Medical

Actimmune

interferon gamma-1b

Actimmune, Immukin (UK)

Pharmacologic class: Biological response modifier

Therapeutic class: Antineoplastic

Pregnancy risk category C

Action

Enhances cellular toxicity and killer cell activity and promotes generation of oxygen metabolites in phagocytes, resulting in destruction of microorganisms.

Availability

Injection: 100 mcg (2 million international units)/0.5-ml vial

Indications and dosages

Chronic granulomatous disease; severe malignant osteoperosis

Adults with body surface area (BSA) above 0.5 m2: 50 mcg/m2 (1 million international units/m2) subcutaneously three times weekly

Adults with BSA of 0.5 m2 or less: 1.5 mcg/kg subcutaneously three times weekly in deltoid or anterior thigh

Contraindications

• Hypersensitivity to drug, its components, or Escherichia coli-derived products

Precautions

Use cautiously in:

• thyroid disorders, bone marrow depression, hepatic or cardiac disease, seizure disorders, compromised CNS function

• pregnant or breastfeeding patients

• children ages 18 and younger.

Administration

• Administer into deltoid muscle by subcutaneous route only.

• Give at bedtime if flulike symptoms occur.

• Provide antiemetics to ease nausea and vomiting, as prescribed.

Adverse reactions

CNS: dizziness, confusion, paresthesia, lethargy, depression, difficulty thinking or concentrating, insomnia, anxiety, fatigue, amnesia, nervousness, drowsiness, asthenia, malaise

CV: chest pain, hypertension, palpitations, arrhythmias

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, pancreatitis

GU: proteinuria

Hematologic: anemia, leukopenia, thrombocytopenia, neutropenia

Musculoskeletal: joint pain, back pain, myalgia

Skin: flushing, rash, dry skin, erythema

Other: flulike symptoms, weight loss, edema, hypersensitivity reaction

Interactions

Drug-drug. Bone marrow depressants: increased bone marrow depression

Zidovudine: increased zidovudine blood level

Drug-diagnostic tests. Hepatic enzymes: increased levels

Neutrophils, platelets: decreased counts

Patient monitoring

Before and monthly during therapy, assess CBC with white cell differential, glucose and electrolyte levels, and liver and kidney function tests.

• Assess fluid intake and output. Keep patient well hydrated.

• Monitor for GI upset. Provide small, frequent meals or antiemetics to ease severe nausea and vomiting.

Monitor patient for mental status changes and depression.

• Assess for flulike symptoms. If these occur, give drug at bedtime and provide supportive care, such as rest and acetaminophen for headache and fever.

Patient teaching

• Teach patient or caregiver how to administer drug subcutaneously, rotate injection sites, and track dosing schedule and injection sites on calendar.

Tell patient to contact prescriber immediately if depression occurs.

• Advise patient to eat small, frequent meals to combat nausea, vomiting, and appetite loss.

• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.

• Inform female patient that drug is linked to fetal abnormalities. Advise her not to get pregnant during therapy, and to use barrier contraception.

• Tell female patient to consult prescriber before breastfeeding.

• Tell patient he'll need regular follow-up examinations and blood tests to monitor drug effects.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

McGraw-Hill Nurse's Drug Handbook, 7th Ed. Copyright © 2013 by The McGraw-Hill Companies, Inc. All rights reserved

Actimmune

A bioengineered form of interferon gamma, which acts as a biologic response modifier by stimulating the human immune system. It is approved by the FDA for patients with chronic granulomatous disease (CGD) and severe, malignant osteopetrosis.
Segen's Medical Dictionary. © 2012 Farlex, Inc. All rights reserved.
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Horizon will retain the rights to Actimmune (recombinant human interferon gamma-1b) in the United States, Canada and Japan.
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The chief executive officer at InterMune, a pharmaceutical manufacturer, issued a press release inaccurately representing conclusions of a medical study for the drug Actimmune, suggesting that the drug would be appropriate for an off-label use.
A host of other products have been associated with equally problematic practices, including Oxycontin, Neurontin, Zyprexa, Fen-Phen, Prempro, Prepulsid, Depakote, Actimmune, Avandia, and Risperdal (see e.g.
Vidara, which has operations both in Ireland and the US, markets Actimmune, a bioengineered form of a protein, which in the US is approved for use in children and adults with chronic granulomatous disease (CGD) and severe, malignant osteopetrosis (SMO).
Murray also notes that the former executive director of InterMune was sentenced for having published misleading and inaccurate information on clinical trials for Actimmune.
Accordingly, this causation argument fails as currently pied."); In re Schering-Plough Corp., 2009 WL 2043604, at *25 (noting that some doctors who prescribed the drug at issue "may have never received any information from [defendant]."); In re Actimmune Mktg.
Total revenue in the first nine months of 2011 reflects slightly higher collaboration revenue, partially offset by lower Actimmune revenue.
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