Severe malignant osteopetrosis

Indication for Interferon gamma-1b

Population group: Suitable for both men and women, only adults (18 - 65 years old)

Interferon gamma-1b is indicated for the reduction in frequency of serious infections in patients with severe, malignant osteopetrosis.

For this indication, competent medicine agencies globally authorize below treatments:

50 mcg/m²

Route of admnistration

Subcutaneous

Defined daily dose

50 - 50 ug per m² of body surface area (BSA)

Dosage regimen

From 50 To 50 ug per m² of body surface area (BSA) once every 2 day(s)

Detailed description

The recommended dosage of interferon gamma-1b for the treatment of patients with CGD or severe, malignant osteopetrosis is 50 mcg/m² for patients whose body surface area is greater than 0.5 m² and 1.5 mcg/kg/dose for patients whose body surface area is equal to or less than 0.5 m². The actually drawn volume has to be controlled before injection. Injections should be administered subcutaneously preferably in the evening three times weekly (for example, Monday, Wednesday, Friday). The optimum sites of injection are the right and the left deltoid and anterior thigh. Interferon gamma-1b can be administered by a physician, nurse, family member or patient when trained in the administration of subcutaneous injections.

Although the most beneficial dose of interferon gamma-1b is not known yet higher doses are not recommended. Safety and efficacy has not been established for interferon gamma-1b given in doses greater or less than the recommended dose of 50 mcg/m². If severe reactions occur, the dosage should be modified (50% reduction) or therapy should be discontinued until the adverse reaction abates.

Active ingredient

It is presumed that interferon gamma-1b increases macrophage cytotoxicity by enhancing the respiratory burst via generation of toxic oxygen metabolites capable of mediating the killing of intracellular micro-organisms.

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