Pegfilgrastim

Trade Names:
Neulasta
- Injection, solution 10 mg/mL

Pharmacology

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Stimulates neutrophil production within bone marrow.

Pharmacokinetics

Elimination

Half-life is 15 to 80 h (subcutaneous injection). Serum clearance is directly related to the number of neutrophils.

Special Populations

No difference in pharmacokinetics based on renal function impairment, including end-stage renal disease.

Pharmacokinetics have not been assessed.

No difference in pharmacokinetics of patients 65 years of age and older compared with patients younger than 65 years of age.

No difference in pharmacokinetics based on gender.

Indications and Usage

To decrease incidence of infection, manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with febrile neutropenia.

Contraindications

Hypersensitivity to filgrastim, pegfilgrastim, or any component of the product.

Dosage and Administration

Subcutaneous 6 mg once per chemotherapy cycle.

General Advice

• Do not administer in period between 14 days before and 24 h after administration of cytotoxic chemotherapy.
• Do not administer the 6 mg fixed-dose formulation in infants, children, and smaller adolescents weighing less than 45 kg.
• For subcutaneous administration only. Not for intradermal, IM, IV, intraarterial administration.
• Avoid shaking syringe.
• Do not administer if particulate matter, cloudiness, or discoloration noted.

Storage/Stability

Store prefilled syringes in original carton in refrigerator (36° to 46°F). Do not freeze. If accidentally frozen, allow to thaw in refrigerator before using. Discard syringe if frozen a second time. May allow syringe to reach room temperature before administering. If removed from refrigerator, keep syringe in original carton to protect from light and use within 48 h. Discard syringe if left at room temperature for greater than 48 h.

Drug Interactions

Use drugs that potentiate the release of neutrophils with caution.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Pyrexia (23%); headache (16%); dizziness, fatigue, generalized weakness, insomnia, taste perversion (at least 15%); asthenia (13%).

Dermatologic

Alopecia (48%); acute febrile neutrophilic dermatosis, flushing, generalized erythema (postmarketing).

GI

Diarrhea (29%); abdominal pain, anorexia, constipation, dyspepsia, mucositis, nausea, stomatitis, vomiting (at least 15%).

Hematologic-Lymphatic

Granulocytopenia, neutropenic fever (at least 15%); leukocytosis; sickle cell crisis (postmarketing).

Hypersensitivity

Allergic reactions including anaphylaxis, skin rash, and urticaria (postmarketing).

Local

Injection site reactions including erythema, induration, and pain (postmarketing).

Musculoskeletal

Bone pain (31%); myalgia (21%); arthralgia (16%); skeletal pain (at least 15%).

Respiratory

Acute respiratory distress syndrome (ARDS) (postmarketing).

Miscellaneous

Fever, peripheral edema (at least 15%); splenic rupture (postmarketing).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established. Do not use 6 mg fixed-dose formulation in infants, children, and smaller adolescents weighing less than 45 kg.

Hypersensitivity

Allergic-type reactions, including anaphylaxis, skin rash, and urticaria may occur.

Renal Function

No dosage adjustment is needed.

ARDS

ARDS may occur. Monitor patient for signs and symptoms of ARDS (eg, fever, respiratory distress).

Sickle cell disease

Use with caution because severe sickle cell crisis may occur in patients with sickle cell disease.

Splenic rupture

Because splenic rupture may occur, do not use pegfilgrastim for peripheral blood progenitor cell mobilization. Monitor patient for signs and symptoms of splenic enlargement (eg, left upper abdominal pain, shoulder tip pain).

Tumor growth

Pegfilgrastim is a growth factor; the possibility that pegfilgrastim can act as a growth factor for any tumor type cannot be excluded.

Overdosage

Symptoms

Max amount that can be safely administered has not been determined.

Patient Information

• If patient or caregiver will be administering at home, review “Information for Patients and Caregivers” insert with the patient or caregiver. Ensure that the patient or caregiver understands how to store, prepare, and administer the dose, and dispose of used equipment and supplies. The first injection should be performed under the supervision of a qualified health care provider.
• Caution patient or caregiver that medication is not to be administered during the time interval beginning 14 days before to 24 h after administration of chemotherapy.
• Advise patient or caregiver to immediately report any of the following to their health care provider: fever or other signs of infection, sore throat, left upper stomach pain, shoulder tip pain, difficulty breathing, rash or hives.
• Advise patient or caregiver to report intolerable injection-site reactions or unusual symptoms to their health care provider.

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