Mounjaro KwikPen

Mounjaro KwikPen

tirzepatide

Manufacturer:

Eli Lilly Italia

Distributor:

Zuellig
Concise Prescribing Info
Contents
Tirzepatide
Indications/Uses
Adjunct to diet & exercise in adults w/ insufficiently controlled type 2 DM as monotherapy when metformin is considered inappropriate due to intolerance or contraindications, or in addition to other medicinal products for the treatment of diabetes. Adjunct to reduced-cal diet & increased physical activity for wt management including wt loss & maintenance in adults w/ initial BMI ≥30 kg/m2 (obesity), or ≥27 to <30 kg/m2 (overwt) in the presence of at least 1 wt-related comorbid condition (eg, HTN, dyslipidaemia, obstructive sleep apnoea, CV disease, prediabetes or type 2 DM).
Dosage/Direction for Use
SC Administer in the abdomen, thigh or upper arm. Initially 2.5 mg once wkly, increased to 5 mg once wkly after 4 wk. If needed, increase dose in 2.5 mg-increments after min of 4 wk on current dose. Recommended maintenance dose: 5, 10 & 15 mg. Max dose: 15 mg once wkly.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Personal or family history of medullary thyroid carcinoma or in patients w/ multiple endocrine neoplasia syndrome type 2.
Special Precautions
Discontinue use if pancreatitis is suspected; do not restart if pancreatitis diagnosis is confirmed. Rotate inj sites w/ each dose. Should be injected into a different inj site if insulin is also injected. Increased risk of hypoglycaemia in combination w/ 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. Caution in patients w/ history of pancreatitis; severe GI disease eg, severe gastroparesis; non-proliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy or diabetic macular oedema. Aspiration in association w/ general anaesth or deep sedation. Contains benzyl alcohol. Ensure to avoid fluid depletion & electrolyte disturbances especially in elderly. Caution in patients to avoid hypoglycaemia while driving & using machines. Caution in patients w/ severe renal or hepatic impairment, & ESRD. Women of childbearing potential should use effective contraception. Not recommended during pregnancy & in women of childbearing potential not using contraception. Discontinue use at least 1 mth before planned pregnancy. Discontinue breastfeeding or discontinue/abstain from therapy taking into account the benefit of breastfeeding for the child & woman. Safety & efficacy in childn <18 yr have not yet been established. Limited data in elderly ≥85 yr.
Adverse Reactions
Hypoglycaemia (w/ sulphonylurea or insulin); nausea, diarrhoea, vomiting, abdominal pain, constipation. Hypersensitivity reactions; hypoglycaemia (w/ metformin & SGLT2i), decreased appetite; dizziness; hypotension; dyspepsia, abdominal distention, eructation, flatulence, GERD; hair loss; fatigue, inj site reactions; increased heart rate, lipase, amylase, & blood calcitonin.
Drug Interactions
Potential impact on absorption rate of concomitantly administered oral medicinal products. Monitor patients on concomitant oral medicinal products w/ narrow therapeutic index (eg, warfarin, digoxin), especially at initiation of tirzepatide treatment & following dose increase. Risk of delayed effect w/ oral medicinal products for which rapid onset of effect is of importance. Reduced Cmax & delayed median tmax of paracetamol.
MIMS Class
Antidiabetic Agents / Anti-Obesity Agents
ATC Classification
A10BX16 - tirzepatide ; Belongs to the class of other blood glucose lowering drugs excluding insulins. Used in the treatment of diabetes.
Presentation/Packing
Form
Mounjaro KwikPen soln for SC inj 10 mg/0.6 mL
Packing/Price
4 dose x 1's;4 dose x 3 × 1's
Form
Mounjaro KwikPen soln for SC inj 12.5 mg/0.6 mL
Packing/Price
4 dose x 1's;4 dose x 3 × 1's
Form
Mounjaro KwikPen soln for SC inj 15 mg/0.6 mL
Packing/Price
4 dose x 1's;4 dose x 3 × 1's
Form
Mounjaro KwikPen soln for SC inj 2.5 mg/0.6 mL
Packing/Price
4 dose x 3 × 1's;4 dose x 1's
Form
Mounjaro KwikPen soln for SC inj 5 mg/0.6 mL
Packing/Price
4 dose x 3 × 1's;4 dose x 1's
Form
Mounjaro KwikPen soln for SC inj 7.5 mg/0.6 mL
Packing/Price
4 dose x 3 × 1's;4 dose x 1's