Pronunciation:

feb-UX-oh-stat

Brand Names:

• Uloric

Dosage Forms:

• Tablet

Warnings:

Warning: Cardiovascular DeathGout patients with established cardiovascular (CV) disease treated with febuxostat had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study.Consider the risks and benefits of febuxostat when deciding to prescribe or continue patients on febuxostat. Febuxostat should only be used in patients who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable .

Classifications:

Therapeutic—

Antigout

Pharmacologic—

Xanthine Oxidase Inhibitor

Uses of This Medicine:

Febuxostat is used to lower hyperuricemia (high uric acid in the blood) in patients with gout who have been treated with allopurinol that did not work well or cannot be treated with allopurinol. This medicine is a xanthine oxidase inhibitor. It works by causing less uric acid to be produced by the body.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of febuxostat in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of febuxostat in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Azathioprine
• Mercaptopurine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alpelisib
• Levoketoconazole
• Methotrexate
• Rosuvastatin
• Theophylline

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Brain or blood vessel disease or
• Diabetes or
• Heart disease, history of—Use with caution. May increase risk for more side effects.

• Cancer or
• Lesch-Nyhan syndrome (inherited condition that causes too much uric acid in the blood) or
• Organ transplant—Use is not recommended in patients with these conditions.

• Heart attack, history of or
• Stroke, history of—Use with caution. There may be an increased risk of these conditions occurring again.

• Kidney disease, severe—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

• Liver disease, severe—Use with caution. This medicine has not been studied in patients with this condition.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food. It may also be taken with an antacid.

Your gout may get worse when you start using this medicine. Keep using this medicine even if this happens. Your doctor may give you other medicines (eg, colchicine or NSAID pain medicines) to help prevent these gout attacks.

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 (tablets):
  • For treatment of hyperuricemia:
    • Adults—At first, 40 milligrams (mg) or 80 mg once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 80 mg per 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—

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

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Do not use azathioprine (Azasan®, Imuran®) or mercaptopurine (Purinethol®) while you are using this medicine. Using these medicines together can cause serious medical problems.

This medicine may increase your risk of having serious heart and blood vessel problems, such as unstable chest pain, heart attack, stroke, or death. Check with your doctor right away if start having chest pain, trouble with breathing, sudden or severe headache, or problems with vision, speech, or walking.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or a skin rash, sores or ulcers on the skin, or fever or chills with 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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

Arm, back, or jaw pain

black, tarry stools

bloody nose

blurred vision

chest pain or discomfort

chills

cloudy urine

confusion

cough

dark urine

decreased frequency or amount of urine

diarrhea

difficult or labored breathing

difficulty with moving

dizziness

dry mouth

fainting

fast, irregular, pounding, or racing heartbeat or pulse

feeling of fullness

fever

gaseous abdominal or stomach pain

general feeling of tiredness and weakness

headache

heavier menstrual periods

inability to speak

increase in heart rate

increased thirst

itching, skin rash

joint pain, stiffness, or swelling

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

lightheadedness

loss of appetite

loss of bladder control

muscle aching or cramping

nausea

nervousness

pain, swelling, or redness in the joints

painful or difficult urination

pale skin

pinpoint red spots on the skin

pounding in the ears

rapid breathing

redness of the skin

right upper abdominal or stomach pain and fullness

runny nose

seizures

severe or sudden headache

shivering

slow or fast heartbeat

slurred speech

sore throat

sores, ulcers, or white spots on the lips or in the mouth

stomach fullness or pain

sunken eyes

sweating

swelling

temporary blindness

thirst

tightness in the chest

trouble sleeping

trouble swallowing

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

vomiting of blood or material that looks like coffee grounds

weakness in the arm or leg on one side of the body, sudden and severe

weight gain

wrinkled skin

yellow eyes and skin

Incidence not known

Blistering, peeling, or loosening of the skin

diarrhea

difficulty with swallowing

hives

hoarseness

lower back or side pain

muscle cramps or spasms

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red skin lesions, often with a purple center

red, irritated eyes

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare

Anxiety

bad, unusual, or unpleasant (after) taste

blistering, crusting, irritation, itching, or reddening of the skin

body aches or pain

breast pain

bruising

burning feeling in the chest or stomach

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

change in taste

changes in hair color

constipation

continuing ringing or buzzing or other unexplained noise in the ears

cough producing mucus

cracked, dry, or scaly skin

decrease in smell

decreased interest in sexual intercourse

deep or fast breathing with dizziness

depression

ear congestion

excess air or gas in the stomach or bowels

feeling of constant movement of self or surroundings

fruit-like breath odor

gum pain

hair loss or thinning of the hair

hearing loss

heartburn

inability to have or keep an erection

inability to move the arms and legs

increased or decreased appetite

increased sensitivity of the skin to sunlight

increased sweating

increased urination

irritability

large, flat, blue, or purplish patches in the skin

loss in sexual ability, desire, drive, or performance

loss of consciousness

loss of voice

muscle or bone pain or stiffness

muscle spasm, tightness, or weakness

muscle twitching

nasal congestion

numbness of the feet, hands, and around the mouth

painful blisters on the trunk of the body

pains in the stomach, side, or abdomen, possibly radiating to the back

sensation of spinning

severe or continuing stomach pain

severe sunburn

shakiness in the legs, arms, hands, or feet

skin rash, encrusted, scaly, and oozing

sleepiness or unusual drowsiness

small red or purple spots on the skin

sneezing

stomach discomfort, upset, or pain

sudden numbness and weakness in the arms and legs

sweating

swelling of the breasts or breast soreness in both females and males

throat irritation

trembling or shaking of the hands or feet

trouble sleeping

unexplained weight loss

unusual drowsiness, dullness, or feeling of sluggishness

weight loss

Incidence not known

Aggressive thoughts

false beliefs that cannot be changed by facts

seeing, hearing, or feeling things that are not there

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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