Specification
Composition
Tizaro 2.5 mg injection: Each pre-filled syringe contains Tirzepatide INN 2.5 mg in0.5 ml solution for injection.
Tizaro 5 mg injection: Each pre-filled syringe contains Tirzepatide INN 5 mg in 0.5ml solution for injection.
Tizaro 7.5 mg injection: Each pre-filled syringe contains Tirzepatide INN 7.5 mg in0.5 ml solution for injection.
Description
Tizaro is a once weekly antihyperglycemic medication. Tizaro contains an activesubstance called Tirzepatide is used to treat adults with type 2 diabetes mellitus.Tirzepatide acts as a GLP-1/GIP receptor dual agonist that selectively binds to andactivates both the GLP-1 and GIP receptor, increases the activity of GLP-1 andGIP. Tizaro reduces the level of sugar in the body through a mechanism of where itstimulates insulin secretion as well as lowers glucagon levels, both inglucose-dependent manner. Thus, when blood glucose is high, insulin secretion isstimulated and glucagon secretion is inhibited. The mechanism of blood glucoselowering also involves the delay in gastric emptying in the early postprandial phase.Tizaro is used on its own when a patient can’t take metformin or with othermedicines for diabetes when they are not enough to control your blood sugarlevels. These other medicines may be taken by mouth and/or insulin given byinjection. It is important to continue to follow the advice on diet and exercise givento patients by the physician.
Indication
Tizaro is a glucose-dependent insulinotropic polypeptide (GIP) receptor andglucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to dietand exercise to improve glycemic control in adults with type-2 diabetes mellitus. Italso indicated for overweight or obesity with or without diabetes.
Limitations of Use:
- Has not been studied in patients with a history of pancreatitis
- Is not indicated for use in patients with type-1 diabetes mellitus
Dosage and Administration
Tizaro is injected subcutaneously and can be taken at any time of day, regardlessof the timing of meals.
Dosage and Administration
Tizaro is injected subcutaneously and can be taken at any time of day, regardless
of the timing of meals.
|
Starting Dose |
Maintenance Dose |
For Additional Glycemic Control |
|
Start Tizaro with 2.5mg once weekly for4weeks |
After 4 weeks increasethe dose to 5 mg onceweekly |
If additional glycemic control isneeded, increase the dosage in2.5 mg increments after at least4 weeks on the current dose. |
Dose Adjustment:
When Tirzepatide is added with Metformin and/or thiazolidinedione therapy, thecurrent dose of metformin and/or thiazolidinedione can be continued unchanged.When Tirzepatide is added with existing therapy of insulin secretagogue(Sulfonylureas) or insulin, a reduction in the dose of sulfonylurea or insulin shouldbe considered to reduce the risk of hypoglycemia. Blood glucose self-monitoring isnecessary to adjust the dose of tirzepatide is started and insulin is reduced. If adose is missed, administer Tizaro as soon as possible within 4 days (96 hours)after the missed dose.
Contraindications
Personal or family history of medullary thyroid carcinoma or in patients withMultiple Endocrine Neoplasia syndrome typeKnown serious hypersensitivity to tirzepatide or any of the excipients
Warnings & Precautions
Pancreatitis: Has been reported in clinical trials. Discontinue promptly ifpancreatitis is suspected.
Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin:Concomitant use with an insulin secretagogue or insulin may increase the risk ofhypoglycemia, including severe hypoglycemia. Reducing dose of insulinsecretagogue or insulin may be necessary.Hypersensitivity Reactions: Hypersensitivity reactions have been reported.Discontinue, if suspected.
Acute Kidney Injury: Monitor renal function in patients with renal impairmentreporting severe adverse gastrointestinal reactions.Severe Gastrointestinal Disease: Use may be associated with gastrointestinaladverse reactions, sometimes severe. Has not been studied in patients withsevere gastrointestinal disease and is not recommended in these patients.Diabetic Retinopathy Complications in Patients with a History of DiabeticRetinopathy: Has not been studied in patients with non-proliferative diabeticretinopathy requiring acute therapy, proliferative diabetic retinopathy, or diabeticmacular edema. Monitor patients with a history of diabetic retinopathy for progression.Acute Gallbladder Disease: Has occurred in clinical trials. If cholelithiasis issuspected, gallbladder studies and clinical follow up are indicated.
Adverse Reactions
The most common adverse reactions, reported in >5% of patients are: nausea,diarrhea, decreased appetite, vomiting, constipation, dyspepsia, and abdominal pain.
Drug Interactions
Delays gastric emptying and has the potential to impact the absorption ofconcomitantly administered oral medications.
Use in Specific Populations
Pregnancy: Based on animal study, may cause fetal harm.Females of Reproductive Potential: Advise females using oral contraceptives toswitch to a non-oral contraceptive method, or add a barrier method ofcontraception for 4 weeks after initiation and for 4 weeks after each doseescalation.
Storage and Handling
Store in a refrigerator at 2°C to 8°C (36°F to 46°F).If needed, each single-dose syringe can be stored unrefrigerated at temperaturesnot to exceed 30°C (86°F) for up to 21 days.Do not freeze. Do not use, if frozen.
Store in the original carton to protect from light.
Packaging
Tizaro 2.5 mg Injection: Each box contains 1 pre-filled syringe of 0.5 ml solution ofTirzepatide 2.5 mg injection.
Tizaro 5 mg Injection: Each box contains 1 pre-filled syringe of 0.5 ml solution of
Tirzepatide 5 mg injection.
Tizaro 7.5 mg Injection: Each box contains 1 pre-filled syringe of 0.5 ml solution ofTirzepatide 7.5 mg injection.
