Duzallo

Duzallo is a prescription medication used to treat high blood uric acid levels. It is a single product containing 2 medications: allopurinol and lesinurad. Lesinurad belongs to a group of drugs called urate transporter inhibitors. These help by increasing excretion of uric acid in the kidney. Allopurinol belongs to a group of drugs called xanthine oxidase inhibitors. These work by decreasing how much uric acid is made in the body.

This medication comes in tablet form and is taken once a day in the morning with food and water.

Common side effects of Duzallo include skin rash, headache, and flu-like symptoms. Duzallo can also cause drowsiness. Do not drive or operate heavy machinery until you know how Duzallo affects you.

Duzallo is a prescription medication used to treat high levels of uric acid in the blood in people with gout.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Duzallo. See the “Duzallo Precautions” section.

Common side effects of Duzallo include the following:

• Headache
• Flu-like symptoms
• Decreased kidney function
• Heartburn, nausea, or upset stomach
• Skin rash
• Diarrhea
• Drowsiness

This is not a complete list of Duzallo side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• mercaptopurine or azathioprine. Your dose may of mercaptopurine or azathioprine may need to be adjusted while taking Duzallo. 
• warfarin (Coumadin, Jantoven). Your doctor may have to monitor labs more often when taking Duzallo.
• hormonal contraceptives. Women should use a back-up method of birth control while taking Duzallo.
• medications that use the enzyme CYP2C9 such as amiodarone or fluconazole.
• medications that use the enzyme CYP3A4 such as budesonide (Entocort), cyclosporine (Neoral, Gengraf, Sandimmune), darifenacin (Enablex), dihydroergotamine (Migranal), fentanyl (Abstral, Fentora, Onsolis, Actiq), pimozide (Orap), quinidine (Cardioquin, Duraquin, Quinact), sirolimus (Rapamune), tacrolimus (Prograf), terfenadine (Seldane), fluticasone (Flovent HFA, Flonase), eletriptan (Relpax), lovastatin (Mevacor), quetiapine (Seroquel), sildenafil (Viagra, Revatio), and simvastatin (Zocor)
• bone marrow suppressing agents such as cyclophosphamide, doxorubicin, bleomycin, procarbazine, and mechloroethamine.
• thiazide diurectics such as hydrochlorothiazide.

This is not a complete list of Duzallo drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Duzallo including the following:

• hypersensitivity (severe allergic reaction). Tell your healthcare provider if you have any chest pain, swelling of the face or mouth, difficulty breathing or swallowing, or a rash.
• a decline in liver function. Tell your healthcare provider if you experience weight loss, lack of appetite, itching, stomach pain or tenderness, or yellowing of your skin or the whites of your eyes. Your doctor will likely run tests to check your liver function.
• severe or life-threatening kidney problems. Tell your doctor if you have or have ever had kidney disease. If you experience any of the following symptoms, call your doctor immediately: decreased urination; swelling of the face, arms, hands, feet, ankles, or lower legs; or unusual tiredness or weakness.
• chest pain. Tell your healthcare provider right away if you have some or all of the symptoms including tightness or pain in the chest, nausea, fatigue, shortness of breath, light headedness, weakness on one side of the body, or slurred speech.
• low blood cell counts. This medication can affect your bone marrow and cause you to have low blood cell counts. Your doctor will do blood tests as needed to check your blood cell counts.

Make sure you drink plenty of fluids and avoid dehydration. It is recommended you drink 2 liters (68 ounces) of fluid each day while taking Duzallo.

Ask your doctor 

Duzallo can cause drowsiness. Do not drive or operate heavy machinery until you know how Duzallo affects you.

Do not take Duzallo if you:

• are allergic to Duzallo or to any of its ingredients
• had a previous skin rash with allopurinol
• have stage 4 or 5 kidney stage, end-stage renal disease, or on dialysis
• have received a kidney transplant
• have a quick break down of cancer cells causing a high level of uric acid in the blood which is called tumor lysis syndrome 
• have a genetic disorder, Lesch-Nyhan syndrome, that causes a high level of uric acid in the blood

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Duzallo, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Duzallo, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Duzallo or to any of its ingredients
• have liver problems
• have kidney problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

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

Tell your doctor if you are pregnant or plan to become pregnant.

There are no well-done studies that have been done in humans or animals with Duzallo.

There have been animal studies of the lesinurad component, and the babies did not show any medical issues related to this medication. In animal studies, pregnant animals were given allopurinol, and some babies had problems. But in human studies, it is not clear if allopurinol affects babies.

Tell your doctor if you are breastfeeding or plan to breastfeed.

There is no information about Duzallo or the lesinurad component in human milk. In animal studies, lesinurad was found in the milk of rats. Allopurinol has been detected in human breast milk, but the effect of allopurinol on a nursing baby is unknown.

Because of the possibility for adverse reactions in nursing infants from Duzallo, a choice should be made whether to stop nursing or to stop the use of this medication. The importance of the drug to the mother should be considered.

Take Duzallo exactly as prescribed.

Duzallo comes in tablet form and is taken once a day in the morning. Take with food and water. 

If you miss a dose, do not take it later in the day. Skip the missed dose and take your next dose at the regular time. Do not take two doses of Duzallo at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose of Duzallo for the treatment of gout is 200 mg/200 mg or 200 mg/300 mg of lesinurad/allopurinol. 

If you take too much Duzallo, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Duzallo at room temperature.
• Keep this and all medicines out of the reach of children.

WARNING: RISK OF ACUTE RENAL FAILURE

• Acute renal failure has occurred with lesinurad, one of the components of DUZALLO.