Roferon-A
Generic name:interferon alfa-2a, recombinant
Dosage form: injection
Drug class:Antineoplastic interferons
Medically reviewed by Drugs.com. Last updated on Jun 21, 2021.
On This Page
- Boxed Warning
- Description
- Clinical Pharmacology
- Clinical Studies
- Indications and Usage
- Contraindications
- Warnings
- Precautions
- Patient Counseling Information
- Drug Interactions
- Adverse Reactions/Side Effects
- Overdosage
- Dosage and Administration
- How Supplied/Storage and Handling
- References
- Supplemental Patient Material
- Medication Guide
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 Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy.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).
Roferon-A Description
Roferon-A (Interferon alfa-2a, recombinant) is a sterile protein product for use by injection. Roferon-A 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 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 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...
