July 30, 2015
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Peg-Intron

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Peg-Intron

PEGINTRON®
(peginterferon alfa-2b)




WARNING

RISK OF SERIOUS DISORDERS AND RIBAVIRIN-ASSOCIATED EFFECTS

Alpha interferons, including PegIntron, may 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 Patients with persistently severe or worsening signs or symptoms of these conditions should be withdrawn from therapy.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 PegIntron therapy [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].

Use with Ribavirin

Ribavirin may cause birth defects and death of the unborn child. Extreme care must be taken to avoid pregnancy in female patients and in female partners of male patients. Ribavirin causes hemolytic anemia. The anemia associated with ribavirin therapy may result in a worsening of cardiac disease. [See ribavirin labeling.]

DRUG DESCRIPTION

PegIntron, peginterferon alfa-2b, 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 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 is supplied in both vials and the REDIPEN single-use pre-filled pen for subcutaneous use.

Vials

Each vial contains either 74 mcg, 118.4 mcg, 177.6 mcg, or 222 mcg of PegIntron 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 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 Single-use Pre-filled Pen

REDIPEN pre-filled pen is a dual-chamber glass cartridge containing lyophilized PegIntron 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 REDIPEN pre-filled pen contains either 67.5 mcg, 108 mcg, 162 mcg, or 202.5 mcg of PegIntron, 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 pre-filled pen contains PegIntron 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 for a single use. Because a small volume of reconstituted solution is lost during preparation of PegIntron, each REDIPEN pre-filled pen contains an excess amount of PegIntron 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; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using peginterferon alfa-2b and call your doctor at once if you have severe or worsening symptoms such as: confusion, depression, tired feeling, anxiety, aggression, tremors, muscle twitching, seizure, unusual thoughts or behavior, or thoughts about suicide or hurting yourself. Once you have had this type of reaction to peginterferon alfa-2b, you must never use it...

Read All Potential Side Effects and See Pictures of Peg-Intron »

Last reviewed on RxList: 6/1/2015
This monograph has been modified to include the generic and brand name in many instances.

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.


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