Linagliptin

Linagliptin is used along with diet and exercise and sometimes with other medications to lower blood sugar levels in patients with type 2 diabetes (condition in which blood sugar is too high because the body does not produce or use insulin normally). Linagliptin is in a class of medications called dipeptidyl peptidase-4 (DPP-4) inhibitors. It works by increasing the amounts of certain natural substances that lower blood sugar when it is high. Linagliptin is not used to treat type 1 diabetes (condition in which the body does not produce insulin and, therefore, cannot control the amount of sugar in the blood) or diabetic ketoacidosis (a serious condition that may develop if high blood sugar is not treated). Linagliptin used in combination with insulin to treat diabetes has not been studied to date.

Over time, people who have diabetes and high blood sugar can develop serious or life-threatening complications, including heart disease, stroke, kidney problems, nerve damage, and eye problems. Taking medication(s), making lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking your blood sugar may help to manage your diabetes and improve your health. This therapy may also decrease your chances of having a heart attack, stroke, or other diabetes-related complications such as kidney failure, nerve damage (numb, cold legs or feet; decreased sexual ability in men and women), eye problems, including changes or loss of vision, or gum disease. Your doctor and other healthcare providers will talk to you about the best way to manage your diabetes.

Linagliptin comes as a tablet to take by mouth. It is usually taken once a day with or without food. Take linagliptin at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take linagliptin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Linagliptin helps to control high blood sugar but does not cure diabetes. Continue to take linagliptin even if you feel well. Do not stop taking linagliptin without talking to your doctor.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with linagliptin and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking linagliptin,

• tell your doctor and pharmacist if you are allergic to linagliptin, any other medications, or any of the ingredients in linagliptin tablets. Ask your pharmacist or check the manufacturer's patient information for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: carbamazepine (Tegretol); insulin; oral medications for diabetes such as acetohexamide, chlorpropamide (Diabinese), glimepiride (Amaryl, in Avandaryl), glipizide (Glucotrol, in Metaglip), glyburide (Diabeta, Glynase, Micronase, in Glucovance), nateglinide (Starlix), pioglitazone (Actos, in Actoplus Met, in Duetact), repaglinide (Prandin), rosiglitazone (Avandia, in Avandamet, in Avandaryl), tolazamide, and tolbutamide; phenytoin (Dilantin); phenobarbital; rifabutin (Mycobutin); rifampin (Rifadin, in Rifamate, in Rifater); and ritonavir (Norvir, in Kaletra). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor and pharmacist what herbal products you are taking or plan to take, especially St. John's wort.

• tell your doctor if you have or have ever had pancreatitis (inflammation of your pancreas), gallstones (stones in your gallbladder), or high triglycerides (a fatty substance in the blood), or if you drink or have ever drunk large amounts of alcohol.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking linagliptin, call your doctor.

• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking linagliptin.

• talk to your doctor about what you should do if you get hurt or if you develop a fever or infection. These conditions may affect your blood sugar and the amount of linagliptin you may need for treatment.

Be sure to follow all diet and exercise recommendations made by your doctor or dietician. It is important to eat a healthy diet, exercise regularly, and lose weight if necessary. This will help to control your diabetes and help linagliptin work more effectively.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.

• Linagliptin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • headache

  • joint pain

• Some side effects can be serious. If you experience any of these symptoms, stop taking linagliptin and call your doctor immediately or get emergency medical treatment:

  • rash

  • itching, flaking, or peeling of the skin

  • hives

  • swelling of the face, lips, tongue, or throat

  • difficulty breathing or swallowing

  • hoarseness

  • ongoing pain that begins in the upper left or middle of the stomach but may spread to the back

  • nausea

  • vomiting

  • loss of appetite

• Linagliptin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

• If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your blood sugar and glycosylated hemoglobin (HbA1c) should be checked regularly to determine your response to linagliptin. Your doctor will also tell you how to check your response to linagliptin by measuring your blood sugar levels at home. Follow these instructions carefully.

You should always wear a diabetic identification bracelet to be sure you get proper treatment in an emergency.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Glyxambi^® (containing Linagliptin, Empagliflozin)
• Jentadueto^® (containing Linagliptin, Metformin)