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Pasatru garetosmab-grts 300 mg/5mL Injection, Solution, Concentrate — NDC 61755-0012-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Pasatru garetosmab-grts 300 mg/5mL Injection, Solution, Concentrate — NDC 61755-012-01 (Billing 61755-0012-01)

by Regeneron Pharmaceuticals, Inc. · 1 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE

This is a package of Pasatru garetosmab-grts 300 mg/5mL Injection, Solution, Concentrate from Regeneron Pharmaceuticals, Inc., marketed since Aug 2026 and currently FDA-listed. It is this product's only package size.

NDC 61755-0012-01
🏷️ FDA NDC (as labeled) 61755-012-01 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 10, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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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 61755-012-01 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
61755 labeler · 012 product · 01 package
Package marketed since
Aug 19, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6175501201 5
FDA record last changed
Sep 10, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 61755-012-01
Product NDC 61755-012
11-digit billing NDC 61755001201
RxCUI 2749959, 2749966
UNII KR9ZSKO5QE
Application # BLA761508
SPL Set ID 0d5cec96-b02b-4f1d-bc66-51e62ce04e3c
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-08-19
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION, CONCENTRATE
Substance GARETOSMAB
Quick answers
  • RxCUI (RxNorm): 2749959
Why two NDCs? The FDA registers this code as 61755-012-01 — 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 → 61755-0012-01. 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

📖 What it is MedlinePlus · NLM

Garetosmab-grts injection is used to reduce formation of new lesions and flare-ups in patients with fibrodysplasia ossificans progressiva (FOP; genetic disorder where muscles, tendons, ligaments and other connective tissue are replaced by bone). Garetosmab-grts is in a class of medications called activin signaling inhibitors. It works by stopping the formation and progression of bony lesions.

Read the full MedlinePlus article ↗

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 mLPer 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
61755-0012-01 You're viewing this Main listing 1 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE 2026-08-19 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Pasatru 300 mg/5mLthis 61755-0012-01 Regeneron 1 vial — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
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 & biosimilar status

🏛️
2026
On the market since
Aug 2026
📍
2026
Currently FDA-listed
listed with the FDA
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII F7LTH1E20Y
    Arginine hydrochloride is an amino acid salt used as a buffer and pH adjuster in medicines. It helps maintain the correct acidity level to keep the drug stable and effective.
  • UNII 4QD397987E
    An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
  • UNII X573657P6P
    Histidine monohydrochloride monohydrate is an amino acid salt used as a buffer in medicines. It helps maintain the proper acidity level of liquid formulations to keep the drug stable and effective.
  • UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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

LabelerRegeneron Pharmaceuticals, Inc.
FDA applicationBLA761508 (BLA)
Labeler code61755
First marketedAug 2026
Product typeHuman Prescription Drug
Portfolio27 products on file

More NDCs from Regeneron Pharmaceuticals, Inc. labeler code 61755

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 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 55 words ▾

1 INDICATIONS AND USAGE PASATRU is indicated to reduce formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP). PASATRU is an activin signaling inhibitor indicated to reduce formation of new heterotopic ossification (HO) lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva (FOP). ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Recommended starting dosage: 10 mg/kg intravenous (IV) infusion over 60 minutes once every 4 weeks. ( 2.2 ) May decrease dosage to 3 mg/kg IV infusion over 60 minutes once every 4 weeks if 10 mg/kg is not tolerated. ( 2.2 ) See Full Prescribing Information for preparation and administration instructions. ( 2.3 )

2.1Pregnancy Testing Prior to Treatment with PASATRU Verify that females of reproductive potential are not pregnant prior to initiating PASATRU [see Contraindications (4) , Warnings and Precautions (5.1) , Use in Specific Populations (8.1 , 8.3) ] .

2.2Recommended Dosage The recommended starting dosage of PASATRU is 10 mg/kg administered as an intravenous infusion over 60 minutes once every 4 weeks. The dosage of PASATRU may be decreased to 3 mg/kg administered as an intravenous infusion over 60 minutes once every 4 weeks if 10 mg/kg is not tolerated. If a dose of PASATRU is missed, administer the dose as soon as possible.

Thereafter, PASATRU should be scheduled once every 4 weeks from the date of the last dose.

2.3Preparation and Administration Instructions Preparation Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. PASATRU is a clear to slightly opalescent, colorless to pale yellow solution. Discard the vial if the solution is cloudy, discolored, or contains particulate matter.

Each vial is intended for one-time use only. Do not shake the vial. Withdraw the required volume from the vial(s) of PASATRU and transfer into an intravenous infusion bag [polyvinyl chloride (PVC), polyolefin (PO), or ethyl vinyl acetate (EVA)] containing a minimum of 50 mL and a maximum of 100 mL of 5% Dextrose Injection, USP to prepare a diluted solution with a final concentration ranging from 0.9 mg/mL to 25 mg/mL.

Mix the diluted solution by gentle inversion. Do not shake the solution. Discard any unused portion left in the vial.

Storage of Infusion Solution Use diluted PASATRU immediately. If not used immediately, store the diluted solution refrigerated at 2°C to 8°C (36°F to 46°F) for no more than 24 hours or at room temperature up to 25°C (77°F) for no more than 16 hours from the time of preparation to the start of infusion. Do not freeze the diluted solution.

Administration If refrigerated, allow the diluted solution to come to room temperature prior to administration. Administer PASATRU diluted solution by intravenous infusion over 60 minutes using an infusion set constructed of PVC, polyethylene (PE)-lined PVC, or polyurethane (PU). A sterile, in-line or add-on, 0.2-micron to 5-micron polyethersulfone (PES) or polyamide (PA) filter is recommended.

PASATRU should be administered using an infusion pump to control the rate of infusion. Upon completion of the PASATRU infusion, flush the infusion line with an adequate volume of sterile 5% Dextrose Injection, USP to ensure that the entire contents of the infusion bag are administered. Do not mix other drugs with PASATRU or administer other drugs concomitantly via the same infusion line.

💊 Dosage Forms and Strengths 38 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 300 mg/5 mL (60 mg/mL) clear to slightly opalescent, colorless to pale yellow solution in a single-dose vial. Injection: 300 mg/5 mL (60 mg/mL) solution in a single-dose vial. ( 3 )

⛔ Contraindications 43 words ▾

4 CONTRAINDICATIONS PASATRU is contraindicated during pregnancy. PASATRU can cause fetal harm when administered to a pregnant woman [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1 , 8.3) ] . Pregnancy. ( 4 , 5.1 , 8.1 , 8.3 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Embryo-Fetal Toxicity: PASATRU can cause fetal harm. Verify females of reproductive potential are not pregnant prior to initiating PASATRU and advise of the potential risk to a fetus and to use effective contraception. Advise the patient to discontinue PASATRU immediately if pregnancy occurs during treatment and to contact their healthcare provider.

( 2.1 , 4 , 5.1 , 8.1 , 8.3 ) Skin and Soft Tissue Infections: Have occurred in patients treated with PASATRU. Advise patients to report signs or symptoms of infection to their healthcare provider. ( 5.2 ) Epistaxis: Spontaneous epistaxis, including serious cases requiring medical intervention, has been reported in patients receiving PASATRU.

Advise patients to seek medical attention if they experience epistaxis that is severe, prolonged and does not resolve with standard first-aid measures. ( 5.3 )

5.1Embryo-Fetal Toxicity PASATRU is contraindicated during pregnancy. Based on its mechanism of action and findings from animal reproduction studies, PASATRU can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) and Clinical Pharmacology (12.1) ] . Intravenous administration of garetosmab-grts to pregnant cynomolgus monkeys resulted in embryo-fetal toxicity, infant mortality, and post-natal malformations at exposures equivalent to or higher than those in patients at the recommended human doses of PASATRU 10 mg/kg or 3 mg/kg every 4 weeks, respectively.

For females of reproductive potential, verify that the patient is not pregnant prior to initiating treatment. Advise females of reproductive potential to use effective contraception during treatment with PASATRU and for 6 months after the last dose. Advise the patient to discontinue PASATRU immediately if pregnancy occurs during treatment and to contact their healthcare provider [see Use in Specific Populations (8.1 , 8.3) ] .

5.2Skin and Soft Tissue Infections Skin and soft tissue infections requiring treatment and/or hospitalization, including abscesses and cellulitis [see Adverse Reactions (6.1) ] , have occurred in patients receiving PASATRU in clinical trials. Advise patients to report signs or symptoms of skin infection, including erythema, pain, swelling, or fever, and to seek medical attention if these occur.

5.3Epistaxis Spontaneous epistaxis, including serious cases requiring medical intervention, has been reported in patients receiving PASATRU. In clinical trials in the FOP population, one serious case of spontaneous epistaxis occurred that required hospitalization for nasal packing and application of a clotting agent. Advise patients to seek medical attention if they experience epistaxis that is severe, prolonged (e.g., lasting more than 20 minutes) and does not resolve with standard first-aid measures.

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Skin and Soft Tissue Infections [see Warnings and Precautions (5.2) ] Epistaxis [see Warnings and Precautions (5.3) ] The most common adverse reactions (incidence ≥10%) are abscess, acne, increased hair growth, madarosis, oral ulcers, and epistaxis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Regeneron at 1-877-372-7287 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. The safety of PASATRU was evaluated in a randomized, double-blind, parallel-group, multicenter, placebo-controlled trial that enrolled a total of 63 adults with FOP. Patients received placebo or PASATRU 10 mg/kg or 3 mg/kg every 4 weeks in the 56-week double-blind treatment period then continued their originally assigned treatment in a double-blind extension phase [see Clinical Studies (14) ] .

Table 1 summarizes the adverse reactions occurring in ≥10% of patients treated with PASATRU (10 mg/kg or 3 mg/kg) every 4 weeks and more frequently than placebo through Week 56. Table 1: Adverse Reactions Occurring in ≥10% of Adults with FOP Treated with PASATRU 10 mg/kg or 3 mg/kg and more Frequently than Placebo Through Week 56 Adverse Reaction Placebo PASATRU 10 mg/kg every 4 weeks PASATRU 3 mg/kg every 4 weeks N=21 n (%) N=23 n (%) N=19 n (%) Abscess Abscess includes abscess, abscess limb, subcutaneous abscess, and tooth abscess.

2 (10%) 8 (35%) 2 (11%) Acne 2 (10%) 7 (30%) 3 (16%) Increased hair growth Increased hair growth includes hirsutism, hypertrichosis, hair growth abnormal, and hair disorder. 0 6 (26%) 8 (42%) Madarosis 4 (19%) 6 (26%) 3 (16%) Oral ulcers Oral ulcers includes aphthous ulcer, lip ulceration, mouth ulceration, oral mucosal blistering, and stomatitis. 1 (5%) 6 (26%) 1 (5%) Epistaxis 5 (24%) 4 (17%) 10 (53%) Folliculitis 2 (10%) 2 (9%) 3 (16%) Paronychia 0 1 (4%) 2 (11%) Rash 0 1 (4%) 5 (26%) Clinically Significant Adverse Reactions Occurring in <10% of Adults with FOP Cellulitis was reported in 1 (4%) patient receiving PASATRU 10 mg/kg every 4 weeks and in none of the patients receiving PASATRU 3 mg/kg every 4 weeks or placebo.

👥 Use in Specific Populations ~3 min read ▾

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

8.1Pregnancy Risk Summary PASATRU is contraindicated for use during pregnancy. Based on its mechanism of action and data from animal reproduction studies, PASATRU can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on PASATRU during pregnancy to evaluate for a drug associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Although there are no data on PASATRU exposure during pregnancy, monoclonal antibodies can be actively transported across the placenta. Inhibition of activin A signaling by PASATRU during pregnancy may adversely affect embryogenesis and fetal organogenesis, including development of the reproductive system (see Clinical Considerations ) . In an enhanced pre- and post-natal developmental (ePPND) toxicity study, intravenous administration of garetosmab-grts to pregnant cynomolgus monkeys resulted in developmental toxicity, including post-natal malformations, neurobehavioral deficits, and infant mortality at exposures equivalent to or higher than those in patients at the recommended human doses of PASATRU 10 mg/kg or 3 mg/kg every 4 weeks, respectively ( see Data ).

If pregnancy occurs during treatment with PASATRU, discontinue treatment immediately, and advise the patient to contact their healthcare provider. The 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 defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Therefore, it is expected that PASATRU may be present in infants exposed in utero.

The potential clinical impact of PASATRU exposure in infants exposed in utero should be considered. Data Animal Data In an ePPND toxicity study, pregnant cynomolgus monkeys were administered intravenous doses of garetosmab-grts 5 mg/kg or 50 mg/kg once weekly beginning from gestation day 20 through delivery, with no evidence of maternal toxicity at either dose level. An increased incidence of post-natal malformations, including neurological deficiencies and testes malformations, were observed in offspring at 5 mg/kg/week (approximately equivalent to or 4 times the recommended human doses of PASATRU 10 mg/kg or 3 mg/kg every 4 weeks, respectively, based on area under the concentration curve [AUC]).

Increased incidences of stillbirth, premature delivery, post-natal malformations including generalized alopecia, and infant mortality were observed in offspring of pregnant monkeys receiving treatment with garetosmab-grts at 50 mg/kg/week (approximately 9 times or 31 times the recommended human doses of PASATRU 10 mg/kg or 3 mg/kg every 4 weeks, respectively, based on AUC).

8.2Lactation Risk Summary There are no data on the presence of PASATRU in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Maternal IgG is known to be present in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to PASATRU are unknown.

Because of the potential for serious adverse reactions of PASATRU absorption in the breastfed infant, including skin and soft tissue infections, and the potential for effects on male reproductive organ development based on the mechanism of action, advise patients that breastfeeding is not recommended during treatment with PASATRU and for 6 months after the last dose.

8.3Females and Males of Reproductive Potential Based on animal data and mechanism of action, PASATRU can cause fetal har… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary PASATRU is contraindicated for use during pregnancy. Based on its mechanism of action and data from animal reproduction studies, PASATRU can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on PASATRU during pregnancy to evaluate for a drug associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Although there are no data on PASATRU exposure during pregnancy, monoclonal antibodies can be actively transported across the placenta. Inhibition of activin A signaling by PASATRU during pregnancy may adversely affect embryogenesis and fetal organogenesis, including development of the reproductive system (see Clinical Considerations ) . In an enhanced pre- and post-natal developmental (ePPND) toxicity study, intravenous administration of garetosmab-grts to pregnant cynomolgus monkeys resulted in developmental toxicity, including post-natal malformations, neurobehavioral deficits, and infant mortality at exposures equivalent to or higher than those in patients at the recommended human doses of PASATRU 10 mg/kg or 3 mg/kg every 4 weeks, respectively ( see Data ).

If pregnancy occurs during treatment with PASATRU, discontinue treatment immediately, and advise the patient to contact their healthcare provider. The 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 defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Therefore, it is expected that PASATRU may be present in infants exposed in utero.

The potential clinical impact of PASATRU exposure in infants exposed in utero should be considered. Data Animal Data In an ePPND toxicity study, pregnant cynomolgus monkeys were administered intravenous doses of garetosmab-grts 5 mg/kg or 50 mg/kg once weekly beginning from gestation day 20 through delivery, with no evidence of maternal toxicity at either dose level. An increased incidence of post-natal malformations, including neurological deficiencies and testes malformations, were observed in offspring at 5 mg/kg/week (approximately equivalent to or 4 times the recommended human doses of PASATRU 10 mg/kg or 3 mg/kg every 4 weeks, respectively, based on area under the concentration curve [AUC]).

Increased incidences of stillbirth, premature delivery, post-natal malformations including generalized alopecia, and infant mortality were observed in offspring of pregnant monkeys receiving treatment with garetosmab-grts at 50 mg/kg/week (approximately 9 times or 31 times the recommended human doses of PASATRU 10 mg/kg or 3 mg/kg every 4 weeks, respectively, based on AUC).

🧒 Pediatric Use 16 words ▾

8.4Pediatric Use The safety and effectiveness of PASATRU have not been established in pediatric patients.

🧓 Geriatric Use 30 words ▾

8.5Geriatric Use Clinical studies of PASATRU did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action FOP is caused by gain-of-function mutations in the intracellular domain of activin receptor type 1 (ACVR1, also known as ALK2), a bone morphogenetic protein (BMP) type I receptor that is expressed in many tissues, including skeletal muscle and cartilage. In patients with FOP, mutant ACVR1 is activated by activin A resulting in heterotopic ossification. Garetosmab-grts is a human IgG4 monoclonal antibody that specifically binds to and inhibits signaling by activin A to block the activation of FOP-mutant ACVR1 and reduce the formation and progression of new heterotopic bone lesions.

12.2Pharmacodynamics No pharmacodynamic studies have been conducted with garetosmab-grts.

12.3Pharmacokinetics Following multiple doses of garetosmab-grts 10 mg/kg or 3 mg/kg administered intravenously every 4 weeks in patients with FOP, the steady-state exposures were approximately dose proportional. The mean (SD) trough concentrations at steady-state following intravenous administration of garetosmab-grts 10 mg/kg or 3 mg/kg every 4 weeks were 99 (34) mg/L or 27 (10) mg/L, respectively, in patients with FOP. Steady-state concentrations were attained by approximately 12 weeks with an accumulation ratio of approximately 1.7-fold.

Distribution The estimated mean (SD) volume of distribution is 5.1 (1.2) L. Elimination Garetosmab-grts is eliminated by parallel linear and non-linear pathways. At higher concentrations, the elimination is predominantly through the linear, non-saturable proteolytic pathway, while at lower concentrations, non-linear, target-mediated clearance predominates.

After the last dose of garetosmab-grts 10 mg/kg or 3 mg/kg administered intravenously every 4 weeks in patients with FOP, the median time to a non-detectable concentration was approximately 24 weeks or 17 weeks, respectively, based on population pharmacokinetic analysis. Metabolism Garetosmab-grts is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG. Specific Populations No clinically meaningful differences in the exposure of garetosmab-grts were observed in adults based on age (18 to 70 years), sex, body weight (32 to 128 kg), race (White 86%, Asian 10%, Black 1%), mild to moderate renal impairment (creatinine clearance 30 to 89 mL/min, estimated by Cockcroft-Gault equation), or mild to moderate hepatic impairment (total bilirubin > 1.5 to ≤ 3 times upper limit of normal [ULN] and any aspartate aminotransferase [AST]) following 10 mg/kg and 3 mg/kg administered once every 4 weeks.

The effect of severe renal impairment or kidney failure (creatinine clearance < 30 mL/min) and severe hepatic impairment (total bilirubin > 3 times ULN and any AST) on garetosmab-grts pharmacokinetics is unknown. Since garetosmab-grts is a monoclonal antibody that is not eliminated via renal pathways and is degraded by widely distributed proteolytic enzymes rather than restricted to hepatic tissue, changes in renal or hepatic function are not expected to impact the pharmacokinetics of garetosmab-grts. Drug Interaction Studies No drug-drug interaction studies have been conducted with garetosmab-grts.

12.6Immunogenicity The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of PASATRU or of other garetosmab products. Among patients with FOP who received PASATRU 10 mg/kg or 3 mg/kg every 4 weeks in clinical trials for up to 76 weeks, 1.3% (1/76) developed anti-garetosmab-grts antibodies.

There are insufficient data to assess whether there are clinically significant effects of anti-drug antibodies on the pharmacokinetics, safety, or effectiveness of PASATRU.

🧬 Mechanism of Action 93 words ▾

12.1Mechanism of Action FOP is caused by gain-of-function mutations in the intracellular domain of activin receptor type 1 (ACVR1, also known as ALK2), a bone morphogenetic protein (BMP) type I receptor that is expressed in many tissues, including skeletal muscle and cartilage. In patients with FOP, mutant ACVR1 is activated by activin A resulting in heterotopic ossification. Garetosmab-grts is a human IgG4 monoclonal antibody that specifically binds to and inhibits signaling by activin A to block the activation of FOP-mutant ACVR1 and reduce the formation and progression of new heterotopic bone lesions.

📦 How Supplied / Storage and Handling 70 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied PASATRU (garetosmab-grts) injection is a clear to slightly opalescent, colorless to pale yellow solution. It is supplied in a carton containing one single-dose vial of: 300 mg/5 mL (60 mg/mL) (NDC 61755-012-01) Storage and Handling Store the unopened vial in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake.

📦 Storage and Handling 31 words ▾

Storage and Handling Store the unopened vial in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake.

📋 Description 105 words ▾

11 DESCRIPTION Garetosmab-grts is an activin signaling inhibitor. Garetosmab-grts is a human IgG4 monoclonal antibody produced by recombinant DNA technology in Chinese hamster ovary cell suspension culture. Garetosmab-grts has an approximate molecular weight of 146 kDa.

PASATRU (garetosmab-grts) injection is a sterile, preservative-free solution for intravenous use. The solution is clear to slightly opalescent, colorless to pale yellow with a pH of 6.3. Each PASATRU 300 mg/5 mL vial contains 300 mg of garetosmab-grts.

Each mL contains 60 mg of garetosmab-grts, arginine hydrochloride (14.7 mg), histidine (1 mg), L-histidine hydrochloride monohydrate (0.7 mg), polysorbate 20 (0.5 mg), sucrose (50 mg), and Water for Injection, USP.

💬 Information for Patients 191 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Embryo-Fetal Toxicity PASATRU can cause fetal harm and is contraindicated during pregnancy. Advise patients to immediately stop PASATRU and contact their healthcare provider if pregnancy occurs during treatment [see Contraindications (4) , Warnings and Precautions (5.1) , and Use in Specific Populations (8.1) ] .

Advise females of reproductive potential to use effective contraception during treatment with PASATRU and for 6 months after the last dose [see Use in Specific Populations (8.3) ] . Skin and Soft Tissue Infections Advise patients that PASATRU may cause abscesses and cellulitis and to report signs or symptoms of infection, such as erythema, pain, swelling, or fever, to their healthcare provider [see Warnings and Precautions (5.2) ] . Epistaxis Advise patients to seek medical attention if they experience epistaxis that is severe, prolonged (e.g., lasting more than 20 minutes) and does not resolve with standard first-aid measures [see Warnings and Precautions (5.3) ] .

Lactation Advise patients not to breastfeed during treatment with PASATRU and for 6 months after the last dose [see Use in Specific Populations (8.2) ] .

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE PASATRU™ (PA-SAH-TROO) (garetosmab-grts) injection, for intravenous use This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: August 2026 What is the most important information I should know about PASATRU?

PASATRU can cause serious side effects, including: Harm to your unborn baby including serious birth defects if taken during pregnancy. Females who are pregnant must not take PASATRU. Females who can become pregnant: Your healthcare provider will ask you to take a pregnancy test to verify that you are not pregnant before starting treatment with PASATRU.

Use effective birth control (contraception) during treatment with PASATRU and for 6 months after the last dose of PASATRU. Talk to your healthcare provider about birth control methods that may be right for you. If you become pregnant or think you may be pregnant during treatment with PASATRU, stop taking PASATRU immediately and call your healthcare provider right away.

Infections of the skin and tissue under the skin requiring treatment or hospitalization, such as infected lumps (abscesses) and bacterial skin infections (cellulitis), may happen while you are taking PASATRU. Call your healthcare provider right away if you have signs or symptoms of skin infection, such as: redness skin feels warm to the touch swelling pain or tenderness fever feeling generally unwell Nosebleeds (epistaxis) including serious nosebleeds that require medical care, can happen while taking PASATRU. Tell your healthcare provider right away if you have a nosebleed that: is severe or heavy does not stop with basic first-aid measures, such as pinching your nose with continuous firm pressure lasts more than 20 minutes See " What are the possible side effects of PASATRU? " for more information about side effects.

What is PASATRU? PASATRU is a prescription medicine used to reduce the formation of new abnormal bone growth outside of the skeleton (heterotopic ossification) and flare-ups in adults with fibrodysplasia ossificans progressiva (FOP). It is not known if PASATRU is safe and effective in children.

Who should not receive PASATRU? Do not receive PASATRU if you: are pregnant. (See " What is the most important information I should know about PASATRU? " ) Before you receive PASATRU, tell your healthcare provider about all your medical conditions, including if you: are breastfeeding.

It is not known whether PASATRU passes into your breast milk. Breastfeeding is not recommended during treatment with PASATRU and for 6 months after the last dose of PASATRU. Talk to your healthcare provider about the best way to feed your baby during this time. are concerned about male fertility.

PASATRU may affect your ability to father a child. Talk to your healthcare provider if this is a concern for you. Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How will I receive PASATRU? Your healthcare provider will give you PASATRU through a needle placed into your vein (intravenous infusion) over 60 minutes. PASATRU should be given 1 time every 4 weeks.

If you miss any infusion appointments, call your healthcare provider as soon as possible to reschedule. After you receive your missed dose, your next infusion will be scheduled every 4 weeks from the date of that dose. What are the possible side effects of PASATRU?

PASATRU may cause serious side effects, including: See " What is the most important information I should know about PASATRU? " The most common side effects of PASATRU include: infected lumps (abscess) acne increased hair growth hair loss of eyebrows or lashes (madarosis) mouth sores (oral ulcers) nosebleeds (epistaxis) These are not all of the possible side effects of PASATRU. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of PASATRU. Medicines ar… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Following multiple doses of garetosmab-grts 10 mg/kg or 3 mg/kg administered intravenously every 4 weeks in patients with FOP, the steady-state exposures were approximately dose proportional. The mean (SD) trough concentrations at steady-state following intravenous administration of garetosmab-grts 10 mg/kg or 3 mg/kg every 4 weeks were 99 (34) mg/L or 27 (10) mg/L, respectively, in patients with FOP. Steady-state concentrations were attained by approximately 12 weeks with an accumulation ratio of approximately 1.7-fold.

Distribution The estimated mean (SD) volume of distribution is 5.1 (1.2) L. Elimination Garetosmab-grts is eliminated by parallel linear and non-linear pathways. At higher concentrations, the elimination is predominantly through the linear, non-saturable proteolytic pathway, while at lower concentrations, non-linear, target-mediated clearance predominates.

After the last dose of garetosmab-grts 10 mg/kg or 3 mg/kg administered intravenously every 4 weeks in patients with FOP, the median time to a non-detectable concentration was approximately 24 weeks or 17 weeks, respectively, based on population pharmacokinetic analysis. Metabolism Garetosmab-grts is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG. Specific Populations No clinically meaningful differences in the exposure of garetosmab-grts were observed in adults based on age (18 to 70 years), sex, body weight (32 to 128 kg), race (White 86%, Asian 10%, Black 1%), mild to moderate renal impairment (creatinine clearance 30 to 89 mL/min, estimated by Cockcroft-Gault equation), or mild to moderate hepatic impairment (total bilirubin > 1.5 to ≤ 3 times upper limit of normal [ULN] and any aspartate aminotransferase [AST]) following 10 mg/kg and 3 mg/kg administered once every 4 weeks.

The effect of severe renal impairment or kidney failure (creatinine clearance < 30 mL/min) and severe hepatic impairment (total bilirubin > 3 times ULN and any AST) on garetosmab-grts pharmacokinetics is unknown. Since garetosmab-grts is a monoclonal antibody that is not eliminated via renal pathways and is degraded by widely distributed proteolytic enzymes rather than restricted to hepatic tissue, changes in renal or hepatic function are not expected to impact the pharmacokinetics of garetosmab-grts. Drug Interaction Studies No drug-drug interaction studies have been conducted with garetosmab-grts.

🧬 Pharmacodynamics 10 words ▾

12.2Pharmacodynamics No pharmacodynamic studies have been conducted with garetosmab-grts.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES The efficacy of PASATRU was evaluated in Study 1 (NCT05394116), a randomized, double-blind, parallel-group, multicenter, placebo-controlled trial in 63 adults with FOP confirmed by an ACVR1 FOP-causing mutation. Patients were randomized to receive PASATRU 10 mg/kg (N=23), PASATRU 3 mg/kg (N=19), or placebo (N=21), intravenously every 4 weeks for 56 weeks using an infusion pump. Upon completion of the first 56 weeks, 61 patients continued to receive their original assigned study treatment in a double-blind extension phase.

The median age of patients was 25 (range: 18 to 42) years; 60% of patients were female; 67% of patients were White, 30% were Asian, 19% were Hispanic or Latino, and 2% were Black or African American. Ninety-five percent (95%) of patients had the R206H genetic mutation. The mean Cumulative Analog Joint Involvement Scale (CAJIS) score (range: 0 to 30) at baseline was 13 (range: 0 to 19).

The primary efficacy endpoint was the number of new HO lesions at Week 56 assessed by low-dose, whole-body computed tomography (WBCT) imaging, with the treatment effect evaluated using the estimated rate ratio for the number of new HO lesions. The key secondary endpoints included the number of clinician-assessed flare-ups through Week 56, the proportion of patients with new HO lesions at Week 56; and the total volume of new HO lesions at Week 56. Statistically significant reductions in the number of new HO lesions at Week 56 were observed in patients receiving PASATRU 10 mg/kg every 4 weeks or 3 mg/kg every 4 weeks compared to placebo (90% reduction or 94% reduction for PASATRU 10 mg/kg or 3 mg/kg, respectively, compared to placebo).

There were a total of 19 new HO lesions observed in 5/21 (24%) patients receiving placebo compared to 2 total lesions in 2/23 (9%) patients or 1 lesion in 1/19 (5%) patients treated with PASATRU 10 mg/kg or 3 mg/kg every 4 weeks, respectively, at Week 56 (see Table 2 ). The number of clinician-assessed flare-ups through Week 56 was 9, 53, and 66 for PASATRU 10 mg/kg, 3 mg/kg, and placebo, respectively. The rate ratio (95% CI) compared to placebo was 0.12 (0.03, 0.42) for PASATRU 10 mg/kg, and 0.85 (0.26, 2.73) for PASATRU 3 mg/kg.

Changes in the proportion of patients with patient-reported flare-ups through Week 56 were not significantly different between placebo and PASATRU treatment groups. The mean new HO volume at Week 56 was 10.5 cm 3 in patients receiving placebo compared to 0.02 cm 3 (mean difference vs. placebo: -10.4 cm 3 [95% CI: -27.5, -0.3]) in patients receiving PASATRU 10 mg/kg every 4 weeks and 0.01 cm 3 (mean difference vs. placebo: -10.4 cm 3 [95% CI: -27.5, -0.3]) in patients receiving PASATRU 3 mg/kg every 4 weeks. These findings were not statistically significant based on the pre-specified Wilcoxon rank-sum test.

Table 2: Efficacy Results in Adults with FOP in Study 1 at Week 56 Placebo PASATRU 10 mg/kg every 4 weeks PASATRU 3 mg/kg every 4 weeks (N = 21) (N = 23) (N = 19) Number of new HO lesions at Week 56, total Total number is defined as the sum of the number of new HO lesions observed in each treatment group at Week 56. (rate Rate is defined as the mean number of new HO lesions per patient at Week 56. ) 19 (0.90) 2 (0.09) 1 (0.05) Rate Ratio vs. Placebo -

0.10Statistically significant (multiplicity-adjusted p-value <0.05). 0.06 (95% CI) (0.01, 0.76) (0, 0.73) % Reduction vs. Placebo 90% 94%

🧪 Nonclinical Toxicology 186 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies have not been conducted with garetosmab-grts. The mutagenic potential of garetosmab-grts has not been evaluated; however, monoclonal antibodies are not expected to alter DNA or chromosomes. Dedicated fertility studies have not been conducted with garetosmab-grts.

Reproductive organs and fertility-related parameters were assessed in sexually mature cynomolgus monkeys in a 26-week study in which garetosmab-grts was administered intravenously once weekly at doses up to 50 mg/kg (approximately 14 times or 49 times the recommended human doses of PASATRU 10 mg/kg or 3 mg/kg every 4 weeks, respectively, based on AUC). Minimal to moderate seminiferous tubule degeneration was observed in male monkeys, which was reversible after a treatment-free recovery period. Changes in sperm concentration, sperm motility, or testosterone levels were not observed.

In 5-week toxicology studies in male rats, intravenous administration of garetosmab-grts resulted in adverse effects including inflammation, granulomas, and epithelial degeneration in the male reproductive tract (testes, epididymis, and efferent ducts) associated with decreases in sperm motility at exposures less than the recommended human doses of PASATRU 10 mg/kg or 3 mg/kg every 4 weeks.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 183 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies have not been conducted with garetosmab-grts. The mutagenic potential of garetosmab-grts has not been evaluated; however, monoclonal antibodies are not expected to alter DNA or chromosomes. Dedicated fertility studies have not been conducted with garetosmab-grts.

Reproductive organs and fertility-related parameters were assessed in sexually mature cynomolgus monkeys in a 26-week study in which garetosmab-grts was administered intravenously once weekly at doses up to 50 mg/kg (approximately 14 times or 49 times the recommended human doses of PASATRU 10 mg/kg or 3 mg/kg every 4 weeks, respectively, based on AUC). Minimal to moderate seminiferous tubule degeneration was observed in male monkeys, which was reversible after a treatment-free recovery period. Changes in sperm concentration, sperm motility, or testosterone levels were not observed.

In 5-week toxicology studies in male rats, intravenous administration of garetosmab-grts resulted in adverse effects including inflammation, granulomas, and epithelial degeneration in the male reproductive tract (testes, epididymis, and efferent ducts) associated with decreases in sperm motility at exposures less than the recommended human doses of PASATRU 10 mg/kg or 3 mg/kg every 4 weeks.

📄 Package Label / Principal Display Panel 46 words ▾

PRINCIPAL DISPLAY PANEL - 5 mL Vial Carton NDC 61755-012-01 Rx only PASATRU™ (garetosmab-grts) Injection 300 mg/5 mL (60 mg/mL) For Intravenous Infusion after Dilution ATTENTION: Dispense the enclosed Medication Guide to each patient. One 5 mL Single-Dose Vial. Discard unused portion. REGENERON PRINCIPAL DISPLAY PANEL

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

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← 61755-0010-01 · Regeneron 61755-0013-01 · Regeneron →
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