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INDICATIONS
Cheapest place to buy saxenda online uk. SAXENDA® (liraglutide injection) is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of:
• 30 kg/m2 or greater (obesity), or
• 27 kg/m2 or greater (overweight) in the presence of at least one weight-related
comorbidity (e.g., hypertension, type 2 diabetes, or dyslipidemia) and who have failed a previous weight management intervention.
Limitation of Use:
1. Clinical efficacy and safety data from patients with BMI 27 to 29.9 kg/m2 in the presence
of at least one weight-related comorbid condition (e.g. hypertension, type 2 diabetes mellitus, or dyslipidemia) are limited (N=149).
Cheapest place to buy saxenda online uk. SAXENDA® is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in pediatric patients aged 12 to less than 18 years with:
- an inadequate response to reduced calorie diet and increased physical activity alone, and
- a body weight above 60 kg (132 lbs), and
- an initial body mass index (BMI) corresponding to ≥30 kg/m2 for adults (obesity) byinternational cut-offs* (see Table 1).Limitations of Use:
1. The safety and effectiveness of SAXENDA® in pediatric patients with type 2 diabetes
have not been established.
Serious Warnings and Precautions
Risk of Thyroid C-cell Tumours
Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumours at clinically relevant exposures in both genders of rats and mice (see NON-CLINICAL TOXICOLOGY). It is unknown whether liraglutide causes thyroid C-cell tumours, including medullary thyroid carcinoma (MTC), in humans, as human relevance could not be ruled out by clinical or nonclinical studies. Cheapest place to buy saxenda online uk.
SAXENDA® is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Based on the findings in rodents, monitoring with serum calcitonin or thyroid ultrasound was performed during clinical trials, but this may have increased the number of unnecessary thyroid surgeries. It is unknown whether monitoring with serum calcitonin or thyroid ultrasound will mitigate human risk of thyroid C-cell tumours. Patients should be counselled regarding the risk and symptoms of thyroid tumours (see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, ADVERSE DRUG REACTIONS AND TOXICOLOGY).
Cheapest place to buy saxenda online uk. DOSAGE AND ADMINISTRATION
Determine the patient’s BMI. BMI is calculated by dividing weight in (kilograms) by height (in meters) squared.
Dosing ConsiderationsSAXENDA® and Victoza® contain the same active ingredient (liraglutide) and therefore should not be used together. SAXENDA® and Victoza® are not a substitute for each other.
Cheapest place to buy saxenda online uk. SAXENDA® and insulin should not be used together. SAXENDA® has not been studied in patients taking insulin.
For Patients with Type 2 Diabetes Mellitus:
SAXENDA® should not be used in combination with another GLP-1 receptor agonist.
When initiating SAXENDA®, consider reducing the dose of concomitantly administered insulin secretagogues (such as sulfonylureas) to reduce the risk of hypoglycemia (see WARNINGS AND PRECAUTIONS, Endocrine and Metabolism and ADVERSE REACTIONS).
SAXENDA® is not a substitute for insulin.
Discontinuation of SAXENDA® in patients with type 2 diabetes may result in an increase in blood glucose.
Recommended Dose and Dosage Adjustment
In adults with an initial BMI of 27 kg/m2 or greater, the recommended daily maintenance dose is 3.0 mg/day. Daily doses higher than 3.0 mg are not recommended.
Cheapest place to buy saxenda online uk. For all patients, the dose escalation schedule in Table 2 should be used to reduce the likelihood of gastrointestinal symptoms. If patients do not tolerate an increased dose during dose escalation, the dose escalation can be changed with a total delay of up to 7 days.
Table 2: Dose escalation schedule
Dose escalation 4 weeks
Maintenance dose
Dose
0.6 mg 1.2 mg 1.8 mg 2.4 mg
3.0 mg
Weeks
1 1 1 1
The 0.6, 1.2, 1.8, and 2.4 mg doses are intended to reduce gastrointestinal symptoms during initial dose escalation.
Treatment with SAXENDA® should be discontinued after 12 weeks on the 3.0 mg/day dose if a patient has not lost at least 5% of their initial body weight (see CLINICAL TRIALS).
Cheapest place to buy saxenda online uk. Pediatrics (aged 12 to less than 18 years): For pediatric patients aged 12 to less than 18 years, similar dose escalation schedule as for adults should be applied (see Table 2). The dose should be increased until 3.0 mg (maintenance dose) or maximum tolerated dose has been reached. Daily doses higher than 3.0 mg are not recommended. Pediatric patients who do not tolerate 3 mg daily may have their maintenance dose reduced to 2.4 mg daily. Discontinue SAXENDA® if the patient cannot tolerate the 2.4 mg dose. If pediatric patients do not tolerate an increased dose during dose escalation, the dose may also be lowered to the previous level. Dose escalation for pediatric patients may take up to 8 weeks.
Evaluate the change in BMI after 12 weeks on the maintenance dose and discontinue SAXENDA® if the patient has not had a reduction in BMI of at least 1% from baseline, since it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment. Cheapest place to buy saxenda online uk.
Administration
SAXENDA® should be taken once daily at any time of day, independent of meals.
SAXENDA® can be injected subcutaneously in the abdomen, thigh or upper arm. The injection site and timing can be changed without dose adjustment. SAXENDA® must not be administered intravenously or intramuscularly.
SAXENDA® solution should be inspected prior to each injection, and the solution should be used only if it is clear, colourless, and contains no particles.
Missed Dose
If a dose is missed, the once-daily regimen should be resumed as prescribed with the next scheduled dose. An extra dose or increase in dose should not be taken to make-up for the missed dose.
Based on the elimination half-life, patients should be advised to reinitiate SAXENDA® at 0.6 mg if more than 3 days have elapsed since the last SAXENDA® dose. This approach will mitigate any gastrointestinal symptoms associated with re-initiation of treatment.
OVERDOSAGE
Overdoses have been reported in clinical trials and post-marketing use of liraglutide. Effects have included severe nausea and severe vomiting. Severe hypoglycemia has also been observed. In the event of overdosage, appropriate supportive treatment should be initiated according to the patient’s clinical signs and symptoms. The patient should be observed for clinical signs of dehydration and blood glucose should be monitored. Cheapest place to buy saxenda online uk.
For management of a suspected drug overdose, contact your regional poison control centre.
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
To help ensure the traceability of biologic products, including biosimilars, health professionals should recognise the importance of recording 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. Cheapest place to buy saxenda online uk.
Table – Dosage Forms, Strengths, Composition and Packaging
Route of Dosage Form / Administration Strength/Composition
Non-medicinal Ingredients
|
subcutaneous |
Injectable, 6 mg/mL |
Disodium phosphate dihydrate, propylene glycol, phenol and water for injections. For a complete listing see Dosage Forms, Composition and Packaging section. |
SAXENDA® is a solution for subcutaneous injection pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3.0 mg (6 mg/mL, 3 mL). SAXENDA® is available in the following package sizes containing disposable, pre-filled, multi-dose pens:
5 x SAXENDA®
Each SAXENDA® pen is for use by a single patient. A SAXENDA® pen should never be shared between patients, even if the needle is changed.
DESCRIPTION
SAXENDA® contains liraglutide, an analog of human GLP-1 and acts as a GLP-1 receptor agonist. The peptide precursor of liraglutide, produced by a process that includes expression of recombinant DNA in Saccharomyces cerevisiae, has been engineered to be 97% homologous to native human GLP-1 by substituting arginine for lysine at position 34. Liraglutide is made by attaching a C-16 fatty acid (palmitic acid) with a glutamic acid spacer on the remaining lysine residue at position 26 of the peptide precursor. Cheapest place to buy saxenda online uk
SAXENDA® is a clear, colourless solution. Each 1 mL of SAXENDA® solution contains 6 mg of liraglutide. Each pre-filled pen contains a 3 mL solution of SAXENDA® equivalent to 18 mg liraglutide (free-base, anhydrous).
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