(Peginterferon alfa-2b) Injection, Powder for Solution for Subcutaneous Use
RISK OF SERIOUS DISORDERS AND RIBAVIRIN-ASSOCIATED EFFECTS
Alpha interferons, including PegIntron (peginterferon alfa-2b) ,may cause or aggravate fatal or life-threatening neuropsychiatric, autoimmune, ischemic, and infectious disorders. Patients should be monitored closely with periodic clinicaland laboratory evaluations.Patients with persistently severeor worsening signs or symptoms of these conditions should bewithdrawn from therapy. In many, but not all cases,these disorders resolve after stopping PegIntron therapy [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].
Ribavirinmay causebirth defects and death of theunborn child.Extremecaremust betaken to avoid pregnancy in femalepatients and in femalepartners ofmalepatients.Ribavirin causes hemolytic anemia. The anemia associated with REBETOL therapy may result in aworsening of cardiac disease. Ribavirin is genotoxic andmutagenic and should beconsidered apotentialcarcinogen.[See REBETOL package insert.]
PegIntron, peginterferon alfa-2b, Powder for Injection is a covalent conjugate of recombinant alfa-2b interferon with monomethoxy polyethylene glycol (PEG). The average molecular weight of the PEG portion of the molecule is 12,000 daltons. The average molecular weight of the PegIntron (peginterferon alfa-2b) molecule is approximately 31,000 daltons. The specific activity of peginterferon alfa-2b is approximately 0.7 x 108 IU/mg protein.
Interferon alfa-2b 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 gene from human leukocytes.
PegIntron (peginterferon alfa-2b) is supplied in both vials and the REDIPEN for subcutaneous use.
Each vial contains either 74 mcg, 118.4 mcg, 177.6 mcg, or 222 mcg of PegIntron (peginterferon alfa-2b) as a white to off-white tablet-like solid that is whole/in pieces or as a loose powder, and 1.11 mg dibasic sodium phosphate anhydrous, 1.11 mg monobasic sodium phosphate dihydrate, 59.2 mg sucrose, and 0.074 mg polysorbate 80. Following reconstitution with 0.7 mL of the supplied Sterile Water for Injection USP, each vial contains PegIntron (peginterferon alfa-2b) at strengths of either 50 mcg per 0.5 mL, 80 mcg per 0.5 mL, 120 mcg per 0.5 mL, or 150 mcg per 0.5 mL.
REDIPEN is a dual-chamber glass cartridge containing lyophilized PegIntron (peginterferon alfa-2b) as a white to off-white tablet or powder that is whole or in pieces in the sterile active chamber and a second chamber containing Sterile Water for Injection USP. Each PegIntron (peginterferon alfa-2b) REDIPEN contains either 67.5 mcg, 108 mcg, 162 mcg, or 202.5 mcg of PegIntron (peginterferon alfa-2b) , and 1.013 mg dibasic sodium phosphate anhydrous, 1.013 mg monobasic sodium phosphate dihydrate, 54 mg sucrose, and 0.0675 mg polysorbate 80. Each cartridge is reconstituted to allow for the administration of up to 0.5 mL of solution. Following reconstitution, each REDIPEN contains PegIntron (peginterferon alfa-2b) at strengths of either 50mcg per 0.5 mL, 80 mcg per 0.5 mL, 120 mcg per 0.5 mL, or 150 mcg per 0.5 mL for a single use. Because a small volume of reconstituted solution is lost during preparation of PegIntron (peginterferon alfa-2b) , each REDIPEN contains an excess amount of PegIntron (peginterferon alfa-2b) powder and diluent to ensure delivery of the labeled dose.
What are the possible side effects of peginterferon alfa-2b (PegIntron, PegIntron Redipen, Sylatron)?
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 peginterferon alfa-2b and call your doctor at once if you have any of these serious side effects:
- vision problems;
- fever, chills, body aches, flu symptoms, pale skin, easy bruising or bleeding, unusual weakness;
- high fever with severe stomach pain and bloody diarrhea.
- severe pain in your upper stomach spreading to your back, nausea and...
Last reviewed on RxList: 7/10/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Peg-Intron Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find the secrets to longer life.