Actimmune

DRUG DESCRIPTION

ACTIMMUNE® (Interferon gamma-1 b), a biologic response modifier, is a single-chain polypeptide containing 140 amino acids. Production of ACTIMMUNE (interferon gamma 1 b) is achieved by fermentation of a genetically engineered Escherichia coli bacterium containing the DNA which encodes for the human protein. Purification of the product is achieved by conventional column chromatography. ACTIMMUNE (interferon gamma 1 b) is a highly purified sterile solution consisting of non-covalent dimers of two identical 16,465 dalton monomers; with a specific activity of 20 million International Units (IU)/mg (2x106 IU per 0.5 mL) which is equivalent to 30 million units/mg.

ACTIMMUNE (interferon gamma 1 b) is a sterile, clear, colorless solution filled in a single-use vial for subcutaneous injection. Each 0.5 mL of ACTIMMUNE contains: 100 mcg (2 million IU) of Interferon gamma-1 b formulated in 20 mg mannitol, 0.36 mg sodium succinate, 0.05 mg polysorbate 20 and Sterile Water for Injection. Note that the above activity is expressed in International Units (1 million IU/50mcg). This is equivalent to what was previously expressed as units (1.5 million U/50mcg).

What are the possible side effects of interferon gamma-1b (Actimmune)?

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

Stop using interferon gamma-1b and call your doctor at once if you have any of these serious side effects:

  • fever, chills, body aches, flu symptoms;
  • easy bruising or bleeding, unusual weakness;
  • feeling light-headed, fainting;
  • fast or uneven heart rate; or
  • sudden numbness or weakness, especially on one side of the...

Read All Potential Side Effects and See Pictures of Actimmune »

What are the precautions when taking interferon gamma 1 b (Actimmune)?

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...

Read All Potential Precautions of Actimmune »


Actimmune Consumer (continued)

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.


Actimmune Patient Information Including Side Effects

Brand Names: Actimmune

Generic Name: interferon gamma-1b (Pronunciation: in ter FEER on GAM a)

  • What is interferon gamma-1b (Actimmune)?
  • What are the possible side effects of interferon gamma-1b (Actimmune)?
  • What is the most important information I should know about interferon gamma-1b (Actimmune)?
  • What should I discuss with my healthcare provider before using interferon gamma-1b (Actimmune)?
  • How should I use interferon gamma-1b (Actimmune)?
  • What happens if I miss a dose (Actimmune)?
  • What happens if I overdose (Actimmune)?
  • What should I avoid while using interferon gamma-1b (Actimmune)?
  • What other drugs will affect interferon gamma-1b (Actimmune)?
  • Where can I get more information?

What is interferon gamma-1b (Actimmune)?

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.

What are the possible side effects of interferon gamma-1b (Actimmune)?

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

Stop using interferon gamma-1b and call your doctor at once if you have any of these serious side effects:

  • fever, chills, body aches, flu symptoms;
  • easy bruising or bleeding, unusual weakness;
  • feeling light-headed, fainting;
  • fast or uneven heart rate; or
  • sudden numbness or weakness, especially on one side of the body.

Less serious side effects may include:

  • problems with memory or concentration;
  • weakness, tired feeling, lack of coordination;
  • pain or redness where the injection was given;
  • nausea, vomiting, diarrhea;
  • muscle or joint pain; or
  • headache.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about interferon gamma-1b (Actimmune)?

Do not use this medication if you are allergic to interferon gamma-1b, or to drug products made from E. Coli bacteria.

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.

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