trabectedin

Contraindicated in:

Severe hypersensitivity;
Severe hepatic impairment;
OB: Pregnancy;
Lactation: Lactation.

Use Cautiously in:

Moderate hepatic impairment (↓ dose);
Severe renal impairment;
Left ventricular ejection fraction (LVEF) <40%, prior cumulative doxorubicin dose ≥300 mg/m², or cardiovascular disease (↑ risk of cardiomyopathy);
Rep: Women of reproductive potential and men with female partners of reproductive potential;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

CV: edema, CAPILLARY LEAK SYNDROME, HF

GI: constipation, diarrhea, hepatotoxicity, nausea, vomiting

GU: ↑serum creatinine, ↓fertility, renal failure

Hemat: anemia, neutropenia, thrombocytopenia

Local: extravasation

Metab: ↓appetite

MS: ↑creatine kinase, arthralgia, myalgia, RHABDOMYOLYSIS

Neuro: fatigue, headache, insomnia

Resp: dyspnea

Interactions ⬆ ⬇

Drug-drug:

Strong CYP3A4 inhibitors, including clarithromycin, conivaptan, itraconazole, ketoconazole (oral), lopinavir, nefazodone, nelfinavir, posaconazole, ritonavir, or voriconazole, may ↑ levels and risk of toxicity; avoid concurrent use.
Strong CYP3A4 inducers, including phenobarbital or rifampin, may ↓ levels and effectiveness; avoid concurrent use.

Drug-Natural Products:

St. John's wort may ↓ levels and effectiveness; avoid concurrent use.

Availability ⬆ ⬇

Lyophilized powder for injection: 1 mg/vial

Route/Dosage ⬆ ⬇

IV (Adults ): 1.5 mg/m² every 21 days; continue until disease progression or unacceptable toxicity.

Hepatic Impairment

IV (Adults ): Moderate hepatic impairment (bilirubin 1.5–3 times upper limit of normal [ULN] and AST/ALT <8 times ULN): 0.9 mg/m² every 21 days; continue until disease progression or unacceptable toxicity.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Interferes with DNA transcription, ultimately disrupting protein synthesis and causing cell death.

Therapeutic effects:

Improved progression-free survival.

Classifications ⬆ ⬇

Therapeutic Classification: antineoplastics

Pharmacologic Classification: alkylating agents

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Extensively distributed.

Protein Binding: 97%.

Metabolism/Excretion: Primarily metabolized via CYP3A in liver to inactive metabolites. 58% excreted in feces and 6% in urine (primarily as metabolites).

Half-Life: 175 hr.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	unknown	unknown	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy. Emphasize the need for periodic lab tests to monitor for side effects.
Advise parents to notify health care professional of all Rx or OTC medications, vitamins, or herbal products, especially St. John's wort, being taken and to consult with health care professional before taking other medications.
Advise patient to notify health care professional immediately if signs and symptoms of myelosuppression (fever, unusual bruising, bleeding, tiredness, paleness), rhabdomyolysis (severe muscle pain or weakness), hepatotoxicity (yellowing of skin and eyes, pain in upper right quadrant, severe nausea or vomiting, difficulty concentrating, disorientation, confusion), cardiomyopathy (new onset chest pain, shortness of breath, fatigue, lower extremity edema, heart palpitations), hypersensitivity (difficulty breathing, chest tightness, wheezing, severe dizziness or light-headedness, swelling of the lips, skin rash), extravasation (redness, swelling, itchiness and discomfort or leakage at infusion site), or capillary leak syndrome (edema with or without hypotension) occur.
Rep: May cause fetal harm. Advise female patients of reproductive potential of the need for effective contraception and to avoid breastfeeding during therapy and for 2 mo following final dose. Advise male patients with female partners of reproductive potential to use effective contraception during and for ≥5 mo after last dose. May damage spermatozoa, leading to potential genetic and fetal abnormalities. May ↓ fertility in males and females. Advise patient to notify health care professional if pregnancy is planned or suspected.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

42973- Apicore Pharmaceuticals Private Limited
- 42973-310-
  - 42973-310-00- 50 kg in 1 DRUM (42973-310-00)

54893- MSN Laboratories Private Limited
- 54893-0092-
  - 54893-0092-7- 1 kg in 1 DRUM (54893-0092-7)

57884- Jiangsu Hengrui Pharmaceuticals Co., Ltd.
- 57884-0033-
  - 57884-0033-1- 47.5 g in 1 CAN (57884-0033-1)

59676- Janssen Products, LP
- 59676-610- YONDELIS
  59676-610-01- 20 mL in 1 VIAL, SINGLE-USE (59676-610-01)

70225- NATCO PHARMA LIMITED
- 70225-1110-
  - 70225-1110-8- 1 g in 1 BOTTLE, GLASS (70225-1110-8)

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Indications ⬇

Contraind./Precautions ⬆ ⬇