Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
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).
Nyvepria therapy should be initiated and supervised by physicians experienced in oncology and/or haematology.
One 6 mg dose (a single pre-filled syringe) of Nyvepria 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 and adolescents have 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.
Nyvepria 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).
Nyvepria may be exposed to room temperature (not above 25°C) for a maximum single period of up to 15 days. Nyvepria left at room temperature for more than 15 days 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 Nyvepria.
Keep the container in the outer carton in order to protect from light.
Pre-filled syringe (type I glass), with a rubber stopper, stainless steel needle and needle cover with an automatic needle guard. The Nyvepria syringe plunger stopper and needle cover are not made with natural rubber latex.
Each pre-filled syringe contains 0.6 mL of solution for injection.
Pack size of one pre-filled syringe, in a carton.
Before use, Nyvepria 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 (not above 25°C) before injecting.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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