Sitagliptin with simvastatin (Juvicor) for type 2 diabetes and high cholesterol

Published in Medicine Update

Date published: About this date

Health and medicines information in this article may have changed since the date published. This information does not replace advice from a health professional.

This Medicine Update is for people with type 2 diabetes and high cholesterol who are taking, or thinking about taking, Juvicor (containing sitagliptin with simvastatin).

Since this article was published Juvicor has been removed from the PBS and marketing  of Juvicor has been voluntarily discontinued by the sponsor in Australia. The individual components sitagliptin and simvastatin will remain on the PBS and will continue to be commercially available in Australia

Summary

Sitagliptin with simvastatin (brand name Juvicor) is a new combination of two existing medicines. The two active ingredients are: sitagliptin for glucose-lowering in type 2 diabetes and simvastatin for cholesterol-lowering.

Many people are prescribed metformin or a sulfonylurea (another type of diabetes medicine) for diabetes. If one of these medicines is not effective enough on its own, adding sitagliptin is an option for some people. If you also have high cholesterol, you may be prescribed a 'statin' cholesterol-lowering medicine, such as simvastatin.

Juvicor replaces sitagliptin and simvastatin (or another type of 'statin') as individual medicines. If you take Juvicor, you must not take sitagliptin or a statin in another medicine as well. This would result in you accidentally taking a double dose of either, or both, active ingredients and could lead to side effects.

If you take Juvicor, you will need to keep taking your primary diabetes medicine (metformin or a sulfonylurea). Check with your doctor about which medicines you should stop and which you should continue. Take any medicines you won't need to your pharmacy for safe disposal.

While combination medicines like Juvicor have some advantages, they can also cause problems.

Combination medicines can be more convenient than taking the medicines as separate tablets, and they are less expensive than buying the medicines individually.

However, there is the risk of accidentally taking the single medicine as well as the combination medicine. Also, if side effects or interactions occur with combination medicines it can be difficult to work out which active ingredient has caused it. Getting used to the medicines individually before taking a combination can reduce this risk.


What Juvicor is

Juvicor (pronounced JU-vi-COR) is a combination medicine. This means it contains two active ingredients. The two active ingredients are:

  • sitagliptin (pronounced SIT-a-GLIP-tin)
  • simvastatin (pronounced SIM-va-STAT-in).

Juvicor is the brand name.

The active ingredient is the chemical in the medicine that makes the medicine work. Many medicines are known by their brand names as well as by the name of the active ingredient. Some medicines are available under several different brand names.

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What Juvicor is for

Juvicor is used to treat people with both type 2 diabetes and high cholesterol. These two conditions often occur together.

Sitagliptin

One of the active ingredients in Juvicor, sitagliptin, helps to reduce blood glucose (sugar) levels in type 2 diabetes.

It is used if you need an extra medicine to manage your diabetes. So you will still need to take another diabetes medicine even if you take Juvicor. This would be either metformin or another type of diabetes medicine called a sulfonylurea.

Simvastatin

The other active ingredient in Juvicor, simvastatin, helps to lower cholesterol levels.

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What does Juvicor do?

If metformin or a sulfonylurea (another type of diabetes medicine) does not lower your blood glucose well enough on its own, and there is a reason you can't take the combination of these two medicines, you may need another diabetes medicine, such as sitagliptin.

If you also have high cholesterol, taking sitagliptin with simvastatin (a cholesterol-lowering medicine) in the combination tablet Juvicor is an option.

Sitagliptin

The sitagliptin in Juvicor lowers glucose levels in the blood by:

  • increasing the amount of insulin in the blood
  • reducing the amount of glucose produced by the liver.

Type 2 diabetes increases the risk of developing cardiovascular disease, kidney disease, eye disease, pain or loss of feeling or poor circulation in the feet, and problems with sexual function.

Although sitagliptin reduces blood glucose levels, it is not yet known if it decreases the risk of these long-term complications of diabetes (see How to decide between Juvicor and other medicines).

Simvastatin

The simvastatin in Juvicor:

  • decreases the amount of cholesterol your liver produces, and
  • increases the amount of cholesterol your liver removes from the blood.

High cholesterol levels increase the risk of cardiovascular problems such as heart attack and stroke.

Talk with your health professional about all the treatment options for treating type 2 diabetes and high cholesterol.

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Who can take Juvicor

You can be prescribed Juvicor through the Pharmaceutical Benefits Scheme (PBS) if you meet the PBS requirements for:

  • treatment with a cholesterol-lowering medicine
  • treatment with sitagliptin.

To get sitagliptin through the PBS, you must also be taking another diabetes medicine. You must:

  • be already taking metformin (e.g. Diaformin, Glucophage) or another type of diabetes medicine called a sulfonylurea (e.g. Amaryl, Daonil, Diamicron, Minidiab) for type 2 diabetes, and
  • be unable to take a combination of metformin and a sulfonylurea. For example, because of side effects.

Who should not take Juvicor

You should not take Juvicor if you:

  • are allergic to any of the ingredients
  • are under 18 years of age
  • are pregnant or breastfeeding
  • have active liver disease
  • have had to stop taking a cholesterol-lowering medicine (including simvastatin) because of muscle pain, weakness or tenderness
  • have type 1 diabetes
  • have had diabetic ketoacidosis (increased ketones in your urine or blood)
  • need to take less than 100 mg per day of sitagliptin because of kidney problems.

Tell your doctor if any of the following apply to you, as Juvicor may not be suitable:

  • you have kidney or liver problems
  • you drink more than 2 standard alcoholic drinks a day.

Juvicor may also not be suitable if you are over 65 years of age, as the risk of side effects is higher.

Juvicor is the brand name of the combination of these two active ingredients:

  • sitagliptin for type 2 diabetes
  • simvastatin for cholesterol-lowering.
Read more about diabetes medicines, including metformin and sulfonylureas.

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How to take Juvicor

Juvicor should be taken once a day at about the same time each day, before or after food. The recommended time for taking Juvicor is the evening because the simvastatin in Juvicor lowers cholesterol more effectively at night, when the liver usually produces more cholesterol.

However, if you are more likely to forget your tablet in the evening, it may be better for you to take it in the morning. Talk to your doctor if this applies to you.

Swallow the tablet with water.

What to do if you forget a dose

If it is not close to the time for your next dose, take it as soon as you remember. However, if it's almost time for your next dose, skip the missed dose.

Do not take a double dose to make up for a missed dose.

Talk to your doctor or pharmacist if you are not sure what to do.

Available dose combinations

Juvicor is available in 3 different dose combinations:

  • 100 mg sitagliptin and 10 mg simvastatin
  • 100 mg sitagliptin and 20 mg simvastatin
  • 100 mg sitagliptin and 40 mg simvastatin.

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Important side effects to consider

Ask your health professional about the possible side effects of this medicine before you take it. Always tell them about any changes to your condition if you're taking a new medicine.

To report possible side effects call the NPS Adverse Medicine Events (AME) Line on 1300 134 237.

People with questions about their medicines or seeking general information about side effects can call NPS Medicines Line on 1300 MEDICINE (1300 633 424).

Both these services are available Monday to Friday, 9am to 5pm AEST.

Both of the active ingredients in Juvicor can have side effects. So you may get side effects from either sitagliptin or simvastatin.

If you experience a suspected side effect when taking Juvicor, it can be difficult to know which active ingredient might be causing the problem.

Side effects from sitagliptin

The most common side effects of sitagliptin are headache and cold-like symptoms. Sitagliptin does not cause hypoglycaemia (low blood glucose) on its own, but it can increase the risk of hypoglycaemia if you take it with a sulfonylurea (another type of diabetes medicine).

Some less common, but serious, side effects can occur with sitagliptin, such as:

  • allergic reactions
  • pancreatitis (inflammation of the pancreas that can result in severe, long-lasting abdominal pain).

You should stop taking Juvicor and seek urgent medical attention if you have:

  • any swelling of the face, mouth, tongue or throat
  • severe, persistent stomach pain. This may be a sign of pancreatitis, a serious problem.

Side effects from simvastatin

Common side effects of simvastatin are:

  • muscle pain
  • stomach upset or pain, nausea, constipation or diarrhoea
  • headache
  • sleep disturbance (e.g. insomnia)
  • dizziness.

Some people may have blood test results showing abnormal liver function when taking simvastatin. This is more likely when first starting simvastatin, and the test results usually return to normal after reducing the dose.

In rare cases, muscle pain can be a sign of breakdown of muscle, which can cause kidney damage. Tell your doctor immediately if you have muscle aches, soreness or weakness that is not caused by exercise, or if you have brown or black coloured urine.

The terms common, uncommon and rare are used to describe the chance of getting a side effect. This is what they mean:

  • common – up to 1 in 10 people (10%) may get this side effect
  • uncommon – fewer than 1 in 100 people (1%) might get this side effect
  • rare – fewer than 1 in 1000 people (0.1%) might get this side effect.

For a list of all possible side effects, see the consumer medicine information (CMI) leaflet for Juvicor (sitagliptin and simvastatin).

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What else you should know about Juvicor

While taking Juvicor, you need to keep taking your other diabetes medicine (metformin or a sulfonylurea). So you will be taking at least 2 diabetes medicines.

Talk to your doctor or pharmacist before taking any other prescription or non-prescription medicines or supplements, including those from a supermarket or health food store, as some other medicines can interact with either of the active ingredients in Juvicor.

If you are taking Juvicor, do not take:

  • the antibiotics clarithromycin (e.g. Klacid), erythromycin (e.g. Eryc), and fusidate (Fucidin)
  • gemfibrozil (e.g. Lopid), for high triglycerides
  • cyclosporin (e.g. Neoral)
  • danazol (e.g. Azol)
  • certain HIV medicines
  • the antifungal medicines itraconazole (Sporanox), ketoconazole (Nizoral Tablets), voriconazole (Vfend) and posaconazole (Noxafil)
  • the hepatitis C medicines boceprevir (Victrelis) and telaprevir (Incivo)
  • St John's wort.

People of Chinese ethnicity should avoid taking more than 1 g/day of vitamin B3 (also known as niacin or nicotinic acid) with Juvicor as it may increase the risk of serious muscle damage. This is due to an interaction between niacin and simvastatin, which occurs only in Chinese people. The risk of this interaction is higher with Juvicor containing the 40 mg strength of simvastatin. Some supplements contain high doses of vitamin B3.

Tell your doctor or pharmacist if you are taking any of the medicines below.

These can also interact with Juvicor. You may not need to avoid them entirely, but the doses may need to be changed or you may need regular checks to make sure there are no problems:

  • the gout medicine colchicine (Colgout, Lengout)
  • other medicines for high cholesterol
  • medicines to prevent blood clots, such as warfarin (Coumadin, Marevan)
  • vitamin B3 (also known as niacin or nicotinic acid)
  • medicines for high blood pressure or heart conditions, such as:
  • verapamil (e.g. Anpec, Isoptin, Tarka, Veracaps)
  • diltiazem (e.g. Cardizem, Coras, Vasocardol)
  • amlodipine (e.g. Amlo, Exforge, Norvasc)
  • amiodarone (e.g. Aratac, Cardinorm, Cordarone X)
  • digoxin (e.g. Lanoxin, Sigmaxin).

Food and drink interactions

Avoid grapefruit and grapefruit juice, as they can increase the risk of side effects with simvastatin in Juvicor. Read more about grapefruit-medicine interactions.

Avoid drinking large amounts of alcohol — it can increase the risk of liver problems with Juvicor. Guidelines recommend not more than 2 standard drinks on any day. Having some alcohol-free days every week may help your body recover from the effects of alcohol.

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Other medicines for type 2 diabetes and high cholesterol

Other medicines for type 2 diabetes

Metformin, sulfonylureas and insulin are all medicines commonly prescribed for diabetes. These medicines have all been used for many years and have been shown to reduce the complications of diabetes — a very important benefit of these medicines.

Although metformin, sulfonylureas and insulin do have side effects, we know more about their side effects over the long-term compared with sitagliptin because they have been used for a longer time.

Sitagliptin should not be used as the first medicine used to treat type 2 diabetes. You must be already taking either metformin or a sulfonylurea before starting sitagliptin to get it through the PBS.

The other types of medicine you might take for type 2 diabetes are:

  • glitazones (Actos, Avandia)
  • exenatide (Byetta)
  • acarbose (Glucobay)
  • other 'gliptins' (this group includes sitagliptin, brand name Januvia; other brands of gliptins are Galvus, Onglyza, Trajenta).

Other medicines for high cholesterol

Simvastatin belongs to a group of medicines called 'statins', which are the most effective cholesterol-lowering medicines. Other statins include atorvastatin (e.g. Lipitor), fluvastatin (e.g. Lescol), pravastatin (e.g. Pravachol) and rosuvastatin (Crestor).

Other cholesterol-lowering medicines include ezetimibe (e.g. Ezetrol), nicotinic acid, gemfibrozil (e.g. Lopid), and fenofibrate (Lipidil).

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How to decide between Juvicor and other medicines

Your doctor will help you understand the potential risks and benefits of Juvicor. You should consider whether:

  • the active ingredients in Juvicor are right for you
  • a combination tablet is suitable for you.

Juvicor may be an option when sitagliptin is the appropriate choice for glucose-lowering, and you need to take a cholesterol-lowering medicine as well.

Sitagliptin and long-term benefits for diabetes

Sitagliptin has been used in Australia for 4 years and in the US for 6 years. It is effective for lowering blood glucose, but there is no evidence showing that it reduces the long-term complications of diabetes.

Cholesterol-lowering medicines

Simvastatin belongs to a group of medicines called 'statins', which are the most effective cholesterol-lowering medicines.

Combinations versus single medicines

Taking 2 medicines in a combination medicine may be more convenient than taking the medicines individually, and it will usually cost you less.

However, taking the medicines individually can be better for some people. For example, if you have a side effect or interaction it is easier to work out which medicine is the cause.

There is also less risk of confusion when taking the medicines individually.

When starting a combination medicine, you may accidentally keep taking medicines that the combination has replaced, because they have different brand names. This may result in you taking more medicine than you need.

It is more complicated to adjust the dose when you are taking a combination medicine. You cannot take more than one tablet of Juvicor, because this will double the dose of both active ingredients. Getting the doses right first by taking individual medicines helps avoid this problem with combinations.

If your cholesterol remains high, even with the maximum strength of simvastatin in Juvicor, you may need to go back to individual medicines or change to a different combination.

If you start Juvicor, use a medicines list and check with your health professional about which medicines you should keep taking and which ones you should stop. Return your unused sitagliptin and/or simvastatin to a pharmacy for disposal to avoid confusion.

Benefits and side effects differ between medicines and from person to person.

Talk with your health professional about all the treatment options for type 2 diabetes and high cholesterol.

Read more about combination medicines.

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What does Juvicor cost?

Cost to the Government

The full cost of Juvicor to the Australian Government is:

  • $97.72 for 100 mg sitagliptin/10 mg simvastatin (pack size 28 tablets)
  • $100.79 for 100 mg sitagliptin/20 mg simvastatin (pack size 28 tablets)
  • $105.22 for 100 mg sitagliptin/40 mg simvastatin (pack size 28 tablets).

Each prescription lasts 28 days, and you can get up to 5 repeats at one time.

Cost to the individual

If you get Juvicor through the Pharmaceutical Benefits Scheme (PBS), the Australian Government pays most of the cost and you will pay only a part, called the co-payment.

At the time of publication, the co-payment for people who are entitled to get Juvicor through the PBS is:

  • $36.10 for people without a concession card
  • $5.90 for concession card holders.

If you're not eligible to get Juvicor through the PBS, you will need to pay the full price for a prescription. This can be different to the full cost to the Australian Government because the cost of private prescriptions varies between pharmacies.

Most medicines prescribed by your doctor are covered by the PBS. This means that the Australian Government pays part of the cost of your medicine. You will need to pay the full price if the medicine is not available on the PBS, or is not available on the PBS for your specific condition.

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Other ways to help manage type 2 diabetes and high cholesterol

Physical activity

Regular physical activity is important for managing diabetes. (e.g. 30 minutes of physical activity on five or more days per week). Resistance training (e.g. using light weights) is recommended, as is aerobic exercise (e.g. walking or cycling). A diabetes educator, exercise physiologist or doctor can advise you on this.

Healthy eating

Healthy eating will help you to manage your diabetes and lower your cholesterol.

Aim for 2 serves of fruit and 5 serves of vegetables a day. Choose wholegrain foods (e.g. bread, pasta and cereals), legumes (e.g. beans and lentils), lean meats, poultry, fish, and low-fat dairy products.

Know your cholesterol and lipid targets

The targets for most people with diabetes are:

  • total cholesterol: less than 4 mmol/L
  • HDL cholesterol: 1 mmol/L or more
  • LDL cholesterol: less than 2 mmol/L
  • triglycerides: less than 2 mmol/L.

Ask your health professional what your individual targets are and what you can do to reach them. Have your cholesterol levels checked at least once every year, or as often as your health professional recommends.

Blood pressure

If you have diabetes, monitoring your blood pressure is just as important as tracking your blood glucose to prevent diabetes-related complications such as heart attack, stroke and damage to your eyes and kidneys.

Steps you can take to lower your blood pressure include:

  • healthy eating
  • reducing your salt intake
  • physical activity
  • achieving a healthy weight
  • reducing alcohol intake, if it's excessive
  • quitting smoking
  • taking medicines when prescribed.

Testing your glucose

Testing your blood glucose levels regularly can help you to manage your diabetes. Speak to your diabetes educator or doctor.

Smoking

The combination of smoking and diabetes greatly increases the risk of heart disease and other complications of diabetes. Quitting smoking will also have a positive impact on your health and substantially reduce your risk of other illnesses. For more information, contact the Quitline on 13 QUIT (13 7848) or get an online quitting coach from www.quitcoach.org.au.

Alcohol

If you drink alcohol, then a low-to-moderate intake is best. Alcohol can make hypoglycaemia more likely with some diabetes medicines.

Current guidelines recommend not more than 2 standard drinks on any day. Having some alcohol-free days every week may help your body recover from the effects of alcohol.

Find out more about diabetes

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Where to find more information about Juvicor

Read the consumer medicine information (CMI) leaflet. The CMI for Juvicor (sitagliptin and simvastatin) will tell you:

  • who should not use the medicine
  • how to take the medicine
  • most of the possible side effects
  • the ingredients.

You can get the CMI leaflet for Juvicor from:

  • your doctor or pharmacist
  • Merck, Sharp & Dohme, the makers of Juvicor (sitagliptin with simvastatin), on 1800 645 712.

Information over the phone

NPS works with healthdirect Australia to provide consumers with information on medicines.

To get information about Juvicor call the NPS Medicines Line on 1300 MEDICINE (1300 633 424) from anywhere in Australia. Service is available Monday–Friday, 9am–5pm EST except NSW public holidays.

To report a side effect with Juvicor

Call the Adverse Medicines Event (AME) Line on 1300 134 237 (Monday–Friday, 9am–5pm EST).

The AME Line lets you report and discuss side effects that might be related to your medicine. Medicine-related side effects are then reported to the Therapeutic Goods Administration (TGA) for assessment and contribute to national medicine safety efforts. Your personal information will remain confidential and your privacy maintained.

More about using medicines wisely

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