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Frequently asked questions about ACTOS Patient information about ACTOS

Tablets: 15 mg, 30 mg, and 45 mg

What is ACTOS?
What is type 2 diabetes?
Why is it important to control type 2 diabetes?
How does ACTOS help treat type 2 diabetes?
Will ACTOS increase my risk of having a heart attack or stroke?
What are the possible serious side effects of ACTOS?
What should I discuss with my health professional before taking ACTOS?
How soon will ACTOS begin to work?
How should I take ACTOS?
What should I do if I miss a dose?
Do I still need to test my blood glucose while using ACTOS?
What other routine laboratory tests are recommended?
Can I take ACTOS with other diabetes drugs?
Will ACTOS interfere with other drugs?
Can ACTOS increase my risk for pregnancy?
What else can I do to help control type 2 diabetes?
Who should not use ACTOS?
How should I store ACTOS?
Where can I find more information about ACTOS?

What is ACTOS?

ACTOS is a clinically proven, once-a-day medicine that belongs to a class of oral diabetes drugs called thiazolidinediones (THIGH-ah-ZO-li-deen-DYE-owns). Thiazolidinediones are also called insulin sensitizers because they treat type 2 diabetes by helping your body better use insulin. ACTOS comes in tablets, is always taken once a day, and, along with healthy eating and physical activity, helps lower blood glucose (sugar) levels.

What is type 2 diabetes?

Type 2 diabetes (formerly called non–insulin-dependent diabetes mellitus or adult-onset diabetes) occurs when the body does not produce enough insulin or cannot properly use the insulin it makes to control blood sugar. Insulin allows sugar to enter the cells of your body. Once inside the cells, sugar is used as a source of energy. If your body is resistant to the effects of insulin, a condition known as insulin resistance, and if it cannot make enough insulin to overcome that resistance, sugar builds up in the blood (hyperglycemia).

Why is it important to control type 2 diabetes?

It is important to control type 2 diabetes because the buildup of sugar in the blood, if not controlled, can lead to serious medical problems such as kidney damage, amputation, heart disease, and blindness.

How does ACTOS help treat type 2 diabetes?

ACTOS, along with healthy eating and physical activity, works by treating insulin resistance, an important defect of type 2 diabetes. ACTOS helps your body use insulin more effectively by making your cells more sensitive to insulin. That is why it is called an insulin sensitizer. It does not cause your body to produce more insulin; instead, it helps your body respond better to insulin’s effects.

Will ACTOS increase my risk of having a heart attack or stroke?

In clinical studies, ACTOS did not increase the risk of having a heart attack or stroke. The ACTOS product information includes FDA-reviewed data from a study of more than 5,000 high-risk patients with a history of macrovascular disease (ie, recent heart attack, stroke, bypass surgery, etc). In this study, there was no difference in the number of macrovascular events (such as heart attacks or strokes) between patients taking ACTOS and those not taking ACTOS. ACTOS is not for everyone. Certain patients with heart failure should not start taking ACTOS. ACTOS can cause or worsen congestive heart failure. Please see Important Safety Information below.

What are the possible serious side effects of ACTOS?

Fluid buildup (edema) can occur when taking ACTOS or other products in this class, and can lead to congestive heart failure (CHF). ACTOS is not recommended in certain patients with heart failure. CHF is different than a heart attack or stroke. It is a condition in which the heart cannot pump blood as effectively as it should. CHF is a serious condition that, while often treatable, requires close monitoring and care by your physician.

ACTOS was generally well tolerated in clinical trials. The most common side effects reported by people taking ACTOS included symptoms of upper respiratory tract infection, headache, sinusitis, muscle soreness, tooth disorder, and sore throat. Occasionally, blood sugar levels increased during clinical trials. This occurred less frequently with ACTOS than with placebo (an inactive comparison pill). As with other insulin sensitizers, weight gain may occur. In addition, mild-to-moderate swelling (edema) and a decrease in blood count (anemia) may occur. Low blood sugar was observed in a few patients who took ACTOS with insulin or with other oral diabetes drugs. Very rarely, some patients have experienced visual changes while taking ACTOS.

What should I discuss with my health professional before taking ACTOS?

ACTOS is not for everyone. You should talk to your health professional if you have a history of congestive heart failure, liver problems, or swelling (edema), or if you are pregnant, intend to become pregnant, or are breast-feeding. ACTOS can cause fluid retention or swelling, which may lead to or worsen heart failure. It is also important to tell your health professional if you are taking other prescription drugs or over-the-counter products.

How soon will ACTOS begin to work?

Your blood sugar levels may be significantly reduced in as quickly as 2 weeks, though the full effect of ACTOS may take several more weeks to be seen. If you do not respond adequately to your starting dose of ACTOS, your health professional may increase your daily dose to improve your blood sugar control.

How should I take ACTOS?

ACTOS only needs to be taken once a day. Food does not change how ACTOS works, so you can take it with or without meals. To help you remember to take ACTOS, it is a good idea to take it at the same time every day.

What should I do if I miss a dose?

If you miss the timing of your daily dose, take ACTOS as soon as you remember within the same day. If you miss a day, do not take a double dose the next day to make up for it.

Do I still need to test my blood sugar while using ACTOS?

Yes. You should test your blood sugar as often as your health professional recommends.

What other routine laboratory tests are recommended?

It is important to have your blood glucose and glycosylated hemoglobin (A1C), a measure of your average blood sugar levels over 2 to 3 months, checked regularly by your health professional. You will also need to have blood tests to check for serious or active liver disease prior to starting ACTOS therapy, and periodically thereafter per the clinical judgment of your health professional.

While taking ACTOS, call your health professional immediately if:

You experience an unusually rapid increase in weight or mild to moderate swelling (edema) or develop shortness of breath or other symptoms of heart failure.
You experience unexplained nausea, vomiting, stomach pain, fatigue, anorexia, or dark urine.

Can I take ACTOS with other diabetes drugs?

Only your health professional can determine which drugs are best for your type 2 diabetes. If healthy eating, physical activity, and a single drug are not enough to control your diabetes, ACTOS can be taken in combination with certain other medicines (sulfonylureas, metformin, or insulin). Because ACTOS works differently than any of these drugs, combining ACTOS with another diabetes drug can provide additional improvements in your blood sugar levels. ACTOS is not likely to cause low blood sugar when taken alone, because it does not cause your body to produce more insulin. However, people taking ACTOS with sulfonylureas or insulin may be at increased risk for low blood sugar, and an adjustment in the dose of sulfonylurea or insulin may be needed.

Will ACTOS interfere with other drugs?

ACTOS can be taken with other common prescription drugs, such as digoxin and warfarin, and other diabetes drugs such as glipizide (a sulfonylurea) and metformin. Always inform your health professional about any other prescription drugs or over-the-counter products you may be taking.

Can ACTOS increase my risk for pregnancy?

If you are a premenopausal woman who is not ovulating, you should know that ACTOS might increase your risk of pregnancy by causing you to ovulate. Therefore, you may need to consider birth control options. However, women using oral contraceptives should talk with their health professionals, as they may be at increased risk for pregnancy if appropriate contraceptive methods or adjustments are not used.

What else can I do to help control type 2 diabetes?

To help control type 2 diabetes, prescription drugs such as ACTOS should be used along with nutritional counseling, weight reduction as needed, and physical activity.

Who should not use ACTOS?

Certain patients with heart failure should not start taking ACTOS. ACTOS should not be taken by people with active liver disease or jaundice (yellowing of the skin), people with type 1 diabetes, women who are pregnant or breast-feeding, or people who are allergic to ACTOS or any of its ingredients. ACTOS should not be used for the treatment of diabetic ketoacidosis (a complication of diabetes in which acids called ketones build up in the blood). ACTOS should be used with caution in people with swelling (edema).

How should I store ACTOS?

Store ACTOS at room temperature, in a container that is tightly closed, and away from moisture and humidity.

Where can I find more information about ACTOS?

This is a summary of some of the most important information about ACTOS. If you have any further questions about type 2 diabetes or ACTOS, you should talk to your health professional