Dosing Calculator & Administration | ACTIMMUNE® (Interferon gamma-1b) HCP

Recommended dosage of ACTIMMUNE^1,2

ACTIMMUNE^® (Interferon gamma-1b) should be administered subcutaneously 3 times weekly. It can be injected by the patient or caregiver after appropriate training by a healthcare professional.^1,2

Body Surface Area	Dose	Frequency	Dose Modification
Greater than 0.5 m² 0.5m² or less	50 mcg x BSA m² Connect with an Amgen Representative to confirm dosing	3 times weekly 3 times weekly	If severe reactions occur, the dosage should be reduced by 50% or therapy should be interrupted until the adverse reaction abates.

Body Surface Area

Dose

Frequency

Dose Modification

Greater than 0.5 m²

0.5m² or less

50 mcg x BSA m²

Connect with an Amgen Representative to confirm dosing

3 times weekly

If severe reactions occur, the dosage should be reduced by 50% or therapy should be interrupted until the adverse reaction abates.

Body Surface Area: Greater than 0.5 m²

Dose: 50 mcg x BSA m²

Frequency: 3 times weekly

Dose Modification: If severe reactions occur, the dosage should be reduced by 50% or therapy should be interrupted until the adverse reaction abates.

Body Surface Area: 0.5m² or less

Dose: Connect with an Amgen Representative to confirm dosing

Frequency: 3 times weekly

Dose Modification: If severe reactions occur, the dosage should be reduced by 50% or therapy should be interrupted until the adverse reaction abates.

ACTIMMUNE is a sterile, clear, colorless solution filled in a single-use vial for subcutaneous injection. Each 0.5 mL of ACTIMMUNE contains 100 mcg (2 million International Units) of interferon gamma-1b.*

*Note that the above activity is expressed in International Units (1 million International Units/50 mcg). This is equivalent to what was previously expressed as units (1.5 million units/50 mcg).

Speak With a Representative

If you have questions or would like to learn more about appropriate dosing and administration, you may connect with a representative.

Dosing Flashcard

For dosing calculations by patient body surface area, download the dosing flashcard.

Administering ACTIMMUNE

^1,3

Parenteral drug products should be inspected visually for particulate matter and discoloration before administration.¹

Contraindications

ACTIMMUNE is contraindicated in patients who develop or have known hypersensitivity to interferon gamma-1b, E. coli-derived products, or any component of the product.¹

Stay informed about ACTIMMUNE and CGD

References

1. ACTIMMUNE (Interferon gamma-1b) [prescribing information] Amgen. 2. Mosteller RD. Simplified calculation of body-surface area. N Engl J Med. 1987;317(17):1098. 3. 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.

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.

You are leaving ACTIMMUNEhcp.com

You are leaving ACTIMMUNEhcp.com

Thank You

Speak With a Representative

Dosing Flashcard

Administering ACTIMMUNE

Stay informed about ACTIMMUNE and CGD

Approved Uses and Important Safety Information

Approved Uses and Important Safety Information