Hydrea

Hydrea is a prescription medication used to treat resistant chronic myelocytic leukemia and is used to treat squamous cell carcinomas of the head and neck, excluding the lip.

Hydrea belongs to a group of drugs called antimetabolites. Hydrea treats cancer by slowing or stopping the growth of cancer cells in your body.

This medication comes in capsule form and is usually taken once daily or every third day, with or without food. 

Swallow the capsules whole; do not split, chew, or crush them.

Common side effects of Hydrea includes decreases in blood cells, stomach problems, such as nausea and vomiting, and loss of appetite. 

Hydrea is a prescription medication used to treat resistant chronic myelocytic leukemia.

It is also used in combination with radiation to treat squamous cell carcinomas of the head and neck, excluding the lip.

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 Hydrea. See the "Hydrea Precautions" section. 

Common side effects of Hydrea include the following:

• Loss of appetite
• Nausea
• Vomiting
• Diarrhea
• Constipation
• Inflammation of the mouth
• Skin reactions such as rash, skin breakage, skin darkening, scaling, and violet elevations
• Nail and skin wasting away
• Painful or difficult urination
• Hair loss
• Drowsiness
• Headache
• Dizziness
• Disorientation
• Hallucinations
• Convulsions
• Impaired kidney function
• Fever
• Chills
• Retaining fluids
• Lack of energy
• Increased liver proteins

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

Serious side effects have been reported with Hydrea 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 Hydrea. Your healthcare provider may change your dose or tell you to stop taking Hydrea 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 Hydrea 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.

• Problems with your Kidneys. Your doctor will evaluate your kidney and liver function before Hydrea use. Hydrea should be used with caution in patients with marked kidney dysfunction. There is an increased risk of liver damage while taking Hydrea.
• Embryo-Fetal Toxicity. If you get pregnant, Hydrea may harm or cause death to your unborn child. You should not become pregnant while taking Hydrea. Make sure you use a contraceptive method. Tell your doctor if you become pregnant or plan to become pregnant while taking Hydrea.

HIV patients should be monitored closely for signs and symptoms of inflammation of pancreas, liver damage, plus weakness, numbness, and pain from nerve damage (usually in the hands and feet).

Do not take Hydrea if you:

• are allergic to Hydrea or any of its 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 Hydrea, there are no specific foods that you must exclude from your diet when receiving this medication.

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

• are allergic to Hydrea or to any of its ingredients
• have human immunodeficiency virus (HIV). Taking Hydrea with certain HIV medicines can cause serious reactions and may lead to death.
• have liver problems
• have kidney problems
• have bone marrow suppression which means a decrease in production of cells responsible for providing immunity (leukocytes), carrying oxygen (erythrocytes), and/or those responsible for normal blood clotting (thrombocytes)
• have low white blood cell count (leukopenia)
• have low amount of a substance helpful in blood clotting (platelets)
• have severe lack of red blood cells in the blood (anemia)
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

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.

Hydrea falls into category D. Hydrea 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 Hydrea.

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

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

Hydrea has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Hydrea, you should discontinue nursing your baby while taking Hydrea.

Take Hydrea exactly as prescribed.

Hydrea comes in capsule form and is usually taken once daily or every third day, depending on the condition being treated. It can be taken with or without food.

While you take Hydrea, your doctor will prescribe folic acid (a vitamin), to decrease some of the side effects of this medication.

Hydrea is a medication that must be handled with care.

• To decrease the risk of contact, advise caregivers to wear disposable gloves when handling Hydrea or bottles containing Hydrea.
• Wash hands with soap and water before and after contact with the bottle or capsules when handling Hydrea.
• Do not open Hydrea capsules. Avoid exposure to crushed or opened capsules.
• When Hydrea is used along with radiation therapy, Hydrea should begin at least seven days before initiation of radiation and continued during radiation as well as indefinitely afterward provided that the patient may be kept under adequate observation.
• Hydrea should be kept away from children and pets.
• Contact your doctor for instructions on how to dispose of outdated capsules.

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:

• tumor type
• disease state
• actual or ideal weight, whichever is less
• how you respond to this medication
• the other medications you are taking
• if continuous or discontinuous treatment is used
• your blood counts, kidney, and liver function

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

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

Do not open Hydrea capsules. Avoid exposure to crushed or opened capsules.

• If contact with crushed or opened capsules occurs on the skin, wash affected area immediately and thoroughly with soap and water.
• If contact with crushed or opened capsules occurs on the eye(s), the affected area should be flushed thoroughly with water or isotonic eyewash designated for that purpose for at least 15 minutes.
• If the powder from the capsule is spilled, immediately wipe it up with a damp disposable towel and discard 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. 

WARNING

Treatment of patients with Hydrea may be complicated by severe, sometimes life-threatening, adverse effects. Hydrea should be administered under the supervision of a physician experienced in the use of this medication for the treatment of sickle cell anemia.

Hydrea is mutagenic and clastogenic, and causes cellular transformation to a tumorigenic phenotype. Hydrea is thus unequivocally genotoxic and a presumed transspecies carcinogen which implies a carcinogenic risk to humans. In patients receiving long-term hydroxyurea for myeloproliferative disorders, such as polycythemia vera and thrombocythemia, secondary leukemias have been reported. It is unknown whether this leukemogenic effect is secondary to Hydrea or is associated with the patient’s underlying disease. The physician and patient must very carefully consider the potential benefits of Hydrea relative to the undefined risk of developing secondary malignancies.