Liraglutide (Saxenda)
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: RISK OF THYROID C-CELL TUMORS • Liraglutide causes dose-dependent and treatment-duration-dependent thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether SAXENDA causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined [see Warnings and Precautions ( 5.1 ), Nonclinical Toxicology ( 13.1 )] . • SAXENDA is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Counsel patients regarding the potential risk of MTC with use of SAXENDA and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with SAXENDA [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 )]. WARNING: RISK OF THYROID C-CELL TUMORS See full prescribing information for complete boxed warning. • Liraglutide causes thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice.
It is unknown whether SAXENDA causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined ( 5.1 ). • SAXENDA is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Counsel patients regarding the potential risk of MTC and the symptoms of thyroid tumors ( 4 , 5.1 , 13.1 ).
GLP-1 Receptor Agonist
Dosing in kidney impairment
Renal Impairment There is limited experience with SAXENDA in patients with mild, moderate, and severe renal impairment, including end‑stage renal disease.
Dosing in liver impairment
Hepatic Impairment There is limited experience in patients with mild, moderate, or severe hepatic impairment. Therefore, SAXENDA should be used with caution in this patient population [see Clinical Pharmacology] .
Preparation and administration
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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-calorie diet and increased physical activity.
Inject SAXENDA subcutaneously once daily at any time of day, without regard to the timing of meals.
Inject SAXENDA subcutaneously in the abdomen, thigh, or upper arm. No dosage adjustment is needed if changing the injection site and/or timing.
Rotate injection sites within the same region in order to reduce the risk of cutaneous amyloidosis [see Adverse Reactions ] .
If a dose is missed, resume the once-daily regimen as prescribed with the next scheduled dose. Do not administer an extra dose or increase the dose to make up for the missed dose.
If more than 3 days have elapsed since the last SAXENDA dosage, reinitiate SAXENDA at 0.6 mg daily and follow the dosage escalation schedule in Table 1 , to reduce the risk of gastrointestinal adverse reactions associated with reinitiation of treatment.
Drug interactions
Check liraglutide (saxenda) against a medication listLabel text (2 paragraphs)
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.
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 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for liraglutide (saxenda). Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary 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. When a pregnancy is recognized, advise the pregnant patient of the risk to a fetus, and discontinue SAXENDA (see Clinical Considerations ). Animal reproduction studies identified increased adverse embryofetal developmental outcomes from exposure during pregnancy.
Liraglutide exposure was associated with early embryonic deaths and an imbalance in some fetal abnormalities in pregnant rats administered liraglutide during organogenesis at doses that approximate clinical exposures at the maximum recommended human dose (MRHD) of 3 mg/day. In pregnant rabbits administered liraglutide during organogenesis, decreased fetal weight and an increased incidence of major fetal abnormalities were seen at exposures below the human exposures at the MRHD (see Animal Data ). The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S.
general population, the estimated background risk of major birth defects and miscarriage of clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryofetal risk Appropriate weight gain based on pre-pregnancy weight is currently recommended for all pregnant patients, including those who already have overweight or obesity, because of the obligatory weight gain that occurs in maternal tissues during pregnancy.
Animal Data Liraglutide has been shown to be teratogenic in rats at or above 0.8-times systemic exposures in obese humans resulting from the maximum recommended human dose (MRHD) of 3 mg/day based on plasma area under the time-concentration curve (AUC) comparison. Liraglutide has been shown to cause reduced growth and increased total major abnormalities in rabbits at systemic exposures below exposure in obese humans at the MRHD based on plasma AUC comparison.
Female rats given subcutaneous doses of 0.1, 0.25 and 1 mg/kg/day liraglutide beginning 2 weeks before mating through gestation day 17 had estimated systemic exposures 0.8-, 3-, and 11-times the exposure in obese humans at the MRHD based on plasma AUC comparison. The number of early embryonic deaths in the 1 mg/kg/day group increased slightly. Fetal abnormalities and variations in kidneys and blood…
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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