Monograph
L04AA06 - Mycophenolic Acid |
Propably not porphyrinogenic |
PNP |
Important Information
Patients on immunosuppressive therapy have an increased risk of infections. Since infections have a potential to trigger acute porphyric attacks vigilance is motivated regarding signs or symptoms of infection and/or possible symptoms of a porphyric attack. Side effects like nausea and vomiting may potentially be porphyrinogenic through reduction in carbohydrate intake.
Side effects
Infections are common in patients using immunosuppressants and since infections might trigger an acute porphyric attack, vigilance regarding signs and symptoms of an infection and/ or a porphyric attack is recommended. Common adverse reactions of mycophenolic acid that can be confused with an acute porphyric attack are nausea and vomiting. These side effects may potentially be porphyrinogenic if leading to a decrease in carbohydrate intake.
Rationale
Mycophenolic acid is not metabolized by cytochrome P450 enzymes. No pharmacokinetic porphyrinogenic effects are suspected.
Chemical description
Mycophenolic acid (or mycophenolate), derived from Penicillium stoloniferuma, is a reversible inhibitor of inosine monophosphate dehydrogenase and thus inhibits purine synthesis. The most commonly used form of the drug is mycophenolate mofetil, the 2-morpholinoethyl ester of mycophenolic acid.
Therapeutic characteristics
Mycophenolic acid is an immunosuppressant used for the prevention of graft rejection, and has also been tried in diseases with an auto-immune or immune-mediated inflammatory component. It is administered orally or as an intravenous infusion.
Metabolism and pharmacokinetics
Mycophenolate undergoes presystemic metabolism to active mycophenolic acid (MPA). MPA undergoes enterohepatic recirculation and secondary increases in plasma MPA concentrations are seen. MPA is metabolised by glucuronidation to the inactive mycophenolic acid glucuronide.
Published experience
Mycophenolate was used uneventfully after kidney transplants in two female AIP patients (Barone, 2001; Warholm, 2003), one 49 year old male AIP patient (El-Haggan, 2002) and one female HCP patient (Telkes 2013).
IPNet drug reports
Uneventful use reported in 4 patients with acute porphyria.
References
# | Citation details | PMID |
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* | Scientific articles | |
1. | The tolerability of newer immunosuppressive medications in a patient with acute intermittent porphyria.
Barone GW, Gurley BJ et al. J Clin Pharmacol. 2001;41(1):113-5. |
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2. | Sirolimus tolerability in a kidney transplant recipient with acute intermittent porphyria.
El-Haggan W, Lobbedez T, et al. Nephrol Dial Transplant. 2002;17(6):1147. |
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3. | Kidney transplantation in hereditary coproporphyria using tacrolimus and mycophenolate mofetil: a case report.
Telkes G, Pusztai A et al. Transplant Proc. 2013;45(10):3703-4. |
24315002 |
4. | Renal transplantation in a case of acute intermittent porphyria.
Warholm C, Wilczek H. J Clin Pharmacol. 2003;43(10):1158-60. |
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* | Drug reference publications | |
5. | McEvoy GK, editor. Mycophenolate. The AHFS Drug Information 2008. Bethesda, MD: American Society of Health-System Pharmacists; 2009. Electronic version (23.08.10).
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6. | Sweetman SC, editor. Martindale: The complete drug reference. Mycophenolic acid. Pharmaceutical Press 2009.
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* | Summary of Product Characteristics | |
7. | The electronic Medicines Compendium (emc). Summary of Product Characteristics (SPC). CellCept.
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Netherlands
CellCept · CellCept 1 g/5 ml, poeder voor orale suspensie · Cellcept 500 mg poeder voor concentraat voor oplossing voor infusie · CellCept capsules, capsule 250 mg · CellCept tabletten, tabletten 500 mg · Mofetil mycophenolate · Mofetil mycophenolate Teva · Myclausen · Myclausen 250 mg, capsule, hard · Myclausen 500 mg, filmomhulde tabletten · Mycofenolaat Mofetil · Mycofenolaat Mofetil Accord 250 mg capsules · Mycofenolaat Mofetil Accord 500 mg filmomhulde tabletten · Mycofenolaat mofetil Mylan 500 mg, filmomhulde tabletten · Mycofenolaat mofetil Sandoz 250 mg, capsules, hard · Mycofenolaat mofetil Sandoz 500 mg, filmomhulde tabletten · Mycofenolaatmofetil · Mycofenolaatmofetil Accord 500 mg poeder voor concentraat voor oplossing voor infusie · Mycofenolaatmofetil Auro 500 mg, filmomhulde tabletten · Mycofenolaatmofetil Aurobindo 250 mg, harde capsules · Mycofenolaatmofetil Aurobindo 500 mg, filmomhulde tabletten · Mycofenolzuur · Mycofenolzuur Accord 180 mg, maagsapresistente tabletten · Mycofenolzuur Accord 360 mg, maagsapresistente tabletten · Myfenax · Myfenax 250 mg capsules · Myfenax 500 mg filmomhulde tabletten · Myfortic · Myfortic 180 mg, maagsapresistente tablet · Myfortic 360 mg, maagsapresistente tabletBelgium
Cellcept · Cellcept 1 g/5 ml susp. buv. (pdr.) · Cellcept 250 mg gél. · Cellcept 500 mg compr. pellic. · Cellcept 500 mg sol. perf. (pdr., à diluer) i.v. flac. · Myclausen · Myclausen 250 mg gél. · Myclausen 500 mg compr. pellic. · Mycophenolat Mofetil · Mycophenolat Mofetil Sandoz 250 mg gél. · Mycophenolat Mofetil Sandoz 500 mg compr. pellic. · Mycophenolate Mofetil · Mycophenolate Mofetil Teva 250 mg gél. · Mycophenolate Mofetil Teva 500 mg compr. pellic. · Myfenax · Myfenax 250 mg gél. · Myfenax 500 mg compr. pellic. · Myfortic · Myfortic 180 mg compr. gastro-résist. · Myfortic 360 mg compr. gastro-résist.United Kingdom
Arzip · Arzip 250mg capsules · Arzip 500mg tablets · CellCept · CellCept 1g/5ml oral suspension · CellCept 250mg capsules · CellCept 500mg powder for solution for infusion vials · CellCept 500mg tablets · Ceptava · Ceptava 180mg gastro-resistant tablets · Ceptava 360mg gastro-resistant tablets · Mycophenolate mofetil · Mycophenolate mofetil 0.1% in White soft paraffin · Mycophenolate mofetil 100mg/5ml oral suspension · Mycophenolate mofetil 125mg/5ml oral suspension · Mycophenolate mofetil 1g/5ml oral suspension sugar free · Mycophenolate mofetil 250mg capsules · Mycophenolate mofetil 250mg/5ml oral suspension · Mycophenolate mofetil 300mg/5ml oral suspension · Mycophenolate mofetil 500mg powder for concentrate for solution for infusion vials · Mycophenolate mofetil 500mg tablets · Mycophenolate mofetil 500mg/5ml oral suspension · Mycophenolic acid · Mycophenolic acid 180mg gastro-resistant tablets · Mycophenolic acid 360mg gastro-resistant tablets · Myfenax · Myfenax 250mg capsules · Myfenax 500mg tablets · Myfortic · Myfortic 180mg gastro-resistant tablets · Myfortic 360mg gastro-resistant tabletsDenmark
Cellcept · Myastad · Myclausen · Mycophenolate mofetil · Mycophenolate mofetil "Hexal" · Mycophenolate mofetil "TEVA" · Mycophenolate mofetil TEVA · Mycophenolatemofetil · Mycophenolatemofetil "Sandoz" · Mycophenolatmofetil · Mycophenolatmofetil "Accord" · Mycophenolatmofetil "Nordic Prime" · Mycophenolatmofetil "Orifarm" · Mycophenolsyre · Mycophenolsyre "Accord" · Myfenax · MyforticNorway
CellCept · Mycophenolatemofetil Accord · Myfenax · Myfortic · Mykofenolat Accord · Mykofenolatmofetil Accord · Mykofenolsyre AccordPoland
CellCept · Marelim · Myclausen · Mycofit · Mycophenolate mofetil Sandoz 250 mg kapsulki twarde · Mycophenolate mofetil Sandoz 500 mg tabletki powlekane · Mycophenolate mofetil Teva · Myfenax · Myfortic · Mykofenolan mofetylu AccordLuxembourg
CELLCEPT · Myclausen · MYCOPHENOLATE MOFETIL · MYCOPHENOLATE MOFETIL-TEVA · Myfenax · MYFORTIC · MYFORTIC-180 · MYFORTIC-360Iceland
Cellcept · Myclausen · Mycofenolsýra · Mycofenolsýra Accord · Mycophenolate mofetil · Mycophenolate mofetil Sandoz · Mycophenolate mofetil Teva · Mycophenolatmofetil · Mycophenolatmofetil Stada · Myfenax · Myfortic · Mykofenolatmofetil · Mykofenolatmofetil ActavisFinland
Cellcept · Myastad · Myclausen · Mycophenolate Mofetil Accord · Mycophenolate mofetil Hexal · Mycophenolate Mofetil Sandoz · Mycophenolate Mofetil Teva · Myfenax · MyforticLatvia
CellCept · Myclausen · Mycophenolate Mofetil · Mycophenolate Mofetil Accord · Mycophenolate mofetil Teva · Myfenax · MyforticSerbia
Cellcept · Cellcept® · Mycophenolat Mofetil · Mycophenolat Mofetil Accord · Myfortic · Myfortic®
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