When was Juxtapid approved by the Food and Drug Administration (FDA)?
When was Juxtapid approved by the Food and Drug Administration (FDA)?
Juxtapid was approved by the FDA in 2012 for adult patients with HoFH along with a low-fat eating plan and other cholesterol-lowering therapies. Many patients who started taking Juxtapid back then are still on this medication because it is working for them.*
Juxtapid is a prescription medicine used along with diet and other lipid lowering treatments, including low-density lipoprotein (LDL) apheresis where available, in adults with homozygous familial hypercholesterolemia (HoFH) to reduce LDL (“bad”) cholesterol, total cholesterol, a protein that carries “bad” cholesterol in the blood (apolipoprotein B), and non-high-density lipoprotein cholesterol (non-HDL-C).
Studies have not been conducted to tell us whether Juxtapid can decrease problems from high cholesterol, such as heart attack, stroke, death, or other health problems. Studies have also not been conducted to tell us whether Juxtapid is safe for use in people with high cholesterol who do not have HoFH, including those with heterozygous familial hypercholesterolemia (HeFH).
*Mosaic Solutions Group [Data January 2013 – July 2020]
How long will I need to take Juxtapid?
At this time, there is no cure for HoFH. Because Juxtapid works by decreasing the amount of cholesterol your body produces, you need to take it regularly to maintain the effect. Learn more about taking Juxtapid here.
Can I get Juxtapid at my local pharmacy where I get all my other prescriptions?
Juxtapid is not available at local pharmacies. It is available only through certified pharmacies that are enrolled in the Juxtapid REMS Program. Juxtapid is delivered right to your door through our specialty pharmacy partners at Accredo.
REMS stands for Risk Evaluation and Mitigation Strategy. There is a registry that collects information about the effects of taking Juxtapid over time. Ask your doctor for more information about this registry or call 1-877-902-4099.
Who will contact me before I start Juxtapid and why?
In the beginning, you’ll speak with each member of the patient support team to make sure that your insurance and Juxtapid questions are answered, you’re on track with your eating plan, and your prescription is filled properly. From there, your support will be tailored to meet your specific needs. Learn more about the support program here.
What are the supplements that come with Juxtapid and how do I take them?
Nutritional supplements are an important part of your treatment plan. Your healthcare provider will recommend that you take nutritional supplements to replace the essential fatty acids and vitamin E that are not absorbed by our body while taking Juxtapid. Be sure to take one of each in the morning with food. Do not take them at night with Juxtapid as they do contain a small amount of fat. Learn more about What to Expect with Juxtapid.
I already eat a healthy diet. Why do I need to speak with a dietitian?
The low-fat eating plan you need to follow while taking Juxtapid is different from traditional heart-healthy eating because all fats count. While taking Juxtapid, you should get less than 20% of your daily calories from fat. By doing this, you may be able to reduce the risk of experiencing stomach problems while taking Juxtapid. Your Patient Educator is specially trained to help you figure out the easiest way to personalize the low-fat eating plan so it works for you.
Why do I need liver tests?
Because of the way Juxtapid works in the liver, it can cause liver problems such as increased liver enzymes or increased fat in the liver. Your doctor should perform blood tests to check your liver before you start Juxtapid, if your dose is increased, and while you take Juxtapid, to ensure that you aren’t showing elevated enzyme levels, which can be an early sign of liver problems. If you do show signs of liver problems, your doctor will either lower your dose or stop Juxtapid altogether. Learn more about What to Expect with Juxtapid.
If I develop increased liver enzymes, will they go down after I stop taking Juxtapid?
In clinical studies, elevated liver enzymes typically went back down after patients either reduced the dose or stopped taking Juxtapid. You should discuss your liver test results with your doctor to determine the best clinical decision for you.
Juxtapid® (lomitapide) capsules is a prescription medicine used along with diet and other lipid lowering treatments, including low-density lipoprotein (LDL) apheresis where available, in adults with homozygous familial hypercholesterolemia (HoFH) to reduce LDL (“bad”) cholesterol, total cholesterol, a protein that carries bad cholesterol in the blood (apolipoprotein B), and non-high-density lipoprotein cholesterol (non-HDL-C).
Studies have not been conducted to tell us whether Juxtapid can help prevent problems from high cholesterol, such as heart attack, stroke, death, or other health problems. Studies have also not been conducted to tell us whether Juxtapid is safe for use in people with high cholesterol but who do not have HoFH, including those with heterozygous familial hypercholesterolemia (HeFH).
Juxtapid is available only through certified pharmacies that are enrolled in the Juxtapid REMS Program. Your doctor must be enrolled and certified in the program in order to prescribe Juxtapid.
Tell your doctor if you have any side effect that bothers you or that does not go away. Stop taking Juxtapid and tell your doctor if you have severe diarrhea, especially if you also have lightheadedness, decreased urine output, or tiredness. These are not all the possible side effects of Juxtapid. For more information, speak with your doctor or pharmacist.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Juxtapid may affect the way other medicines work, and other medicines may affect how Juxtapid works.