Roferon-A (Interferon alfa-2a, Recombinant) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 26, 2012

Roferon-A

Hepatitis B »

What is hepatitis?

The term 'hepatitis' simply means inflammation of the liver. Hepatitis may be caused by a virus or a toxin such as alcohol. Other viruses that can cause injury to liver cells include the hepatitis A and hepatitis C viruses. These viruses are not related to each other or to hepatitis B virus and differ in their structure, the ways they are spread among individuals, the severity of symptoms they can cause, the way they are treated, and the outcome of the infection.

What is the scope of the problem?

Hepatitis B is an infection of the liver caused by the hepatitis B virus (HBV). It is estimated that 350 million individuals worldwide are infected with the virus, which causes 620,000 deaths worldwide each year. According to the Centers for Disease Control (CDC), approximately 46,000 new cases of hepatitis B occurred in the United States in 2006.

In the United States, rates of new infection were highest ...

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Roferon-A

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ROFERON-A
(interferon alfa-2a, recombinant)

Alpha-interferons, including Interferon alfa-2a, cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinical and laboratory evaluations. Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy. In many, but not all cases, these disorders resolve after stopping Interferon alfa-2a therapy (see WARNINGS and ADVERSE REACTIONS).

DRUG DESCRIPTION

Roferon-A (Interferon alfa-2a, recombinant) is a sterile protein product for use by injection. Roferon-A (interferon alfa-2a, recombinant) is manufactured by recombinant DNA technology that employs a genetically engineered Escherichia coli bacterium containing DNA that codes for the human protein. Interferon alfa-2a, recombinant is a highly purified protein containing 165 amino acids, and it has an approximate molecular weight of 19,000 daltons. Fermentation is carried out in a defined nutrient medium containing the antibiotic tetracycline hydrochloride, 5 mg/L. However, the presence of the antibiotic is not detectable in the final product. Roferon-A (interferon alfa-2a, recombinant) is supplied in prefilled syringes. Each glass syringe barrel contains 0.5 mL of product. In addition, there is a needle, which is ½ inch in length.

Single Use Prefilled Syringes

3 million IU (11.1 mcg/0.5 mL) Roferon-A (interferon alfa-2a, recombinant) per syringe — The solution is colorless and each 0.5 mL contains 3 MIU of Interferon alfa-2a, recombinant, 3.605 mg sodium chloride, 0.1 mg polysorbate 80, 5 mg benzyl alcohol as a preservative and 0.385 mg ammonium acetate.

6 million IU (22.2 mcg/0.5 mL) Roferon-A (interferon alfa-2a, recombinant) per syringe — The solution is colorless and each 0.5 mL contains 6 MIU of Interferon alfa-2a, recombinant, 3.605 mg sodium chloride, 0.1 mg polysorbate 80, 5 mg benzyl alcohol as a preservative and 0.385 mg ammonium acetate.

9 million IU (33.3 mcg/0.5 mL) Roferon-A (interferon alfa-2a, recombinant) per syringe — The solution is colorless and each 0.5 mL contains 9 MIU of Interferon alfa-2a, recombinant, 3.605 mg sodium chloride, 0.1 mg polysorbate 80, 5 mg benzyl alcohol as a preservative and 0.385 mg ammonium acetate.

The route of administration is by subcutaneous injection.

What are the possible side effects of interferon alfa-2a (Roferon-A)?

Call your doctor or seek emergency medical attention if you develop symptoms of depression or are contemplating suicide; become unusually irritable, anxious (nervous), or aggressive; or experience other mood or behavior changes. In some cases, interferon alfa-2a has caused serious mood or behavioral problems.

Problems with body organs such as the heart, lungs, and eyes have been experienced by people taking interferon alfa-2a or other similar drugs. Contact your doctor immediately if you develop difficulty breathing, chest pain,...

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What are the precautions when taking interferon alfa-2a, recombinant (Roferon-A)?

Before using interferon alfa, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as albumin), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe liver conditions (e.g., autoimmune hepatitis, decompensated liver disease).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood cell disorders (e.g., anemia, neutropenia, thrombocytopenia), cancer, diabetes, eye problems, heart disease (e.g., angina, irregular heartbeat), high blood...

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Last reviewed on RxList: 11/25/2008
This monograph has been modified to include the generic and brand name in many instances.