Medexus Pharmaceuticals

ON - Toronto

Pharmaceutical

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Focus: Specialty Pharmaceuticals

Medexus Pharmaceuticals is a life sciences company focused on Specialty Pharmaceuticals.

Neurology

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INTRAVENOUS · POWDER

12.1 Mechanism of Action Treosulfan is an alkylating agent. DNA alkylation is thought to be responsible for the cytotoxic activities of treosulfan. Treosulfan showed hematopoietic stem cell depleting activity as well as immunosuppressive and antitumor activity in mouse models of leukemia. 12.2 Pharmacodynamics Increase in treosulfan exposure was associated with an increased incidence of infection-related death. Treosulfan time course of pharmacodynamic response is unknown. 12.3 Pharmacokinetics Treosulfan pharmacokinetic parameters were observed at the approved recommended dosage, unless otherwise specified. Treosulfan is a prodrug. Treosulfan mean ± SD area under the curve (AUC) is 1,200 ± 211 hr mcg/mL. There was no dose accumulation. Distribution Treosulfan mean (CV%) volume of distribution is approximately 41 liters (CV%: 19%). Treosulfan does not bind to plasma albumin. Elimination Treosulfan mean (± standard deviation) terminal half-life is 1.7 ± 0.4 hours. Metabolism The pharmacologically inactive treosulfan is converted spontaneously under physiological conditions into the active monoepoxide intermediate (2S,3S)‑1,2‑epoxybutane‑3,4‑diol‑4‑methanesulfonate) and finally to active L‑diepoxibutane (2S,3S)‑1,2:3,4‑diepoxybutane). Excretion A median of 42% of the treosulfan dose is excreted unchanged in the urine within 24 hours, and 89% of this unchanged fraction is excreted within the first 8 hours after administration. Specific Populations No clinically significant differences in the pharmacokinetics of treosulfan based on sex, mild renal impairment (CLcr 60‑89 mL/min), or mild hepatic impairment (total bilirubin less than or equal to ULN with AST greater than ULN or total bilirubin greater than 1 to 1.5 times ULN with any AST). The effect of moderate or severe renal impairment, moderate or severe hepatic impairment, and age ≥ 65 years on treosulfan pharmacokinetics is unknown. Pediatric Patients Treosulfan exposure in pediatric patients with BSA < 0.7 m and with BSA 0.7 to < 1.1 m are 11% and 5% higher, respectively, compared to adults. No clinically significant difference in treosulfan median terminal half‑life was observed between pediatric patients and adults. The median terminal half‑life of the active monoepoxide intermediate was 1.6 hrs in pediatric patients. Drug Interaction Studies In Vitro Studies CYP Enzymes : Treosulfan is a CYP2D6 substrate and its monoepoxide intermediate is a CYP2C8 substrate. Treosulfan inhibits CYP2C19 and CYP3A4 (using midazolam as substrate), but does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2D6, or CYP3A4 (using testosterone as substrate). Transporter Systems : Treosulfan does not inhibit BCRP, BSEP, MATE1, OATP1B1, OATP1B3, OAT1, OAT3, OCT1, or OCT2.

combination with fludarabineolder with acute myeloid leukemia (AML)older with myelodysplastic syndrome (MDS)

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Portfolio: 2 approved products

Top TAs: Oncology

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2 total products

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