Adult Dosing

Ovarian cancer

• 260 mg/m²/day PO divided qid x 14 or 21 days of each 28 day cycle
• Discontinue temporarily for 14 days or longer and subsequently restart at 200 mg/m²/day for any of the following
• GI intolerance unresponsive to symptomatic measures
• WBC < 2,000/mm³ or granulocyte count < 1,000/mm³
• Platelet count < 75,000/mm³
• Progressive neurotoxicity

• Discontinue if neurologic symptoms fail to stabilize

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Palliative treatment of persistent or recurrent ovarian cancer following first-line therapy with a cisplatin and/or alkylating agent-based combination

• Hypersensitivity to any of the ingredients of the product
• Severe myelosuppression
• Neurologic toxicity, except cisplatin-related neuropathy

• Altretamine should only be administered under the supervision of a physician experienced in the use of antineoplastic agents
• Monitor CBC at least monthly, prior to the initiation of each course, and as clinically indicated
• Perform neurologic examination regularly due to the possibility of altretamine related neurotoxicity

Renal Dose Adjustment

• Renal impairment: Use with caution; dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Do not administer to patients with preexisting severe bone marrow depression or severe neurological toxicity
• Concurrent MAO inhibitors may cause severe orthostatic hypotension
• Risk of myelosuppression and neurological toxicity; perform CBC and neurological examinations regularly
• Discontinue therapy, if neurologic symptoms fail to stabilize on the reduced dose schedule

Pregnancy Category:D

Breastfeeding: Safety unknown; considered incompatible with breastfeeding due to potential for toxicity in nursing infants

• GI: Nausea, vomiting, anorexia, hepatic toxicity, increased alkaline phosphatase
• CNS: Seizures, fatigue, anorexia, ataxia, dizziness, vertigo, mood disorders
• NEURO: Peripheral neuropathy, neurotoxicity
• GU: Renal toxicity (increased BUN/Scr)
• DERM: Pruritus, alopecia, skin rash
• HEMA: Dose-related myelosuppression (anemia, leukopenia, thrombocytopenia)

• Alkylating agent; precise mechanism of cytotoxic effect unknown
• Well absorbed following oral administration
• Metabolized by liver; CYP450: Unknown
• Renally excreted (1% unchanged)
• Half-Life: 4.7-10.2 hrs

US Trade Name(s)

• Hexalen

US Availability

Hexalen

• CAPS: 50 mg

Canadian Trade Name(s)

• Hexalen

Canadian Availability

Hexalen

• CAPS: 50 mg

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Hematology/Oncology

Antineoplastics

Miscellaneous Agents

Pricing data from www.DrugStore.com in U.S.A.

• Hexalen 50 MG CAPS [Bottle] (EISAI)
  100 mg = $1168.04
  300 mg = $3253.93

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Hexalen 50 MG Oral Capsule

Ingredient(s): Altretamine

Imprint: USB;001

Color(s): White

Shape: Capsule

Size (mm): 3.00

Score: 1

Inactive Ingredient(s): lactose / calcium stearate

Drug Label Author:
Eisai Inc.

DEA Schedule:
Non-Scheduled

Drug Name: Hexalen 50 MG Oral Capsule

Ingredient(s): Altretamine

Imprint: USB;001

Color(s): Brown

Shape: Capsule

Size (mm): 3.00

Score: 1

Inactive Ingredient(s): anhydrous lactose / calcium stearate / capsugel size 3 hard gelatin capsule

Drug Label Author:
MGI PHARMA, INC.

DEA Schedule:
Non-Scheduled