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ACTIMMUNE efficacy

Graph showing median time to disease progression for SMO patients taking ACTIMMUNE® (Interferon gamma-1b)

A clinical trial showed that the median time to disease progression was significantly delayed in the ACTIMMUNE 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.

Reference

1. ACTIMMUNE^® (Interferon gamma-1b) [prescribing information] Amgen.

Approved Uses and 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-1b, 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
- Myelosuppression or receiving other potentially myelosuppressive agents
- Severe renal insufficiency
- Age <1 year
Monitoring:
- Before starting ACTIMMUNE and every 3 months during treatment, hematologic tests, blood chemistries, and urinalysis are recommended for all patients
- Patients begun on ACTIMMUNE before the age of 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

USE IN SPECIFIC POPULATIONS

ACTIMMUNE should be used during pregnancy only if the potential benefit to the patient outweighs the potential risk to the fetus
It is not known if ACTIMMUNE is excreted in human milk, so either ACTIMMUNE or nursing should be discontinued dependent on the importance of the drug to the patient
In younger patients, long-term effects of ACTIMMUNE on fertility are not known
In animal studies, both male and female fertility was negatively impacted by doses significantly higher than the maximum clinical dose

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

Please see Full Prescribing Information for additional safety information.

Approved Uses and 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-1b, 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
- Myelosuppression or receiving other potentially myelosuppressive agents
- Severe renal insufficiency
- Age 1 year
Monitoring:
- Before starting ACTIMMUNE and every 3 months during treatment, hematologic tests, blood chemistries, and urinalysis are recommended for all patients
- Patients begun on ACTIMMUNE before the age of 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

USE IN SPECIFIC POPULATIONS

ACTIMMUNE should be used during pregnancy only if the potential benefit to the patient outweighs the potential risk to the fetus
It is not known if ACTIMMUNE is excreted in human milk, so either ACTIMMUNE or nursing should be discontinued dependent on the importance of the drug to the patient
In younger patients, long-term effects of ACTIMMUNE on fertility are not known
In animal studies, both male and female fertility was negatively impacted by doses significantly higher than the maximum clinical dose

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

Please see Full Prescribing Information for additional safety information.

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ACTIMMUNE efficacy

Approved Uses and Important Safety Information

Approved Uses and Important Safety Information