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MOUNJARO KWIKPEN is a brand name for Tirzepatide, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: MOUNJARO (tirzepatide injection) is indicated for once-weekly administration as an adjunct to diet and exercise to improve glycemic control for the treatment of adult patients with type 2 diabetes mellitus. • As monotherapy when metformin is inappropriate due to contraindication or intolerance. • In combination with:…
Verbatim from this product's HC label. Tap a section to expand.
3 Pharmacokinetics). 2 CONTRAINDICATIONS MOUNJARO is contraindicated: • in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non- medicinal ingredient (including benzyl alcohol when using MOUNJARO KwikPen), or component of the container (see 7 WARNINGS AND PRECAUTIONS).
(For a complete listing of the ingredients, see
and 16 NON-CLINICAL TOXICOLOGY). 1 Dosing Considerations An increased risk of hypoglycemia was seen with concomitant use of a sulfonylurea or basal insulin with MOUNJARO To reduce the risk of hypoglycemia, a reduction in the dose of insulin secretagogue or insulin should be considered when MOUNJARO is added to either of these existing therapies.
In a clinical trial in patients with a baseline HbA1c ≤8%, the basal insulin dose was decreased by 20% when treatment with MOUNJARO was initiated (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS). 5 mg injected subcutaneously only once weekly.
5 mg dosage is for treatment initiation and is not intended for glycemic control. After 4 weeks, increase the dose to 5 mg injected subcutaneously once weekly. 5 mg increments after no less than 4 weeks on the current dose. • The maximum dose is 15 mg injected subcutaneously once weekly.
3 Pharmacokinetics). 3 Pharmacokinetics). 3 Pharmacokinetics). • Pediatrics (<18 years): The safety and effectiveness of MOUNJARO have not been studied in patients under 18 years of age. 3 Pediatrics). 4 Administration • Prior to initiation of MOUNJARO, train patients on proper injection technique.
Advise the patient to carefully read the Instructions for Use included with the Patient Medication Information leaflet before administering the medicinal product. 5 mL dose volume). • Administer MOUNJARO once weekly, any time of day, with or without meals.
MOUNJARO should not be administered daily. • MOUNJARO is to be injected subcutaneously in the abdomen, in the thigh, or in the upper arm. Rotate injection sites with each dose. • Visually inspect MOUNJARO before use. It should appear clear and colourless to slightly yellow.
Do not use MOUNJARO if particulate matter or discoloration is seen. • When using MOUNJARO with insulin, administer as separate injections and never mix. It is acceptable to inject MOUNJARO and insulin in the same body region, but the injections should not be adjacent to each other.
1 Dosing Considerations and 7 WARNINGS AND PRECAUTIONS). Limitations of Use MOUNJARO has not been studied in combination with short-acting, medium-acting, or dual formulation insulins. MOUNJARO is not a substitute for insulin. MOUNJARO should not be used in patients with type 1 diabetes mellitus (formerly known as insulin-dependent diabetes mellitus or IDDM).
MOUNJARO should not be used for the treatment of diabetic ketoacidosis. 1 Pediatrics Pediatrics (<18 years of age): The safety and efficacy of MOUNJARO have not been studied in pediatric patients. MOUNJARO is not indicated for use in pediatric patients.
3 Pharmacokinetics). 2 CONTRAINDICATIONS MOUNJARO is contraindicated: • in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non- medicinal ingredient (including benzyl alcohol when using MOUNJARO KwikPen), or component of the container (see 7 WARNINGS AND PRECAUTIONS).
(For a complete listing of the ingredients, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). • in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) (see 7 WARNINGS AND PRECAUTIONS).
2 Breast-feeding). MOUNJARO and MOUNJARO KwikPen (tirzepatide injection) Page 5 of 61 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions RISK OF THYROID C-CELL TUMORS • Tirzepatide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors (adenomas and carcinomas) at clinically relevant exposures in male and female rats (see 16 NON-CLINICAL TOXICOLOGY).
It is unknown whether MOUNJARO causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC) in humans. The human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined (see 7 WARNINGS AND PRECAUTIONS).
MOUNJARO is contraindicated: • in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non- medicinal ingredient (including benzyl alcohol when using MOUNJARO KwikPen), or component of the container (see 7 WARNINGS AND PRECAUTIONS).
(For a complete listing of the ingredients, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). • in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) (see 7 WARNINGS AND PRECAUTIONS).
2 Breast-feeding). MOUNJARO and MOUNJARO KwikPen (tirzepatide injection) Page 5 of 61
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Tirzepatide in Canada.
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• MOUNJARO should not be administered intramuscularly or intravenously. • Patients using the single-dose prefilled pen or vial go through 4 different pens or vials per month. • Patients using the multi-dose prefilled pen (MOUNJARO KwikPen) go through 1 MOUNJARO KwikPen per month as one pen delivers 4 doses of the same concentration of tirzepatide.
5 Missed Dose If a dose is missed, instruct patients to administer 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. Changing Weekly Dosing Schedule The day of weekly administration can be changed, if necessary, as long as the time between two doses is at least 3 days (72 hours).
, nausea). In the event of overdose, appropriate supportive care (including frequent blood glucose monitoring) should be initiated according to the patient’s clinical signs and symptoms. A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the long half-life of MOUNJARO.
For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING MOUNJARO is a clear and colourless to slightly yellow solution that is free of particles.
Table 1 lists the dosage forms, strengths, composition, and packaging for each presentation. 5 mL Hydrochloric acid solution, sodium chloride, sodium hydroxide solution, sodium phosphate dibasic heptahydrate, water for injection (preservative-free).
4 mL) Benzyl alcohol (preservative), glycerin, hydrochloric acid solution, phenol (preservative), sodium chloride, sodium hydroxide solution, sodium phosphate dibasic heptahydrate, water for injection. MOUNJARO is packaged in a cardboard outer carton and is available in packs of 4 single-dose prefilled pens, or individual single-dose vial.
MOUNJARO KwikPen is packaged in a cardboard outer carton and is available as an individual multi-dose prefilled pen. 7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. 4 mg benzyl […]
• MOUNJARO is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumors.
Patients should be counseled regarding the risk and symptoms of thyroid tumors (see 2 CONTRAINDICATIONS, 7 WARNINGS AND PRECAUTIONS,