Boceprevir
Consumer Medicine Information
NOTICE: This Consumer Medicine Information (CMI) is intended for persons
living in Australia. This page contains answers to some common
questions about . It does
not contain all the information that is known about
. It does not take the
place of talking to your doctor or pharmacist. All medicines have risks
and benefits. Your doctor has weighed the risk of you using this medicine
against the benefits he/she expects it will have for you. If you have
any concerns about using this medicine, ask your doctor or pharmacist.
Bookmark or print this page, you may need 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.
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)
'ergot' type medicines, such as dihydro-ergotamine mesylate or ergotamine tartrate
sildenafil, tadalafil (when used to treat pulmonary arterial hypertension)
alfuzosin (used to treat an enlarged prostate)
simvastatin, lovastatin (used to treat high cholesterol).
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.
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
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 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:
1.
if you are allergic to any other medicines or any food, dyes or preservatives.
2.
if you have any liver problems (besides hepatitis C)
3.
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.
While taking the combination of VICTRELIS with ribavirin and peginterferon alpha, serious allergic reactions have been reported.
Symptoms of an allergic reaction may include:
hives, itching or skin rash
swelling of the face, lips, tongue or throat. 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.
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.
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; hives; swelling of the face, lips, tongue or throat; 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 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 or peeling of the skin.
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.
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.
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
54-68 Ferndell Street,
South Granville, NSW 2142
Australia
Australian Registration Number
AUST R 179059
Date of Preparation
January 2013