Monograph
M05BC01 - Dibotermin Alfa |
Not porphyrinogenic |
NP |
Rationale
Dibotermin alfa is not metabolized by CYP. The osteoinductive protein is exclusively locally active. In patients subjected to pre-drilling of the bone marrow canal prior to nailing, the frequency of possibly porphyrogenic infection is increased and may motivate attention.
There are no other physiological effects of relevance to acute porphyria.
Chemical description
Osteoinductive protein
Therapeutic characteristics
Dibotermin alfa is indicated for spinal fusion operation L4-S1 and open tibia reposition and marrow nailing via pre-drilled canal. It is administered as an injection in connection with marrow nailing or nailing through a predrilled canal.
Hepatic exposure
Insignificant.
Metabolism and pharmacokinetics
Dibotemin alfa is not recovered in the systemic circulation. Preclinical data suggest that any dibotermin alfa escaping the implant to circulation would be rapidly degraded in the same manner as other endogenous proteins. It is not metabolized by cytochrome P450 enzymes.
References
| # | Citation details | PMID |
|---|---|---|
| * | Drug reference publications | |
| 1. | Sweetman SC, editor. Martindale: The complete drug reference. Dibotermin alfa. Pharmaceutical Press 2009.
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| * | Government bodies | |
| 2. | European Public Assessment Report, InducOs (Scientific discussion).European Medicines Agency (EMEA). Accessible from: emea.europa.eu
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| * | Summary of Product Characteristics | |
| 3. | The electronic Medicines Compendium (emc). Summary of Product Characteristics (SPC). InducOs.
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