Medication Use in Special Populations for Orforglipron

Whether individuals in special populations can use orforglipron and whether dosage adjustments are necessary must be comprehensively determined by a physician based on liver function classification, renal function, blood glucose control, fertility plans, and lactation status. Do not make decisions on your own.

1. Pregnancy

May cause fetal harm. Once pregnancy is confirmed, the pregnant woman should be informed of the potential risk to the fetus, and this product should be discontinued.

2. Lactation

Not recommended during breastfeeding. There are no data on whether orforglipron or its metabolites pass into human milk, what effects it may have on the nursing infant, or its impact on milk production.

3. Females of Reproductive Potential and Contraception

Females of reproductive potential should use effective contraception during treatment with this product, based on animal reproduction studies and the potential fetal risks associated with exposure during pregnancy.

Individuals using oral hormonal contraceptives should switch to a non-oral method of contraception or add a barrier method for 30 days after starting this product and for 30 days following each dose increase.

4. Pediatric and Adolescent Use

Safety and efficacy have not been established.

5. Geriatric Use (65 Years and Older)

No overall differences in safety or efficacy were observed between patients aged 65 and older and younger adult patients, though greater sensitivity in some older individuals cannot be ruled out.

6. Hepatic Impairment

Patients with mild hepatic impairment (Child-Pugh Class A) have orforglipron exposure similar to those with normal liver function, and no dose adjustment is required.

For patients with moderate hepatic impairment (Child-Pugh Class B), dose adjustment is not recommended, and specific management will be determined by a physician.

In patients with severe hepatic impairment (Child-Pugh Class C), the AUC increases by 4.6-fold; use is not recommended.

7. Renal Impairment

No dose adjustment is required for patients with renal impairment. Renal function must be monitored when dehydration reactions occur, especially during the initiation and dose-escalation phases.

8. Patients with Type 2 Diabetes

The risk of hypoglycemia is increased, especially when used concomitantly with insulin or sulfonylureas. Initiation of this product may require reducing the dose of insulin or sulfonylureas as determined by a physician; blood glucose should be monitored before initiation and throughout treatment.

Regarding diabetic retinopathy: transient worsening of diabetic retinopathy has been reported with rapid improvements in blood glucose; this product has not been studied in patients with diabetic retinopathy and/or macular edema requiring acute treatment. Patients with a history of diabetic retinopathy should be monitored for disease progression, and any changes in vision should be reported to a doctor.

Warm Reminder: Please complete the corresponding monitoring as prescribed during your treatment. If pregnancy is confirmed, if you experience persistent vomiting or diarrhea preventing you from eating or drinking, vision changes, symptoms of hypoglycemia, or if you are planning surgery or an examination requiring anesthesia, please inform your doctor or seek medical attention immediately.