Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Fresenius Kabi Deutschland GmbH, Else-Kroener Strasse 1, 61352 Bad Homburg v.d.Hoehe, Germany
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Stimufend therapy should be initiated and supervised by physicians experienced in oncology and/or haematology.
One 6 mg dose (a single pre-filled syringe) of Stimufend is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy.
No dose change is recommended in patients with renal impairment, including those with end-stage renal disease.
The safety and efficacy of pegfilgrastim in children has not yet been established. Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
Stimufend is injected subcutaneously. The injections should be given into the thigh, abdomen or upper arm.
For instructions on handling of the medicinal product before administration, see section 6.6.
Single doses of 300 mcg/kg have been administered subcutaneously to a limited number of healthy volunteers and patients with non-small cell lung cancer without serious adverse reactions. The adverse events were similar to those in subjects receiving lower doses of pegfilgrastim.
3 years.
Store in a refrigerator (2°C-8°C).
Stimufend may be exposed to room temperature (not above 30°C) for a maximum single period of up to 72 hours. Stimufend left at room temperature for more than 72 hours should be discarded.
Do not freeze.
Keep the container in the outer carton in order to protect from light.
Pre-filled syringe (Type I glass), with a bromobutyl fluorotec stopper, stainless steel needle, needle cap and an automatic needle guard.
The needle cap of the pre-filled syringe contains dry natural rubber (a derivative of latex) (see section 4.4).
Each pre-filled syringe contains 0.6 mL of solution for injection.
Pack size of one pre-filled syringe, in a blistered packaging.
Before use, Stimufend solution should be inspected visually for particulate matter. Only a solution that is clear and colourless should be injected.
Excessive shaking may aggregate pegfilgrastim, rendering it biologically inactive.
Allow the pre-filled syringe to come to room temperature for 30 minutes before using the syringe.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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