VICTRELIS Capsules

If you miss a dose of VICTRELIS Capsules and

it is more than 2 hours before your next dose is due, take the missed dose with food. Then continue taking your capsules as normal.
it is less than 2 hours before your next dose is due, the missed dose should be skipped.

Do not double the next dose to make up for the dose that you missed.

If you have trouble remembering when to use your medicine, ask your pharmacist for some hints.

If you use too much (overdose)

Immediately telephone your doctor or Poisons Information Centre (telephone number for Australia: 13 11 26) for advice, or go to the Emergency Department at your nearest hospital. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Keep the telephone number handy.

While you are using VICTRELIS Capsules

Things you must do

Use VICTRELIS Capsules exactly as your doctor has prescribed.

Tell your doctor immediately if you have an allergic reaction.

Symptoms of an allergic reaction may include:

hives, itching or skin rash
swelling of the face, lips or tongue. This may lead to difficulty in swallowing.
shortness of breath, wheezing, difficulty in breathing or a tight feeling in your chest.

Tell all doctors, dentists and pharmacists who are treating you that you are using VICTRELIS Capsules.

Stop using VICTRELIS Capsules in combination with ribavirin if you become pregnant and immediately tell your doctor. If your partner becomes pregnant while you are using VICTRELIS Capsules in combination with ribavirin, ask your partner to tell her doctor immediately.

Keep all your doctor’s appointments so that your progress can be checked. Your doctor will carry out blood tests to monitor your response to treatment.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking VICTRELIS Capsules.

If you plan to have surgery that needs a general anaesthetic, tell your doctor or dentist that you are using this medicine.

Things you must not do

VICTRELIS Capsules do not affect your ability to drive or use machines. However, peginterferon alfa injections may cause dizziness and tiredness in some people. If you become drowsy from the combination therapy, do not drive or use machinery.

Do not use it to treat any other complaints.

Do not give this therapy to anyone else, even if their symptoms seem similar to yours.

Do not let yourself run out of medicine over weekends or holiday periods.

Check with your doctor immediately:

if you notice any signs of anaemia, such as tiredness, being short of breath, and looking pale.

Side effects

All medicines have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Ask your doctor or pharmacist any questions you may have.

Stop taking VICTRELIS Capsules, in combination with peginterferon alpha and ribavirin, and tell your doctor immediately if you suddenly get an itchy rash, swelling of the face, lips or tongue, wheezing or troubled breathing or faintness. These could be signs of a serious allergic reaction.

Check with your doctor IMMEDIATELY if any of the following side effects occurs:

signs of anaemia such as tiredness, being short of breath and looking pale
signs of a low number of white blood cells such as getting more infections than usual
signs of a low number of platelets, red and white blood cell counts (pancytopenia) such as tiredness, being short of breath and looking pale, getting more infections than usual, and bruising easily
signs that your liver is not working properly (decompensation) including swollen abdomen, swelling of the legs, bruising, vomiting blood and difficulty is staying awake or alert

You may need urgent medical attention.

Tell your doctor if you notice any of the following and they worry you:

flu-like symptoms such as headache, fatigue, fever and chills
shortness of breath, shortness of breath while exercising, dizziness
cough, dry mouth or taste change
thirst
weight loss, loss of appetite
nausea (feeling sick), vomiting or diarrhoea/intestinal gas
unusual weakness, painful and swollen joints, muscular ache and pain
not being able to sleep, depression, anxiety, irritability
hair loss/change in hair texture, itching, rash or dry of the skin

The following additional side effects have been reported in general use with VICTRELIS in combination with peginterferon alpha and ribavirin:

hives
mouth ulcers
sore mouth
serious skin reactions, including blistering and peeling of the skin
infection of the blood
pneumonia

Other side effects not listed above may also occur in some patients. If you notice any other side effects, check with your doctor.

Check with your doctor as soon as possible if you have any problems while using the combination therapy, even if you do not think the problems are connected with the medicines.

Do not be alarmed by the list of possible side effects. You may not experience any of them.

After using VICTRELIS Capsules

Storage

Keep VICTRELIS Capsules where children cannot reach.

VICTRELIS Capsules are to be stored at 2-8°C until dispensed to the patient.

For patient use, VICTRELIS Capsules may be stored in the refrigerator until the expiration date printed on the label.

After being dispensed to patients, VICTRELIS Capsules can be stored below 30°C for up to 3 months.

Store in the original packaging.

Do not store the capsules in the bathroom or near a sink. Heat and dampness can destroy some medicines.

A locked cupboard at least 1.5 metres above the ground is a good place to store medicines.

Disposal

Return any unused medicine to your pharmacist.

Product description

What it looks like

VICTRELIS Capsules are comprised of a yellowish-brown, opaque cap with an “MSD” logo imprinted in red ink and off-white, opaque body with the code “314” imprinted in red ink.

The capsules are packaged in blister packs of 84 capsules. Each blister tray contains three pouches with each pouch containing four capsules. The available pack size is 336 capsules (four week pack).

Ingredients

Each VICTRELIS Capsule contains:

boceprevir 200mg
sodium lauryl sulfate
microcrystalline cellulose
lactose monohydrate
croscarmellose sodium
pre-gelatinized starch
magnesium stearate

The VICTRELIS yellowish-brown capsule cap contains:

gelatin
titanium dioxide
E172 Red Iron Oxide E172 Yellow Iron Oxide

The VICTRELIS off-white opaque capsule body contains:

gelatine
titanium dioxide
E172 Yellow Iron Oxide

The capsule is printed with red ink. The red ink contains shellac, ethanol anhydrous and isopropyl alcohol.

Supplier

Merck Sharp & Dohme (Australia) Pty Limited
Level 1 Building A
26 Talavera Road
Macquarie Park NSW 2113
Australia

Australian Registration Number

AUST R 179059

Date of Preparation

February 2017

Published by MIMS June 2017