Xultophy Side Effects

Generic name: insulin degludec / liraglutide

Medically reviewed by Drugs.com. Last updated on Jul 23, 2024.

Note: This document provides detailed information about Xultophy Side Effects associated with insulin degludec / liraglutide. Some dosage forms listed on this page may not apply specifically to the brand name Xultophy.

Applies to insulin degludec / liraglutide: subcutaneous solution.

Precautions

It is very important that your doctor check your progress at regular visits especially during the first few weeks you use this medicine. Blood and urine tests may be needed to check for unwanted effects.

Never share insulin pens with others under any circumstances. It is not safe for one pen to be used for more than one person. Sharing needles or pens can result in transmission of hepatitis viruses, HIV, or other bloodborne illnesses.

It is very important to follow carefully any instructions from your health care team about:

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
• Other medicines—Do not take other medicines during the time you are using insulin degludec and liraglutide combination unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to:

• Wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all of your medicines.
• Keep an extra supply of Xultophy® and syringes with needles or injection devices on hand in case high blood sugar occurs.
• Keep some kind of quick-acting sugar handy to treat low blood sugar.
• Have a glucagon kit and a syringe and needle available in case severe low blood sugar occurs. Check and replace any expired kits regularly.

Too much of this medicine can cause hypoglycemia (low blood sugar). Low blood sugar also can occur if you use this medicine with another antidiabetic medicine, changes in insulin regimen (eg, insulin strength, type of insulin, injection site), delay or miss a meal or snack, exercise more than usual, or drink alcohol. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly.

Symptoms of low blood sugar include anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, difficulty in thinking, dizziness or lightheadedness, drowsiness, excessive hunger, fast heartbeat, headache, irritability or abnormal behavior, nervousness, nightmares, restless sleep, shakiness, slurred speech, and tingling in the hands, feet, lips, or tongue.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes, or drink fruit juice, non diet soft drink, or sugar dissolved in water to relieve the symptoms. Also, check your blood for low blood sugar. Get to a doctor or a hospital right away if the symptoms do not improve. Someone should call for emergency help immediately if severe symptoms such as convulsions (seizures) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. Members of your household also should know how to use it.

Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your antidiabetic medicine or insulin, changes in insulin regimen, you overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual.

Symptoms of high blood sugar include: blurred vision, drowsiness, dry mouth, flushed, dry skin, fruit-like breath odor, increased urination, ketones in the urine, loss of appetite, stomachache, nausea or vomiting, tiredness, troubled breathing (rapid and deep), unconsciousness, and unusual thirst.

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

This medicine can cause low blood sugar. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Check with your doctor right away if you have the following symptoms while using this medicine: a mass in the neck, difficulty with swallowing, hoarseness, or troubled breathing. These may be symptoms of a serious thyroid problem.

Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you receive the medicine.

This medicine may cause low levels of potassium in your blood. Do not use medicines, supplements, or salt substitutes that contain potassium unless you have discussed this with your doctor.

Using this medicine together with other diabetes medicine (eg, thiazolidinedione [TZD] medicine) may cause serious heart problems or edema (fluid retention). Check with your doctor immediately if you are rapidly gaining weight, having chest pain or discomfort, extreme tiredness or weakness, trouble breathing, uneven heartbeat, or excessive swelling of the hands, wrist, ankles, or feet.

Common side effects of Xultophy

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:

Serious side effects of Xultophy

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:

For healthcare professionals

Applies to insulin degludec / liraglutide: subcutaneous solution.

General adverse events

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.^[Ref]

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)^[Ref]

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.^[Ref]

Metabolic

• Very common (10% or more): Hypoglycemia
• Common (1% to 10%): Decreased appetite
• Uncommon (0.1% to 1%): Dehydration
• Frequency not reported: Weight gain^[Ref]

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.^[Ref]

Endocrine

Liraglutide:

• Frequency not reported: Increased blood calcitonin, goitre^[Ref]

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^[Ref]

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.^[Ref]

Local

• Common (1% to 10%): Injection site reaction
• Frequency not reported: Lipodystrophy^[Ref]

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.^[Ref]

Cardiovascular

• Uncommon (0.1% to 1%): Increased heart rate
• Frequency not reported: Peripheral edema^[Ref]

Mean increase in heart rate of 2 to 3 beats per minute has been observed; long-term clinical effects are unknown.^[Ref]

Dermatologic

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

Insulin degludec:

Postmarketing period: Localized cutaneous amyloidosis^[Ref]

Immunologic

• Rare (less than 0.1%): Antibody formation^[Ref]

Ocular

Insulin:

• Frequency not reported: Temporary worsening of diabetic retinopathy, transitory reversible ophthalmologic refraction disorder^[Ref]

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

Oncologic

Liraglutide:

• Frequency not reported: Thyroid neoplasm, malignant neoplasms

Postmarketing: Medullary thyroid carcinoma^[Ref]

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.^[Ref]

Renal

• 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^[Ref]

Liraglutide

Hepatic

Liraglutide:

• Common (1% to 10%): Elevated serum bilirubin, cholelithiasis
• Uncommon (0.1% to 1%): Cholecystitis

Postmarketing: Cholestasis, hepatitis, elevated liver enzymes, hyperbilirubinemia^[Ref]

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 required 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 events required hospitalization or cholecystectomy.^[Ref]

Nervous system

• Common (1% to 10%): Headache
• Frequency not reported: Acute painful peripheral neuropathy^[Ref]

Acute painful peripheral neuropathy may occur with abrupt improvement in glycemic control; however, long-term improvement may decrease the risk of progression.^[Ref]

Respiratory

• Common (1% to 10%): Nasopharyngitis, upper respiratory infection^[Ref]

See also:

Frequently asked questions

• What is the difference between Soliqua and Xultophy?
• What are the active ingredients in Xultophy?
• How and where should I inject insulin?
• What are the different types of insulin?

Further information

Xultophy side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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