MOUNJARO KWIKPEN 10/MG/0.6/ML 1/PENFILL @

Indications

Approved Uses

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

Dosage & Administration

Dosing by Condition

Type 2 diabetes (adults): 2.5 mg SC once weekly for 4 weeks (initiation), then 5 mg once weekly; if additional glycemic control is needed, increase by 2.5 mg increments after at least 4 weeks on the current dose. Maintenance doses: 5 mg, 10 mg, or 15 mg once weekly; maximum 15 mg once weekly.

Initial Dose

2.5 mg subcutaneously once weekly for 4 weeks (this dose is for treatment initiation and not for glycemic control).

Maintenance Dose

5 mg to 15 mg subcutaneously once weekly

Maximum Dose

10 mg/0.6 mL subcutaneously once weekly (maintenance dose for this 10 mg/0.6 mL KwikPen; maximum overall 15 mg once weekly in adults)

Children's Dosage

Approved for pediatric patients 10 years of age and older: 10 mg subcutaneously once weekly

Dose Adjustment Notes

Titrate in 2.5 mg steps no more frequently than every 4 weeks based on tolerability/need. No dose adjustment is required for renal or hepatic impairment. Consider reducing doses of concomitant insulin and/or sulfonylureas to reduce hypoglycemia risk. The weekly dosing day may be changed if needed, provided the time between doses is at least 72 hours (3 days).

How to Take

Inject subcutaneously once weekly in the abdomen, thigh, or upper arm. Rotate injection sites. Use a new needle for each injection and remove/discard the needle after the injection (do not store the pen with a needle attached).

How to Prepare

Inspect MOUNJARO visually before use. It should appear clear and colorless to slightly yellow. Do not use MOUNJARO if particulate matter or discoloration is seen.

Side Effects

Common Side Effects

Nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia/indigestion, abdominal pain; injection-site reactions can also occur.

Side Effect Frequency

Very common (≥10%): nausea, diarrhea, decreased appetite, vomiting, constipation. Common (1%-<10%): abdominal pain, dyspepsia, injection-site reactions, fatigue, eructation (belching), flatulence, gastroesophageal reflux. Hypoglycemia is common when used with insulin or a sulfonylurea. Uncommon/rare: pancreatitis, gallbladder disease, hypersensitivity reactions, acute kidney injury (typically secondary to dehydration).

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: boxed warning/contraindication for MTC/MEN2; pancreatitis (discontinue if suspected); hypoglycemia with insulin/secretagogues; acute kidney injury risk secondary to dehydration from GI adverse effects; severe GI adverse reactions/avoid in severe GI disease; gallbladder disease; hypersensitivity reactions; potential worsening of diabetic retinopathy in patients with pre-existing retinopathy; not for type 1 diabetes and not a substitute for insulin.

Age Restriction

Approved for pediatric patients 10 years of age and older at 10 mg subcutaneously once weekly

Drug Interactions

Interaction Severity

MAJOR/clinically significant: insulin and insulin secretagogues (e.g., sulfonylureas) - increased hypoglycemia risk; consider dose reduction and monitor glucose. MODERATE: oral hormonal contraceptives - delayed gastric emptying may reduce exposure; advise alternative non-oral contraception or add a barrier method for 4 weeks after initiation and for 4 weeks after each dose escalation. MODERATE/monitor: other oral drugs where timing/exposure is critical (delayed gastric emptying); monitor clinical response (e.g., warfarin/INR as clinically indicated).

Food Interaction

No food restrictions; may be administered with or without meals.

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Consult Doctor

Children

Approved for pediatric patients 10 years of age and older: 10 mg subcutaneously once weekly

Storage & Patient Advice

Preparation Instructions

Inspect MOUNJARO visually before use. It should appear clear and colorless to slightly yellow. Do not use MOUNJARO if particulate matter or discoloration is seen.

Missed Dose

If a dose is missed, administer it 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 take the next dose on the regularly scheduled day.

Stopping the Medicine

Can be stopped without tapering, but should be done in consultation with the prescriber because glycemic control/weight effects may worsen after stopping.

Overdose

Expected overdose effects are primarily gastrointestinal (e.g., severe nausea/vomiting) and may include hypoglycemia particularly with concomitant insulin/sulfonylureas; treat with supportive care, monitor glucose, and manage hypoglycemia as needed-no specific antidote.

Patient Counseling

Inject once weekly on the same day each week (any time of day, with or without meals); rotate sites (abdomen, thigh, upper arm). Store refrigerated at 2-8°C; do not freeze. Use a new needle each time and remove it after injection; do not share pens. Expect GI effects (nausea/diarrhea/vomiting/constipation), especially after starting or dose increases; eat smaller meals and maintain hydration. If used with insulin or a sulfonylurea, recognize and treat hypoglycemia. Seek urgent care for severe/persistent abdominal pain (possible pancreatitis) and report neck mass/hoarseness/dysphagia (thyroid tumor warning); avoid use with personal/family history of medullary thyroid carcinoma or MEN2. If using oral contraceptives, use non-oral contraception or add a barrier method for 4 weeks after starting and after each dose increase.

Pharmacology

Duration of Effect

Provides therapeutic exposure across a 7-day dosing interval (once-weekly dosing).

Product Information

Available Dosage Forms

Solution for injection in pre-filled pen (KwikPen), solution for injection in pre-filled autoinjector (single-dose)

Composition per Dose

Each 0.6 mL dose: 10 mg tirzepatide in 2.4 mL pre-filled KwikPen (16.7 mg/mL)

Generic Availability

No

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

Insulin Type

Not an insulin

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.