Pegasys

DRUG DESCRIPTION

PEGASYS, peginterferon alfa-2a, is a covalent conjugate of recombinant alfa-2a interferon (approximate molecular weight [MW] 20,000 daltons) with a single branched bis-monomethoxy polyethylene glycol (PEG) chain (approximate MW 40,000 daltons). The PEG moiety is linked at a single site to the interferon alfa moiety via a stable amide bond to lysine. Peginterferon alfa-2a has an approximate molecular weight of 60,000 daltons. Interferon alfa-2a is produced using recombinant DNA technology in which a cloned human leukocyte interferon gene is inserted into and expressed in Escherichia coli.

PEGASYS is a sterile, preservative-free, colorless to light yellow injectable solution administered subcutaneously.

180 mcg/1.0 mL Vial: Each vial contains approximately 1.2 mL of solution to deliver 1.0 mL of drug product. Subcutaneous (sc) administration of 1.0 mL of 180 meg of drug product (expressed as the amount of interferon alfa-2a) also contains acetic acid (0.05 mg), benzyl alcohol (10.0 mg), polysorbate 80 (0.05 mg), sodium acetate trihydrate (2.62 mg), and sodium chloride (8.0 mg) at pH 6.0 0.5.

180 mcg/0.5 mL Prefilled Syringe: Each syringe contains 0.6 mL of solution to deliver 0.5 mL of drug product. Subcutaneous (sc) administration of 0.5 mL delivers 180 meg of drug product (expressed as the amount of interferon alfa-2a) also contains acetic acid (0.0231 mg), benzyl alcohol (5.0 mg), polysorbate 80 (0.025 mg), sodium acetate trihydrate (1.3085 mg), and sodium chloride (4.0 mg) at pH 6.0 0.5.

What are the possible side effects of peginterferon alfa-2a (Pegasys)?

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-2a and call your doctor at once if you have any of these serious side effects:

  • confusion, severe depression, thoughts of hurting yourself or others;
  • unusual anxiety, aggression, or unusual thoughts or behaviors;
  • sudden numbness, weakness, or loss of balance or coordination;
  • fever, chills, body...

Read All Potential Side Effects and See Pictures of Pegasys

What are the precautions when taking peginterferon alfa-2a (Pegasys)?

Before using peginterferon alfa-2a, tell your doctor or pharmacist if you are allergic to it; or to polyethylene glycol (PEG); 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: other severe liver disease (e.g., autoimmune hepatitis, hepatic decompensation).

Before taking this medication, tell your doctor or pharmacist your medical history, especially of: psychiatric conditions (e.g., depression), low blood counts (e.g., red cells, white cells, or platelets), heart disease, thyroid problems,...

Read All Potential Precautions of Pegasys


Pegasys Consumer (continued)

SIDE EFFECTS: Flu-like symptoms (e.g., fever, chills, muscle aches, fatigue, headache, joint pain, nausea, stomach pain, cough) may occur. If instructed to do so, you may take pain/fever-reducing medications (e.g., acetaminophen, ibuprofen) to help with these symptoms. Dry mouth, loss of appetite, weight loss, trouble sleeping, diarrhea, dry skin, or redness/swelling at the injection site may also occur. If any of these effects persist or worsen, notify 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, unusually slow/fast/pounding heartbeat, change in the amount of urine, severe stomach pain with nausea/vomiting, black/tarry stools, vomit that looks like coffee grounds, yellowing eyes or skin, dark urine, increased thirst, increased urination, bloody diarrhea, numbness/tingling of arms/legs.

Get medical help right away if any of these rare but very serious side effects occur: chest pain, vision changes, seizures, one-sided weakness.

This drug may infrequently cause severe mental/mood changes (e.g., suicidal thoughts or severe depression). If you notice these symptoms, stop your treatment with peginterferon and get medical help right away.

A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: 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-2a, tell your doctor or pharmacist if you are allergic to it; or to polyethylene glycol (PEG); 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: other severe liver disease (e.g., autoimmune hepatitis, hepatic decompensation).

Before taking this medication, tell your doctor or pharmacist your medical history, especially of: psychiatric conditions (e.g., depression), low blood counts (e.g., red cells, white cells, or platelets), heart disease, thyroid problems, autoimmune disease (e.g., rheumatoid arthritis, lupus, psoriasis), eye problems, kidney disease, lung disease (e.g., COPD, asthma, pneumonia), history of cancer, intestinal disease ( e.g., colitis), pancreatitis, history of drug/alcohol abuse, diabetes, other infections (e.g., HIV, hepatitis B, chickenpox), high blood triglyceride levels, history of organ transplant, liver problems (other than hepatitis C).

Do not have immunizations/vaccinations without the consent of your doctor.

Use caution with sharp objects like safety razors or nail cutters and avoid activities such as contact sports to lower the chance of getting cut, bruised, or injured.

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

This medicine may cause stomach bleeding. Daily use of alcohol and this medicine may increase your risk for stomach bleeding.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects.

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. It is recommended that men and women use birth control measures while being treated with this medication and for the 6 months after treatment has stopped. If you become pregnant or think you may be pregnant, inform your doctor immediately.

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


Pegasys Patient Information Including Side Effects

Brand Names: Pegasys

Generic Name: peginterferon alfa-2a (Pronunciation: peg in ter FEAR on AL fa 2 a)

  • What is peginterferon alfa-2a (Pegasys)?
  • What are the possible side effects of peginterferon alfa-2a (Pegasys)?
  • What is the most important information I should know about peginterferon alfa-2a (Pegasys)?
  • What should I discuss with my healthcare provider before using peginterferon alfa-2a (Pegasys)?
  • How should I use peginterferon alfa-2a (Pegasys)?
  • What happens if I miss a dose (Pegasys)?
  • What happens if I overdose (Pegasys)?
  • What should I avoid while using peginterferon alfa-2a (Pegasys)?
  • What other drugs will affect peginterferon alfa-2a (Pegasys)?
  • Where can I get more information?

What is peginterferon alfa-2a (Pegasys)?

Peginterferon alfa-2a is made from human proteins that help the body fight viral infections.

Peginterferon alfa-2a is used to treat chronic hepatitis B or C. Peginterferon alfa-2a is often used together with another medication called ribavirin (Copegus, Rebetol, RibaPak, Ribasphere, RibaTab).

Peginterferon alfa-2a may also be used for other purposes not listed in this medication guide.

What are the possible side effects of peginterferon alfa-2a (Pegasys)?

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-2a and call your doctor at once if you have any of these serious side effects:

  • confusion, severe depression, thoughts of hurting yourself or others;
  • unusual anxiety, aggression, or unusual thoughts or behaviors;
  • sudden numbness, weakness, or loss of balance or coordination;
  • fever, chills, body aches, flu symptoms;
  • easy bruising or bleeding;
  • worsening of psoriasis;
  • chest pain, uneven heartbeats, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • cough, stabbing chest pain, feeling short of breath;
  • severe pain in your upper stomach spreading to your back, fast heart rate;
  • blurred vision, headache or pain behind your eyes; or
  • fever with severe stomach pain and bloody diarrhea.

Less serious side effects may include:

  • increased hunger, thirst, or urination;
  • feeling mildly anxious or irritable;
  • headache, muscle or joint pain;
  • nausea, vomiting, dry mouth, loss of appetite;
  • hair loss, weight loss;
  • sleep problems (insomnia);
  • skin itching; or
  • pain, redness, swelling, or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about peginterferon alfa-2a (Pegasys)?

Peginterferon alfa-2a is often used together with another medication called ribavirin (Copegus, Rebetol, RibaPak, Ribasphere, RibaTab). Ribavirin is known to cause birth defects or death in an unborn baby. You may need to have a negative pregnancy test before starting this combination treatment.

If a man fathers a child while using ribavirin, the baby may have birth defects.

You should not use this medication if you are allergic to peginterferon alfa-2a, or if you have autoimmune hepatitis, liver failure, or a hemoglobin blood cell disorder such as sickle-cell anemia or thalassemia, if you are pregnant, or if you are a man and your female sexual partner is pregnant.

Before using this medication, tell your doctor if you have lung disease, kidney disease, heart disease, a thyroid disorder, colitis, HIV or AIDS, an autoimmune disorder (such as psoriasis, lupus, rheumatoid arthritis), a history of organ transplant, or any liver problems other than hepatitis. Also tell your doctor if you have ever had a heart attack, cancer, drug or alcohol addiction, or depression, mental illness, or suicidal thoughts.

Treatment with peginterferon alfa-2a does not prevent spread of the hepatitis virus to other people. Follow your doctor's instructions about how to prevent passing the disease to another person.

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