Actimmune (INTERFERON GAMMA 1B-INJECTABLE)

GENERIC NAME: INTERFERON GAMMA 1B - INJECTION (IN-ter-FEER-on GAM-ma wun-bee)

BRAND NAME(S): Actimmune

USES: This medication is used to reduce the frequency and severity of serious infections due to chronic granulomatous disease, a disorder that runs in families. This drug is often used along with antibiotics to help prevent these serious infections.This medication is also used to slow the worsening of malignant osteopetrosis, another disorder that runs in families, that affects bones, nerves, and blood.This medication is the same as a protein that your body naturally produces (interferon). In the body, it is thought to work by affecting cell function/growth and the body's natural defenses (immune system) in many ways. Adding more interferon may help your body fight off serious infections.

HOW TO USE: Read the Patient Information Leaflet available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions, consult your doctor or pharmacist.This medication is given by injection under the skin, usually 3 times weekly (e.g., Monday, Wednesday, and Friday) or as directed by your doctor. This medication is best used in the evening before bedtime to reduce side effects.If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Do not shake the solution. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.It is important to change the location of the injection site with each dose to avoid problem areas under the skin. Therefore, choose a different injection site with each dose. The thighs and upper arms are recommended sites for the injection. Do not inject into skin that is irritated, sore, or infected.Dosage is based on your medical condition and response to therapy. Do not change the dose or how often you use this medication without your doctor's approval. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each evening that you have a scheduled dose.

SIDE EFFECTS: Injection site reactions (pain/swelling/redness), diarrhea, upset stomach, nausea, or vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Flu-like symptoms such as headache, tiredness, fever, chills, and muscle aches may occur, especially when you first start this medication. These symptoms usually last about 1 day after the injection and improve or go away after a few months of continued use. You can reduce these side effects by injecting this medicine at bedtime and using a fever reducer/pain reliever such as acetaminophen before or after each dose. Consult your doctor or pharmacist for more information.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: lightheadedness, fainting, mental/mood changes (e.g., confusion, depression), shaking (tremors), trouble walking, slow/fast/irregular heartbeat, shortness of breath, swelling of the ankles/feet, increasing tiredness, joint pain, butterfly-shaped rash on the face, easy bleeding/bruising, persistent nausea/vomiting, seizures, signs of infection (e.g., fever, persistent sore throat), stomach/abdominal pain, black/tarry stools, dark urine, change in the amount of urine, yellowing eyes/skin.Get medical help right away if any of these rare but very serious side effects occur: chest/jaw/left arm pain, weakness on one side of the body, slurred speech, sudden vision changes, pain/redness/swelling of the arms/legs, calf pain/swelling that is warm to the touch, coughing up blood.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 interferon, tell your doctor or pharmacist if you are allergic to it; 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: heart disease (e.g., angina, irregular heartbeat, congestive heart failure), liver disease, seizure disorder, blood cell disorders (e.g., anemia, neutropenia, thrombocytopenia).Children, especially those younger than 1 year, may be at greater risk for effects on the liver while using this drug. The manufacturer recommends regular laboratory tests (liver function tests), especially in children younger than 1 year.This medication is not recommended for use during pregnancy. Consult your doctor for more details.It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: drugs that may affect your immune system (e.g., cancer chemotherapy, prednisone, cyclosporine), hydroxyurea, theophyllines (e.g., aminophylline, theophylline).

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.Laboratory and/or medical tests (e.g., complete blood count, kidney and liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule. Do not double the dose to catch up.

STORAGE: Store in the refrigerator between 36-46 degrees F (2-8 degrees C). Do not freeze. This medication should not be left at room temperature for more than 12 hours before use. If this occurs, do not use the medication and do not put it back into the refrigerator. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.