Interferon Gamma 1b

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• confusion, hallucinations;
• a seizure (convulsions);
• low blood cell counts--fever, chills, flu-like symptoms, swollen gums, mouth sores, skin sores, easy bruising, unusual bleeding; or
• kidney problems--little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath.

Your doses may be delayed or reduced if you have certain side effects.

Common side effects may include:

• fever, chills;
• diarrhea;
• headache;
• feeling tired;
• rash; or
• redness or tenderness 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.

Pregnancy Category: C

Lactation: Not known whether excreted in breast milk, discontinue drug or do not nurse

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Interferon gamma-1b is made from human proteins. Interferons help the body fight viral infections.

Interferon gamma-1b is used to prevent serious infections in people with a condition called chronic granulomatous disease. Interferon gamma-1b is also used to slow the progression of a bone disorder called malignant osteopetrosis.

Interferon gamma-1b may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to interferon gamma-1b, or to drug products made from E. coli bacteria.

To make sure interferon gamma-1b is safe for you, tell your doctor if you have:

• kidney disease;

• liver disease;

• heart rhythm problems;

• congestive heart failure;

• a nerve-muscle disorder;

• bone marrow suppression;

• a history of transient ischemic attacks (TIAs), including "mini-stroke";

• a history of seizures; or

• an allergy to rubber.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

This medicine may affect fertility (your ability to have children), whether you are a man or a woman.

It is not known whether interferon gamma-1b passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Interferon gamma-1b is not approved for use by anyone younger than 1 year old.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• If you have a latex allergy, talk with your doctor.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how interferon gamma-1b affects you.
• Talk with your doctor before you drink alcohol.
• If you have heart disease, talk with your doctor. The flu-like side effects of interferon may be stressful to heart patients.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Have your urine checked as you have been told by your doctor.
• Talk with your doctor before getting any vaccines. Use with this medicine may either raise the chance of an infection or make the vaccine not work as well.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using interferon gamma-1b while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Chronic granulomatous disease: Reduction in the frequency and severity of serious infections associated with chronic granulomatous disease

Malignant osteopetrosis (severe): To delay time to disease progression in patients with severe, malignant osteopetrosis

If severe reactions occur, reduce dose by 50% or therapy should be interrupted until adverse reaction abates.

Based on 50 mcg/m2 dose administered 3 times weekly for chronic granulomatous disease

>10%:

Central nervous system: Fever (52%), headache (33%), chills (14%), fatigue (14%)

Dermatologic: Rash (17%)

Gastrointestinal: Diarrhea (14%), vomiting (13%)

Local: Injection site erythema or tenderness (14%)

1% to 10%:

Central nervous system: Depression (3%)

Gastrointestinal: Nausea (10%), abdominal pain (8%)

Neuromuscular & skeletal: Myalgia (6%), arthralgia (2%), back pain (2%)

<1%, postmarketing, and/or case reports: Alkaline phosphatase elevated, atopic dermatitis, granulomatous colitis, hepatomegaly, hypersensitivity reactions, hypokalemia, neutropenia, Stevens-Johnson syndrome

Additional adverse reactions noted at doses >100 mcg/m2 administered 3 times weekly: ALT increased, AST increased, autoantibodies increased, bronchospasm, chest discomfort, confusion, dermatomyositis exacerbation, disorientation, DVT, gait disturbance, GI bleeding, hallucinations, heart block, heart failure, hepatic insufficiency, hyperglycemia, hypertriglyceridemia, hyponatremia, hypotension, interstitial pneumonitis, lupus-like syndrome, MI, neutropenia, pancreatitis (may be fatal), Parkinsonian symptoms, PE, proteinuria, renal insufficiency (reversible), seizure, syncope, tachyarrhythmia, tachypnea, thrombocytopenia, TIA

Adverse events have been observed in animal reproduction studies.