Consumer medicine information

Saxenda 6 mg/mL Solution for injection

Liraglutide

BRAND INFORMATION

Brand name

Saxenda

Active ingredient

Liraglutide

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Saxenda 6 mg/mL Solution for injection.

1. Why am I using Saxenda®?


Saxenda® contains the active ingredient liraglutide. Saxenda® is used in weight loss, in addition to diet and exercise in adults aged 18 years or older.
For more information, see Section 1. Why am I using Saxenda®? in the full CMI.

2. What should I know before I use Saxenda®?


Do not use if you have ever had an allergic reaction to liraglutide or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Saxenda®? in the full CMI.

3. What if I am taking other medicines?


Some medicines may interfere with Saxenda® and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Saxenda®?

  • Your doctor or pharmacist will have given you advice on how to use your medicine.
  • The usual starting dose of Saxenda® is 0.6 mg once per day, which will be increased step wise until reaching the recommended dose of 3.0 mg once a day.

More instructions can be found in Section 4. How do I use Saxenda®? in the full CMI.

5. What should I know while using Saxenda®?

Things you should do
  • Remind any doctor, dentist or pharmacist or health professional you visit that you are using Saxenda®.
  • Tell your doctor if you have diabetes, or a racing heartbeat when at rest.
  • Do not use Saxenda® in combination with other medicines that contain GLP-1 receptor agonists.
Things you should not do
  • Do not stop using this medicine unless your doctor tells you to.
Driving or using machines
  • Be careful driving or operating machinery until you know how Saxenda® affects you.
Drinking alcohol
  • n/a
Looking after your medicine
  • Before opening, store Saxenda® pens in a refrigerator (2°C to 8°C). Do not freeze.
  • During use, Saxenda® pens can be stored for 1 month either at room temperature (below 30°C) or in a refrigerator (2°C to 8°C). Store the pen without a needle attached.

For more information, see Section 5. What should I know while using Saxenda®? in the full CMI.

6. Are there any side effects?


The most common side effects are feeling sick (nausea), being sick (vomiting), diarrhoea, constipation, headache, changed sense of taste, dizziness, indigestion (dyspepsia), feeling bloated, burping, wind (flatulence) or dry mouth, heartburn, painful or swollen abdomen, low blood sugar (a hypo), injection site reactions, fast heartbeat, feeling weak or tired, difficulty sleeping (insomnia), increase of pancreatic enzymes and rash. More serious side effects include severe and persistent pain in the abdomen, lump or swelling in the neck, hoarseness, trouble swallowing or shortness of breath, signs of reduced kidney function, signs of gallbladder problems, depression and bowel obstruction.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRAND INFORMATION

Brand name

Saxenda

Active ingredient

Liraglutide

Schedule

S4

 

1 Name of Medicine

Liraglutide (rys).

2 Qualitative and Quantitative Composition

Saxenda contains liraglutide, a human glucagon-like peptide-1 (GLP-1) analogue that binds to and activates the GLP-1 receptor (GLP-1R). Liraglutide is produced by recombinant DNA technology using Saccharomyces cerevisiae.
Saxenda is a solution for injection in a pre-filled pen. One mL contains 6 mg salt-free anhydrous liraglutide. One pre-filled pen contains 18 mg liraglutide in 3 mL.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Saxenda is a solution for injection. It is a sterile, clear, colourless, isotonic solution, pH = 8.15.

4 Clinical Particulars

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).
From clinical trials and post-market use of liraglutide, deliberate or accidental administration of doses up to 24 times the recommended maintenance dose (72 mg) have been reported, including one case of a 6-fold overdose (18 mg daily) given for 7 months. These included instances where patients needed hospitalisation either due to severe events of vomiting, nausea and diarrhoea, or as a precaution. In some reports, glucose infusion was administered. Severe hypoglycaemia has also been observed. All patients were reported to have recovered from the events without complications.
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.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Liraglutide was not mutagenic in the bacterial Ames assay, and not clastogenic in human lymphocytes in vitro, or in rat lymphocytes and bone marrow in vivo.
Carcinogenicity. See Section 4.4 Special Warnings and Precautions for Use.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

In liraglutide, the lysine at position 34 has been replaced with arginine, and a palmitic acid has been attached via a glutamoyl spacer to lysine at position 26.
Chemical structure. Liraglutide (rys) has the molecular formula C172H265N43O51 and a molecular weight of 3751.20 daltons.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSLIRAGL.gif CAS number. 204656-20-2.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/SAXENDST.gif