Thalidomide

تالیدومید

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🎗️ 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

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🛡️ Safety & information

Contraindications

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

👥 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 …”

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