with results similar tothose for cycle 1.
Study 3 was a randomized, double-blind, placebo-controlled study that employed docetaxel 100 mg/m2 administeredevery 21 days for up to 4 cycles for the treatment of metastatic or non-metastatic breast cancer. In this study, 928patients were randomized to receive a single subcutaneous injection of pegfilgrastim (6 mg) or placebo on day 2 ofeach chemotherapy cycle. Study 3 met the major trial outcome measure of demonstrating that the incidence offebrile neutropenia (defined as temperature ≥ 38.2°C and ANC ≤ 0.5 x109/L) was lower for pegfilgrastim-treatedpatients as compared to placebo-treated patients (1% versus 17%, respectively, p < 0.001). The incidence ofhospitalizations (1% versus 14%) and IV anti-infective use (2% versus 10%) for the treatment of febrile neutropeniawas also lower in the pegfilgrastim-treated patients compared to the placebo-treated patients.
Study 4 was a multicenter, randomized, open-label study to eva luate the efficacy, safety, and pharmacokinetics [seeClinical Pharmacology (12.3)] of pegfilgrastim in pediatric and young adult patients with sarcoma. Patients withsarcoma receiving chemotherapy age 0 to 21 years were eligible. Patients were randomized to receive subcutaneouspegfilgrastim as a single dose of 100 mcg/kg (n= 37) or subcutaneous filgrastim at a dose 5 mcg/kg/day (n=6)following myelosuppressive chemotherapy. Recovery of neutrophil counts was similar in the pegfilgrastim andfilgrastim groups. The most common adverse reaction reported was bone pain.
16 HOW SUPPLIED/STORAGE AND HANDLING
UDENYCA (pegfilgrastim-cbqv) injection is a clear, colorless, preservative-free solution supplied in a prefilledsingle-dose syringe with an UltraSafe Passive™ Needle Guard, containing 6mg of pegfilgrastim-cbqv.
The needle cap of the prefilled syringe is not made with natural rubber latex.
UDENYCA is provided in a dispensing pack containing one 6 mg/0.6 mL prefilled syringe (NDC 70114-101-01).
UDENYCA prefilled syringe does not bear graduation marks and is intended only to deliver the entire contents ofthe syringe (6 mg/0.6 mL) for direct administration. Use of the prefilled syringe is not recommended for directadministration for pediatric patients weighing less than 45 kg who require doses that are less than the full contents ofthe syringe.
Store refrigerated between 2° to 8°C (36° to 46°F) in the carton to protect from light. Do not shake. Discardsyringes stored at room temperature for more than 48 hours. Avoid freezing; if frozen, thaw in the refrigeratorbefore administration. Discard syringe if frozen more than once.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use)Advise patients of the following risks [See Warnings and Precautions (5)]:
• Splenic rupture
• Acute Respiratory Distress Syndrome
• Serious allergic reactions
• Sickle cell crisis
• Glomerulonephritis
• Capillary Leak Syndrome
• Aortitis
Instruct patients who self-administer UDENYCA using the single-dose prefilled syringe of the:
• Importance of following the Instructions for Use (see Instructions for Use)
• Dangers of reusing syringes
• Importance of following local requirements for proper disposal of used syringes.
UDENYCA™ (pegfilgrastim-cbqv)
Manufactured by |
