Juvisync

Generic Name: sitagliptin/simvastatin (SIT-a-GLIP-tin /SIM-va-STAT-in)
Brand Name: Juvisync

Juvisync is used for:

Treating type 2 diabetes and lowering high cholesterol and triglycerides in certain patients. It also increases high-density lipoprotein (HDL) ("good") cholesterol levels. It is used along with diet and exercise. It is used in certain patients to reduce the risk of heart attack, stroke, and death due to coronary heart disease. It is also used to reduce the need for medical procedures to open blocked blood vessels. It may also be used for other conditions as determined by your doctor.

Juvisync is a dipeptidyl peptidase-4 (DPP-4) inhibitor and HMG-CoA reductase inhibitor (statin) combination. The DPP-4 inhibitor works by increasing the amount of insulin released by your body and decreasing the amount of sugar made by your body. The statin works by reducing the production of certain fatty substances in the body, including cholesterol.

Do NOT use Juvisync if:

  • you are pregnant, may become pregnant, or are breast-feeding
  • you are allergic to any ingredient in Juvisync
  • you have type 1 diabetes
  • you have high blood or urine ketone levels (diabetic ketoacidosis)
  • you have severe kidney problems
  • you have liver problems or unexplained abnormal liver function tests
  • you take boceprevir, clarithromycin, cobicistat, cyclosporine, danazol, erythromycin, gemfibrozil, an HIV protease inhibitor (eg, ritonavir), itraconazole, ketoconazole, nefazodone, posaconazole, telaprevir, telithromycin, or voriconazole

Contact your doctor or health care provider right away if any of these apply to you.

Before using Juvisync:

Some medical conditions may interact with Juvisync. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of angioedema (swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness) caused by another DPP-4 inhibitor (eg, saxagliptin)
  • if you have low blood pressure, kidney problems, low thyroid function, muscle problems or a family history of muscle problems, or serious metabolism, hormonal, or electrolyte problems
  • if you drink alcohol or have a history of seizures, liver problems, or alcohol abuse
  • if you have a history of inflammation of the pancreas (pancreatitis) or stones in your gallbladder (gallstones)
  • if you are scheduled for major surgery or have recently had major surgery or a serious injury, or if you have a serious infection
  • if you have had an organ transplant and are taking medicine to suppress a rejection reaction

Some MEDICINES MAY INTERACT with Juvisync. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Amiodarone, amlodipine, azole antifungals (eg, itraconazole, ketoconazole, posaconazole, voriconazole), boceprevir, cobicistat , colchicine, cyclosporine, danazol, diltiazem, dronedarone, fibrates (eg, gemfibrozil, clofibrate, fenofibrate), HIV protease inhibitors (eg, ritonavir), lomitapide, macrolide antibiotics (eg, clarithromycin, erythromycin), nefazodone, niacin, ranolazine, telaprevir, telithromycin, or verapamil because they may increase the risk of muscle or kidney problems
  • Rosiglitazone because the risk of swelling of the hands, legs, or feet may be increased
  • Insulin or sulfonylureas (eg, glipizide) because the risk of low blood sugar may be increased
  • Anticoagulants (eg, warfarin), digoxin, or macrolide immunosuppressants (eg, tacrolimus) because the risk of their side effects may be increased by Juvisync

This may not be a complete list of all interactions that may occur. Ask your health care provider if Juvisync may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Juvisync:

Use Juvisync as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Juvisync comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Juvisync refilled.
  • Take Juvisync by mouth with or without food in the evening, unless directed otherwise by your doctor.
  • Swallow Juvisync whole. Do not break, crush, or chew before swallowing. Tell your doctor if you cannot swallow tablets whole.
  • Do not eat grapefruit or drink grapefruit juice while you use Juvisync.
  • Take Juvisync on a regular schedule to get the most benefit from it.
  • Continue to take Juvisync even if you feel well. Do not miss any doses.
  • If you miss a dose of Juvisync, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Juvisync.

Important safety information:

  • Juvisync may cause liver problems. Rarely, severe and sometimes fatal liver failure has been reported in patients taking Juvisync. Your risk of developing liver problems may be greater if you drink alcohol daily or in large amounts with Juvisync, or if you have a history of liver problems. Check with your doctor before drinking alcohol while you are taking Juvisync. Tell your doctor right away if you experience symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, loss of appetite, or stomach pain; unusual tiredness).
  • Carry an ID card at all times that says you have diabetes.
  • Follow the diet and exercise program given to you by your health care provider. Proper diet, regular exercise, and regular blood sugar testing are important for best results with Juvisync.
  • Check your blood sugar levels as directed by your doctor. If they are often higher or lower than they should be and you take Juvisync exactly as prescribed, tell your doctor.
  • It may be harder to control your blood sugar during times of stress, such as fever, infection, injury, or surgery. Talk with your doctor about how to control your blood sugar if any of these occur. Do not change the dose of your medicine without checking with your doctor.
  • Tell your doctor or dentist that you take Juvisync before you receive any medical or dental care, emergency care, or surgery. Juvisync may need to be stopped for a few days before certain types of surgery.
  • Do NOT take more than the recommended dose without checking with your doctor.
  • Muscle problems (myopathy) may occur with Juvisync. The risk of muscle problems may be greater in people who take higher doses of Juvisync, in people older than 64 years old, in women, or in people who have kidney problems or low thyroid function. It may also be greater in those who take it with certain other medicines (eg, niacin), especially in Chinese patients. Tell your doctor right away if you notice any unexplained muscle pain, tenderness, or weakness, especially if you also have a fever or general body discomfort. Tell your doctor if you have muscle problems that persist even after your doctor has told you to stop taking Juvisync.
  • Juvisync usually does not cause low blood sugar. However, low blood sugar may occur when it is used along with certain other medicines for diabetes (eg, insulin, sulfonylureas). Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you hungrier. It is a good idea to carry a reliable source of glucose (eg, tablets, gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or nondiet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.
  • Severe and sometimes fatal inflammation of the pancreas (pancreatitis) has been reported in patients taking Juvisync. Discuss any questions or concerns with your doctor. Contact your doctor immediately if you develop severe or persistent stomach or back pain with or without nausea or vomiting.
  • Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Rarely, changes to the skin, hair, and nails (eg, discoloration, dryness, hair loss) may occur. Check with your doctor if these effects become bothersome or cause you concern.
  • Lab tests, including blood cholesterol levels, blood glucose, hemoglobin A1c, liver and kidney function, and creatine phosphokinase (CPK) blood levels, may be performed while you use Juvisync. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Juvisync with caution in the ELDERLY; they may be more sensitive to its effects, especially muscle problems.
  • Juvisync should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in children have not been confirmed.
  • Women who are able to become pregnant should use effective birth control while taking Juvisync. Check with your doctor if you have questions about using birth control.
  • PREGNANCY and BREAST-FEEDING: Do not use Juvisync if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Juvisync is found in breast milk. Do not breast-feed while taking Juvisync.

Possible side effects of Juvisync:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; headache; mild stomach pain; nausea; runny or stuffy nose; sore throat; upper respiratory tract infection.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); burning, numbness, or tingling; change in the amount of urine produced; confusion; dark or red-colored urine; decreased sexual ability; depression; dizziness; fast or irregular heartbeat; fever, chills, or persistent cough or sore throat; joint pain; memory problems (eg, forgetfulness, memory loss); muscle pain, tenderness, or weakness (with or without fever and fatigue); red, swollen, blistered, or peeling skin; shortness of breath; swelling of the hands, legs, or feet; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, severe or persistent nausea or stomach pain, yellowing of the skin or eyes); symptoms of pancreas inflammation (eg, severe stomach or back pain with or without nausea or vomiting); trouble sleeping; unusual bruising or bleeding; unusual tiredness or weakness; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Juvisync:

Store Juvisync at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Juvisync out of the reach of children and away from pets.

General information:

  • If you have any questions about Juvisync, please talk with your doctor, pharmacist, or other health care provider.
  • Juvisync is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Juvisync or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Juvisync. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Juvisync. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Juvisync.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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