Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Clinigen Healthcare Limited, Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire, DE14 2WW, United Kingdom
IMMUKIN is indicated for the reduction of the frequency of serious infections in patients with chronic granulomatous disease (CGD) (see also section 4.4).
IMMUKIN is indicated for the reduction in frequency of serious infections in patients with severe, malignant osteopetrosis (see also section 4.4 and 5.1).
The recommended dosage of IMMUKIN 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. IMMUKIN 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 IMMUKIN is not known yet higher doses are not recommended. Safety and efficacy has not been established for IMMUKIN 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.
The experience in children is limited (see sections 4.4 and 5.1).
IMMUKIN is for subcutaneous use.
IMMUKIN has been administered at higher doses (>100 mcg/m²) to patients with advanced malignancies by the intravenous or intramuscular route.
Central nervous system adverse reactions including decreased mental status, gait disturbance and dizziness have been observed, particularly in cancer patients receiving doses greater than 100 mcg/m²/day. These abnormalities were reversible within a few days upon dose reduction or discontinuation of therapy.
Blood disorders including reversible neutropenia and thrombocytopenia as well as the onset of increased hepatic enzymes and of triglycerides have also been observed.
Patients with pre-existing cardiac disease may experience an acute, self-limited exacerbation of their cardiac condition at doses of 250 mcg/m²/day or higher, as observed in early clinical trials, although no direct cardiotoxic effect has been demonstrated.
Further undesirable effects which may occur as a consequence of overdosing as observed in respective clinical trials in other than the registered indications are outlined in section 4.8 above.
3 years.
IMMUKIN is for single use only.
The formulation does not contain a preservative. Once opened, the content of a vial should be used immediately. The unused portion of any vial should be discarded.
Store in a refrigerator (2°C–8°C). Do not freeze.
3 ml glass vials (Type I borosilicate glass) which are stoppered with grey butyl rubber stoppers with aluminium/polypropylene flip-off type caps.
Pack sizes: 1, 3, 5, 6 and 12 vial(s) in one folding box. Not all pack sizes may be marketed.
Vials of IMMUKIN must not be shaken vigorously.
Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration.
Any unused medicinial product or waste material should be disposed of in accordance with local requirements.
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