Micofenolato de mofetilo
Mycophenolate Mofetil
Mycophenolate mofetil (RS-61443)
También conocido como: CellCept · Cellmune · Imuxgen · Munotras · Mycept · Myfortic · Refrat · RS-61443 · MMF · Mycophenolic acid (active metabolite) · MPA
Revisado por el equipo veterinario de VetSheetActualizado 5 abr 2026Referencia veterinaria basada en la evidencia
Las dosis son una referencia clínica para profesionales veterinarios autorizados. Confirme siempre con el prospecto actual y cada paciente individual.
Dosis por especie
🌎 NA — North America🌍 EU — Europe
Perros
| Indicación | Dosis | Vía | Frecuencia | Duración | Región |
|---|---|---|---|---|---|
| Immune-mediated hemolytic anemia (IMHA) | 12-17 mg/kg PO once daily or divided twice daily | PO | q12-24h | — | 🌎 NA |
| IMHA, myasthenia gravis or glomerulonephritis | 12-17 mg/kg PO once daily or divided twice daily | PO | q12-24h | — | 🌎 NA |
| Immune-mediated hemolytic anemia (IMHA) | 400-600 mg/m2 orally twice daily | PO | q12h | — | 🌎 NA |
| Adjunctive treatment of glomerulonephritis | 10-20 mg/kg PO q12h | PO | q12h | 3-4 weeks trial | 🌎 NA |
| Pemphigus foliaceous | 22-39 mg/kg/day divided into 3 daily doses | PO | q8h | — | 🌎 NA |
| Pemphigus foliaceous | 20-40 mg/kg/day PO divided q8h | PO | q8h | — | 🌎 NA |
| Aplastic anemia | 10 mg/kg PO q12h | PO | q12h | — | 🌎 NA |
| Rescue agent for generalized myasthenia gravis | 500 mg (15-20 mg/kg) diluted and given IV over 2-4 hours | IV | q24h | 13 days | 🌎 NA |
- Immune-mediated hemolytic anemia (IMHA): Given with prednisolone (at 2 mg/kg q12-24h). Dogs also received ranitidine and sucralfate in the study.
- IMHA, myasthenia gravis or glomerulonephritis: Given with prednisone (at 2.2 mg/kg q12-24h).
- Immune-mediated hemolytic anemia (IMHA): Extrapolated from human medicine. Gastrointestinal side effects are common and dose limiting.
- Adjunctive treatment of glomerulonephritis: Trial of single drug therapy for 3-4 weeks recommended.
- Pemphigus foliaceous: Success rates of approx 50%; most dogs require glucocorticoids to control signs.
- Pemphigus foliaceous: Steroid-sparing only.
- Aplastic anemia: First effects observed 2 weeks later; complete remission in approx 3 weeks.
- Rescue agent for generalized myasthenia gravis: Given daily IV until swallowing oral meds, then switched to 10-11 mg/kg PO q12h.
Gatos
| Indicación | Dosis | Vía | Frecuencia | Duración | Región |
|---|---|---|---|---|---|
| IMHA | 10 mg/kg PO q12h | PO | q12h | — | 🌎 NA |
- IMHA: Use with caution due to feline glucuronidation deficiency.
Las dosis son una referencia clínica para profesionales veterinarios autorizados. Confirme siempre con el prospecto actual y cada paciente individual.
Resumen
El micofenolato de mofetilo (MMF) es un potente fármaco inmunosupresor utilizado cada vez más en medicina veterinaria como agente ahorrador de esteroides o terapia de rescate para enfermedades inmunomediadas graves y refractarias.
Las aplicaciones clínicas clave incluyen:
- Anemia hemolítica inmunomediada (AHIM)
- Glomerulonefritis
- Miastenia gravis
- Pénfigo foliáceo
- Protocolos de rechazo en trasplantes de órganos
Aunque se ha sugerido para la enfermedad inflamatoria intestinal (EII), su uso es complejo debido a que los efectos adversos primarios del fármaco en perros son gastrointestinales (gastritis, diarrea e inflamación intestinal). Perla clínica: El MMF a menudo se prefiere sobre la azatioprina en algunos casos críticos debido a su inicio de acción relativamente rápido, pero su alto costo y los efectos secundarios gastrointestinales graves pueden ser factores limitantes. La experiencia en gatos es muy limitada y debe usarse con extrema precaución debido a las deficiencias felinas en las vías de glucuronidación.
Mecanismo de acción
Mycophenolate mofetil (MMF) is a prodrug that is rapidly hydrolyzed in vivo to its active form, mycophenolic acid (MPA).
- MPA non-competitively and reversibly inhibits inosine monophosphate dehydrogenase (IMPDH).
- IMPDH is the rate-limiting enzyme in the de novo synthesis of guanosine nucleotides.
- Because T-lymphocytes and B-lymphocytes are highly dependent on this de novo purine synthesis pathway (and lack the purine salvage pathways utilized by other cell types), MPA selectively inhibits their proliferative responses.
- This leads to → suppression of B-cell antibody formation and → inhibition of leukocyte recruitment to inflammatory sites and allotransplant tissues.
Seguridad y advertencias
Contraindicaciones
- Documented hypersensitivity to mycophenolate
- Pregnancy (teratogenic effects noted in animal models)
- Caution in patients with severe renal dysfunction (dosage adjustment may be required)
- Caution in cats (deficient in glucuronidation metabolism)
- Pre-existing bone marrow suppression
- Pre-existing infections
Efectos adversos
- Diarrhea (can be severe)
- Vomiting
- Anorexia
- Lethargy / reduced activity
- Weight loss
- Lymphopenia
- Increased rates of dermal infections
- Increased susceptibility to systemic infections
- Potential increased risk of malignancy/lymphoma
- Bone marrow suppression
- Nausea
- Diarrhoea
- Increased incidence of infections (e.g., pyoderma, Malassezia)
- Increased risk of lymphoma (reported in humans)
- Headache (reported in humans)
- Hypertension (reported in humans)
- Peripheral oedema (reported in humans)
- Confusion (reported in humans)
- Coughs (reported in humans)
- Tremors (reported in humans)
Precauciones
Black Box Warning: In humans, mycophenolate carries a warning regarding a potential increased risk for lymphoma and susceptibility to infections associated with its use.
- Intravenous Administration: Must be administered over at least two hours. Do NOT give as an IV bolus or via rapid IV infusion.
- Feline Patients: The active metabolite (MPA) is primarily excreted as a glucuronide metabolite. Cats are deficient in this metabolic process; use with extreme caution.
- Pregnancy: Teratogenic (increased resorptions and malformations). Avoid use during pregnancy.
- Handling: Due to teratogenic risks, tablets or capsules should not be crushed, split, or opened. Personnel and owners should wear gloves when handling.
Interacciones farmacológicas
Increased serum concentrations of acyclovir and the phenolic glucuronide of mycophenolic acid
Decreased absorption of mycophenolate; separate dosing by at least 2 hours
Potentially increased concentrations of free mycophenolic acid
Increased risk for bone marrow suppression; use together not recommended in humans
Decreased absorption of mycophenolate; separate dosing by at least 2 hours
Potentially increased serum levels of mycophenolic acid and the phenolic glucuronide of mycophenolic acid
May be less effective; avoid use
Competes for secretion, resulting in increased concentrations of either drug
Concomitant administration may decrease the absorption of mycophenolate
Monitorización
- Clinical efficacy (resolution of immune-mediated disease signs)
- Complete Blood Count (CBC) for bone marrow suppression
- Renal and hepatic function panels
- Serum electrolytes
- Gastrointestinal effects (monitor weight, appetite, and client reports of vomiting/diarrhea)
- Complete Blood Count (CBC) to monitor for bone marrow suppression
- Gastrointestinal signs (nausea, vomiting, diarrhea)
- Signs of secondary infections (e.g., skin lesions, lethargy, fever)
Farmacocinética
Vida media
Absorción
Absorbed orally but with wide inter-patient and inter-dose variation. Bioavailability in dogs ranges from 54-87%. In humans, oral bioavailability averages 94%, but food reduces peak levels of MPA by up to 40%.
Distribución
Volume of distribution at steady-state in dogs is approximately 5 L/kg, with wide inter-patient variability (±4.5).
Metabolismo
Rapidly hydrolyzed in vivo to the active form, mycophenolic acid (MPA). MPA is primarily metabolized via glucuronidation (cats are deficient in this pathway).
Eliminación
Primarily excreted in the urine, both unchanged (approx. 5%) and as the glucuronide metabolite (approx. 90%).
Sobredosis
In oral acute studies performed in mice and monkeys, no deaths occurred in dosages up to 4,000 mg/kg and 1,000 mg/kg, respectively. In small animals, acute gastrointestinal disturbances (severe vomiting, diarrhea) could be expected. Treatment should be symptomatic and supportive.
Productos disponibles
Formulaciones
- Oral capsules
- Oral tablets
- Lyophilized powder for injection
- 250 mg capsule
- 500 mg tablet
- 1 g/5 ml powder for oral suspension
- 180 mg tablet
- 360 mg tablet
- 500 mg powder for reconstitution and slow i.v. infusion
Etiquetado para humanos
- Mycophenolate Mofetil Oral Capsules: 250 mg (CellCept®)
- Mycophenolate Mofetil Oral Tablets: 500 mg (CellCept®)
- Mycophenolate Mofetil Powder for Oral Suspension: 200 mg/mL (reconstituted) (CellCept®)
- Mycophenolate Mofetil Lyophilized Powder for Injection: 500 mg in 20 mL vials (CellCept®)
- CellCept (250 mg capsule, 500 mg tablet, 1 g/5 ml oral suspension)
- Myfortic (180 mg, 360 mg tablets)
- 500 mg powder for injection
Estado regulador
Human-approved product used off-label in veterinary medicine under the cascade. POM status.
Human-approved product used off-label in veterinary medicine under the cascade. POM status.
Sin datos reguladores para: 🇺🇸 US · 🇭🇰 HK · 🇹🇼 TW · 🇯🇵 JP · 🇰🇷 KR · 🇦🇺 AU
Almacenamiento y estabilidad
Tablets and capsules: Store between 15-30°C and protect from light. Oral suspension: Store powder between 15-30°C. Once reconstituted, store at room temperature or refrigerate (do not freeze); discard unused portion after 60 days. Injectable: Store between 15-30°C. Reconstitute with 5% dextrose. Do not mix with other medications. Administer within 6 hours of dilution.
Información para el cliente
- Administración: Preferiblemente administrar con el estómago vacío. Sin embargo, si se presentan vómitos o falta de apetito, puede administrarlo con comida para ver si mejora la tolerancia.
- Precauciones de manipulación: Debido a que este fármaco puede causar defectos congénitos, no triture, parta ni abra las cápsulas/tabletas. Las mujeres embarazadas deben evitar manipular este medicamento. Lávese bien las manos después de la administración.
- Efectos secundarios: El malestar gastrointestinal es el efecto secundario más común. Comuníquese con su veterinario de inmediato si la diarrea persiste, se vuelve grave o si su mascota deja de comer.
- Riesgo de infección: Este medicamento suprime el sistema inmunológico. Mantenga a su mascota alejada de animales enfermos y notifique a su veterinario si nota signos de infección (letargo, fiebre, nuevas lesiones cutáneas).
La referencia de medicamentos de VetSheet está destinada a profesionales veterinarios autorizados como ayuda para la toma de decisiones clínicas, no como sustituto del criterio profesional ni del prospecto actual del fabricante.