Anvisa approved the registration of a new version of Mounjaro, a tirzepatide-based medication indicated for the treatment of adults with type 2 diabetes. The decision, published in Diário Oficial of Essa change differentiates the product from the previous version, for single use per pen.
The approval covers six concentrations in subcutaneous injectable solution: 4.17 mg/mL, 8.33 mg/mL, 12.5 mg/mL, 16.7 mg/mL, 20.8 mg/mL and 25 mg/mL. Registration was granted to Eli Lilly of Brasil through Resolução-RE nº 1,041, of Gerência-Geral of Medicamentos of
Mounjaro acts as a dual agonist of GIP and GLP-1 receptors, hormones that help control blood glucose and regulate appetite. The medication is administered weekly and should be used in conjunction with diet and exercise to improve glycemic control in patients with type 2 diabetes.
Change in pen shape
The main innovation of the approved version is the multidose pen, called Mounjaro Multidose. Patients can now administer multiple doses with the same device, which reduces the number of pens discarded throughout treatment.
This change facilitates adherence to the therapeutic regimen, especially for those who need progressive adjustments in dosage. The new presentation maintains the subcutaneous application mechanism, carried out by the patient himself after medical advice.
Indication and mechanism of action
Mounjaro remains exclusively indicated for the treatment of type 2 diabetes in adults. Tirzepatide stimulates insulin secretion in a glucose-dependent manner, reduces glucagon production and delays gastric emptying.
These effects contribute to the reduction of fasting and postprandial glucose levels. Estudos clinicians demonstrate that the medication promotes effective glycemic control and significant weight loss in patients with diabetes.
Dosage is started at lower levels and adjusted according to the patient’s response and tolerance to side effects. Use requires a prescription and regular medical monitoring.
Approval process and next steps
Anvisa evaluated quality, safety and efficacy data presented by the manufacturer to grant registration to the new presentation. The resolution was published after complete technical analysis by Gerência-Geral de Medicamentos.
Although registration is active, effective commercialization in pharmacies depends on pricing by Câmara of Regulação of Mercado of Medicamentos and the launch strategy of Eli Lilly of Brasil. Essas steps are necessary to make the product available on the national market.
Expected benefits for patients
The multidose pen represents a more practical option for the daily lives of those who perform weekly applications. Reducing the number of devices per treatment can reduce the environmental impact associated with the disposal of medical materials.
Patients with type 2 diabetes who use the medication report greater convenience with similar formats in other injectable therapies. Maintaining glycemic control remains the primary objective, with additional support in managing body weight.
The medicine must be stored refrigerated before first use and at room temperature after opening, according to the instructions in the leaflet.
Current availability of Mounjaro on Brasil
The single-use pen version already has a previous registration and is in the process of being introduced onto the market. Multidose approval expands the options available to doctors and patients.
Treatment with tirzepatide requires individualized assessment, considering health history and possible contraindications. Efeitos Common adverse events include nausea, diarrhea, and decreased appetite, which generally decrease over time.
