Garetosmab-grts

Para qué se usa Garetosmab-grts

Cita de la sección «Indications and Usage» (indicaciones y uso) de la etiqueta aprobada por la FDA. Se muestra en inglés, tal como la publica la FDA.

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).

— Etiqueta de la FDA: Pasatru, Regeneron Pharmaceuticals, Inc., vigente desde el 14 de agosto de 2026. Leer la etiqueta completa en DailyMed →

Etiqueta citada: la de la presentación más común (injection, solution, concentrate, intravenous), Pasatru, Regeneron Pharmaceuticals, Inc.; abarca 1 producto del directorio NDC de la FDA. Las citas sobre efectos secundarios, interacciones, dosis y embarazo de abajo vienen de esta misma etiqueta.

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Efectos secundarios de Garetosmab-grts

Cita de la sección «Adverse Reactions» (reacciones adversas) de la etiqueta aprobada por la FDA. Se muestra en inglés. Avise a su médico de cualquier efecto secundario que le preocupe.

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.

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(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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. 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.

— Etiqueta de la FDA: Pasatru, Regeneron Pharmaceuticals, Inc., vigente desde el 14 de agosto de 2026. Leer la etiqueta completa en DailyMed →

Dosis de Garetosmab-grts

Cita de la sección «Dosage and Administration» (dosis y administración) de la etiqueta aprobada por la FDA. Se muestra en inglés. Su dosis es la que le receta su médico: no la cambie por su cuenta.

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.

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(2.3) 2.1 Pregnancy 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)]. 2.2 Recommended 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. 2.3 Preparation 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.

— Etiqueta de la FDA: Pasatru, Regeneron Pharmaceuticals, Inc., vigente desde el 14 de agosto de 2026. Leer la etiqueta completa en DailyMed →

Garetosmab-grts en el embarazo

Cita de la parte sobre embarazo (Pregnancy) de la etiqueta aprobada por la FDA. Se muestra en inglés. Pregunte a su médico antes de tomar cualquier medicamento si está embarazada o planea estarlo.

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.

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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).

— Etiqueta de la FDA: Pasatru, Regeneron Pharmaceuticals, Inc., vigente desde el 14 de agosto de 2026. Leer la etiqueta completa en DailyMed →

Cuándo no se debe usar Garetosmab-grts

Cita de la sección «Contraindications» (contraindicaciones) de la etiqueta aprobada por la FDA. Se muestra en inglés.

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)

— Etiqueta de la FDA: Pasatru, Regeneron Pharmaceuticals, Inc., vigente desde el 14 de agosto de 2026. Leer la etiqueta completa en DailyMed →

Presentaciones y vía de administración

Empresas que tienen este medicamento

Empresas en el directorio NDC de la FDA: la empresa que aparece en el envase (fabricante o distribuidor), con su número de productos con receta.

• Regeneron Pharmaceuticals, Inc.1 producto

Historial de aprobación de la FDA

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Fuentes

1. Etiqueta aprobada por la FDA en DailyMed (Biblioteca Nacional de Medicina) — Pasatru, Regeneron Pharmaceuticals, Inc., vigente desde el 14 de agosto de 2026; vía openFDA, datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
2. NDC Directory (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
3. Drugs@FDA (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
4. Drug recall enforcement reports (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 27 de octubre de 2026, consultados el 31 de octubre de 2026
5. Drug shortages (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026

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