"Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
Akman pleaded guilty in the U.S. District Court"...
(Interferon alfa-2b) for Intramuscular, Subcutaneous, Intralesional, or Intravenous Injection
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 Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy.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.
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 alfa2b 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 x 108 IU/mg protein as measured by the HPLC assay.
Powder for Injection
|Vial Strength Million IU||mL Diluent||Final Concentration after Reconstitution million IU/mL*||mg INTRON A† per vial||Route of Administration|
|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|
|* Each mL also contains 20 mg glycine, 2.3 mg sodium
phosphate dibasic, 0.55 mg sodium phosphate monobasic, and 1.0 mg human
† Based on the specific activity of approximately 2.6 x 108 IU/mg protein, as measured by HPLC assay.
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|
|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|
|* 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 x 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).
These packages do not require reconstitution prior to administration (see DOSAGE AND ADMINISTRATION). INTRON A Solution for Injection is a clear, colorless solution.
What are the possible side effects of interferon alfa-2b (Intron A)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using interferon alfa-2b and call your doctor at once if you have a serious side effect such as:
- severe depression, aggressive behavior, or thoughts of hurting yourself or others;
- fast, slow, or uneven heart rate, feeling like you might pass out;
- fever, chills, body aches, flu symptoms, pale skin, easy bruising or bleeding, unusual weakness;
- vision or hearing...
What are the precautions when taking interferon alfa-2b, recombinant for injection (Intron A)?
See also Warning section.
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.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood cell disorders (e.g., anemia, neutropenia, thrombocytopenia), blood clots, cancer, diabetes, eye problems, heart disease (e.g., angina, irregular heartbeat), high blood pressure, HIV infection, immune system diseases (e.g., lupus, psoriasis, rheumatoid arthritis), intestinal disease (e.g., colitis), kidney disease, liver disease (e.g., autoimmune hepatitis,...
Last reviewed on RxList: 9/25/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Intron A Information
Intron A - User Reviews
Intron A User Reviews
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