Limitations of Use

Concomitant use with another GLP-1 receptor agonist is not recommended.

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.

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)].

5.1 Risk of Thyroid C-Cell Tumors

In products with GLP-1 receptor agonist activity that are pharmacologically active in rats and mice, rodent thyroid C-cell tumors (adenomas and carcinomas) have been observed at clinically relevant exposures and are considered GLP-1 receptor-dependent effects in rodents. Orforglipron is not pharmacologically active in rats or mice and did not produce tumors in rodents [see Nonclinical Toxicology (13.1)]. While orforglipron is pharmacologically active at the human GLP-1 receptor, the human relevance of GLP-1 receptor-dependent thyroid C-cell tumors observed in rodents has not been determined [see Nonclinical Toxicology (13.1)].

Cases of MTC in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans.

FOUNDAYO is contraindicated in patients with a personal or family history of MTC or in patients with MEN 2. Counsel patients regarding the potential risk for MTC with the use of FOUNDAYO and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, or persistent hoarseness).

Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with FOUNDAYO. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin values may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.

5.2 Acute Pancreatitis

Acute pancreatitis has been reported in patients treated with FOUNDAYO. Fatal and non-fatal hemorrhagic or necrotizing pancreatitis have been observed in patients treated with GLP-1 receptor agonists [see Adverse Reactions (6)]. After initiation of FOUNDAYO, observe patients carefully for signs and symptoms of acute pancreatitis, which may include persistent or severe abdominal pain (sometimes radiating to the back) and which may or may not be accompanied by nausea or vomiting. If pancreatitis is suspected, discontinue FOUNDAYO and initiate appropriate management.

5.3 Severe Gastrointestinal Reactions

Use of FOUNDAYO has been associated with gastrointestinal adverse reactions, sometimes severe. In clinical trials, severe gastrointestinal adverse reactions were reported more frequently among patients treated with orforglipron (approximately 3%) than patients who received placebo (1%). Severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists [see Adverse Reactions (6)]. FOUNDAYO is not recommended in patients with severe gastroparesis.

5.4 Acute Kidney Injury Due to Volume Depletion

There have been reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with GLP-1 receptor agonists or FOUNDAYO. The majority of the reported events occurred in patients who experienced gastrointestinal adverse reactions leading to dehydration such as nausea, vomiting, or diarrhea [see Adverse Reactions (6)]. Monitor renal function in patients reporting adverse reactions to FOUNDAYO that could lead to volume depletion, especially during dosage initiation and escalation of FOUNDAYO.

5.5 Hypoglycemia

FOUNDAYO lowers blood glucose and can cause hypoglycemia.

In a trial of adults with type 2 diabetes and BMI ≥27 kg/m2 (Trial 2), hypoglycemia (plasma glucose <54 mg/dL) was reported in 2% of patients treated with orforglipron versus 0.2% of patients receiving placebo. One patient treated with orforglipron and no patients receiving placebo reported severe hypoglycemia in Trial 2. In Trial 2, 7% of patients treated with orforglipron once daily in combination with sulfonylurea reported hypoglycemia compared with 0.5% of patients not taking a sulfonylurea [see Adverse Reactions (6.1)]. There is also increased risk of hypoglycemia in patients treated with FOUNDAYO in combination with insulin [see Drug Interactions (7.2)]. Hypoglycemia has also been associated with FOUNDAYO and GLP-1 receptor agonists in adults without type 2 diabetes [see Adverse Reactions (6.1)].

Inform patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. In patients with diabetes, monitor blood glucose prior to starting FOUNDAYO and during FOUNDAYO treatment. The risk of hypoglycemia may be lowered by a reduction in the dose of insulin or sulfonylurea (or other concomitantly administered insulin secretagogue).

5.6 Hypersensitivity Reactions

Serious hypersensitivity reactions (e.g., anaphylaxis, angioedema) have been reported with GLP-1 receptor agonists [see Adverse Reactions (6.2)]. If hypersensitivity reactions occur, advise the patient to promptly seek medical attention and discontinue use of FOUNDAYO. FOUNDAYO is contraindicated in patients with a prior serious hypersensitivity reaction to orforglipron or to any of the excipients in FOUNDAYO. Use caution in a patient with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to these reactions with FOUNDAYO.

5.7 Diabetic Retinopathy Complications in Patients with Type 2 Diabetes

Temporary worsening of diabetic retinopathy has been reported with rapid improvement in glucose control. FOUNDAYO has not been studied in patients with diabetic retinopathy and/or macular edema requiring acute treatment. Monitor patients with a history of diabetic retinopathy for progression of diabetic retinopathy.

5.8 Acute Gallbladder Disease

Treatment with FOUNDAYO and GLP-1 receptor agonists is associated with an increased occurrence of acute gallbladder disease. In a pool of two clinical trials for weight reduction (Trials 1 and 2), cholelithiasis was reported in 1% of patients treated with orforglipron once daily and 0.7% of placebo-treated patients, and acute cholecystitis was reported in 0.4% of patients treated with orforglipron once daily and 0.3% of placebo-treated patients [see Adverse Reactions (6)]. Acute gallbladder events were associated with weight reduction. If cholecystitis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated.

5.9 Pulmonary Aspiration During General Anesthesia or Deep Sedation

FOUNDAYO delays gastric emptying [see Clinical Pharmacology (12.2)]. There have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations.

Available data are insufficient to inform recommendations to mitigate the risk of pulmonary aspiration during general anesthesia or deep sedation in patients taking FOUNDAYO, including whether modifying preoperative fasting recommendations or temporarily discontinuing FOUNDAYO could reduce the incidence of retained gastric contents. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking FOUNDAYO.

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of FOUNDAYO has been established in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition based on adequate and well-controlled trials of an investigational orforglipron formulation (Trials 1 and 2), referred to in this section as FOUNDAYO [see Clinical Studies (14)]. This section of labeling presents safety data from administration of the investigational orforglipron formulation shown as equivalent dosages of once daily FOUNDAYO [see Dosage and Administration (2.1)].

6.2 Postmarketing Experience

The following adverse reactions have been reported during post-approval use of GLP-1 receptor agonists. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal Disorders: acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death; ileus, intestinal obstruction, severe constipation including fecal impaction

Hypersensitivity: anaphylaxis, angioedema

Pulmonary: Pulmonary aspiration has occurred in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation

Renal and Urinary Disorders: acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis

7.1 Effect of Other Drugs on FOUNDAYO

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

7.2 Effect of FOUNDAYO on Other Drugs

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

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 [see Clinical Pharmacology (12.3)].

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.

8.1 Pregnancy

8.2 Lactation

8.3 Females and Males of Reproductive Potential

8.4 Pediatric Use

Safety and effectiveness of FOUNDAYO have not been established in pediatric patients.

8.5 Geriatric Use

In a pool of Trials 1 and 2, 399 (13%) FOUNDAYO-treated patients were 65 years of age or older, and 33 (1%) FOUNDAYO-treated patients were 75 years of age or older at baseline [see Clinical Studies (14)]. No overall differences in safety or effectiveness of FOUNDAYO have been observed between patients 65 years of age or older and younger adult patients.

8.6 Hepatic Impairment

FOUNDAYO is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C) [see Clinical Pharmacology (12.3)].

No dosage modification of FOUNDAYO is recommended in patients with mild or moderate hepatic impairment (Child-Pugh Class A and B, respectively) [see Clinical Pharmacology (12.3)].

8.7 Renal Impairment

No dosage modification of FOUNDAYO is recommended for patients with renal impairment. In subjects with renal impairment including end-stage renal disease (ESRD), no change in orforglipron pharmacokinetics (PK) was observed [see Clinical Pharmacology (12.3)]. Monitor renal function in patients reporting adverse reactions to FOUNDAYO that could lead to volume depletion [see Warnings and Precautions (5.4)].

12.1 Mechanism of Action

FOUNDAYO is a GLP-1 receptor agonist that binds to and activates the human GLP-1 receptor.

GLP-1 is a physiological regulator of appetite and caloric intake. GLP-1 receptors are present in brain regions that regulate appetite. In animal studies, orforglipron distributed to and activated neurons in brain regions that regulate appetite and food intake.

12.2 Pharmacodynamics

FOUNDAYO reduces body weight, with greater fat mass loss than lean mass loss. FOUNDAYO decreases food intake. This effect is likely mediated by decreased appetite.

FOUNDAYO delays gastric emptying. The delay is largest after the first dose and diminishes over time.

12.3 Pharmacokinetics

The pharmacokinetics of orforglipron is similar between healthy subjects and patients with overweight (BMI ≥27 kg/m2) or obesity. Steady state exposure is achieved after approximately 1 week of once daily administration.

The data below refer to FOUNDAYO dosages [see Dosage and Administration (2.1)]. Except in the food effect study, data were generated with the corresponding orforglipron investigational formulation [see Adverse Reactions (6.1)].

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Orforglipron is not pharmacologically active in rats or mice. In a 2-year rat carcinogenicity study, orforglipron was non-carcinogenic at oral daily doses of 5, 30, and 200 mg/kg/day resulting in exposures approximately 3, 9, and 26 times the clinical exposure at the MRHD, respectively, based on AUC. In a 26-week study in Tg.RasH2 transgenic mice, orforglipron was non-carcinogenic at oral daily doses of 5, 30, and 200 mg/kg/day. For other GLP-1 receptor agonists that are pharmacologically active in rats, thyroid C-cell hyperplasia, and thyroid C-cell adenoma and carcinoma have been observed at clinically relevant exposures and are considered an on-target class effect. Orforglipron would be expected to have the same on-target class effect if it was pharmacologically active in rats. The human relevance of these findings is unknown.

Orforglipron was not mutagenic or clastogenic in a bacterial reverse mutation test, an in vitro micronucleus test in human lymphoblastoid cells, or in an in vivo bone marrow micronucleus study in rats.

There were no effects on male and female fertility in rats orally administered orforglipron up to 200 mg/kg/day (19 times and 36 times the clinical exposure at the MRHD, respectively, based on AUC).

Overview of Trials 1 and 2

The effectiveness of FOUNDAYO has been established in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition based on adequate and well-controlled trials of an investigational orforglipron formulation (Trials 1 and 2), referred to in this section as FOUNDAYO. This section of labeling presents efficacy data from administration of the investigational orforglipron formulation shown as equivalent dosages of once daily FOUNDAYO [see Dosage and Administration (2.1)].

FOUNDAYO was studied in two randomized, double-blind, placebo-controlled trials (Trials 1 and 2) in adults aged 18 years and older. In these trials, all patients received standard lifestyle intervention which included instruction on reduced-calorie diet and physical activity counseling (recommended minimum of 150 minutes/week) that began with the first dose of trial medication or placebo and continued throughout the trials.

In Trial 1 patients were randomized in a 3:3:3:4 ratio to FOUNDAYO 5.5 mg once daily, 9 mg once daily, 17.2 mg once daily, or placebo once daily. In Trial 2 patients were randomized in a 1:1:1:2 ratio to FOUNDAYO 5.5 mg once daily, 9 mg once daily, 17.2 mg once daily, or placebo once daily. In Trials 1 and 2, dosages were titrated according to the dosage escalation described in Section 2.1. In these trials, the primary efficacy parameter was mean percent change in body weight after 72 weeks of treatment.

Trial 1 (NCT05869903) was a 72-week trial that enrolled 3,127 adult patients with obesity (BMI ≥30 kg/m2), or with overweight (BMI 27 to <30 kg/m2) and at least one weight-related comorbid condition, such as dyslipidemia, hypertension, obstructive sleep apnea, or cardiovascular disease; patients with type 2 diabetes were excluded. At baseline, mean age was 45 years (range 18 to 88 years), 64% were female, 56% were White, 28% were Asian, 9% were Black or African American, and 0.4% were American Indian/Alaska Native. A total of 38% were Hispanic or Latino ethnicity. Mean baseline body weight was 103.2 kg and mean BMI was 37 kg/m2. At baseline, 40% of patients had hypertension, 39% had dyslipidemia, 11% had obstructive sleep apnea, 1.4% had coronary artery disease, and 1.5% had cerebrovascular disease.

Trial 2 (NCT05872620) was a 72-week trial that enrolled 1,613 adult patients with BMI ≥27 kg/m2 and type 2 diabetes. Patients included in the trial had baseline HbA1c 7% to 10% and were treated with either diet and exercise alone, or any oral anti-hyperglycemic agent except dipeptidyl peptidase-4 (DPP-4) inhibitors or GLP-1 receptor agonists. Patients who were taking injectable glucose-lowering agents, including insulin, GLP-1 receptor agonists, or pramlintide were also excluded. At baseline, mean age was 57 years (range 20 to 92 years), 47% were female, 71% were White, 17% were Asian, 7% were Black or African American, and 0.3% were American Indian/Alaska Native. A total of 30% were Hispanic or Latino ethnicity. Mean baseline body weight was 101.4 kg, mean BMI was 35.6 kg/m2, and mean HbA1c was 8%. At baseline, 74% of patients had hypertension, 71% had dyslipidemia, 13% had obstructive sleep apnea, 7% had coronary artery disease, 5% had cerebrovascular disease, and 11% had diabetic retinopathy.

Results for Trials 1 and 2

The proportions of patients who discontinued trial drug in Trial 1 were 22%, 22%, and 24% for the 5.5 mg, 9 mg, and 17.2 mg once daily FOUNDAYO-treated groups, respectively, and 30% for the placebo-treated group. The proportion of patients who discontinued trial drug in Trial 2 were 19%, 22%, and 20% for the 5.5 mg, 9 mg, and 17.2 mg once daily FOUNDAYO-treated groups, respectively, and 20% for the placebo-treated group.

For Trials 1 and 2, the primary efficacy parameter was mean percent change in body weight from baseline to Week 72. After 72 weeks of treatment in Trials 1 and 2, there was a statistically significant reduction in body weight in the FOUNDAYO-treated groups compared with the placebo groups (see Table 6). A reduction in body weight was observed with FOUNDAYO regardless of age, sex, race, ethnicity, baseline BMI, and glycemic status.

The time courses of weight reduction from baseline with FOUNDAYO and placebo through Week 72 are depicted in Figure 1 for Trial 1 and Figure 2 for Trial 2.

Figure 1: Change Over Time in Body Weight in Trial 1 in Patients with Obesity or Overweight with ≥1 Weight-related Comorbid Condition (without Type 2 Diabetes)

Abbreviation: W72 TRE = treatment effect under treatment regimen estimand at Week 72.

Displayed results are from randomized patients and treatment regimen estimand data points set. (1) Observed mean value from Week 0 to Week 72, and (2) model-based estimate ± standard error at Week 72 using primary modified multiple imputation.

Figure 2: Change Over Time in Body Weight in Trial 2 in Patients with Obesity or Overweight and Type 2 Diabetes

Abbreviation: W72 TRE = treatment effect under treatment regimen estimand at Week 72.

Displayed results are from randomized participants and treatment regimen estimand data points set. (1) Observed mean value from Week 0 to Week 72, and (2) model-based estimate ± standard error at Week 72 using primary modified multiple imputation.

The cumulative frequency distributions of percentage change in body weight are shown in Figure 3 for Trial 1 and Figure 4 for Trial 2. One way to interpret this figure is to select a change in body weight of interest on the horizontal axis and note the corresponding proportions of patients (vertical axis) in each treatment group who achieved at least that degree of weight reduction. For example, the vertical line arising from -10% in Figure 3 intersects the FOUNDAYO 17.2 mg once daily and placebo curves at approximately 55% and 13%, respectively, which correspond to the values shown in Table 6.

Figure 3: Changes in Body Weight (%) from Baseline to Week 72 in Trial 1 in Patients with Obesity or Overweight with ≥1 Weight-related Comorbid Condition (without Type 2 Diabetes)

Note: Based on average percent weight change of each randomized patient within each specific treatment group from 100 imputed datasets including observed data and imputed data using the primary modified multiple imputation method for missing values.

Figure 4: Changes in Body Weight (%) from Baseline to Week 72 in Trial 2 in Patients with Obesity or Overweight and Type 2 Diabetes

Based on average percent weight change of each randomized patient within each specific treatment group from 100 imputed datasets including observed data and imputed data using the primary modified multiple imputation method for missing values.

Effect of FOUNDAYO on Anthropometry and Cardiometabolic Parameters in Trials 1 and 2

Changes in waist circumference and cardiometabolic parameters with FOUNDAYO are shown in Table 7 for Trial 1 and Trial 2.

16.1 How Supplied

FOUNDAYO (orforglipron) tablets are supplied in bottles with desiccant and child-resistant closure in cartons as follows:

16.2 Storage and Handling

• 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.

Risk of Thyroid C-Cell Tumors

Inform patients that in studies with rodents, medicines that work like FOUNDAYO caused thyroid C-cell tumors and that the human relevance of this finding has not been determined. Counsel patients to report symptoms of thyroid tumors (e.g., a lump in the neck, persistent hoarseness, dysphagia, or dyspnea) to their healthcare provider [see Boxed Warning, Warnings and Precautions (5.1)].

Acute Pancreatitis

Inform patients of the potential risk for acute pancreatitis and its symptoms: severe abdominal pain that may radiate to the back, and which may or may not be accompanied by nausea or vomiting. Instruct patients to discontinue FOUNDAYO promptly and contact their healthcare provider if pancreatitis is suspected [see Warnings and Precautions (5.2)].

Severe Gastrointestinal Adverse Reactions

Inform patients of the potential risk of severe gastrointestinal adverse reactions. Instruct patients to contact their healthcare provider if they have severe or persistent gastrointestinal symptoms [see Warnings and Precautions (5.3)].

Acute Kidney Injury Due to Volume Depletion

Inform patients of the potential risk of acute kidney injury due to dehydration and volume depletion associated with gastrointestinal adverse reactions. Advise patients to take precautions to avoid fluid depletion. Inform patients of the signs and symptoms of acute kidney injury and instruct them to promptly report any of these signs or symptoms or persistent (or extended) nausea, vomiting, and diarrhea to their healthcare provider [see Warnings and Precautions (5.4)].

Hypoglycemia

Inform patients of the risk of hypoglycemia and educate patients on the signs and symptoms of hypoglycemia. Advise patients taking insulin or insulin secretagogue therapy such as a sulfonylurea that they may have an increased risk of hypoglycemia when using FOUNDAYO and to report signs and/or symptoms of hypoglycemia to their healthcare provider [see Warnings and Precautions (5.5)].

Hypersensitivity Reactions

Inform patients that serious hypersensitivity reactions have been reported with use of FOUNDAYO. Advise patients on the symptoms of hypersensitivity reactions and instruct them to stop taking FOUNDAYO and seek medical advice promptly if such symptoms occur [see Warnings and Precautions (5.6)].

Diabetic Retinopathy Complications in Patients with Type 2 Diabetes

Inform patients with type 2 diabetes to contact their healthcare provider if they experience changes in vision during treatment with FOUNDAYO [see Warnings and Precautions (5.7)].

Acute Gallbladder Disease

Inform patients of the risk of acute gallbladder disease. Instruct patients to contact their healthcare provider for appropriate clinical follow-up if gallbladder disease is suspected [see Warnings and Precautions (5.8)].

Pulmonary Aspiration During General Anesthesia or Deep Sedation

Inform patients that FOUNDAYO may cause their stomach to empty more slowly which may lead to complications with anesthesia or deep sedation during planned surgeries or procedures. Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking FOUNDAYO [see Warnings and Precautions (5.9)].

Pregnancy

Advise a pregnant patient of the potential risk to a fetus. Advise patients to inform their healthcare provider if they are pregnant or intend to become pregnant during treatment with FOUNDAYO. Advise women of childbearing potential to use effective contraception during treatment with FOUNDAYO [see Use in Specific Populations (8.1, 8.3)]. Advise patients that there will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to FOUNDAYO during pregnancy [see Use in Specific Populations (8.1)].

Contraception

Use of FOUNDAYO may reduce the efficacy of oral hormonal contraceptives. 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 [see Drug Interactions (7.3), Use in Specific Populations (8.3), Clinical Pharmacology (12.3)].

Administration

Inform patients to take one FOUNDAYO tablet orally once daily with or without food. Advise patients to swallow tablets whole and not to break, crush, or chew tablets [see Dosage and Administration (2.1)]. Advise patients to keep FOUNDAYO in the original bottle and carton to protect from light [see How Supplied/Storage and Handling (16.2)].

Missed Doses

Inform patients if a dose of FOUNDAYO is missed, it should be taken as soon as possible. Instruct patients not to double up the next dose. If 7 or more consecutive doses are missed, instruct patients to restart dosage escalation at a lower dosage [see Dosage and Administration (2.3)].

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