Cytoprotective and supportive care agents:

Indications for: COSELA

To decrease the incidence of chemotherapy-induced myelosuppression when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC).

Adult Dosage:

Give by IV infusion over 30mins within 4hrs prior to initiating chemotherapy on each day chemotherapy is administered. 240mg/m2 per dose. Dosing interval on sequential days should not exceed 28hrs. If Cosela is discontinued, wait 96hrs from the last dose of Cosela before resuming chemotherapy only. Dose modification for adverse reactions: see full labeling.

Children Dosage:

Not established.

COSELA Warnings/Precautions:

Monitor for inj-site reactions (eg, pain, erythema), including phlebitis, thrombophlebitis; permanently discontinue if Grade 3 or 4 reactions occur. Monitor for hypersensitivity reactions (eg, edema, urticaria, pruritus, anaphylactic reactions); withhold therapy if Grade 2 reactions occur until recovery to Grade ≤1; permanently discontinue if Grade 3 or 4 reactions occur. Monitor for interstitial lung disease (ILD)/pneumonitis (eg, cough, dyspnea, hypoxia); permanently discontinue if Grade 3 or 4, or recurrent Grade 2 occurs. Moderate or severe hepatic impairment: not recommended. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraceptive during and for ≥3 weeks after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥3 weeks after the last dose).

COSELA Classification:

Kinase inhibitor.

COSELA Interactions:

May potentiate certain OCT2, MATE1, MATE-2K substrates (eg, dofetilide, dalfampridine, cisplatin). Increased risk of serious ventricular arrhythmias associated with QT interval prolongation (including torsade de pointes) with concomitant dofetilide. Increased risk of seizures with concomitant dalfampridine. Monitor closely for dose-related nephrotoxicity with concomitant cisplatin.

Adverse Reactions:

Fatigue, hypocalcemia, hypokalemia, hypophosphatemia, increased AST, headache, pneumonia; respiratory failure, hemorrhage, thrombosis.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial—1