Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Evive Biotechnology Ireland LTD, 20 Kildare Street, Dublin 2, D02 T3V7, Ireland
Ryzneuta is indicated for the 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).
Ryzneuta therapy should be initiated and supervised by physicians experienced in oncology and/or haematology.
One 20 mg dose (a single pre-filled syringe) of Ryzneuta 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 Ryzneuta in children have not yet been established and no data are available.
Ryzneuta is for subcutaneous use. It is provided in a pre-filled syringe for manual administration.
The injections should be given into the thigh, abdomen, buttock or upper arm.
For instructions on handling of the medicinal product before administration, see section 6.6.
A single subject administered 40 mg efbemalenograstim alfa during a chemotherapy cycle (20 mg injections on consecutive days) reported adverse events that were similar to those in subjects receiving lower doses of efbemalenograsim alfa.
3 years.
Store in a refrigerator (2°C–8°C).
Ryzneuta may be exposed to room temperature (not above 30°C) for a maximum single period of up to 48 hours. Ryzneuta left at room temperature for more than 48 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 Ryzneuta.
Keep the pre-filled syringe 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 cap.
The needle cap on the prefilled syringe contains dry natural rubber (latex) (see section 4.4).
Each pre-filled syringe contains 1 mL of solution for injection.
Pack size of one pre-filled syringe
Before use, Ryzneuta solution should be inspected visually for particulate matter. Only a solution that is clear and colourless should be injected.
Do not shake. Excessive shaking may aggregate efbemalenograstim alfa, rendering it biologically inactive.
Allow the pre-filled syringe to reach room temperature for approximately 30 minutes before injecting.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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