Peg-Intron

DRUG DESCRIPTION

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.

Vials

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

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)?

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:

  • confusion, severe depression or anxiety, aggression, thoughts of hurting yourself or others;
  • vision problems;
  • fever, chills, body aches, flu symptoms, pale skin, easy bruising or bleeding, unusual...

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

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

Before using peginterferon alfa-2b, 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 using this medication tell your doctor or pharmacist your medical history, especially of: psychiatric conditions (e.g., depression), history of drug/alcohol abuse, sleep problems, low blood counts (e.g., red cells, white cells, or...

Read All Potential Precautions of Peg-Intron


Peg-Intron Consumer (continued)

SIDE EFFECTS: Flu-like symptoms (e.g., fever, chills, muscle aches, fatigue, headache, joint pain, nausea, stomach pain) may occur. If instructed to do so, taking pain/fever-reducing medications (e.g., acetaminophen, ibuprofen) or injecting this medication at bedtime may help reduce some of these symptoms. Dry mouth, increased sweating, loss of appetite, weight loss, trouble sleeping, diarrhea, dry skin, redness/swelling at the injection site, throat/sinus infections, or menstrual period problems 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, increased thirst/urination, unusually slow/fast/pounding heartbeat, severe stomach pain with nausea/vomiting, 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-2b, 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 using this medication tell your doctor or pharmacist your medical history, especially of: psychiatric conditions (e.g., depression), history of drug/alcohol abuse, sleep problems, 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), cancer, inflammation of the bowels (e.g., colitis), pancreatitis, diabetes, other infections (HIV, hepatitis B), high blood triglyceride levels, history of organ transplant.

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 using this medication 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.


Peg-Intron Patient Information Including Side Effects

Brand Names: PegIntron, PegIntron Redipen

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

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

What is peginterferon alfa-2b (Peg-Intron)?

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

Peginterferon alfa-2b is used to treat chronic hepatitis C in adults. Peginterferon alfa-2b is often used in combination with another medication called ribavirin (Copegus, Rebetol, RibaPak, Ribasphere, RibaTab) to treat hepatitis C in adults and children who are at least 3 years old.

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

What are the possible side effects of peginterferon alfa-2b (Peg-Intron)?

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:

  • confusion, severe depression or anxiety, aggression, thoughts of hurting yourself or others;
  • 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 vomiting, fast heart rate;
  • cough, feeling short of breath, chest pain, uneven heartbeats;
  • sudden numbness or weakness, headache, confusion, problems with vision, speech, or balance; or
  • new or worsening liver symptoms (upper stomach pain, dark urine, jaundice).

Less serious side effects may include:

  • dizziness, tired feeling;
  • headache, joint or muscle pain;
  • nausea, dry mouth, loss of appetite, weight loss;
  • sleep problems (insomnia);
  • feeling mildly anxious, depressed, or irritable; 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-2b (Peg-Intron)?

You should not use this medication if you are allergic to peginterferon alfa-2b, or if you have autoimmune hepatitis, severe liver or kidney disease, or a hemoglobin blood cell disorder such as sickle-cell anemia or thalassemia.

Peginterferon alfa-2b is often used together with another medication called ribavirin (Copegus, Rebetol, RibaPak, Ribasphere, RibaTab), which is known to cause birth defects or death in an unborn baby. Do not use peginterferon alfa-2b and ribavirin if you are pregnant, or if you are a man and your female sexual partner is pregnant.

Before using peginterferon alfa-2b, tell your doctor about all of your medical conditions, especially kidney disease, liver problems other than hepatitis, heart disease or high blood pressure, a thyroid disorder, eye problems, HIV or AIDS, ulcerative colitis, a blood cell disorder, an autoimmune disorder such as lupus or psoriasis, or a history of heart attack, stroke, organ transplant, depression, mental illness, drug or alcohol addiction, or suicidal thoughts or behaviors.

There are many other medicines that can interact with peginterferon alfa-2b. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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