Monograph
L04AX06 - Pomalidomide |
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, vomiting, diarrhea and constipation may potentially be porphyrinogenic through reduction in carbohydrate intake.
Side effects
Infections are common in patients using immunosuppressant drugs. 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 pomalidomide that can be confused with an acute porphyric attack are nausea, vomiting, diarrhea and constipation. These side effects may potentially be porphyrinogenic if leading to a decrease in carbohydrate intake.
Rationale
Pomalidomide is a substrate of CYP1A2 and CYP3A4, and it is not an inducer or a mechanism-based inhibitor of CYP enzymes. No pharmacokinetic porphyrinogenic effects are suspected.
Chemical description
Isoindolones. Pomalidomide is an analogue of thalidomide.
Therapeutic characteristics
Pomalidomide has immunomodulatory and antineoplastic effect and is used in combination with corticosteroid in the treatment of multiple myeloma. Pomalidomide is more potent than both thalidomide (100 times) and Lenalidomide (10 times) (SPC).
It is administered orally.
Metabolism and pharmacokinetics
In vitro studies show that pomalidomide is mainly metabolized by CYP1A2 and 3A4, with minor contributions from CYP2C19 and CYP2D6 (Hoffmann 2013, Scott 2014). It is excreted primarily as metabolites in the urine. In vitro studies indicate that pomalidomide is a substrate of P-glycoprotein, and that it is not an inducer or inhibitor of CYP-enzymes (Kassera 2015).
References
# | Citation details | PMID |
---|---|---|
* | Scientific articles | |
1. | Absorption, metabolism and excretion of [14C]pomalidomide in humans following oral administration.
Hoffmann M, Kasserra C, et al. Cancer Chemother Pharmacol. 2013 Feb;71(2):489-501 |
23203815 |
2. | Pomalidomide: Evaluation of cytochrome P450 and transporter-mediated drug-drug interaction potential in vitro and in healthy subjects.
Kasserra C, Assaf M, et al. J Clin Pharmacol. 2015 Feb;55(2):168-78 |
25159194 |
3. | J. Pomalidomide:
Scott L. a review of its use in patients with recurrent multiple myeloma. 2014 Apr;74(5):549-62. |
24590685 |
* | Summary of Product Characteristics | |
4. | The electronic Medicines Compendium (emc). Summary of Product Characteristics (SPC). (Imnovid).
|
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Imnovid · Imnovid 1 mg, harde capsules · Imnovid 2 mg, harde capsules · Imnovid 3 mg, harde capsules · Imnovid 4 mg, harde capsules · Polidma · Polidma 1 mg, harde capsules · Polidma 2 mg, harde capsules · Polidma 3 mg, harde capsules · Polidma 4 mg, harde capsules · Pomalidomide · Pomalidomide Accord 1 mg harde capsules · Pomalidomide Accord 2 mg harde capsules · Pomalidomide Accord 3 mg harde capsules · Pomalidomide Accord 4 mg harde capsules · Pomalidomide G.L. 1 mg harde capsules · Pomalidomide G.L. 2 mg harde capsules · Pomalidomide G.L. 3 mg harde capsules · Pomalidomide G.L. 4 mg harde capsules · Pomalidomide Genthon 1 mg, harde capsules · Pomalidomide Genthon 2 mg, harde capsules · Pomalidomide Genthon 3 mg, harde capsules · Pomalidomide Genthon 4 mg, harde capsules · Pomalidomide Glenmark 1 mg, harde capsules · Pomalidomide Glenmark 2 mg harde capsules · Pomalidomide Glenmark 3 mg harde capsules · Pomalidomide Glenmark 4 mg harde capsules · Pomalidomide Krka 1 mg harde capsules · Pomalidomide Krka 2 mg harde capsules · Pomalidomide Krka 3 mg harde capsules · Pomalidomide Krka 4 mg harde capsules · Pomalidomide Sandoz 1 mg, harde capsules · Pomalidomide Sandoz 2 mg, harde capsules · Pomalidomide Sandoz 3 mg, harde capsules · Pomalidomide Sandoz 4 mg, harde capsules · Pomalidomide Synthon 1 mg, harde capsules · Pomalidomide Synthon 2 mg, harde capsules · Pomalidomide Synthon 3 mg, harde capsules · Pomalidomide Synthon 4 mg, harde capsules · Pomalidomide Viatris 1 mg harde capsules · Pomalidomide Viatris 2 mg harde capsules · Pomalidomide Viatris 3 mg harde capsules · Pomalidomide Viatris 4 mg harde capsules · Pomalidomide Zentiva 1 mg harde capsules · Pomalidomide Zentiva 2 mg harde capsules · Pomalidomide Zentiva 3 mg harde capsules · Pomalidomide Zentiva 4 mg harde capsules · Sivolix · Sivolix 1 mg, harde capsules · Sivolix 2 mg, harde capsules · Sivolix 3 mg, harde capsules · Sivolix 4 mg, harde capsulesBelgium
Imnovid · Imnovid 1 mg gél. · Imnovid 2 mg gél. · Imnovid 3 mg gél. · Imnovid 4 mg gél. · Pomalidomide · Pomalidomide Accord 1 mg gél. · Pomalidomide Accord 2 mg gél. · Pomalidomide Accord 3 mg gél. · Pomalidomide Accord 4 mg gél. · Pomalidomide Krka 1 mg gél. · Pomalidomide Krka 2 mg gél. · Pomalidomide Krka 3 mg gél. · Pomalidomide Krka 4 mg gél. · Pomalidomide Teva 1 mg gél. · Pomalidomide Teva 2 mg gél. · Pomalidomide Teva 3 mg gél. · Pomalidomide Teva 4 mg gél. · Pomalidomide Viatris 1 mg gél. · Pomalidomide Viatris 2 mg gél. · Pomalidomide Viatris 3 mg gél. · Pomalidomide Viatris 4 mg gél. · Pomalidomide Zentiva 1 mg gél. · Pomalidomide Zentiva 2 mg gél. · Pomalidomide Zentiva 3 mg gél. · Pomalidomide Zentiva 4 mg gél.United Kingdom
Imnovid · Imnovid 1mg capsules · Imnovid 2mg capsules · Imnovid 3mg capsules · Imnovid 4mg capsules · Pomalidomide · Pomalidomide 1mg capsules · Pomalidomide 2mg capsules · Pomalidomide 3mg capsules · Pomalidomide 4mg capsulesDenmark
Imnovid · Pomalidomide · Pomalidomide "Glenmark" · Pomalidomide ViatrisNorway
Imnovid · Pomalidomide ViatrisPoland
Imnovid · Pomalidomide Accord · Pomalidomide Glenmark · Pomalidomide Krka · Pomalidomide PPH · Pomalidomide Viatris · Pomalidomide ZentivaLuxembourg
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Imnovid · Pomalidomide · Pomalidomide Accord · Pomalidomide Krka · Pomalidomide Viatris · Pomalidomide WH · Pomalidomide ZentivaFinland
Imnovid · Pomalidomid Avansor · Pomalidomide Accord · Pomalidomide Glenmark · Pomalidomide Grindeks · Pomalidomide Krka · Pomalidomide Sandoz · Pomalidomide Teva · Pomalidomide Viatris · Pomalidomide ZentivaLatvia
Imnovid · Pomalidomide · Pomalidomide Accord · Pomalidomide Grindeks · Pomalidomide Krka · Pomalidomide Sandoz · Pomalidomide Viatris · Pomalidomide ZentivaSerbia
Imnovid · Imnovid®
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