Saxenda 6 mg/mL
liraglutide · INJECTION, SOLUTION · Novo Nordisk
Saxenda is a injection, solution containing liraglutide at 6 mg/mL, taken subcutaneous. Manufactured by Novo Nordisk.
Key Facts
- Brand Name
- Saxenda
- Generic Name
- liraglutide
- NDC Code (Product)
0169-2800- Manufacturer
- Novo Nordisk
- Strength
- 6 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- NDA206321
- Drug Class
- GLP-1 Receptor Agonist [EPC]
- Marketing Start
- 12/31/2014
Recall History
Novo Nordisk Inc
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE SAXENDA is indicated in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: • 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. Limitations of Use • SAXENDA contains liraglutide. Coadministration with other liraglutide-containing products or with any other glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended. • The safety and effectiveness of SAXENDA in pediatric patients with type 2 diabetes have not been established. SAXENDA is a glucagon like peptide 1 (GLP-1) receptor agonist indicated in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: • Adults and pediatric patients aged 12 years and older with body weight greater than 60 kg and obesity. ( 1 ) • Adults with overweight in the presence of at least one weight-related comorbid condition. ( 1 ) Limitations of Use: • Coadministration with other liraglutide-containin…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Inject SAXENDA subcutaneously in the abdomen, thigh, or upper arm once daily at any time of day, without regard to the timing of meals. ( 2.1 ) • The recommended dose of SAXENDA is 3 mg daily. ( 2.2 ) • Initiate at 0.6 mg per day for one week. In weekly intervals, increase the dose until a dose of 3 mg is reached. ( 2.2 ) • 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. ( 2.2 ) • Pediatric patients who do not tolerate 3 mg daily may have their dose reduced to 2.4 mg daily. ( 2.2 ) • Adult patients with type 2 diabetes should monitor blood glucose prior to starting SAXENDA and during SAXENDA treatment. ( 2.2 ) 2.1 Important Administration Instructions • Prior to initiation of SAXENDA, train patients on proper injection technique. Refer to the accompanying Instructions for Use for complete administration instructions with illustrations. • Inspect SAXENDA visually prior to each injection. Only use if solution is clear, colorless, and contains no particles. • Administer SAXENDA in combination with a reduced-cal…
Contraindications
4 CONTRAINDICATIONS SAXENDA is contraindicated in: • Patients with a personal or family history of medullary thyroid carcinoma (MTC) or patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) [see Warnings and Precautions ( 5.1 )]. • Patients with a serious hypersensitivity reaction to liraglutide or to any of the excipients in SAXENDA. Serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with SAXENDA [see Warnings and Precautions ( 5.8 )]. • Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2. ( 4 ) • Hypersensitivity to liraglutide or any excipients in SAXENDA. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS SAXENDA delays gastric emptying. May impact absorption of concomitantly administered oral medications. Use with caution. ( 7 ) 7.1 Oral Medications SAXENDA causes a delay of gastric emptying, and thereby has the potential to impact the absorption of concomitantly administered oral medications. In clinical pharmacology trials, liraglutide did not affect the absorption of the tested orally administered medications to any clinically relevant degree. Nonetheless, monitor for potential consequences of delayed absorption of oral medications concomitantly administered with SAXENDA.
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described below or elsewhere in the prescribing information: • Risk of Thyroid C-Cell Tumors [see Warnings and Precautions ( 5.1 )] • Acute Pancreatitis [see Warnings and Precautions ( 5.2 )] • Acute Gallbladder Disease [see Warnings and Precautions ( 5.3 )] • Risk for Hypoglycemia with Concomitant Use of Anti-Diabetic Therapy [see Warnings and Precautions ( 5.4 )] • Heart Rate Increase [see Warnings and Precautions ( 5.5 )] • Acute Kidney Injury Due to Volume Depletion [see Warnings and Precautions ( 5.6 )] • Severe Gastrointestinal Adverse Reactions [see Warnings and Precautions ( 5.7 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.8 )] • Pulmonary Aspiration During General Anesthesia or Deep Sedation [see Warnings and Precautions ( 5.9 )] 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc. at 1-844…
Frequently Asked Questions
What is Saxenda used for?
Saxenda contains liraglutide. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is Saxenda a controlled substance?
Saxenda is not classified as a controlled substance by the DEA.
What is the generic name for Saxenda?
The generic name for Saxenda is liraglutide. There are 11 other brand versions of liraglutide.
What is the NDC code for Saxenda 6 mg/mL?
The NDC (National Drug Code) for Saxenda 6 mg/mL is 0169-2800, listed by Novo Nordisk.