Xromi

Pronunciation: ex-ro-mee
Generic name: hydroxyurea oral solution
Dosage form: oral solution
Drug class: Antimetabolites

Medically reviewed by Carmen Pope, BPharm. Last updated on Apr 23, 2024.

What is Xromi?

Xromi (hydroxyurea) is an oral solution that may be used to reduce the frequency of painful crises and reduce the need for blood transfusions in children aged 6 months to less than 2 years old, with sickle cell anemia who have recurrent moderate to severe painful crises.

How Xromi produces its beneficial effects in children with sickle cell anemia is not well understood although research has shown it increases HbF (fetal hemoglobin) levels, decreases neutrophils, increases the water content of red blood cells, increases the deformity of sickled cells, and changes how RBCs adhere to endothelium.

Xromi is not for use in adults. It is not known if Xromi is safe and effective in children less than 6 months old.

Xromi was FDA-approved on 4 April 2024. Hydroxyurea, the ingredient in Xromi, was first approved on December 7, 1967.

Xromi side effects

Xromi can cause serious side effects, such as low blood cell counts, and hemolytic anemia, and increase the risk of cancer. See warnings below.

Other serious side effects may include:

Skin ulcers and death of tissue (gangrene). These have happened most often in people who receive interferon therapy or have a history of interferon therapy. Your child’s healthcare provider will decrease your child’s dose or stop treatment with Xromi if your child develops any skin ulcers
Enlarged red blood cells (macrocytosis). Macrocytosis can make it difficult to detect a decrease in folic acid. Your child’s healthcare provider may prescribe a folic acid supplement for your child
Respiratory (breathing) problems. Some people have developed life-threatening respiratory conditions called interstitial lung disease. Tell your child’s healthcare provider right away if your child gets any of the following symptoms: fever, cough, or shortness of breath

The most common side effects of Xromi affecting more than 33% of people include:

low blood levels of a type of white blood cell (neutropenia)
low blood levels of platelets (thrombocytopenia)

These are not all the possible side effects of Xromi. Call your child’s doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Warnings

Your child should not take Xromi if they are allergic to hydroxyurea, Xromi, or any of the inactive ingredients in the solution.

Xromi can cause severe bone marrow suppression and should not be given to children whose bone marrow function is markedly depressed.

Xromi can cause serious side effects including:

Low blood cell counts, including low red blood cells, white blood cells, and platelets. These can be severe and life-threatening. If your child’s white blood cell count becomes very low, your child is at increased risk for infection. Your child’s healthcare provider will check your child’s blood cell counts before and during treatment with Xromi. Tell your child’s healthcare provider right away if your child gets any of the following symptoms fever or chills, shortness of breath, body aches, bleeding or unexplained bruising, or feeling very tired
Hemolytic anemia (the fast breakdown of red blood cells), has happened in people who take Xromi. Tell your child’s healthcare provider if your child develops yellowing of their skin (jaundice) or blood in their urine. Your child’s healthcare provider may do blood tests if your child has persistent or worsening anemia not related to sickle cell anemia.
Cancer. Hydroxyurea is carcinogenic. Some people have developed cancer, such as leukemia and skin cancer, after taking Xromi for a long time. Your child’s healthcare provider will check your child for cancer. You should protect your child’s skin from the sun using sunblock, hats, and sun-protective clothing.

Research has shown the active ingredient in Xromi, hydroxyurea, may cause fertility problems in males and harm to an unborn baby. Xromi is not approved in adults but you should talk to your child’s healthcare provider if this is a concern.

Before taking

Before your child takes Xromi, tell your child’s healthcare provider about all of their medical conditions, including if your child:

has kidney problems or is receiving hemodialysis.
has liver problems.
has human immunodeficiency virus (HIV) or takes HIV medicines. Taking Xromi with certain HIV medicines can cause serious reactions and may lead to death.
has increased levels of uric acid in their blood (hyperuricemia).
has a history of receiving interferon therapy or is currently receiving interferon therapy.
has leg wounds or ulcers.
plans to receive any vaccinations. Your child should not receive “live vaccines” during treatment with Xromi.
is using a continuous glucose monitor (CGM) to test their blood glucose. Hydroxyurea may affect the sensor glucose results and may lead to low blood sugar (hypoglycemia). Talk to the child’s healthcare provider who prescribed the CGM about whether it is safe to use while your child is taking Xromi.

How is Xromi administered?

Parents and caregivers should read the Instructions for Use that come with Xromi for information about the right way to measure and give a dose. If you have any questions, talk to your child’s healthcare provider or pharmacist.

You should be careful handling Xromi and wear disposable gloves when handling oral dosing syringes or bottles.
Wash your hands with soap and water before and after handling these.
Women who are pregnant, planning to be pregnant, or breastfeeding should not handle Xromi.
Avoid contact with the oral solution. If contact with the oral solution happens on the skin, wash the skin area right away and thoroughly with soap and water. If contact with the oral solution happens in the eyes, flush the eyes thoroughly with water and isotonic eyewash used for that purpose for at least 15 minutes.
If the oral solution is spilled, wipe it up right away with a damp disposable towel. Throw the damp disposable towel away in a closed container such as a plastic bag. The spill area should then be cleaned up using a detergent solution followed by clean water.

Xromi dosage

Administer Xromi exactly as your child’s healthcare provider tells you to administer it.

The dosage of Xromi for your child is based on their weight. Your healthcare provider will tell you exactly how much to give your child. This dosage may change as your child grows or depending on the blood counts.
Xromi is taken once a day at the same time each day.
It should be taken with or after meals. Try to administer it the same way each day.
Have your child drink some water after each dose.

Oral dosing syringes should be rinsed washed with cold or warm water and dried completely before the next use. Store oral dosing syringes in a clean place in the refrigerator with the medicine.

During treatment with Xromi, your child’s healthcare provider will do blood tests regularly to check your child’s blood cell counts and liver function. Your healthcare provider may change your child’s dose if you have side effects.

What happens if I give my child too much Xromi?

If you give your child too much Xromi, call your child’s healthcare provider or go to the nearest hospital emergency room right away.

What other drugs will affect Xromi?

Tell your doctor about all the medicines that your child takes, including prescription and nonprescription medicines, vitamins, and herbal supplements. Xromi and some medicines may interact with each other and may not work as well, or cause possible serious side effects. Especially tell your doctor if your child takes:

HIV medications, such as didanosine.

Xromi may interfere with laboratory tests that measure uric acid, urea, or lactic acid, rendering falsely elevated results.

Xromi may also falsely elevate sensor glucose results from certain continuous glucose monitoring (CGM) systems and may lead to low blood glucose levels if sensor glucose results are relied upon to dose insulin.

This is not a complete list of interactions. Talk to your healthcare provider or pharmacist for a full list of interactions.

Storage

Refrigerate Xromi in a clean part of the refrigerator between 35°F to 46°F (2°C to 8°C). Do not freeze. It comes in a bottle with a child-resistant cap. Keep the bottle tightly closed.

Use Xromi oral solution within 12 weeks of opening the bottle. Dispose of (throw away) any unused medicine and the dosing syringes after 12 weeks.

Xromi is a hazardous drug. Place the finished Xromi bottle and syringes in a plastic bag and ask your pharmacist for instructions on how to throw away (dispose of) Xromi that is expired or no longer needed.

Do not use after the expiration date on the carton and bottle.

Keep out of the reach of children. Accidental ingestion can be lethal for children.