eflapegrastim

Binds to granulocyte colony-stimulating factor (G-CSF) receptors on immature neutrophils, stimulating them to divide and differentiate. Also activates mature neutrophils.

Therapeutic effects:

Decreased incidence of febrile neutropenia in patients who are neutropenic from chemotherapy.

Pharmacokinetics ⬆ ⬇

Absorption: Well absorbed after SUBQ administration.

Distribution: Minimal distribution to tissues.

Metabolism/Excretion: Metabolized inside cells that contain G-CSF receptors. Excretion pathway unknown.

Half-Life: 16–115 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	6–144 hr	unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Serious allergic reactions to eflapegrastim, pegfilgrastim, or filgrastim.

Use Cautiously in:

Sickle cell disease (↑ risk of sickle cell crisis);
Patients with breast or lung cancer receiving chemotherapy and/or radiotherapy (↑ risk of myelodysplastic syndrome or acute myeloid leukemia);
Malignancy with myeloid characteristics;
OB: Safety not established in pregnancy;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

CV: peripheral edema, aortitis

Derm: flushing, rash

GI: abdominal pain, diarrhea, ↓appetite, nausea

GU: glomerulonephritis

Hemat: anemia, thrombocytopenia, ACUTE MYELOID LEUKEMIA, excessive leukocytosis, MYELODYSPLASTIC SYNDROME, sickle cell crises

Local: injection site reactions

MS: arthralgia, bone pain, myalgia

Neuro: dizziness, fatigue, headache

Resp: cough, ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS)

Misc: fever, CAPILLARY LEAK SYNDROME, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS), SPLENIC RUPTURE, splenomegaly, TUMOR GROWTH

Interactions ⬆ ⬇

Drug-drug:

None reported

Route/Dosage ⬆ ⬇

SC (Adults ): 13.2 mg administered once per chemotherapy cycle (should be administered ~24 hr after receiving chemotherapy; should not be administered from 14 days before to 24 hr after administration of chemotherapy).

Availability ⬆ ⬇

Solution for injection: 13.2 mg/0.6 mL

Assessment ⬆ ⬇

Monitor for signs and symptoms of splenic enlargement or rupture.
Assess for signs and symptoms of ARDS (acute dyspnea, fever, lung infiltrates).If symptoms occur,discontinue therapy.
Monitor for signs and symptoms of severe allergic reactions, including anaphylaxis. If severe allergy occurs,permanently discontinue therapy and provide appropriate medical treatment.
Monitor for hypotension and edema.If symptoms of capillary leak syndrome occur,consider discontinuing therapy and do not delay standard symptomatic treatment.
Monitor for aortitis (fever, malaise, back pain, ↑ inflammatory markers) as early as the 1st wk after start of therapy. If symptoms occur and aortitis suspected,discontinue therapy.
May cause transient positive bone-imaging changes.

Lab Test Considerations:

Monitor for azotemia, micro- or macrohematuria, and proteinuria. If glomerulonephritis suspected and confirmed with biopsy,consider dose ↓ or interruption of eflapegrastim until glomerulonephritis resolves.
Monitor CBC during therapy. Discontinue if WBC count ≥ 100 × 10⁹/L. May also cause ↓ platelet count.

Implementation ⬆ ⬇

SC: Bring sealed blister tray to room temperature for 30 min. Do not freeze or shake. Discard if dropped on hard surface or at room temperature ≥12 hr.
- Remove single-dose prefilled syringe from tray. Examine solution. Do not use if discolored or contains particulates. May administer in outer upper arms, abdomen, thighs, or upper outer buttock. Administer entire contents of syringe.

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to notify health care professional regarding when to give next dose if a dose is missed. Advise patient to read Patient Information before starting therapy.
Instruct patient to notify health care professional immediately if signs and symptoms of spleen enlargement or rupture (left upper abdominal or shoulder pain), allergic reaction (rash, fever, dizziness, swelling of mouth, shortness of breath), ARDS (fever, fast or difficulty breathing), glomerulonephritis (swelling of face or ankles; bloody, dark, or ↓ urination), myelodysplastic syndrome (easy bruising or bleeding), acute myeloid leukemia, or aortitis (abdominal or back pain, fatigue) occur.
Discuss risk of sickle cell crisis with patients with sickle cell disease before administering.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.
Home Care Issues: Instruct on correct technique for injection, care, and disposal of equipment. Caution patient not to reuse needle or syringe. Provide patient with a puncture-proof container for needle disposal.

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇