Pronunciation:

le-SIN-ure-ad

Brand Names:

• Zurampic

Warnings:

Acute renal failure has occurred with lesinurad and was more common when lesinurad was given alone. Lesinurad should be used in combination with a xanthine oxidase inhibitor .

Uses of This Medicine:

Lesinurad is used together with a xanthine oxidase inhibitor (eg, allopurinol, febuxostat) to treat gout. It works to lower uric acid levels in the blood.

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 lesinurad 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 lesinurad in the elderly.

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.

• Mavacamten

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.

• Buprenorphine
• Carbamazepine
• Clarithromycin
• Cyclosporine
• Desogestrel
• Dienogest
• Drospirenone
• Estetrol
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etonogestrel
• Fedratinib
• Gestodene
• Levonorgestrel
• Medroxyprogesterone
• Mestranol
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Oliceridine
• Palovarotene
• Pimavanserin
• Pralsetinib
• Quizartinib
• Segesterone
• Sufentanil
• Tacrolimus
• Tramadol
• Ulipristal
• Zolpidem
• Zuranolone

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:

• Kidney disease—Use with caution. May make this condition worse.

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 should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take this medicine with food and water in the morning and together with your xanthine oxidase inhibitor (eg, allopurinol, febuxostat).

Drink extra fluids each day, at least 2 liters or 68 ounces, to create more urine. This may help prevent kidney problems.

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 gout:
    • Adults—200 milligrams (mg) as a single dose in the morning.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, 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 this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

This medicine may cause kidney problems. Tell your doctor right away if you have decreased urine output, depression, dizziness, a headache, lethargy, muscle twitching, nausea, rapid weight gain, seizures, swelling of the face, ankles, or hands, or unusual tiredness or weakness after taking this medicine.

Heart or blood vessel problems may occur with this medicine. Tell your doctor if you have chest pain or discomfort, confusion, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, sweating, trouble speaking, or slow speech, or are unable to move your arms, legs, or facial muscles.

Birth control pills, patches, and injections may not work as well while you are using lesinurad. Use another form of birth control together with your birth control pills to keep from getting pregnant. Check with your doctor if you have any questions.

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:

Incidence not known

Agitation

chest pain or discomfort

confusion

decreased urine output

depression

difficulty with speaking

dizziness

double vision

headache

hostility

inability to move the arms, legs, or facial muscles

inability to speak

irritability

lethargy

muscle twitching

nausea

pain or discomfort in the arms, jaw, back, or neck

rapid weight gain

seizures

shortness of breath

slow speech

sweating

swelling of the face, ankles, or hands

unusual tiredness or weakness

vomiting

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:

More common

Chills

cough

diarrhea

fever

general feeling of discomfort or illness

joint pain

loss of appetite

muscle aches and pains

runny nose

shivering

sore throat

trouble sleeping

Less common

Heartburn

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.