Monograph
L04AC07 - Tocilizumab |
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 tocilizumab 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
Antibody preparation with no CYP metabolism. Based on the pharmacokinetics, tocilizumab is not expected to have any porphyrinogenic effects.
Chemical description
Tocilizumab is a humanized monoclonal antibody against interleukin 6 receptor.
Therapeutic characteristics
Tocilizumab is used for the treatment of moderate to severe active rheumatoid arthritis in combination with methotrexate or as monotherapy. It is administered as an intravenous infusion.
Metabolism and pharmacokinetics
The metabolism of tocilizumab is expected to be similar as for endogenous antibodies, which are metabolised to peptides and amino acids in various body tissues and in plasma by circulating phagocytic cells or by their target antigen-containing cells.
Immunosuppressive treatment can reverse the down regulation of the expression of CYP enzymes (CYP 3A4, 1A2, 2C9 or 2C19) caused by inflammatory cytokines. This effect is not suspected to be porphyrinogenic as the CYP enzyme activity is not induced above a normal level.
References
# | Citation details | PMID |
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* | Scientific articles | |
1. | Keizer, R.J., Huitema, A.D.R., Clinical Pharmacokinetics of Therapeutic Monoclonal Antibodies.
Clin Pharmacokinet. 2010 Aug 1;49(8):493-507 |
20608753 |
* | Drug reference publications | |
2. | Sweetman SC, editor. Martindale: The complete drug reference. Tocilizumab. Pharmaceutical Press 2009.
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* | Summary of Product Characteristics | |
3. | Norwegian medicines agency. Summary of Product Characteristics (SPC). RoActemra.
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4. | The electronic Medicines Compendium (emc). Summary of Product Characteristics (SPC). RoActemra.
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Similar drugs
Tradenames and packages
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Netherlands
RoActemra · RoActemra 162 mg oplossing voor injectie in een voorgevulde spuit · RoActemra, 20 mg/ml concentraat voor oplossing voor infusie · Tofidence · Tofidence 20 mg/ml concentraat voor oplossing voor infusie · Tyenne · Tyenne 162 mg oplossing voor injectie in voorgevulde pen · Tyenne 162 mg oplossing voor injectie in voorgevulde spuit · Tyenne 20 mg/ml concentraat voor oplossing voor infusieBelgium
RoActemra · RoActemra 162 mg sol. inj. s.c. ser. préremplie · RoActemra 162 mg sol. inj. s.c. stylo prérempli · RoActemra 20 mg/ml sol. perf. (à diluer) i.v. flac. · Tofidence · Tofidence 20 mg/ml sol. perf. (à diluer) i.v. flac. · Tyenne · Tyenne 162 mg sol. inj. s.c. ser. préremplie · Tyenne 162 mg sol. inj. s.c. stylo prérempli · Tyenne 20 mg/ml sol. perf. (à diluer) i.v. flac.United Kingdom
RoActemra · RoActemra 162mg/0.9ml solution for injection pre-filled pens · RoActemra 162mg/0.9ml solution for injection pre-filled syringes · RoActemra 200mg/10ml concentrate for solution for infusion vials · RoActemra 400mg/20ml concentrate for solution for infusion vials · RoActemra 80mg/4ml concentrate for solution for infusion vials · Tyenne · Tyenne 162mg/0.9ml solution for injection pre-filled pens · Tyenne 162mg/0.9ml solution for injection pre-filled syringes · Tyenne 200mg/10ml concentrate for solution for infusion vials · Tyenne 400mg/20ml concentrate for solution for infusion vials · Tyenne 80mg/4ml concentrate for solution for infusion vialsDenmark
RoActemra · TyenneNorway
RoActemraPoland
RoActemra · Tofidence · TyenneLuxembourg
RoActemraIceland
RoActemra · Tofidence · TyenneFinland
RoActemra · Tofidence · TyenneLatvia
RoActemra · Tofidence · TyenneSerbia
Actemra · Actemra®
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