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POVIZTRA is a brand name for Semaglutide, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
g. Ozempic®, Rybelsus®) or any other GLP-1 receptor agonist. • In patients with Type 2 diabetes mellitus, monitor blood glucose prior to starting and during POVIZTRA™ treatment. Discontinuation of POVIZTRA™ in these patients may result in an increase in blood glucose.
1 Clinical Trial Adverse Reactions – Pediatrics, 14 CLINICAL TRIALS). • POVIZTRA™ is not a substitute for insulin. • POVIZTRA™ should be discontinued in cases of pregnancy, acute pancreatitis, or hypersensitivity reactions. 4 mg once-weekly is reached after 16 weeks as shown in Table 2.
Follow the dose escalation to reduce the likelihood of gastrointestinal symptoms. If patients do not tolerate a dose during dose escalation, consider delaying dose escalation for 4 weeks. 4 mg Adults (aged 18 years and older) Serious Warnings and Precautions • In rodents, semaglutide causes dose-dependent and treatment-duration- dependent thyroid C-cell tumours at clinically relevant exposures.
It is unknown whether POVIZTRA™ causes thyroid C-cell tumours, including medullary thyroid carcinoma (MTC), in humans as human relevance of semaglutide-induced rodent thyroid C-cell tumours has not been determined (see 7 WARNINGS AND PRECAUTIONS and 16 NON-CLINICAL TOXICOLOGY).
g. a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with POVIZTRA™ (see 2 CONTRAINDICATIONS, 7 WARNINGS AND PRECAUTIONS, 8 ADVERSE REACTIONS AND 16 NON-CLINICAL TOXICOLOGY).
7 mg weekly, for a maximum of 4 weeks. 4 mg dose. Pediatrics (aged 12 to less than 18 years) For adolescents from the age of 12 to less than 18 years old, the same dose escalation schedule as for adults should be applied (see Table 2).
4 mg once-weekly dose following the dose escalation schedule in Table 2. 7 mg once-weekly. 7 mg once-weekly dose. 4 mg or maximum tolerated dose; patients not demonstrating progress by 12 weeks of maintenance treatment are less likely to achieve and sustain clinically meaningful BMI improvement with continued treatment.
Patients with Type 2 diabetes mellitus Patients with Type 2 diabetes taking sulfonylureas or insulin have an increased risk of hypoglycemia when taking POVIZTRA™. When initiating POVIZTRA™, consider reducing the dose of concomitantly administered insulin or insulin secretagogues (such as sulfonylureas) to reduce the risk of hypoglycemia (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS).
Geriatrics (> 65 years of age) From population-PK modelling, no dose adjustment is required based on age (see 10 CLINICAL PHARMACOLOGY). Therapeutic experience of POVIZTRA™ is limited in patients ≥ 85 years of age. Pediatrics (< 12 years of age) The efficacy and safety of POVIZTRA™ in pediatric patients aged below 12 years have not been studied.
, 7 WARNINGS AND PRECAUTIONS, 8 ADVERSE REACTIONS AND 16 NON-CLINICAL TOXICOLOGY). 7 mg weekly, for a maximum of 4 weeks. 4 mg dose. Pediatrics (aged 12 to less than 18 years) For adolescents from the age of 12 to less than 18 years old, the same dose escalation schedule as for adults should be applied (see Table 2).
4 mg once-weekly dose following the dose escalation schedule in Table 2. 7 mg once-weekly. 7 mg once-weekly dose. 4 mg or maximum tolerated dose; patients not demonstrating progress by 12 weeks of maintenance treatment are less likely to achieve and sustain clinically meaningful BMI improvement with continued treatment.
Patients with Type 2 diabetes mellitus Patients with Type 2 diabetes taking sulfonylureas or insulin have an increased risk of hypoglycemia when taking POVIZTRA™. When initiating POVIZTRA™, consider reducing the dose of concomitantly administered insulin or insulin secretagogues (such as sulfonylureas) to reduce the risk of hypoglycemia (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS).
Geriatrics (> 65 years of age) From population-PK modelling, no dose adjustment is required based on age (see 10 CLINICAL PHARMACOLOGY). Therapeutic experience of POVIZTRA™ is limited in patients ≥ 85 years of age. Pediatrics (< 12 years of age) The efficacy and safety of POVIZTRA™ in pediatric patients aged below 12 years have not been studied.
POVIZTRA™ is not indicated for the treatment of pediatric patients below 12 year of age. Patients with renal insufficiency Based on population-PK modelling, no dosage adjustment is required for patients with renal insufficiency (see 10 CLINICAL PHARMACOLOGY).
POVIZTRA™ is not recommended for use in patients with end-stage renal disease (see 7 WARNINGS AND PRECAUTIONS, Renal, Acute Kidney Injury and 10 CLINICAL PHARMACOLOGY). Patients with hepatic insufficiency The efficacy and safety of POVIZTRA™ in patients with hepatic insufficiency has not been studied.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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POVIZTRA™ is not indicated for the treatment of pediatric patients below 12 year of age. Patients with renal insufficiency Based on population-PK modelling, no dosage adjustment is required for patients with renal insufficiency (see 10 CLINICAL PHARMACOLOGY).
POVIZTRA™ is not recommended for use in patients with end-stage renal disease (see 7 WARNINGS AND PRECAUTIONS, Renal, Acute Kidney Injury and 10 CLINICAL PHARMACOLOGY). Patients with hepatic insufficiency The efficacy and safety of POVIZTRA™ in patients with hepatic insufficiency has not been studied.
Therefore, POVIZTRA™ should be used with caution in this patient population (see 10 CLINICAL PHARMACOLOGY). 4 Administration POVIZTRA™ solution should be inspected visually prior to each injection and should be clear, colourless, and contain no particles.
Do not use POVIZTRA™ if particulate matter or colouration is seen. Administer POVIZTRA™ subcutaneously in the abdomen, thigh, or upper arm. e. POVIZTRA™ (semaglutide […]
Therefore, POVIZTRA™ should be used with caution in this patient population (see 10 CLINICAL PHARMACOLOGY). 4 Administration POVIZTRA™ solution should be inspected visually prior to each injection and should be clear, colourless, and contain no particles.
Do not use POVIZTRA™ if particulate matter or colouration is seen. Administer POVIZTRA™ subcutaneously in the abdomen, thigh, or upper arm. e. POVIZTRA™ (semaglutide injection) Product Monograph Page 8 of 73 rotate) the site of injection for each administration.
The time of day of the injection and the injection site can be changed without dose adjustment. Do not administer POVIZTRA™ intravenously or intramuscularly. Administer POVIZTRA™ once weekly, on the same day each week, at any time of day, with or without meals.
The day of weekly administration can be changed if necessary, as long as the time between two doses is at least 3 days (≥ 72 hours). 5 Missed Dose If a patient misses one dose and the next scheduled dose is at least 2 days (48 hours) away, instruct the patient to administer POVIZTRA™ as soon as possible.
If a patient misses one dose and the next schedule dose is less than 2 days (48 hours) away, inform the patient to not take that dose of POVIZTRA™. The patients can resume their once-weekly dosing as scheduled. If a patient misses more than 2 consecutive POVIZTRA™ doses, inform them to resume dosing as scheduled or, if needed, instruct them to reinitiate POVIZTRA™ according to the dose escalation schedule, which may reduce the occurrence of gastrointestinal symptoms associated with reinitiation of treatment.
5 Overdose Overdose with semaglutide or other GLP-1 receptor agonists may be associated with severe hypoglycemia, severe nausea and severe vomiting which could lead to dehydration. There is no specific antidote for overdose with POVIZTRA™.
In the event of overdose the patient should be observed for clinical signs and appropriate supportive treatment initiated according to the patient’s clinical signs and symptoms. A prolonged period of observation and treatment for these symptoms may be necessary, taking into account the long half-life of semaglutide of approximately 1 week.
For management of a suspected drug overdose, contact your regional poison control centre. 6 Dosage Forms, Strengths, Composition and Packaging To help ensure the traceability of biologic products, healthcare professionals should record both the brand name and the non-proprietary (active ingredient) name as well as other product- specific identifiers such as the Drug Identification Number (DIN) and the batch/lot number of the product supplied.
4. 25 mg dose pen: POVIZTRA™ is provided in a pre-filled, fixed dose, single-use disposable pen. 5 mg of semaglutide. 5 mg dose pen: POVIZTRA™ is provided in a pre-filled, fixed dose, single-use disposable pen. One mL of solution contains 1 mg of semaglutide.
5 mL 1 mg dose pen: POVIZTRA™ is provided in a pre-filled, fixed dose, single-use disposable pen. One mL of solution contains 2 mg of […]