axatilimab

Therapeutic Classification: none assigned

Pharmacologic Classification: monoclonal antibodies, temporary class

REMS

Chronic graft-versus-host disease after failure of ≥2 prior lines of systemic therapy.

Inhibits colony stimulating factor-1 receptors, which reduces concentrations of monocytes and macrophages, thereby decreasing fibrosis and inflammation within tissues.

Therapeutic effects:

Reduced severity of chronic graft-versus-host disease.

Absorption: IV administration results in complete bioavailability.

Distribution: Minimally distributed to tissues.

Metabolism/Excretion: Metabolized by catabolic pathways into small peptides.

Half-Life: 10.7–108 hr.

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	rapid	end of infusion	unknown

Contraindicated in:

OB: Pregnancy;
Lactation: Lactation.

Use Cautiously in:

Rep: Women of reproductive potential;
Pedi: Children <40 kg (safety and effectiveness not established).

CV: edema, hypertension

Derm: rash, pruritus

EENT: periorbital edema

F and E: hypercalcemia, hypophosphatemia

GI: ↑amylase, ↑lipase, ↑liver enzymes, diarrhea, nausea

Hemat: anemia, bleeding

Metab: ↓appetite

MS: ↑CK, pain

Neuro: dizziness, fatigue, headache

Resp: cough, dyspnea

Misc: fever, infection, infusion-related reactions

Drug-drug:

None reported.

IV (Adults and Children ≥40 kg): 0.3 mg/kg (max dose = 35 mg) every 2 wk; continue until disease progression or unacceptable toxicity.

Solution for injection: 50 mg/mL

Assess for infusion-related reactions (fever, chills, rash, flushing, dyspnea, hypertension). If Grade 1 or 2 infusion-related reactions occur, start symptomatic management (antihistamines, antipyretics). Stop axatilimab infusion until resolution or ↓ infusion rate by 50%. Premedicate with an antihistamine and an antipyretic, and resume infusion at 50% of the prior rate for subsequent axatilimab infusions. If Grade 3 or 4 infusion-related reactions occur, permanently discontinue axatilimab.
Assess for development of infections (fever; signs of bacterial, viral, or fungal infections).
Pedi: Monitor bone growth/development in pediatric patients.

Lab Test Considerations:

Verify negative pregnancy status before starting treatment.
Evaluate ALT, AST, alkaline phosphatase, CK, amylase, and lipase before starting therapy, every 2 wk for the 1st mo, and every 1–2 mo thereafter until abnormalities are resolved. If Grade 3 ↑ AST or ALT with total bilirubin Grade ≤1 (on day of dosing) occurs, hold axatilimab until Grade 2; then resume at 0.2 mg/kg (max = 23 mg) every 2 wk. Monitor for ↑ of AST or ALT regardless of the time of the reaction. If ALT or AST ≥3 times upper limit of normal (ULN) with total bilirubin ≥2 times ULN and alkaline phosphatase <2 times ULN (regardless of time of reaction), hold axatilimab and assess for drug-induced liver injury. If drug-induced liver injury confirmed, permanently discontinue axatilimab. If Grade 4 ↑ AST or ALT occurs, permanently discontinue axatilimab.
Monitor for ↑ CK, amylase, or lipase. If Grade ≥3 ↑ CK, amylase, or lipase occurs with no evidence of end-organ damage occurs, continue without dose ↓. If Grade ≥3 ↑ CK, amylase, or lipase occurs with evidence of end-organ damage occurs, permanently discontinue axatilimab. If symptomatic Grade ≥3 ↑ CK, amylase, or lipase occurs, permanently discontinue axatilimab.
Assess for nonhematologic adverse reactions. If Grade 3 nonhematologic reactions occur, hold axatilimab until Grade 2. If delayed ≤4 wk from planned infusion: Resume axatilimab at 0.2 mg/kg (max = 23 mg) once every 2 wk. If delayed >4 wk from planned infusion: Permanently discontinue axatilimab. If Grade 4 nonhematologic reactions occur, permanently discontinue axatilimab.
May ↓ phosphate and hemoglobin, and ↑ GGT and calcium.

IV Administration:

Y-Site Incompatibility:
- Do not administer other drugs through same IV line

Explain purpose and side effects of medication. Advise patient to read Patient Information before starting therapy.
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.
Advise patient of the signs/symptoms of infusion-related reactions and to seek medical assistance if any occur.
Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected. Advise women of reproductive potential to use effective contraception during therapy and for 30 days after last dose. Advise women not to breastfeed during therapy and for 30 days after the last dose.

Reduced severity of chronic graft-versus-host disease.

NDC Code

83277- AGC Biologics, Inc.
- 83277-005-
  - 83277-005-01- 6000 mL in 1 BAG (83277-005-01)

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Indications ⬆ ⬇

Action ⬆ ⬇

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Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

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Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆ ⬇

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