Cholesterol Basics

What is cholesterol?

Cholesterol is a waxy substance that's found in all the cells of the human body.

Not all cholesterol is bad - your body needs cholesterol to build cells, make hormones, vitamin D and the bile salts required for digestion.

Approximately 75% of the cholesterol in your blood is produced by your body, mainly in the liver. The remaining 25% comes from your diet (especially from food sources like meat, poultry & processed fatty foods).

Race, age and gender are some crucial factors that can impact the amount of cholesterol produced by your body.

Eating unhealthy food can elevate your body's cholesterol levels. Foods that are high in trans and/or saturated fat can result in increased levels of cholesterol in your blood.

Types of Cholesterol

LDL-C

LDL-C stands for Low-Density Lipoprotein Cholesterol. It is commonly known as "bad cholesterol".

The role of LDL-C is to transport cholesterol from your liver to your entire body. Excess LDL-C in your blood enhances your blood cholesterol levels. When your cholesterol is too high, excess cholesterol can be deposited within your blood vessels, resulting in the formation of plaques on the artery walls.

As the artery walls become narrower, it limits the blood flow to the heart. In extreme situations, this condition can result in a stroke or a heart attack.* Thus, your ultimate goal should be minimizing the level of LDL-C in your body.

Please note that Zypitamag has not been clinically demonstrated to reduce cardiovascular morbidity or mortality. Zypitamag has been shown to reduce LDL-C levels by up to 45%.

HDL-C

HDL-C stands for High-Density Lipoprotein Cholesterol.

It is known as "good cholesterol" because it helps carry cholesterol back to your liver from other parts of your body, including the arteries. Once the liver receives this cholesterol, only then can it remove the excess cholesterol from your body.

Importance of Checking Cholesterol

The only way to know your cholesterol levels is to have them checked. You can do this by having a simple blood test ordered by your health care provider. Thus, it's crucial to get your cholesterol levels tested regularly.

Sources of High Cholesterol

* The effect of ZYPITAMAG on cardiovascular morbidity and mortality has not been determined.

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Important Safety Information for Zypitamag® (pitavastatin) tablets

Who should NOT take ZYPITAMAG?

ZYPITAMAG is not right for everyone. Do not take ZYPITAMAG if:

You have a known allergy to ZYPITAMAG or any of its ingredients.
You have active liver problems, including some abnormal liver test results.
You are nursing, pregnant or may become pregnant, as it may harm the baby.
You are currently taking cyclosporine or gemfibrozil.

What is the most important information I should know and talk to my doctor about?

Call your healthcare provider or get help right away if you experience any symptoms of an allergic reaction, such as rash, itching, or hives.
Muscle problems may be an early sign of rare, serious conditions. Tell your doctor right away if you have any unexplained muscle pain, weakness, or tenderness, particularly if accompanied by malaise or fever, or if these muscle signs or symptoms persist after discontinuing ZYPITAMAG.
Serious liver problems have been reported rarely in patients taking statins, including pitavastatin. Your doctor should do liver tests before you start, and if you have symptoms of liver problems while you are taking ZYPITAMAG. Tell your healthcare provider right away if you feel more tired than usual, have a loss of appetite, upper belly pain, dark-colored urine, or yellowing of the skin or eyes.
Tell your doctor about all your medical conditions and medications you take including nonprescription medicines, vitamins, or herbal supplements.
Increases in blood sugar levels have been reported with statins, including pitavastatin.
Tell your doctor about your alcohol use.
Tell your healthcare provider of a known or suspected pregnancy.

What are the most common side effects of ZYPITAMAG?

The most common side effects of ZYPITAMAG in clinical studies were:

Back pain
Constipation
Diarrhea
Muscle pain
Pain in the legs or arms

This is not a complete list of side effects. Talk to your healthcare provider for more information.

You are encouraged to report negative side effects of all drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

How should I store and take ZYPITAMAG?

Store ZYPITAMAG tablets at room temperature, in a dry place, and out of the reach of children.
Take ZYPITAMAG orally once daily with or without food at the same time each day.
Swallow the tablet whole. Do not split, crush, dissolve, or chew.
The maximum recommended dosage is ZYPITAMAG 4 mg once daily.
If you take too much ZYPITAMAG or you or someone else takes an overdose, call your doctor and/or local Poison Control Center.

Other important information I should know about ZYPITAMAG.

ZYPITAMAG has not been studied to evaluate its effect on reducing heart-related disease or death.
ZYPITAMAG is available by prescription only.

For additional information, please see the full Prescribing Information.