Xultophy

How does this medication work? What will it do for me?

Insulin degludec – liraglutide is a combination of two medications. Insulin degludec is an ultra long-acting insulin. It begins to work a few hours after injection, and the effects last up to 42 hours. After injection, insulin degludec is released slowly and constantly into the bloodstream. Liraglutide belongs to a group of medications known as glucagon-like peptide-1 (GLP-1) receptor agonists. It is used along with other medications to improve blood glucose (sugar) levels for people with type 2 diabetes. It works by helping your body make more insulin and control blood glucose levels.

Insulin is a naturally occurring hormone made by the pancreas that helps our body use or store the glucose (sugar) it gets from food. For people with diabetes, either the pancreas does not make enough insulin to meet the body's requirements or the body cannot properly use the insulin that is made. As a result, glucose cannot be used or stored properly and accumulates in the bloodstream.

Insulin degludec – liraglutide is used in combination with other diabetes medications, in addition to diet and exercise, to improve blood sugar levels.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each 1 mL of clear, colourless, sterile solution in a 3 mL prefilled, disposable pen injector contains 100 units of insulin degludec and 3.6 mg liraglutide. Nonmedicinal ingredients: glycerol, phenol, zinc acetate, hydrochloric acid, sodium hydroxide, and water for injection.

How should I use this medication?

Your dose of insulin degludec – liraglutide should be injected subcutaneously (under the skin) of the thigh, upper arm, or abdomen, once daily. The recommended starting dose of this medication depends on whether you have previously used basal (long-acting) insulin or a GLP-1 inhibitor.

Depending on your body's needs and blood glucose monitoring, your doctor or diabetes educator will advise you to adjust your dose until your fasting blood glucose is appropriate for you. Your doctor or diabetes educator will determine the appropriate dose for you according to various lifestyle factors and the blood glucose values you get while monitoring your blood glucose. The maximum recommended daily dose is 50 units of insulin degludec/1.8 mg of liraglutide once daily.

Do not inject this medication into the vein and do not use insulin degludec - liraglutide in insulin infusion pumps.

If you are unsure how to use the prefilled injection pen or this medication, ask your doctor, pharmacist or diabetes educator to show you. Don't use this medication until you know how to administer it.

Insulin degludec - liraglutide should be clear and colourless. Do not use this medication if you notice anything unusual in the appearance of the solution, such as cloudiness, discolouration, or clumping. It is not necessary to shake or rotate the vial before use. It should not be mixed with any other insulins or solutions.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to use this medication exactly as prescribed by your doctor.

If you miss a dose, skip the missed dose and continue with your regular dosing schedule. If you miss more than 3 doses, talk to your doctor about the appropriate dose to resume with. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Before using a prefilled pen for injection, store the medication in the original carton, in the refrigerator. Do not freeze the medication. Discard the medication if it is allowed to freeze. After the first use, store the prefilled pen at room temperature for up to 21 days. If there is any medication remaining in the pen after 21 days, safely discard the pen and start a new one. Protect this medication from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not use this medication if you:

• are allergic to insulin degludec, liraglutide, or any ingredients of the medication
• have a personal or family history of medullary thyroid cancer or Multiple Endocrine Neoplasia Syndrome Type 2 (MEN2)
• are pregnant
• are breast-feeding
• are experiencing low blood glucose

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• bloating
• constipation
• decreased appetite
• diarrhea
• gas
• heartburn
• injection site reactions (e.g., swelling, pain, itching, bruising)
• nausea
• stomach ache
• tiredness
• vomiting

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• changes to the skin at the injection site
• chest pain
• increased heart rate
• lumps under the skin
• signs of abnormal heart rhythms (such as fast or slow heart rate, palpitations), fainting or seizures
• signs of an allergic reaction (e.g., rash itching or hives)
• signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)
• signs of kidney problems (e.g., change in the amount or colour of urine, increased urination at night, blood in the urine, swelling in the feet or legs)
• signs of high blood sugar (hyperglycemia; e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
• signs of low blood glucose (hypoglycemia; e.g., anxiety; blurred vision; changes in vision; confusion; difficulty concentrating; difficulty speaking; dizziness; drowsiness; fast heartbeat; headache; hunger; nausea; nervousness; numbness or tingling of the lips, fingers, or tongue; sweating; tiredness; trembling; weakness)
• signs of low potassium in the body (e.g., weakness, fatigue, muscle cramps, constipation)
• swelling of arms, legs, ankles
• symptoms of gallstones (e.g., abdominal pain, pain between shoulders, nausea, vomiting)
• thyroid tumour (e.g., difficulty swallowing, lump in the neck, persistent hoarseness)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
• symptoms of a serious allergic reaction (e.g., swelling of face or throat, sudden sweating, vomiting, difficulty breathing, rapid heartbeat, itchy skin rash, and dizziness)
• unconsciousness

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Blood glucose monitoring: It is important for anyone using insulin to monitor their blood glucose levels regularly, as recommended by their doctor or diabetes educator. It is especially important to test blood glucose more often when your insulin dose or schedule changes, or when you are ill or under stress. If blood tests consistently show high or low blood glucose levels, contact your doctor or diabetes educator.

Diabetes identification: It is important to either wear a bracelet (or necklace) or carry a card indicating you have diabetes and are taking medication to manage your blood glucose levels.

Heart problems: This medication may increase heart rate and may affect how electrical impulses travel through the heart muscle. It can cause fluid to build up in the body and can contribute to heart failure. If you have heart disease (e.g., recent heart attack, angina, heart failure) or an abnormal heart rhythm (e.g., heart block or fast heart rate), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Contact your doctor as soon as possible if you develop symptoms of heart problems such as shortness of breath, chest pain, rapid heartbeat, or swollen ankles.

Changes at injection site: Fatty tissue under the skin at the injection site may shrink or thicken if you inject yourself too often at the same site. To help avoid this effect, change the site with each injection. Talk to your doctor or diabetes educator if you notice your skin pitting or thickening at the injection site.

Intestinal problems: The safety and effectiveness of using this medication for people with inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) or who have slowed movement through the intestinal tract due to diabetes have not been established. If you have digestive system problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney function: The safety and effectiveness of using this medication for people with reduced kidney function has not been studied. Ensure that you are drinking enough water to prevent dehydration, particularly if you experience nausea, vomiting, or diarrhea, or in extreme heat. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Low blood glucose (hypoglycemia): People who use liraglutide or insulin are more at risk of experiencing hypoglycemia (low blood sugar). Symptoms of mild to moderate hypoglycemia may occur suddenly and can include cold sweat, nervousness or shakiness, fast heartbeat, headache, hunger, confusion, lightheadedness, weakness, and numbness or tingling (tongue, lips, or fingers). Mild to moderate hypoglycemia may be treated by eating foods or drinks that contain sugar. You should always carry a quick source of sugar, such as hard candies, glucose tablets, juice, or regular soft drinks (not diet soft drinks). If you experience symptoms of hypoglycemia, eat one of these sources of sugar and then rest. If you feel symptoms of hypoglycemia coming on, don't take insulin.

Signs of severe hypoglycemia can include disorientation, loss of consciousness, and seizures. People who are unable to take sugar by mouth or who are unconscious may require an injection of glucagon or treatment with intravenous (into the vein) glucose.

Pancreatitis (inflammation of the pancreas): Although pancreatitis has not been seen with the use of insulin degludec – liraglutide, liraglutide on its own has been associated with pancreatitis. If you experience symptoms of pancreatitis such as severe and persistent abdominal pain that may move to the back with or without vomiting, contact your doctor immediately. If you have previously had pancreatitis, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Potassium levels: Insulin degludec – liraglutide can cause decreased levels of potassium in the body. Decreased potassium levels in the blood can cause muscle cramping in the arm or leg muscles, muscle weakness or tiredness, tingling or numbness, nausea or vomiting. In cases of severely reduced levels of potassium, low blood pressure causing fainting and irregular heartbeat are possible. Report any of these symptoms to your doctor as soon as possible.

Risk of thyroid cancer: In rare cases, people have developed thyroid cancer while using liraglutide. People with a personal or family history of thyroid cancer or people who have multiple endocrine neoplasia syndrome type 2 (a disease where people have tumours in more than one gland in their body) should not use this medication.

Report any lumps or growths on your neck or throat, difficulty swallowing, or ongoing hoarseness to your doctor as soon as possible.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if insulin degludec or liraglutide pass into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

Seniors: People over the age of 65 are more likely to experience side effects of taking insulin degludec - liraglutide. Doses for seniors may need to be lower and increased more slowly than for other adults.

What other drugs could interact with this medication?

There may be an interaction between insulin degludec- liraglutide and any of the following:

• acetylsalicylic acid (ASA)
• alcohol
• androgens (e.g.,  testosterone)
• atypical antipsychotics (e.g., clozapine, olanzapine, quetiapine, risperidone)
• basiliximab
• beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
• chloroquine
• clarithromycin
• corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
• danazol
• disopyramide
• diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
• estrogens (e.g., conjugated estrogen, estradiol, ethinyl estradiol)
• everolimus
• glucagon
• goserelin
• hepatitis C antivirals (e.g., elbasvir, grazoprevir, ledipasvir, sofosbuvir, velpatasvir)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• hydroxychloroquine
• lanreotide
• leuprolide
• mifepristone
• monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
• niacin
• octreotide
• other diabetes medications (e.g., acarbose, canagliflozin, glyburide, insulin, lixisenatide, metformin, rosiglitazone, saxagliptin)
• pasireotide
• pentamidine
• progestins (e.g., dienogest, levonorgestrel, medroxyprogesterone, norethindrone)
• protein kinase inhibitors (e.g., ceritinib, dabrafenib, nilotinib, sunitinib)
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
• salbutamol
• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
• somatropin
• sulfonamide antibiotics ("sulfas"; e.g., sulfisoxazole, sulfamethoxazole)
• tacrolimus
• tramadol
• vorinostat

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Xultophy