LIVALO® (pitavastatin) tablets (LIV-ah-lo) — Consumer Brief Summary Information, Cont’d
What is LIVALO?
• LIVALO is a prescription medicine that belongs to a group of
cholesterol-lowering medicines called “statins.”
• LIVALO, along with diet, lowers total cholesterol, “bad”
cholesterol (LDL-C) and triglycerides. It can also raise “good”
• The effect of LIVALO on cardiovascular morbidity and mortality
has not been determined.
What is the most important information I should talk with my
• 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, tenderness, or weakness particularly if accompanied by
malaise or fever, or if these muscle signs or symptoms persist
after discontinuing LIVALO.
• Serious liver problems have been reported rarely in patients
taking statins, including LIVALO. Your doctor should do liver tests
before you start, and if you have symptoms of liver problems
while you are taking LIVALO. 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
• Increases in blood sugar levels have been reported with statins,
• Tell your doctor about all your medical conditions and
medications you take including nonprescription medicines,
vitamins, or herbal supplements.
• Tell your doctor about your alcohol use.
• Tell your healthcare provider of a known or suspected pregnancy.
Who should NOT take LIVALO?
Do not take LIVALO if:
• You have a known allergy to LIVALO or any of its ingredients.
• You have active liver problems which may include some
abnormal liver test results.
• You are nursing, pregnant; or may become pregnant, as it may
harm the baby.
• You are currently taking cyclosporine.
What are the most common side effects of LIVALO?
The most common side effects of LIVALO in clinical
• Back pain
• 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.
Can other medications affect my treatment with LIVALO?
Yes, other medications may affect LIVALO; you should consult
with your doctor if you take any of the following:
• Other drugs for high cholesterol (i.e., fenofibrates, niacin)
What should I tell my doctor before taking LIVALO?
Tell your doctor if:
• You are allergic to LIVALO, or any of its ingredients; you may
get a full list of ingredients from your doctor or pharmacist.
• You are having or have been told you have active liver or
• You are pregnant, think you are pregnant, are planning to
become pregnant, or are breast-feeding.
• You are taking other medications, discuss all medication, both
prescription and over-the-counter, with your doctor.
• You consume alcoholic beverages.
• You are diabetic or have been told you may develop diabetes as
the doctor may wish to monitor your blood glucose more closely.
How should I store and take LIVALO?
• Store LIVALO at room temperature, in a dry place, protected
from light, and keep out of the reach of children.
• LIVALO should be taken at the same time every day, with or
• The maximum recommended dosage of LIVALO is 4 mg
• Swallow the tablet whole. Do not split, crush, dissolve, or chew.
• If you take too much LIVALO or you or someone else takes an
overdose, call your doctor or call Poison Control (1-800-222-1222).
LIV-RA-0126 PI of 10/2019
The information provided is not complete.
Please see the full Prescribing Information available at www.LivaloRx.com.
Manufactured for: Kowa Company, Limited Tokyo 103-8433 Japan
Manufactured by: Patheon Pharmaceuticals, Inc. Cincinnati, OH 45237 USA or by Kowa Company, LTD Nagoya, 462-0024 Japan
Marketed and Distributed by: Kowa Pharmaceuticals America, Inc. Montgomery, AL 36117 USA
© Kowa Pharmaceuticals America, Inc. (2019) — All rights reserved. LIV-MT-3758 December 2019