RYZNEUTA- efbemalenograstim alfa-vuxw injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

EFBEMALENOGRASTIM ALFA (UNII: 5UPW5HJW3O) (EFBEMALENOGRASTIM ALFA - UNII:5UPW5HJW3O)

Available from:

Evive Biotechnology Singapore PTE. LTD.

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

RYZNEUTA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Limitations of Use RYZNEUTA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. RYZNEUTA is contraindicated in patients with a history of serious allergic reactions to granulocyte stimulating factors such as efbemalenograstim alfa-vuxw, pegfilgrastim, or filgrastim products [see Warnings and Precautions ( 5.3)] . Risk Summary Although available data with RYZNEUTA use in pregnant women are insufficient to establish whether there is a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes, there are available data from published studies in pregnant women exposed to other human G CSF products. These studies have not established an association of G-CSF product use during pregnancy with major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal studies, no evidence of reproductive/developmental toxicity occurred in the offspring of pregnant rats and rabbits that received cumulative doses of efbemalenograstim alfa-vuxw approximately 2.6 and 0.7 times, respectively, the recommended human dose (based on body surface area). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Three studies were conducted in pregnant rats dosed with efbemalenograstim alfa-vuxw at cumulative doses up to approximately 2.6 times the recommended human dose at the following stages of gestation: during the period of organogenesis, from mating through the first half of pregnancy, and from the first trimester through delivery and lactation. No evidence of fetal loss or structural malformations was observed in any study. Growth and learning were also unaffected. Pregnant rabbits were dosed with efbemalenograstim alfa-vuxw every other day during organogenesis at cumulative doses up to 0.7 times the recommended human dose showed no signs of fetal loss or structural malformations. Maternal toxicity (decreased weight gain or weight loss and/or death) was observed when higher cumulative doses of efbemalenograstim alfa-vuxw were used in an early dose-ranging study in rabbits. Risk Summary There are no data on the presence of efbemalenograstim alfa-vuxw or its metabolite in either human or animal milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for efbemalenograstim alfa-vuxw and any potential adverse effects on the breastfed child from efbemalenograstim alfa-vuxw or from the underlying maternal condition. Safety and effectiveness in pediatric patients have not been established. Clinical studies of RYZNEUTA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience with RYZNEUTA has not identified differences in responses between the elderly and younger patients.

Product summary:

RYZNEUTA (efbemalenograstim alfa-vuxw) injection is a clear, colorless, preservative-free solution supplied in a prefilled single-dose syringe with a 27-gauge, 1/2-inch needle and an UltraSafe Passive™ Needle Guard, containing 20 mg of efbemalenograstim alfa-vuxw. Caution: This product contains natural rubber latex which may cause allergic reactions. The needle cap of the prefilled syringe contains natural rubber; persons with latex allergies should not administer this product. RYZNEUTA is provided in a dispensing pack containing one 20 mg/mL prefilled syringe (NDC 73491-627-01). RYZNEUTA prefilled syringe does not bear graduation marks and is intended only to deliver the entire contents of the syringe (20 mg/mL) for direct administration to adult patients. Store refrigerated at 2° to 8°C (36° to 46°F) in the carton to protect from light. Do not shake. Discard syringes stored at room temperature for more than 48 hours. Do not freeze. Discard syringe if frozen.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

RYZNEUTA- EFBEMALENOGRASTIM ALFA-VUXW INJECTION
EVIVE BIOTECHNOLOGY SINGAPORE PTE. LTD.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RYZNEUTA
SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR RYZNEUTA.
RYZNEUTA
(EFBEMALENOGRASTIM ALFA-VUXW) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2023
INDICATIONS AND USAGE
RYZNEUTA is a leukocyte growth factor indicated to decrease the
incidence of infection, as manifested by
febrile neutropenia, in adult patients with non-myeloid malignancies
receiving myelosuppressive anti-
cancer drugs associated with a clinically significant incidence of
febrile neutropenia. ( 1)
Limitations of Use
RYZNEUTA is not indicated for the mobilization of peripheral blood
progenitor cells for hematopoietic stem
cell transplantation. ( 1)
DOSAGE AND ADMINISTRATION
Recommended Dose: 20 mg administered subcutaneously once per
chemotherapy cycle. ( 2.1)
Administer approximately 24 hours after cytotoxic chemotherapy. Do not
administer between 14 days
before and 24 hours after administration of cytotoxic chemotherapy. (
2.1)
DOSAGE FORMS AND STRENGTHS
Injection: 20 mg/mL solution in a single-dose prefilled syringe. ( 3)
CONTRAINDICATIONS
Patients with a history of serious allergic reactions to granulocyte
stimulating factors such as
efbemalenograstim alfa-vuxw, pegfilgrastim, or filgrastim products. (
4)
WARNINGS AND PRECAUTIONS
Fatal splenic rupture: Evaluate patients who report left upper
abdominal or shoulder pain for an
enlarged spleen or splenic rupture. ( 5.1)
Acute respiratory distress syndrome (ARDS): Evaluate patients who
develop fever, lung infiltrates, or
respiratory distress. Discontinue RYZNEUTA in patients with ARDS. (
5.2)
Serious allergic reactions, including anaphylaxis: Permanently
discontinue RYZNEUTA in patients with
serious allergic reactions. ( 5.3)
Sickle cell crises in Patients with Sickle Cell Disorders: Discontinue
RYZNEUTA if sickle cell crisis occurs. (
5.4)
Glomerulonephritis: Evalua