Fenofibric Acid Delayed Release Capsules

Treatment of Severe Hypertriglyceridemia

Fenofibric acid delayed-release capsules are indicated as adjunctive therapy to diet to reduce triglycerides (TG) in patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacological intervention. Markedly elevated levels of serum triglycerides (e.g. greater than 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibric acid delayed-release capsule therapy on reducing this risk has not been adequately studied.

Treatment of Primary Hypercholesterolemia or Mixed Dyslipidemia

Fenofibric acid delayed-release capsules are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), triglycerides (TG), and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia.

Important Limitations of Use

Fenofibrate at a dose equivalent to 135 mg of fenofibric acid  did not reduce coronary heart disease morbidity and mortality in 2 large, randomized controlled trials of patients with type 2 diabetes mellitus [see Warnings and Precautions (5.1)].

General Considerations for Treatment

Laboratory studies should be performed to establish that lipid levels are abnormal before instituting fenofibric acid delayed-release capsule therapy.

Every reasonable attempt should be made to control serum lipids with non-drug methods including appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that may be contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (beta-blockers, thiazides, estrogens) should be discontinued or changed if possible, and excessive alcohol intake should be addressed before triglyceride-lowering drug therapy is considered. If the decision is made to use lipid-altering drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.

Drug therapy is not indicated for patients who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of VLDL.

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Fenofibric acid is the active metabolite of fenofibrate. Adverse events reported by 2% or more of patients treated with fenofibrate and greater than placebo during double-blind, placebo-controlled trials are listed in Table 1. Adverse events led to discontinuation of treatment in 5.0% of patients treated with fenofibrate and in 3.0% treated with placebo. Increases in liver tests were the most frequent events, causing discontinuation of fenofibrate treatment in 1.6% of patients in double-blind trials.

Clinical trials with fenofibric acid did not include a placebo-control arm. However, the adverse event profile of fenofibric acid was generally consistent with that of fenofibrate. The following adverse events not listed above were reported in greater than or equal to 3% of patients taking fenofibric acid alone:

Gastrointestinal Disorders: Diarrhea, dyspepsia

General Disorders and Administration Site Conditions: Pain

Infections and Infestations: Nasopharyngitis, sinusitis, upper respiratory tract infection

Musculoskeletal and Connective Tissue Disorders: Arthralgia, myalgia, pain in extremity

Nervous System Disorders: Dizziness

Postmarketing Experience

The following adverse events have been identified during postapproval use of fenofibrate: rhabdomyolysis, pancreatitis, renal failure, muscle spasms, acute renal failure, hepatitis, cirrhosis, anemia, asthenia, and severely depressed HDL-cholesterol levels.

Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

There is no specific treatment for overdose with fenofibric acid. General supportive care of the patient is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur. If indicated, elimination of unabsorbed drug should be achieved by emesis or gastric lavage; usual precautions should be observed to maintain the airway. Because fenofibric acid is highly bound to plasma proteins, hemodialysis should not be considered.

Fenofibric acid delayed -release capsules are available as follows:

45 mg - Each #3 capsule with yellow opaque cap and body imprinted with  and 2838 on both cap and body in black ink contains choline fenofibrate equivalent to 45 mg fenofibric acid. Capsules are supplied in bottles of 90 (NDC 0228-2838-09).

135 mg - Each #0 capsule with brown opaque cap and yellow opaque body imprinted with  and 2839 on both cap and body in black ink contains choline fenofibrate equivalent to 135 mg fenofibric acid. Capsules are supplied in bottles of 90 (NDC 0228-2839-09) and bottles of 500 (NDC 0228-2839-50).

Dispense in a tight, light-resistant container as defined in the USP.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.

Keep out of the reach of children.

See Medication Guide

Patients should be advised:

• of the potential benefits and risks of fenofibric acid delayed-release capsules.
• to read the Medication Guide before starting fenofibric acid delayed-release capsule therapy and to reread it each time the prescription is renewed.
• of medications that should not be taken in combination with fenofibric acid delayed-release capsules.
• to continue to follow an appropriate lipid-modifying diet while taking fenofibric acid delayed-release capsules.
• to take fenofibric acid delayed-release capsules once daily, without regard to food, at the prescribed dose, swallowing each capsule whole.
• to return for routine monitoring.
• to inform their physician of all medications, supplements, and herbal preparations they are taking and any change to their medical condition. Patients should also be advised to inform their physicians prescribing a new medication that they are taking fenofibric acid delayed-release capsules.
• to inform their physician of any muscle pain, tenderness, or weakness; onset of abdominal pain; or any other new symptoms.

Brands listed are the trademarks of their respective owners.

Manufactured by:
Actavis Elizabeth LLC
200 Elmora Avenue
Elizabeth, NJ 07207 USA

40-9118

Revised – July 2015

Fenofibric Acid (FEN-oh-FYE-bric AS-id)

Delayed-Release Capsules

Rx Only

Read this Medication Guide before you start taking fenofibric acid delayed-release capsules and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about fenofibric acid delayed-release capsules?

Fenofibric acid delayed-release capsules can cause muscle pain, tenderness or weakness, which may be symptoms of a rare but serious muscle condition called rhabdomyolysis. In some cases rhabdomyolysis can cause kidney damage and death. The risk of rhabdomyolysis may be higher when fenofibric acid delayed-release capsules are given with statins. If you take a statin, tell your healthcare provider.

What are fenofibric acid delayed-release capsules?

Fenofibric acid delayed-release capsules are a prescription medicine used to treat cholesterol in the blood by lowering the total amount of triglycerides and LDL (bad) cholesterol, and increasing the HDL (good) cholesterol. Fenofibric acid delayed-release capsules have not been shown to lower your risk of having heart problems or a stroke. You should be on a low fat and low cholesterol diet while you take fenofibric acid delayed-release capsules.

The safety and effectiveness of fenofibric acid delayed-release capsules in children is not known.

Who should not take fenofibric acid delayed-release capsules?

Do not take fenofibric acid delayed-release capsules if you:

• are allergic to fenofibric acid, or any of the ingredients in fenofibric acid delayed-release capsules. See the end of this Medication Guide for a list of all the ingredients in fenofibric acid delayed-release capsules.
• have severe kidney disease.
• have liver disease.
• have gallbladder disease.
• are a nursing mother.

Talk to your healthcare provider before you take fenofibric acid delayed-release capsules if you have any of these conditions.

What should I tell my healthcare provider before taking fenofibric acid delayed-release capsules?

Before taking fenofibric acid delayed-release capsules, tell your healthcare provider about all your medical conditions, including if you:

• are allergic to any medicines.
• have ever had kidney problems.
• have ever had liver problems.
• have ever had gallbladder problems.
• are pregnant or if you plan to become pregnant. It is not known if fenofibric acid delayed-release capsules will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if fenofibric acid passes into your breast milk. You and your healthcare provider should decide if you will take fenofibric acid delayed-release capsules or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

Using fenofibric acid delayed-release capsules with certain other medicines can affect the way these medicines work and other medicines may affect how fenofibric acid delayed-release capsules works. In some cases, using fenofibric acid delayed-release capsules with other medicines can cause serious side effects.

Know all the medicines you take. Keep a list of them and show it to your healthcare provider when you get a new medicine.

It is especially important to tell your healthcare provider if you take any of the medicines listed below:

• anticoagulants, also known as blood thinners (warfarin, Coumadin)
• bile acid resins
• cyclosporine

Ask your healthcare provider if you are not sure if your medicine is one of these.

How should I take fenofibric acid delayed-release capsules?

• You should be on a low fat and low cholesterol diet while you take fenofibric acid delayed-release capsules.
• Take fenofibric acid delayed-release capsule one time each day as prescribed by your healthcare provider.
• Take fenofibric acid delayed-release capsules with or without food.
• Swallow fenofibric acid delayed-release capsules whole. Do not break, crush, dissolve, or chew fenofibric acid delayed-release capsules before swallowing. If you cannot swallow fenofibric acid delayed-release capsules whole, tell your healthcare provider, you may need a different medicine.
• If you miss a dose of fenofibric acid delayed-release capsules, take it as soon as you remember. If it is almost time for your next dose, just skip the missed dose. Take the next dose at your regular time. If you are not sure about your dosing, call your healthcare provider. Do not take more than one dose of fenofibric acid delayed-release capsules a day unless your healthcare provider tells you to.
• If you take too many fenofibric acid delayed-release capsules, contact your healthcare provider or your local emergency department.
• Do not change your dose or stop fenofibric acid delayed-release capsules unless your healthcare provider tells you to.
• Your healthcare provider may do blood tests before you start taking fenofibric acid delayed-release capsules and during treatment. See your healthcare provider regularly to check your cholesterol and triglyceride levels and to check for side effects.

What are the possible side effects with fenofibric acid delayed-release capsules?

Fenofibric acid delayed-release capsules may cause serious side effects, including: 

• muscle pain, tenderness, or weakness. See "What is the most important information that I should know about fenofibric acid delayed-release capsules?"
• tiredness and fever.
• abdominal pain, nausea, or vomiting. These may be signs of inflammation (swelling) of the gallbladder or pancreas.

Call your healthcare provider right away if you have any of these serious side effects.

The most common side effects with fenofibric acid delayed-release capsules include:

• headache
• heartburn (indigestion)
• nausea
• muscle aches
• increases in muscle or liver enzymes that are measured by blood tests

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of fenofibric acid delayed-release capsules. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How do I store fenofibric acid delayed-release capsules?

• Store fenofibric acid delayed-release capsules between 59° to 86° F (15° to 30° C).
• Protect fenofibric acid delayed-release capsules from moisture.

Keep fenofibric acid delayed-release capsules and all medicines out of the reach of children.

General information about the safe and effective use of fenofibric acid delayed-release capsules

Medicines are sometimes prescribed for conditions that are not mentioned in the Medication Guide. Do not use fenofibric acid delayed-release capsules for a condition for which it was not prescribed. Do not give fenofibric acid delayed-release capsules to other people, even if they have the same condition you have. It may harm them.

This Medication Guide summarizes the most important information about fenofibric acid delayed-release capsules. If you would like more information, talk to your healthcare provider. You can also ask your pharmacist or healthcare provider for information that is written for health professionals.

For more information call Actavis at 1-800-432-8534.

What are the ingredients in fenofibric acid delayed-release capsules?

Active Ingredient: Fenofibric acid

Inactive Ingredients: ammonio methacrylate copolymer, (Type A Powder), ammonio methacrylate copolymer, (Type B Powder), hydroxypropyl cellulose, sodium lauryl sulfate, sugar spheres (which contain sucrose and corn starch), talc, and triethyl citrate.

Capsule shell: Each of the capsule shells contains gelatin, titanium dioxide and yellow iron oxide. In addition, the 135 mg capsule shells also contain black iron oxide and red iron oxide.

Imprinting ink: black Tek-Print ink SW-9008 or SW-9009, which contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Brands listed are the trademarks of their respective owners.

Manufactured by:
Actavis Elizabeth LLC
200 Elmora Avenue
Elizabeth, NJ 07207 USA

40-9118

(MG 41-1142/0715)