Xultophy Prefilled Pen

Xultophy is a prescription medication approved by the FDA (Food & Drug Administration) to manage type 2 diabetes in adults. It combines insulin degludec and liraglutide as its active ingredient. It’s a subcutaneous injection administered daily using a prefilled pen. Each pen holds a solution with 100 units of insulin degludec and 3.6 mg of liraglutide per mL. Xultophy lowers blood sugar levels by enhancing insulin release, reducing glucagon, and slowing gastric emptying. Dosages start at 10 units for new users or 16 units for those previously on either drug. The maximum dosage is 50 units daily. Xultophy is intended for long-term use, emphasizing the importance of adherence to a healthy diet and exercise.

Xultophy is a brand-name prescription medication designed to lower blood sugar levels in adults with type 2 diabetes. It combines two active ingredients: insulin degludec, a long-acting insulin, and liraglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist. This combination works by enhancing insulin release, reducing glucagon secretion, and slowing gastric emptying, helping to manage blood sugar levels effectively.

Xultophy is administered once daily as a subcutaneous injection using a prefilled pen containing 3 mL of solution with 100 units of insulin degludec and 3.6 mg of liraglutide per mL. The initial dosage varies based on prior use of either drug, starting at 10 units (10 units of insulin degludec and 0.36 mg of liraglutide) for new users or 16 units for those transitioning from either medication. The maximum daily dosage is 50 units. Proper administration involves injecting Xultophy into the thighs, abdomen, or upper arms, ideally at the same time each day. It’s crucial to avoid sharing the pen to prevent infections. If a dose is missed, it should be skipped, and the next dose should be taken as scheduled.

Side effects may include hypoglycemia, nausea, diarrhea, and potentially serious effects like pancreatitis, kidney damage, or thyroid tumors. Xultophy also carries a boxed warning for thyroid tumor risk. Before starting Xultophy, discussing medical history and possible interactions with other medications with a healthcare provider is essential. Long-term adherence to Xultophy, combined with a healthy diet and exercise, can significantly aid in managing type 2 diabetes.

Xultophy is a prescribed brand-name medication specifically approved for managing blood sugar levels. It is primarily used to:

• Lower blood sugar levels in adults diagnosed with type 2 diabetes. It is most effective when combined with a healthy diet and regular exercise.

What Are the Forms & Strengths of Xultophy?

• Form and Usage: Xultophy is available as a liquid solution in a prefilled pen designed for subcutaneous injection (injection under the skin). It is used once daily.
• Composition and Strengths:
  • Insulin Degludec: Each milliliter (mL) of the Xultophy solution contains 100 units of insulin degludec.
  • Liraglutide: Each milliliter (mL) of the Xultophy solution contains 3.6 mg of liraglutide.
• Packaging: Each Xultophy pen holds 3 mL of the solution.
• Safety Guidelines: Each Xultophy pen is intended for use only by one person. Do not share your Xultophy pen with anyone else, even if you change the needle. Sharing pens or needles can lead to the spread of infections.

What Are the Recommended Dosage of Xultophy?

Xultophy Dosage for Type 2 Diabetes

• Starting Dosage:
  • New Users: If you have never taken either of the active ingredients in Xultophy (long-acting insulin or liraglutide), your starting dose should be 10 units per day. This dose includes 10 units of insulin degludec and 0.36 mg of liraglutide.
  • Current Users: If you are currently taking long-acting insulin or liraglutide, your starting dose should be 16 units per day. This dose includes 16 units of insulin degludec and 0.58 mg of liraglutide. Your doctor might ask you to stop using your current insulin or liraglutide before you begin Xultophy.
• Maximum Dosage:
  • The highest dose you can take each day is 50 units, which provides 50 units of insulin degludec and 1.8 mg of liraglutide.
• General Guidelines:
  • Always follow your doctor’s instructions when using Xultophy.
  • Dosages may vary based on individual health needs and the doctor’s assessment.

[Note: Remember, these recommendations may vary from person to person. Discuss it with your doctor, and they’ll customize your dosage accordingly.]

• Following Instructions: Always use Xultophy as directed by your doctor or healthcare provider. Xultophy is administered as a subcutaneous injection, meaning it is injected under the skin. Do this once each day at about the same time for best results. You can inject it into your thighs, abdomen, or upper arms.
• Using the Pen: Xultophy comes in a prefilled, disposable pen. Use a new needle for each injection to ensure cleanliness and avoid infection. It’s important never to share your pen with anyone, even if you change the needle.
• Instructional Support: The manufacturer provides an instructional video on their website, which demonstrates how to prepare your pen and administer your injection properly.
• Timing Your Doses: You can take Xultophy at any time of the day, but try to take it at the same time each day for consistency. If you miss a dose, wait until your next scheduled dose to take it. Do not take more than one dose at a time, as this can lead to dangerously low blood sugar levels.
• Reminder Tips: To ensure you don’t miss a dose, consider setting a reminder on your phone or using a medication timer.
• Long-term Use: Xultophy is intended for long-term treatment. If your doctor determines that Xultophy is safe and effective for you, you will likely use it as a continual part of your diabetes management.

[Note: Your doctor will decide the right amount for you based on your condition, following guidelines and studies on the drug. They’ll adjust it as needed over time.]

Xultophy combines two active ingredients that help control blood sugar in different ways:

• Insulin Degludec: This is a long-acting insulin, much like your body’s naturally produced insulin. It helps lower your blood sugar by moving glucose (sugar) from your blood into your muscle and fat cells. It also prevents your liver from producing and releasing more glucose into your blood.
• Liraglutide: This drug helps reduce your blood sugar by boosting your body’s insulin release. Liraglutide also lowers glucagon levels—a hormone that raises blood sugar levels, working in the opposite way to insulin. Additionally, liraglutide slows down how quickly your stomach empties after eating, which helps slow down sugar absorption from your food and can make you feel fuller longer.

After you inject Xultophy, it begins to work within a few hours, but it might take a few months to see the full effects on your average blood sugar levels.

Common Xultophy Side Effects: Most side effects from Xultophy are minor and usually disappear within a few days or weeks. If they become more severe or don’t go away, you should talk to your doctor or pharmacist. Here are some of the more common side effects you might experience with Xultophy:

• Nausea
• Diarrhea
• Headache
• Infections, such as a cold
• Hypoglycemia (low blood sugar)

Serious Xultophy Side Effects: These side effects from Xultophy are rare but can happen. If you experience serious side effects, you should contact your doctor immediately. If your symptoms feel life-threatening or if you think you’re having a medical emergency, call 911 right away. Here are some serious side effects and their symptoms that you might encounter:

• Kidney damage or failure. Signs may include:
  • Swelling in your ankles, legs, or feet
  • Nausea or vomiting
  • Trouble breathing
  • Feeling very tired or weak
  • Confusion
• Pancreatitis (inflammation in your pancreas). Signs may include:
  • Vomiting
  • Severe pain in the middle part of your upper belly
• Gallbladder damage. Signs may include:
  • Fever
  • Yellowing of the whites of your eyes or your skin
  • Nausea or vomiting
  • Belly pain (usually in the middle part of your upper belly)
• Possible risk of thyroid cancer
• Hypokalemia (low potassium level). Signs may include:
  • Fast or irregular heartbeat
  • Muscle aches or stiffness
  • Tingling or numbness in your legs, arms, feet, or hands
  • Muscle cramps or spasms (sudden muscle contractions)
  • Feeling extremely weak or tired
• Severe allergic reaction
• Severe hypoglycemia (very low blood sugar level)

[Note: Remember, this list may not cover all possible side effects. Always consult with your healthcare giver for medical advice about side effects.]

FDA Warning: Thyroid Tumor Risk: Xultophy has a boxed warning from the FDA, the most serious type of warning. This alerts doctors and patients about potentially dangerous effects. Using Xultophy may increase the risk of thyroid tumors and a type of thyroid cancer called medullary thyroid carcinoma (MTC). One of the drugs in Xultophy, liraglutide, has been shown to increase thyroid tumor risk in animals. It’s not known if it can cause thyroid tumors in humans.

Your doctor will discuss the potential risks of thyroid tumors and MTC with you. They will advise you to watch for symptoms such as a lump in your neck, trouble breathing or swallowing, or a raspy voice. If you develop thyroid tumors or MTC, your doctor may have you stop taking Xultophy and switch to a different medication.

You should not take Xultophy if you have multiple endocrine neoplasia syndrome type 2 (MEN 2), which causes tumors in the endocrine glands. Avoid using Xultophy if you or a family member currently has or has had MTC.

Before starting Xultophy, talk with your doctor about your medical history. Certain conditions or factors may make Xultophy unsuitable for you, including:

• Alcohol: Alcohol can affect how Xultophy regulates your blood sugar. It can also increase your blood sugar levels since it contains sugar. Avoid alcohol or be very cautious until you’re comfortable with your Xultophy dosage. If you drink, discuss with your doctor how to manage your diabetes treatment. They may adjust your dose or recommend frequent blood sugar checks.
• Birth Control: The safety of Xultophy during pregnancy is unknown. If you or your partner could become pregnant, discuss birth control options with your doctor. Xultophy can interact with birth control pills, possibly causing high blood sugar. Your doctor may adjust your Xultophy dose or recommend frequent blood sugar checks.
• Pregnancy: Animal studies showed that liraglutide (one of the drugs in Xultophy) caused birth defects and fetal death, while insulin degludec did not. However, animal results don’t always apply to humans. There isn’t enough information about Xultophy’s safety during pregnancy. Diabetes itself can be harmful during pregnancy. If you’re pregnant or planning to become pregnant, discuss the benefits and risks of Xultophy and other treatment options with your doctor.
• Breastfeeding: In animal studies, both liraglutide and insulin degludec were found in breastmilk. It’s unclear if this applies to humans. If you are breastfeeding or plan to, discuss with your doctor whether it’s safe to use Xultophy.
• Heart Failure: If you have heart failure, taking Xultophy with thiazolidinediones (TZDs) could worsen your condition. If you develop new or worsening heart failure, your doctor may monitor your symptoms, adjust your dose, or recommend stopping Xultophy.
• Pancreas, Kidney, or Gallbladder Problems: Xultophy may worsen conditions affecting your kidneys, pancreas, or gallbladder, possibly leading to organ failure. Your doctor may recommend avoiding Xultophy, depending on the severity of your condition.
• Hypokalemia (Low Potassium): Xultophy could worsen low potassium levels. Your doctor may monitor your potassium levels and symptoms, adjust your dose, or recommend stopping Xultophy based on your condition’s severity.
• Severe Allergy: If you’re allergic to any of the ingredients in Xultophy, it may not be safe for you. Your doctor will suggest alternative diabetes medications.
• Hyperglycemia or Hypoglycemia: Frequent episodes of low or high blood sugar can be worsened by Xultophy. Your doctor may adjust your dose, recommend more frequent blood sugar checks, or switch your medication.

Xultophy should not be used by people with:

• an active hypoglycemia episode
• a personal history of multiple endocrine neoplasia syndrome type 2 (MEN 2)
• a personal or family history of medullary thyroid carcinoma (MTC)
• hypersensitivity to any ingredient in Xultophy

If you miss a dose of Xultophy, wait until your next scheduled dose to take it. This helps prevent your blood sugar level from dropping too low, which can happen if you take two doses too close together. To avoid missing a dose, consider setting a reminder on your phone or using a medication timer.

[Note: If you have missed a dose of your medication and are unsure about when to take the next one, immediately consult your doctor or pharmacist.]

Using more than the recommended dosage of Xultophy can cause serious side effects. Symptoms of an overdose may include:

• Severe hypoglycemia (low blood sugar), which can cause:
  • Headache
  • Sweating
  • Hunger
  • Fast heartbeat
  • Difficulty speaking or seeing
  • Dizziness, weakness, shakiness, or lightheadedness
  • Confusion or drowsiness
  • Feeling anxious, irritated, or moody
• Severe vomiting and nausea

If you take too much Xultophy and experience severe hypoglycemia, use a rescue medication like glucagon (Baqsimi, GlucaGen) to raise your blood sugar level. Even after using a rescue medication, you should call 911 or go to the nearest emergency room immediately. This is important because Xultophy contains long-acting insulin, which can lower your blood sugar for a longer period than the rescue medication can counteract.

[Note: If you consumed more than the recommended dose, get medical help right away or call the Poison Help line at 1-800-222-1222.]

• Packaging: Keep Xultophy pens in their original packaging, away from heat and light.
• Freezing: Do not freeze Xultophy pens. If a pen has been frozen, do not use it.
• Unopened Pens: Store unopened Xultophy pens in the refrigerator (36°F to 46°F / 2°C to 8°C). You can keep them refrigerated until their expiration date.
• Storage Duration: Once opened, you can store the pen for up to 21 days.
• Temperature: Store the opened pen at either room temperature (59°F to 86°F / 15°C to 30°C) or in the refrigerator (36°F to 46°F / 2°C to 8°C).
• Disposal: After 21 days, dispose of the opened pen.
• Needle Removal: Always remove the needle from your pen and discard it after each injection.
• Pen Storage: Store the pen without the needle attached to prevent infections and medication leakage.
• Safety: Dispose of any unused Xultophy safely to prevent accidental use by others, including children and pets, and to protect the environment.

[Note: Discuss with your healthcare professional about the proper disposal of any unused medicine and any questions you may have regarding its storage.]

Xultophy can interact with several other medications, supplements, and foods, causing different effects. Some interactions may reduce the effectiveness of the drug, while others may increase side effects. Before taking Xultophy, discuss all your prescription, over-the-counter medications, vitamins, herbs, and supplements with your doctor and pharmacist to avoid potential interactions. Below are the drugs that can interact with Xultophy:

Diabetes Medications: Taking Xultophy with other diabetes drugs can change your blood sugar levels.

• Drugs that Lower Blood Sugar: Combining Xultophy with these medications can increase the risk of severe hypoglycemia (low blood sugar).
• Glucagon: Using Xultophy with glucagon (GlucaGen, Baqsimi) can increase the risk of hyperglycemia (high blood sugar). Glucagon raises blood sugar levels.
• Thiazolidinediones (TZDs): These medications may increase the risk of heart failure when taken with Xultophy. Examples include:
  • Pioglitazone (Actos)
  • Rosiglitazone (Avandia)

Heart Medications: Some heart medications can change your blood sugar levels when taken with Xultophy.

• Risk of Hypoglycemia: Examples include:
  • ARBs, such as valsartan (Diovan)
  • Disopyramide (Norpace)
  • ACE inhibitors, such as lisinopril (Zestril)
  • Fenofibrate (Lipofen)
• Risk of Hyperglycemia: Examples include:
  • Diuretics, such as furosemide (Lasix)
  • Niacin (Niaspan)
• Masking Hypoglycemia Symptoms: Examples include:
  • Alpha agonists, such as clonidine (Catapres)
  • Beta-blockers, such as atenolol (Tenormin) and metoprolol (Lopressor)

Mental Health Medications: Certain mental health drugs can affect your blood sugar levels when used with Xultophy.

• Risk of Hypoglycemia: Examples include:
  • Lithium salts (Lithobid)
  • MAOIs, such as phenelzine (Nardil)
  • SSRIs, such as fluoxetine (Prozac)
• Risk of Hyperglycemia: Examples include:
  • Lithium salts (Lithobid)
  • Antipsychotics, such as olanzapine (Zyprexa) and chlorpromazine

Hormone Medications: Hormone drugs can also affect blood sugar levels when taken with Xultophy.

• Risk of Hypoglycemia: Example:
  • Octreotide (Sandostatin)
• Risk of Hyperglycemia: Examples include:
  • Androgens, such as danazol
  • Estrogens, such as conjugated estrogens (Premarin)
  • Thyroid hormones, such as levothyroxine (Synthroid)
  • Growth hormones, such as somatropin (Humatrope)
  • Oral contraceptives (birth control pills)
  • Adrenal hormones, such as epinephrine (EpiPen)

Antibiotics, Antivirals, and Other Anti-Infective Medications: These medications can change your blood sugar levels when taken with Xultophy.

• Risk of Hypoglycemia: Examples include:
  • Certain anti-infectives, such as pentamidine (Pentam)
  • Sulfonamide antibiotics, such as sulfamethoxazole/trimethoprim (Bactrim)
• Risk of Hyperglycemia: Examples include:
  • Certain anti-infectives, such as isoniazid or pentamidine (Pentam)
  • Antivirals, such as atazanavir (Reyataz)

Other Drugs: Certain other drugs can also affect blood sugar levels when used with Xultophy.

• Risk of Hypoglycemia: Examples include:
  • Pain medications, such as salicylates (aspirin)
  • Vasodilators, such as pentoxifylline
• Risk of Hyperglycemia: Examples include:
  • Corticosteroids, such as budesonide (Entocort EC, Uceris) and prednisone (Deltasone, Rayos)
  • Asthma medications, such as albuterol (Ventolin) or terbutaline

What Are the Other Xultophy Interactions?

• Xultophy and Herbs and Supplements: No herbs or supplements are known to interact with Xultophy. However, it’s important to consult your doctor or pharmacist before using any of these products while taking Xultophy.
• Xultophy and Foods: No specific foods are known to interact with Xultophy. However, eating foods high in carbohydrates and sugars can raise your blood sugar levels. Your doctor might adjust your Xultophy dose or recommend more frequent blood sugar monitoring based on your diet.

[Note: This isn’t a complete list, and there could be other drugs that interact with Xultophy. Make sure to tell your doctor about any prescription, over-the-counter medicines, and herbal products you’re taking.]

If you need an alternative to Xultophy for treating type 2 diabetes, several other medications are available. Your doctor can help you find the best option based on your specific needs. Some Xultophy alternatives include:

• Sulfonylureas, such as:
  • Amaryl (glimepiride)
  • Glucotrol (glipizide)
  • DiaBeta (glyburide)
  • Glynase (glyburide)
• Biguanides, such as:
  • Glumetza (metformin)
  • Glucophage (metformin)
  • Riomet (metformin)
• Thiazolidinediones (TZDs), such as:
  • Actos (pioglitazone)
  • Avandia (rosiglitazone)
• Meglitinides, such as:
  • Prandin (repaglinide)
  • Starlix (nateglinide)
• Dipeptidyl peptidase-4 (DPP-4) inhibitors, such as:
  • Januvia (sitagliptin)
  • Nesina (alogliptin)
  • Tradjenta (linagliptin)
  • Onglyza (saxagliptin)
• Sodium-glucose cotransporter 2 (SGLT2) inhibitors, such as:
  • Invokana (canagliflozin)
  • Farxiga (dapagliflozin)
  • Jardiance (empagliflozin)
• Insulin (long-acting forms), such as:
  • Levemir (insulin detemir)
  • Lantus (insulin glargine)
  • Toujeo (insulin glargine)
  • Tresiba (insulin degludec)
• Glucagon-like peptide 1 (GLP-1) receptor agonists, such as:
  • Ozempic (semaglutide)
  • Adlyxin (lixisenatide)
  • Bydureon (exenatide)
  • Byetta (exenatide)
  • Victoza (liraglutide)
  • Saxenda (liraglutide)

[Note: Your doctor will choose what’s best for you. Don’t use any of these alternative medications without consulting your healthcare provider. Taking them by yourself may cause serious side effects.]

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