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pegfilgrastim (Rx)Brand and Other Names:Neulasta

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

prefilled syringe

  • 6mg/0.6mL
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Myelosuppressive Chemotherapy Adjunct

6mg SC once per chemotherapy cycle

Not for administration in the period 14 days before & 24 hours after admin of cytotoxic chemotherapy

Indicated to decrease incidence of infection in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy assoc with febrile neutropenia

Myelosuppression (Orphan)

Orphan designation for treatment of subjects at risk of developing myelosuppression after a radiological or nuclear incident

Orphan sponsor

  • Amgen, Inc.; One Amgen Center Drive M/S 17-2-B; Thousand Oaks, CA 91320-1799

Dosage Forms & Strengths

prefilled syringe

  • 6mg/0.6mL
more...

Prevention of Chemotherapy Induced Neutropenia

<45 kg: 100 mcg/kg per chemotherapy cycle; not to exceed 6 mg/dose; do not administer in the period 14 days before and 24-72 hr after administration of cytotoxic chemotherapy

≥45kg: 6 mg SC once per chemotherapy cycle; do not administer in the period 14 days before and 24 hr after administration of cytotoxic chemotherapy

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Adverse Effects

>10%

Peripheral edema (12%)

Asthenia (13%)

Headache (16%)

Vomiting (13%)

Bone pain (31-57%)

Myalgia (21%)

Weakness (13%)

Alopecia (15-72%)

Pyrexia (23%)

Frequency Not Defined

Acute respiratory distress syndrome

Sickle cell crisis

Splenic rupture

Hyperuricemia

Elevated lactate dehydrogenase

Elevated alkaline phosphatase

Allergic reaction

Postmarketing Reports

Gastrointestinal disorders: Splenic rupture

Blood and lymphatic system disorder: Sickle cell crisis

Hypersensitivity Reactions: Allergic reactions/hypersensitivity, including anaphylaxis, skin rash, and urticaria, generalized erythema and flushing, cutaneous vasculitis to skin, and subcutaneous tissue disorders

Respiratory, thoracic, and mediastinal disorder: ARDS

General disorders and administration site conditions: Injection site reactions

Skin and subcutaneous tissue disorders: Sweet’s syndrome, cutaneous vasculitis

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Warnings

Contraindications

Hypersensitivity to E. coli derived proteins or any component

Cautions

Permanently discontinue therapy if serious allergic reaction occurs

Capillary leak syndrome may occur; may vary in frequency and severity; manage symptoms; delayed treatment may be life-threatening

Glomerulonephritis reported; if suspected, evaluate for cause; if causality likely, consider dose-reduction or interruption of therapy

Monitoring of complete blood count (CBC) during therapy recommended; higher counts reported

Acute respiratory distress syndrome (ARDS) reported; evaluate symptoms including fever, pulmonary infiltrates, or respiratory distress; discontinue if ARDS occurs

Not for use 14 days before or 24 hr after administering cytotoxic chemotherapy, because of potential increase in sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy; effect not studied

The 6 mg fixed dose is not for use in infants, children, and adolescents weighing <45 kg

Not indicated for peripheral blood progenitor cell (PBRC) mobilization for hematopoietic stem cell transplantation

Pegfilgrastim may potentially act as growth factor for any tumor type, including myeloid malignancies and myelodysplasia

Associated with rare cases of splenic rupture; evaluate if patient experiences left upper abdominal &/or shoulder tip pain

May precipitate sickle cell crises in patients with sickle cell anemia

The body Injector uses acrylic adhesive; for patients who have reactions to acrylic adhesives, use of this product may result in a significant reaction

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: not known if excreted in breast milk

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Recombinant PEG-conjugated human G-CSF; acts on hematopoietic cells to stimulate production, maturation & activation of neutrophilsl; increases migration and cytotoxicity of neutrophils.

Pharmacokinetics

Half-Life: 15-80 hr (adults); 20-30 hr (children)

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Images

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Formulary

FormularyPatient Discounts

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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