Actimmune (Interferon gamma-1b)

Horizon Pharma Inc.

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Interferons

Chronic Granulomatous Disease

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.

This medication is given by injection under the skin as directed by your doctor, usually 3 times weekly (e.g., Monday, Wednesday, and Friday). 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. The dosage is based on your body size, medical condition, and response to treatment. 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.

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. 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, signs of infection (e.g., fever, persistent sore throat), stomach/abdominal pain, black/tarry stools, dark urine, signs of kidney problems (such as 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, seizures, 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.

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).

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222.

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 right away to establish a new dosing schedule. Do not double the dose to catch up.

Store in the refrigerator. 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.