Rebetol Capsule: Uses, Dosage, Side Effects, Precautions and Alternates

Quick overview

Rebetol Capsule contains ribavirin, an antiviral medicine from the nucleoside analogue class. It is used to treat chronic hepatitis C infection, but only when combined with an interferon medicine such as peginterferon alfa-2b or interferon alfa-2b. Rebetol is never used on its own, and it is taken by mouth twice a day with food. It can cause a range of side effects and requires important precautions, particularly around pregnancy, kidney function, and liver function.

What is Rebetol Capsule

Rebetol is a capsule medicine containing ribavirin, a man-made nucleoside analogue that acts against certain viruses. It is never used by itself. It must always be taken together with another medicine called an interferon (peginterferon alfa-2b or interferon alfa-2b) to treat long-term (chronic) hepatitis C infection.

Rebetol Capsule uses

• Treats chronic hepatitis C
• Helps suppress hepatitis C virus replication
• Used with other antiviral medicines
• Helps achieve sustained viral clearance

Benefits of Rebetol Capsule

• Provides oral antiviral therapy
• Supports successful hepatitis C treatment when used in an appropriate combination
• Can be used in eligible pediatric and adult patients

How Rebetol Capsule works

Ribavirin is a man-made building-block (nucleoside analogue) that has shown activity against some viruses in laboratory studies. However, exactly how Rebetol combined with other medicines fights the hepatitis C virus in the body is not fully understood. On its own, Rebetol does not clear the hepatitis C virus or improve liver damage, which is why it must always be combined with an interferon medicine.

Rebetol Capsule dosage

Always take Rebetol together with the interferon medicine your doctor has prescribed (peginterferon alfa-2b or interferon alfa-2b) — never take Rebetol alone. Take your dose by mouth twice a day, once in the morning and once in the evening, with food (a meal). Swallow capsules whole with water — do not chew, crush, or open them.

If you cannot swallow capsules, or you weigh less than about 47 kg, ask your doctor about the oral solution form instead. If you forget a dose, take it as soon as you remember on the same day; if a whole day has passed, do not double up — contact your doctor.

Children and adolescents need a dose based on their body weight, and this may use a combination of capsules taken morning and evening. In people with kidney problems, the dose may need to be changed by the doctor. Continue taking the medicine for as long as your doctor has prescribed, even if you feel well, unless told to stop.

Available forms and strengths

• Hard capsule (200 mg ribavirin)
• Oral solution (40 mg/mL ribavirin)

Side effects of Rebetol Capsule

Common

• Headache
• Tiredness (fatigue) and weakness
• Fever, chills, and flu-like symptoms
• Nausea, vomiting, and diarrhea
• Loss of appetite and weight loss
• Muscle aches and joint pain
• Hair loss, dry skin, itching, and rash
• Trouble sleeping (insomnia)
• Feeling depressed, anxious, or irritable
• Dizziness
• Cough and shortness of breath
• Decreased red blood cells (anemia) and low white blood cell counts

Serious

• Severe depression, suicidal thoughts, or attempted suicide
• Aggressive behavior or thoughts of harming others
• Severe destruction of red blood cells (hemolytic anemia) that can worsen heart problems and, rarely, cause fatal or non-fatal heart attacks
• Severe allergic reaction (swelling of face/throat, hives, difficulty breathing, anaphylaxis)
• Serious eye problems, including vision loss
• Inflammation of the pancreas (pancreatitis) — severe stomach pain, nausea, vomiting
• Severe lung problems, including pneumonia, in rare cases fatal
• Severe drops in white blood cells or platelets, increasing risk of infection or bleeding
• Liver problems, including worsening liver function
• Kidney problems or kidney failure
• Growth problems (reduced height) in children and adolescents that may not fully recover
• Thyroid problems (too much or too little thyroid hormone)
• Severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis
• Seizures (convulsions)
• Stroke or signs of reduced blood flow to the brain

Warnings and precautions

• This medicine should never be used alone to treat hepatitis C — it only works when combined with an interferon medicine, and using it by itself will not treat the infection effectively.
• This medicine can cause serious birth defects or death of an unborn baby. It must not be used by anyone who is pregnant or by men whose partners are pregnant, and extreme care must be taken to prevent pregnancy during and for months after treatment.
• This medicine can break down red blood cells, causing anemia that may worsen heart disease and has led to fatal and non-fatal heart attacks. People with serious heart conditions should not take this medicine, and others with heart disease need close monitoring.
• Serious mental health effects, including severe depression, suicidal thoughts, and attempts at suicide, have occurred during combination treatment, and these have been reported more often in children and teenagers than in adults.
• In children and teenagers, this treatment can slow growth, and some children do not reach the height they would otherwise have reached, even years after treatment ends.
• People with HIV who are also being treated for it with certain antiviral medicines may be at higher risk of serious complications, such as a dangerous buildup of lactic acid in the body or worsening liver function, when taking this medicine.
• Taking this medicine together with azathioprine (a medicine that suppresses the immune system) can cause severe reductions in blood cell counts, so this combination should generally be avoided.
• Rebetol must not be used during pregnancy because it can cause serious birth defects or death of the unborn baby. Women must have a negative pregnancy test before starting and must use two reliable forms of birth control during treatment and for months afterward. Men taking Rebetol must also avoid getting a partner pregnant, using contraception for months after stopping treatment, because the medicine can affect sperm.
• Rebetol should not be used while breastfeeding. It is not known if the medicine passes into breast milk, but because of the risk of harm to a nursing baby, breastfeeding should be stopped before starting treatment.
• People with kidney problems process this medicine differently, and higher levels can build up in the body, increasing the risk of side effects. Kidney function should be checked before starting treatment, and the dose may need to be lowered, especially in people with moderate to severe kidney impairment.
• Patients who develop significant problems with their liver while taking this medicine need to be watched closely by their doctor, as treatment may need to be adjusted or stopped.
• Rebetol itself is unlikely to affect your ability to drive or use machines, but the other medicine it is combined with may cause tiredness, sleepiness, or confusion. If you experience these effects, you should avoid driving or operating machinery.

Storage

• Do not store above 30°C
• Keep out of the sight and reach of children
• Do not use after the expiry date shown on the carton (the expiry date refers to the last day of that month)
• Do not use the capsules if you notice any change in their appearance
• Any unused medicine or waste material should be disposed of according to local requirements — do not throw medicines away via wastewater or household waste; ask your pharmacist how to dispose of medicines no longer needed

When to see a doctor

• Get emergency help right away if you notice signs of a severe allergic reaction, such as hives, swelling of the face or throat, wheezing, or difficulty breathing.
• Contact your doctor immediately if you develop chest pain, a cough that won't go away, or if your heartbeat feels different or irregular — these can be signs of a serious heart problem.
• Seek medical help right away if you feel confused, very depressed, have thoughts of suicide, or think about harming others.
• Contact your doctor if you have severe stomach pain, see black or tar-like stools, or notice blood in your stool or urine, as these can signal serious internal problems.
• Get medical attention if you have heavy nosebleeds, a fever or chills that start after you've been on treatment for a few weeks, or sudden problems with your eyesight or hearing.
• Tell your doctor right away if you develop a severe skin rash or significant redness of the skin.

Alternatives

• Epclusa
• Mavyret
• Harvoni