Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Mylan S.A.S., 117 allée des Parcs, 69800, Saint-Priest, France
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).
Pegfilgrastim therapy should be initiated and supervised by physicians experienced in oncology and/or haematology.
One 6 mg dose (a single pre-filled syringe) of pegfilgrastim 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.
Fulphila 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).
Fulphila may be exposed to room temperature (not above 30°C) for a maximum single period of up to 72 hours. Fulphila left at room temperature for more than 72 hours should be discarded.
Do not freeze. Accidental exposure to freezing temperatures for a single period of less than 24 hours does not adversely affect the stability of Fulphila.
Keep the container in the outer carton in order to protect from light.
Pre-filled syringe (Type I glass), with a fluorotec-coated bromobutyl rubber stopper and a stainless steel needle with or without an automatic needle guard.
Pack size of one pre-filled syringe, in blistered packaging.
Before administration, Fulphila 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.
The pre-filled syringe should be allowed to reach room temperature before injecting.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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