Mimrylo (rusfertide) is filed as Hepcidin mimetic. The sections below restate public label fields stored for this profile.
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 )
Rusfertide is a mimetic of the endogenous hormone hepcidin that blocks the iron transporter ferroportin.
5 WARNINGS AND PRECAUTIONS New or Worsening Thrombocytosis: MIMRYLO may increase platelet counts in patients with PV. After initiating MIMRYLO and during dose modifications, monitor complete blood count (CBC) every 2 to 4 weeks, or as clinically indicated. ( 5.1 ) Injection-Site Reactions: Injection site reactions have been reported in patients treated with MIMRYLO. Use ice, topical corticosteroid creams, antihistamines or analgesics, as needed, to treat injection site pain and swelling. ( 5.2 ) Embryo-Fetal Toxicity: Based on animal data, MIMRYLO can cause fetal harm. Advise females of the potential risk to the fetus and to use effective contraception. ( 5.3 ) 5.1 New or Worsening Thrombocytosis MIMRYLO may increase platelet counts in patients with PV. Within 4 weeks of treatment initiation, platelet counts increased by an average of 31% from baseline. Thirty-six percent of patients had platelet counts that exceeded 600 x 10 9 /L, and 6% had platelet counts that exceeded 1,000 x 10 9 /L. Platelet counts generally plateaued on treatment by Week 8. MIMRYLO was discontinued due to increased platelet counts in 1% of patients. After initiating MIMRYLO and during dose modifications, monitor CBC every 2 to 4 weeks or as clinically indicated. Platelet elevations associated with MIMRYLO may require cytoreductive therapy initiation, modification, or MIMRYLO dose modifications or discontinuation. 5.2 Injection-Site Reactions Injection site reactions occurred in 135 (47%) patients treated with MIMRYLO in VERIFY. The most common (>5%) injection site reactions reported were erythema (27%), pruritus (17%), pain (15%), and swelling (8%). Two patients experienced Grade 3 injection site reactions, and all other patients experienced Grade 1 or Grade 2 injection site reactions; most did not require medication for treatment. Two patients (0.7%) experienced injection site reactions that led to treatment discontinuation. Use ice, topical corticosteroid creams, antihistamines or analgesics, as needed, to treat injection site pain and swelling [see Dosage and Administration (2.4) ] . 5.3 Embryo-Fetal Toxicity Based on findings from animal reproduction studies, MIMRYLO may cause fetal harm when administered to a pregnant woman. Administration of MIMRYLO to pregnant rats and rabbits during organogenesis resulted in structural anomalies and embryo-fetal lethality, respectively, at exposures lower than the maximum recommended human dose. Pregnancy testing is recommended for females of reproductive potential prior to treatment with MIMRYLO. Advise females of reproductive potential to use an effective method of contraception during treatment with MIMRYLO and for at least 30 days after the final dose. Advise patients to stop taking MIMRYLO if they become pregnant [see Use in Specific Populations (8.1 , 8.3) ] .
4 CONTRAINDICATIONS None. None. ( 4 )
Injection site reactions (56%); Anemia (16%)
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
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.
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Patient Information and Instructions for Use ). Subcutaneous Dosing Technique Provide guidance to patients and caregivers on proper subcutaneous administration technique, and how to use MIMRYLO [see Instructions for Use ] . Missed Dose Instruct patients to call healthcare provider if they are unsure when to inject a missed dose [see Dosage and Administration (2.3) ] . New or Worsening Thrombocytosis Advise patients that MIMRYLO may increase platelet counts. Instruct patients to contact their healthcare provider if they experience signs or symptoms of bleeding or blood clots, such as unusual bruising or bleeding, chest pain, shortness of breath, leg pain or swelling, or sudden severe headache [see Warnings and Precautions (5.1) ] . Injection Site Reactions Advise patients that injection site reactions may occur with MIMRYLO. Instruct patients to contact their healthcare provider if they experience severe or persistent injection site reactions. Inform patients that ice, topical corticosteroid creams, antihistamines, or analgesics may be used to manage injection site pain and swelling [see Warnings and Precautions (5.2) and Dosage and Administration (2.4) ] . Embryo-Fetal Toxicity MIMRYLO may cause fetal harm. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1) ] . Advise female patients of reproductive potential to use effective contraception during treatment with MIMRYLO and for at least 30 days after the final dose [see Use in Specific Populations (8.3) ] . Lactation Advise females not to breastfeed during treatment with MIMRYLO and for 30 days after the final dose [see Use in Specific Populations (8.2) ] . Distributed by: Takeda Pharmaceuticals America, Inc. Cambridge, MA 02142 MIMRYLO is a trademark of Takeda Pharmaceuticals U.S.A., Inc. TAKEDA and are registered trademarks of Takeda Pharmaceutical Company Limited. ©2026 Takeda Pharmaceuticals U.S.A., Inc. All rights reserved. R1 logo
According to its FDA label, Mimrylo (rusfertide) is approved 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 ) For medical advice, please talk to your prescriber or pharmacist.
Mimrylo (rusfertide) belongs to the Hepcidin mimetic class of medications.
The FDA label lists Mimrylo (rusfertide) as: 3 DOSAGE FORMS AND STRENGTHS For injection: a sterile, white to off-white lyophilized powder for reconstitution in single-dose vials containing 9.5 mg, 19 mg, 28 mg, 41 mg, and 54 mg rusfertide (provided as rusfertide acetate) per vial, co-packaged with a clear diluent solution. For injection: 9.5 mg, 19 mg, 28 mg, 41 mg, and 54 mg of rusfertide as a lyophilized powder in single-dose vials for reconstitution. ( 3 ); subcutaneous route. Available strengths and packaging vary by manufacturer.
Not yet. As of the most recent FDA data we ingest, no A-rated generic equivalent is listed for Mimrylo. Availability changes as patents expire.
Our ingest of the FDA label for Mimrylo (rusfertide) does not include a Boxed Warning at this time. See the full label on DailyMed for the current, authoritative version.
The FDA Enforcement Report does not show an active/ongoing recall for Mimrylo (rusfertide) in our latest ingest. Recall data can change daily — verify at FDA.gov.
The FDA record lists the approval date for Mimrylo (rusfertide) as 2026-08-28.
The FDA label lists Takeda Pharmaceuticals America, Inc. as a labeler/manufacturer of Mimrylo (rusfertide). Multiple firms may market generics of the same molecule.
The FDA label states: "Storage and Handling 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 expira…" Follow the packaging insert for the authoritative guidance.
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