Cosela

— THERAPEUTIC CATEGORIES —
  • Cytoprotective and supportive care agents

Cosela Generic Name & Formulations

General Description

Trilaciclib 300mg; lyophilized cake for IV infusion after reconstitution and dilution; preservative-free; contains mannitol.

Pharmacological Class

Kinase inhibitor.

How Supplied

Single-dose vial—1

Manufacturer

Generic Availability

NO

Cosela Indications

Indications

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).

Cosela Dosage and Administration

Adult

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

Not established.

Cosela Contraindications

Not Applicable

Cosela Boxed Warnings

Not Applicable

Cosela Warnings/Precautions

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 Pharmacokinetics

See Literature

Cosela Interactions

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.

Cosela Adverse Reactions

Adverse Reactions

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

Cosela Clinical Trials

See Literature

Cosela Note

Not Applicable

Cosela Patient Counseling

See Literature

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