MIMRYLO Solution for injection Ref.[116914] Active ingredients: Rusfertide

2.1 Recommended Dosage

• MIMRYLO is for subcutaneous use only.
• The recommended weekly dosage range of MIMRYLO is 9.5 mg to 108 mg.
  • The recommended starting dose of MIMRYLO is 19 mg once a week.
  • Doses above 54 mg will require two injections.
  • Doses greater than 82 mg should be administered on separate days.
• Administer MIMRYLO subcutaneously on a weekly dosing schedule. See Table 1.

Table 1. MIMRYLO Weekly Dosing Instructions:

^* Doses higher than 54 mg are administered as 2 injections. If the weekly dosage is greater than 82 mg, administer your first injection on day 1 and the second injection on day 4 or 5.

• Adjust the dose of MIMRYLO based on efficacy or safety [see Dosage and Administration (2.2)].

2.2 Dose Modifications

Monitor complete blood count (CBC) every 2 to 4 weeks or as clinically indicated during dose modifications.

Dose increase

After a minimum of 2 weeks at the current weekly dose, dose increase may be considered according to Table 2 and based on medical judgement to reduce or to maintain hematocrit at the recommended level below 45%. Allow a minimum of 2 weeks between dose increases.

Table 2. Recommended MIMRYLO Dose Increase to Reduce or to Maintain Hematocrit Below 45%:

Dose decrease

For Grade ≥2 anemia or for drug-related Grade ≥3 toxicities, reduce the dose of MIMRYLO according to Table 3.

Table 3. Recommended MIMRYLO Dose Decrease for Patients Experiencing Grade ≥2 Anemia or for Drug-Related Grade ≥3 Toxicities:

2.3 Missed Dose

• For patients injecting once a week
  • If the injection is missed by 1 to 4 days, take the missed injection immediately and then resume regular dosing schedule.
  • If the injection is missed by more than 4 days, take the missed injection immediately. Take the next injection 3 days later and then resume the regular dosing schedule.
• For patients injecting two times a week
  • If the injection is missed by 1 to 2 days, take the missed injection immediately and take the next injection 3 days later. Then resume the regular dosing schedule.
  • If the injection is missed by more than 2 days, skip the missed injection and continue the regular dosing schedule.

2.4 Preparation and Administration Instructions

Prior to treatment initiation, healthcare providers should show patient and/or caregivers how to prepare and inject MIMRYLO subcutaneously into the abdomen, thigh, or upper arm. Advise patients and/or caregivers to contact healthcare providers with questions. For detailed instructions on the preparation and administration of MIMRYLO, see the Instructions for Use provided in the product carton.

Preparation:

• Determine the number of vial(s) of MIMRYLO needed for the full dose.
• MIMRYLO must be reconstituted using the provided diluent prefilled syringe.
• Attach the vial adapter to the vial(s).
• Attach the diluent syringe to the vial adapter.
• Inject all of the diluent from the attached syringe into the vial containing lyophilized powder. Do not remove the syringe from the vial adapter.
• Gently swirl the vial to reconstitute. This may take about 2 minutes. Do not shake.
• Set the vial on a clean flat surface and let it sit to allow the liquid to settle and any excess foam to disappear. This may take about 1 minute.
• Visually inspect that the reconstituted solution is clear with very little foam, colorless, and free from visible particles. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
• Withdraw all of the reconstituted solution from the vial into the syringe.
• After reconstitution, MIMRYLO may be stored at room temperature between 20°C to 25°C (68°F to 77°F) for up to 4 hours.
• After reconstitution, administer MIMRYLO as soon as possible, but no later than 4 hours. Discard reconstituted solution if not used within 4 hours.

Administration:

• Attach the needle to the syringe.
• Administer subcutaneously into the abdomen at least 2 inches from the navel, outer area of upper arm, or front of the thigh. The outer area of the upper arms may be used only if the injection is being given by a caregiver.
  • Do not select a site where the skin is tender, bruised, red, irritated, hard or broken.
  • Do not inject into the same spot twice in a row. Change (rotate) sites between injections.
• Weekly doses exceeding 54 mg are administered as 2 injections.
  • If the weekly dose is greater than 82 mg, administer your first injection on day 1 and the second injection on day 4 or 5.

• Store at room temperature between 20°C to 25°C (68°F to 77°F).
• Do not freeze.
• Store in the original carton to protect from light.
• Do not use the vial or the diluent prefilled syringe after the expiration date on the carton.
• For detailed instructions on the preparation and administration of MIMRYLO, see the Instructions for Use provided in the product carton.
• After reconstitution, MIMRYLO may be stored at room temperature between 20°C to 25°C (68°F to 77°F) for up to 4 hours.
• After reconstitution, administer MIMRYLO within 4 hours.
• Discard reconstituted solution if not used within 4 hours.