Mounvia 2.5 SC Injection
Tirzepatide
2.5 mg/0.5 ml
Synovia Pharma PLC
| Pack size | 5 mg pre-filled |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 2000.00 AED |
Available as:
Indications
Mounvia 2.5 SC Injection is used for:
Obesity, Type 2 Diabetes Mellitus
Adult Dose
Injection
Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
2.5 mg SC once weekly for 4 weeks initially; THEN increase to 5 mg SC once weekly
If additional glycemic control is needed, increase by 2.5-mg increments after at least 4 weeks at the current dose
Maximum dose: 15 mg SC once weekly
Note: 2.5-mg dose is intended for treatment initiation and is not effective for glycemic control
Hepatic impairment
Any stage: No dosage adjustment required
Child Dose
Renal Dose
Renal impairment
Any stage, including end-stage renal disease: No dosage adjustment is required
Administration
SC Preparation
Inspect visually before use
Solution should appear clear and colorless to slightly yellow; discard if particulate matter or discoloration observed
When using with insulin, administer as separate injections and never mix
May inject tirzepatide and insulin in same body region, but injections should not be adjacent to each other
SC Administration
Administer SC in abdomen, thigh, or upper arm
Rotate injection site with each dose
Administer once weekly, at any time of day, with or without meals
Change day of weekly administration: May be changed, if necessary, as long as time between 2 doses is at least 3 days (72 hr)
Contra Indications
Known hypersensitivity to tirzepatide or to any of the product components
Personal or family history of MTC or in patients with multiple endocrine neoplasia syndrome type 2
Precautions
Based on findings in rats and mice, may cause thyroid C-cell tumors, including MTC, in humans; human relevance of tirzepatide-induced rodent thyroid C-cell tumors has not been determined
Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, observed in patients treated with GLP-1 receptor agonists; after initiating, monitor for signs and symptoms of pancreatitis (eg, persistent severe abdominal pain, which sometimes radiates to the back and may or may not be accompanied by vomiting); if pancreatitis suspected, discontinue and do not restart if confirmed
Rapid improvement in glucose control associated with temporary worsening of diabetic retinopathy; tirzepatide has not been studied in patients with nonproliferative diabetic retinopathy requiring acute therapy, proliferative diabetic retinopathy, or diabetic macular edema; monitor patients with a history of diabetic retinopathy
Gastrointestinal (GI) adverse reactions, sometimes severe, reported; has not been studied in patients with severe GI disease, including severe gastroparesis, and is not recommended in these patients
Acute gallbladder disease (eg, cholelithiasis, cholecystitis) reported in GLP-1 receptor agonist trials and postmarketing surveillance; if suspected, gallbladder studies and appropriate clinical follow-up are indicated
Kidney injury
Acute kidney injury and worsening of chronic renal failure, which may sometimes require hemodialysis in patients treated with GLP-1 receptor agonists, has been described
Most reported events occurred in patients who had experienced nausea, vomiting, diarrhea, or dehydration
Events also reported in patients without known underlying renal disease
Monitor renal function when initiating or escalating doses in patients reporting severe adverse GI reactions
Pregnancy-Lactation
Pregnancy
Data are insufficient regarding use in pregnant females to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
Based on animal reproduction studies, there may be risks to the fetus from tirzepatide exposure during pregnancy
Use during pregnancy only if potential benefit justifies the potential risk to the fetus
Clinical considerations
Poorly controlled diabetes in pregnancy increases maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications
Poorly controlled diabetes increases fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity
Contraception
Tirzepatide may reduce efficacy of oral hormonal contraceptives owing to delayed gastric emptying
This delay is largest after the first dose and diminishes over time
Advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive method or to add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation
Animal studies
In pregnant rats administered tirzepatide during organogenesis, fetal growth reductions and fetal abnormalities occurred at clinical exposure based on AUC
In rabbits administered tirzepatide during organogenesis, fetal growth reductions were observed at clinically relevant exposures based on AUC
Increased incidences of external, visceral, and skeletal malformations observed
These increased effects coincided with pharmacologically-mediated reductions in maternal body weights and food consumption
Lactation
Data are unavailable on presence of drug in animal or human milk, effects on breastfed infants, or effects on milk production
Interactions
Insulin secretagogues or insulin
May require dosage modification
Coadministration with insulin secretagogues (eg, sulfonylureas) or insulin may increase risk of hypoglycemia
Consider lower dose of secretagogue or insulin to reduce risk of hypoglycemia
Inform patients using concomitant medications of risk of hypoglycemia and educate them on signs and symptoms of hypoglycemia
Oral drugs with narrow therapeutic index
Caution/dosage modification
Tirzepatide may delay gastric emptying, thereby potentially impacting oral absorption
Caution with drugs having a narrow therapeutic index (eg, warfarin)
Advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive method, or to add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each tirzepatide dose escalation
Adverse Effects
Side effects of Tirzepatide :
>10%
Blood glucose <54 mg/dL (added to basal insulin) (14-19%)
Nausea (12-18%)
Diarrhea (12-17%)
Decreased appetite (5-11%)
Zepbound
Nausea (25-28%)
Diarrhea (19-23%)
Constipation (11-17%)
Vomiting (8-13%)
1-10%
Vomiting (5-9%)
Dyspepsia (5-8%)
Constipation (5-7%)
Abdominal pain (5-6%)
Injection site reactions (3.2%)
Hypersensitivity reactions (3.2%)
Severe hypoglycemia (add-on to basal insulin) (1-2%)
<1%
Acute gallbladder disease (0.6%)
Mechanism of Action
Dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist
GIP is an incretin hormone that induces insulin secretion in response to a meal (primarily by hyperosmolarity of glucose in the duodenum) to facilitate the metabolism of carbohydrates, fats, and proteins
GLP-1 receptor agonists increase insulin secretion in the presence of elevated blood glucose, suppress glucagon postprandially, delay gastric emptying to decrease postprandial glucose, and decrease glucagon secretion
Pharmacodynamic effects observed include lower fasting and postprandial glucose concentration, decreased food intake, and reduced body weight
Delays gastric emptying; delay is largest after first dose and this effect diminishes over time
Note
Mounvia 2.5 2.5 mg/0.5 ml SC Injection manufactured by Synovia Pharma PLC. Its generic name is Tirzepatide. Mounvia 2.5 is availble in Bangladesh.
Farmaco BD drug index information on Mounvia 2.5 SC Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.