Cladribine (oral)
کلادریبین (خوراکی)
🎗️ Antineoplastic And Immunomodulating AgentsPurine analogue
Market / country: 🇺🇸 USA
Mavenclad (US)
🧮 Dose calculator
Multiple sclerosis (relapsing) · Regimen source: FDA Mavenclad · 2.2FDA Mavenclad · 2.5FDA Mavenclad · 2.6FDA Mavenclad · 2.4
🛡️ Safety & information
Contraindications
- ⛔ Current malignancy; pregnancy and people of reproductive potential without effective contraception (6 months women, 14 weeks men); HIV; active chronic infections (hepatitis, TB); hypersensitivity; breastfeeding on treatment days and for 10 days after. FDA Mavenclad · 4
Warnings
- • Boxed warning: malignancies and risk of teratogenicity. FDA Mavenclad · Boxed Warning
- • Lymphopenia; infections (zoster, TB); haematologic toxicity; GVHD with non-irradiated blood; liver injury; cardiac failure. FDA Mavenclad · 5
Formulations
- 10 mg tablet — tablet 🇺🇸 USA FDA Mavenclad · 3
👥 Special populations
- 🤰 PregnancyContraindicated
Label: contraindicated in pregnancy. FDA Mavenclad · 4
“MAVENCLAD is contraindicated: in patients with current malignancy [see Warnings and Precautions (5.1) ]. in pregnant women and in females and males of reproductive potential who do not plan to use effective contraception during MAVENCLAD dosing and for 6 months after the last dose in each treatment course for females, …”
- 🤱 BreastfeedingContraindicated
Label: contraindicated while breastfeeding. FDA Mavenclad · 4
“… atients with a history of hypersensitivity to cladribine [see Warnings and Precautions (5.8) ]. in females intending to breastfeed on a MAVENCLAD treatment day and for 10 days after the last dose [see Use in Specific Populations (8.2) ].”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Mavenclad · 8.4
“The safety and effectiveness in pediatric patients (below 18 years of age) have not been established.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Mavenclad · 8.5
“Caution is recommended when MAVENCLAD is used in elderly patients, taking into account the potential greater frequency of decreased hepatic, renal, or cardiac function, concomitant diseases, and other drug therapy.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Mavenclad · 8.3
“Contraception Females Females of reproductive potential should prevent pregnancy by use of effective contraception during MAVENCLAD dosing and for at least 6 months after the last dose in each treatment course.”
🔗 Reference links
- FDA (approval record)NDA022561
- DailyMed (FDA label)FDA Mavenclad
- MedlinePlus (NIH)CladribineCladribine Injection
- WHO ATC/DDDL04AA40
- Darooyab (Iran)Cladribine
🇮🇷 Registered in Iran Darooyab · G-971/Cladribine
Dosage forms with Iranian generic codes, per Darooyab.
- 00305 · CLADRIBINE 10MG/10ML VIAL · ویال کلادریبین ۱۰ میلیگرم / ۱۰ میلیلیتر
- 02377 · CLADRIBINE 10MG/5ML VIAL · ویال کلادریبین ۱۰ میلیگرم / ۵ میلیلیتر
- 52958 · CLADRIBINE 10 mg TABLET · قرص کلادریبین ۱۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Mavenclad · 3FDA Mavenclad · 2.2FDA Mavenclad · 2.5FDA Mavenclad · 2.6FDA Mavenclad · 2.4FDA Mavenclad · 4FDA Mavenclad · Boxed WarningFDA Mavenclad · 5FDA Mavenclad · SPL approval / marketing categoryFDA Mavenclad · 8.4FDA Mavenclad · 8.5FDA Mavenclad · 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-971/Cladribine
- Clinical review⚠ Unverified