Special Alerts:
[Posted 03/09/2007] FDA notified healthcare professionals of the early termination of the INSPIRE clinical study of interferon gamma-1b (Actimmune) for idiopathic pulmonary fibrosis (IPF). The study was stopped because an interim analysis showed that patients with IPF who received interferon gamma-1b did not benefit. The trial compared survival in patients getting interferon gamma-1b or an inactive injection (placebo). An analysis showed that 14.5% of patients treated with interferon gamma-1b died as compared to 12.7% of patients treated with placebo. Interferon gamma-1b is not approved by the FDA to treat IPF. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Actimmune, http://www.fda.gov/cder/drug/advisory/interferon_gamma_1b.htm and http://www.fda.gov/cder/drug/infopage/inerferon_gamma_1b/default.htm.
Before using interferon gamma-1b, tell your doctor if you are allergic to any drugs, or if you have heart rhythm problems, congestive heart failure, history of heart disease or blood clots, or epilepsy or another seizure disorder.
Interferon gamma-1b is usually given three times weekly. Do not use the medication every day unless your doctor has told you to.
Store interferon gamma-1b in the refrigerator but do not allow it to freeze. Throw away any interferon gamma-1b that has been out of the refrigerator for more than 12 hours. Do not put it back into the refrigerator.To be sure this medication is not causing harmful effects, your blood may need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled appointments.
Interferon gamma-1b is made from human proteins. Interferons help the body fight viral infections.
Interferon gamma-1b is a specific interferon used to prevent infections in people with a condition called chronic granulomatous disease. Interferon gamma-1b is also used to treat a congenital bone disorder called osteopetrosis.
Interferon gamma-1b may also be used for other purposes not listed in this medication guide.
Before using interferon gamma-1b, tell your doctor if you are allergic to any drugs, or if you have:
heart rhythm problems;
congestive heart failure;
history of heart disease or blood clots; or
epilepsy or other seizure disorder.
If you have any of these conditions, you may need a dose adjustment or special tests to safely use interferon gamma-1b.
FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether interferon gamma-1b passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.Interferon gamma-1b is given as an injection under the skin of your upper arm or thigh. Your doctor, nurse, or other healthcare provider will give you this injection. You may be given instructions on how to use your injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.
Interferon gamma-1b is usually given 3 times weekly. Do not use the medication every day unless your doctor has told you to.
Use a different place on your arm or thigh each time you give yourself an injection. Your doctor will show you the places on your body where you can safely inject the medication. Do not inject interferon gamma-1b into the same place two times in a row.
Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
To be sure this medication is not causing harmful effects, your blood may need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled appointments.
A single use vial of interferon gamma-1b is for one dose only. After measuring your dose from the vial, throw the bottle away even if there is still some medication left in it.
Do not shake the medication vial (bottle). Vigorous shaking can ruin the medicine. Do not draw your interferon gamma-1b dose into a syringe until you are ready to give yourself an injection. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription. Store interferon gamma-1b in the refrigerator but do not allow it to freeze. Throw away any interferon gamma-1b that has been out of the refrigerator for more than 12 hours. Do not put it back into the refrigerator.![]() |
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