Droxia

Droxia is a prescription medication used to reduce the frequency of episodes of severe pain from sickle cell anemia and to reduce the need for blood transfusions in adults with sickle cell anemia.

Droxia belongs to a group of drugs called antimetabolites. Droxia treats sickle cell anemia by helping to prevent formation of sickle-shaped red blood cells.This medication comes in capsule form and is usually taken once a day, with or without food. 

Some of the common side effects of Droxia include hair loss, skin rash, and fever. 

Droxia is a prescription medicine that is used to reduce the frequency of painful crises (episodes of severe pain) and reduce the need for blood transfusions in adults with sickle cell anemia. 

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

• E.R. Squibb & Sons, L.L.C.

Serious side effects have been reported with Droxia. See the "Droxia Precautions" section. 

Common side effects of Droxia include the following:

• hair loss
• skin rash
• fever
• stomach disturbances
• weight gain
• bleeding
• virus infection
• discolored nails 

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

Tell your doctor if you have any side effect that bothers you or that does 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 certain medications for HIV (human immunodeficiency virus) or AIDS (acquired immunodeficiency syndrome) such as didanosine (Videx), indinavir (Crixivan) and stavudine (Zerit).

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

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

• Low blood counts. Low blood counts including low red blood cells, white blood cells, and platelets, and can be severe and life-threatening. If your white blood cell count becomes very low, you are at increased risk for infection. Your healthcare provider will check your blood cell counts before and during treatment with Droxia. Your healthcare provider may change your dose or tell you to stop taking Droxia if you have low blood cell counts. Tell your healthcare provider right away if you get any of the following symptoms:

• fever
• chills
• body aches
• feeling very tired
• shortness of breath
• bleeding

• Cancer. Some people have developed cancer, such as leukemia and skin cancer, after taking Droxia for a long time. Your healthcare provider will check you for cancer. You should protect your skin from the sun using sunblock, hats, and sun-protective clothing.
• Skin ulcers. Skin ulcers have been seen in patients taking Droxia therapy. Contact your doctor if skin ulcers develop while you are taking Droxia. This has occurred most often in people who receive interferon therapy or have a history of interferon therapy. Your healthcare provider will stop treatment with Droxia if you develop any skin ulcers.
• Embryo-fetal toxicity: If you become pregnant while taking Droxia this may harm or cause death to your unborn child. You should not become pregnant while taking Droxia. Make sure you use a contraceptive method. Tell your doctor if you become pregnant or plan to become pregnant while taking Droxia.
• Drug interactions. Droxia can interact with certain medications used for HIV and cause serious, life-threatening side effects. Tell your doctor if you take medications for HIV.

Do not take Droxia if you are allergic to any of the ingredients. Tell your doctor if you think you have ever had an allergic reaction.

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 Droxia, there are no specific foods that you must exclude from your diet when receiving this medication.

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

• are allergic to Droxia or to any of its ingredients
• have kidney problems or are receiving hemodialysis
• have liver problems
• have human immunodeficiency virus (HIV). Taking Droxia with certain HIV medicines can cause serious reactions and may lead to death.
• have increased level of uric acid in your blood (hyperuricemia)
• have a history of receiving interferon therapy or are currently receiving interferon therapy
• are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. Droxia can pass into your breast milk. Do not breastfeed during treatment with Droxia. Talk to your healthcare provider about the best way to feed your baby.

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.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Droxia falls into category D. Droxia can cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, there is a potential for harm to the fetus. You should not become pregnant while taking Droxia.

It is recommended females use effective contraception during and after treatment with Droxia for at least 30 days after therapy. Females of reproductive potential should also ensure that their male partner, who is/has taken Droxia, uses effective contraception during and after treatment for at least 1 year after therapy. Males of reproductive potential to use effective contraception during and after treatment with Droxia for at least 1 year after therapy.

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

Take Droxia exactly as prescribed.

• Droxia comes in capsule form and is usually taken once a day, with or without food.
• Droxia is usually taken once a day. Take it at the same time each day.
• Your healthcare provider will determine the right starting dose of Droxia for you based on your weight. Your dose will then be increased slowly to your maximum tolerated dose (a dose that does not produce severely low blood counts).
• Your healthcare provider will check your blood cell counts before and during treatment with Droxia. Depending on the results, your dosage may be adjusted or the drug may be stopped for a while.

Droxia is a medicine that must be handled with care. People who are not taking Droxia should not be exposed to it. To decrease the risk of exposure, you or your caregivers should do the following when handling Droxia:

• Wear disposable gloves when handling Droxia capsules or bottles containing Droxia.
• Wash your hands before and after handling Droxia capsules or bottles containing Droxia.
• Do not open the capsules.
• Avoid contact with crushed or opened capsules. If contact from crushed or opened capsules happens on the skin, wash the skin area right away with soap and water. If contact from crushed or opened capsules happens on the eye(s), flush the eye(s) thoroughly with water or isotonic eyewash designated for that purpose for at least 15 minutes.
• If the powder from the capsule is spilled, wipe it up right away with a damp disposable towel, and throw it away in a closed container, such as a plastic bag; as should the empty capsules. The spill areas should then be cleaned three times using a detergent solution followed by clean water.

Try not to miss your dose of Droxia, but if you do, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses during the same day. If you miss more than one dose, call your doctor for instructions.

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:

• actual or ideal weight, whichever is less
• how you respond to this medication
• your blood counts, liver function, and kidney function
• other medications you are taking

The recommended initial dose of Droxia for sickle cell anemia is 15 mg/kg/day as a single dose.The dose will then be increased slowly until your maximum tolerated dose (maximum dose that does NOT produce severely low blood counts) or 35 mg/kg/day is reached. 

If you accidentally take an overdose of Droxia, seek medical attention immediately. Contact your doctor, local Poison Control Center, or emergency room.

• Store Droxia at 25°C (77°F) in a tightly closed container.
• Keep this and all medicines out of the reach of children.

WARNING: MYELOSUPPRESSION AND MALIGNANCIES

SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.

Myelosuppression: DROXIA may cause severe myelosuppression. Do not give if bone marrow function is markedly depressed. Monitor blood counts at baseline and throughout treatment. Interrupt treatment and reduce dose as necessary.

Malignancies: Hydroxyurea is carcinogenic. Advise sun protection and monitor patients for malignancies.