efbemalenograstim alfa

REMS

To reduce the incidence of infection in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

Action ⬆ ⬇

Binds to and stimulates immature neutrophils to divide and differentiate.

Therapeutic effects:

Reduction in incidence of infection, including febrile neutropenia.

Pharmacokinetics ⬆ ⬇

Absorption: Extent of absorption following SUBQ administration unknown.

Distribution: Well distributed to tissues.

Metabolism/Excretion: Metabolized into smaller peptides via catabolic pathways. Excretion pathways unknown.

Half-Life: 35 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	24–48 hr	unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity to efbemalenograstim alfa, filgrastim, or pegfilgrastim.

Use Cautiously in:

Patients with breast or lung cancer receiving chemotherapy and/or radiotherapy (↑ risk of myelodysplastic syndrome or acute myeloid leukemia);
Sickle cell disease (↑ risk of sickle cell crisis);
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

CV: aortitis, CAPILLARY LEAK SYNDROME

GI: nausea, SPLENIC RUPTURE, splenomegaly

GU: glomerulonephritis

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

MS: bone pain

Neuro: fatigue

Resp: ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS), pulmonary infiltrates

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Interactions ⬆ ⬇

Drug-drug:

None reported.

Route/Dosage ⬆ ⬇

SC (Adults ): 20 mg administered once per chemotherapy cycle ≥24 hr after cytotoxic chemotherapy. Not to be administered within 14 days before and <24 hr after cytotoxic chemotherapy.

Availability ⬆ ⬇

Solution for SUBQ injection (prefilled syringes): 20 mg/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 efbemalenograstim alfa and do not delay standard symptomatic treatment.
Monitor for aortitis (fever, malaise, back pain, ↑ inflammatory markers [c-reactive protein and WBC]) 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 efbemalenograstim alfa until glomerulonephritis resolves.
Monitor CBC during therapy. Discontinue if WBC count ≥100 × 10⁹/L. May also cause ↓ platelet count.

Implementation ⬆ ⬇

Health care professional must administer medication. Contains natural rubber latex; people with latex allergy should not use.
SC: Bring carton to room temperature for a minimum of 30 min. Discard if at room temperature ≥48 hr.
- Examine solution in single-dose prefilled syringe. Do not use if discolored or contains particulates. May administer in outer upper arms, abdomen, or thighs. Rotate sites. Inject only into intact tissue without scarring, leaving a 2-in diameter around the navel. 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.
Instruct patient to notify health care professional if allergic to latex.
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.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇