SAXENDA® 6mg/ml – 3mg Pen (International English)

SAXENDA® (liraglutide) is a GLP-1 receptor agonist indicated for chronic weight management in adults and adolescents. It comes in a 3 mL pre-filled pen containing 6 mg/mL of liraglutide, allowing for dose escalation up to 3 mg daily. SAXENDA® works by mimicking the action of glucagon-like peptide-1 (GLP-1), regulating appetite, delaying gastric emptying, and promoting satiety.

This prescription medication is approved for adults with a BMI ≥30 kg/m², or ≥27 kg/m² with comorbidities (e.g., type 2 diabetes, hypertension), and adolescents aged 12 years or older with obesity and weight >60 kg. When combined with a calorie-restricted diet and increased physical activity, SAXENDA® supports clinically significant weight loss and reduces cardiometabolic risk factors.

• Each pen delivers customizable daily doses from 0.6 mg to 3.0 mg
• Not to be used with other GLP-1 agonists or weight loss products
• Requires gradual dose escalation to improve tolerability

SAXENDA® is administered once daily via subcutaneous injection into the abdomen, thigh, or upper arm, at any time of day, independent of meals.

Key Features:

• Titrated dose escalation minimizes GI side effects
• 3.0 mg daily is the target maintenance dose

Protocol Details:

• Week 1: 0.6 mg/day
• Week 2: 1.2 mg/day
• Week 3: 1.8 mg/day
• Week 4: 2.4 mg/day
• Week 5 and onward: 3.0 mg/day
• If >3 days are missed, restart at 0.6 mg/day and titrate again
• Use a new needle for each injection
• Rotate injection sites to avoid cutaneous amyloidosis

SAXENDA® is indicated as an adjunct to lifestyle changes for long-term weight management in both adults and pediatric patients.

Indications:

• Adults with BMI:
  • ≥30 kg/m² (obesity), or
  • ≥27 kg/m² (overweight) with ≥1 weight-related comorbidity
• Adolescents (≥12 years) with:
  • Body weight >60 kg and BMI corresponding to adult obesity

Contraindications:

• Pregnancy
• Personal or family history of medullary thyroid carcinoma (MTC)
• Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• Hypersensitivity to liraglutide or excipients

Side Effects:

• Common: Nausea, vomiting, diarrhea, constipation, headache
• Serious: Pancreatitis, gallbladder disease, hypoglycemia, suicidal ideation, renal impairment

SAXENDA® is a clear, colorless solution designed for subcutaneous injection. Each pen contains liraglutide, a GLP-1 receptor agonist structurally similar to human GLP-1.

• Liraglutide: 6 mg/mL
• Total per pen: 18 mg in 3 mL
• Excipients:
  • Disodium phosphate dihydrate (1.42 mg)
  • Propylene glycol (14 mg)
  • Phenol (5.5 mg)
  • Water for injection
• pH: Approximately 8.15
  

Each SAXENDA® package is designed for single-patient, multi-dose use, featuring precise and adjustable delivery.

• 1 pre-filled pen with 3 mL of solution
• Pen delivers 0.6 to 3.0 mg/day
• No needles included – sold separately
• Patient Instructions for Use enclosed

SAXENDA® may cause gastrointestinal and systemic side effects, particularly during dose escalation. Most are mild to moderate and resolve over time.

Common Side Effects (≥5%):

• Nausea (up to 39%)
• Vomiting (15%)
• Diarrhea (20%)
• Constipation (19%)
• Injection site reactions
• Headache
• Fatigue

Serious Side Effects:

• Thyroid tumors (MTC risk – boxed warning)
• Pancreatitis
• Gallstones
• Suicidal thoughts
• Hypoglycemia (especially with diabetes medications)

Proper storage ensures product stability and safety throughout use.

• Before first use: Store in refrigerator at 2–8°C (36–46°F)
• After first use: Store at room temp (15–30°C) or refrigerated for up to 30 days
• Do not freeze
• Protect from light
• Always use a new needle and cap the pen after each use