MOUNJARO KWIKPEN 12.5MG/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.

Off-Label Uses

Off-label: weight management/obesity (where not specifically approved under the Mounjaro indication), and investigational/off-label metabolic conditions such as NAFLD/NASH or PCOS-related metabolic dysfunction.

Dosage & Administration

Dosing by Condition

Type 2 diabetes mellitus (adults): 2.5 mg SC once weekly for 4 weeks, then 5 mg once weekly; if additional control needed, increase by 2.5 mg every ≥4 weeks to maintenance 5-15 mg once weekly (max 15 mg 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

15 mg subcutaneously once weekly (maximum maintenance dose).

Children's Dosage

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

Dose Adjustment Notes

Increase dose in 2.5 mg increments after at least 4 weeks on the current dose based on tolerability/need; if not tolerated, consider delaying escalation. The weekly dosing day can be changed if ≥72 hours between doses. No routine dose adjustment is required for renal or hepatic impairment, but monitor closely if severe GI reactions occur (risk of dehydration/AKI).

How to Take

For subcutaneous injection only: Inject tirzepatide once weekly in the abdomen, thigh, or upper arm; rotate injection sites. Administer at any time of day, with or without meals. Do not shake. The day of weekly administration may be changed if the time between doses is at least 72 hours.

How to Prepare

Ready-to-use pre-filled pen (no reconstitution); visually inspect the solution before injection-use only if clear to slightly opalescent and colorless to slightly yellow, and do not use if discolored or contains particles.

Side Effects

Common Side Effects

Nausea, diarrhea, decreased appetite, vomiting, constipation, dyspepsia/indigestion, and abdominal pain; injection-site reactions may occur. Hypoglycemia risk increases when used with insulin or a sulfonylurea.

Side Effect Frequency

Very common (≥10%): nausea, diarrhea. Common (1%-<10%): decreased appetite, vomiting, constipation, abdominal pain, injection-site reactions, fatigue, eructation, flatulence, gastroesophageal reflux; hypoglycemia when used with insulin or sulfonylurea.

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

Boxed warning/contraindication for MTC/MEN2; pancreatitis risk (discontinue if suspected); hypoglycemia risk with insulin/secretagogues (consider dose reduction); acute kidney injury risk from dehydration due to GI adverse effects; severe GI disease/gastroparesis-use not recommended; diabetic retinopathy complications may worsen with rapid glycemic improvement; acute gallbladder disease; serious hypersensitivity reactions.

Age Restriction

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

Drug Interactions

Drug Interactions

Insulin/insulin secretagogues: increased hypoglycemia risk (consider dose reduction). Delayed gastric emptying may affect absorption of oral drugs; oral contraceptives may have reduced exposure-use non-oral or add barrier contraception for 4 weeks after initiation and 4 weeks after each dose escalation.

Interaction Severity

MAJOR: Concomitant insulin or sulfonylureas (increased hypoglycemia risk-consider dose reduction and monitor). MODERATE: Oral hormonal contraceptives (delayed gastric emptying may reduce exposure-use non-oral or add barrier contraception for 4 weeks after initiation and after each dose increase).

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.

Elderly

Standard adult dosing; no dose adjustment required based on age alone. Use with caution in elderly patients prone to dehydration from GI side effects; monitor renal function

Kidney Impairment

No dose adjustment required for renal impairment, including end-stage renal disease; monitor renal function if severe GI reactions occur (risk of dehydration/AKI).

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 (no reconstitution); visually inspect the solution before injection-use only if clear to slightly opalescent and colorless to slightly yellow, and do not use if discolored or contains particles.

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).

Stopping the Medicine

Can be stopped without tapering, but glycemic control and weight benefits may diminish; consult prescriber before stopping.

Overdose

Likely symptoms: severe nausea/vomiting and hypoglycemia (especially with insulin/secretagogues). Management: supportive care, treat hypoglycemia with glucose, maintain hydration/monitor renal function; no specific antidote; seek urgent medical care.

Patient Counseling

Inject once weekly on the same day each week SC in abdomen/thigh/upper arm and rotate sites; may take with or without meals; do not shake. If changing the dosing day, ensure ≥72 hours between doses. Missed dose: take within 96 hours or skip. Common GI effects (nausea/diarrhea/vomiting/constipation) are expected early-eat smaller meals and stop when full. If using insulin or a sulfonylurea, monitor for hypoglycemia. Seek urgent care for severe/persistent abdominal pain (pancreatitis) or symptoms of gallbladder disease. Counsel on boxed warning risk of thyroid C-cell tumors and to report neck mass/hoarseness/dysphagia; avoid in patients with personal/family history of MTC or MEN2. If using oral contraceptives, use non-oral or add barrier contraception for 4 weeks after starting and after each dose increase. Store refrigerated 2-8°C; do not freeze.

Monitoring Requirements

Monitor glycemic control (SMBG as appropriate and HbA1c periodically), weight, and tolerability; monitor for pancreatitis symptoms and gallbladder disease; monitor renal function in patients with severe GI adverse reactions (dehydration risk); if pre-existing diabetic retinopathy, monitor for progression; monitor for hypoglycemia when used with insulin/sulfonylurea.

Pharmacology

Mechanism of Action

A dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist. It increases insulin secretion, reduces glucagon secretion, and slows gastric emptying to lower blood glucose levels and reduce appetite.

Duration of Effect

Approximately 1 week (supports once-weekly dosing).

Half-Life

Approximately 5 days (120 hours)

Metabolism

Proteolytic cleavage of the peptide backbone, beta-oxidation of the C18 fatty diacid moiety, and amide hydrolysis; not metabolized via CYP450 enzymes

Excretion

Elimination occurs via proteolytic degradation to amino acids/peptide fragments; intact tirzepatide is not expected to be excreted unchanged, and specific renal vs fecal excretion percentages are not characterized in labeling.

Product Information

Available Dosage Forms

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

Composition per Dose

Each 0.5 mL dose: 12.5 mg tirzepatide (as free peptide) in solution for injection

Generic Availability

No

OTC Alternatives

No OTC alternative

Diabetes Type

Type 2

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