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Ribasphere

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING

RIBASPHERE (ribavirin, USP) monotherapy is not effective for the treatment of chronic hepatitis C virus infection and should not be used alone for this indication (seeWARNINGS).
The primary clinical toxicity of ribavirin is hemolytic anemia. The anemia associated with ribavirin therapy may result in worsening of cardiac disease that has led to fatal and nonfatal myocardial infarctions. Patients with a history of significant or unstable cardiac disease should not be treated with ribavirin (seeWARNINGS,ADVERSE REACTIONS, andDOSAGE AND ADMINISTRATION).
Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin. In addition, ribavirin has a multiple dose half-life of 12 days, and it may persist in non-plasma compartments for as long as 6 months. Ribavirin therapy is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of therapy in both female patients and in female partners of male patients who are taking ribavirin therapy. At least two reliable forms of effective contraception must be utilized during treatment and during the 6-month posttreatment follow-up period (seeCONTRAINDICATIONS,WARNINGS, andPRECAUTIONS: Information for Patients, and Pregnancy: Category X).

RIBASPHERE DESCRIPTION


Ribasphere




Mechanism of Action


CLINICAL PHARMACOLOGY

Pharmacokinetics



PRECAUTIONSDOSAGE AND ADMINISTRATION

Elimination and Metabolism


USE IN SPECIFIC POPULATIONS


Race


Renal Dysfunction
WARNINGSDOSAGE AND ADMINISTRATION

Hepatic Impairment


Pediatric Patients


Elderly Patients


Gender


DRUG INTERACTIONS



Nucleoside Analogues

PRECAUTIONS: Drug Interactions

Drugs Metabolized by Cytochrome P450

PRECAUTIONS: Drug Interactions

CLINICAL STUDIES

HCV Patients

Table 1




HCV Genotypes

Table 2




Other Treatment Response Predictors




INDICATIONS & USAGE



RIBASPHERE CONTRAINDICATIONS


  • ●     Patients with known hypersensitivity to RIBASPHERE (ribavirin, USP) or to any component of the tablet.
  • ●     Women who are pregnant.
  • ●     Men whose female partners are pregnant.
  • ●     Patients with hemoglobinopathies (e.g., thalassemia major or sickle-cell anemia).

  • ●     Autoimmune hepatitis.
  • ●     Hepatic decompensation (Child-Pugh score greater than 6; class B and C) in cirrhotic CHC monoinfected patients before or during treatment.

WARNINGS

RIBASPHERE(ribavirin, USP) 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.

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 PEGASYS package insert and MEDICATION GUIDE should be reviewed in their entirety prior to initiation of combination treatment for additional safety information.

General


Pregnancy
Ribavirin may cause birth defects and/or death of the exposed fetus. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin has demonstrated significant teratogenic and/or embryocidal effects in all animal species in which adequate studies have been conducted. These effects occurred at doses as low as one twentieth of the recommended human dose of ribavirin. RIBASPHERE (ribavirin, USP) 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 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 RIBASPHERE (ribavirin, USP) therapy and for 6 months after therapy has stopped (seeCONTRAINDICATIONSandPRECAUTIONS: Information for Patientsand Pregnancy: Category X).

Anemia
The primary toxicity of ribavirin is hemolytic anemia (hemoglobin <10 g/dL), which was observed in approximately 13% of all ribavirin and peginterferon alfa-2a treated patients in clinical trials (seePRECAUTIONS: Laboratory Tests). The anemia associated with ribavirin occurs within 1 to 2 weeks of initiation of therapy. 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. Patients should then be followed as clinically appropriate.
Fatal and nonfatal myocardial infarctions have been reported in patients with anemia caused by ribavirin. Patients should be assessed for underlying cardiac disease before initiation of ribavirin therapy. Patients with pre-existing cardiac disease should have electrocardiograms administered before treatment, and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be suspended or discontinued (seeDOSAGE AND ADMINISTRATION: RIBASPHERE (ribavirin, USP) Dosage Modification Guidelines). Because cardiac disease may be worsened by drug induced anemia, patients with a history of significant or unstable cardiac disease should not use RIBASPHERE (ribavirin, USP) (seeADVERSE REACTIONS).

Hepatic Failure
CONTRAINDICATIONS

Hypersensitivity

ADVERSE REACTIONS: Postmarketing Experience

Pulmonary


Other

CLINICAL PHARMACOLOGY: Special Populations


PRECAUTIONS




INFORMATION FOR PATIENTS


CONTRAINDICATIONSWARNINGS
ADVERSE REACTIONSLaboratory Tests




LABORATORY TESTS




  • ●     Platelet countcells/mm3 (as low as 75,000 cells/mm3 in patients with cirrhosis)
  • ●     Absolute neutrophil count (ANC)cells/mm3
  • ●     TSH and T4 within normal limits or adequately controlled thyroid function
  • ●     ECG (seeWARNINGS)
  • ●     Hemoglobing/dL for women andg/dL for men in CHC monoinfected patients


DRUG INTERACTIONS



Nucleoside Analogues

WARNINGSPRECAUTIONSDOSAGE AND ADMINISTRATION: Dose Modifications

CLINICAL PHARMACOLOGY: Drug Interactions





CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

Carcinogenesis


Mutagenesis


Impairment of Fertility




PREGNANCY

CONTRAINDICATIONS










NURSING MOTHERS



PEDIATRIC USE



GERIATRIC USE

CLINICAL PHARMACOLOGY: Special Populations

Effect of Gender


RIBASPHERE ADVERSE REACTIONS

WARNINGS











Laboratory Test Values
DOSAGE AND ADMINISTRATION: Dose Modifications

Postmarketing Experience
WARNINGS: Hypersensitivity

OVERDOSAGE



DOSAGE & ADMINISTRATION

CHC Monoinfection
Table 4
Table 4



Table 2
Dose Modifications

Table 5WARNINGS




Renal Impairment
WARNINGSCLINICAL PHARMACOLOGY: Special Populations

HOW SUPPLIED


























STORAGE AND HANDLING



SPL MEDGUIDE

















  • ●     You are a female and you are pregnant or plan to become pregnant during treatment or during the 6 months after your treatment has ended. (SeeWhat is the most important information I should know about RIBASPHERE?andWhat should I avoid while taking RIBASPHERE?.)
  • ●     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 RIBASPHERE or during the 6 months after your treatment has ended. (SeeWhat is the most important information I should know about RIBASPHERE?andWhat should I avoid while taking RIBASPHERE?.)
  • ●     You are breast feeding. We do not know if RIBASPHERE can pass through your milk and if it can harm your baby. You will need to choose either to breast-feed or take RIBASPHERE, 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 RIBASPHERE. The active ingredient in RIBASPHERE is ribavirin. See the end of this Medication Guide for a list of all the ingredients in RIBASPHERE.

  • ●     mental health problems, such as depression or anxiety: RIBASPHERE and peginterferon alfa-2a combination therapy may make them worse. Tell your healthcare provider if you are being treated or had treatment in the past for any mental problems, including depression, thoughts of ending your life (suicidal thoughts) or a feeling of loss of contact with reality, such as hearing voices or seeing things that are not there (psychosis). Tell your healthcare provider if you take any medicines for these problems.
  • ●     high blood pressure, heart problems or have had a heart attack. RIBASPHERE may worsen heart problems such as high blood pressure, increased heart rate, and chest pain. Tell your healthcare provider if you have or had a heart problem. Patients who have had certain heart problems should not take RIBASPHERE.
  • ●     blood disorders, including anemia (low red blood cell count), thalassemia (Mediterranean anemia) and sickle-cell anemia. RIBASPHERE can reduce the number of red blood cells you have. This may make you feel dizzy or weak and could worsen any heart problems you might have.
  • ●     kidney problems. If your kidneys do not work properly, you may have worse side effects from RIBASPHERE treatment and require a lower dose.
  • ●     liver problems (other than hepatitis C virus infection).
  • ●     organ transplant, and you are taking medicine that keeps your body from rejecting your transplant (suppresses your immune system).
  • ●     thyroid disease. RIBASPHERE and peginterferon alfa-2a combination therapy may make your thyroid disease worse or harder to treat. RIBASPHERE and peginterferon alfa-2a treatment may be stopped if you develop thyroid problems that cannot be controlled by medicine.
  • ●     have or had drug or alcohol addiction or abuse.
  • ●     cancer.
  • ●     infection with hepatitis B virus.
  • ●     diabetes. RIBASPHERE and peginterferon alfa-2a combination therapy may make your diabetes worse or harder to treat.
  • ●     past interferon treatment for hepatitis C virus infection that did not work for you.



  • ●     Your healthcare provider will determine the right dose of RIBASPHERE based on your weight.
  • ●     Take RIBASPHERE 1 time in the morning and 1 time at night (2 times a day). Take RIBASPHERE the same 2 times each day.
  • ●     Take RIBASPHERE with food.
  • ●     It is very important to follow your dosing schedule and your healthcare provider's instructions on how to take your medicines.
  • ●     Take RIBASPHERE for as long as it is prescribed, and do not take more than your healthcare provider prescribes.
  • ●     If you miss a dose of RIBASPHERE and remember the same day, take the missed dose as soon as you remember. If the whole day has passed, ask your healthcare provider what to do. Do not take 2 doses at the same time.
  • ●     Your healthcare provider may adjust your dose of RIBASPHERE based on blood tests that show your response to treatment and side effects you may have.
  • ●     Females taking RIBASPHERE or female sexual partners of male patients taking RIBASPHERE must have a pregnancy test:
  • ●               before treatment begins
  • ●               every month during treatment
  • ●               for 6 months after treatment ends to make sure there is no pregnancy



  • ●     Do not get pregnant. If you or your sexual partner get pregnant during treatment with RIBASPHERE or in the 6 months after treatment ends, tell your healthcare provider right away. (See "What is the most important information I should know about treatment with RIBASPHERE?".) Talk with your healthcare provider about birth control methods and how to avoid pregnancy. You must use extreme care to avoid pregnancy during and for 6 months after treatment in female and male patients.
  • ●     Do not take RIBASPHERE alone to treat your hepatitis C virus infection. RIBASPHERE should be used in combination with peginterferon alfa-2a to treat chronic hepatitis C virus infections. (See "What is the most important information I should know about treatment with RIBASPHERE?".)
  • ●     Do not breast feed. RIBASPHERE may pass through your milk and may harm your baby.
  • ●     Do not drink alcohol, including beer, wine, and liquor. This may make your liver disease worse.
  • ●     Do not drive or operate machinery if RIBASPHERE makes you feel tired, dizzy or confused.
  • ●     Do not take other medicines unless your healthcare provider knows about them. Take only medicines prescribed or approved by your healthcare provider. These include prescription and non-prescription medicines, vitamins or herbal supplements. Talk to your healthcare provider before starting any new medicine.


  • ●     Harm to unborn children. RIBASPHERE may cause birth defects or death of an unborn child. (For more details, see "What is the most important information I should know about RIBASPHERE?".)
  • ●     Anemia. Anemia is a reduction in the number 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.

  • ●     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
  • ●     you have psoriasis (a skin disease) and it gets worse
  • ●     you become very depressed or think about suicide (ending your life)
  • ●     Skin rash can occur in patients taking peginterferon alfa-2a. In some patients a rash can be serious. If you develop a rash with fever, blisters, or sores inyour mouth, nose or eyes or conjunctivitis (red or inflamed eyes, likepink eye), stop using peginterferon alfa-2a and call your doctor right away.

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

















PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Ribasphere

Ribasphere

Ribasphere

RIBAVIRIN TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-486(NDC:66435-103)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
RIBAVIRIN RIBAVIRIN 400 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
lactose monohydrate
CROSCARMELLOSE SODIUM
water
povidone
MAGNESIUM STEARATE
POLYVINYL ALCOHOL
titanium dioxide
POLYETHYLENE GLYCOL 3350
talc
FD&C BLUE NO. 1
carnauba wax

Product Characteristics

Color Size Imprint Code Shape
blue 18 mm 400;3RP OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-486-34 27 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077456 2011-08-18


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