Mycophenolate mofetil
مایکوفنولات موفتیل
🎗️ Antineoplastic And Immunomodulating AgentsImmunosuppressant (antimetabolite)
Market / country: 🇺🇸 USA
CellCept (US)
🧮 Dose calculator
Prevention of organ transplant rejection · Regimen source: FDA Mycophenolate · 2.2
- • With cyclosporine or tacrolimus and steroids. Graft GFR <25: no more than 1 g twice daily. ANC <1300: interrupt or reduce. FDA Mycophenolate · 2.5
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to mycophenolate mofetil or mycophenolic acid. FDA Mycophenolate · 4
Warnings
- • Boxed warning: first-trimester loss and congenital malformations (contraception required), lymphoma and skin malignancy, serious infections. FDA Mycophenolate · Boxed Warning
Formulations
- 250 mg capsule — capsule 🇺🇸 USA FDA Mycophenolate · 3
👥 Special populations
- 🤰 PregnancyDangerous / avoid
Label: can cause fetal harm. Dangerous in pregnancy. FDA Mycophenolate · Boxed Warning
“WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES and SERIOUS INFECTIONS See full prescribing information for complete boxed warning Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Mycophenolate · 8.2
“Risk Summary There are no data on the presence of mycophenolate in human milk, or the effects on milk production.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Mycophenolate · 8.4
“Safety and effectiveness have been established in pediatric patients 3 months and older for the prophylaxis of organ rejection of allogenic kidney, heart or liver transplants.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Mycophenolate · 8.5
“In general, dose selection for a geriatric patient should take into consideration the presence of decreased hepatic, renal or cardiac function and of concomitant drug therapies [see Adverse Reactions (6.1) , Drug Interactions (7) ].”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Mycophenolate · 8.3
“Contraception Female Patients Females of reproductive potential taking mycophenolate mofetil must receive contraceptive counseling and use acceptable contraception (see Table 9 for acceptable contraception methods).”
🔗 Reference links
- FDA (approval record)ANDA217828
- DailyMed (FDA label)FDA Mycophenolate
- MedlinePlus (NIH)MycophenolateMycophenolate Injection
- WHO ATC/DDDL04AA06
- Darooyab (Iran)Mycophenolate-Mofetil
🇮🇷 Registered in Iran Darooyab · G-2741/Mycophenolate-Mofetil
Dosage forms with Iranian generic codes, per Darooyab.
- 01755 · MYCOPHENOLATE MOFETIL 250MG CAP · کپسول مایکوفنولات موفتیل ۲۵۰ میلیگرم
- 01752 · MYCOPHENOLATE MOFETIL 250MG TAB · قرص مایکوفنولات موفتیل ۲۵۰ میلیگرم
- 01753 · MYCOPHENOLATE MOFETIL 500MG TAB · قرص مایکوفنولات موفتیل ۵۰۰ میلیگرم
- 11606 · MYCOPHENOLATE SODIUM 180MG TAB · قرص مایکوفنولات سدیم ۱۸۰ میلیگرم
- 11607 · MYCOPHENOLATE SODIUM 360MG TAB · قرص مایکوفنولات سدیم ۳۶۰ میلیگرم
- 50710 · MYCOPHENOLATE MOFETIL POWDER, FOR SUSPENSION ORAL 1 g/5mL 110 g · سوسپانسیون خوراکی مایکوفنولات موفتیل ۱ گرم / ۵ میلیلیتر ۱۱۰ گرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Mycophenolate · 3FDA Mycophenolate · 2.2FDA Mycophenolate · 2.5FDA Mycophenolate · 2.3FDA Mycophenolate · 2.4FDA Mycophenolate · 4FDA Mycophenolate · Boxed WarningFDA Mycophenolate · SPL approval / marketing categoryFDA Mycophenolate · 8.2FDA Mycophenolate · 8.4FDA Mycophenolate · 8.5FDA Mycophenolate · 8.3
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-2741/Mycophenolate-Mofetil
- Clinical review⚠ Unverified