FOUNDAYO Film-coated tablet Ref.[116652] Active ingredients: Orforglipron

2.1 Recommended Dosage and Administration

Recommended Administration:

• Take FOUNDAYO orally once daily, with or without food.
• Swallow tablets whole. Do not break, crush, or chew.
• Do not take more than one tablet per day.

Recommended Dosage Escalation:

Follow the FOUNDAYO starting dosage and escalation described below to reduce the risk of gastrointestinal (GI) adverse reactions [see Warnings and Precautions (5.3), Adverse Reactions (6)].

• The starting dosage is 0.8 mg orally once daily. After at least 30 days on the 0.8 mg dosage, increase the dosage to 2.5 mg once daily.
• After at least 30 days on the 2.5 mg dosage, increase the dosage to 5.5 mg once daily.
• The dosage may be increased to the next dosage level (9 mg, 14.5 mg, or 17.2 mg once daily) after at least 30 days on the current dosage, based on treatment response and tolerability.
• The maximum dosage of FOUNDAYO is 17.2 mg once daily.

2.2 Dosage Modification for Concomitant Use with CYP3A4 Inhibitors and CYP3A4 Inducers

FOUNDAYO dosage modification may be required to manage interactions with some concomitant medications [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].

Strong CYP3A4 Inhibitors:

• Avoid strong CYP3A4 inhibitors that also inhibit OATP1B when taking FOUNDAYO.
• The maximum dosage of FOUNDAYO is 9 mg once daily when used concomitantly with a strong CYP3A4 inhibitor [see Drug Interactions (7.1), Clinical Pharmacology (12.3)].

Strong and Moderate CYP3A4 Inducers:

• Avoid strong CYP3A4 inducers when taking FOUNDAYO.
• Monitor FOUNDAYO effectiveness when concomitantly using moderate CYP3A4 inducers and escalate FOUNDAYO dosage as needed [see Dosage and Administration (2.1, 2.3), Drug Interactions (7.1), Clinical Pharmacology (12.3)].

2.3 Recommendations Regarding Missed Dose

• If a dose is missed, instruct patients to take the dose as soon as possible.
• Advise patients not to double up the next dose.
• If 7 or more consecutive doses are missed, reinitiate dosage escalation at a lower dosage to reduce the risk of gastrointestinal adverse reactions [see Dosage and Administration (2.1), Warnings and Precautions (5.3), Adverse Reactions (6)].

In the event of an overdose, consider contacting Poison Control (1-800-222-1222) or a medical toxicologist for latest recommendations. Initiate appropriate supportive treatment according to the patient's clinical signs and symptoms. A period of observation and treatment for these symptoms may be necessary, considering the half-life of orforglipron [see Clinical Pharmacology (12.3)].

• Store FOUNDAYO at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature].
• FOUNDAYO is light sensitive. Protect from light by keeping in the original bottle and carton and replacing the cap each time after opening. If the carton is no longer available, store bottle away from light.