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Xultophy 100/3.6

Generic Name: insulin degludec and liraglutide (IN su lin de GLOO dek and LIR a GLOO tide)
Brand Names: Xultophy
Xultophy information from Drugs.com, includes Xultophy side effects, interactions and indications.
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Drug Information:
Xultophy is an injection pen containing a combination of insulin degludec and liraglutide. Insulin is a hormone that works by lowering levels of Glucose (sugar) in the blood. Insulin degludec is a long-acting insulin that starts to work several hours after injection and keeps working evenly for 24 hours. Liraglutide is similar to a hormone that occurs naturally in the body and helps control blood sugar, insulin levels, and digestion. Xultophy is used to lower blood sugar in adults with type 2 diabetes mellitus. This medicine should be used together with diet and exercise. Learn more

Xultophy 100/3.6 Side Effects

Xultophy Side Effects

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.

For the Consumer

Applies to insulin degludec/liraglutide: subcutaneous solution

Warning

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

  • Anxiety
  • bloating
  • bloody urine
  • blurred vision
  • chills
  • cold, clammy skin
  • cold sweats
  • coma
  • confusion
  • constipation
  • convulsions
  • cool, pale skin
  • cough
  • darkened urine
  • decreased frequency or amount of urine
  • depression
  • difficulty swallowing
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • fast heartbeat
  • fast, weak pulse
  • fever
  • flushed, dry skin
  • fruit-like breath odor
  • headache
  • hives, itching, or rash
  • hoarseness when speaking
  • increased hunger
  • increased thirst
  • increased urination
  • indigestion
  • irregular heartbeat
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • lightheadedness
  • loss of appetite
  • lower back or side pain
  • lumps in the neck
  • muscle pain or cramps
  • nausea or vomiting
  • nightmares
  • noisy, rattling breathing
  • numbness or tingling in the hands, feet, or lips
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • slurred speech
  • sweating
  • tightness in the chest
  • trouble breathing or swallowing
  • troubled breathing at rest
  • unexplained weight loss
  • unusual tiredness or weakness
  • weight gain
  • yellow eyes or skin

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:

More common

  • Body aches or pain
  • chills
  • diarrhea
  • ear congestion
  • loss of voice
  • muscle aches
  • sneezing
  • sore throat
  • stuffy or runny nose

Incidence not known

  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

For Healthcare Professionals

Applies to insulin degludec / liraglutide: subcutaneous solution

General

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.

Gastrointestinal

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

Liraglutide:

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.

Metabolic

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

Endocrine

Liraglutide:

Frequency not reported: Increased blood calcitonin, goitre

Hypersensitivity

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

Liraglutide:

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.

Local

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

Cardiovascular

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

Dermatologic

Uncommon (0.1% to 1%): Rash, pruritus, urticaria

Immunologic

Rare (less than 0.1%): Antibody formation

Ocular

Temporary worsening of diabetic retinopathy may occur with abrupt improvement in glycemic control; however, long-term improvement may decrease the risk of progression.

Insulin:

Frequency not reported: Temporary worsening of diabetic retinopathy, transitory reversible ophthalmologic refraction disorder

Oncologic

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.

Liraglutide:

Frequency not reported: Thyroid neoplasm, malignant neoplasms

Postmarketing: Medullary thyroid carcinoma

Renal

Liraglutide

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

Hepatic

Liraglutide:

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.

Nervous system

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.

Respiratory

Common (1% to 10%): Nasopharyngitis, upper respiratory infection

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Xultophy 100/3.6 (www.drugs.com/xultophy.html).