Orforgliproninteractions

Strong CYP3A4 Inhibitors: The maximum dosage of FOUNDAYO is 9 mg once daily when used concomitantly with a strong CYP3A4 inhibitor. Avoid concomitant use with strong CYP3A4 inhibitors that also inhibit OATP1B.

CYP3A4 Inducers: Avoid concomitant use with strong CYP3A4 inducers. Monitor FOUNDAYO effectiveness and escalate dosage as needed when used concomitantly with moderate CYP3A4 inducers.

Simvastatin: Do not exceed simvastatin 20 mg once daily when used concomitantly with FOUNDAYO. FOUNDAYO delays gastric emptying and has the potential to impact the absorption of concomitantly administered oral medications.

7.1 Effect of

Other Drugs on FOUNDAYO Table 2 includes clinically relevant interactions where concomitant use of other drugs affects FOUNDAYO.

Table 2: Clinically Relevant Effects of Other Drugs on FOUNDAYO Strong CYP3A4 Inhibitors Intervention The maximum dosage of FOUNDAYO is 9 mg once daily when used concomitantly with a strong CYP3A4 inhibitor. Avoid concomitant use of FOUNDAYO with strong CYP3A4 inhibitors that also inhibit OATP1B (e.g., ritonavir). Clinical Impact CYP3A4 inhibitors increase FOUNDAYO exposure, which may increase the risk of FOUNDAYO-associated adverse reactions. Strong CYP3A4 inhibitors that also clinically inhibit OATP1B are expected to significantly increase plasma concentrations of FOUNDAYO, which may increase the risk of FOUNDAYO-associated adverse reactions. Strong CYP3A4 Inducers Intervention Avoid concomitant use of FOUNDAYO with strong CYP3A4 inducers. Clinical Impact Induction of CYP3A4 decreases FOUNDAYO exposure, which may reduce the effectiveness of FOUNDAYO. Moderate CYP3A4 Inducers Intervention Monitor FOUNDAYO effectiveness and escalate dosage as needed when used concomitantly with moderate CYP3A4 inducers. Clinical Impact Induction of CYP3A4 decreases FOUNDAYO exposure, which may reduce the effectiveness of FOUNDAYO.

7.2 Effect of FOUNDAYO on

Other Drugs Table 3 includes clinically relevant interactions where concomitant use of FOUNDAYO affects other drugs.

Table 3: Clinically Relevant Effects of FOUNDAYO on Other Drugs Simvastatin Intervention Do not exceed simvastatin 20 mg once daily when concomitantly used with FOUNDAYO. Clinical Impact Use of FOUNDAYO with simvastatin increased exposure of the active metabolite simvastatin acid two-fold. A two-fold increase in simvastatin acid exposure at the highest simvastatin dose could be clinically meaningful. Insulin or Insulin Secretagogue (e.g., Sulfonylurea) Intervention When initiating FOUNDAYO, consider reducing the dose of concomitantly administered insulin or insulin secretagogues (e.g., sulfonylureas). Clinical Impact FOUNDAYO stimulates insulin release in the presence of elevated blood glucose concentrations which could increase the risk for hypoglycemia when used in combination with insulin or insulin secretagogues.

7.3 Effect of FOUNDAYO on

Oral Medications FOUNDAYO delays gastric emptying and thereby has the potential to impact the absorption of concomitantly administered oral medications. Advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive method or add a barrier method of contraception for 30 days after initiation with FOUNDAYO and for 30 days after each dose escalation. Hormonal contraceptives that are not administered orally should not be affected.