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All about: Pegfilgrastim

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

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

Mechanism of Action

Pharmacology

Stimulates neutrophil production within bone marrow.

Pharmacokinetics

Elimination

T 1/ 2 is 15 to 80 hr (SC 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

SC 6 mg once per chemotherapy cycle. Do not administer in period between 14 days before and 24 hr 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.

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

Drug Interactions

Drugs potentiating the release of neutrophils (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

  • Explain name, dose, action and potential side effects of drug. 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 hr 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.
  • Instruct women to notify health care provider if becoming pregnant, planning on becoming pregnant, or breastfeeding.
  • Instruct patient not to take any prescription or OTC medications or dietary supplements unless advised by health care provider.
  • Remind patient or caregiver that office visits and laboratory tests will be required to monitor therapy and to be sure to keep appointments.

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