v3 · current
C. Laurent (Regulatory Affairs Lead) · 08 Apr 2024 · 5f4f4ce97b0f…
Added Latin name for St. John's Wort; extended contraceptive washout period per PSUR 1
Effect of other medicinal products on Veraxanib Veraxanib is primarily metabolised by CYP3A4. Concomitant use of strong CYP3A4 inducers (e.g. rifampicin, phenytoin, carbamazepine, St. John's Wort [Hypericum perforatum]) is contraindicated as they significantly decrease veraxanib exposure (see section 4.3). Caution is advised with moderate CYP3A4 inducers; close monitoring for reduced efficacy is recommended. Concomitant use of strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, clarithromycin) may increase veraxanib exposure. Use with caution and consider dose reduction if toxicity occurs. Effect of Veraxanib on other medicinal products In vitro data suggest veraxanib is a weak inhibitor of CYP2D6. Caution should be exercised when co-administering medicinal products that are CYP2D6 substrates with a narrow therapeutic index (e.g. certain antidepressants, antipsychotics). Veraxanib may reduce the efficacy of oral hormonal contraceptives. Non-hormonal or additional contraceptive measures should be used concurrently and for at least one month after stopping Veraxanib (see section 4.6).
v2
Dr. S. Patel (CMC Regulatory) · 12 Sept 2023 · d16a75f841db…
Added St. John's Wort to CYP3A4 inducers; added contraceptive interaction per Day 150 pharmacology update
Effect of other medicinal products on Veraxanib Veraxanib is primarily metabolised by CYP3A4. Concomitant use of strong CYP3A4 inducers (e.g. rifampicin, phenytoin, carbamazepine, St. John's Wort) is contraindicated as they significantly decrease veraxanib exposure (see section 4.3). Caution is advised with moderate CYP3A4 inducers; close monitoring for reduced efficacy is recommended. Concomitant use of strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, clarithromycin) may increase veraxanib exposure. Use with caution and consider dose reduction if toxicity occurs. Effect of Veraxanib on other medicinal products In vitro data suggest veraxanib is a weak inhibitor of CYP2D6. Caution should be exercised when co-administering medicinal products that are CYP2D6 substrates with a narrow therapeutic index (e.g. certain antidepressants, antipsychotics). Veraxanib may reduce the efficacy of oral hormonal contraceptives. Non-hormonal or additional contraceptive measures should be used (see section 4.6).
v1
Dr. A. Müller (MAH Medical Affairs) · 15 Mar 2023 · 22dbd91ea752…
Initial submission
Effect of other medicinal products on Veraxanib Veraxanib is primarily metabolised by CYP3A4. Concomitant use of strong CYP3A4 inducers (e.g. rifampicin, phenytoin, carbamazepine) is contraindicated as they significantly decrease veraxanib exposure (see section 4.3). Caution is advised with moderate CYP3A4 inducers. Concomitant use of strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, clarithromycin) may increase veraxanib exposure. Use with caution and consider dose reduction if toxicity occurs. Effect of Veraxanib on other medicinal products In vitro data suggest veraxanib is a weak inhibitor of CYP2D6. Caution should be exercised when co-administering medicinal products that are CYP2D6 substrates with a narrow therapeutic index.