Antara

Name: Antara

How should this medicine be used?

Fenofibrate comes as a capsule, a delayed-release (long-acting) capsule, and a tablet to take by mouth. It is usually taken once a day. Some fenofibrate products (Fenoglide, Lipofen, and Lofibra) should be taken with a meal. Other brands (Antara, Fibricor, Tricor, Triglide, and Trilipix) may be taken with or without food. Ask your doctor or pharmacist if you do not know if you should take your medication with food. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take fenofibrate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on an average dose of fenofibrate and may increase or decrease your dose depending on the results of laboratory tests that you will take to measure the amount of fatty substances in your blood. Your doctor may tell you to stop taking fenofibrate if your test results do not show improvement after 2 months.

If you are taking Trilipix tablets, swallow the tablets whole; do not split, chew, or crush them.

If you are taking Triglide tablets, do not use any tablets that are chipped or broken.

Fenofibrate will help decrease the amount of fatty substances in your blood only as long as you continue to take it. Continue to take fenofibrate even if you feel well. Do not stop taking fenofibrate without talking to your doctor.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Indications

Primary Hypercholesterolemia And Mixed Dyslipidemia

Antara is 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 adult patients with primary hyperlipidemia or mixed dyslipidemia.

Severe Hypertriglyceridemia

Antara is also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied.

Important Limitations Of Use

Fenofibrate was not shown to reduce coronary heart disease morbidity and mortality in patients with type 2 diabetes mellitus [see WARNINGS AND PRECAUTIONS].

How should I take Antara (fenofibrate)?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Some brands of fenofibrate should be taken with meals to help your body better absorb the medicine. Other brands may be taken with or without food. Follow the directions on your medicine label.

Use fenofibrate regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not crush, break, or dissolve the fenofibrate capsule or tablet. Swallow it whole.

If you also take cholestyramine, colesevelam, colestipol: these other medicines should be taken at least 1 hour after or 4 hours before you take fenofibrate.

Fenofibrate is only part of a treatment program that may also include diet, exercise, and weight control. Follow your doctor's instructions very closely.

While using fenofibrate, you may need frequent blood tests. Your liver and gallbladder function may also need to be checked.

Store at room temperature away from moisture, heat, and light. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative.

Proper Use of fenofibrate

This section provides information on the proper use of a number of products that contain fenofibrate. It may not be specific to Antara. Please read with care.

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, or do not use it for a longer time than your doctor ordered.

In addition to this medicine, your doctor may change your diet to one that is low in fat, sugar, and cholesterol. Carefully follow your doctor's order about any special diet.

This medicine is usually taken once a day. Take the medicine at the same time each day to maintain the medication's effect.

Fenoglide®, Lipofen®, Lofibra™, and Tricor® should be taken with a meal. Antara® and Triglide® can be taken with or without a meal.

Swallow Antara® capsules, Tricor® tablets, or Triglide® tablets whole. Do not open, crush, break, chew, or dissolve them. Do not take chipped or broken Triglide® tablets.

If you are also using cholestyramine, colesevelam, or colestipol, you must take Triglide® at least 1 hour before or 4 to 6 hours after you take these medicines.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (capsules):
    • For high cholesterol:
      • Adults—
        • Antara®: At first, 130 milligrams (mg) once a day with a meal.
        • Lipofen®: At first, 150 mg once a day with a meal. Your doctor may adjust your dose as needed.
        • Lofibra™: 200 mg once a day with a meal.
      • Children—Use and dose must be determined by your doctor.
    • For high triglycerides or fats:
      • Adults—
        • Antara®: At first, 43 to 130 milligrams (mg) once a day with a meal. Your doctor may adjust your dose as needed. However, the dose is usually not more than 130 mg per day.
        • Lipofen®: At first, 50 to 150 mg once a day with a meal. Your doctor may adjust your dose as needed. However, the dose is usually not more than 150 mg per day.
        • Lofibra™: At first, 67 mg once a day with a meal. Your doctor may increase your dose as needed.
      • Children—Use and dose must be determined by your doctor.
  • For oral dosage form (tablets):
    • For high cholesterol:
      • Adults—
        • Fenoglide®: At first, 120 milligrams (mg) per day. Your doctor may adjust your dose as needed.
        • Tricor®: At first, 160 mg once a day. Your doctor may adjust your dose as needed.
        • Triglide®: 160 mg once a day.
      • Children—Use and dose must be determined by your doctor.
    • For high triglycerides or fats:
      • Adults—
        • Fenoglide®: At first, 40 to 120 milligrams (mg) per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 120 mg per day.
        • Tricor®: At first, 54 to 160 mg once a day. Your doctor may adjust your dose as needed.
        • Triglide®: 160 mg once a day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep Triglide® tablets in its original container. Protect from heat, light, and moisture.

Precautions While Using Antara

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly to lower your cholesterol and triglyceride (fat) levels and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Check with your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have unusual tiredness or a fever. These could be symptoms of a serious muscle problem called myopathy.

Check with your doctor right away if you have dark-colored urine, diarrhea, a fever, muscle cramps or spasms, muscle pain or stiffness, or feel very tired or weak. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.

Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

This medicine may increase your risk of having gallstones. Check with your doctor right away if you have severe stomach pain with nausea and vomiting.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have any of the following symptoms while using this medicine: blistering, peeling, or loose skin, chills, diarrhea, itching, joint or muscle pain, rash, red skin lesions, often with a purple center, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.

Check with your doctor right away if you have signs of a fever, chills, or sore throat. These could be symptoms of an infection resulting from low white blood cell counts, which may be caused by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

What are some things I need to know or do while I take Antara?

  • Tell all of your health care providers that you take Antara. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • If you are taking warfarin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with this medicine.
  • If you take cholestyramine or colestipol, take them at least 4 hours before or 1 hour after Antara.
  • Follow the diet and workout plan that your doctor told you about.
  • If you are 65 or older, use this medicine with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Antara while you are pregnant.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
  • Signs of gallstones like sudden pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or eyes; or fever with chills.
  • Very bad joint pain or swelling.
  • Feeling very tired or weak.
  • Chest pain or pressure.
  • Fever or chills.
  • Shortness of breath.
  • Coughing up blood.
  • Swelling, warmth, numbness, change of color, or pain in a leg or arm.
  • Any unexplained bruising or bleeding.
  • Very bad muscle problems may happen with Antara. This can also lead to kidney problems. Tell your doctor if you have muscle pain or weakness, mainly if you feel very tired or weak or have a fever. Tell your doctor if you are unable to pass urine or you have a change in how much urine is passed.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

Contraindications

Antara is contraindicated in:

  • patients with severe renal impairment, including those receiving dialysis [see Clinical Pharmacology (12.3) ].
  • patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities [see Warnings and Precautions (5.3) ].
  • patients with pre-existing gallbladder disease [see Warnings and Precautions (5.5) ].
  • nursing mothers [see Use in Specific Populations (8.3) ].
  • patients with known hypersensitivity to fenofibric acid or fenofibrate [see Warnings and Precautions (5.9) ].

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Where can i get more information?

Your pharmacist can provide more information about fenofibrate.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 7.01. Revision date: 2/13/2013.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

In Summary

Common side effects of Antara include: increased serum aspartate aminotransferase and increased serum alanine aminotransferase. Other side effects include: abnormal hepatic function tests, increased creatine phosphokinase, and increased serum transaminases. See below for a comprehensive list of adverse effects.

For Healthcare Professionals

Applies to fenofibrate: oral capsule, oral tablet

General

The most frequently reported side effects were abnormal liver tests, AST increased, ALT increased, creatine phosphokinase (CPK) increased, and rhinitis.[Ref]

Hepatic

Common (1% to 10%): Liver function tests abnormal, AST increased, ALT increased
Uncommon (0.1% to 1%): Cholelithiasis
Rare (less than 0.1%): Hepatitis
Postmarketing reports: Cirrhosis, liver fatty deposit, cholecystitis, jaundice, cholangitis, biliary colic[Ref]

Respiratory

Very common (10% or more): Rhinitis (up to 23.2%), bronchitis (16.4%)
Common (1% to 10%): Respiratory disorder, pharyngitis, sinusitis
Uncommon (0.1% to 1%): Pulmonary embolism
Very rare (less than 0.01%): Interstitial pneumopathy
Frequency not reported: Cough increased, dyspnea, asthma, pneumonia, laryngitis
Postmarketing reports: Interstitial lung disease[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (up to 25.1%), back pain (up to 15%)
Common (1% to 10%): Back pain, myalgia
Uncommon (0.1% to 1%): Diffuse myalgia, myositis, muscle cramp, muscle weakness
Very rare (less than 0.01%): Rhabdomyolysis
Frequency not reported: Arthritis, tenosynovitis, joint disorder, arthrosis, leg cramp, bursitis, myasthenia
Postmarketing reports: Muscle spasm[Ref]

Gastrointestinal

Very common (10% or more): Abdominal pain (up to 15.9%)
Common (1% to 10%): Nausea, constipation, diarrhea, vomiting, flatulence
Uncommon (0.1% to 1%): Pancreatitis
Frequency not reported: Dyspepsia, gastroenteritis, rectal disorder, esophagitis, gastritis, colitis, tooth disorder, gastrointestinal disorder, duodenal ulcer, peptic ulcer, rectal hemorrhage, eructation, gamma glutamyl transpeptidase, dry mouth[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness
Rare (less than 0.1%): Peripheral neuropathy
Frequency not reported: Migraine, paresthesia, hypertonia, neuralgia, somnolence[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus, urticaria
Uncommon (0.1% to 1%): Photosensitivity reaction
Rare (0.01% to 0.1%): Alopecia
Very rare (less than 0.01%): Cutaneous photosensitivity with erythema, vesiculation, nodulation
Frequency not reported: Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, eczema, acne, sweating, fungal dermatitis, skin disorder, contact dermatitis, maculopapular rash, nail disorder, skin ulcer
Postmarketing reports: Ecchymosis[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Deep vein thrombosis
Frequency not reported: Angina pectoris, hypertension, vasodilatation, coronary artery disorder, electrocardiogram abnormal, extrasystole, myocardial infarct, peripheral vascular disorder, varicose vein, cardiovascular disorder, hypotension, palpitation, arrhythmia, phlebitis, tachycardia, atrial fibrillation[Ref]

Ocular

Common (1% to 10%): Conjunctivitis
Frequency not reported: Eye disorder, amblyopia, abnormal vision, cataract specified, refraction disorder[Ref]

Other

Very common (10% or more): Accidental injury (up to 18.4%), flu syndrome (up to 17.9%), chest pain (up to 10.1%)
Common (1% to 10%): Creatine phosphokinase increased, malaise, vertigo, fatigue
Uncommon (0.1% to 1%): Serum creatinine increased, urea increased
Rare (less than 0.1%): Sexual asthenia
Frequency not reported: Pain, infection, cyst, hernia, fever, peripheral edema, ear pain, otitis media, herpes zoster, herpes simplex, weight gain, weight loss, edema
Postmarketing reports: Asthenia[Ref]

Genitourinary

Uncommon (0.1% to 1%): Sexual dysfunction
Frequency not reported: Urinary frequency, prostatic disorder, dysuria, gynecomastia, vaginal moniliasis, cystitis[Ref]

Hematologic

Rare (less than 0.1%): Hemoglobin decreased, leukopenia
Frequency not reported: Eosinophilia, lymphadenopathy, thrombocytopenia, anemia
Postmarketing reports: Hematocrit decreased[Ref]

Metabolic

Frequency not reported: Appetite increased, anorexia, diabetes mellitus, hypoglycemia, gout, hyperuricemia
Postmarketing reports: High-density lipoprotein cholesterol levels severely depressed[Ref]

Renal

Frequency not reported: Kidney function abnormal, urolithiasis
Postmarketing reports: Renal failure, acute renal failure[Ref]

Psychiatric

Common (1% to 10%): Insomnia
Frequency not reported: Depression, libido decreased, anxiety, nervousness[Ref]

Endocrine

Frequency not reported: Diabetes mellitus[Ref]

Hypersensitivity

Rare (less than 0.1%): Hypersensitivity reaction
Frequency not reported: Allergic reaction[Ref]

Some side effects of Antara may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Fenofibrate Breastfeeding Warnings

Animal studies in rats during lactation revealed evidence of decreased survival and weight gain in offspring.

Use should be avoided. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: This drug should not be used during breastfeeding due to the potential for serious adverse events in nursing infants and the concern over disruption of infant lipid metabolism.

(web3)