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Sylatron

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Sylatron

SYLATRON™
(peginterferon alfa-2b)

Sylatron

WARNING

DEPRESSION AND OTHER NEUROPSYCHIATRIC DISORDERS

The risk of serious depression, with suicidal ideation and completed suicides, and other serious neuropsychiatric disorders are increased with alpha interferons, including SYLATRON. Permanently discontinue SYLATRON in patients with persistently severe or worsening signs or symptoms of depression, psychosis, or encephalopathy. These disorders may not resolve after stopping SYLATRON [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].

DRUG DESCRIPTION

SYLATRON (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 SYLATRON molecule is approximately 31,000 daltons. The specific activity of pegylated interferon alfa-2b is approximately 0.7 x 108 international units/mg protein.

Interferon alfa-2b is a 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.

Each vial contains either 296 mcg, 444 mcg or 888 mcg of peginterferon alfa-2b as a sterile, white to off-white lyophilized powder, and dibasic sodium phosphate anhydrous (1.11 mg), monobasic sodium phosphate dihydrate (1.11 mg), polysorbate 80 (0.074 mg), and sucrose (59.2 mg). Following reconstitution with 0.7 mL of Sterile Water for Injection USP, each vial contains SYLATRON at 40 mcg per 0.1 mL, 60 mcg per 0.1 mL, or 120 mcg per 0.1 mL.

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...

Read All Potential Side Effects and See Pictures of Sylatron »

What are the precautions when taking peginterferon alfa-2b (Sylatron)?

Before using peginterferon alfa-2b, tell your doctor or pharmacist if you are allergic to it; or to polyethylene glycol (PEG); or to other interferons; or if you have any other allergies. This product may contain inactive ingredients, 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: liver disease, psychiatric conditions (such as depression), history of drug/alcohol abuse, thyroid disease, diabetes, eye problems, inflammation of the bowels (such as colitis), pancreatitis, high blood triglyceride levels.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can...

Read All Potential Precautions of Sylatron »

Last reviewed on RxList: 1/23/2013
This monograph has been modified to include the generic and brand name in many instances.

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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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