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DGI-050 Off-Label Uses of Mycophenolate Mofetil
  1. MC Izquierdo Navarro1,
  2. V Martinez Santana1,
  3. C Matallana Martin1,
  4. MT Sánchez Sánchez1
  1. Hospital Clínico Universitario, Pharmacy Department, Valladolid, Spain

Abstract

Background The implementing Law 1015/2009 normalises the compassionate use of investigational drugs, access to off-label and unauthorised drugs in Spain.

Mycophenolate mofetil/Mycophenolic Acid (MM/MA) have been used in off-label conditions to treat kidney diseases.1–5

Purpose To describe the dose and effectiveness of MM/MA in the treatment of nephritis.

Materials and Methods Observational, cross-sectional study including all patients diagnosed with nephritis treated with MM/MA in off-label conditions during July 2012.

Diagnosis and dose were recorded. Serum creatinine and the value of urinary proteins were collected at the beginning of the treatment and during the month of the study.

Results 22 patients were included, 14 were treated with MA and 8 with MM.

Of the patients treated with MA, 50% asked to be treated for nephritis, 28.6% for lupus and 21.4% for polyarteritis nodosa. (Both the lupus and the polyarteritis nodosa were giving clinical kidney symptoms.)

The usual dosage was every 12 hours (12/14), the most used dose being 360 mg (10/14).

The mean serum creatinine at the beginning of treatment was 1.14 mg/dl (SD .4) and decreased to 0.95 mg/dl (SD 0.3) at the end of the study. The urinary proteins value decreased from 35.4 (SD 7.3) at the beginning of treatment to 26.2 (SD 3.2) at the end of the study.

Of the patients treated with MM 62.5% requested treatment of nephritis and 37.5% of lupus. (The usual dosage was every 12 hours (7/8), the most used dose being 500 mg (3/8), 400 mg (2/8),1500 mg, 1000 mg and 250 mg (1/8).

The mean serum creatinine at the beginning of treatment was 1.35 mg/dl (SD 0.6) and decreased to 1.13 mg/dl (SD 0.5) at the end of the study. The urinary proteins value decreased from 30.11 (SD 8.2) at the beginning of treatment to 22.12 (SD 5.1) at the end of the study.

Conclusions Long-term monitoring (almost 6 months) of serum creatinine and urinary proteins is required, as in previous studies conducted, to evaluate the effectiveness of treatment.

References

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  2. Chan T-M, Tse K-C, Tang CS-O, Mok M-Y, Li F-K. Long-Term Study of Mycophenolate Mofetil as Continuous Induction and Maintenance Treatment for Diffuse Proliferative Lupus Nephritis. JASN. 2005 ene 4;16(4):1076–84.

  3. Sahin GM, Sahin S, Kantarci G, Ergin H. Mycophenolate mofetil treatment for therapy-resistant glomerulopathies. Nephrology. 2007 mar 16;12(3):285–8.

  4. Appel GB, Contreras G, Dooley MA, Ginzler EM, Isenberg D, Jayne D, et al, Mycophenolate Mofetil Versus Cyclophosphamide for Induction Treatment of Lupus Nephritis. JASN. 2009 ene 5;20(5):1103–12.

  5. Therapy of diffuse or focal proliferative lupus nephritis [Internet]. [citado 2012 nov 11]. Available a partir de: http://www.uptodate.com/contents/therapy-of-diffuse-or-focal-proliferative-lupus-nephritis?source=search_result&search=1.%09Ronald+J+Falk+ et+al.+Therapy+of+diffuse+or+focal+proliferative+lupus+nephritis.+Up+to+Date%2C+2011&selectedTitle=1%7E150

No conflict of interest.

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