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Common Questions

What is the safety profile of ACTIMMUNE®?

What is the efficacy of ACTIMMUNE®?

What is the preferred test for CGD?

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ACTIMMUNE® significantly reduced the frequency and severity of serious infections* in patients with chronic granulomatous disease (CGD) in an international,† pivotal trial1,2  

ACTIMMUNE® (Interferon gamma-1b) demonstrated meaningful reductions in the total number and rate of serious infections in patients with chronic granulomatous disease (CGD).

ACTIMMUNE® (Interferon gamma-1b) clinical trial results chart

ACTIMMUNE® (Interferon gamma-1b) clinical trial results chart

ACTIMMUNE® reduced the relative risk of serious infections1,2

The treatment effect of ACTIMMUNE® was seen early and maintained for the duration of the study.

ACTIMMUNE® (Interferon gamma-1b) clinical trial results chart

ACTIMMUNE® (Interferon gamma-1b) clinical trial results chart

ACTIMMUNE® delivered efficacy across various patient types1,2

In subgroup analyses, ACTIMMUNE® was beneficial regardless of age or type of CGD inheritance. There was a 67% reduction in relative risk of serious infection in patients receiving ACTIMMUNE® compared with placebo across all groups.

  • More than 85% of patients were receiving prophylactic antibiotics (trimethoprim-sulfamethoxazole or dicloxacillin) in addition to ACTIMMUNE® or placebo

pre- and postactivation DHR histograms

pre- and postactivation DHR histograms

‡ A serious event was defined as a serious infection requiring hospitalization and intravenous antibiotics.

§ Statistically significant; P < .05

ACTIMMUNE® significantly decreased hospitalization days compared with placebo1,2

Treatment with ACTIMMUNE® reduced the number of hospitalization days by 67%.

ACTIMMUNE® (Interferon gamma-1b) clinical trial results chart

ACTIMMUNE® (Interferon gamma-1b) clinical trial results chart

In patients needing hospitalization, the average length of stay was 33% shorter for those in the ACTIMMUNE® group compared with those in the placebo group (32 vs 48 days, P = .02).

In addition, more than twice as many patients in the placebo group compared with the ACTIMMUNE® group were hospitalized for more than 28 days (13 vs 6 patients).

ACTIMMUNE® helped keep patients free of serious infections for up to 12 months1,2

More than twice as many patients treated with ACTIMMUNE® remained free of serious infection for up to 12 months compared with patients treated with placebo.

Of patients with CGD receiving ACTIMMUNE®,

77%

were free of serious infection for up to the 12 months of the study||
compared to

30%

of patients who received placebo (P = .0006)

*Serious infection was defined as a clinical event requiring hospitalization and intravenous antibiotics.

†United States and Europe.

||Mean duration of ACTIMMUNE® treatment was 8.9 months.

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References: 1. ACTIMMUNE® (Interferon gamma-1b) [prescribing information] Horizon. 2. The International Chronic Granulomatous Disease Cooperative Study Group. A controlled trial of interferon gamma to prevent infection in chronic granulomatous disease. N Engl J Med. 1991;324(8):509-516.

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

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