Cerivastatin (patient information)

Associate Editor:

IMPORTANT NEWS ALERT
On August 8, 2001 the U.S. Food and Drug Administration (FDA) announced that Bayer Pharmaceutical Division is voluntarily withdrawing Baycol (cerivastatin) from the U.S. market because of reports of sometimes fatal rhabdomyolysis, a severe muscle adverse reaction from this cholesterol-lowering (lipid-lowering) product. The FDA agrees with and supports this decision. All patients taking Baycol should contact their healthcare providers to discuss treatment alternatives.

For more information please refer to http://www.fda.org

DRUG CLASS AND MECHANISM
Cerivastatin is a drug that lowers cholesterol in the blood by blocking the enzyme in the liver that is responsible for producing cholesterol. It lowers total cholesterol as well as the LDL subfraction of cholesterol in the blood. LDL cholesterol is believed to be the "bad" cholesterol that is primarily responsible for the development of coronary artery disease. Lowering LDL cholesterol levels retards and may even reverse coronary artery disease. Cerivastatin is in the same class of drugs (HMGCoA reductase inhibitors) as atorvastatin (Lipitor), simvastatin (Zocor), pravastatin (Pravachol), lovastatin (Mevacor), and fluvastatin (Lescol). Cerivastatin was approved by the FDA in 1997.

GENERIC AVAILABLE
No

PRESCRIPTION REQUIREMENTS
Yes

PREPARATIONS
Tablets, 0.3mg, 0.4mg, and 0.8mg.

STORAGE
Tablets should be stored at room temperature, 15-30 C (59-86 F).

PRESCRIBED FOR
Cerivastatin is used for the treatment of high blood cholesterol. Elevated blood cholesterol first is treated with exercise, weight loss, and a diet low in cholesterol and saturated fats. If these measures fail to reduce the cholesterol adequately, cholesterol-lowering medications such as cerivastatin may be added. The National Cholesterol Education Program (NCEP) has published treatment guidelines for using drugs such as cerivastatin. These guidelines recommend treatment depending on the level of LDL cholesterol as well as the presence of other risk factors such as diabetes, hypertension, cigarette smoking, low HDL cholesterol level (the "good" cholesterol), and family history of early coronary heart disease. The effectiveness of cerivastatin in lowering cholesterol is dose-related, that is, the higher the dose the greater the lowering of cholesterol. Blood cholesterol determinations are performed at regular intervals during treatment so that the dose may be adjusted.

DOSING
Cerivastatin usually is taken once daily at bedtime. It may be taken with or without food.

DRUG INTERACTIONS
With other drugs in the same class as cerivastatin, the risk of muscle damage (see below) is increased when they are given at the same time as other medications such as cyclosporine (Sandimmune; Neoral), gemfibrozil (Lopid), erythromycin, itraconazole (Sporanox) and nicotinic acid. It is assumed that cerivastatin will interact similarly.

PREGNANCY
It is not known if cerivastatin causes harm to the fetus if taken during pregnancy. Cerivastatin may be used in pregnancy if the physician feels that its benefits outweigh its potential risks.

NURSING MOTHERS
It is not known if cerivastatin is secreted in breast milk. Therefore, the physician and patient must weigh the benefits against the potential risks of treating nursing mothers.

SIDE EFFECTS
Cerivastatin generally is well-tolerated, and side effects are rare. Minor side effects include constipation, diarrhea, fatigue, gas, heartburn, nasal congestion, and headache. Cerivastatin should be used with caution in patients with alcoholic or other liver diseases. Persistently abnormal liver tests during treatment are rare but may require discontinuation of the medication. Rare cases of muscle damage due to inflammation (myositis) have been reported with other drugs in the same class as cerivastatin, and is presumed also to occur with cerivastatin as well. (Muscle inflammation causes the release of muscle protein, myoglobin, into the blood where it is carried to the kidneys and leads to kidney failure.)