Simplified at last.

Now, just two tablets a day instead of up to six^1,2

• RibaPak™ (ribavirin) is the first 400 mg and 600 mg ribavirin tablets for chronic hepatitis C virus infection
• Treatment with RibaPak requires up to 66% fewer tablets than with Copegus® (ribavirin, USP)*

Tablets required for treatment^1,2

*Copegus is a registered trademark of Hoffmann-La Roche.

• Each RibaPak 400 mg and 600 mg tablet is comparable to two or three 200 mg tablets of Copegus³
• Seven-day dose-at-a-glance package minimizes confusion and helps you keep track of every tablet taken
• Fewer tablets, easy to use—and cost-effective

Ask your healthcare provider about simplified hepatitis C dosing with RibaPak.

For more information and support, contact the following organizations:

American Liver Foundation
liverfoundation.org

Centers for Disease Control and Prevention
cdc.gov/ncidod/diseases/hepatitis/index.htm

Veteran Affairs National Hepatitis C Program
hepatitis.va.gov

Hepatitis C Outreach Project
hcop.org

Hepatitis Foundation International
hepfi.org

National Hepatitis C Coalition
nationalhepatitis-c.org

For more information about RibaPak, visit www.ribapak.com or call 1-800-828-9393.

RibaPak in combination with peginterferon alfa-2a is indicated for the treatment of adults with chronic hepatitis C virus infection who have compensated liver disease and have not been previously treated with interferon alpha. Patients in whom efficacy was demonstrated included patients with compensated liver disease and histological evidence of cirrhosis (Child-Pugh class A). RibaPak should be taken with food.

Please see Important Safety Information, including the boxed WARNING for hemolytic anemia and use in pregnancy. RibaPak must not be used alone because ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus infection. RibaPak must be used in combination with peginterferon alfa-2a. Please see the complete Prescribing Information for RibaPak. The peginterferon alfa-2a package insert and Medication Guide should also be reviewed in their entirety prior to initiation of combination treatment for additional safety information.

References: 1. RibaPak Prescribing Information. Par Pharmaceutical Companies, Inc. 2005. 2. Copegus Prescribing Information. Hoffmann-La Roche Inc. 2005. 3. Data on file. Par Pharmaceutical Companies, Inc.

Important Safety Information for Patients

What is the most important information I should know about RibaPak™ (ribavirin)?

1. RibaPak may cause birth defects or death of an unborn child. Therefore, if you are pregnant or your partner is pregnant or plans to become pregnant, do not take RibaPak. Female patients and female partners of male patients being treated with RibaPak must not become pregnant during treatment and for 6 months after treatment has stopped.
   
   Before and during the treatment period you must have pregnancy tests that show you are not pregnant. You must also use 2 effective forms of birth control during therapy and for 6 months after stopping therapy. Male patients should use a condom with spermicide as one of the two forms.
   
   If you or a female sexual partner becomes pregnant, you should tell your healthcare provider right away. There is a Ribavirin Pregnancy Registry that collects information about pregnancy outcomes of female patients and female partners of male patients exposed to ribavirin. You or your healthcare provider are encouraged to contact the Registry at 1-800-593-2214.
   
2. RibaPak can cause a dangerous drop in your red blood cell count. RibaPak can cause anemia, which is a decrease in the number of red blood cells. This can be dangerous, especially if you have heart or breathing problems. This may cause a worsening of heart (cardiovascular) or circulatory problems. Some patients may get chest pain and rarely, a heart attack. Patients with a history of heart disease have the highest chance of this. Tell you healthcare provider, before taking RibaPak if you have or have ever had any heart or breathing problems. Your healthcare provider should check your red blood cell count before you start treatment with RibaPak and often during the first 4 weeks of treatment. Your red blood cell count may be done more often if you have any heart or breathing problems.
   
3. Do not take RibaPak alone to treat hepatitis C virus infection. RibaPak does not treat hepatitis C virus infections by itself. RibaPak should be used in combination with peginterferon alfa-2a to treat continuing (chronic) hepatitis C virus infections. You should read the Medication Guide for peginterferon alfa-2a because it has additional important information about treatment that is not covered in this Medication Guide. Your healthcare provider or pharmacist should give you a copy of the peginterferon alfa-2a Medication Guide.

Who should not take RibaPak?

Do not use RibaPak if:

• You are a female patient and you are pregnant or plan to become pregnant during treatment or during the 6 months after your treatment has ended.
• You are a male patient with a female sexual partner who is pregnant or plans to become pregnant at any time while you are being treated with RibaPak or during the 6 months after your treatment has ended.
• You are breast feeding. We do not know if RibaPak can pass through your milk and if it can harm your baby. You will need to choose either to breast-feed or take RibaPak, but not both.
• You have a liver disease called autoimmune hepatitis (hepatitis caused by your immune system attacking your liver).
• You have unstable or severe liver disease.
• You are allergic to any of the ingredients in RibaPak. The active ingredient in RibaPak is ribavirin. See the Medication Guide for a list of all the ingredients in RibaPak.

Tell your healthcare provider before starting treatment with RibaPak in combination with peginterferon alfa-2a (see the peginterferon alfa-2a Medication Guide) if you have or had any of the following medical conditions because treatment may make some conditions worse:

• mental health problems, such as depression or anxiety
• high blood pressure, heart problems or have had a heart attack
• blood disorders including anemia (low red blood cell count), thalassemia (Mediterranean anemia) and sickle-cell anemia
• kidney problems
• liver problems
• organ transplant
• thyroid disease
• have or had drug or alcohol addiction or abuse
• cancer
• infection with hepatitis B virus
• diabetes
• past interferon treatment for hepatitis C virus infection that did not work for you.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins or herbal supplements.

What are the possible side effects of RibaPak?

The most serious side effects of RibaPak are:

• Harm to unborn children. RibaPak may cause birth defects or death of an unborn child.
• Anemia. Anemia is the reduction of red blood cells you have. Anemia can be dangerous, especially if you have heart or breathing problems. Tell your healthcare provider right away if you feel tired, have chest pain or shortness of breath. These may be signs of low red blood cell counts.
• Liver problems. Some patients may develop worsening of liver function. Some of the symptoms may include stomach bloating, confusion, brown urine, and yellow eyes. Tell your healthcare provider immediately if any of these symptoms occur.

Call your healthcare provider right away if you have any of the following symptoms. They may be signs of a serious side effect of RibaPak and peginterferon alfa-2a treatment.

• trouble breathing
• hives or swelling
• chest pain
• severe stomach pain or low back pain
• bloody diarrhea or bloody stools (bowel movements). These may look like black tar.
• bruising or unusual bleeding
• change in your vision
• high fever (temperature greater than 100.5°F)
• you have psoriasis (a skin disease) and it gets worse
• you become very depressed or think about suicide (ending your life)

The most common side effects of RibaPak are likely to be the same as for other ribavirin products. These are:

• feeling tired
• nausea and appetite loss
• rash and itching
• cough

These are not all the possible side effects of RibaPak treatment. Take RibaPak with food. Do not drink alcohol while taking RibaPak. For more information, ask your doctor or pharmacist and see the peginterferon alfa-2a Medication Guide.

Important Safety Information for Healthcare Professionals

Contraindications

RibaPak is contraindicated in patients with known hypersensitivity to RibaPak or to any component of the tablet, women who are pregnant, men whose female partners are pregnant, and patients with hemoglobinopathies (eg, thalassemia major or sickle cell anemia). RibaPak and peginterferon alfa-2a combination therapy is contraindicated in patients with autoimmune hepatitis or hepatic decompensation (Child-Pugh score greater than 6; class B and C) in cirrhotic chronic hepatitis C monoinfected patients before or during treatment.

WARNINGS

RibaPak must not be used alone because ribavirin monotherapy is not effective for the treatment of chronic hepatitis C virus infection. The safety and efficacy of ribavirin have only been established when used together with peginterferon alfa-2a, recombinant.

BECAUSE THE INITIAL DROP IN HEMOGLOBIN MAY BE SIGNIFICANT, IT IS ADVISED THAT HEMOGLOBIN OR HEMATOCRIT BE OBTAINED PRETREATMENT AND AT WEEK 2 AND WEEK 4 OF THERAPY OR MORE FREQUENTLY IF CLINICALLY INDICATED.

RibaPak and peginterferon alfa-2a should be discontinued in patients who develop evidence of hepatic decompensation during treatment.

There are significant adverse events caused by ribavirin/peginterferon alfa-2a therapy, including severe depression and suicidal ideation, hemolytic anemia, suppression of bone marrow function, autoimmune and infectious disorders, pulmonary dysfunction, pancreatitis, and diabetes. The peginterferon alfa-2a package insert and Medication Guide should be reviewed in their entirety prior to initiation of combination treatment for additional safety information.

RibaPak THERAPY SHOULD NOT BE STARTED UNLESS A REPORT OF A NEGATIVE PREGNANCY TEST HAS BEEN OBTAINED IMMEDIATELY PRIOR TO PLANNED INITIATION OF THERAPY. Patients should be instructed that RibaPak may cause birth defects and/or death to the exposed fetus and to use at least two forms of effective contraception during treatment and for 6 months after treatment has been stopped. Pregnancy testing should occur monthly during RibaPak therapy and for 6 months after therapy has stopped (see CONTRAINDICATIONS and PRECAUTIONS: Information for Patients, and Pregnancy: Category X in complete Prescribing Information).

Adverse Reactions

The most common adverse events reported for ribavirin/peginterferon alfa-2a combination therapy observed in clinical trials (N=451) were fatigue/asthenia (65%), headache (43%), pyrexia (41%), myalgia (40%), irritability/anxiety/nervousness (33%), insomnia (30%), alopecia (28%), neutropenia (27%), nausea/vomiting (25%), rigors (25%), anorexia (24%), injection site reaction (23%), arthralgia (22%), depression (20%), pruritus (19%), and dermatitis (16%).

In all studies, one or more serious adverse reactions occurred in 10% of chronic hepatitis C monoinfected patients receiving peginterferon alfa-2a alone or in combination with ribavirin. The most common serious adverse event (3%) was bacterial infection (eg, sepsis, osteomyelitis, endocarditis, pyelonephritis, pneumonia). Other serious adverse events occurred at a frequency of <1% and included: suicide, suicidal ideation, psychosis, aggression, anxiety, drug abuse and drug overdose, angina, hepatic dysfunction, fatty liver, cholangitis, arrhythmia, diabetes mellitus, autoimmune phenomena (eg, hyperthyroidism, hypothyroidism, sarcoidosis, systemic lupus erythematosus, rheumatoid arthritis), peripheral neuropathy, aplastic anemia, peptic ulcer, gastrointestinal bleeding, pancreatitis, colitis, corneal ulcer, pulmonary embolism, coma, myositis, and cerebral hemorrhage, and thrombotic thrombocytopenic purpura.

Please see accompanying complete Prescribing Information for RibaPak. The peginterferon alfa-2a package insert and Medication Guide should also be reviewed in their entirety prior to initiation of combination treatment for additional safety information.