trilaciclib

REMS

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

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity;
Moderate or severe hepatic impairment (total bilirubin >1.5x ULN);
OB: Pregnancy (may cause fetal harm);
Lactation: Lactation.

Use Cautiously in:

Rep: Women of reproductive potential;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

CV: peripheral edema

Derm: rash

Endo: hyperglycemia

F and E: hypocalcemia, hypokalemia, hypophosphatemia

GI: ↑liver enzymes, upper abdominal pain

Hemat: BLEEDING, NEUTROPENIA, THROMBOSIS, anemia, thrombocytopenia, leukopenia

Local: injection site reactions

Neuro: STROKE, fatigue, headache

Resp: pneumonia, INTERSTITIAL LUNG DISEASE/PNEUMONITIS, RESPIRATORY FAILURE

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA), INFUSION REACTIONS

Interactions ⬆ ⬇

Drug-drug:

May ↑ dofetilide levels and risk of toxicity, including QT interval prolongation.
May ↑ dalfampridine levels and risk of toxicity, including seizures.
May ↑ cisplatin levels and risk of toxicity, including nephrotoxicity.

Availability ⬆ ⬇

Lyophilized powder for injection: 300 mg/vial

Route/Dosage ⬆ ⬇

IV (Adults ): 240 mg/m² administered within 4 hr prior to the start of chemotherapy on each day chemotherapy is administered. Do not exceed an interval of more than 28 days between doses.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Acts as a reversible cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor, which leads to hematopoietic stem and progenitor cell G1 cell cycle arrest, thereby preventing the cells from proliferating in the presence of cytotoxic chemotherapy. This effect results in myelopreservation.

Therapeutic effects:

Decreased incidence of chemotherapy-induced myelosuppression.

Classifications ⬆ ⬇

Therapeutic Classification: myeloprotective agents

Pharmacologic Classification: kinase inhibitors

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Extensively distributed to extravascular tissues.

Metabolism/Excretion: Extensively metabolized. Primarily excreted in feces (7% as unchanged drug), with 14% being excreted in urine (2% as unchanged drug).

Half-Life: 14 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	unknown	unknown	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose of trilaciclib to patient.
Advise patient to notify health care professional if signs and symptoms of injection-site reactions, hypersensitivity reactions, or interstitial lung disease/pneumonitis occur.
Instruct 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 Rx, OTC, or herbal products.
Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception and avoid breastfeeding during and for at least 3 wk after last dose of trilaciclib. Inform patient that trilaciclib may impair fertility in females.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

73462- G1 Therapeutics, Inc.
- 73462-101- COSELA
  - 73462-101-01- 1 VIAL, GLASS in 1 CARTON (73462-101-01) / 20 mL in 1 VIAL, GLASS

73594- Pharmacosmos Therapeutics Inc.
- 73594-0101- COSELA
  - 73594-0101-1- 1 VIAL, GLASS in 1 CARTON (73594-0101-1) / 20 mL in 1 VIAL, GLASS

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Indications ⬇