Thalidomide
تالیدومید
🎗️ Antineoplastic And Immunomodulating AgentsImmunomodulatory agent
Market / country: 🇺🇸 USA
Thalomid (US)
🧮 Dose calculator
Multiple myeloma · Regimen source: FDA Thalomid · 2.2
- • Only under an oncologist; continue until progression or unacceptable toxicity. Dose adjustments for toxicity and interactions per label. FDA Thalomid · 2.2
- • Cutaneous erythema nodosum leprosum: 100–300 mg/day (severe up to 400). Only through REMS; pregnancy testing before and during treatment. FDA Thalomid · 2.3FDA Thalomid · 2.1
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Pregnancy. FDA Thalomid · 4.1
- ⛔ Hypersensitivity to thalidomide or its components. FDA Thalomid · 4.2
Warnings
- • Boxed warning: severe embryo-fetal toxicity (birth defects, fetal death) — even a single dose; venous and arterial thromboembolism (prophylaxis in myeloma). FDA Thalomid · Boxed Warning
- • Somnolence; peripheral neuropathy; dizziness and orthostatic hypotension; neutropenia; bradycardia; severe skin reactions; seizures. FDA Thalomid · 5
Formulations
- 50 mg capsule — capsule 🇺🇸 USA FDA Thalomid · 3
- 100 mg capsule — capsule 🇺🇸 USA FDA Thalomid · 3
- 150 mg capsule — capsule 🇺🇸 USA FDA Thalomid · 3
- 200 mg capsule — capsule 🇺🇸 USA FDA Thalomid · 3
👥 Special populations
- 🤰 PregnancyContraindicated
Label: contraindicated in pregnancy. FDA Thalomid · 4
“• Pregnancy ( Boxed Warning , 4.1 , 5.1 , 5.2 , 8.1 , 17 ) • Demonstrated hypersensitivity to the drug or its components ( 4.2 , 5.16 , 6.2 ) 4.1 Pregnancy THALOMID is contraindicated in females who are pregnant.”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Thalomid · 8.2
“Because many drugs are excreted in human milk and because of the potential for adverse reactions in a breastfed child from THALOMID, advise women not to breastfeed during treatment with THALOMID.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Thalomid · 8.4
“Safety and effectiveness in pediatric patients below the age of 12 years 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 Thalomid · 8.5
“One hundred and seventy-six (52%) of 336 patients treated with THALOMID in combination with dexamethasone were ≥65 of age while 50 (15%) were ≥75.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Thalomid · 8.3
“Contraception Females Females of reproductive potential must commit either to abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously: one highly effective form of contraception – tubal ligation, IUD, hormonal (birth control pills, injections, hormonal …”
🔗 Reference links
- FDA (approval record)NDA020785
- DailyMed (FDA label)FDA Thalomid
- MedlinePlus (NIH)Thalidomide
- WHO ATC/DDDL04AX02
- Darooyab (Iran)Thalidomide
🇮🇷 Registered in Iran Darooyab · G-4285/Thalidomide
Dosage forms with Iranian generic codes, per Darooyab.
- 21850 · THALIDOMIDE 100MG CAP · کپسول تالیدوماید ۱۰۰ میلیگرم
- 04339 · THALIDOMIDE 100MG TAB · قرص تالیدوماید ۱۰۰ میلیگرم
- 51822 · THALIDOMIDE 50MG CAP · کپسول تالیدوماید ۵۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Thalomid · 3FDA Thalomid · 2.2FDA Thalomid · 2.3FDA Thalomid · 2.1FDA Thalomid · 4.1FDA Thalomid · 4.2FDA Thalomid · Boxed WarningFDA Thalomid · 5FDA Thalomid · SPL approval / marketing categoryFDA Thalomid · 4FDA Thalomid · 8.2FDA Thalomid · 8.4FDA Thalomid · 8.5FDA Thalomid · 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-4285/Thalidomide
- Clinical review⚠ Unverified