Thalidomide

• 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.

• Approved by the EMA and in Germany for the treatment of multiple myeloma and erythema nodosum leprosum
• In the USA: Erythema nodosum leprosum; leprosy reaction in leprosy lepromatosa, mainly cutaneous and neuritic manifestations.
• In Australia: multiple myeloma, erythema nodosum leprosum; leprosy reaction in leprosy lepromatosa, especially cutaneous and neuritic manifestations.
• Further indications: see table 1.
• Off-label use indications (according to studies):
• Very effective:
  • Stomatitis aphthosa
  • Behcet, M.
  • Lupus erythematosus, systemic
  • Severe therapy resistant cutaneous lupus erythematosus (Chasset et al. 2018)
  • Prurigo nodularis.
• Moderately effective:
  • Prurigo, actinic
  • Pruritus, renal
  • Langerhans cell histiocytosis
  • Sarcoidosis
  • Erythema exsudativum multiforme
  • Graft-versus-Host Disease, chronic
  • Lymphocytic infiltration of the skin.
• Possibly effective:
  • Kaposi's Sarcoma
  • lichen planus
  • Melanoma, malignant
  • Pyoderma gangraenosum.

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

• 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.

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.

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

Dosage for different indications