Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Napp Pharmaceuticals Limited, Cambridge Science Park, Milton Road, Cambridge, CB4 0GW
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).
Pelmeg therapy should be initiated and supervised by physicians experienced in oncology and/or haematology.
One 6 mg dose (a single pre-filled syringe) of Pelmeg is recommended for each chemotherapy cycle, given at least 24 hours after cytotoxic chemotherapy.
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.
No dose change is recommended in patients with renal impairment, including those with end stage renal disease.
Pelmeg 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 μg/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.
36 months.
Store in a refrigerator (2°C–8°C).
Pelmeg may be exposed to room temperature (not above 30°C) for a maximum single period of up to 96 hours. Pelmeg left at room temperature for more than 96 hours should be discarded.
Do not freeze. Accidental exposure to freezing temperatures for two periods of less than 72 hours each does not adversely affect the stability of Pelmeg.
Keep the container in the outer carton in order to protect from light.
Pre-filled syringe (Type I glass), with a bromobutyl rubber stopper and a stainless steel needle with an automatic needle guard.
Each pre-filled syringe contains 0.6 mL of solution for injection. Pack size of one pre-filled syringe in a blistered packaging.
Before administration, Pelmeg 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 reach room temperature before injecting.
Any unused product or waste material should be disposed of in accordance with local requirements.
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