Liraglutid

Saxenda

Zugelassene Anwendungsgebiete

• Adults and pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity.
• Adults with overweight in the presence of at least one weight-related comorbid condition.
• The safety and effectiveness of SAXENDA in pediatric patients with type 2 diabetes have not been established.
• Coadministration with other liraglutide-containing products or with any other GLP-1 receptor agonist is not recommended.

Darreichungsformen und Stärken

• Injection: 6 mg/mL clear, colorless solution in a 3 mL prefilled, single-patient-use pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg.

Einnahme

• Inject SAXENDA subcutaneously in the abdomen, thigh, or upper arm once daily at any time of day, without regard to the timing of meals.
• The recommended dose of SAXENDA is 3 mg daily.
• Initiate at 0.6 mg per day for one week. In weekly intervals, increase the dose until a dose of 3 mg is reached.
• 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.
• Pediatric patients who do not tolerate 3 mg daily may have their dose reduced to 2.4 mg daily.
• Adult patients with type 2 diabetes should monitor blood glucose prior to starting SAXENDA and during SAXENDA treatment. Important Administration Instructions

Darf nicht angewendet werden bei

• Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2.
• Hypersensitivity to liraglutide or any excipients in SAXENDA.

Wechselwirkungen

• SAXENDA delays gastric emptying.
• May impact absorption of concomitantly administered oral medications.
• Use with caution.

Warnhinweise und Vorsichtsmaßnahmen

• Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including SAXENDA. Discontinue if pancreatitis is suspected.
• Acute Gallbladder Disease: If cholelithiasis or cholecystitis are suspected, gallbladder studies are indicated.
• Hypoglycemia: Can occur in adults when SAXENDA is used with an insulin secretagogue (e.g. a sulfonylurea) or insulin. The risk may be lowered by a reduction in the dose of concomitantly administered insulin secretagogues or insulin. In the pediatric clinical trial, patients did not have type 2 diabetes. Hypoglycemia occurred in SAXENDA-treated pediatric patients.
• Heart Rate Increase: Monitor heart rate at regular intervals.
• Acute Kidney Injury Due to Volume Depletion: Monitor renal function in patients reporting adverse reactions that could lead to volume depletion.
• Severe Gastrointestinal Adverse Reactions: Use has been associated with gastrointestinal adverse reactions, sometimes severe. SAXENDA is not recommended in patients with severe gastroparesis.
• Hypersensitivity Reactions: Postmarketing reports of serious hypersensitivity reactions (e.g., anaphylactic reactions and angioedema). Discontinue SAXENDA and other suspect medications and promptly seek medical advice.
• Pulmonary Aspiration During General Anesthesia or Deep Sedation: Has been reported in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures. Instruct patients to inform healthcare providers of any planned surgeries or procedures.

Häufige Nebenwirkungen

• Most common adverse reactions, reported in greater than or equal to 5% are: nausea, diarrhea, constipation, vomiting, injection site reactions, headache, hypoglycemia, dyspepsia, fatigue, dizziness, abdominal pain, increased lipase, upper abdominal pain, pyrexia, and gastroenteritis.
• most common adverse reactions leading to discontinuation were nausea (2.9% versus 0.2% for SAXENDA and placebo, respectively), vomiting (1.7% versus less than 0.1%), and diarrhea (1.4% versus 0%).

Schwangerschaft

Based on animal reproduction studies, there may be risks to the fetus from exposure to SAXENDA during pregnancy. SAXENDA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Additionally, weight loss offers no benefit to a pregnant patient and may cause fetal harm.

Wirkmechanismus

Liraglutide is an acylated human GLP-1 receptor agonist with 97% amino acid sequence homology to endogenous human GLP-1(7-37). Like endogenous GLP-1, liraglutide binds to and activates the GLP-1 receptor, a cell-surface receptor coupled to adenylyl cyclase activation through the stimulatory G-protein, Gs. Endogenous GLP-1 has a half-life of 1.5 to 2 minutes due to degradation by the ubiquitous endogenous enzymes, dipeptidyl peptidase 4 (DPP-4) and neutral endopeptidases (NEP).

Zulassungsinhaber:

Novo Nordisk Pharmaceutical Industries, LP

Stand der Fachinformation:

25. Februar 2026

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