Generic Name : INTERFERON ALFA-2B,RECOMB.
Route : INJECTION
Dose Form : VIAL (ML)
Strength : 10 million unit/mL
AHFS Therapeutic Classifications
08182000 INTERFERONS
10000000 ANTINEOPLASTIC AGENTS
92200000 IMMUNOMODULATORY AGENTS
Active Ingredients
CAS
003424 interferon alfa-2b,recomb. 099210658
Inactive Ingredients
CAS
003199 phenol 000108952
003785 edetic acid 000060004
INTRON A- interferon alfa-2b
INTRON A- interferon alfa-2b injection, solution
Merck Sharp & Dohme Corp.
For Injection
PRODUCT INFORMATION
WARNING
Alpha interferons, including INTRON� A, 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 Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy.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 INTRON A therapy. See WARNINGS and ADVERSE REACTIONS.
DESCRIPTION
INTRON� A (Interferon alfa-2b) for intramuscular, subcutaneous, intralesional, or intravenous Injection is a purified sterile recombinant interferon product.
INTRON A recombinant for Injection has been classified as an alpha interferon and is a water-soluble protein with a molecular weight of 19,271 daltons produced by recombinant DNA techniques. It is obtained from the bacterial fermentation of a strain of Escherichia coli bearing a genetically engineered plasmid containing an interferon alfa-2b gene from human leukocytes. The fermentation is carried out in a defined nutrient medium containing the antibiotic tetracycline hydrochloride at a concentration of 5 to 10 mg/L; the presence of this antibiotic is not detectable in the final product. The specific activity of interferon alfa-2b, recombinant is approximately 2.6 � 108 IU/mg protein as measured by the HPLC assay.
Powder for Injection
Vial StrengthMillion IU mL Diluent Final Concentration after Reconstitution million IU/mL * mg INTRON A � per vial Route of Administration
*
Each mL also contains 20 mg glycine, 2.3 mg sodium phosphate dibasic, 0.55 mg sodium phosphate monobasic, and 1.0 mg human albumin.
�
Based on the specific activity of approximately 2.6 � 108 IU/mg protein, as measured by HPLC assay.
10 1 10 0.038 IM, SC, IV, IL
18 1 18 0.069 IM, SC, IV
50 1 50 0.192 IM, SC, IV
Prior to administration, the INTRON A Powder for Injection is to be reconstituted with the provided Diluent for INTRON A (Sterile Water for Injection USP) (see DOSAGE AND ADMINISTRATION). INTRON A Powder for Injection is a white to cream-colored powder.
Solution Vials for Injection
Vial Strength Concentration * mg INTRON A � per vial Route of Administration
*
Each mL contains 7.5 mg sodium chloride, 1.8 mg sodium phosphate dibasic, 1.3 mg sodium phosphate monobasic, 0.1 mg edetate disodium, 0.1 mg polysorbate 80, and 1.5 mg m-cresol as a preservative.
�
Based on the specific activity of approximately 2.6 � 108 IU/mg protein as measured by HPLC assay.
�
This is a multidose vial which contains a total of 22.8 million IU of interferon alfa-2b, recombinant per 3.8 mL in order to provide the delivery of six 0.5-mL doses, each containing 3 million IU of INTRON A (for a label strength of 18 million IU).
�
This is a multidose vial which contains a total of 32.0 million IU of interferon alfa-2b, recombinant per 3.2 mL in order to provide the delivery of five 0.5-mL doses, each containing 5 million IU of INTRON A (for a label strength of 25 million IU).
18� MIU multidose 3 million IU/0.5 mL 0.088 IM, SC
25� MIU multidose 5 million IU/0.5 mL 0.123 IM, SC, IL
These packages do not require reconstitution prior to administration (see DOSAGE AND ADMINISTRATION). INTRON A Solution for Injection is a clear, colorless solution.
CLINICAL PHARMACOLOGY
General
The interferons are a family of naturally occurring small proteins and glycoproteins with molecular weights of approximately 15,000 to 27,600 daltons produced and secreted by cells in response to viral infections and to synthetic or biological inducers.
Preclinical Pharmacology
Interferons exert their cellular activities by binding to specific membrane receptors on the cell surface. Once bound to the cell membrane, interferons initiate a complex sequence of intracellular events. In vitro studies demonstrated that these include the induction of certain enzymes, suppression of cell proliferation, immunomodulating activities such as enhancement of the phagocytic activity of macrophages and augmentation of the specific cytotoxicity of lymphocytes for target cells, and inhibition of virus replication in virus-infected cells.
In a study using human hepatoblastoma cell line HB 611, the in vitro antiviral activity of alpha interferon was demonstrated by its inhibition of hepatitis B virus (HBV) replication.
The correlation between these in vitro data and the clinical results is unknown. Any of these activities might contribute to interferon's therapeutic effects.
