Interferon gamma -1b is an exogenous protein, which may lead to the occurrence of antibodies during the course of treatment. In addition to tests normally required for monitoring patients with CGD or severe, malignant osteopetrosis, patients should have performed the following tests before beginning IMMUKIN therapy and at appropriate periods during treatment: haematologic tests, including complete blood counts, differential and platelet counts blood chemistries, including renal and liver function tests urinalysis. vaccines) should be avoided because of the risk for unexpected amplified immune response (see section 4.5). Simultaneous administration of interferon gamma-1b with other heterologous serum protein preparations or immunological preparations (e.g. Caution should be exercised when administering IMMUKIN to patients with myelosuppression. Reversible neutropenia and thrombocytopenia that can be severe and may be dose related have been observed during IMMUKIN therapy. Caution should be especially observed in patients with hepatic insufficiency. Liver transaminase values returned to baseline in all patients and did not recur with rechallenge except in one patient. Treatment with IMMUKIN was interrupted in all 6 of these patients and restarted at a reduced dosage in 4.
In one case this occurred as early as 7 days after starting therapy. The incidence appeared to be higher in patients less than 1 year of age compared to older children with 6 out of 10 developing elevated enzyme levels. Patients with serious hepatic insufficiency and patients with severe renal insufficiency should be treated with caution since the possibility of interferon gamma-1b accumulation exists in those patients.Įlevations of AST and /or ALT (up to 25-fold) have been observed during IMMUKIN therapy. Patients with pre-existing cardiac disease may experience an acute, self-limiting exacerbation of their cardiac condition at doses of 250 mcg / m 2 / day or higher, as observed in early clinical trials, although no direct cardiotoxic effect has been demonstrated.Ĭaution should be exercised when treating patients with known seizure disorders and/or compromised central nervous system function. In the pivotal clinical efficacy study the overwhelming majority of the patients were receiving prophylactic antimicrobial therapy (see section 5.1). The use of IMMUKIN does not exclude the need for any additional antimicrobial coverage that might be required for the management of CGD. The experience in children is limited (see sections 4.4 and 5.1) If severe reactions occur, the dosage should be modified (50 % reduction) or therapy should be discontinued until the adverse reaction abates. Safety and efficacy has not been established for IMMUKIN given in doses greater or less than the recommended dose of 50 mcg / m 2. IMMUKIN can be administered by a physician, nurse, family member or patient when trained in the administration of subcutaneous injections.Īlthough the most beneficial dose of IMMUKIN is not known yet higher doses are not recommended. The optimum sites of injection are the right and the left deltoid and anterior thigh. Injections should be administered subcutaneously preferably in the evening three times weekly (for example, Monday, Wednesday, Friday). The actually drawn volume has to be controlled before injection. The recommended dosage of IMMUKIN for the treatment of patients with CGD or severe, malignant osteopetrosis is 50 mcg / m 2 for patients whose body surface area is greater than 0.5 m 2 and 1.5 mcg / kg / dose for patients whose body surface area is equal to or less than 0.5 m 2.
Date of first authorisation/renewal of the authorisation
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