Sylatron

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 (peginterferon alfa-2b) 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 (peginterferon alfa-2b) at 40 mcg per 0.1 mL, 60 mcg per 0.1 mL, or 120 mcg per 0.1 mL.

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


Sylatron Consumer (continued)

SIDE EFFECTS: See also Warning section.

Flu-like symptoms (such as fever, chills, muscle/joint aches, fatigue, headache, nausea, stomach pain) may occur. If instructed to do so, taking pain/fever-reducing medications (such as acetaminophen) or injecting this medication at bedtime may help reduce some of these flu-like symptoms. Dry mouth, bad taste in mouth, increased sweating, loss of appetite, weight loss, trouble sleeping, dizziness, diarrhea, vomiting, dry skin, or redness/swelling at the injection site may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: persistent sore throat or fever, easy or unusual bleeding/bruising, unusually severe fatigue, increased thirst/urination, severe stomach pain with nausea/vomiting, bloody diarrhea.

Get medical help right away if you have any serious side effects, including: chest/jaw/left arm pain, unusually slow/fast/pounding heartbeat, vision changes (such as blurred vision, decrease in vision).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication is not recommended for use during pregnancy because of possible serious harm to the unborn baby. Consult your doctor for more details and to discuss reliable forms of birth control. If you become pregnant or think you may be pregnant, inform your doctor right away.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.



Related Drugs Index: