MOUNJARO KWIKPEN 2.5MG/0.6ML 2.4ML X1

Indications

Approved Uses

Type 2 diabetes mellitus: adjunct to diet and exercise to improve glycemic control in adults.

Off-Label Uses

Off-label: chronic weight management (where not specifically approved under the local Mounjaro label), metabolic dysfunction-associated steatotic liver disease/NASH (investigational), and PCOS-related metabolic dysfunction (off-label).

Dosage & Administration

Dosing by Condition

Type 2 diabetes (adults): 2.5 mg SC once weekly for 4 weeks (initiation dose), then 5 mg once weekly; if additional glycemic control needed, increase by 2.5 mg increments after at least 4 weeks on the current dose; maximum 15 mg once weekly.

Initial Dose

2.5 mg subcutaneously once weekly for 4 weeks (not intended as therapeutic dose; used for tolerability)

Maintenance Dose

5 mg to 15 mg subcutaneously once weekly.

Maximum Dose

15 mg subcutaneously once weekly.

Children's Dosage

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

Dose Adjustment Notes

Titrate in 2.5 mg steps no more frequently than every 4 weeks based on tolerability/need; if not tolerated, consider returning to the prior dose. No dose adjustment is generally required for renal or hepatic impairment, but monitor renal function if severe GI reactions/dehydration occur. When used with insulin or sulfonylurea, consider dose reduction of those agents to reduce hypoglycemia risk. Oral hormonal contraceptive exposure may be reduced after initiation and each dose escalation-advise a non-oral method or add a barrier method for 4 weeks after starting and for 4 weeks after each dose increase.

How to Take

For subcutaneous use only: inject once weekly under the skin of the abdomen, thigh, or upper arm; rotate injection sites. Administer on the same day each week, any time of day, with or without meals. Inspect solution before use; do not use if discolored or contains particles. Do not share the pen between patients, even if the needle is changed.

How to Prepare

Ready-to-use pre-filled pen; visually inspect solution (clear to slightly opalescent, colorless to slightly yellow) and do not use if discolored/particulate; attach a new needle before each injection

Side Effects

Common Side Effects

Nausea, diarrhea, vomiting, constipation, decreased appetite, dyspepsia/indigestion, abdominal pain; injection-site reactions can occur; hypoglycemia mainly when used with insulin or a sulfonylurea.

Side Effect Frequency

Very common (≥10%): nausea, diarrhea, vomiting, constipation. Common (1-10%): decreased appetite, injection-site reactions, fatigue, eructation/flatulence/GERD; hypoglycemia mainly when used with insulin or sulfonylurea. Uncommon/rare: pancreatitis, gallbladder disease.

Safety & Warnings

Contraindications

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

Warnings & Precautions

Key warnings/precautions: thyroid C-cell tumor risk; contraindicated with personal/family history of MTC or MEN2; pancreatitis (discontinue if suspected); hypoglycemia risk with insulin/sulfonylureas; dehydration/AKI risk from GI adverse effects; diabetic retinopathy complications; gallbladder disease; severe hypersensitivity; not for type 1 diabetes or DKA; caution in severe GI disease/gastroparesis; consider interaction impact on oral drugs (notably oral contraceptives and narrow therapeutic index agents).

Age Restriction

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

Drug Interactions

Drug Interactions

Insulin and insulin secretagogues (e.g., sulfonylureas): increased hypoglycemia risk-dose reduction may be needed; Oral drugs: delayed gastric emptying may affect absorption (use caution with narrow therapeutic index drugs); Oral hormonal contraceptives: reduced exposure-use alternative non-oral contraception or add barrier method for 4 weeks after initiation and after each dose escalation.

Interaction Severity

MAJOR: Insulin and insulin secretagogues (e.g., sulfonylureas) - increased hypoglycemia risk; consider dose reduction and monitor. MODERATE: Oral hormonal contraceptives - reduced exposure after initiation and dose escalation; use non-oral or add barrier for 4 weeks after start and each increase. MODERATE: Other oral drugs, especially narrow therapeutic index agents - delayed gastric emptying may affect absorption; monitor clinical effect and adjust as needed.

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

Elderly

Standard adult dosing - no dose adjustment required based on age alone; titrate based on tolerability and glycemic response; monitor for dehydration and renal function

Kidney Impairment

No dose adjustment required in renal impairment (including severe impairment/ESRD), but monitor closely for dehydration and acute kidney injury if significant GI adverse effects occur.

Liver Impairment

No dose adjustment required in hepatic impairment.

Storage & Patient Advice

Storage Conditions

store in a refrigerator (2°c - 8°c)

Preparation Instructions

Ready-to-use pre-filled pen; visually inspect solution (clear to slightly opalescent, colorless to slightly yellow) and do not use if discolored/particulate; attach a new needle before each injection

Missed Dose

If a dose is missed, take it 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.

Stopping the Medicine

Can be stopped without tapering, but do not stop abruptly without a plan-glycemic control may worsen; consult prescriber to arrange alternative diabetes management.

Overdose

Expected symptoms: marked gastrointestinal effects (nausea/vomiting/diarrhea) and hypoglycemia (especially with insulin/sulfonylurea). Management: supportive care, monitor glucose and treat hypoglycemia, maintain hydration; consider prolonged observation due to long half-life; contact poison control/seek urgent care.

Patient Counseling

Use once weekly on the same day each week; may be taken any time of day with or without meals; rotate injection sites (abdomen/thigh/upper arm). Store refrigerated at 2-8°C per SFDA; do not freeze; protect from heat/light; do not use if solution is not clear/colorless. Do not share the pen. Common GI effects (nausea, vomiting, diarrhea, constipation) are common early-eat smaller meals and avoid high-fat foods if needed; maintain hydration. Seek urgent care for severe/persistent abdominal pain (pancreatitis) or symptoms of gallbladder disease. Discuss hypoglycemia risk if used with insulin/sulfonylurea. Counsel on thyroid C-cell tumor warning and to report neck mass/hoarseness/dysphagia. If using oral hormonal contraception, use a non-oral method or add barrier contraception for 4 weeks after starting and for 4 weeks after each dose increase.

Monitoring Requirements

Monitor glycemic control (SMBG as appropriate and HbA1c periodically). Monitor for GI intolerance/dehydration and check renal function if severe GI reactions occur. Monitor for signs/symptoms of pancreatitis and gallbladder disease. Monitor for hypoglycemia when used with insulin or sulfonylurea. Monitor body weight. In patients with pre-existing diabetic retinopathy, monitor for worsening if rapid glycemic improvement occurs.

Pharmacology

Mechanism of Action

A dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist that increases insulin secretion, reduces glucagon secretion, and slows gastric emptying to improve glycemic control and reduce appetite.

Duration of Effect

Approximately 1 week (supports once-weekly dosing).

Half-Life

Approximately 5 days (120 hours)

Metabolism

Metabolized by proteolytic cleavage of the peptide backbone, beta-oxidation of the C20 fatty diacid moiety, and amide hydrolysis; not CYP450-mediated

Product Information

Available Dosage Forms

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

Composition per Dose

Each 0.6 mL dose: 2.5 mg tirzepatide; excipients include sodium phosphate dibasic heptahydrate, sodium chloride, L-arginine hydrochloride, polysorbate 80, water for injection

Generic Availability

No

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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