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Note: This document contains side effect information about insulin degludec / liraglutide. Some of the dosage forms listed on this page may not apply to the brand name Xultophy.
Applies to insulin degludec/liraglutide: subcutaneous solution
Subcutaneous route (Solution)
Liraglutide, a component of insulin degludec/liraglutide is known to cause dose-dependent and treatment-duration dependent thyroid C-cell tumors in rats and mice. It is unknown whether this component causes thyroid C-cell tumors in humans. Use is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Along with its needed effects, insulin degludec/liraglutide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking insulin degludec / liraglutide:
Incidence not known
Some side effects of insulin degludec / liraglutide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
Applies to insulin degludec / liraglutide: subcutaneous solution
The most frequently reported adverse reactions included hypoglycemia and gastrointestinal adverse reactions, such as nausea diarrhea, vomiting, constipation, dyspepsia, gastritis, abdominal pain, flatulence, gastroesophageal reflux disease, and abdominal distention.
Common (1% to 10%): Nausea, diarrhea, vomiting, constipation, dyspepsia, gastritis, abdominal pain, flatulence, gastroesophageal reflux disease, abdominal distension, decreased appetite, increased lipase
Uncommon (0.1% to 1%): Pancreatitis, including necrotizing pancreatitis
Postmarketing reports: Acute pancreatitis, hemorrhagic and necrotizing pancreatitis (sometimes resulting in death)
Gastrointestinal adverse events occur more frequently at the beginning of therapy and generally diminish within a few days or weeks of continued use. Nausea was transient for most patients.
Weight gain may occur and has been attributed to the anabolic effects of insulin. After 26 weeks of insulin degludec / liraglutide 100/3.6, a mean increase of 2 kg occurred.
Very common (10% or more): Hypoglycemia
Common (1% to 10%): Decreased appetite
Uncommon (0.1% to 1%): Dehydration
Frequency not reported: Weight gain
Frequency not reported: Increased blood calcitonin, goitre
Uncommon (0.1% to 1%): Urticaria, rash, pruritus, face swelling
Rare (less than 0.1%): Hypersensitivity manifested with swelling of tongue and lips, diarrhea, nausea, tiredness, and itching
Postmarketing reports: Anaphylactic reaction
Postmarketing reports: Angioedema, anaphylactic reactions, rash, pruritus
Hypersensitivity reactions including urticaria, pruritus, and/or swelling of the face have been reported following administration of this drug. Few case of anaphylactic reaction with additional symptoms such as hypotension, palpitations, dyspnea, and edema has been reported postmarketing.
Injection site reactions included injection site hematoma, pain, hemorrhage, erythema, nodules, swelling, discolorations, pruritus, warmth, and injection site mass. These reactions are generally mild and transient, disappearing with continued treatment. Lipodystrophy may occur at the injection site. Rotation of injection site may help reduce the risk of developing these reactions.
Common (1% to 10%): Injection site reaction
Frequency not reported: Lipodystrophy
Mean increase in heart rate of 2 to 3 beats per minute has been observed; long-term clinical effects are unknown.
Uncommon (0.1% to 1%): Increased heart rate
Frequency not reported: Peripheral edema
Uncommon (0.1% to 1%): Rash, pruritus, urticaria
Rare (less than 0.1%): Antibody formation
Temporary worsening of diabetic retinopathy may occur with abrupt improvement in glycemic control; however, long-term improvement may decrease the risk of progression.
Frequency not reported: Temporary worsening of diabetic retinopathy, transitory reversible ophthalmologic refraction disorder
Pooled analysis of liraglutide clinical trials reveals the incidence rate for malignant neoplasms at 10.9, 6.3, and 7.2 per 1000 patient-years for liraglutide, placebo, and active comparator treated patients, respectively. Incidence rates were based on investigator-reported events, medical history, pathology reports, and surgical reports from both blinded and open-label studies. Seven cases of papillary thyroid carcinoma were in liraglutide-treated patients and 1 case in a comparator-treated patient. Most were less than 1 cm in greatest diameter and diagnosed in surgical pathology specimens after thyroidectomy prompted by findings on protocol-specified screening with serum calcitonin or thyroid ultrasound. Seven malignant neoplasm events were reported beyond 1-year exposure to study medication: 4 colon, 1 prostate and 1 nasopharyngeal in liraglutide-treated patients with 1 (colon) reported in a comparator-treated patient.
Frequency not reported: Thyroid neoplasm, malignant neoplasms
Postmarketing: Medullary thyroid carcinoma
Frequency not reported: Renal impairment, acute renal failure
Postmarketing reports: Increased serum creatinine, acute renal failure or worsening of chronic renal failure, sometimes requiring hemodialysis
Common (1% to 10%): Elevated serum bilirubin, cholelithiasis
Uncommon (0.1% to 1%): Cholecystitis
Postmarketing: Cholestasis, hepatitis, elevated liver enzymes, hyperbilirubinemia
Cholelithiasis and cholecystitis have been reported in liraglutide trials. In doses of up to 3 mg, cholelithiasis and cholecystitis were reported in 1.5% (vs 0.5%) and 0.6% (vs 0.2%), respectively (compared to placebo). The majority of patients with cholelithiasis and cholecystitis require cholecystectomy. In the cardiovascular outcomes trial, liraglutide-treated patients reported an acute event of gallbladder disease such as cholelithiasis or cholecystitis more frequently than those receiving placebo (3.6% vs 1.9%). Most of these event required hospitalization of cholecystectomy.
Common (1% to 10%): Headache
Frequency not reported: Acute painful peripheral neuropathy
Acute painful peripheral neuropathy may occur with abrupt improvement in glycemic control; however, long-term improvement may decrease the risk of progression.
Common (1% to 10%): Nasopharyngitis, upper respiratory infection
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