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.

interferon gamma-1b

(in-ter-feer-on) ,

Actimmune

(trade name)

Classification

Therapeutic: immune modifiers
Pharmacologic: interferons
Pregnancy Category: C

Indications

Diminished severity and frequency of infectious complications of chronic granulomatous disease.Slow disease progression in severe, malignant osteopetrosis.

Action

A protein produced by recombinant DNA technology that is capable of activating phagocytes, enhancing their ability to kill pathogens, including:
  • Staphylococcus aureus,
  • Toxoplasma gondii,
  • Leishmania donovani,
  • Listeria monocytogenes,
  • Mycobacterium avium intracellulare.
Interferon gamma has antiproliferative effects superior to interferon alpha and beta.

Therapeutic effects

Decreased incidence and severity of infection in patients with chronic granulomatous disease.
Slowed disease progression of severe, malignant osteopetrosis.

Pharmacokinetics

Absorption: Well absorbed after subcut administration.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: 5.9 hr.

Time/action profile (blood levels)

ROUTEONSETPEAKDURATION
Subcutunknown4 hrunknown

Contraindications/Precautions

Contraindicated in: Hypersensitivity to interferon gamma, Escherichia coli–derived products, mannitol, or polysorbate.
Use Cautiously in: cardiovascular disease; Bone marrow depression; Pregnancy, lactation, or children <1 yr (safety not established).

Adverse Reactions/Side Effects

Central nervous system

  • headache (most frequent)
  • decreased mental status
  • dizziness

Gastrointestinal

  • nausea (most frequent)
  • vomiting (most frequent)
  • abdominal pain

Dermatologic

  • rash (most frequent)

Hematologic

  • neutropenia
  • thrombocytopenia

Local

  • edema or tenderness at injection site (most frequent)

Musculoskeletal

  • arthralgia (most frequent)
  • myalgia (most frequent)
  • back pain

Neurologic

  • gait disturbances

Miscellaneous

  • chills (most frequent)
  • fever (most frequent)

Interactions

Drug-Drug interaction

May have additive bone marrow–depressing effects with antineoplastics or radiation therapy.

Route/Dosage

Body Surface Area >0.5 m2
Subcutaneous (Children) 50 mcg/m2 (1 million units/m2) 3 times weekly.
Body Surface Area ≤0.5 m2
Subcutaneous (Children >1 yr) 1.5 mcg/kg 3 times weekly.

Availability

Injection: 100 mcg (3 million units)/vial

Nursing implications

Nursing assessment

  • Assess patient for signs and symptoms of infection before and throughout therapy. Flu-like syndrome (fever, headache, chills, myalgia, fatigue) is a frequent side effect that may decrease in severity as treatment continues. Side effects may be minimized by administering at bedtime. Headache and fever may be treated with acetaminophen. If adverse reactions are severe, dose may be reduced by 50% or discontinued.
  • Lab Test Considerations: Monitor CBC with differential, platelet count, blood chemistries including liver and kidney function, and urinalysis before and every 3 mo throughout therapy.

Potential Nursing Diagnoses

Risk for infection (Indications)

Implementation

  • Vial must be refrigerated; do not freeze. If vial is left at room temperature for more than 12 hr, discard vial. Vials do not contain a preservative and are for single use only. Do not shake.
  • Subcutaneous: Administer in the right or left arm or anterior thigh.

Patient/Family Teaching

  • Home Care Issues: Instruct patient or family on proper technique for administering injection and care and disposal of equipment. Provide a puncture-proof container for disposal of needles.
    • Advise patient of the need for contraception throughout therapy.

Evaluation/Desired Outcomes

  • Decrease in frequency and severity of infections in patients with chronic granulomatous disease.
  • Slowed disease progression in severe, malignant osteopetrosis.

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.
References in periodicals archive ?
Actimmune is approved by the Food and Drug Administration for use in children and adults with chronic granulomatous disease and severe, malignant osteopetrosis.
M2 EQUITYBITES-May 9, 2016-Horizon Pharma completes enrolment for Phase three ACTIMMUNE study
M2 PHARMA-May 9, 2016-Horizon Pharma completes enrolment for Phase three ACTIMMUNE study
Horizon Pharma plc, a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, today announced that it, in collaboration with Fox Chase Cancer Center Temple Health, has initiated a Phase 1 clinical study to evaluate ACTIMMUNE (interferon gamma-1b) in combination with nivolumab in advanced solid tumors.
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.
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.
Total revenue in the first nine months of 2011 reflects slightly higher collaboration revenue, partially offset by lower Actimmune revenue.
2010), Rogelio Rosario listed gamma interferon under the brand name Actimmune.
Specifically, he was charged with issuing a misleading press release about a clinical trial that contributed to off-label sales of the Actimmune drug for treating idiopathic pulmonary fibrosis.
Brisbane CA), was indicted last week on wire fraud and felony Food, Drug and Cosmetic Act charges for his role in the creation and dissemination of false and misleading information about the efficacy of InterMune's drug Actimmune (interferon gamma-1B) as a treatment for idiopathic pulmonary fibrosis (IPF), the Justice Department said.