What is the most important information I should know about Hydrea?

• Hydrea can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. It is important that you not miss any scheduled visits to your doctor.
• Do not use this medication if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.
• Talk with your doctor if you have trouble swallowing the capsule. Your doctor may instruct you to open the capsule, pour the medicine powder into a glass of water, and drink this mixture. If you open a capsule, do not inhale the powder or let it come in contact with your skin. Wash your hands before and after handling the pills, and wear disposable gloves when opening the capsule. If any of the medicine is spilled, wipe up the spill with a damp cloth and throw the cloth away in a sealed plastic bag. Keep all medicine and empty capsule shells out of the reach of children and pets.
• Handle the tablets and capsules with extreme care. The medicine from a crushed or broken tablet or capsule can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. Wash your hands before and after handling the pills or the medicine bottle. For best protection, wear disposable gloves whenever handling the bottle or the pills. Ask your doctor or pharmacist how to safely dispose of any unused tablets or capsules.
• Call your doctor promptly if you have any skin changes such as pinpont red spots, red patches, skin ulcers, or darkened skin (especially on your legs or feet). These may be early signs of a serious side effect.

What is Hydrea?

• Hydrea affects certain cells in the body, such as cancer cells or sickled red blood cells.
• Hydrea is used to treat melanoma (a type of skin cancer), chronic myelocytic leukemia, cancer of the ovary, and primary squamous cell (skin) cancer of the head and neck. Hydrea is also used to treat sickle cell anemia.
• Hydrea may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking Hydrea?

• Before taking Hydrea, tell your doctor if you are being treated with radiation therapy or using interferon (Roferon, Intron, Rebetron, Actimmune, Betaseron, Rebif, Infergen, Alferon).
• Before taking this medication, tell your doctor if you have:
  • poor bone marrow function;
  • liver disease; or
  • kidney disease.
• If you have any of these conditions, you may not be able to use Hydrea, or you may need a dosage adjustment or special tests during treatment.
• FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use Hydrea if you are pregnant. Tell your doctor if you become pregnant during treatment. Use an effective form of birth control while you are using this medication.
• Hydrea can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
• Older adults may be more sensitive to the side effects of this medicine.

How should I take Hydrea?

• Take this medication exactly as it was prescribed for you. Do not take the medication in larger or smaller amounts, or take it for longer than recommended by your doctor.
• Take each dose with a full glass of water.
• Hydrea can be taken with or without food.
• Handle the tablets and capsules with extreme care. The medicine from a crushed or broken tablet or capsule can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. Wash your hands before and after handling the pills or the medicine bottle. For best protection, wear disposable gloves whenever handling the bottle or the pills. Ask your doctor or pharmacist how to safely dispose of any unused tablets or capsules.
• Talk with your doctor if you have trouble swallowing the capsule. Your doctor may instruct you to open the capsule, pour the medicine powder into a glass of water, and drink this mixture. If you open a capsule, do not inhale the powder or let it come in contact with your skin. Wash your hands before and after handling the pills, and wear disposable gloves when opening the capsule. If any of the medicine is spilled, wipe up the spill with a damp cloth and throw the cloth away in a sealed plastic bag. Keep all medicine and empty capsule shells out of the reach of children and pets.
• Hydrea can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. It is important that you not miss any scheduled visits to your doctor.
• If you vomit shortly after taking a dose Hydrea, contact your doctor. You may need to take another dose. Follow your doctor's instructions.
• It is important to take Hydrea regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
• Store Hydrea at room temperature away from moisture and heat.

What happens if I miss a dose?

• Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

• Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it.

What should I avoid while taking Hydrea?

• Do not allow anyone else to take your medication or handle the medicine bottle, tablets, or capsules. Anyone preparing or handling this medicine for you should wear disposable gloves and wash hands before and after handling the medicine.
• Avoid contact with people who have colds, the flu, or other contagious illnesses. Contact your doctor immediately if you develop signs of infection.
• Do not receive a “live” vaccine while you are being treated with Hydrea, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.

What are the possible side effects of Hydrea?

• Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
• Call your doctor at once if you have any of these serious side effects:
  • pinpoint red spots on your skin;
  • red patches, skin ulcers, or darkened skin (especially on your legs or feet);
  • fever, chills, body aches, flu symptoms;
  • nausea or vomiting;
  • loss of appetite;
  • diarrhea;
  • white patches or sores inside your mouth or on your lips; or
  • easy bruising or bleeding, unusual weakness.
• Other less serious side effects may be more likely to occur, such as:
  • constipation;
  • skin rash;
  • itching;
  • leg sores;
  • redness of the face;
  • hair loss;
  • drowsiness;
  • headache; or
  • dizziness.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

What other drugs will affect Hydrea?

• There may be other drugs that can affect Hydrea. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.