Lesinurad and allopurinol (Oral)

Lesinurad and allopurinol combination is used to reduce uric acid levels in the blood for people with gout, when allopurinol alone has not been effective.

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

It is very important that your doctor checks 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.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, troubled breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney 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.

Heart and 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, slow speech, or are unable to move your arms, legs, or facial muscles.

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.

This medicine may make you drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Birth control pills, patches, implants, and injections may not work as well while you are using lesinurad and allopurinol combination. Use another form of birth control to prevent pregnancy. Check with your doctor if you have any questions.

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

In deciding to use a medicine, you and your doctor need to think about the risks and benefits. For this medicine, consider the following:

Allergies

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

Pediatric

There have not been appropriate studies on how age affects the use of the lesinurad and allopurinol combination in children. Safety and effectiveness have not been established.

Geriatric

Studies so far have not shown any specific problems in older adults that would limit the use of the lesinurad and allopurinol combination. However, older patients may be more sensitive to the effects of this medicine compared to younger adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when this medication is used during breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together with caution. In such cases, your doctor may want to adjust the dose or take other precautions. It is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been chosen based on 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.

• Didanosine
• Mavacamten

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

• Acenocoumarol
• Azathioprine
• Buprenorphine
• Capecitabine
• Captopril
• Desogestrel
• Dienogest
• Drospirenone
• Enalapril
• Enalaprilat
• Estetrol
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etonogestrel
• Fedratinib
• Fluorouracil
• Gestodene
• Levoketoconazole
• Levonorgestrel
• Medroxyprogesterone
• Mercaptopurine
• Mestranol
• Methotrexate
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Palovarotene
• Pegloticase
• Phenprocoumon
• Pimavanserin
• Pralsetinib
• Quizartinib
• Segesterone
• Tegafur
• Ulipristal
• Warfarin
• Zolpidem
• Zuranolone

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both medicines.

• Aluminum Hydroxide
• Cyclosporine
• Vidarabine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around mealtime or with certain types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Severe kidney disease (e.g., end stage kidney disease, patients on dialysis, or patients who have received a kidney transplant) or
• Lesch-Nyhan syndrome (a genetic condition that leads to high uric acid levels in the blood) or
• Tumor lysis syndrome (electrolyte and metabolic issues)—Should not be used in patients with these conditions.

• Heart and blood vessel disease or
• Liver disease—Use with caution. May worsen these conditions.

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

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

More common

• Rash
• rash with flat lesions or small raised lesions on the skin

Less common

• Chest pain or discomfort
• confusion
• difficulty in speaking
• double vision
• headache
• inability to move the arms, legs, or facial muscles
• inability to speak
• nausea
• pain or discomfort in the arms, jaw, back, or neck
• slow speech
• sweating
• vomiting

Rare

• Anxiety
• black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• bloating
• blood in the urine or stools
• bloody nose
• blue or pale skin
• bruising
• chest pain, possibly moving to the left arm, neck, or shoulder
• chills
• clay-colored stools
• constipation
• cough
• dark urine
• depression
• diarrhea
• difficulty breathing
• difficulty in moving
• dizziness
• dry mouth
• eye pain
• fast heartbeat
• fever
• general feeling of illness
• general tiredness and weakness
• incoherent speech
• increased urination
• indigestion
• joint or muscle pain
• large, flat, blue or purplish patches on the skin
• lightheadedness, dizziness, or fainting
• loss of appetite
• metallic taste
• muscle pain, stiffness, tenderness, wasting, or weakness
• noisy breathing
• painful or difficult urination
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pinpoint red spots on the skin
• red skin lesions, often with a purple center
• red, irritated eyes
• right upper abdominal pain and fullness
• slow or irregular heartbeat
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• stomach pain
• swelling of the feet or lower legs
• swollen glands
• thirst
• tightness in the chest
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• upper right abdominal pain
• vomiting of blood
• weight loss
• yellow eyes or skin

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:

Less common

• Runny nose
• shivering
• trouble sleeping

Rare

• Belching
• blurred vision
• burning feeling in the chest or stomach
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• changes in vision
• decreased appetite
• heartburn
• impaired vision
• increased sweating
• indigestion
• loss of taste
• redness, soreness, or itching of the skin
• sleepiness or unusual drowsiness
• sores, welts, or blisters
• stomach discomfort, upset, or pain
• swelling of the breasts or breast soreness in both females and males
• tenderness in the stomach area
• unsteadiness or awkwardness
• weakness in the arms, hands, legs, or feet

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.

In the U.S.

• Duzallo

Pharmacologic Class: Xanthine Oxidase Inhibitor

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 in the morning with food and water. Drink at least 2 liters (L) (68 ounces) of water each day to stay hydrated.

Your doctor may give you other medicines before starting treatment with this medicine to prevent flare-ups of gout.

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 forms (tablets):For lowering uric acid levels in the blood: Adults—1 tablet (200 milligrams [mg] lesinurad and 200 mg allopurinol) once a day. Your doctor may adjust your dose as needed. 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.

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.