This page is for healthcare professionals treating patients with severe malignant osteopetrosis.
This page is for HCPs treating patients with SMO.

A clinical trial showed that the median time to disease progression was significantly delayed in the ACTIMMUNE® (Interferon gamma-1b) plus calcitriol arm vs calcitriol alone.*

In an analysis that combined data from a second study, 19 out of 24 (79%) patients on ACTIMMUNE® (± calcitriol) for at least 6 months exhibited reduced trabecular bone volume compared to baseline.1

Trial design: A controlled, randomized study in patients with SMO was conducted with ACTIMMUNE® administered subcutaneously 3 times weekly. Sixteen patients were randomized to receive ACTIMMUNE® plus calcitriol (n = 11) or calcitriol alone (n = 5). Patients ranged in age from 1 month to 8 years, with the mean being 1.5 years.1

*Disease progression is defined by death, significant reduction in hemoglobin or platelet counts, serious bacterial infection requiring antibiotics, 50 dB decrease in hearing, or progressive optic atrophy.1

For more information, download the ACTIMMUNE® Full Prescribing Information.

References: 1. ACTIMMUNE® (Interferon gamma-1b) [prescribing information]. Dublin, Ireland: Horizon Pharma Ireland Ltd; 2016.

Important Safety Information

INDICATIONS AND USAGE

ACTIMMUNE® (Interferon gamma-1b) is indicated:

Important Safety Information

INDICATIONS AND USAGE

ACTIMMUNE® (Interferon gamma-1b) is indicated:

  • For reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease
  • For delaying time to disease progression in patients with severe, malignant osteopetrosis

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • In patients who develop or have known hypersensitivity to interferon-gamma, E coli-derived products, or any component of the product

WARNINGS AND PRECAUTIONS

  • ACTIMMUNE should be used with caution in patients with:
    • Pre-existing cardiac conditions, including ischemia, congestive heart failure, or arrhythmia
    • Seizure disorders or compromised central nervous system function; reduce dose or discontinue
    • Myelosuppression, or receiving other potentially myelosuppressive agents; consider dose reduction or discontinuation of therapy
    • Severe renal insufficiency
    • Age <1 year

  • Monitoring:
    • Patients begun on ACTIMMUNE before age 1 year should receive monthly assessments of liver function. If severe hepatic enzyme elevations develop, ACTIMMUNE dosage should be modified
    • Monitor renal function regularly when administering ACTIMMUNE in patients with severe renal insufficiency; accumulation of interferon gamma-1b may occur with repeated administration. Renal toxicity has been reported in patients receiving ACTIMMUNE

  • Pregnancy, Lactation, and Fertility:
    • ACTIMMUNE should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus
    • Use of ACTIMMUNE by lactating mothers is not recommended. ACTIMMUNE or nursing should be discontinued dependent on the importance of the drug to the mother
    • Long-term effects of ACTIMMUNE on fertility are not known

DRUG INTERACTIONS

  • Concomitant use of drugs with neurotoxic, hematotoxic, or cardiotoxic effects may increase the toxicity of interferons
  • Avoid simultaneous administration of ACTIMMUNE with other heterologous serum protein or immunological preparations (eg, vaccines)

ADVERSE REACTIONS

  • The most common adverse experiences occurring with ACTIMMUNE therapy are “flu-like” symptoms such as fever, headache, chills, myalgia, or fatigue, which may decrease in severity as treatment continues, and may be minimized by bedtime administration of ACTIMMUNE. Acetaminophen may be used to prevent or partially alleviate the fever and headache
  • Isolated cases of acute serious hypersensitivity reactions have been observed in patients receiving ACTIMMUNE
  • Reversible neutropenia, thrombocytopenia, and elevations of AST and/or ALT have been observed during ACTIMMUNE therapy
  • At doses 10 times greater than the weekly recommended dose, ACTIMMUNE may exacerbate pre-existing cardiac conditions, or may cause reversible neurological effects such as decreased mental status, gait disturbance, and dizziness