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MIMRYLO rusfertide Kit — NDC 63020-0745-40 package photo
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MIMRYLO rusfertide Kit — NDC 63020-745-40 (Billing 63020-0745-40)

by Takeda Pharmaceuticals America, Inc. · 1 KIT in 1 CARTON * 41 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * .6 mL in 1 SYRINGE

This is a package of MIMRYLO rusfertide Kit from Takeda Pharmaceuticals America, Inc., marketed since Aug 2026 and currently FDA-listed. It is this product's only package size.

NDC 63020-0745-40
🏷️ FDA NDC (as labeled) 63020-745-40 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 63020-745-40 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
63020 labeler · 745 product · 40 package
Package marketed since
Aug 28, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6302074540 6
FDA record last changed
Sep 17, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63020-745-40
Product NDC 63020-745
11-digit billing NDC 63020074540
RxCUI 2751601, 2751606, 2751608, 2751610, 2751612, 2751614, 2751616, 2751618,
Application # NDA220605
SPL Set ID 101aff01-31ed-4841-a8b6-0a5a8503189b
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-08-28
Route SUBCUTANEOUS
Dosage form KIT
Quick answers
  • RxCUI (RxNorm): 2751601
Why two NDCs? The FDA registers this code as 63020-745-40 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 63020-0745-40. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63020-0745-40 You're viewing this Main listing 1 KIT in 1 CARTON * 41 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * .6 mL in 1 SYRINGE 2026-08-28 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Mimrylo 63020-0765-60 Takeda 1 kit — — FDA listed —
Mimrylo 63020-0715-10 Takeda 1 kit — — FDA listed —
Mimrylo 63020-0725-20 Takeda 1 kit — — FDA listed —
Mimrylothis 63020-0745-40 Takeda 1 kit — — FDA listed —
Mimrylo 63020-0735-30 Takeda 1 kit — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2026
On the market since
Aug 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerTakeda Pharmaceuticals America, Inc.
Application holderTAKEDA PHARMACEUTICALS AMERICA INC
FDA applicationNDA220605 (NDA)
Labeler code63020
First marketedAug 2026
Product typeHuman Prescription Drug
Portfolio154 products on file

More NDCs from Takeda Pharmaceuticals America, Inc. labeler code 63020

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 38 words ▾

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 )

⏱️ Dosage and Administration ~3 min read ▾

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 )

2.1Recommended 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) ] .

2.2Dose 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

2.3Missed 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.

2.4Preparation 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… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 71 words ▾

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 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

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 )

5.1New 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.

5.2Injection-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) ] .

5.3Embryo-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) ] .

🤒 Adverse Reactions ~2 min read ▾

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 .

6.1Clinical 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

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Breastfeeding not recommended. ( 8.2 )

8.1Pregnancy Risk Summary There are no available data on MIMRYLO use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Based on findings from animal studies, MIMRYLO may cause fetal harm when administered to a pregnant woman [see Warnings and Precautions (5.3) ] . In animal reproductive studies, subcutaneous administration of rusfertide to pregnant rats and rabbits during organogenesis at exposures lower than the human exposure (based on AUC) at the maximum recommended human dose (MRHD) resulted in malformations and embryo fetal lethality, respectively [see Data ] .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Animal Data In an embryo-fetal development study in pregnant rats, rusfertide administered subcutaneously at 0.3, 1, and 3 mg/kg/dose administered every three days from gestation day (GD) 6 to 15 caused dose-dependent increases in the incidence of craniofacial and CNS malformations (narrowed nasopharynx, dilated cerebral ventricles, enlarged olfactory lobes, eye defects and fused ribs) at doses 1 mg/kg/dose and higher at exposures less than the clinical exposures at the MRHD based on AUC. In an embryo-fetal development study in pregnant rabbits, rusfertide administered subcutaneously at 0.03, 0.1, 0.3, and 1 mg/kg/dose from GD 7 to 16 caused embryo-fetal lethality at a dose of 1 mg/kg at exposures less than the clinical exposures at the MRHD based on AUC.

8.2Lactation Risk Summary There are no data on the presence of rusfertide in either human or animal milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in the breastfed child, including impaired iron absorption, advise patients not to breastfeed during treatment with MIMRYLO and for 30 days after the final treatment.

8.3Females and Males of Reproductive Potential Based on animal data, MIMRYLO may cause fetal malformations at doses with exposures less than the clinical exposure at the MRHD [see Use in Specific Populations (8.1) ] . Pregnancy testing Pregnancy testing is recommended for females of reproductive potential. Contraception Females MIMRYLO may cause fetal harm when administered to pregnant women.

Advise female patients of reproductive potential to use effective contraception during treatment with MIMRYLO and for at least 30 days after the final dose of MIMRYLO [see Use in Specific Populations (8.1) and Nonclinical Toxicology (13.1) ].

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

8.5Geriatric Use There were 71 (25%) patients 65 years of age and older that received MIMRYLO in the VERIFY study [see Clinical Studies (14) ] , while 22 (8%) were 75 years of age and older. No overall differences in safety or effectiveness of MIMRYLO have been observed between patients 65 years of age and older and younger adult patients.

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary There are no available data on MIMRYLO use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Based on findings from animal studies, MIMRYLO may cause fetal harm when administered to a pregnant woman [see Warnings and Precautions (5.3) ] . In animal reproductive studies, subcutaneous administration of rusfertide to pregnant rats and rabbits during organogenesis at exposures lower than the human exposure (based on AUC) at the maximum recommended human dose (MRHD) resulted in malformations and embryo fetal lethality, respectively [see Data ] .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Data Animal Data In an embryo-fetal development study in pregnant rats, rusfertide administered subcutaneously at 0.3, 1, and 3 mg/kg/dose administered every three days from gestation day (GD) 6 to 15 caused dose-dependent increases in the incidence of craniofacial and CNS malformations (narrowed nasopharynx, dilated cerebral ventricles, enlarged olfactory lobes, eye defects and fused ribs) at doses 1 mg/kg/dose and higher at exposures less than the clinical exposures at the MRHD based on AUC. In an embryo-fetal development study in pregnant rabbits, rusfertide administered subcutaneously at 0.03, 0.1, 0.3, and 1 mg/kg/dose from GD 7 to 16 caused embryo-fetal lethality at a dose of 1 mg/kg at exposures less than the clinical exposures at the MRHD based on AUC.

🧒 Pediatric Use 13 words ▾

8.4Pediatric Use Safety and effectiveness in pediatric patients have not been established.

🧓 Geriatric Use 61 words ▾

8.5Geriatric Use There were 71 (25%) patients 65 years of age and older that received MIMRYLO in the VERIFY study [see Clinical Studies (14) ] , while 22 (8%) were 75 years of age and older. No overall differences in safety or effectiveness of MIMRYLO have been observed between patients 65 years of age and older and younger adult patients.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Rusfertide is a mimetic of the endogenous hormone hepcidin that blocks the iron transporter ferroportin. Inhibition of ferroportin by rusfertide reduces availability of iron for production of red blood cells resulting in lower hematocrit levels.

12.2Pharmacodynamics In healthy participants receiving single subcutaneous doses of 9.5 mg, 19 mg, 28 mg, 41 mg, and 54 mg MIMRYLO, the maximum reduction in serum iron was noted approximately 24 to 48 hours post dose. The higher doses (41 mg and 54 mg) of MIMRYLO resulted in a more sustained reduction in serum iron up to 96 hours. In the Phase 3 VERIFY study, mean ferritin concentrations increased from 21 mcg/L at baseline to 124 mcg/L at Week 32 and 174 mcg/L at Week 52 for patients who were randomized to receive MIMRYLO.

The exposure-response relationships of MIMRYLO have not been fully characterized. Cardiac Electrophysiology At 1.3 times the geometric mean rusfertide maximum plasma concentration (C max ) achieved with the maximum recommended weekly dose of 108 mg MIMRYLO, clinically significant QTc interval prolongation was not observed.

12.3Pharmacokinetics Rusfertide pharmacokinetics were characterized after a single-dose of 9.5 mg to 54 mg in healthy participants. After subcutaneous administration, rusfertide C max and AUC increased less than dose proportionally over the dose range of 9.5 mg to 54 mg (0.5 to 2.8 times the recommended starting dosage). Rusfertide pharmacokinetics were predicted in patients with PV using population PK analysis.

At the weekly recommended starting dose of 19 mg MIMRYLO, the predicted mean (±SD) rusfertide steady state C max and AUC were 220 (±76.1) ng/mL and 17,800 (±6140) h·ng/mL, respectively. At the weekly dose of 82 mg MIMRYLO, the predicted mean (±SD) rusfertide steady state C max and AUC were 751 (±254) ng/mL and 66200 (±23,300) h·ng/mL, respectively. At the maximum recommended weekly dose of 108 mg MIMRYLO, the predicted mean (±SD) rusfertide steady state C max and AUC were 867 (±297) ng/mL and 105,000 (±36,900) h·ng/mL, respectively.

In healthy participants, steady state concentrations of rusfertide were achieved after approximately 3 once weekly doses. Mean accumulation ratios of rusfertide following once weekly subcutaneous administration of 54 mg were 1.6 and 1.3 for AUC and C max , respectively. Absorption Following subcutaneous administration of 19 mg MIMRYLO in healthy participants, the median (min, max) rusfertide time to peak concentration (T max ) was 24 hours (4, 48 hours).

The absolute bioavailability of rusfertide following subcutaneous administration of 19 mg MIMRYLO is approximately 51%. At steady state, rusfertide exposures were similar following subcutaneous administration of MIMRYLO in the abdomen, thigh, or upper arm. Distribution Rusfertide is highly bound to plasma proteins (>99%).

The blood-to-plasma ratio is 2.7. Following subcutaneous administration of 19 mg MIMRYLO in healthy participants, the mean (±SD) rusfertide apparent volume of distribution (Vz/F) was 38.4 (±19.1) L. Elimination Following subcutaneous administration of 19 mg MIMRYLO in healthy participants, the mean (±SD) rusfertide apparent clearance (CL/F) was 0.930 (±0.233) L/h, and the mean (±SD) rusfertide plasma elimination half-life was 28.6 (±11.3) hours.

Metabolism Rusfertide is catabolized into smaller peptides via 2 independent pathways. One pathway involves proteolysis by trypsin-like proteases to form metabolite M1, which undergoes further proteolysis to form metabolite M4. Rusfertide also undergoes hydroxylation to form metabolite M9.

M1 is a minor metabolite (<1% of total drug-related exposure). M4 and M9 are pharmacologically active but have potencies that are approximately 65% and 14% of the potency of rusfertide, respectively. Following multiple-dose subcutaneous administration of 54 mg MIMRYLO in healthy participants, M4 and M9 account for approximately 15% and 31% of total drug-related expos… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 39 words ▾

12.1Mechanism of Action Rusfertide is a mimetic of the endogenous hormone hepcidin that blocks the iron transporter ferroportin. Inhibition of ferroportin by rusfertide reduces availability of iron for production of red blood cells resulting in lower hematocrit levels.

📦 How Supplied / Storage and Handling 197 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied MIMRYLO for injection is supplied in a carton for each individual dosage strength comprising a single-dose vial containing a sterile, preservative-free, white to off-white lyophilized powder and a single-dose prefilled syringe containing a clear, colorless solution (diluent) with a luer lock adapter and soft inner tip cap. Not made with natural rubber latex. Dosage Strength (mg/vial) Color Cap Indicator Vial NDC Number Carton NDC Number

9.5Blue 63020-710-10 63020-715-10 19 Lime 63020-720-20 63020-725-20 28 Burgundy 63020-730-30 63020-735-30 41 Yellow 63020-740-40 63020-745-40 54 White 63020-760-60 63020-765-60 Prefilled Diluent Syringe NDC 63020-600-05 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 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.

📋 Description ~1 min read ▾

11 DESCRIPTION MIMRYLO (rusfertide) for injection, for subcutaneous use, a hepcidin mimetic, is a synthetic cyclic peptide (disulfide) isolated as an acetate salt. The chemical name for rusfertide is S 6 , S 16 -cyclo[ N -isovaleryl-Asp-Thr-His-Phe-Pro-Cys-Ile- Nε -( N -palmitoyl-γ-Glu)-Lys-Phe-Glu-Pro-Arg-Ser-Lys-Gly-Cys-Lys-NH 2 ] acetate. Rusfertide acetate has the following chemical structure: Rusfertide acetate is an amorphous white to off-white powder, light sensitive and hygroscopic with low solubility in ethanol or acetonitrile.

The aqueous solubility in pH range of 2.5 to 7.4 is ≥112 mg/mL. The average molecular weight for the free base is 2442.0 u. The molecular formula for the free base is C 114 H 181 N 27 O 28 S 2 .

MIMRYLO for injection is supplied as a sterile, preservative-free, white to off-white lyophilized powder in a single-dose glass vial. The 9.5 mg dose strength delivers 9.5 mg of rusfertide (provided as rusfertide acetate), mannitol (25 mg), sodium acetate trihydrate (1.36 mg), and glacial acetic acid/sodium hydroxide for pH adjustment, for subcutaneous injection after reconstitution with the provided diluent. The 19 mg, 28 mg, 41 mg, and 54 mg dose strengths deliver 19 mg, 28 mg, 41 mg and 54 mg of rusfertide (provided as rusfertide acetate), mannitol (20 mg), sodium acetate trihydrate (1.36 mg), and glacial acetic acid/sodium hydroxide for pH adjustment, for subcutaneous injection after reconstitution with the provided diluent.

The diluent for MIMRYLO is a sterile, preservative-free solution containing sodium acetate trihydrate (1.36 mg/mL), zinc acetate dihydrate (2.2 mg/mL), and glacial acetic acid for adjusting the pH to nominal pH of 5.4 in Water for Injection, USP. It is a clear, colorless solution, free from visible particles, and is provided in a glass prefilled syringe. After reconstitution, MIMRYLO is a clear and colorless solution free from visible particles. chemical structure

💬 Information for Patients ~1 min read ▾

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

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Rusfertide pharmacokinetics were characterized after a single-dose of 9.5 mg to 54 mg in healthy participants. After subcutaneous administration, rusfertide C max and AUC increased less than dose proportionally over the dose range of 9.5 mg to 54 mg (0.5 to 2.8 times the recommended starting dosage). Rusfertide pharmacokinetics were predicted in patients with PV using population PK analysis.

At the weekly recommended starting dose of 19 mg MIMRYLO, the predicted mean (±SD) rusfertide steady state C max and AUC were 220 (±76.1) ng/mL and 17,800 (±6140) h·ng/mL, respectively. At the weekly dose of 82 mg MIMRYLO, the predicted mean (±SD) rusfertide steady state C max and AUC were 751 (±254) ng/mL and 66200 (±23,300) h·ng/mL, respectively. At the maximum recommended weekly dose of 108 mg MIMRYLO, the predicted mean (±SD) rusfertide steady state C max and AUC were 867 (±297) ng/mL and 105,000 (±36,900) h·ng/mL, respectively.

In healthy participants, steady state concentrations of rusfertide were achieved after approximately 3 once weekly doses. Mean accumulation ratios of rusfertide following once weekly subcutaneous administration of 54 mg were 1.6 and 1.3 for AUC and C max , respectively. Absorption Following subcutaneous administration of 19 mg MIMRYLO in healthy participants, the median (min, max) rusfertide time to peak concentration (T max ) was 24 hours (4, 48 hours).

The absolute bioavailability of rusfertide following subcutaneous administration of 19 mg MIMRYLO is approximately 51%. At steady state, rusfertide exposures were similar following subcutaneous administration of MIMRYLO in the abdomen, thigh, or upper arm. Distribution Rusfertide is highly bound to plasma proteins (>99%).

The blood-to-plasma ratio is 2.7. Following subcutaneous administration of 19 mg MIMRYLO in healthy participants, the mean (±SD) rusfertide apparent volume of distribution (Vz/F) was 38.4 (±19.1) L. Elimination Following subcutaneous administration of 19 mg MIMRYLO in healthy participants, the mean (±SD) rusfertide apparent clearance (CL/F) was 0.930 (±0.233) L/h, and the mean (±SD) rusfertide plasma elimination half-life was 28.6 (±11.3) hours.

Metabolism Rusfertide is catabolized into smaller peptides via 2 independent pathways. One pathway involves proteolysis by trypsin-like proteases to form metabolite M1, which undergoes further proteolysis to form metabolite M4. Rusfertide also undergoes hydroxylation to form metabolite M9.

M1 is a minor metabolite (<1% of total drug-related exposure). M4 and M9 are pharmacologically active but have potencies that are approximately 65% and 14% of the potency of rusfertide, respectively. Following multiple-dose subcutaneous administration of 54 mg MIMRYLO in healthy participants, M4 and M9 account for approximately 15% and 31% of total drug-related exposure, respectively, at steady state.

Excretion Following subcutaneous administration of MIMRYLO, rusfertide concentrations in the urine were below the detection limit. Specific Populations No clinically meaningful differences in the pharmacokinetics of rusfertide were observed based on age (20 to 86 years), race (White, Asian, Other), sex, body weight (44.5 to 151 kg), or mild-to-moderate renal impairment (eGFR 30 to 89 mL/min). Patients with Renal Impairment Following subcutaneous administration of 19 mg MIMRYLO, no clinically meaningful difference was observed in rusfertide systemic exposures (AUC) between participants with severe renal impairment (eGFR <30 mL/min) and participants with normal renal function (eGFR ≥90 mL/min).

Patients with Hepatic Impairment Following subcutaneous administration of 19 mg MIMRYLO, no clinically meaningful difference was observed in rusfertide systemic exposures (AUC) between participants with moderate hepatic impairment (Child-Pugh B) and participants with normal hepatic function. MIMRYLO has not been studied in participants with severe (Child-Pugh C) hepatic impairment. Drug Interaction Studies In… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 139 words ▾

12.2Pharmacodynamics In healthy participants receiving single subcutaneous doses of 9.5 mg, 19 mg, 28 mg, 41 mg, and 54 mg MIMRYLO, the maximum reduction in serum iron was noted approximately 24 to 48 hours post dose. The higher doses (41 mg and 54 mg) of MIMRYLO resulted in a more sustained reduction in serum iron up to 96 hours. In the Phase 3 VERIFY study, mean ferritin concentrations increased from 21 mcg/L at baseline to 124 mcg/L at Week 32 and 174 mcg/L at Week 52 for patients who were randomized to receive MIMRYLO.

The exposure-response relationships of MIMRYLO have not been fully characterized. Cardiac Electrophysiology At 1.3 times the geometric mean rusfertide maximum plasma concentration (C max ) achieved with the maximum recommended weekly dose of 108 mg MIMRYLO, clinically significant QTc interval prolongation was not observed.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES VERIFY The efficacy of MIMRYLO was evaluated in a multicenter, randomized, double-blind, placebo-controlled Phase 3 study in 293 adult patients with PV [NCT05210790]. Eligible patients required at least 3 phlebotomies in the 28 weeks or 5 phlebotomies in 1 year prior to randomization due to inadequate hematocrit control while receiving ongoing standard of care therapy which included phlebotomy alone or phlebotomy plus one or more cytoreductive agents. The mean age at baseline was 57 years (range 27-86 years); 27% of patients were female and73% were male; 262 patients (89.4%) were White, 9 patients (3.1%) were Asian, 2 patients (0.7%) were Black or African American, 2 patients (0.7%) were American Indian or Alaska Native, and 18 patients (6.1%) were of other, not reported, or unknown race; 14 patients (4.8%) were of Hispanic or Latino ethnicity.

At randomization, patients were receiving phlebotomy only (44.7%), phlebotomy + hydroxyurea (38.9%), phlebotomy + ruxolitinib (2.4%), phlebotomy + interferon (13.3%), and phlebotomy + combination of cytoreductive therapies (0.6%). Of all enrolled patients, 53.2% of patients were considered low risk defined as age less than 60 years and no history of previous thrombotic event(s). 46.8% of patients were considered high risk defined as age greater than or equal to 60 years and/or a history of previous thrombotic event(s).

At baseline, the mean ± SD hematocrit was 42.4 ± 1.97 for the placebo arm and 42.2 ± 2.21 for the MIMRYLO arm. Patients were randomized 1:1 to MIMRYLO or placebo from Week 0 to Week 32. The patients that completed 32 weeks of treatment were eligible to receive open-label treatment with MIMRYLO until Week 52 followed by long-term extension treatment with MIMRYLO until week 156.

The starting dosage of MIMRYLO was 19 mg subcutaneously once a week. The dose was then titrated to control and maintain hematocrit <45%. During the 32-week randomized controlled period, the median duration of MIMRYLO treatment exposure was 32 weeks, and 91.2% of patients completed through Week 32.

The efficacy of MIMRYLO was based on the proportion of patients achieving a response (defined as absence of phlebotomy eligibility) between Week 20 to Week 32. Phlebotomy eligibility was defined as a confirmed hematocrit greater than or equal to 45% that is at least 3 percentage (absolute) points higher than the hematocrit obtained at baseline or a hematocrit greater than or equal to 48%. Fatigue was measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 8a standardized score, where higher scores indicate greater fatigue.

Efficacy results are presented in Table 5 . Table 5: Efficacy Results of VERIFY Study Endpoint Placebo (N=146) MIMRYLO (N=147) ANCOVA=Analysis of Covariance; CI=confidence interval; HCT=hematocrit; LSM=least-squares means; SE=standard error Proportion of patients achieving a Response Responders are defined as patients with absence of phlebotomy eligibility. Phlebotomy eligibility was defined as either (1) A confirmed HCT ≥45% that was at least 3% (absolute) higher than the baseline HCT, where confirmation was defined as 2 consecutive HCT assessments that were ≥45% and at least 3% higher than the baseline HCT, or (2) HCT ≥48%.

(Week 20 to Week 32) n (%) 48 (32.9) 113 (76.9) Common Risk Difference (95% CI) 43.8% (33.5%, 54.2%) p-value P-value is obtained from the Cochran-Mantel-Haenszel test stratifying by ongoing standard of care therapy. <0.0001 Mean Number of Phlebotomies (Baseline to Week 32), LSM±SE LS Means, 95% CI, and p-value are obtained from ANCOVA model adjusted for pre-treatment number of phlebotomies, treatment, and stratification variable (ongoing standard of care therapy). 1.82±0.227 0.53±0.224 LSM Difference (SE) (95% CI) -1.29±0.152 (-1.59, -1.00) p-value <0.0001 Proportion of patients Maintaining HCT Values <45% A single HCT ≥45% was permitted.

(Week 0 to Week 32), n (%) 21 (14.4) 92 (62.6) Common Risk Diffe… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 217 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Rusfertide was not carcinogenic in a 6-month transgenic mouse study at subcutaneous doses up to 25 mg/kg/week or in a 2-year rat carcinogenicity study at doses up to 3 mg/kg/ week. In rats, systemic exposure at the highest dose tested was comparable to clinical exposure at the maximum recommended human dose (MRHD), based on AUC. Rusfertide was not mutagenic in a bacterial reverse mutation assay (Ames), in vitro chromosomal aberration test (cultured human peripheral blood lymphocytes) or in a rat in vivo lymphocyte chromosome aberration study.

In separate fertility and early embryonic development studies in female and male rats, rusfertide was administered subcutaneously once weekly in females at doses of 0.3, 1, or 3 mg/kg/dose beginning 15 days prior to cohabitation and then once every three days during the cohabitation and gestation periods until gestation day 7, and once weekly males at doses of 1, 3, or 10 mg/kg/dose for 4 weeks prior to cohabitation, and during cohabitation and post cohabitation mating periods, for a total of ≥7 weeks. Rusfertide had no effect on mating, estrous cycle, fertility, sperm parameters, or any ovarian and uterine parameters at any dose at exposures approximately 1-fold in females and 2.6-fold in males the clinical exposure at the MRHD based on AUC.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 214 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Rusfertide was not carcinogenic in a 6-month transgenic mouse study at subcutaneous doses up to 25 mg/kg/week or in a 2-year rat carcinogenicity study at doses up to 3 mg/kg/ week. In rats, systemic exposure at the highest dose tested was comparable to clinical exposure at the maximum recommended human dose (MRHD), based on AUC. Rusfertide was not mutagenic in a bacterial reverse mutation assay (Ames), in vitro chromosomal aberration test (cultured human peripheral blood lymphocytes) or in a rat in vivo lymphocyte chromosome aberration study.

In separate fertility and early embryonic development studies in female and male rats, rusfertide was administered subcutaneously once weekly in females at doses of 0.3, 1, or 3 mg/kg/dose beginning 15 days prior to cohabitation and then once every three days during the cohabitation and gestation periods until gestation day 7, and once weekly males at doses of 1, 3, or 10 mg/kg/dose for 4 weeks prior to cohabitation, and during cohabitation and post cohabitation mating periods, for a total of ≥7 weeks. Rusfertide had no effect on mating, estrous cycle, fertility, sperm parameters, or any ovarian and uterine parameters at any dose at exposures approximately 1-fold in females and 2.6-fold in males the clinical exposure at the MRHD based on AUC.

📄 Patient Package Insert ~3 min read ▾

This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: 08/2026 PATIENT INFORMATION MIMRYLO ™ (mim-rahy-loh) (rusfertide) for injection, for subcutaneous use What is MIMRYLO?

MIMRYLO is a prescription medicine that is used to treat erythrocytosis (high red blood cell count) in adults with polycythemia vera. It is not known if MIMRYLO is safe and effective in children. Before using MIMRYLO, tell your healthcare provider about all of your medical conditions, including if you: are pregnant or plan to become pregnant.

MIMRYLO may harm your unborn baby. Females who are able to become pregnant: Your healthcare provider may do a pregnancy test before you start treatment with MIMRYLO. Use effective birth control (contraception) during treatment and for at least 30 days after the final dose of MIMRYLO.

Tell your healthcare provider right away if you become pregnant or think that you may be pregnant during treatment with MIMRYLO. Stop taking MIMRYLO if you become pregnant. are breastfeeding or plan to breastfeed. It is not known if MIMRYLO passes into your breast milk.

Do not breastfeed during treatment with MIMRYLO and for 30 days after the final dose of MIMRYLO. Talk to your healthcare provider about the best way to feed your baby during this time. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use MIMRYLO? See the detailed Instructions for Use that comes with MIMRYLO for information on how to prepare and inject a dose of MIMRYLO. Use MIMRYLO exactly as your healthcare provider tells you to.

Your healthcare provider will tell you how much MIMRYLO to inject and when to inject it. Do not inject more than your prescribed dose. Do not change your dose or stop treatment with MIMRYLO unless your healthcare provider tells you.

MIMRYLO is given as an injection under your skin (subcutaneous injection). Inject MIMRYLO under the skin in the stomach area (abdomen) at least 2 inches away from the belly button (navel), front of the thigh, or the upper outer arm. Choose a different site each time you inject MIMRYLO.

Your healthcare provider should show you or your caregiver how to prepare and inject MIMRYLO. Contact your healthcare provider if you have questions. Do not inject yourself or someone else until you have been shown how to inject MIMRYLO.

MIMRYLO is available in more than 1 strength. Make sure the MIMRYLO strength you have matches your prescribed strength. Your prescribed dose may require more than 1 injection.

Do not give more than two injections a day. If your weekly dose is greater than 82 mg, give your first injection on day 1 and the second injection on day 4 or 5. If you inject one time a week: If you miss a dose by 1 to 4 days, take the missed injection as soon as you remember.

Then continue with your regular weekly schedule. If you miss a dose by more than 4 days, take the missed injection as soon as you remember. Take your next injection 3 days later and then return to your regular weekly schedule.

If you inject two times a week: If you miss a dose by 1 to 2 days, take the missed injection as soon as you remember. Take your next injection 3 days later and then return to your regular schedule. If you miss a dose by more than 2 days, skip the dose and continue with your regular injection schedule.

Contact your healthcare provider if you do not know when to inject a missed dose. What are the possible side effects of MIMRYLO? MIMRYLO may cause serious side effects, including: New or worsening increased blood platelets (thrombocytosis) .

MIMRYLO may increase blood platelet counts. Your healthcare provider will do blood tests when you start and during treatment with MIMRYLO to check your platelet counts. Injection-site reactions.

MIMRYLO may cause injection-site reactions such as redness, itching, pain, swelling, bruising, hardening at the injection site, and irritation. If you get… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

INSTRUCTIONS FOR USE MIMRYLO™ (mim-rahy-loh) (rusfertide) for injection, for subcutaneous use This Instructions for Use contains information on how to prepare and inject MIMRYLO. Read this Instructions for Use before you begin preparing and injecting MIMRYLO and each time you get a refill. There may be new information.

Your healthcare provider should show you or your caregiver how to prepare and inject MIMRYLO. Do not inject yourself or someone else until you have been shown how to inject MIMRYLO. Available Strengths Supplies Needed to Inject MIMRYLO ( Figure A ) Supplies Included in the MIMRYLO Carton Additional Supplies ( not included in the carton ) Figure A If you do not have these items, ask your pharmacist.

Important Information You Need to Know Before Preparing and Injecting MIMRYLO For injection under the skin (subcutaneous injection) only. MIMRYLO is available in more than 1 strength. Make sure the MIMRYLO strength you have matches your prescribed strength.

If you have any questions on preparing or injecting MIMRYLO , contact your healthcare provider. Your prescribed dose may require more than 1 injection. Do not administer more than two injections daily.

If your weekly dosage is greater than 82 mg, administer your first injection on day 1 and the second injection on day 4 or 5. The supplies included in the MIMRYLO carton, vial adapter, needle, and alcohol swabs are for single use only. Do not reuse any of these supplies.

Do not use if any of the supplies are opened, damaged, or missing. Do not use if MIMRYLO is expired. MIMRYLO is supplied as a single-dose vial of powder for mixing (reconstitution).

Before you inject MIMRYLO, you must mix (reconstitute) MIMRYLO with liquid (diluent) that comes in a syringe. Do not prepare MIMRYLO for injection until you are ready to inject. Keep the medicine at room temperature after mixing ( see Storing MIMRYLO ).

Inject MIMRYLO within 4 hours of mixing. Do not touch the gray rubber stopper on the top of the vial. Do not let the vial adapter tip or spike touch your hands or any surface.

Do not let the syringe tip or needle touch your hands or any surface. Do not throw away the needle or syringe in your household trash. See “ After Injecting MIMRYLO ” section below for more information.

This product is not made with natural rubber latex. Storing MIMRYLO Store the MIMRYLO at room temperature between 68° to 77°F (20° to 25°C) ( Figure B ). Do not freeze.

Store MIMRYLO in the original carton to protect it from light. Do not use the vial or diluent syringe after the expiration date on the carton. After mixing, MIMRYLO may be stored at room temperature between 68° to 77°F (20° to 25°C) for up to 4 hours.

Use MIMRYLO within 4 hours after mixing. Throw away (dispose of) the mixed MIMRYLO if not used within 4 hours. Keep MIMRYLO and all medicines out of the reach of children.

Figure B Getting Started 1 Washing hands and checking the supplies

1.1Wash hands well with soap and water ( Figure C ). Figure C

1.2Check your prescribed dose ( Figure D ). MIMRYLO is available in more than 1 strength. Your prescribed dose may require more than 1 injection.

1.3Check the expiration date on the outside of the carton ( Figure D ). Figure D Do not use MIMRYLO if the expiration date has passed and contact your healthcare provider.

1.4Take all items out of the carton . Remove the prefilled syringe by the body only. Do not remove the diluent syringe from the carton by its plunger rod or syringe cap.

1.5Check if the supplies have been opened, damaged, or are missing ( Figure E ). Do not use if any of the supplies are opened, damaged or missing. Figure E

1.6Gather additional supplies ( Figure F ). Figure F Preparing MIMRYLO for Injection (Reconstitution) 2 Attaching the vial adapter to the medicine vial

2.1Take off the cap from the medicine vial ( Figure G ). Throw away the medicine vial cap into household trash. Figure G

2.2Clean gray rubber stopper on top of the medicine vial with a new alcohol swab (… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL - 9.5 mg Vial Label NDC 63020-710-10 Rx Only Mimrylo ™ (rusfertide) for injection 9.5 mg per vial Reconstitute prior to use. For subcutaneous use only. Single-Dose Vial. Discard Unused Portion. Takeda PRINCIPAL DISPLAY PANEL - NDC 63020-710-10

PRINCIPAL DISPLAY PANEL - 19 mg Vial Label NDC 63020-720-20 Rx Only Mimrylo ™ (rusfertide) for injection 19 mg per vial Reconstitute prior to use. For subcutaneous use only. Single-Dose Vial. Discard Unused Portion. Takeda PRINCIPAL DISPLAY PANEL - NDC 63020-720-20

PRINCIPAL DISPLAY PANEL - 28 mg Vial Label NDC 63020-730-30 Rx Only Mimrylo ™ (rusfertide) for injection 28 mg per vial Reconstitute prior to use. For subcutaneous use only. Single-Dose Vial. Discard Unused Portion. Takeda PRINCIPAL DISPLAY PANEL - NDC 63020-730-30

PRINCIPAL DISPLAY PANEL - 41 mg Vial Label NDC 63020-740-40 Rx Only Mimrylo ™ (rusfertide) for injection 41 mg per vial Reconstitute prior to use. For subcutaneous use only. Single-Dose Vial. Discard Unused Portion. Takeda PRINCIPAL DISPLAY PANEL - NDC 63020-740-40

PRINCIPAL DISPLAY PANEL - 54 mg Vial Label NDC 63020-760-60 Rx Only Mimrylo ™ (rusfertide) for injection 54 mg per vial Reconstitute prior to use. For subcutaneous use only. Single-Dose Vial. Discard Unused Portion. Takeda PRINCIPAL DISPLAY PANEL - NDC 63020-760-60

PRINCIPAL DISPLAY PANEL Diluent For Mimrylo ™ for injection NDC 63020-600-05 Rx Only For drug diluent use only — reconstitute as directed. Takeda Pharmaceuticals America, Inc. Cambridge, MA 02142 Single-Dose PCR-780-21185 PRINCIPAL DISPLAY PANEL - NDC 63020-600-05

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
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Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Takeda Pharmaceuticals America, Inc.. Listing status can change — the directory data on this page refreshes weekly.
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← 63020-0735-30 · Takeda 63020-0765-60 · Takeda →
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