Patient Medication Information: uses, side effects, how to take - Ibavyr
What is IBAVYR used for?
IBAVYR is used in adults to treat chronic hepatitis C (CHC) infection. It is used along with other medicines.
You will be started on your treatment with IBAVYR by a doctor who has experience in treating CHC infection.
How does IBAVYR work?
IBAVYR works by reducing the amount of hepatitis C virus in your body. The exact way IBAVYR works is not completely known. It may stop the virus from making more copies of itself in the body.
Serious Warnings and Precautions
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What are the ingredients in IBAVYR?
Medicinal ingredients: Ribavirin
Non-medicinal ingredients:
200 mg tablets: Colloidal Silicon Dioxide, Crospovidone, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Sodium Croscarmellose, Talc, Titanium Dioxide.
400 mg tablets: Colloidal Silicon Dioxide, Crospovidone, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Red Iron Oxide, Sodium Croscarmellose, Titanium Dioxide, Yellow Iron Oxide.
600 mg tablets: Colloidal Silicon Dioxide, Crospovidone, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Sodium Croscarmellose, Talc, Titanium Dioxide.
IBAVYR comes in the following dosage forms:
Tablets: 200 mg, 400 mg, 600 mg
Do not use IBAVYR if:
- you are allergic to ribavarin
- you are allergic to any of the other ingredients in IBAVYR or to any part of the container.
- you are pregnant or planning to become pregnant
- you are a male and have a female partner who is pregnant or is planning to become pregnant
- you have a blood disorder known as a hemoglobinopathy such as thalassemia or sickle cell anemia
- you are taking didanosine, a medicine used to treat HIV.
Read the Patient Medication Information for the other medicines that you take along with IBAVYR. Talk to your healthcare professional for more information.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take IBAVYR. Talk about any health conditions or problems you may have, including if you:
- have a blood disorder such as anemia or low blood count
- have a history of any bleeding such as nosebleeds, bleeding from your gastrointestinal tract
- have any other medical condition
- have a heart problem or have had a heart problem in the past
- have kidney problems.
- have an organ transplant planned in the near future.
Other warnings you should know about:
Pregnancy and Birth Defects
Females:
IBAVYR can cause birth defects or death of your unborn baby. It must not be taken during pregnancy. If you are a woman of childbearing age who is taking IBAVYR, you must avoid pregnancy. Do not become pregnant during treatment with IBAVYR or within 6 months after stopping treatment. You must have a negative pregnancy test before you start taking IBAVYR and each month during treatment. Tell your healthcare professional right away if you become pregnant while taking IBAVYR. You must use two methods of effective birth control during treatment with IBAVYR and for six months after stopping treatment. Effective birth control includes a barrier method, such as a condom plus an additional method like birth control pills.
If you are taking IBAVYR and SOVALDI (sofosbuvir) together, you must use two (one for each partner) non-hormonal methods of effective birth control, such as the barrier method. Birth control pills may not be effective in women taking SOVALDI. Talk to your healthcare professional about pregnancy risk and effective methods of birth control.
Males:
IBAVYR must not be taken if your female partner is pregnant or planning to become pregnant. If you are a man, and you have a female partner who may become pregnant, you must avoid pregnancy. You or your partner must use two methods of effective birth control during the time you are taking IBAVYR and for six months after stopping treatment. In addition, your partner must be tested for pregnancy each month during your treatment and for the six months after treatment has stopped. Tell your healthcare professional right away if your partner becomes pregnant while you are taking IBAVYR. Talk to your healthcare professional about pregnancy risk and effective methods of birth control.
Blood and Heart Problems
Tell your doctor before taking IBAVYR if you have a heart problem or if you have had a heart problem in the past. Your healthcare professional might give you an electrocardiogram before you start taking IBAVYR and during treatment.
IBAVYR may cause anemia (low levels of red blood cells) within 1 to 2 weeks after you start treatment. Because this can be a serious problem, your doctor may give you a blood test to measure your levels of red blood cells before you start treatment and during the treatment. Your doctor will decide how often you will need these blood tests.
IBAVYR may cause other blood problems when it is taken with the medicine azathioprine. Some patients may develop a condition which affects bone marrow, resulting in low red blood cells and white blood cells in your body. If this happens to you, your doctor may stop your treatment.
Infecting others with hepatitis C virus:
IBAVYR does not stop you from spreading hepatitis C virus to others. You should avoid infecting others with hepatitis B virus. Always use condoms when you have sex. Never reuse or share needles or other injection equipment. Talk to your healthcare professional about preventing the spread of the hepatitis C virus.
Do not drink alcohol during your treatment with IBAVYR.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with IBAVYR:
- azathioprine, used to prevent organ rejection after transplantation.
- didanosine, used to treat Human Immunodeficiency Virus (HIV) infection.
- lamivudine, used to treat HIV.
- stavudine, used to treat HIV.
- zidovudine, used to treat HIV.
How to take IBAVYR:
- Always take IBAVYR exactly as your healthcare professional has told you to.
- Check with your healthcare professional or pharmacist if you are not sure.
- IBAVYR is not effective when used alone. It must always be used along with other medicines to treat chronic hepatitis C infections. Your healthcare professional will tell you what other medicines you must take with IBAVYR.
- IBAVYR should be taken twice a day (once in the morning and once in the evening).
- Always take IBAVYR with food.
Usual dose:
Adults
- Your healthcare professional will determine your dose based on your body weight, disease characteristics and your treatment regimen.
- Your healthcare professional will tell you how long you need to take IBAVYR. Over time, your doctor might change your dose.
Overdose:
| If you think you, or a person you are caring for, have taken too much IBAVYR, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
Missed Dose:
If you miss a dose of IBAVYR, take it as soon as you remember, and then take the next dose at your usual time. If it is almost time for the next dose (less than 6 hours before the next dose), wait and take the next dose at your usual time. Do not take two doses at the same time to make up for a missed dose.
What are possible side effects from using IBAVYR?
These are not all the possible side effects you may have when taking IBAVYR. If you experience any side effects not listed here, tell your healthcare professional.
Side effects when taken with other medications:
- tiredness
- headache
- difficulty sleeping
- nausea
- irritability
- itching (pruritus)
- influenza-like illness
- weakness
Serious side effects and what to do about them
| Symptom / effect* | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Anemia (low red blood cells): weakness, fatigue, shortness of breath, pale skin, dizziness | ✓ | ||
| Neutropenia (low white blood cells): increased infections, fatigue, fever, aches and pains and flue-like symptoms. | ✓ | ||
| Thrombocytopenia (low blood platelets): bruising or increased tendency to bleed, fatigue, weakness. | ✓ | ||
| Dyspnea (shortness of breath): tightening in the chest, difficulty breathing, feeling of suffocation. | ✓ | ||
| COMMON | |||
| Hemolytic anemia (loss of red blood cells): Abnormal paleness or lack of color of the skin, yellowish skin, eyes, and mouth (jaundice), dark-colored urine, fever, weakness, dizziness, increased | ✓ | ||
Serious side effects and what to do about them
| Symptom / effect* | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|
| Only if severe | In all cases | ||
|---|---|---|---|
| heart rate. Worsening of heart disease may occur, resulting in heart attack. | |||
| Skin disorders: blistering, peeling, or loosening of the skin; hives or welts; red skin lesions; a severe skin rash; sores or ulcers on the skin. | ✓ | ||
| Eye disorders: blurred vision, decreased vision, changes in vision. | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
- Store at room temperature (15 to 30°C).
- Keep the bottle tightly closed.
- Keep out of reach and sight or children.
- Bring unused and expired prescription drugs to your local pharmacist for proper disposal.
If you want more information about IBAVYR:
- Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this
- Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; or by calling the manufacturer’s phone number, 1-888-550-6060.
PENDOPHARM, Division of Pharmascience Inc.
Montréal, QC, Canada
H4P 2T4
www.pendopharm.com