MOUNJARO KWIKPEN 15MG/0.6ML 3ML X1

Indications

Approved Uses

As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Dosage & Administration

Dosing by Condition

Type 2 diabetes mellitus (adults): 2.5 mg SC once weekly for 4 weeks, then 5 mg once weekly; may increase by 2.5 mg every ≥4 weeks as needed/tolerated to 7.5 mg, 10 mg, 12.5 mg, up to a maximum of 15 mg once weekly.

Initial Dose

2.5 mg subcutaneously once weekly for 4 weeks.

Maintenance Dose

5 mg to 15 mg subcutaneously once weekly (titrated in 2.5 mg increments every 4 weeks based on tolerability)

Maximum Dose

15 mg subcutaneously once weekly.

Children's Dosage

Approved for pediatric patients 10 years of age and older with type 2 diabetes mellitus; maximum 10 mg subcutaneously once weekly.

Dose Adjustment Notes

Start at 2.5 mg once weekly for 4 weeks (initiation dose not intended for glycemic control), then increase to 5 mg once weekly; if needed, increase by 2.5 mg increments no more frequently than every 4 weeks as tolerated. If a dose increase is not tolerated, consider delaying escalation. No routine dose adjustment is required for renal or hepatic impairment; consider reducing concomitant insulin or sulfonylurea to mitigate hypoglycemia risk.

How to Take

Administer tirzepatide subcutaneously once weekly (same day each week) in the abdomen, thigh, or upper arm; rotate injection sites. May be given at any time of day, with or without meals. Do not mix with insulin or other injectables in the same syringe; if used with insulin, inject as separate injections (may be in the same body region but not adjacent). Follow the specific pen Instructions for Use for needle attachment and dose delivery; for the KwikPen presentation, deliver the prescribed dose and hold the needle in the skin for ~10 seconds to ensure full dose delivery.

Safety & Warnings

Contraindications

Personal or family history of medullary thyroid carcinoma (MTC), Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), known serious hypersensitivity to tirzepatide or its excipients.

Warnings & Precautions

Key warnings/precautions: thyroid C-cell tumor risk-contraindicated with personal/family history of MTC or MEN 2; pancreatitis (discontinue if suspected); acute gallbladder disease; hypoglycemia with insulin/secretagogues; acute kidney injury risk with severe GI reactions/dehydration; severe GI adverse reactions; diabetic retinopathy complications with rapid glycemic improvement; not for type 1 diabetes and not a substitute for insulin; limited data in patients with prior pancreatitis.

Age Restriction

Approved for pediatric patients 10 years of age and older with type 2 diabetes mellitus.

Drug Interactions

Interaction Severity

MAJOR/clinically significant: Insulin and sulfonylureas (increased hypoglycemia risk-consider dose reduction and close glucose monitoring). MODERATE: Oral hormonal contraceptives (delayed gastric emptying may reduce exposure-use alternative/backup contraception for 4 weeks after initiation and for 4 weeks after each dose escalation). MODERATE: Narrow-therapeutic-index oral drugs where timing/absorption changes matter (monitor/adjust as needed); Warfarin-monitor INR more closely when starting or escalating.

Food Interaction

No food restrictions; administer with or without meals.

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Approved for pediatric patients 10 years of age and older with type 2 diabetes mellitus; maximum 10 mg subcutaneously once weekly.

Storage & Patient Advice

Missed Dose

If a dose is missed, administer as soon as possible within 4 days (96 hours). If more than 4 days have passed, skip the missed dose and take the next dose on the regularly scheduled day. Do not take two doses within 3 days (72 hours) of each other.

Patient Counseling

Inject tirzepatide subcutaneously once weekly on the same day each week, at any time of day, with or without food; if you need to change the weekly dosing day, ensure at least 72 hours (3 days) between doses. Rotate injection sites (abdomen, thigh, or upper arm) and do not inject into areas that are tender, bruised, red, or hard. If a dose is missed, take it within 4 days (96 hours); if more than 4 days have passed, skip and take the next dose on the regular day. Common GI effects (nausea, vomiting, diarrhea, constipation) are dose-related-eat smaller/low-fat meals and maintain hydration. Seek urgent care for severe/persistent abdominal pain (possible pancreatitis), symptoms of gallbladder disease, or signs of serious allergic reaction. Risk of hypoglycemia increases when used with insulin or a sulfonylurea-monitor glucose and the prescriber may need to reduce those agents. Contraindicated in patients with a personal/family history of medullary thyroid carcinoma or MEN2; report neck lump/hoarseness/dysphagia. If using oral hormonal contraception, use a backup method for 4 weeks after starting tirzepatide and for 4 weeks after each dose escalation due to reduced oral contraceptive exposure. Not insulin and not indicated for type 1 diabetes.

Pharmacology

Mechanism of Action

Dual GIP and GLP-1 receptor agonist that enhances glucose-dependent insulin secretion, suppresses inappropriate glucagon, slows gastric emptying, and reduces appetite/energy intake.

Duration of Effect

Approximately 1 week (supports once-weekly dosing).

Product Information

Available Dosage Forms

Solution for injection for subcutaneous use in a pre-filled pen (KwikPen).

Generic Availability

No

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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