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Lenalidomide

لنالیدومید

⚠ Unverified

🎗️ Antineoplastic And Immunomodulating AgentsImmunomodulatory drug (thalidomide analogue)

🤰 Pregnancy:Contraindicated 🤱 Breastfeeding:Dangerous / avoid 👶 Children:Use with caution 👴 Older adults:Use with caution ⚥ Females & males of reproductive potential:Use with caution 🇮🇷 Registered in Iran ⛔ 1 contraindications 🇺🇸 FDA approved (NDA) NDA021880 ATC L04AX04

Market / country: 🇺🇸 USA

Revlimid (US)

🧮 Dose calculator

Disease / regimen

Multiple myeloma · Regimen source: FDA Revlimid · 2.1

• Maintenance after auto-HSCT: 10 mg daily continuously. Do not open or chew. Only through the REMS programme. FDA Revlimid · 2.1 FDA Revlimid · 2.7 FDA Revlimid · 5.2
• Only under an oncologist; protocol, cycle interval and adjustment rest with the treating team. FDA Revlimid · 2

Formulation

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🛡️ Safety & information

Contraindications

⛔ Pregnancy; severe hypersensitivity to lenalidomide (angioedema, SJS, TEN). FDA Revlimid · 4

Warnings

• Boxed warning: embryo-fetal toxicity (two negative pregnancy tests and two contraceptive methods), haematologic toxicity (neutropenia, thrombocytopenia), venous and arterial thromboembolism. FDA Revlimid · Boxed Warning

Renal adjustment

• eGFR < 60: CrCl 30–60: 10 mg (maintenance/MDS: 5 mg); below 30: per Table 3. FDA Revlimid · 2.6, Table 3

Formulations

25 mg capsule — capsule 🇺🇸 USA FDA Revlimid · 3
10 mg capsule — capsule 🇺🇸 USA FDA Revlimid · 3
5 mg capsule — capsule 🇺🇸 USA FDA Revlimid · 3
15 mg capsule — capsule 🇺🇸 USA FDA Revlimid · 3
20 mg capsule — capsule 🇺🇸 USA FDA Revlimid · 3

👥 Special populations

🤰 PregnancyContraindicated
Label: contraindicated in pregnancy. FDA Revlimid · 4
“Due to the results of this developmental monkey study, and lenalidomide's structural similarities to thalidomide, a known human teratogen, lenalidomide is contraindicated in females who are pregnant [see Boxed Warning ].”
🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Revlimid · 8.2
“Because many drugs are excreted in human milk and because of the potential for adverse reactions in breastfed children from REVLIMID, advise women not to breastfeed during treatment with REVLIMID.”
👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Revlimid · 8.4
“Safety and effectiveness have not been established in pediatric patients.”
👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Revlimid · 8.5
“Since elderly patients are more likely to have decreased renal function, care should be taken in dose selection.”
⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Revlimid · 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)NDA021880
DailyMed (FDA label)FDA Revlimid
MedlinePlus (NIH)Lenalidomide
WHO ATC/DDDL04AX04
Darooyab (Iran)Lenalidomide

🇮🇷 Registered in Iran Darooyab · G-4686/Lenalidomide

Dosage forms with Iranian generic codes, per Darooyab.

18193 · LENALIDOMIDE 10 MG CAP. · کپسول لنالیدوماید ۱۰ میلی‌گرم .
12847 · LENALIDOMIDE 25MG CAP · کپسول لنالیدوماید ۲۵ میلی‌گرم
50392 · LENALIDOMIDE 15MG CAP · کپسول لنالیدوماید ۱۵ میلی‌گرم
51479 · LENALIDOMIDE 5MG CAP · کپسول لنالیدوماید ۵ میلی‌گرم

📚 Reference status for this drug

Shows which sources have references recorded for this drug and which do not.

FDA label (DailyMed)✅ Present
FDA Revlimid · 3 FDA Revlimid · 2.1 FDA Revlimid · 2.7 FDA Revlimid · 5.2 FDA Revlimid · 2 FDA Revlimid · 2.2 FDA Revlimid · 4 FDA Revlimid · Boxed Warning FDA Revlimid · 2.6, Table 3 FDA Revlimid · SPL approval / marketing category FDA Revlimid · 8.2 FDA Revlimid · 8.4 FDA Revlimid · 8.5 FDA Revlimid · 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)✅ Present
Darooyab · G-4686/Lenalidomide
Clinical review⚠ Unverified

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