MIMRYLO

MIMRYLO is an FDA-registered drug product whose active ingredient is RUSFERTIDE. It is labelled by Takeda Pharmaceuticals America, Inc. taken by subcutaneous and marketed as a human prescription drug product. Identifiers on file: NDC 63020-715, application NDA220605, label effective 20260828. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing RUSFERTIDE are most often described in connection with: treatment erythrocytosis, polycythemia vera, usage mimrylo, hepcidin mimetic. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE MIMRYLO is indicated for the treatment of erythrocytosis in adults with polycythemia vera (PV). MIMRYLO is a hepcidin mimetic indicated for the treatment of erythrocytosis in adults with polycythemia vera (PV). ( 1 )

2 DOSAGE AND ADMINISTRATION Recommended starting dose: 19 mg by subcutaneous injection once a week. ( 2.1 ) Adjust dose based on efficacy or safety to a maximum of 108 mg weekly. ( 2.1 ) See Full Prescribing Information for instructions on preparation and administration. ( 2.4 ) 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 MIMRYLO Weekly Dose 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. Dosing Instructions Frequency During Each Week 9.5 mg Single injection Once weekly 19 mg 28 mg 41 mg 54 mg 69 mg 28 mg AND 41 mg Once weekly on the Same Day 82 mg 41 mg AND 41 mg Once weekly on the Same Day 95 mg Day 1: 54 mg Day 4 or 5: 41 mg Day 1 and Day 4 or 5 108 mg Day 1: 54 mg Day 4 or 5: 54 mg 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% Current Weekly Dose Increase Weekly Dose to 9.5 mg 19 mg 19 mg 28 mg 28 mg 41 mg 41 mg 54 mg 54 mg 69 mg 69 mg 82 mg 82 mg 95 mg 95 mg 108 mg 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 Current Weekly Dose Decrease Weekly Dose to 9.5 mg Discontinue treatment 19 mg 9.5 mg 28 mg 19 mg 41 mg 28 mg 54 mg 41 mg 69 mg 54 mg 82 mg 69 mg 95 mg 82 mg 108 mg 95 mg 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.

4 CONTRAINDICATIONS None. None. ( 4 )

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: New or Worsening Thrombocytosis [see Warnings and Precautions (5.1) ] Injection-Site Reactions [see Warnings and Precautions (5.2) ] Most common adverse reactions (incidence >15%) were injection site reactions (56%), and anemia (16%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc. at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Polycythemia Vera VERIFY The safety of MIMRYLO was evaluated in VERIFY [see Clinical Studies (14) ] , a Phase 3, randomized double-blind, placebo-controlled study in patients with PV. During the randomized controlled period (Week 0 to Week 32), 145 patients received MIMRYLO and 146 patients received placebo. Following the randomized controlled period, patients in the placebo arm crossed over to MIMRYLO, resulting in a total of 285 patients exposed to MIMRYLO during the study. The median duration of exposure to MIMRYLO was 61 weeks (range; 2 weeks to 133 weeks) with 65% of patients exposed to ≥52 weeks. During the randomized controlled period (Week 0 to Week 32), the most common (>15%) adverse reactions in the MIMRYLO arm were injection site reactions (56%) and anemia (16%). One (0.4%) patient experienced a serious adverse reaction of anemia. Dosage reductions of MIMRYLO due to an adverse reaction occurred in 30 (11%) patients. Adverse reactions which required dosage reduction included anemia in 28 (10%) patients, dyspnea in 2 (0.7%) patients and thrombocytosis in 1 (0.4%) patient. Adverse reactions which resulted in permanent discontinuation of MIMRYLO included injection site reactions in 2 (0.7%) patients, thrombocytosis in 2 (0.7%) patients and anemia in 1 (0.4%) patient. Table 4 summarizes the adverse reactions occurring in ≥5% of the patients with a difference of ≥5 percentage points between the MIMRYLO arm and the placebo arm in the randomized part (Week 0 to Week 32) of the VERIFY study. Table 4: Adverse Reactions Occurring in ≥5% Patients with a Difference of ≥5 Percentage Points Between the MIMRYLO Arm and the Placebo Arm in VERIFY (Week 0 to Week 32) Adverse Reaction MIMRYLO (n = 145) PLACEBO (n = 146) All Grades (%) Grade 3 (%) All Grades (%) Grade 3 (%) Injection site reactions 56 0.7 33 0 Anemia Includes anemia and hemoglobin decreased. 16 0 4.1 0 Thrombocytosis Includes thrombocytosis and platelet count increased. 8 0 0.7 0 Dyspnea Includes dyspnea and dyspnea exertional. 8 0 1.4 0

What is MIMRYLO used for?
1 INDICATIONS AND USAGE MIMRYLO is indicated for the treatment of erythrocytosis in adults with polycythemia vera (PV). MIMRYLO is a hepcidin mimetic indicated for the treatment of erythrocytosis in adults with polycythemia vera (PV). ( 1 )

Who makes MIMRYLO?
Takeda Pharmaceuticals America, Inc. is the labeler of record for MIMRYLO.

What form does MIMRYLO come in?
administered by subcutaneous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is MIMRYLO prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has MIMRYLO been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.