Saxenda 6 mg/ml solution for injection in pre-filled pen

Product Information *

  • Company:

    Novo Nordisk Limited
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 25 May 2021

File name

Saxenda Package leaflet v7-April2021-clean_1621955795.pdf

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - use in children and adolescents
  • Change to section 3 - dose and frequency
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 1

'What Saxenda is used for' updated to include:

Saxenda can be used as an adjunct to a healthy nutrition and increased physical activity for weight management in adolescents from the age of 12 years and above who have:

•        obesity (diagnosed by your doctor)

•        body weight above 60 kg

You should only continue using Saxenda if you have lost at least 4% of your BMI after 12 weeks on the 3.0 mg/day dose or maximum tolerated dose (see section 3). Consult your doctor before you continue.

 

Section 2 - children and adolescents

Text update:

The safety and efficacy of Saxenda in children below 12 years of age has not been studied.

Saxenda® should not be used in children and adolescents under 18 years of age. This is because the effects and safety of this medicine have not been studied in this age group.

 

Section 3 - How much to inject

Text additions:

Adults

 

Adolescents (≥ 12 years)

For adolescents from the age of 12 to below 18 years old a similar dose escalation schedule as for adults should be applied (see above table for adults). 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.

 

Section 6 - Date of revision

Revision date updated to: 04/2021

Updated on 25 May 2021

File name

Saxenda SmPC-IE-v11-April2021_clean_1621955300.pdf

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.1 - indication for adolescents from the age of 12 years added as follows:

Adults

Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of:

•        30 kg/m² (obesity), or

•        27 kg/m² to <30 kg/m² (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia or obstructive sleep apnoea.

Treatment with Saxenda should be discontinued after 12 weeks on the 3.0 mg/day dose if patients have not lost at least 5% of their initial body weight.

 

Adolescents (≥12 years)

Saxenda can be used as an adjunct to a healthy nutrition and increased physical activity for weight management in adolescent patients from the age of 12 years and above with:

•        obesity (BMI corresponding to ≥30 kg/m2 for adults by international cut-off points)* and

•        body weight above 60 kg.

Treatment with Saxenda should be discontinued and re-evaluated if patients have not lost at least 4% of their BMI or BMI z score after 12 weeks on the 3.0 mg/day or maximum tolerated dose.

*IOTF BMI cut-off points for obesity by sex between 12–18 years (see table 1) (refer to SmPC for Table 1)

 

Section 4.2:

New text added:

Adults

Adolescents (≥12 years)

For adolescents from the age of 12 to below 18 years old a 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.

Text update:

No dose adjustment is required for adolescents from the age of 12 years and above. The safety and efficacy of Saxenda in children below 12 years of age has not been established (see section 5.1).

The safety and efficacy of Saxenda in children and adolescents below 18 years of age have not yet been established.  Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on posology can be made.

 

Section 4.4:

New text added:

Paediatric population

Episodes of clinically significant hypoglycaemia have been reported in adolescents (≥12 years) treated with liraglutide. Patients should be informed about the characteristic symptoms of hypoglycaemia and the appropriate actions.

 

Section 4.5:

New text added:

Paediatric population

Interaction studies have only been performed in adults.

 

Section 4.8

Table 3 updated to clarify:

'Adverse reactions reported in adults'

Text update:

In a clinical trial conducted in adolescents of 12 years to less than 18 years with obesity, 125 patients were exposed to Saxenda for 56 weeks.

Overall, the frequency, type and severity of adverse reactions in the adolescents with obesity were comparable to that observed in the adult population. Vomiting occurred with a 2-fold higher frequency in adolescents compared to adults.

The percentage of patients reporting at least one episode of clinically significant hypoglycaemia was higher with liraglutide (1.6%) compared to placebo (0.8%). No severe hypoglycaemic episodes occurred in the trial.

Saxenda is not recommended for use in paediatric patients.  Gastrointestinal disorders were the most frequently reported adverse events in two dose escalation studies completed so far.

 

Section 5.1

'Paediatric Population' updated to include:

In a double-blind trial comparing the efficacy and safety of Saxenda versus placebo on weight loss in adolescent patients aged 12 years and above with obesity, Saxenda was superior to placebo in weight reduction (evaluated as BMI Standard Deviation Score) after 56 weeks of treatment (table 9).

A greater proportion of the patients achieved ≥5% and ≥10% reductions in BMI with liraglutide than with placebo, as well as greater reductions in mean BMI and body weight (table 9). After 26 weeks of off-trial product follow-up period, weight regain was observed with liraglutide vs placebo (table 9).

Refer to SmPC for Table 9.

 

Section 5.2

'Paediatric Population' updated:

Pharmacokinetic properties for liraglutide 3.0 mg were assessed in clinical studies for adolescent patients with obesity aged 12 to less than 18 years (134 patients, body weight 62-178 kg). The liraglutide exposure in adolescents (age 12 to less than 18 years) was similar to that in adults with obesity. 

 

Pharmacokinetic properties were also assessed in a clinical pharmacology study in the paediatric population with obesity aged 7-11 years (13 patients, body weight 54-87 kg) respectively.

Exposure associated with 3.0 mg liraglutide was found to be comparable between the children aged 7 to 11, adolescents and adults with obesity, after correction for body weight.

 

Section 5.3

Text added:

In juvenile rats, liraglutide caused delayed sexual maturation in both males and females at clinical relevant exposures. These delays had no impact upon fertility and reproductive capacity of either sex, or on the ability of the females to maintain pregnancy.

Section 10:

Date of Revision updated to: 04/2021

 

 

Updated on 01 October 2020

File name

Saxenda Package leaflet v6-Sep2020-clean_1601581603.pdf

Reasons for updating

  • Change to section 3 - how to take/use

Free text change information supplied by the pharmaceutical company

Section 3

If you use more Saxenda® than you should

If you use more Saxenda® than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you. You may need medical treatment. The following effects may happen:

•        feeling sick (nausea)

•        being sick (vomiting)

•        low blood sugar (hypoglycaemia). Please refer to ‘Common side effects’ for warning signs of low blood sugar.

Updated on 01 October 2020

File name

Saxenda SmPC-IE-v10-Sep2020_clean_1601581521.pdf

Reasons for updating

  • Change to section 4.9 - Overdose

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.9

From clinical trials and post-marketing use of liraglutide overdoses have been reported up to 72 mg (24 times the recommended dose for weight management). Events reported included severe nausea, and severe vomiting and severe hypoglycaemia.  which are also the expected symptoms of an overdose with liraglutide. None of the reports included severe hypoglycaemia. All patients recovered without complications.

In the event of overdose, 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.

Updated on 06 February 2020

File name

Package leaflet v5-Dec2019-clean_2_1581005056.pdf

Reasons for updating

  • Correction of spelling/typing errors

Free text change information supplied by the pharmaceutical company

Correction of missing image

Updated on 19 December 2019

File name

Package leaflet v5-Dec2019-clean_1576767083.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - driving and using machines
  • Change to section 3 - how to take/use
  • Removal of Black Inverted Triangle

Free text change information supplied by the pharmaceutical company

Black triangle removed

Section 1

- Minor text update "Saxenda® is a weight loss medicine that contains the active substance liraglutide. It is similar to a natural occurring hormone called glucagon-like peptide-1 (GLP-1) "

- units added after BMI figures, i.e. kg/m²

 

Section 2

- 'Children and adolescents' section updated to: "Saxenda® should not be used in children and adolescents under 18 years of age. This is because the effects and safety of this medicine have not been studied in this age group. "

- 'Driving and using machines' section updated to:

Saxenda® is unlikely to affect your ability to drive and use machines.

Some patients may feel dizziness when taking Saxenda mainly during the first 3 months of treatment (see section ‘Possible side effects’). If you feel dizziness be extra careful while driving or using machines. If you need any further information, talk to your doctor, pharmacist or nurse.""

Section 3

- sentence update under 'How much to inject': "Your doctor should will instruct you to gradually increase your dose by 0.6 mg usually each week until you reach the recommended dose of 3.0 mg once a day."

 

 

 

Updated on 19 December 2019

File name

Saxenda SmPC IE v9_renewal_clean_1576766679.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Removal of Black Inverted Triangle

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

 

Section 4.2:

relocation within Section 4.2 of information on missed doses

 

Section 4.4

- text added regarding Traceability

- Section heading added for 'Patients with heart failure'. (note: section content unchanged)

- Section heading added for 'Special populations'. (note: section content unchanged)

- Section added for 'Hyperglycaemia in insulin treated patients with diabetes mellitus'. Section content relocated to section 4.4 from section 4.2

 

Section 4.7.

Text updated to include information on dizziness:

"Saxenda has no or negligible influence on the ability to drive and use machines. However, dizziness can be experienced mainly during the first 3 months of treatment with Saxenda. Driving or use of machines should be exercised with caution if dizziness occurs."

 

Section 4.8:

Sentence updated as follows: "Overall, gastrointestinal reactions were the most frequently reported adverse reactions during treatment (67.9%)"

 

Section 5.1

Deletion of text from section on 'Paediatric population': Studies in the paediatric population are ongoing. Currently available results are too limited to draw conclusions on the efficacy of Saxenda in children.

 

 

Updated on 08 October 2019

File name

Package leaflet v4-Sept2019-clean_1570527139.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect

Free text change information supplied by the pharmaceutical company

Section 4: addition of 'delay in the emptying of hte stomach' added as an uncommon side effect

Section 4: Update to the HPRA contact details for hte reporting of side effects

Updated on 08 October 2019

File name

Saxenda SmPC IE v8_clean_1570527011.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.8:

(1) addition of uncommon adverse reaction in Table 2 as follows:

'Delayed gastric emptying****

****From controlled phase 2, 3a and 3b clinical trials"

 

(2) HPRA contact details updated to short version

Section 10: revision of text date updated to "09/2019"

Updated on 17 September 2019

File name

Package leaflet v3-July2019-clean_2_1568719450.pdf

Reasons for updating

  • Improved presentation of PIL

Free text change information supplied by the pharmaceutical company

Improved presentation of PIL images

Updated on 08 August 2019

File name

Package leaflet v3-July2019-clean_1565165531.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink

Updated on 07 August 2019

File name

Saxenda SmPC IE v7_remove insulin warning_clean_1565165365.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4: text update

"Patients with type 2 diabetes mellitus receiving liraglutide in combination with insulin and/or a sulfonylurea may have an increased risk of hypoglycaemia. The risk of hypoglycaemia may be lowered by a reduction in the dose of insulin and/or sulfonylurea. The addition of Saxenda in patients treated with insulin has not been evaluated."

 

Section 4.8: addition of text

"Hypoglycaemia in patients with type 2 diabetes mellitus treated with insulin

In a clinical trial in overweight or obese patients with type 2 diabetes mellitus treated with insulin and liraglutide 3.0 mg/day in combination with diet and exercise and up to 2 OADs, severe hypoglycaemia (requiring third party assistance) was reported by 1.5% of patients treated with liraglutide 3.0 mg/day. In this trial, documented symptomatic hypoglycaemia (defined as plasma glucose ≤3.9 mmol/L accompanied by symptoms) was reported by 47.2% of patients treated with liraglutide 3.0 mg/day and by 51.8% of patients treated with placebo. Among patients concomitantly treated with sulfonylurea, 60.9% of patients treated with liraglutide 3.0 mg/day and 60.0% of patients treated with placebo reported documented symptomatic hypoglycaemic events."

Updated on 23 May 2019

File name

Saxenda Package leaflet June-2017_1558607573.pdf

Reasons for updating

  • New PIL for new product

Updated on 23 May 2019

File name

Saxenda SmPC UK-IE v6 clean-prac_1558607467.pdf

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

New SPC for new product