Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: ERA Consulting GmbH, Lange Strasse 70, 29664 Walsrode, Germany, Tel: +49 (0) 5161 9890 0, Fax: +49 (0) 5161 9890 18, E-mail: EUAgent@eraconsulting.com
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.
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.
Pegfilgrastim 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.
2 years.
Store in a refrigerator (2°C – 8°C).
UDENYCA may be exposed to room temperature (not above 30°C) for a maximum single period of up to 72 hours. When left at room temperature for more than 72 hours it 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 pegfilgrastim.
Keep the container in the outer carton in order to protect from light.
Pre-filled syringe, with a coated bromobutyl rubber stopper and a stainless steel needle with automatic needle guard.
Each pre-filled syringe contains 0.6 ml of solution for injection.
Pack size: Each carton contains 1 pre-filled syringe with an automatic needle guard blistered in a plastic tray.
Before administration, pegfilgrastim 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 medicinal product or waste material should be disposed of in accordance with local requirements.
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