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Pegfilgrastim

Pronouncation: (peg-fill-GRAH-stim)
Class: Colony-stimulating factor

Trade Names:
Neulasta
- Solution for injection 10 mg/mL

Pharmacology

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As a treatment for...	Avg User Ratings [?]
Neutropenia Associated with Chemotherapy	2 comments Rate it!	8.5

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Stimulates neutrophil production within bone marrow.

Pharmacokinetics

Elimination

T _{1/ 2} is 15 to 80 h (subcutaneous injection). Serum clearance is directly related to the number of neutrophils.

Indications and Usage

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

Contraindications

Hypersensitivity to Escherichia coli -derived proteins, filgrastim, pegfilgrastim, or any component of the product.

Dosage and Administration

Adults

Subcutaneous 6 mg once per chemotherapy cycle. Do not administer in period between 14 days before and 24ߙh after administration of cytotoxic chemotherapy. Do not administer the 6ߙmg fixed-dose formulation in infants, children, and smaller adolescents weighing less than 45 kg.

General Advice

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 48ߙh. Discard syringe if left at room temperature for greater than 48 h.

Drug Interactions

Drugs potentiating the release of neutrophilsߙ(eg, lithium)

Use drugs that potentiate the release of neutrophils with caution.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Fatigue; headache; insomnia; dizziness.

Dermatologic

Alopecia.

GI

Nausea; diarrhea; vomiting; constipation; anorexia; taste perversion; dyspepsia; abdominal pain; stomatitis.

Hematologic

Granulocytopenia; leukocytosis.

Musculoskeletal

Skeletal pain; myalgia; arthralgia; medullary bone pain.

Miscellaneous

Fever; generalized weakness; peripheral edema; mucositis; neutropenic fever.

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established. Do not administer 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.

Adult respiratory distress syndrome

Adult respiratory distress syndrome may occur. Monitor patient for signs and symptoms of adult respiratory distress syndrome (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).

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 professional.
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.