- Approval Id
- 2f288ad7c425dac8
- Drug Name
- MOUNJARO INJECTION 12.5MG/0.5ML
- Product Name
- MOUNJARO INJECTION 12.5MG/0.5ML
- Approval Number
- SIN16719P
- Approval Date
- 2023-03-01
- Registrant
- DKSH SINGAPORE PTE. LTD.
- Licence Holder
- DKSH SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, SOLUTION
- Dosage
- **2 DOSAGE AND ADMINISTRATION**
**2.1 Dosage**
- The recommended starting dosage of MOUNJARO is 2.5 mg injected subcutaneously once weekly. The 2.5 mg dosage is for treatment initiation and is not intended for glycemic control.
- After 4 weeks, increase the dosage to 5 mg injected subcutaneously once weekly.
- If additional glycemic control is needed, increase the dosage in 2.5 mg increments after at least 4 weeks on the current dose.
- The maximum dosage of MOUNJARO is 15 mg injected subcutaneously once weekly.
- If a dose is missed, instruct patients to administer MOUNJARO 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.
- The day of weekly administration can be changed, if necessary, as long as the time between the two doses is at least 3 days (72 hours).
**2.2 Important Administration Instructions**
- Administer MOUNJARO once weekly, any time of day, with or without meals.
- Inject MOUNJARO subcutaneously in the abdomen, thigh, or upper arm.
- Rotate injection sites with each dose.
- 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.
- 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.
- In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
- Route Of Administration
- SUBCUTANEOUS
- Indication Info
- **1 INDICATIONS AND USAGE**
MOUNJARO™ is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Limitations of Use
- MOUNJARO has not been studied in patients with a history of pancreatitis _\[see Warnings and Precautions (5.2)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_.
- MOUNJARO is not indicated for use in patients with type 1 diabetes mellitus.
- Contraindications
- **4 CONTRAINDICATIONS**
MOUNJARO is contraindicated 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) _\[see Warnings and Precautions (5.1)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_.
- Known serious hypersensitivity to tirzepatide or any of the excipients in MOUNJARO _\[see Warnings and Precautions (5.4)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_ _\]_.
- Atc Code
- Pending
- Atc Item Name
- xpending
- Pharma Manufacturer Name
- DKSH SINGAPORE PTE. LTD.
- Company Detail Path
- /organization/cbda6ad0d0b82155/dksh-singapore-pte-ltd
