Product information and disease description Product description Product information Drug/Drug, drug/disease interactions

Effects of other drugs on Tovorafenib

7 evidence topics · 4 sources

Strong or moderate CYP2C8 inhibitors and inducers: US prescribing information

“Avoid coadministration of OJEMDA with a strong or moderate CYP2C8 inhibitor.” (opens the source at this quote in a new tab)
“Tovorafenib is a CYP2C8 substrate. Strong or moderate CYP2C8 inhibitors are predicted to increase tovorafenib exposure based on a mechanistic understanding of its elimination [see Clinical Pharmacology (12.3) ], which may increase the risk of adverse reactions with OJEMDA.” (opens the source at this quote in a new tab)
“Avoid coadministration of OJEMDA with a strong or moderate CYP2C8 inducer.” (opens the source at this quote in a new tab)
“Tovorafenib is a CYP2C8 substrate. Strong or moderate CYP2C8 inducers are predicted to decrease tovorafenib exposure based on a mechanistic understanding of its elimination [see Clinical Pharmacology (12.3) ], which may reduce the effectiveness of OJEMDA.” (opens the source at this quote in a new tab)

Examples of CYP2C8 modulators: EU product information

“Coadministration of tovorafenib with a strong or moderate CYP2C8 inhibitor (e.g. gemfibrozil) should be avoided.” (opens the source at this quote in a new tab)
“Coadministration of tovorafenib with a strong or moderate CYP2C8 inducer (e.g. carbamazepine) should be avoided.” (opens the source at this quote in a new tab)

Evidentiary basis: no clinical DDI studies and ongoing gemfibrozil and carbamazepine study

“No clinical DDI studies were conducted.” (opens the source at this quote in a new tab)
“In response, the Applicant stated that a Phase 1 drug-drug interaction study of tovorafenib as a victim is ongoing. This study will assess the effects of gemfibrozil (a strong CYP2C8 inhibitor) and carbamazepine (a moderate CYP2C8 inducer) on the pharmacokinetics of tovorafenib in healthy participants (REC).” (opens the source at this quote in a new tab)

Transporters

“Tovorafenib is not a substrate of BCRP, P-glycoprotein (P-gp), OATP1B1 and OATP1B3. Tovorafenib has not been evaluated as a substrate of OAT1, OAT3, MATE1, MATE2-K and OCT2.” (opens the source at this quote in a new tab)

Anticoagulants and antiplatelet agents: hemorrhage risk

“The risk of haemorrhage may be increased with concomitant use of anticoagulants and antiplatelet therapy.” (opens the source at this quote in a new tab)

Clinical trial restriction: PNOC014

“Patients also could not receive treatment with strong CYP2C inducers or CYP2C8 inhibitors within 14 days of the first dose.” (opens the source at this quote in a new tab)

Drug-disease interaction: NF1 loss of function

“Based on these non-clinical data and discussions, and literature articles Rastogi et al. (2025)/ Bessler et al. (2024)2, in the NF1-LOF setting, there is a potential risk of increased tumour growth in response to tovorafenib, and this is reflected in the sections 4.4 and 5.3 of the SmPC.” (opens the source at this quote in a new tab)

Gastric acid-reducing agents

No evidence found.