MODERIBA Use and Important Safety Information
Moderiba™ (ribavirin, USP) is a prescription medicine used with another medicine called peginterferon alfa-2a to treat
chronic (lasting a long time) hepatitis C infection in people whose liver still works normally, and who have not been
treated before with a medicine called an interferon alpha. It is not known if Moderiba is safe and will work in children
under 5 years of age.
Important Safety Information
What is the most important information I should know about Moderiba?
- You should not take Moderiba alone to treat chronic hepatitis C infection.
- Moderiba may cause you to have a blood problem (hemolytic anemia) that can worsen any heart problems
you have, and cause you to have a heart attack or die.
- Tell your healthcare provider if you have ever had any heart problems. Moderiba may not be right for you. If you
experience chest pain while taking Moderiba, get emergency medical attention right away.
- Moderiba may cause birth defects or death of your unborn baby.
- If you are pregnant or your sexual partner is pregnant, do not take Moderiba. You or your sexual partner should not
become pregnant while you take Moderiba and for 6 months after treatment is over. You must use two forms of birth
control when you take Moderiba and for 6 months after treatment.
- Females must have a pregnancy test immediately before starting Moderiba, every month while taking Moderiba, and every month for 6 months after treatment with Moderiba.
- If you or your female sexual partner becomes pregnant while taking Moderiba or within 6 months after you stop taking Moderiba, tell your healthcare provider right away. You or your healthcare provider should contact the Ribavirin Pregnancy Registry by calling 1‑800‑593‑2214.
Who should not take Moderiba?
- Do not take Moderiba if you:
- have certain types of hepatitis caused by your immune system attacking your liver (autoimmune hepatitis)
- have certain blood disorders, such as thalassemia major or sickle-cell anemia (hemoglobinopathies)
- take didanosine (Videx® or Videx® EC)
What should I tell my healthcare provider BEFORE starting Moderiba?
- Before you take Moderiba, tell your healthcare provider if you have or have had:
- treatment for hepatitis C that did not work for you
- serious allergic reactions to Moderiba or any of the ingredients in Moderiba
- breathing problems. Moderiba may cause or worsen breathing problems you already have.
- vision problems. Moderiba may cause eye problems or worsen eye problems you already have. You should have an eye exam before you start treatment with Moderiba.
- certain blood disorders, such as anemia
- high blood pressure, heart problems, or have had a heart attack
- thyroid problems
- diabetes. Moderiba and peginterferon alfa-2a combination therapy may make your diabetes worse or harder to treat.
- liver problems other than hepatitis C virus infection
- human immunodeficiency virus (HIV) or other immunity problems
- mental health problems, including depression or thoughts of suicide
- kidney problems
- an organ transplant
- drug addiction or abuse
- hepatitis B virus infection
- are breastfeeding
- any other medical condition
- Also tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
- Especially tell your healthcare provider if you take any medicines to treat HIV or if you take azathioprine (Imuran®, Azasan®).
How should I take Moderiba?
- Take Moderiba exactly as your healthcare provider tells you. Your healthcare provider will tell you how much Moderiba to take and when to take it. For children 5 years of age and older, your healthcare provider will prescribe the dose of Moderiba based on weight.
- Take Moderiba with food.
- If you miss a dose of Moderiba, take the missed dose as soon as possible during the same day. Do not double the next dose. If you have questions about what to do, call your healthcare provider.
- If you take too much Moderiba, call your healthcare provider or local Poison Control Center right away, or go to the nearest hospital emergency room right away.
- Your healthcare provider should do blood tests before you start treatment with Moderiba, at weeks 2 and 4 of treatment, and then as needed to see how well you are tolerating treatment and to check for side effects. Your healthcare provider may change your dose of Moderiba based on blood test results or side effects you may have.
- If you have heart problems, your healthcare provider should check your heart by doing an electrocardiogram before you start treatment with Moderiba, and if needed during treatment.
What should I avoid while taking Moderiba?
- Moderiba can make you feel tired, dizzy, or confused. You should not drive or operate machinery if you have any of these symptoms.
- Do not drink alcohol, including beer, wine, and liquor. This may make your liver disease worse.
What are the possible side effects of Moderiba?
- Moderiba may cause serious side effects, including:
- Swelling and irritation of your pancreas (pancreatitis). You may have stomach pain, nausea, vomiting, or diarrhea.
- Severe allergic reactions. Symptoms may include hives; wheezing; trouble breathing; chest pain; swelling of your mouth, tongue, or lips; or severe rash.
- Serious breathing problems. Difficulty breathing may be a sign of a serious lung infection (pneumonia) that can lead to death.
- Serious eye problems that may lead to vision loss or blindness
- Liver problems. Some people may get worsening of liver function. Tell your healthcare provider right away if you have any of these symptoms: stomach bloating, confusion, brown urine, or yellow eyes.
- Severe depression
- Suicidal thoughts and attempts
- Effect on growth in children. Children can experience a delay in weight gain and height increase while being treated with peginterferon alfa-2a and Moderiba. Catch-up in growth happens after treatment stops, but some children may not reach the height that they were expected to have before treatment.
- Call your healthcare provider or get medical care right away if you develop any of the above symptoms.
- Common side effects of Moderiba taken with peginterferon alfa-2a include:
- flu-like symptoms: feeling tired, headache, shaking along with high temperature (fever), and muscle or joint aches
- mood changes, feeling irritable, anxiety, and difficulty sleeping
- loss of appetite, nausea, vomiting, and diarrhea
- hair loss
These are not all the possible side effects of Moderiba treatment.
This is the most important information you should know about Moderiba. For more information, talk to your healthcare provider. Also read the Medication Guide for PEGASYS® (peginterferon alfa-2a).
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.
If you cannot afford your medication, contact: www.pparx.org or call the toll-free phone number (1‑888‑4PPA‑NOW) for assistance.