RibaPak

Name: RibaPak

Warnings

Black Box Warnings

Oral

  • Monotherapy not effective for treatment of chronic hepatitis C virus (HCV) infection and should not be used alone for this indication
  • Hemolytic anemia is the primary toxicity, which may result in worsening of cardiac disease and lead to fatal and nonfatal MI; do not use if history of significant or unstable cardiac disease
  • Significant teratogenic and/or embryocidal effects demonstrated in all animal species exposed to ribavirin
  • Half-life is 12 days, and drug may persist in nonplasma compartments for as long as 6 months
  • Contraindicated during pregnancy and in the male partners of pregnant women
  • Extreme care must be taken to avoid pregnancy during therapy and for 6 months after completion of treatment in both female patients and female partners of male patients taking ribavirin
  • At least 2 reliable forms of effective contraception must be used during treatment and during the 6-month posttreatment follow-up period

Inhalation

  • Aerosolized ribavirin in patients requiring mechanical ventilator assistance should be administered only by health care providers and support staff familiar with this mode of administration and the specific ventilator being used
  • Strictly follow procedures that minimize drug precipitate accumulation to avoid mechanical ventilator dysfunction
  • Sudden respiratory function deterioration in infants may occur during initiation of aerosolized ribavirin
  • Carefully monitor respiratory function during treatment
  • If sudden deterioration of respiratory function occurs, stop treatment and reinstitute only with extreme caution, continuous monitoring, and possibly bronchodilator coadministration
  • Aerosolized ribavirin not indicated for adults
  • Produces testicular lesions in rodents and is teratogenic in all animal species in which adequate studies have been conducted (rodents and rabbits)

Contraindications

Women who are or may become pregnant

Men whose female partners are pregnant

Known hypersensitivity reactions to ribavirin (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme)

Autoimmune hepatitis

Hemoglobinopathies (eg, thalassemia major, sickle-cell anemia)

CrCl <50 mL/min

Coadministration with didanosine; exposure to the active metabolite of didanosine (dideoxyadenosine 5'-triphosphate) is increased; fatal hepatic failure, as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactatemia/lactic acidosis have been reported with this combination

Cautions

Mechanically ventilated patients

Preexisting cardiac disease  

May need interruption if CV status deteriorates

Risk of hemolytic anemia

Do NOT use for influenza

Only Copegus studied in HCV/HIV coinfectees, however the modified dose is CDC recommended

Ribavirin may cause birth defects and/or death of unborn child (see Black Box Warnings and Contraindications)

There are significant adverse reactions caused by ribavirin/ interferon alfa therapy, including severe depression and suicidal or homicidal ideation, hemolytic anemia, suppression of bone marrow function, autoimmune and infectious disorders, pulmonary dysfunction, pancreatitis, and diabetes; suicidal ideation may occur more frequently among pediatric patients, primarily adolescents, compared to adult patients (2.4% versus 1%) during treatment and off-therapy follow-up

Suspend ribavirin and alfa interferon combination therapy in patients with signs and symptoms of pancreatitis and discontinue in patients with confirmed pancreatitis

Pulmonary symptoms, including dyspnea, pulmonary infiltrates, pneumonitis, pulmonary hypertension, and pneumonia, reported during therapy with ribavirin with alpha interferon combination therapy; occasional cases of fatal pneumonia have occurred; sarcoidosis or the exacerbation of sarcoidosis reported; closely monitor patient or if necessary discontinue therapy if pulmonary infiltrate or pulmonary function impairment observed

Dental and periodontal disorders reported in patients receiving ribavirin and interferon alfa combination therapy; dry mouth could have damaging effect on teeth and mucous membranes of mouth during long-term treatment with combination of ribavirin and interferon alfa; patients should brush teeth thoroughly twice daily and have regular dental examinations; if vomiting occurs, they should be advised to rinse out their mouth thoroughly afterwards

Take extreme care to avoid pregnancy

Risk of hemolytic anemia

Anemia associated with treatment may result in worsening of cardiac disease

Genotoxic and mutagenic: Potential carcinogen

Ocular disorders reported when ribavirin is used in combination therapy with alpha interferons (eg, decrease or loss of vision, retinopathy including macular edema, retinal artery or vein, thrombosis, retinal hemorrhages; cotton wool spots, optic neuritis, papilledema, serous retinal detachment)

Study in boys showed growth rate inhibited (ie, height percentile decreases) with peginterferon alfa-2b plus ribavirin

Pancytopenia and bone marrow suppression reported when coadministered with pegylated interferon and azathioprine

Hepatic decompensation

  • Patients with chronic hepatitis C (CHC) and cirrhosis may be at risk of hepatic decompensation and death when treated with alpha interferons, including PEGASYS
  • Cirrhotic CHC patients coinfected with HIV receiving highly active antiretroviral therapy (HAART) and interferon alfa-2a with or without ribavirin appear to be at increased risk for the development of hepatic decompensation compared to patients not receiving HAART

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ribavirin tablets in children younger than 5 years of age, ribavirin capsules and oral liquid in children younger than 3 years of age. The safety and efficacy of ribavirin tablets, capsules, and oral liquid have not been established in these age groups.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

How should I take RibaPak (ribavirin)?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Ribavirin is not effective when used alone to treat hepatitis C. It must be used together with an interferon alfa product.

Take ribavirin with food.

Do not crush, chew, break, or open a ribavirin capsule. Swallow it whole. Tell your doctor if you have trouble swallowing the capsule.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Use ribavirin regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Drink extra fluids while you are taking ribavirin to keep from getting dehydrated, especially during exercise or in hot weather.

Ribavirin can cause dry mouth, which could lead to tooth decay or gum disease. If you vomit while taking ribavirin, rinse your mouth out with water to prevent damage to your teeth or gums. Be sure to have regular dental exams while you are taking this medication.

Store ribavirin tablets or capsules at room temperature away from moisture, heat, and light.

Store ribavirin liquid (oral solution) in the refrigerator. Do not allow it to freeze.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What other drugs will affect RibaPak (ribavirin)?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • azathioprine; or

  • medicines to treat HIV or AIDS.

This list is not complete. Other drugs may interact with ribavirin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

For the Consumer

Applies to ribavirin: oral capsule, oral solution, oral tablet

Other dosage forms:

  • inhalation powder for solution

Along with its needed effects, ribavirin (the active ingredient contained in RibaPak) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ribavirin:

More common
  • Anxiety
  • black, tarry stools
  • body aches or pain
  • chest pain
  • congestion
  • cough or hoarseness
  • crying
  • depersonalization
  • diarrhea
  • difficult or labored breathing
  • discouragement
  • dry mouth
  • dryness of the throat
  • dysphoria
  • euphoria
  • feeling sad or empty
  • feeling unusually cold
  • fever or chills
  • general feeling of discomfort or illness
  • headache
  • hyperventilation
  • irregular heartbeats
  • irritability
  • joint pain
  • lack of appetite
  • loss of interest or pleasure
  • lower back or side pain
  • mental depression
  • muscle aches and pains
  • nausea
  • nervousness
  • painful or difficult urination
  • pale skin
  • paranoia
  • poor concentration
  • quick to react or overreact emotionally
  • rapidly changing moods
  • restlessness
  • right upper abdominal or stomach pain
  • runny nose
  • shaking
  • shivering
  • shortness of breath
  • sleeplessness
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • sweating
  • tender, swollen glands in the neck
  • tightness in the chest
  • trouble with concentrating
  • trouble with sleeping
  • trouble with swallowing
  • troubled breathing with exertion
  • unable to sleep
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • voice changes
  • vomiting
  • wheezing
Less common
  • Bleeding gums
  • blood in the urine or stools
  • constipation
  • depressed mood
  • dry skin and hair
  • feeling cold
  • hair loss
  • husky voice
  • muscle cramps and stiffness
  • pinpoint red spots on the skin
  • right upper abdominal or stomach fullness
  • slowed heartbeat
  • weight gain
Incidence not known
  • Blistering, flaking, or peeling of the skin

Some side effects of ribavirin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Acid or sour stomach
  • being forgetful
  • belching
  • blurred vision
  • bone pain
  • change in taste or bad, unusual, or unpleasant (after) taste
  • cracked, scaly skin
  • crusting, irritation, itching, or reddening of the skin
  • difficulty with moving
  • dizziness or lightheadedness
  • feeling of constant movement of self or surroundings
  • hair loss or thinning of the hair
  • heartburn
  • indigestion
  • lack or loss of strength
  • menstrual changes
  • pain or tenderness around the eyes and cheekbones
  • rash
  • sensation of spinning
  • sneezing
  • stomach discomfort, upset, or pain
  • stuffy nose
  • swelling
  • swollen joints
  • weight loss
Less common
  • Back pain
  • burning, dry, or itching eyes
  • discharge, excessive tearing
  • feeling of warmth
  • redness of the face, neck, arms, and occasionally, upper chest
  • redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
  • skin rash, encrusted, scaly, and oozing
Incidence not known
  • Change in hearing
  • loss of hearing

Usual Pediatric Dose for Respiratory Syncytial Virus

20 mg/mL as the starting solution in the drug reservoir of the SPAG-2 unit, with continuous aerosol administration for 12 to 18 hours per day for 3 to 7 days

Comments:
-The operator's manual for the SPAG-2 should be consulted.
-Using 20 mg/mL, the aerosol concentration for a 12-hour delivery period averages 190 mcg/L of air.
-Ribavirin should not be administered simultaneously or combined with any other aerosolized medications.
-Sudden deterioration of respiratory function has been associated with initiation of ribavirin inhalation therapy in infants; careful monitoring of respiratory function during therapy recommended. If initiation of inhaled ribavirin produces sudden deterioration of respiratory function, therapy should be discontinued and restarted only with extreme caution, continuous monitoring, and coadministration of bronchodilators should be considered.

Approved indication: For treatment of hospitalized infants and young children with severe lower respiratory tract infections due to respiratory syncytial virus

Liver Dose Adjustments

Data not available

Precautions

Consult WARNINGS section for dosing related precautions.

Safety and efficacy of ribavirin capsules and oral solution have not been established in patients younger than 3 years. Safety and efficacy of ribavirin tablets have not been established in patients younger than 5 years.

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