PegIntron

PegIntron is a prescription medicine that is used:

• with ribavirin and an approved hepatitis C virus (HCV) protease inhibitor to treat chronic (lasting a long time) hepatitis C infection in adults.
• with ribavirin to treat chronic (lasting a long time) hepatitis C infection in people 3 years and older with stable liver problems.
• alone, sometimes to treat adults who have chronic (lasting a long time) hepatitis C infection with stable liver problems and who can not take ribavirin.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• aldesleukin (Proleukin)
• fluoxetine (Prozac, Sarafem, Symbyax)
• methadone (Dolophine, Methadose)
• pegloticase (Krystexxa)
• ribavirin (Copegus, Rebetol, Ribasphere, Virazole)
• telbivudine (Tyzeka)
• theophylline 
• zidovudine (Retrovir, in Combivir, Trizivir)

This is not a complete list of PegIntron drug interactions. Ask your doctor or pharmacist for more information.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of PegIntron there are no specific foods that you must exclude from your diet when receiving PegIntron.

• Take PegIntron exactly as your healthcare provider tells you to.
• PegIntron is given as an injection under your skin (subcutaneous injection). Your healthcare provider should show you how to prepare and measure your dose of PegIntron, and how to inject yourself before you use PegIntron for the first time.
• Do not take more than your prescribed dose. Call your healthcare provider right away if you take too much PegIntron.
• Inject PegIntron one time each week unless instructed differently by your healthcare provider. Call your healthcare provider for instructions if you miss a dose.
• If you miss a dose of PegIntron, take the missed dose as soon as possible during the same day or the next day, then continue on your regular dosing schedule. If several days go by after you miss a dose, check with your healthcare provider about what to do.
• Do not inject more than 1 dose of PegIntron in one week without talking to your healthcare provider.
• If you take too much PegIntron, call your healthcare provider right away. Your healthcare provider may examine you more closely, and do blood tests.
• Your healthcare provider should do regular blood tests before you start PegIntron, and during treatment to see how well the treatment is working and to check you for side effects.
• Expect to get "flu-like" symptoms when taking PegIntron. To help reduce flu-like symptoms:
  • Follow your healthcare provider's instructions about taking acetaminophen before future doses of PegIntron.
  • Inject PegIntron at bedtime to help reduce flu-like symptoms.

It is important for you to keep all appointments with your healthcare provider. Call your healthcare provider if you miss an appointment. There may be special instructions for you.

• Store PegIntron vials in the carton at 59°F to 86°F (15°C to 30°C).
• After mixing, use PegIntron right away or store it in the refrigerator for no longer than 24 hours at 36°F to 46°F (2°C to 8°C).
• Do not freeze PegIntron.

Keep PegIntron and all medicines out of the reach of children.

You should not use this medicine if you have liver failure or autoimmune hepatitis. You should not use peginterferon alfa-2b with ribavirin if you have severe kidney disease, or a hemoglobin blood cell disorder (sickle-cell anemia, thalassemia).

Do not use peginterferon alfa-2b and ribavirin if you are pregnant, or if you are a man and your sexual partner is pregnant. Prevent pregnancy while using this medicine, and for at least 6 months after you stop using it.

Peginterferon alfa-2b may cause serious or fatal side effects, and can worsen a medical condition you already have. Call your doctor if you have symptoms such as mood or behavior changes, chest pain, fast heartbeats, trouble breathing, numbness or weakness, loss of coordination, fever, chills, a cough with mucus, burning when you urinate, or bloody diarrhea.

Get emergency medical help if you have signs of an allergic reaction: hives, or a rash that spreads and causes blistering and peeling; chest pain, anxiety, difficult breathing; swelling of your face, lips, tongue, or throat.

Peginterferon alfa-2b can cause life-threatening infections, autoimmune disorders, serious mood or behavior problems, or a stroke.

Stop using peginterferon alfa-2b and call your doctor at once if you have unusual changes in mood or behavior, such as: depression, irritability, aggression, hallucinations, thoughts about hurting yourself, or falling back into a previous pattern of drug addiction. Once you have had this type of reaction to peginterferon alfa-2b, you may not be able to use it again.

Call your doctor at once if you have other serious side effects, such as:

• vision loss;

• severe stomach pain with bloody diarrhea;

• easy bruising, unusual bleeding;

• high blood sugar--increased thirst or urination, hunger, fruity breath odor, tiredness, weight loss;

• lung problems--sudden chest discomfort, wheezing, trouble breathing;

• nerve problems--numbness, tingling, or burning pain in your arms or legs;

• new or worsened autoimmune disorders--skin problems, joint pain or swelling, cold feeling or pale appearance in your fingers or toes;

• pancreas problems--severe pain in your upper stomach spreading to your back, vomiting, fever;

• signs of infection--fever, chills, body aches, cough with yellow or pink mucus, pain or burning when you urinate, increased urination;

• signs of a stroke or heart attack--chest pain spreading to your jaw or shoulder, fast heartbeats, trouble breathing, sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, loss of coordination;

• thyroid problems--weight changes, skin changes, thinking problems, feeling hot or cold all the time; or

• worsening liver symptoms--upper stomach pain or swelling, loss of appetite, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• flu-like symptoms, weakness, feeling tired;

• mild depression or sadness, feeling anxious or irritable;

• nausea, vomiting, loss of appetite, weight loss;

• thinning hair; or

• redness, swelling, or itching 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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis and Mutagenesis

Pegintron has not been tested for its carcinogenic potential. Neither Pegintron nor its components, interferon or methoxypolyethylene glycol, caused damage to DNA when tested in the standard battery of mutagenesis assays, in the presence and absence of metabolic activation.

Use with Ribavirin: See ribavirin labeling for additional warnings relevant to Pegintron therapy in combination with ribavirin.

Impairment of Fertility

Pegintron may impair human fertility. Irregular menstrual cycles were observed in female cynomolgus monkeys given subcutaneous injections of 4239 mcg/m2 Pegintron alone every other day for 1 month (approximately 345 times the recommended weekly human dose based upon body surface area). These effects included transiently decreased serum levels of estradiol and progesterone, suggestive of anovulation. Normal menstrual cycles and serum hormone levels resumed in these animals 2 to 3 months following cessation of Pegintron treatment. Every other day dosing with 262 mcg/m2 (approximately 21 times the weekly human dose) had no effects on cycle duration or reproductive hormone status. The effects of Pegintron on male fertility have not been studied.

NDC 0085-1297-02

Peginterferon alfa-2b
Pegintron®
REDIPEN®
SINGLE-DOSE DELIVERY SYSTEM
Powder for Injection and Diluent (Sterile Water for Injection USP)

PAK 4

Contains four 120 mcg/0.5 mL REDIPEN UNITS

ATTENTION PHARMACIST:

1. Each patient is required to receive the enclosed
   Medication Guide.
2. Remove physician insert before dispensing this
   package to patients.

REFRIGERATE
Rx only

120 mcg/0.5 mL

For Subcutaneous Use

NDC 0085-4356-01

Peginterferon alfa-2b
Pegintron®
Powder for Injection
Single-Use Vial

Rx only

Medication Guide for patient enclosed.

Dosage and Administration:
See package insert. Read accompanying directions.
Reconstitute as directed in package insert.

150 mcg per 0.5 mL

For Subcutaneous Use