For further information on ANTARA®, including trade inquiries:
Call: 866-587-4617
Fax: 866-587-4627
Email: customerservice@lupinusa.com
Lupin Pharmaceuticals, Inc.
Harborplace Tower
111 S. Calvert Street, 21st Floor
Baltimore, MD 21202
Phone: 800-399-2561
Fax: 913-451-6409
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA. gov/medwatch, or call 1-800-FDA-1088.
Uses
ANTARA® (fenofibrate) capsules is used to treat high cholesterol and high triglyceride levels in your blood.
ANTARA® and Your Diet
Talk with your doctor about a cholesterol-lowering diet prior to being prescribed ANTARA®. You should continue this diet during treatment with ANTARA®. ANTARA® can be taken without regard to meals.
ANTARA® and Heart Disease
The effects of ANTARA® on heart and non-heart-related disease resulting in disability and death has not been established. Fenofibrate, the active ingredient in ANTARA®, was not shown to reduce sickness or death due to heart disease in patients with type 2 diabetes mellitus (T2DM).
ANTARA® and Dosing
Your kidneys are your body’s main way of removing ANTARA® from your system. The starting dose of ANTARA® is 90 mg per day. If you have reduced kidney function, your ANTARA® treatment should start at a dosage of 30 mg/day. If you are elderly, you should also be started at a dosage of 30 mg/day. Speak to your doctor about your health and dosing amounts that are right for you.
Who Should Not Take ANTARA®?
ANTARA® should not be used by nursing mothers, people who are allergic or sensitive to fenofibrates, who have liver disease, gallbladder disease or severe kidney problems.
Fenofibrates and Checking Your Liver Function
Fenofibrates may be associated with increasing certain liver enzymes found in the blood. These enzymes are called serum transaminases. Your doctor should monitor your liver function regularly. If your levels continue to be 3 times higher than the normal limit, your cholesterol-lowering treatment with ANTARA® should be stopped. Ask your doctor about your liver function and at what intervals you should have it checked.
Fenofibrates in Combination With a Statin Medication
Taking ANTARA® while also taking a statin medication (HMG-CoA reductase inhibitor) should be avoided unless you and your doctor decide the benefits outweigh the risks. Speak to your doctor if you are taking a statin. Using a fibrate alone, even without a statin, can occasionally result in muscle inflammation and skeletal muscle disorders. If you experience any type of muscle pain, tenderness, or weakness, contact your doctor immediately.
Fenofibrates and Gallstones
In some instances, fenofibrates may lead to gallstones. Tell your doctor if you experience the following symptoms: abdominal pain, nausea or vomiting, fever or chills, chronic diarrhea, yellow-tinted skin and unusual stools or urine.
ANTARA® and Pregnancy
Safety in pregnant women has not been established. Inform your doctor if you are pregnant or are considering getting pregnant while on a course of treatment with ANTARA®.
ANTARA® and Other Possible Drug Interactions
Use of ANTARA® may increase the effects of blood thinners, such as Coumadin® (warfarin sodium). Please inform your doctor if you are currently taking a blood thinner. Using immunosuppressants with ANTARA® may lead to poor kidney function. Tell your doctor if you are taking an immunosuppressant.
To avoid a drug interaction, patients should take ANTARA® at least 1 hour before or 4 to 6 hours after taking a bile acid binding resin.
Be sure to tell your doctor about all medications, supplements, and herbal preparations you are taking and report any change to your medical condition or the medicines you take.
Other Warnings and Precautions
Other precautions include inflammation of your pancreas, paradoxical decreases in HDL cholesterol levels, and blood changes. Please see Full Prescribing Information for a complete list of precautions.
The risk information provided here is not complete. To learn more, talk about ANTARA with your doctor or pharmacist. Click here to view the FDA-approved product labeling.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA. gov/medwatch, call 1-800-FDA-1088, or call Lupin Pharmaceuticals, Inc. at 1-800-399-2561.
Uses
ANTARA® (fenofibrate) capsules is used to treat high cholesterol and high triglyceride levels in your blood.
ANTARA® and Your Diet
Talk with your doctor about a cholesterol-lowering diet prior to being prescribed ANTARA®. You should continue this diet during treatment with ANTARA®. ANTARA® can be taken without regard to meals.
ANTARA® and Heart Disease
The effects of ANTARA® on heart and non-heart-related disease resulting in disability and death has not been established. Fenofibrate, the active ingredient in ANTARA®, was not shown to reduce sickness or death due to heart disease in patients with type 2 diabetes mellitus (T2DM).
ANTARA® and Dosing
Your kidneys are your body’s main way of removing ANTARA® from your system. The starting dose of ANTARA® is 90 mg per day. If you have reduced kidney function, your ANTARA® treatment should start at a dosage of 30 mg/day. If you are elderly, you should also be started at a dosage of 30 mg/day. Speak to your doctor about your health and dosing amounts that are right for you.
Who Should Not Take ANTARA®?
ANTARA® should not be used by nursing mothers, people who are allergic or sensitive to fenofibrates, who have liver disease, gallbladder disease or severe kidney problems.
Fenofibrates and Checking Your Liver Function
Fenofibrates may be associated with increasing certain liver enzymes found in the blood. These enzymes are called serum transaminases. Your doctor should monitor your liver function regularly. If your levels continue to be 3 times higher than the normal limit, your cholesterol-lowering treatment with ANTARA® should be stopped. Ask your doctor about your liver function and at what intervals you should have it checked.
Fenofibrates in Combination With a Statin Medication
Taking ANTARA® while also taking a statin medication (HMG-CoA reductase inhibitor) should be avoided unless you and your doctor decide the benefits outweigh the risks. Speak to your doctor if you are taking a statin. Using a fibrate alone, even without a statin, can occasionally result in muscle inflammation and skeletal muscle disorders. If you experience any type of muscle pain, tenderness, or weakness, contact your doctor immediately.
Fenofibrates and Gallstones
In some instances, fenofibrates may lead to gallstones. Tell your doctor if you experience the following symptoms: abdominal pain, nausea or vomiting, fever or chills, chronic diarrhea, yellow-tinted skin and unusual stools or urine.
ANTARA® and Pregnancy
Safety in pregnant women has not been established. Inform your doctor if you are pregnant or are considering getting pregnant while on a course of treatment with ANTARA®.
ANTARA® and Other Possible Drug Interactions
Use of ANTARA® may increase the effects of blood thinners, such as Coumadin® (warfarin sodium). Please inform your doctor if you are currently taking a blood thinner. Using immunosuppressants with ANTARA® may lead to poor kidney function. Tell your doctor if you are taking an immunosuppressant.
To avoid a drug interaction, patients should take ANTARA® at least 1 hour before or 4 to 6 hours after taking a bile acid binding resin.
Be sure to tell your doctor about all medications, supplements, and herbal preparations you are taking and report any change to your medical condition or the medicines you take.
Other Warnings and Precautions
Other precautions include inflammation of your pancreas, paradoxical decreases in HDL cholesterol levels, and blood changes. Please see Full Prescribing Information for a complete list of precautions.
The risk information provided here is not complete. To learn more, talk about ANTARA with your doctor or pharmacist. Click here to view the FDA-approved product labeling.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA. gov/medwatch, call 1-800-FDA-1088, or call Lupin Pharmaceuticals, Inc. at 1-800-399-2561.
