palifermin

REMS

Severe oral mucositis (≥WHO grade 3) associated with myelotoxic therapy in patients requiring autologous hematopoietic stem cell support for hematologic malignancies.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity to palifermin or other E. coli–derived proteins;
OB: Pregnancy;
Lactation: Lactation.

Use Cautiously in:

Allogeneic hematopoietic stem cell support (↑ risk of exacerbated mucositis);
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

Derm: erythema, pruritus, rash

GI: tongue thickening/discoloration

GU: ↓fertility

Metab: ↑amylase, ↑lipase

MS: arthralgia

Neuro: dysesthesia, dysgeusia

Interactions ⬆ ⬇

Drug-drug:

Unfractionated heparin and low-molecular weight heparin↑ levels (flush tubing with saline between use).
Administration within 24 hr after myelotoxic therapy (chemotherapy/radiation)↑ severity and duration of mucositis.

Availability ⬆ ⬇

Powder for injection: 6.25 mg/vial

Route/Dosage ⬆ ⬇

IV (Adults ): 60 mcg/kg/day for 3 days before and 3 days after myelotoxic therapy.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Enhances proliferation of epithelial cells.

Therapeutic effects:

Decreased incidence/duration of mucositis.

Classifications ⬆ ⬇

Therapeutic Classification: cytoprotective agents

Pharmacologic Classification: keratinocyte growth factors

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: 4.5 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	unknown	end of dose	unknown

Patient/Family Teaching ⬆ ⬇

Explain the purpose of palifermin to patient.
Inform patient of evidence of tumor growth and stimulation in cell culture and animal models.
Advise patient to notify health care professional if rash, erythema, edema, pruritus, oral/perioral dysesthesia (tongue discoloration, tongue thickening, alteration of taste) occur.
Rep: May cause fetal harm. Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding during therapy and for at least 2 wk after last dose. May impair female and male fertility.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

66658- Swedish Orphan Biovitrum AB (publ)
- 66658-113- KEPIVANCE
  - 66658-113-03- 3 VIAL, SINGLE-USE in 1 CARTON (66658-113-03) / 1.2 mL in 1 VIAL, SINGLE-USE (66658-113-01)

section name header

Indications ⬇