NEULASTA/FULPHILA/ LAPELGA/NYVEPRIA (Pegfilgrastim)
NEULASTA/FULPHILA/ LAPELGA/NYVEPRIA (Pegfilgrastim)
NEULASTA/FULPHILA/ LAPELGA/NYVEPRIA (Pegfilgrastim)
NEULASTA/FULPHILA/ LAPELGA/NYVEPRIA (Pegfilgrastim)
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NEULASTA/FULPHILA/ LAPELGA/NYVEPRIA (Pegfilgrastim)

Vendor
AMGEN/BGP/APOTEX/PFIZER
Regular price
$3,299.99 USD
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$3,299.99 USD
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prescription refrigerated

What is this medication?

NEULASTA/FULPHILA/LAPELGA/NYVEPRIA (Pegfilgrastim)
Colony Stimulating FactorHematopoietic Agent

Pegfilgrastim is indicated for the treatment of hematopoietic radiation injury syndrome, acute (NEULASTA ONLY); Prevention of chemotherapy-induced neutropenia (NEULASTA, FULPHILA, LAPELGA, and NYVEPRIA).

What is a biosimilar biologic drug?

Manufacturers have found cost-efficient ways to recreate the molecules used in the original or “reference” biologic drug.  Biosimilars are highly “similar” to a reference biological drug despite differing in their chemical composition.  

The FDA approval of biosimilar drugs is based on a totality of evidence which is used by regulators in the approval of reference and biological drugs.  The FDA uses the same approach in evaluating biosimilars to confirm that there are no clinically meaningful differences in safety and efficacy between the reference biologic drug and the biosimilar.  The rigorous standard for authorization means that you can have confidence knowing that the quality, safety, and efficacy of a biosimilar is the same as any other biologic drug.

NEULASTA is a biologic
FULPHILA is a biosimilar to NEULASTA (Pegfilgrastim)
LAPELGA is a biosimilar to NEULASTA (Pegfilgrastim)
NYVEPRIA is a biosimilar to NEULASTA (Pegfilgrastim)

What are the ingredients in this medication?

NEULASTA
Medicinal ingredient:
Pegfilgrastim
Non-medicinal ingredients:
Polysorbate 20, sodium acetate, sorbitol, water for injection. Preservative-free.

FULPHILA
Medicinal ingredient: 
Pegfilgrastim
Non-medicinal ingredients: 
Polysorbate 20, sodium acetate, sorbitol, and water for injection. Preservative-free.

LAPELGA
Medicinal ingredient:
Pegfilgrastim
Non-medicinal ingredients: 
Polysorbate 20, sodium acetate, sorbitol, and water for injection. Preservative-free.

NYVEPRIA
Medicinal ingredient:
Pegfilgrastim
Non-medicinal ingredients: 
Polysorbate 20, sodium acetate, sorbitol, and water for injection. Preservative-free.

How does this medication work? 

NEULASTA/FULPHILA/LAPELGA/NYVEPRIA (Pegfilgrastim) stimulates the production, maturation, and activation of neutrophils.  It also activates neutrophils to increase both their migration and cytotoxicity. Pegfilgrastim has a prolonged duration of effect compared to filgrastim and a reduced renal clearance.

How should I take this medication? 

Prevention of chemotherapy-induced neutropenia:
SQ
: Inject 6 mg subcutaneously once per chemotherapy cycle, beginning at least 24 hours after completion of chemotherapy; Note: Do not administer in the period between 14 days before and 24 hours after administration of cytotoxic chemotherapy.

Hematopoietic radiation injury syndrome, acute (NEULASTA ONLY):
SQ:
 Inject 6 mg subcutaneously once weekly for 2 doses. Obtain a baseline CBC prior to administration, but do not delay pegfilgrastim use if a CBC is not readily obtainable. Administer the first dose as soon as possible after suspected or confirmed radiation exposure >2 gray (Gy). Administer the second dose 1 week after the first dose.

How to Take: Administer subcutaneously.  Pegfilgrastim products are available in prefilled syringes for manual subcutaneous administration or as a kit for use with the On-body injector (OBI) (NEULASTA). Direct administration of doses <6 mg using the prefilled syringe is not recommended by the manufacturer (it does not have graduation marks necessary for accurate measurement of doses other than 6 mg); use caution to avoid dosing errors.  Follow detailed administration instructions provided with product.  

You Need to Avoid:  Do not use 6 mg fixed dose in infants, children, or adolescents <45 kg. 

What should I watch for while using this medication? 

Before starting NEULASTA/FULPHILA/LAPELGA/NYVEPRIA (Pegfilgrastim), make sure your physician is aware of any allergies or medications you currently take, if you have sickle cell disease, are pregnant, or breastfeeding. Pegfilgrastim use has been associated with rare but serious adverse events such as aortitis, capillary leak syndrome, hematologic effects, hypersensitivity reactions, nephrotoxicity, respiratory distress syndrome, and splenic rupture.

What size needle does this medication use?

NEULASTA
Prefilled syringe: 27-gauge, ½ inch needle

FULPHILA
Prefilled syringe: 29-gauge, ½ inch needle

LAPELGA
Prefilled syringe: 27-gauge, ½ inch needle

NYVEPRIA
Prefilled syringe: 27-gauge, ½ inch needle

What if I miss a dose?

Contact you doctor if you missed a dose. Pegfilgrastim must be taken at specific times during the chemotherapy cycle to prevent the possibility of dangerous drug interactions. Your doctor will give you instructions for what to do if you miss a dose.

How should I store this medication?

Store under refrigeration at 2°C to 8°C (36°F to 46°F) and protect from light. Allow prefilled syringe to reach room temperature for ≥30 minutes; discard if kept at room temperature for >48 hours (NEULASTA), >72 hours (FULPHILA), or >15 days (NYVEPRIA). The On-body injector kit (NEULASTA) should be kept refrigerated until 30 minutes prior to use and should not be held at room temperature for >12 hours prior to use (discard if stored at room temperature for >12 hours).

Do not freeze. If syringe for manual injection is inadvertently frozen, allow to thaw in refrigerator; discard if frozen more than one time. Do not shake product.

What are the possible side effects of using this medication?

Ostealgia, and limb pain.

Note this is not a complete list of side effects for NEULASTA/FULPHILA/LAPELGA/NYVEPRIA (Pegfilgrastim), only common ones.