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Droxia (hydroxyurea) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to help reduce how often painful crises happen and reduce the need for blood transfusions in people with sickle cell anemia who have repeated moderate to severe painful crises.
Droxia is a type of medicine called an antimetabolite. It blocks the production of DNA. However, the exact way Droxia helps people with sickle cell anemia is not fully known.
Droxia may raise fetal hemoglobin, lower certain white blood cells called neutrophils, increase the amount of water in red blood cells, and help sickled red blood cells bend more easily. These effects may play a role in how Droxia works.
Doctors prescribe Droxia to help reduce how often painful crises happen and reduce the need for blood transfusions in people with sickle cell anemia who have repeated moderate to severe painful crises.
Droxia comes as a capsule that is taken by mouth once a day. Swallow the capsule whole. Do not open, break, or chew it.
Droxia is a cytotoxic medicine, which means it can damage cells. You or your caregiver should wear disposable gloves when handling the capsules or bottle. Wash your hands with soap and water before and after handling Droxia.
Avoid touching the contents of an opened or crushed capsule. If the medicine gets on your skin, wash the area right away with soap and water. If it gets in your eyes, rinse them well with water or an isotonic eyewash for at least 15 minutes.
If powder from a capsule spills, wipe it up right away with a damp disposable towel. Put the towel and any empty capsules in a closed container, such as a plastic bag. Clean the spill area three times with detergent solution, followed by clean water.
The recommended starting dose of Droxia is 15 milligrams per kilogram once a day. The dose is based on the person’s actual or ideal body weight, whichever is lower.
Blood counts should be checked every two weeks during treatment.
If blood counts stay in an acceptable range, the dose may be increased by 5 milligrams per kilogram per day every 12 weeks. The dose may be increased until the highest tolerated dose is reached, up to a maximum of 35 milligrams per kilogram per day.
If blood counts become too low, Droxia should be stopped until the blood counts recover. Treatment may then be restarted at a dose that is 2.5 milligrams per kilogram per day lower than the dose that caused the problem.
For people with a creatinine clearance below 60 milliliters per minute or with end-stage kidney disease, the Droxia dose should be reduced by 50 percent.
This information is based on prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.
In clinical studies of Droxia, the most common side effects occurred in 30 percent or more of people.
These include:
Blood-related side effects may include:
Droxia can cause serious side effects that may require immediate medical attention. These include:
Get medical help right away if you think you are having a serious reaction.
This drug has a boxed warning, the FDA’s strongest safety warning, for some of the serious risks mentioned above. A boxed warning does not mean the drug is unsafe for everyone or that everyone faces the same level of risk.
Waylis Therapeutics LLC, the manufacturer of Droxia, offers the Waylis Patient Copay Savings Program. Eligible people with commercial insurance may pay as little as $10. If you have government insurance or no insurance, the website provides information on other ways to save.
The Waylis Patient Access and Affordability Program also offers support from a care coordinator.
To learn more, visit the Waylis Patient Access and Affordability Program website or call 888-218-8897.
Before you start Droxia, your doctor will check your blood counts. If you can become pregnant, your healthcare provider will also check your pregnancy status before treatment.
Tell your doctor if you plan to get any vaccines. You should not receive live vaccines while taking Droxia.
Before taking Droxia, tell your doctor if you:
Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.
Do not take Droxia if you have had an allergic reaction to hydroxyurea or any ingredient in Droxia.
Droxia can harm your child if you are pregnant. If you can become pregnant, use effective birth control while taking Droxia and for at least six months after treatment ends. Avoid becoming pregnant during treatment. Tell your healthcare provider right away if you become pregnant or think you may be pregnant.
If you are male and have a female partner who can become pregnant, use a condom during treatment and for at least one year after treatment ends. Droxia can affect sperm and may cause fertility problems in males.
Do not breastfeed while taking Droxia.
These answers are fact-checked by our editorial staff.
How effective is Droxia for sickle cell anemia?
Droxia was studied in 299 adults with sickle cell anemia who had moderate to severe disease and at least three painful crises during the previous year. People who took hydroxyurea had a median of 2.5 painful crises per year, compared with 4.6 per year in people who took a placebo.
People taking hydroxyurea also had fewer painful crises that required a hospital visit, fewer episodes of chest syndrome, and fewer blood transfusions.
The median time to the first painful crisis was 2.76 months with hydroxyurea compared with 1.35 months with placebo. The median time to the second painful crisis was 6.58 months with hydroxyurea compared with 4.13 months with placebo.
How long does Droxia take to work for sickle cell anemia?
The clinical study does not give a specific amount of time for Droxia to begin reducing painful crises.
Fetal hemoglobin levels may increase within four to 12 weeks after starting treatment. However, the prescribing information says it has not been clearly shown that higher fetal hemoglobin levels directly lead to fewer painful crises.
Does Droxia interact with other medicines?
Yes. Droxia can interact with some medicines and can also affect certain test results.
Certain HIV medicines, including didanosine and stavudine, may cause serious problems when taken with hydroxyurea. These problems can include inflammation of the pancreas, liver damage, and nerve damage. The combination of hydroxyurea, didanosine, and stavudine should be avoided because fatal liver problems have been reported.
Droxia can also cause falsely high results on some laboratory tests for uric acid, urea, and lactic acid. It may also cause falsely high blood sugar readings on some CGMs.
Tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.
What tests or monitoring are needed with Droxia for sickle cell anemia?
Your healthcare provider will check your blood counts before you start Droxia and every two weeks during treatment.
Fetal hemoglobin levels may also be checked every three to four months to help see how well Droxia is working.
If you have anemia that does not improve or gets worse, your healthcare provider may order blood tests to check for hemolysis, which is the breakdown of red blood cells.
On MySickleCellTeam, people share their experiences with sickle cell disease, get advice, and find support from others who understand.
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