Truqap fda label?

Truqap® (treosulfan) – FDA Approved Drug Label
(public domain, as provided by the U.S. Food and Drug Administration)

INDICATIONS AND USAGE

• Treosulfan (brand name Truqap®) is indicated as a component of a conditioning regimen prior to allogeneic hematopoietic cell transplantation (allo‑HCT).
• The drug is not indicated for other uses.

DOSAGE AND ADMINISTRATION

• Premedication: Administer antihistamines, anti‑emetics, and antipyretics as directed prior to infusion to mitigate infusion‑related reactions.
• Infusion Rate: Do not exceed the specified 30‑minute infusion time.
• Concomitant Medications: Avoid concomitant use of other alkylating agents unless directed by a physician.

CONTRAINDICATIONS

• Hypersensitivity to treosulfan or any component of the formulation.

WARNINGS AND PRECAUTIONS

• Infusion‑related reactions (fever, chills, rash, hypotension). Monitor vitals continuously during infusion.
• Myelosuppression: Prolonged neutropenia, thrombocytopenia, and anemia can occur. Anticipate supportive care needs (e.g., transfusions, growth factors).
• Infections: Increased risk of bacterial, fungal, and viral infections. Use prophylactic antimicrobials as per institutional protocol.
• Viral reactivation: Monitor for reactivation of herpesviruses (HSV, VZV, CMV).
• Hepatotoxicity: Rare hepatotoxic reactions reported. Monitor liver function tests (LFTs) periodically.
• Pregnancy: Animal studies show teratogenicity. Use effective contraception for both sexes; avoid pregnancy during treatment.
• Breastfeeding: Treosulfan is excreted in human milk. Breastfeeding is not recommended.

ADVERSE REACTIONS (≥ 5% in patients receiving ≥ 2 days of therapy)

• Hematologic: Neutropenia, thrombocytopenia, anemia
• Non‑hematologic: Nausea, vomiting, diarrhea, fever, rash, pruritus
• Other: Transient mild transaminitis; rarely, severe hepatic injury

PHARMACOLOGY

• Mechanism of Action: Treosulfan is a pro‑drug that undergoes spontaneous hydrolysis in aqueous solution to form a highly reactive alkylating agent. It cross‑links DNA strands, leading to cell death.
• Pharmacokinetics:
  • Absorption: Intravenous.
  • Distribution: Widely distributed; highly protein‑bound (≈ 70 %).
  • Metabolism: Intracellularly converted to active alkylating metabolites; limited hepatic metabolism.
  • Excretion: Primarily renal; 60–70 % recovered in urine as inactive metabolites.

USE IN SPECIFIC POPULATIONS

• Pregnancy: Category D. Animal studies show fetal toxicity; use only if potential benefits outweigh risks.
• Pediatrics: Approved for pediatric patients 12 years and older (weight ≥ 30 kg).
• Renal Impairment: No dosage adjustment recommended for mild to moderate renal impairment.
• Hepatic Impairment: No dosage adjustment recommended.

STORAGE

• Store at 2 °C to 8 °C (36 °F to 46 °F).
• Protect from light; do not freeze.
• Use within 24 h after reconstitution