Mounjaro

Tirzepatide

Treatment of adults w/ insufficiently controlled type 2 DM as an adjunct to diet & exercise: as monotherapy when metformin is considered inappropriate due to intolerance or contraindications; in addition to other medicinal products for diabetes treatment. Wt management, including wt loss & maintenance, as an adjunct to a reduced-calorie diet & increased physical activity in adults w/ an initial BMI of ≥30 kg/m², or ≥27 to <30 kg/m² in the presence of at least 1 wt-related comorbid condition (eg, HTN, dyslipidaemia, obstructive sleep apnoea, CV disease, prediabetes, or type 2 DM).

SC Initially 2.5 mg once wkly. After 4 wk, increase to 5 mg once wkly. If needed, increase dose in 2.5 mg increments after a min of 4 wk on the current dose. Recommended maintenance doses: 5 mg, 10 mg & 15 mg. Max dose: 15 mg once wkly.

May be taken with or without food.

Hypersensitivity.

Rotate inj sites w/ each dose. Mounjaro should be injected into a different inj site if insulin is also being injected. Consider individual benefit/risk profile when deciding on whether to continue treatment if patients have been unable to lose at least 5% of their initial body wt 6 mth after titrating to the highest tolerated dose. Reports of acute pancreatitis. Increased risk of hypoglycaemia in patients receiving tirzepatide in combination w/ an insulin secretagogue (eg, sulphonylurea) or insulin. Associated w/ GI adverse reactions, including nausea, vomiting, & diarrhoea, which may lead to dehydration, which could lead to deterioration in renal function including acute renal failure. Contains 5.4 mg benzyl alcohol in each 0.6 mL dose; patients w/ hepatic or renal impairment should be informed of the potential risk of metabolic acidosis due to accumulation of benzyl alcohol over time. Has not been studied in patients w/ history of pancreatitis; severe GI disease, including severe gastroparesis; non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy, or diabetic macular oedema. Limited experience in patients w/ severe renal impairment & ESRD; severe hepatic impairment. Not recommended during pregnancy & in women of childbearing potential not using contraception. Discontinue treatment at least 1 mth before a planned pregnancy. Discontinue breast-feeding or discontinue/abstain from tirzepatide therapy. Safety & efficacy in childn <18 yr have not yet been established. Very limited data are available in elderly ≥85 yr.

Nausea, diarrhoea. Hypersensitivity reactions; abdominal pain, dyspepsia, abdominal distention, eructation, flatulence, GERD; fatigue, inj site reactions; increased lipase. Type 2 DM: Hypoglycaemia (when used w/ sulphonylurea or insulin). Hypoglycaemia (when used w/ metformin & SGLT2 inhibitor), decreased appetite; vomiting, constipation; increased heart rate, increased amylase. Wt management: Vomiting, constipation. Dizziness; hypotension-related events; hair loss.

Potential to impact the absorption rate of concomitantly administered oral medicinal products. Monitor patients on oral medicinal products w/ narrow therapeutic index (eg, warfarin, digoxin), especially at initiation of tirzepatide treatment & following dose increase. Consider risk of delayed effect in oral medicinal products for which a rapid onset of effect is of importance. Limited information about tirzepatide's effect on the pharmacokinetics & efficacy of OCs in obese or overweight women; reduced efficacy of OCs cannot be excluded.

Antidiabetic Agents / Anti-Obesity Agents

A10BX16 - tirzepatide ; Belongs to the class of other blood glucose lowering drugs excluding insulins. Used in the treatment of diabetes.

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