FULPHILA- pegfilgrastim-jmdb injection

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Mylan Institutional LLC

administration_route:

SUBCUTANEOUS

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Fulphila 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 (14.1)] . Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. Fulphila 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)] . Although available data with Fulphila 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 established an association of filgrastim 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 that received cumulative doses of pegfilgrastim approximately 10 times the recommended human dose (based on body surface area). In pregnant rabbits, increased embryolethality and spontaneous abortions occurred at 4 times the maximum recommended human dose simultaneously with signs of maternal toxicity (see Data ). 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 risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Retrospective studies indicate that exposure to pegfilgrastim is without significant adverse effect on fetal outcomes and neutropenia. Preterm deliveries have been reported in some patients. Pregnant rabbits were dosed with pegfilgrastim subcutaneously every other day during the period of organogenesis. At cumulative doses ranging from the approximate human dose to approximately 4 times the recommended human dose (based on body surface area), the treated rabbits exhibited decreased maternal food consumption, maternal weight loss, as well as reduced fetal body weights and delayed ossification of the fetal skull; however, no structural anomalies were observed in the offspring from either study. Increased incidences of post-implantation losses and spontaneous abortions (more than half the pregnancies) were observed at cumulative doses approximately 4 times the recommended human dose, which were not seen when pregnant rabbits were exposed to the recommended human dose. Three studies were conducted in pregnant rats dosed with pegfilgrastim at cumulative doses up to approximately 10 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. Cumulative doses equivalent to approximately 3 and 10 times the recommended human dose resulted in transient evidence of wavy ribs in fetuses of treated mothers (detected at the end of gestation but no longer present in pups evaluated at the end of lactation). There are no data on the presence of pegfilgrastim products in human milk, the effects on the breastfed child, or the effects on milk production. Other filgrastim products are secreted poorly into breast milk, and filgrastim products are not absorbed orally by neonates. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Fulphila and any potential adverse effects on the breastfed child from Fulphila or from the underlying maternal condition. The safety and effectiveness of pegfilgrastim have been established in pediatric patients. No overall differences in safety were identified between adult and pediatric patients based on postmarketing surveillance and review of the scientific literature. Use of pegfilgrastim in pediatric patients for chemotherapy-induced neutropenia is based on adequate and well-controlled studies in adults with additional pharmacokinetic and safety data in pediatric patients with sarcoma [see Clinical Pharmacology (12.3) and Clinical Studies (14.1)] . Of the 932 patients with cancer who received pegfilgrastim in clinical studies, 139 (15%) were aged 65 and over, and 18 (2%) were aged 75 and over. No overall differences in safety or effectiveness were observed between patients aged 65 and older and younger patients.

leaflet_short:

Fulphila single-dose prefilled syringe for manual use Fulphila (pegfilgrastim-jmdb) Injection is a clear, colorless solution supplied in a prefilled single-dose syringe for manual use containing 6 mg pegfilgrastim-jmdb, supplied with a 29 gauge, 1/2-inch needle with an UltraSafe Passive Plus™ Needle Guard. Fulphila is provided in a dispensing pack containing one sterile 6 mg/0.6 mL prefilled syringe. NDC 67457-833-06 Fulphila 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 2° to 8°C (36° to 46°F) in the carton to protect from light or physical damage. Do not shake. Discard syringes stored at room temperature for more than 72 hours. Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard syringe if frozen more than once.

authorization_status:

Biologic Licensing Application

SPC

FULPHILA- PEGFILGRASTIM INJECTION
MYLAN INSTITUTIONAL LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FULPHILA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FULPHILA.
FULPHILA (PEGFILGRASTIM-JMDB) INJECTION, FOR SUBCUTANEOUS USE
INITIAL U.S. APPROVAL: 2018
FULPHILA (PEGFILGRASTIM-JMDB) IS BIOSIMILAR* TO NEULASTA
(PEGFILGRASTIM). (1)
RECENT MAJOR CHANGES
Warnings and Precautions, Thrombocytopenia (5.7) 03/2021
Warnings and Precautions, Myelodysplastic Syndrome (MDS) and Acute
Myeloid Leukemia (AML)
(5.10) 03/2021
INDICATIONS AND USAGE
Fulphila is a leukocyte growth factor indicated to
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Limitations of Use
Fulphila is not indicated for the mobilization of peripheral blood
progenitor cells for hematopoietic stem cell
transplantation.
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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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)
®
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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. (1.1)
Patients with cancer receiving myelosuppressive chemotherapy
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6 mg administered subcutaneously once per chemotherapy cycle. (2.1)
Do not administer between 14 days before and 24 hours after
administration of cytotoxic
chemotherapy. (2.1)
Use weight based dosing for pediatric patients weighing less than 45
kg; refer to Table 1. (2.2)
Injection: 6 mg/0.6 mL solution in a single-dose prefilled syringe for
manual use only. (3)
Fatal splenic rupture: Evaluate patients who report left upper
abdominal or shoulder pain f