What is Juvisync?

Sitagliptin and simvastatin combination is used together with a proper diet and exercise to treat type 2 diabetes. It is also used together with a proper diet to treat high cholesterol and triglyceride (fats) levels in the blood. This medicine may help prevent medical problems caused by clogged blood vessels such as heart attacks and strokes.

Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor. It helps to control blood sugar levels by increasing substances in the body that make the pancreas release more insulin. It also signals the liver to stop producing sugar (glucose) when there is too much sugar in the blood.

Simvastatin belongs to the group of medicines called statins. It works to reduce the amount of cholesterol in the blood by blocking the production of cholesterol.

This medicine was available only with your doctor's prescription. The Juvisync™ product will no longer be marketed in the United States as of September 26, 2013, but may be available in other countries.

Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Your doctor will give you instructions about diet, exercise, testing your blood sugar, and adjusting your dose when you are sick. Carefully follow your doctor's instructions.

Swallow the tablet whole. Do not break, crush, or chew it.

If you are taking diltiazem (Cardizem®), dronedarone (Multaq®), or verapamil (Calan®, Isoptin®, Verelan®) together with this medicine, your dose of Juvisync™ should not be higher than 100 milligrams (mg) of sitagliptin and 10 mg of simvastatin per day, unless otherwise directed by your doctor. Do not use more than 100 mg of sitagliptin and 20 mg of simvastatin per day together with amiodarone (Cordarone®), amlodipine (Norvasc®), lomitapide (Juxtapid™), or ranolazine (Ranexa®). When used together with higher doses of Juvisync™, these medicines may increase your risk of muscle injury and could result in kidney problems.

Avoid drinking grapefruit juice while you are taking this medicine. Grapefruit juice may increase your risk of muscle injury and could result in kidney problems.

Do not drink large amounts of alcohol with this medicine. This could cause unwanted effects on the liver.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For type 2 diabetes and high cholesterol:
    • For patients who are not taking sitagliptin or simvastatin:
      • Adults—At first, 100 milligrams (mg) of sitagliptin and 40 mg of simvastatin combination once a day in the evening. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.
    • For patients who are already taking simvastatin:
      • Adults—At first, 100 milligrams (mg) of sitagliptin and the dose of simvastatin you are already taking. It is taken once a day in the evening. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies have not been performed on the relationship of age to the effects of sitagliptin and simvastatin combination in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sitagliptin and simvastatin combination in the elderly. However, elderly patients are more likely to have age-related kidney or muscle problems, which may require caution and an adjustment in the dose for patients receiving sitagliptin and simvastatin combination.

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Amprenavir
• Atazanavir
• Boceprevir
• Clarithromycin
• Cobicistat
• Cyclosporine
• Danazol
• Darunavir
• Erythromycin
• Fosamprenavir
• Gemfibrozil
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Letermovir
• Lopinavir
• Mibefradil
• Mifepristone
• Nefazodone
• Nelfinavir
• Paritaprevir
• Posaconazole
• Ritonavir
• Saquinavir
• Telaprevir
• Telithromycin
• Tipranavir
• Voriconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acarbose
• Acenocoumarol
• Amiodarone
• Amlodipine
• Azithromycin
• Balofloxacin
• Besifloxacin
• Bezafibrate
• Carbamazepine
• Ceritinib
• Chlorpropamide
• Ciprofibrate
• Ciprofloxacin
• Clofibrate
• Colchicine
• Conivaptan
• Dabigatran Etexilate
• Dalfopristin
• Daptomycin
• Delavirdine
• Diltiazem
• Duvelisib
• Eltrombopag
• Enoxacin
• Eslicarbazepine Acetate
• Fenofibrate
• Fenofibric Acid
• Fleroxacin
• Fluconazole
• Flumequine
• Fosnetupitant
• Fusidic Acid
• Gatifloxacin
• Gemifloxacin
• Glecaprevir
• Glimepiride
• Glipizide
• Glyburide
• Ivosidenib
• Lanreotide
• Levofloxacin
• Lomefloxacin
• Lomitapide
• Lumacaftor
• Metformin
• Moxifloxacin
• Nadifloxacin
• Nateglinide
• Netupitant
• Niacin
• Norfloxacin
• Octreotide
• Ofloxacin
• Pasireotide
• Pazopanib
• Pazufloxacin
• Pefloxacin
• Pibrentasvir
• Prulifloxacin
• Quinupristin
• Ranolazine
• Repaglinide
• Risperidone
• Rufloxacin
• Simeprevir
• Sparfloxacin
• Tadalafil
• Thioctic Acid
• Tolazamide
• Tolbutamide
• Tolvaptan
• Tosufloxacin
• Verapamil
• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Albiglutide
• Alitretinoin
• Atenolol
• Betaxolol
• Bisoprolol
• Bosentan
• Carteolol
• Carvedilol
• Celiprolol
• Clopidogrel
• Digoxin
• Dronedarone
• Efavirenz
• Esmolol
• Fosphenytoin
• Interferon Beta
• Labetalol
• Levobunolol
• Levothyroxine
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Oat Bran
• Oxcarbazepine
• Oxprenolol
• Pectin
• Penbutolol
• Phenytoin
• Pindolol
• Practolol
• Propranolol
• Rifampin
• Sotalol
• St John's Wort
• Ticagrelor
• Timolol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Cranberry Juice
• Grapefruit Juice

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol use, excessive or history of or
• Chinese ancestry or
• Gallbladder stones or
• Hypothyroidism (an underactive thyroid), uncontrolled or
• Kidney disease or
• Liver disease, history of or
• Pancreas problems, history of—Use with caution. May cause side effects to become worse.

• Angioedema (swelling of the face, lips, tongue, throat, arms, or legs) with sitagliptin or other DPP-4 inhibitors, history of—Use with caution. May increase the risk of this condition occurring again.

• Diabetic ketoacidosis (high ketones and acid in the blood) or
• Kidney disease, severe or
• Liver disease, active or
• Type 1 diabetes—Should not be used in patients with these conditions.

• Electrolyte disorders, severe or
• Endocrine disorders, severe or
• Epilepsy (seizures), not well-controlled or
• Hypotension (low blood pressure) or
• Major surgery or trauma, recent or
• Metabolic disorders, severe or
• Sepsis (severe infection in the blood)—Patients with these conditions may be at risk for muscle or kidney problems.

• Muscle pain, tenderness, or weakness, history of—Use with caution. May make these conditions worse.

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Do not use this medicine if you are also taking any of the following medicines: boceprevir (Victrelis®), cobicistat-containing products (Stribild®), cyclosporine (Gengraf®, Neoral®, Sandimmune®), danazol (Danocrine®), gemfibrozil (Lopid®), nefazodone (Serzone®), telaprevir (Incivek®), certain antibiotics (such as clarithromycin, erythromycin, itraconazole, ketoconazole, posaconazole, telithromycin, voriconazole, Nizoral®), or medicines to treat HIV/AIDS (such as atazanavir, indinavir, nelfinavir, ritonavir, saquinavir, tipranavir, Crixivan®, Kaletra®, Lexiva®, Norvir®, Prezista®, Reyataz®). Using these medicines together with sitagliptin and simvastatin combination may increase your risk of muscle injury and could result in kidney problems.

Chinese patients who are taking large amounts of niacin (greater than or equal to 1 gram or 1000 milligrams per day) together with this medicine may have an increased risk for muscle injury. Talk to your doctor if you are Chinese or have Chinese ancestry and take large amounts of niacin (Niacor®, Niaspan®). You may need a different dose of this medicine.

Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have unusual tiredness or a fever. These could be symptoms of serious muscle problems, such as myopathy or immune-mediated necrotizing myopathy (IMNM). Myopathy is more common when high doses of simvastatin (eg, 80 milligrams) are used, but some people get myopathy with lower doses.

Call your doctor right away if you have dark-colored urine, diarrhea, a fever, muscle cramps or spasms, muscle pain or stiffness, or unusual tiredness or weakness. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.

Call your doctor right away if you have dark-colored urine, a general feeling of tiredness or weakness, a headache, light-colored stools, loss of appetite, stomach pain, upper right stomach pain, vomiting, weight loss, or yellow eyes or skin. These could be symptoms of liver damage.

Tell your doctor right away if you have sudden and severe stomach pain, nausea, vomiting, fever, or lightheadedness. These may be symptoms of pancreatitis (swelling and inflammation of the pancreas).

This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions (Stevens-Johnson syndrome). These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

This medicine may cause hypoglycemia (low blood sugar). Low blood sugar can also occur if you delay or miss a meal or snack, exercise more than usual, drink alcohol, cannot eat because of nausea or vomiting, take certain medicines, or take sitagliptin with another type of diabetes medicine (eg, insulin, glimepiride, metformin, or pioglitazone). Symptoms of low blood sugar must be treated before they cause you to pass out (unconsciousness). People feel different symptoms with low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly.

Symptoms of low blood sugar include anxiety, behavior changes similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty with thinking, drowsiness, excessive hunger, a fast heartbeat, headaches that continue, nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, or unusual tiredness or weakness.

If symptoms of low blood sugar occur, check your blood sugar level. If you have low blood sugar, eat glucose tablets or gel, corn syrup, honey, or sugar cubes, or drink fruit juice, non-diet soft drinks, or sugar dissolved in water. Glucagon is a medicine that is used in emergency situations when severe symptoms, such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe and needle, and know how to use it. The members of your family should also know how to use glucagon.

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 you have diabetes with a list of all your medicines.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine if you have major surgery, a major injury, or you develop other serious health problems.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.