NYVEPRIA- pegfilgrastim-apgf injection, solution

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

PEGFILGRASTIM (UNII: 3A58010674) (PEGFILGRASTIM - UNII:3A58010674)

제공처:

Pfizer Laboratories Div Pfizer Inc

관리 경로:

SUBCUTANEOUS

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

NYVEPRIA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see Clinical Studies (14)] . Limitations of Use NYVEPRIA is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. NYVEPRIA is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis [see Warnings and Precautions (5.3)] . Risk Summary Although available data with NYVEPRIA or pegfilgrastim product 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 filgrastim products. These studies have not establishe

제품 요약:

NYVEPRIA (pegfilgrastim-apgf) injection is a clear, colorless solution supplied in a prefilled single-dose syringe for manual use containing 6 mg pegfilgrastim-apgf, supplied with a 27-gauge 1/2-inch needle and a BD UltraSafe Plus™ Passive Needle Guard. The NYVEPRIA syringe plunger stopper and needle cover are not made with natural rubber latex. NYVEPRIA is provided in a dispensing pack containing one sterile 6 mg/0.6 mL prefilled syringe (NDC 0069-0324-01). NYVEPRIA prefilled syringe does not bear graduation marks and is intended only to deliver the entire contents of the syringe (6 mg/0.6 mL) for direct administration. Use of the prefilled syringe is not recommended for direct administration for pediatric patients weighing less than 45 kg who require doses that are less than the full contents of the syringe. Store refrigerated between 36°F to 46°F (2°C to 8°C) in the carton to protect from light. Do not shake. Discard syringes stored at room temperature for more than 15 days. Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard syringe if frozen more than once.

승인 상태:

Biologic Licensing Application

제품 특성 요약

NYVEPRIA- PEGFILGRASTIM-APGF INJECTION, SOLUTION
PFIZER LABORATORIES DIV PFIZER INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NYVEPRIA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NYVEPRIA.
NYVEPRIA™ (PEGFILGRASTIM-APGF) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2020
NYVEPRIA (pegfilgrastim-apgf) is biosimilar* to NEULASTA
(pegfilgrastim) (1)
RECENT MAJOR CHANGES
Warnings and Precautions, Thrombocytopenia (5.7)
04/2021
Warnings and Precautions, Myelodysplastic Syndrome (MDS) and Acute
Myeloid
Leukemia (AML) (5.10)
04/2021
INDICATIONS AND USAGE
NYVEPRIA is a leukocyte growth factor indicated to decrease the
incidence of infection, as manifested by
febrile neutropenia, in patients with non-myeloid malignancies
receiving myelosuppressive anti-cancer
drugs associated with a clinically significant incidence of febrile
neutropenia. (1)
Limitations of Use
NYVEPRIA is not indicated for the mobilization of peripheral blood
progenitor cells for hematopoietic stem
cell transplantation. (1)
DOSAGE AND ADMINISTRATION
Patients with cancer receiving myelosuppressive chemotherapy
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DOSAGE FORMS AND STRENGTHS
Injection: 6 mg/0.6 mL solution in a single-dose prefilled syringe for
manual use only. (3)
CONTRAINDICATIONS
Patients with a history of serious allergic reactions to human
granulocyte colony-stimulating factors such
as pegfilgrastim products or filgrastim products. (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (≥5% difference in incidence compared
to placebo) are bone pain and
pain in extremity. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT PFIZER INC. AT
1-800-438-1985 OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
*Biosimilar means that the biological product is approved based on
data demonstrating that it is highly
6 mg administered subcutaneously once per chemotherapy cycle. (2.1)
Do not administer between 14 days before and 24 hours afte