PEG-Intron

What is PEG-Intron?

• PEG-Intron (peginterferon alfa-2b) is an antiviral used for treatment of Chronic Hepatitis C (CHC) in patients with compensated liver disease.

Peginterferon alfa-2b

What are the uses of this medicine?

PEG-Intron (peginterferon alfa-2b) is a prescription medicine that is used:

• with ribavirin and an approved hepatitis C virus (HCV) protease inhibitor to treat chronic (lasting a long time)hepatitisC infection in adults.
• with ribavirin to treat chronic (lasting a long time) hepatitis C infection in people 3 years and older with stable
• liver problems.
• alone, sometimes to treat adults who have chronic (lasting a long time) hepatitis C infection with stable liver
• problems and who cannot take ribavirin.

• People with hepatitis C have the virus in their blood and in their liver. PEG-Intron reduces the amount of virus in the body and helps the body's immune system fight the virus.
• Ribavirin is a drug that helps to fight the viral infection but does not work when used by itself to treat chronic hepatitis C.

How does this medicine work?

• Pegylated recombinant human interferon alfa-2b is an inducer of the innate anti-HCV immune response.
• The biological activity of PEG-Intron is derived from its interferon alfa-2b moiety.
• Peginterferon alfa-2b binds to and activates the human type 1 interferon receptor.
• Upon binding, the receptor subunits dimerize, and activate multiple intracellular signal transduction pathways.
• Signal transduction is initially mediated by the JAK/STAT activation, which may occur in a wide variety of cells.
• Interferon receptor activation also activates NFκB in many cell types.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have had a serious allergic reaction to another alpha interferon or to any of the ingredients in PEG-Intron.
• have certain types of hepatitis (autoimmune hepatitis).
• have certain other liver problems.
• in combination with ribavirin:
• if you are a female who is pregnant or plans to become pregnant.
• if you are a male with a female partner who is pregnant.
• Ribavirin may cause birth defects and death of an unborn baby.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• PEG-Intron and certain other medicines may affect each other and cause side effects.
• Especially tell your healthcare provider if you take the anti-hepatitis B medicine telbivudine (Tyzeka).

Is this medicine FDA approved?

• peginterferon alfa-2b was Approved for medical use in the United States in 2001.

How should this medicine be used?

Recommended dosage:

• PEG-Intron is used in combination with other products including ribavirin and HCV direct-acting antivirals.

PEG-Intron Combination Therapy: Adults:

• The recommended dose of PEG-Intron is 1.5 mcg/kg/week.

Pediatric Patients:

• The recommended dose of PEG-Intron is 60 mcg/m2/week subcutaneously for pediatric patients aged 3 to 17 years.
• Patients who reach their 18th birthday while receiving PEG-Intron/ribavirin should remain on the pediatric dosing regimen.
• The treatment duration for patients with genotype 1 is 48 weeks

PEG-Intron Monotherapy:

• The recommended dose of PEG-Intron regimen is 1 mcg/kg/week subcutaneously for 1 year administered on the same day of
• the week.

• Dose reduction is recommended in patients experiencing certain adverse reactions or renal dysfunction.

Administration:

• PEG-Intron is administered by subcutaneous injection.
• Take your prescribed dose of PEG-Intron every week, on the same day of each week and at the same time.
• PEG-Intron comes as a:
• powder in a single-use vial
• single-use REDIPEN
• If you miss a dose of PEG-Intron, take the missed dose as soon as possible during the same day or the next day, then continue on your regular dosing schedule. If several days go by after you miss a dose, check with your healthcare provider about what to do.
• Do not inject more than 1 dose of PEG-Intron in one week without talking to your healthcare provider.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection

This medicine is available in fallowing brand namesː

• PEG-Intron

What side effects can this medication cause?

The most common side effects of this medicine include:

• Flu-like symptoms
• Tiredness
• Appetite problems
• Skin reactions
• Hair thinning
• PEG-Intron may cause fertility problems in females, which may affect the ability to have children.

PEG-Intron may cause serious side effects including:

• Mental health problems, including suicide
• Heart problems
• Stroke or symptoms of a stroke
• New or worsening autoimmune problems
• Infections
• Serious eye problems
• Blood problems
• pancreatitis
• colitis
• Lung problems
• Severe liver problems
• Thyroid problems
• Blood sugar problems
• Serious allergic reactions and skin reactions
• Growth problems in children
• Nerve problems
• Dental and gum problems

What special precautions should I follow?

• Life-threatening or fatal neuropsychiatric events, including suicide, suicidal and homicidal ideation, depression, relapse of drug addiction/overdose, and aggressive behavior sometimes directed towards others have occurred in patients with and without a previous psychiatric disorder during PEG-Intron treatment. PEG-Intron should be used with caution in patients with a history of psychiatric disorders.
• Cardiovascular events, which include hypotension, arrhythmia, tachycardia, cardiomyopathy, angina pectoris, and myocardial infarction, have been observed in patients treated with PEG-Intron. Patients with a history of significant or unstable cardiac disease should not be treated with PEG-Intron/ribavirin combination therapy
• PEG-Intron causes or aggravates hypothyroidism and hyperthyroidism. Patients who develop these conditions during treatment and cannot be controlled with medication should not continue PEG-Intron therapy.
• Decrease or loss of vision, retinopathy including macular edema, retinal artery or vein thrombosis, retinal hemorrhages and cotton wool spots, optic neuritis, papilledema, and serous retinal detachment may be induced or aggravated by treatment with peginterferon alfa-2b or other alpha interferons.
• Peginterferon alfa-2b treatment should be discontinued in patient who develop new or worsening ophthalmologic disorders.
• Ischemic and hemorrhagic cerebrovascular events have been observed in patients treated with interferon alfa-based therapies, including PEG-Intron.
• PEG-Intron suppresses bone marrow function, sometimes resulting in severe cytopenias. PEG-Intron should be discontinued in patients who develop severe decreases in neutrophil or platelet counts.
• Development or exacerbation of autoimmune disorders (e.g., thyroiditis, thrombotic thrombocytopenic purpura, idiopathic thrombocytopenic purpura, rheumatoid arthritis, interstitial nephritis, systemic lupus erythematosus, and psoriasis) has been observed in patients receiving PEG-Intron. PEG-Intron should be used with caution in patients with autoimmune disorders.
• Fatal and nonfatal pancreatitis has been observed in patients treated with alpha interferon. PEG-Intron therapy should be suspended in patients with signs and symptoms suggestive of pancreatitis and discontinued in patients diagnosed with pancreatitis.
• Fatal and nonfatal ulcerative or hemorrhagic/ischemic colitis have been observed within 12 weeks of the start of alpha interferon treatment. PEG-Intron treatment should be discontinued immediately in patients who develop these signs and symptoms.
• Dyspnea, pulmonary infiltrates, pneumonia, bronchiolitis obliterans, interstitial pneumonitis, pulmonary hypertension, and sarcoidosis, some resulting in respiratory failure or patient deaths, may be induced or aggravated by PEG-Intron or alpha interferon therapy. Because of the fever and other "flu-like" symptoms associated with PEG-Intron administration, it should be used cautiously in patients with debilitating medical conditions, such as those with a history of pulmonary disease (e.g., chronic obstructive pulmonary disease).
• Chronic Hepatitis C (CHC) patients with cirrhosis may be at risk of hepatic decompensation and death when treated with alpha interferons, including PEG-Intron. PEG-Intron treatment should be immediately discontinued if decompensation (Child-Pugh score greater than 6) is observed.
• Increases in serum creatinine levels have been observed in patients with renal insufficiency receiving interferon alpha products, including PEG-Intron.
• Serious, acute hypersensitivity reactions (e.g., urticaria, angioedema, bronchoconstriction, anaphylaxis) and cutaneous eruptions (Stevens-Johnson syndrome, toxic epidermal necrolysis) have been rarely observed during alpha interferon therapy. If such a reaction develops during treatment with PEG-Intron, discontinue treatment and institute appropriate medical therapy immediately.
• PEG-Intron alone or in combination with ribavirin may cause severe decreases in neutrophil and platelet counts, and hematologic, endocrine (e.g., TSH), and hepatic abnormalities. Patients who have pre-existing cardiac abnormalities should have electrocardiograms done before treatment with PEG-Intron/ribavirin.
• Dental and periodontal disorders have been reported in patients receiving PEG-Intron/ribavirin combination therapy. Patients should brush their teeth thoroughly twice daily and have regular dental examinations. If vomiting occurs, patients should be advised to rinse out their mouth thoroughly afterwards.
• Elevated triglyceride levels have been observed in patients treated with interferon alpha, including PEG-Intron therapy. Discontinuation of PEG-Intron therapy should be considered for patients with symptoms of potential pancreatitis, such as abdominal pain, nausea, or vomiting, and persistently elevated triglycerides.
• Peripheral neuropathy has been reported when alpha interferons were given in combination with telbivudine. The safety and efficacy of telbivudine in combination with interferons for the treatment of chronic hepatitis B has not been demonstrated.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• PEG-Intron may be used in combination with ribavirin.
• If PEG-Intron is administered with ribavirin, the combination regimen is contraindicated in pregnant women and men whose female partners are pregnant because ribavirin may cause birth defects and death of the unborn child.

Can this medicine be used in children?

• It is not known if PEG-Intron use in children younger than 3 years old is safe and will work.

What are the active and inactive ingredients in this medicine?

Active Ingredient:

Inactive Ingredients:

Who manufactures and distributes this medicine?

Manufactured by:

• Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA

What should I know about storage and disposal of this medication?

PEG-Intron REDIPEN single-use pre-filled pen:

• PEG-Intron REDIPEN pre-filled pen should be stored at 2-8°C (36-46°F).
• After reconstitution, the solution should be used immediately, but may be stored up to 24 hours at 2-8°C (36-46°F).
• The reconstituted solution contains no preservative, and is clear and colorless.
• DO NOT FREEZE.
• Keep away from heat.

PEG-Intron Vials:

• PEG-Intron should be stored at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
• After reconstitution with supplied diluent, the solution should be used immediately but may be stored up to 24 hours at 2-8°C (36-46°F).
• The reconstituted solution contains no preservative, and is clear and colorless.
• DO NOT FREEZE.
• Keep away from heat.

• Dailymed label info on PEG-Intron
• FDA PEG-Intron

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