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Xromi (hydroxyurea) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) for children 6 months and older with sickle cell anemia who have repeated moderate to severe pain crises. Xromi helps reduce how often these painful episodes happen and lowers the need for blood transfusions.
Xromi is a type of medicine called an antimetabolite. It blocks an enzyme that helps the body make DNA. However, the exact way Xromi helps children with sickle cell anemia is not fully known. It may increase fetal hemoglobin, a type of hemoglobin that helps red blood cells carry oxygen. It may also lower certain white blood cells called neutrophils, increase the amount of water in red blood cells, and help sickled red blood cells become more flexible.
Doctors prescribe Xromi for children 6 months and older with sickle cell anemia who have repeated moderate to severe pain crises. Xromi helps reduce how often these painful episodes happen and lowers the need for blood transfusions.
Xromi comes as a liquid medicine taken by mouth once a day. It should be taken at the same time each day, with or after food.
Xromi is a cytotoxic medicine and must be handled carefully. Caregivers should wear disposable gloves when handling the bottle or oral dosing syringes. They should also wash their hands with soap and water before and after handling the medicine.
Avoid contact with the oral solution. If the medicine touches the skin, nose, or mouth, wash the area right away with soap and water. If it gets into the eyes, rinse them thoroughly with water or an appropriate eyewash solution for at least 15 minutes.
The recommended starting dose of Xromi is 15 milligrams per kilogram of body weight, taken by mouth once daily. This means the healthcare provider calculates the dose based on how much the child weighs.
Blood counts should be checked every two weeks while the dose is being adjusted. If blood counts stay within an acceptable range, the healthcare provider may increase the dose by 5 milligrams per kilogram per day every eight to 12 weeks. The dose may be increased until the child reaches the highest dose they can safely tolerate, up to 35 milligrams per kilogram per day.
If blood counts become too low, Xromi may need to be stopped until they recover. If blood counts recover within one week, treatment may restart at the same dose. If recovery takes longer than one week or the problem happens twice within three months, the dose should be reduced by 5 milligrams per kilogram per day.
Once the child reaches a stable dose, blood counts should be checked every four weeks for two months and then as needed, based on the healthcare provider’s judgment.
For children with a creatinine clearance below 60 milliliters per minute or with end-stage kidney disease, the starting dose of Xromi should be reduced by 50 percent. Creatinine clearance is a measure of how well the kidneys are working. These children also need close monitoring of their blood counts.
This information is based on the prescribing information, but their healthcare provider may tailor your child’s treatment plan. Always follow their guidance.
In a clinical study of Xromi, involving 32 children with sickle cell anemia, the most common side effects occurred in about 5 percent to 13 percent of people. These include:
Xromi 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.
Rare Disease Therapeutics, Inc, the manufacturer of Xromi, offers the Xromi copay assistance program. Eligible people with commercial insurance may pay as little as $25 per prescription.
The eVoucher is applied automatically at participating pharmacies, with no forms, coupons, or enrollment required.
To learn more, visit the Xromi copay assistance program website.
Before starting Xromi, your child’s doctor will check their blood cell counts. For adolescents who can become pregnant, the doctor will also check their pregnancy status before treatment.
Tell your child’s doctor about any vaccines your child has received or plans to receive. Children taking Xromi should not receive live vaccines because they may cause serious infections.
Your child should not take Xromi if they are allergic to hydroxyurea or any ingredient in Xromi.
Tell your child’s doctor about all medicines they take, including prescription drugs, over-the-counter (OTC) medicines, vitamins, and herbal supplements.
Before your child starts taking Xromi, tell the doctor if your child:
Xromi may cause falsely high blood sugar readings on certain CGM devices. This could lead to dangerously low blood sugar if those readings are used to decide how much insulin to take. If your child uses a CGM, talk to the healthcare provider who prescribed it about other ways to check blood sugar during Xromi treatment.
If your child misses a dose of Xromi, give it as soon as you remember, but only on the same day. If you cannot give the missed dose that day, skip it and give the next dose at the usual time. Do not give two doses to make up for a missed dose. Contact your child’s healthcare provider if you have questions about a missed dose.
Xromi can harm the baby during pregnancy. For adolescents who can become pregnant, a healthcare provider should check pregnancy status before treatment. They should use effective birth control during treatment and for at least six months after treatment ends.
Male adolescents who have female partners who can become pregnant should use effective birth control during treatment and for at least one year afterward. Xromi may also cause fertility problems in males.
People should not breastfeed while taking Xromi because it may cause serious harm to a breastfed baby.
Talk to your child’s healthcare provider if you have questions about pregnancy, birth control, fertility, or breastfeeding.
These answers are fact-checked by our editorial staff.
How effective is Xromi for sickle cell anemia?
Xromi helps reduce how often painful crises happen and lowers the need for blood transfusions in children 6 months and older with sickle cell anemia who have repeated moderate to severe pain crises.
In a study involving 32 children with sickle cell anemia, Xromi was associated with increases in fetal hemoglobin, a type of hemoglobin that helps red blood cells carry oxygen.
In children treated with hydroxyurea for up to 15 months, the average amount of fetal hemoglobin compared with total hemoglobin at the end of the study was:
These results show changes in fetal hemoglobin levels. They do not tell us exactly how much Xromi reduced painful crises in these children.
How long does Xromi take to work for sickle cell anemia?
The information available does not say exactly how long Xromi takes to reduce painful crises.
Your child’s doctor may check fetal hemoglobin levels every three to four months to help see how well Xromi is working.
Blood cell counts are also checked every two weeks while the dose is being adjusted to help monitor treatment safety.
Does Xromi interact with other medicines?
Yes. Xromi can interact with certain medicines, including some used to treat HIV.
Taking hydroxyurea with certain HIV medicines, such as didanosine or stavudine, has been linked to serious side effects, including inflammation of the pancreas, liver damage, and nerve problems. Some of these reactions have been life-threatening or fatal.
Xromi can also affect certain blood and urine test results and cause falsely high blood sugar readings on some continuous glucose monitors (CGMs).
Tell your child’s doctor about all medicines your child takes, including prescription medicines, OTC medicines, vitamins, and herbal supplements. Also tell the doctor if your child uses a CGM.
On MySickleCellTeam, people share their experiences with sickle cell disease, get advice, and find support from others who understand.
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