Author: Prof. Dr. med. Peter Altmeyer

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Last updated on: 29.10.2020

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Talidomida; Thalidomide

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Thalidomide (N-Phtalimidoglutarimide) is a glutamate derivative, which is present as a racemate in R- and S- enantiomers. The plasma protein binding is 55% and 65% respectively. More than 90% of the active ingredient absorbed from the gastrointestinal tract is excreted via urine and feces within 48 hours. The "first-pass" effect of the liver is minimal, as it is almost exclusively hydrolysed and passively excreted via the kidneys. The maximum concentration is 1-2 mg/l and is reached approximately 3-4 hours after administration.

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4,7–12,7 h

Pharmacodynamics (Effect)
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  • Sedative: activation of the central nervous sleep centre.
  • Probably antineoplastic: Increased response of renal cell carcinomas to IL-2 by reduction of CRP and IL-6.
  • Antiangiogenic: Decrease in the production of FGF-2 and VEGF, inhibition of angioneogenesis, via receptor inhibition of VEGFR by interference with interleukin-6 (Il-6), and by immunomodulation via control of cytotoxicity of NK and killer cells.
  • Immunomodulatory: Inhibition of the function of various inflammatory cells.
  • Reduction of cell proliferation.

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Dosage and method of use
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See Table 1.

Undesirable effects
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Teratogenicity, exanthema, pruritus, urticaria, constipation, fatigue, slowing of reaction, nausea, dizziness, headache. Prolonged use may cause sensory neuropathies of the upper extremities with a glove-like distribution pattern, with par- and hypaesthesias (immediate discontinuation of the preparation, regular neurological examinations!)

Notice! If pruritus, erythema or wheals occur under therapy, an attempt can first be made to suppress the symptoms with H1 antagonists!

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Enhanced effect of CNS-dampening substances such as sedatives, barbiturates, neuroleptics, tricyclic antidepressants and alcohol. Increase in the level of action and toxicity of acetaminophen.

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  • Pregnancy (phocomellia, damage to the inner and outer ear, atresia of the gastrointestinal tract, malformations of the heart and the large vessels already with a single administration of the preparation in early pregnancy), lactation, thalidomide hypersensitivity.
  • Also: Polyneuritis or polyneuropathy not induced by leprosy, e.g. caused by lead, heavy metals, alcohol abuse, vitamin deficiency, drugs, diabetes mellitus. No assured protection of the concept.
  • Toxic epidermal necrolysis.

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Thalidomide Celgene

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Remember! Thalidomide Celgene for use in Germany is only available from pharmacies that are registered for the Celgene S.T.E.P.S. program.

Cave! Women who are to be treated with thalidomide must have an effective anti-conception, using at least two methods. Here, the S.T.E.P.S. program prescribes a highly effective method combined with an effective method. Highly effective methods are intrauterine device [coil], tubal ligation, vasectomy of the partner, hormonal contraception with the "pill", hormone injection or hormone implant. Effective methods are latex condoms, diaphragm, cervical cap. In addition, anticonception must begin at least 4 weeks before thalidomide therapy. According to the S.T.E.P.S. programme, men who are to be treated with thalidomide must use latex condoms without exception during all sexual contact with women with childbirth potential. Highly effective anti-conception in the partner is also recommended, see also Apremilast, a thalidomide analogue.

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Attention and the ability to react are limited. The ability to actively participate in road traffic or to operate machinery is considerably impaired. Driving vehicles, operating machines or other dangerous activities should be avoided during the treatment!

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  1. Announcement of the German Federal Medical Association (2004) Dt Ärztebl: 101
  2. Chasset F et al (2018) Efficacy and tolerance profile of thalidomide in cutaneous lupus erythematosus:
    Asystematic review and meta-analysis. J Am Acad Dermatol 78:342-350.
  3. Dander CS et al (2004) Successful treatment of cutaneous langerhans cell histiocytosis with thalidomide. Dermatology 208: 149-152
  4. Du W, Hattori Y et al (2004)Tumor angiogenesisis in the bone marrow of multiple myeloma patients and its alteration by thalidomide treatment. Catholic Int 54: 285-294
  5. Kedar I et al (2004) Thalidomide reduces serum C-reactive protein and interleukin-6 and induces response to IL-2 in a fraction of metastatic renal cell cancer patients who feiled IL-2-based therapy. Int J Cancer 110: 260-265
  6. Nguyen YT et al (2004) Treatment of cutaneous sarcoidosis with thalidomide. J Am Acad Dermatol 50: 235-24
  7. Ständer S et al (2006) Diagnostic and therapeutic procedures in chronic pruritis. J Dtsch Dermatol Ges 4: 350-370
  8. Teo SK et al (2004) Clinical pharmacokinetics of thalidomide. Clin Pharmacokine 43: 311-27
  9. Wu JJ et al (2005) Thalidomide: dermatological indications, mechanisms of action and side effects. Br J Dermatol 153: 254-273

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Dosage for different indications



Erythema nodosum leprosum

100-400 mg/day p.o.

Maintenance dose 50-100 mg/day

Prurigo nodularis Hyde

200-400 mg/day p.o.

Actinic prurigo

100-300 mg/day p.o.

Chronic discoid lupus erythematosus

100-400 mg/day p.o.

Stomatitis aphthosa

100-400 mg/day p.o.

M. Behçet

200-400 mg/day p.o.

Graft-versus-Host disease

100-800 mg/day p.o.

Maintenance dose 100-200 mg/day

Nephrogenic Pruritus

100 mg/day p.o.

Post-zoster neuralgia

100-300 mg/day p.o.


Last updated on: 29.10.2020