Draft Guidance on Iron Dextran

Type of study: Fasting Design: Single-dose, randomized, parallel, in vivo Strength: 100 mg per vial (Eq 50 mg/mL iron) Subjects: Male or female patients with iron deficiency anemia who are indicated for their initial treatment with parenteral iron dextran (who have not received parenteral iron supplementation in the past) Additional comments: (1) Iron dextran may be administered either intravenously or intramuscularly. The sponsor should choose a route of administration and use the same route of administration for all subjects. (2) The total treatment dose of iron dextran should be given over the course of multiple days. However, only PK samples acquired after the first dose should be included in the statistical analysis. The Day 1 dose should include the same fixed-dose of iron dextran for all patients and subsequent doses (if needed) would include the remainder of the total dose calculated for each individual to achieve their total dose. The total dose of iron dextran for each subject should be calculated according to the RLD label. All subjects should receive the same dose (maximum of 2 mL) on the first day of treatment (Day 1). The second dose (if any) should be given no earlier than 5 days after the first dose. PK sampling should be performed starting on Day 1 until the second dose is given. A sufficient number of samples should be acquired to adequately characterize the PK profile of iron dextran before the second dose is administered. No sampling is required following administration of the second dose or subsequent doses. The sponsor should propose the Day 1 dose, along with appropriate justification for their selection, as part of the study protocol. The Day 1 dose should be divided to include a test dose (0.5 mL) of the product to be administered at a gradual rate over at least 30 seconds according to the product label and the subjects should be monitored for at least an hour. The remainder of the Day 1 dose can be administered if no adverse reactions are observed.

Post time: Jul-10-2023