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.
Dosage Forms and Strengths:
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).
Usual dose:
When you first start using SAXENDA, the starting dose is 0.6 mg once a day. Your dose should be increased after using SAXENDA® for one week until you reach the 3.0 mg dose. After that, do not change your dose unless your healthcare professional tells you to. SAXENDA is injected 1 time each day, at any time during the day. You can take SAXENDA with or without food. Your doctor should start you on a diet and exercise program when you start taking SAXENDA. Stay on this program while you are taking SAXENDA
INDICATIONS AND CLINICAL USE:
SAXENDA (liraglutide) 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 (obese), 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.eased further to 1.8mg daily.
DOSAGE FORMS, COMPOSITION AND PACKAGING:
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).
POSSIBLE SIDE EFFECTS
- feeling sick (nausea), being sick (vomiting), diarrhea, constipation - these usually go away after a few days or weeks
- lower appetite
- problems affecting the stomach and intestines such as: indigestion (dyspepsia), inflamed lining of the stomach (gastritis), stomach discomfort, upper stomach pain, heart burn, Feeling bloating, wind (flatulence), belching, dry mouth
- feeling weak or tired
- changed sense of taste
- dizziness
- gallstones
- injection site reactions (such as bruising, pain, irritation, itching and rash)
- low blood sugar (hypoglycemia) - the warning signs of low blood sugar may come on suddenly.
Storage:
-Do not use SAXENDA after the expiry date which is stated on the label and carton. The expiry date refers to the last day of that month.
-Before you start to use SAXENDA, store it in a refrigerator (2ºC to 8ºC) away from the freezer compartment. Do not freeze it.
-When SAXENDA is being used, you can keep it for 1 month either at room temperature (not above 30ºC) or in a refrigerator (2ºC to 8ºC).
-Do not use SAXENDA if it has been frozen.
-Always remove the injection needle after each injection and store your SAXENDA pen without an injection needle attached.
-This prevents contamination, infection, and leakage. It also ensures that the dosing is accurate.
-When you are not using the pen, keep the cap on. This will protect the medicine from light. Protect SAXENDA from high temperatures and sunlight.
-Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
-Keep out of reach and sight of children.
