How does this medication work? What will it do for me?
Boceprevir, peginterferon alfa-2b and ribavirin are three medications that work in combination to help the immune system fight the hepatitis C virus by making it harder for the virus to reproduce within the body. Boceprevir belongs to the class of medications known as protease inhibitors. Protease is an enzyme that viruses need for reproduction. Boceprevir blocks the action of protease, slowing the growth of the virus. Peginterferon alfa-2b belongs to the group of medications known as interferons. It works to help the body fight infections. Ribavirin belongs to the group of medications known as antivirals. It helps fight infection by interfering with the reproduction of the virus.
This combination medication is used to treat chronic (long-term) hepatitis C for people who have not been treated before, who have been treated with interferons and not responded well, and people with stable liver disease, including cirrhosis.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each hard gelatin capsule with an opaque yellowish-brown cap imprinted with the Merck logo in red ink and an opaque off-white body with the code “314” imprinted in red ink contains boceprevir 200 mg. Nonmedicinal ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pre-gelatinized starch, sodium lauryl sulfate, gelatin, red iron oxide, titanium dioxide, yellow iron oxide and shellac.
Peginterferon alfa-2b powder for solution in RediPen or Clearclick Delivery System
Pegetron Redipen or Clearclick Single-Dose Delivery System consists of a dual chamber glass cartridge with a chamber containing peginterferon alfa-2b as a white to off-white lyophilized powder and another chamber containing Sterile Water for Injection. The cartridge is provided in a pen device for reconstitution, dose preparation and subcutaneous administration, to deliver doses of 80, 100, 120 or 150 µg in 0.5 mL of reconstituted solution. Each Redipen contains 108, 135, 162 or 202.5 µg of peginterferon alfa-2b. Following reconstitution of the powder with the diluent contained within the cartridge, each Redipen gives a final volume of 0.675 mL for administration of up to 0.5 mL. The reconstituted solution contains 160, 200, 240, 300 µg / mL respectively. Nonmedicinal ingredients: sodium phosphate dibasic anhydrous, sodium phosphate monobasic dihydrate, sucrose, and polysorbate 80.
Each opaque, white, hard gelatin capsule, filled with a white powder and printed with the Schering-Plough logo and "200 mg" in blue ink, contains ribavirin 200 mg. Nonmedicinal ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, gelatin, silicon dioxide, sodium lauryl sulfate, and titanium dioxide.
How should I use this medication?This medication is available as a package containing boceprevir capsules, peginterferon alfa-2b injections, and ribavirin capsules.
The usual adult dose of boceprevir is 800 mg (four 200 mg capsules) taken three times a day with food such as a light meal or snack.
The ribavirin capsules are taken by mouth twice daily (morning and evening) with food. Dosing is based on body weight.
The injection is injected subcutaneously (under the skin) once weekly on the same day of the week. Dosing is based on body weight.
The doses of the ribavirin and peginterferon alfa-2b may vary depending on whether this is the first time you have been prescribed these medications and the strain of HCV being treated. It is important that the boceprevir dose is not reduced, as this may cause the treatment to fail.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
Boceprevir - peginterferon alfa-2b - ribavirin is used with the guidance and supervision of a doctor. Your doctor or nurse will assist you in the preparation and injection of your first dose (or first few doses). Do not attempt to inject this medication on your own until you completely understand how to inject a dose. If you are unsure of how to prepare or administer a dose, ask a health care professional to clarify for you.
Before injecting the prepared medication, check the solution to ensure that it is clear, colourless and completely dissolved. After the medication has been mixed, it should be used right away.
It is important to take this medication exactly as prescribed by your doctor. If you miss a dose of boceprevir, and it is more than 2 hours before the next dose is due, take it as soon as possible with food, and continue with your regular schedule. If it is less than 2 hours before the next dose is due, skip the missed dose and continue with your regular dosing schedule. If you miss a dose of peginterferon alfa-2b, take it as soon as possible and continue with your dosing schedule. If you miss a dose of ribavirin, take it as soon as possible and continue with your regular schedule. If you miss 2 doses, contact your doctor or pharmacist for advice. Do not take a double dose of any of these medications to make up for a missed one.
Store these medications in the refrigerator at 2°C to 8°C in their original containers. Boceprevir and ribavirin may be stored in their original containers at room temperature (15°C to 30°C) for up to 3 months if necessary. Protect these medications from light and moisture, and keep them out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not use boceprevir -peginterferon alfa-2b - ribavirin if you:
- are allergic to boceprevir, peginterferon alfa-2b, ribavirin, or any ingredients of the medication
- are allergic to any other interferon
- are breast-feeding
- you or your partner are pregnant or are planning to become pregnant during 6 months after treatment ends
- have liver disease caused by the body's immune system (autoimmune hepatitis)
- have worsening liver failure (decompensated liver disease)
- have epilepsy
- have or have had autoimmune diseases (including autoimmune hepatitis)
- have severe psychiatric conditions or a history of severe psychiatric disorder
- have severely reduced kidney function
- have uncontrolled thyroid disorders
- are taking any of the following medications:
- alpha blockers (e.g., alfuzosin, doxazosin, tamsulosin)
- ergotamine, dihydroergotamine or ergonovine
- lovastatin or simvastatin
- midazolam or triazolam
- sildenafil or tadalafil (for pulmonary arterial hypertension)
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- aggressive behavior
- blood pressure changes
- blurred vision
- changes in hearing
- inflammation of the bowel (e.g., abdominal pain, bloody diarrhea, fever)
- persistent cough
- severe headache
- signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
- signs of unusual bleeding (e.g., bloody diarrhea, blood in urine, pinpoint-sized red spots on skin, bleeding gums, unusual bruising or cuts that don't stop bleeding)
- signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
- signs of heart problems (e.g., unusual tiredness or weakness, chest pain, difficulty breathing, fast or irregular heartbeat, swelling of the feet, ankles, or lower leg)
- signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
- signs of lung problems (e.g., trouble breathing, infection, pneumonia, new or worsening pulmonary hypertension [high blood pressure in the lung])
- signs of kidney problems (e.g., difficulty urinating, painful urination, decreased urine production)
- signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
- symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- convulsions (seizures)
- severe, sudden signs of anemia
- signs of a serious allergic reaction (swelling of face or throat, hives, or difficulty breathing)
- signs of bleeding in the stomach (e.g., bloody, black, or tarry stools, spitting up of blood, vomiting blood or material that looks like coffee grounds)
- signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
- signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
- signs of stroke (e.g., sudden headache, weakness or numbness in an arm or leg, difficulty speaking or understanding, sudden vision difficulty, dizziness)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Allergic reaction: In rare cases, this medication may cause severe allergic reaction. If you notice hives, swelling of the face or throat, or difficulty breathing, stop using this medication and get medical help immediately.
Anemia: Boceprevir - peginterferon alfa-2b - ribavirinmay cause low levels of red blood cells, a condition called anemia. If you experience symptoms of anemia, such as dizziness, shortness of breath, feeling unusually tired or pale skin, contact your doctor as soon as possible.
Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood. If you have sickle cell disease or thalassemia, using boceprevir -peginterferon alfa-2b - ribavirin is not recommended.
Birth control: Treatment that includes boceprevir - peginterferon alfa-2b - ribavirin can cause severe birth defects to an unborn child. Both partners should use a reliable form of birth control while taking this medication and for 6 months afterwards (the time it takes for ribavirin to be cleared from the body). For women, your doctor will not give you boceprevir until you have had a negative pregnancy test. Your doctor should have you continue to do monthly pregnancy tests to ensure that you do not become pregnant while using this medication.
Methods of birth control that use hormones, such as a birth control pill, patch or injection, may not be fully reliable as boceprevir interacts with many medications and may change the way that your body uses the hormones. At least 2 forms of non-hormonal birth control (condom, diaphragm) must be used while you are taking this medication.
Colitis: There is a risk of developing serious forms of colitis with peginterferon alfa-2b treatment. The symptoms resolve when peginterferon alfa-2b treatment is stopped. If you experience symptoms of colitis such as abdominal pain, bloody diarrhea, and fever, contact your doctor immediately.
Diabetes: Boceprevir - peginterferon alpha-2b - ribavirin may cause an increase in blood sugar levels and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.
If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Depression and other psychiatric disorders: Peginterferon alfa-2b has been known to cause symptoms of depression and other psychiatric disorders. If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking this medication contact your doctor as soon as possible.
People with pre-existing psychiatric conditions or a history of a severe psychiatric disorder should not take this medication, as it may worsen these conditions. If you feel depressed, aggressive, or suicidal, or if you have hallucinations, stop using this medication and contact your doctor as soon as possible.
Fertility: This medication may impair fertility in men and women.
Flu-like symptoms: Peginterferon alfa-2b may cause a flu-like reaction, with aching muscles, fever, chills, and headache. Your doctor may prescribe acetaminophen before each dose of peginterferon alfa-2b and as needed to help reduce these symptoms.
Drowsiness/reduced alertness: This treatment may cause confusion, dizziness, fatigue or blurred vision. Do not drive, operate machinery, or perform other hazardous tasks until you have determined how this medication affects you.
Fluids: This medication may cause dehydration, which can lead to side effects such as dizziness and in severe cases, kidney problems. Make sure you are drinking adequate fluids, especially on hot days or when exercising.
Heart disease: If you have had a heart attack, heart disease, or changes in heart rhythm (arrhythmias), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
This medication may cause heart problems for people who have not had heart problems in the past. If you experience symptoms such as chest pain or pressure, difficulty breathing, pounding or irregular heartbeat, contact your doctor immediately.
Infection: Treatment with boceprevir - peginterferon alfa 2-b - ribavirin appears to reduce the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.
Infection with HIV or hepatitis B: The safety and effectiveness of treatment with boceprevir has not been established for people with who have hepatitis C and HIV and/or Hepatitis B.
Kidney disease: People with kidney disease should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. People with severely reduced kidney function should not use this medication.
Liver function: Peginterferon alfa-2b can cause decreased liver function. Your doctor will order blood tests check your liver function. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
If you experience signs of decreased liver function such as pale stools, dark urine, yellowing of the skin or eyes, contact your doctor as soon as possible.
Oral health: This medication can cause dry mouth which may lead to dental disease. Good oral hygiene, including regular brushing and flossing, should be practiced while using boceprevir - peginterferon alfa-2b - ribavirin.
Organ Transplantation: The safety and efficacy of boceprevir treatment has not been established for patients with liver or other organ transplants. Boceprevir may interact with medications used to prevent rejection of the transplanted organ. If you have had an organ transplant, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Other medical conditions: This medication may cause or worsen autoimmune disorders, lung problems, high cholesterol levels (specifically triglycerides), and circulation problems. If you have any of these conditions, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Pancreatitis: Interferon treatment can cause serious forms of pancreatitis (inflammation of the pancreas). If you have a history of, or are at risk for, developing pancreatitis, you should be closely monitored by your doctor while taking this medication. If you develop signs of pancreatitis (e.g., upper left abdominal pain, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen), contact your doctor.
Thyroid disease: Treatment with peginterferon alfa-2b may cause changes to the way your thyroid gland works. Your doctor will monitor your thyroid function with blood tests while you are taking this medication. If you have a history of thyroid disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Vision changes: Rarely, this medication can cause vision problems, such as loss of acuity or visual field. People taking this medication should have regular eye examinations and report any changes in vision to their doctor immediately.
Pregnancy: Neither boceprevir nor peginterferon alfa-2b have been studied for use by pregnant women. Ribavirin has been shown to cause serious problems in the developing fetus. The combination of boceprevir - peginterferon alfa-2b - ribavirin should not be used by pregnant women or by men whose partners are pregnant. Both partners should use a reliable form of birth control while taking this medication and for 6 months afterwards (the time it takes for ribavirin to be cleared from the body). Tell your doctor immediately if you become pregnant while using this medication.
Breast-feeding: It is not known if boceprevir, peginterferon alfa-2b or ribavirin pass into breast milk. Because side effects of this medication could be harmful to the baby, women should not breast-feed while using this medication.
Children and adolescents: The safety and effectiveness of using this medication have not been established for children and adolescents less than 18 years of age.
What other drugs could interact with this medication?There may be an interaction between boceprevir - peginterferon alfa-2b - ribavirin and any of the following:
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.