Ribavirin

What it is used for

Ribavirin for inhalation solution, USP is indicated for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to respiratory syncytial virus. Treatment early in the course of severe lower respiratory tract infection may be necessary to achieve efficacy. Only severe RSV lower respiratory tract infection should be treated with ribavirin for inhalation solution, USP.

The vast majority of infants and children with RSV infection have disease that is mild, self-limited, and does not require hospitalization or antiviral treatment. Many children with mild lower respiratory tract involvement will require shorter hospitalization than would be required for a full course of ribavirin for inhalation solution, USP aerosol (3 to 7 days) and should not be treated with the drug.

Thus the decision to treat with ribavirin for inhalation solution, USP should be based on the severity of the RSV infection. The presence of an underlying condition such as prematurity, immunosuppression or cardiopulmonary disease may increase the severity of clinical manifestations and complications of RSV infection. Use of aerosolized ribavirin for inhalation solution, USP in patients requiring mechanical ventilator assistance should be undertaken only by physicians and support staff familiar with this mode of administration and the specific ventilator being used (see WARNINGS, and DOSAGE AND ADMINISTRATION ).

Diagnosis RSV infection should be documented by a rapid diagnostic method such as demonstration of viral antigen in respiratory tract secretions by immunofluorescence 3,4 or ELISA 5 before or during the first 24 hours of treatment. Treatment may be initiated while awaiting rapid diagnostic test results. However, treatment should not be continued without documentation of RSV infection.

Non-culture antigen detection techniques may have false positive or false negative results. Assessment of the clinical situation, the time of year and other parameters may warrant reevaluation of the laboratory diagnosis. Description of Studies Non-Mechanically-Ventilated Infants: In two placebo controlled trials in infants hospitalized with RSV lower respiratory tract infection, aerosolized ribavirin for inhalation solution, USP treatment had a therapeutic effect, as judged by the reduction in severity of clinical manifestations of disease by treatment day 3.

3,4 Treatment was most effective when instituted within the first 3 days of clinical illness. Virus titers in respiratory secretions were also significantly reduced with ribavirin for inhalation solution, USP in one of these original studies. Additional controlled studies conducted since these initial trials of aerosolized ribavirin for inhalation solution, USP in the treatment of RSV infection have supported these data.

Mechanically-Ventilated Infants: A randomized, double-blind, placebo-controlled evaluation of aerosolized ribavirin for inhalation solution, USP at the recommended dose was conducted in 28 infants requiring mechanical ventilation for respiratory failure caused by documented RSV infection. Mean age was 1.4 months (SD, 1.7 months).

Seven patients had underlying diseases predisposing them to severe infection and 21 were previously normal. Aerosolized ribavirin for inhalation solution, USP treatment significantly decreased the duration of mechanical ventilation required (4.9 vs. 9.9 days, p=0.01) and duration of required supplemental oxygen (8.7 vs.

13.5 days, p=0.01). Intensive patient management and monitoring techniques were employed in this study. These included endotracheal tube suctioning every 1 to 2 hours; recording of proximal airway pressure, ventilatory rate, and F l O 2 every hour; and arterial blood gas monitoring every 2 to 6 hours. To reduce the risk of ribavirin for inhalation solution, USP precipitation and ventilator malfunction, heated wire tubing, two bacterial filters connected in series in the expiratory limb of the ventilator (with filt

The most important thing to know

1. Ribavirin capsules may cause birth defects, miscarriage or death of your unborn baby. Do not take ribavirin capsules if you or your sexual partner is pregnant or plan to become pregnant.

In females: Do not become pregnant during treatment or within 9 months after you stop treatment with ribavirin capsules.

• Females must have a pregnancy test before starting ribavirin capsules, during treatment with ribavirin capsules, and for 9 months after you stop treatment with ribavirin capsules.
• You must use effective birth control during treatment and for 9 months after you stop treatment with ribavirin capsules.

In males: Your sexual partner should not become pregnant during your treatment or within 6 months after you stop treatment with ribavirin capsules. You and your female sexual partner must use effective birth control during treatment and for 6 months after you stop treatment with ribavirin capsules.

Tell your healthcare provider right away if:

• You become pregnant during treatment or within 9 months after you stop taking ribavirin capsules.
• Your female sexual partner becomes pregnant during your treatment or within 6 months after you stop treatment with ribavirin capsules.

2. Ribavirin capsules may cause a significant drop in your red blood cell count and cause anemia in some cases. Anemia has been associated with worsening of heart problems, and in rare cases can cause a heart attack and death. Tell your healthcare provider if you have ever had any heart problems. Ribavirin capsules may not be right for you. Get medical help right away if you experience chest pain. 3. Do not take ribavirin capsules alone to treat chronic hepatitis C infection. Ribavirin capsules should be used in combination with either interferon alfa-2b or peginterferon alfa-2b to treat chronic hepatitis C infection. What are ribavirin capsules?

Ribavirin capsules are a medicine used with either interferon alfa-2b or peginterferon alfa-2b to treat chronic (lasting a long time) hepatitis C infection in people 3 years and older with liver disease.

It is not known if ribavirin capsules use for longer than 1 year is safe and will work.

It is not known if ribavirin capsules use in children younger than 3 years old is safe and will work.

How to take it

• Take ribavirin capsules exactly as your healthcare provider tells you. Your healthcare provider will tell you how much ribavirin capsules to take and when to take them.
• Take ribavirin capsules with food.
• Take ribavirin capsules whole. Do not open, break, or crush ribavirin capsules before swallowing. If you cannot swallow ribavirin capsules whole, tell your healthcare provider.
• If you miss a dose of ribavirin capsules, 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 ribavirin capsules, call your healthcare provider or go to the nearest hospital emergency room right away.

Side effects, and when to stop

Ribavirin capsules may cause serious side effects, including:

• Swelling and irritation of your pancreas (pancreatitis). Symptoms may include: stomach pain, nausea, vomiting, or diarrhea.
• 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.
• Dental problems. Brush your teeth well 2 times each day. Get regular dental exams. If you vomit at any time during treatment with ribavirin capsules, rinse out your mouth well.
• Severe blood disorders. You may have an increased risk of developing severe blood disorders when ribavirin capsules is used in combination with pegylated alpha interferons and azathioprine. Your healthcare provider should do blood tests during your treatment with ribavirin capsules in combination with pegylated alpha interferon and azathioprine to check you for these problems.
• Growth problems in children. Weight loss and slowed growth are common in children during combination treatment with ribavirin capsules and peginterferon alfa-2b or interferon alfa-2b. Most children will go through a growth spurt and gain weight after treatment stops. Some children may not reach the height that they were expected to have before treatment. Talk to your healthcare provider if you are concerned about your child’s growth during treatment with ribavirin capsules and peginterferon alfa-2b or with ribavirin capsules and interferon alfa-2b.
• Severe depression.
• Thoughts of hurting yourself or others, and suicide attempts. Adults and children who take ribavirin capsules, especially teenagers, are more likely to have suicidal thoughts or attempt to hurt themselves during treatment with ribavirin capsules. Call your healthcare provider right away or go to the nearest hospital emergency room if you have new or worse depression or thoughts about hurting yourself or others or dying.

The most common side effects of ribavirin capsules in adults include:

• flu-like symptoms - feeling tired or weak, headache, shaking chills along with high temperature (fever), nausea, and muscle aches
• mood changes, feeling irritable

The most common side effects of ribavirin capsules in children include:

• fever
• headache
• a decrease in blood cells that fight infection (neutropenia)
• tiredness
• decreased appetite
• vomiting

These are not all the possible side effects of ribavirin capsules. For more information ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Who should not take it

Do not take ribavirin capsules if you have:

• ever had serious allergic reactions to the ingredients in ribavirin capsules. See the end of this Medication Guide for a complete list of ingredients.
• certain types of hepatitis (autoimmune hepatitis).
• certain blood disorders (hemoglobinopathies).
• severe kidney disease.
• taken or currently take didanosine.

Talk to your healthcare provider before taking ribavirin capsules if you have any of these conditions.

What to say before you start

Before you take ribavirin capsules, tell your healthcare provider if you have or ever had:

• treatment for hepatitis C that did not work for you
• breathing problems. Ribavirin capsules may cause or worsen breathing problems you already have.
• vision problems. Ribavirin capsules may cause eye problems or worsen eye problems you already have. You should have an eye exam before you start treatment with ribavirin capsules.
• certain blood disorders such as anemia (low red blood cell count)
• high blood pressure, heart problems, or have had a heart attack. Your healthcare provider should check your blood and heart before you start treatment with ribavirin capsules.
• thyroid problems
• liver problems other than hepatitis C infection
• human immunodeficiency virus (HIV) or any immunity problems
• mental health problems, including depression and thoughts of hurting yourself or others
• kidney problems
• an organ transplant
• diabetes. Ribavirin capsules may make your diabetes worse or harder to treat.
• any other medical condition
• are breastfeeding. It is not known if ribavirin passes into your breast milk. You and your healthcare provider should decide if you will take ribavirin capsules or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription medicines, vitamins, and herbal supplements. Ribavirin capsules may affect the way other medicines work.

Especially tell your healthcare provider if you take didanosine or a medicine that contains azathioprine.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

Storing it

• Store ribavirin capsules at room temperature between 68°F to 77°F (20°C to 25°C).

Keep ribavirin capsules and all medicines out of the reach of children.

General information about the safe and effective use of ribavirin capsules. It is not known if treatment with ribavirin capsules will cure hepatitis C virus infections or prevent cirrhosis, liver failure, or liver cancer that can be caused by hepatitis C virus infections. It is not known if taking ribavirin capsules will prevent you from infecting another person with the hepatitis C virus. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ribavirin capsules for a condition for which it was not prescribed. Do not give ribavirin capsules to other people, even if they have the same symptoms that you have. They may harm them. You can ask your pharmacist or healthcare provider for information about ribavirin capsules that is written for health professionals.