ZEPBOUND Solution for injection Ref.[109319] Active ingredients: Tirzepatide

2.1 Patient Selection

Select adult patients for ZEPBOUND treatment as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management based on their BMI. Table 1 presents a chart for determining BMI based on height and weight. BMI is calculated by dividing weight (in kilograms) by height (in meters) squared.

Table 1. BMI Conversion Chart:

2.2 Recommended Dosage

• The recommended starting dosage of ZEPBOUND is 2.5 mg injected subcutaneously once weekly. The 2.5 mg dosage is for treatment initiation and is not intended for chronic weight management.
• After 4 weeks, increase the dosage to 5 mg injected subcutaneously once weekly.
• The dosage may be increased in 2.5 mg increments, after at least 4 weeks on the current dose.
• The recommended maintenance dosages of ZEPBOUND in adults are 5 mg, 10 mg, or 15 mg injected subcutaneously once weekly.
• Consider treatment response and tolerability when selecting the maintenance dosage. If patients do not tolerate a maintenance dosage, consider a lower maintenance dosage.
• The maximum dosage of ZEPBOUND is 15 mg injected subcutaneously once weekly.

2.3 Recommendations Regarding Missed Dose

• If a dose is missed, instruct patients to administer ZEPBOUND as soon as possible within 4 days (96 hours) after the missed dose. If more than 4 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day. In each case, patients can then resume their regular once weekly dosing schedule.
• The day of weekly administration can be changed, if necessary, as long as the time between the two doses is at least 3 days (72 hours).

2.4 Important Administration Instructions

• Prior to initiation of ZEPBOUND, train patients and caregivers on proper injection technique. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations.
• Inspect ZEPBOUND visually before use. It should appear clear and colorless to slightly yellow. Do not use ZEPBOUND if particulate matter or discoloration is seen.
• Administer ZEPBOUND once weekly at any time of day, with or without meals.
• Inject ZEPBOUND subcutaneously in the abdomen, thigh, or upper arm.
• Rotate injection sites with each dose.

In the event of an overdosage, contact the Poison Help Line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. Appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. A period of observation and treatment for these symptoms may be necessary, taking into account the half-life of tirzepatide of approximately 5 days.

• Store ZEPBOUND in a refrigerator at 2°C to 8°C (36°F to 46°F).
• If needed, each single-dose pen can be stored unrefrigerated at temperatures not to exceed 30°C (86°F) for up to 21 days. If ZEPBOUND is stored at room temperature, it should not be returned to the refrigerator.
• Discard if not used within 21 days after removing from the refrigerator.
• Do not freeze ZEPBOUND. Do not use ZEPBOUND if frozen.
• Store ZEPBOUND in the original carton to protect from light.