Hydrea

The active ingredient in Hydrea is hydroxyurea. Hydroxyurea belongs to a class of medications known as antimetabolites. To grow and spread, cancer cells replicate their DNA to multiply throughout the body. The mechanism of action of antimetabolites is to stop the production of new DNA and to halt cancer growth. However, our bodies also need to make DNA as a way of maintaining normal function. Alongside killing cancer cells, Hydrea can also kill and damage the noncancerous, healthy cells in our body, explaining many of the side effects seen during treatment.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide, before using Hydrea. However, the following is a synopsis of the general guidelines for the use of Hydrea:

• Hydrea should be used exactly as prescribed.
• Your dose of Hydrea will depend on the type of cancer you have, the stage, and other patient-specific factors. Generally, those with kidney problems will take a lower dose compared to other patients to prevent the increased risk of side effects. The capsules are to be taken whole and should not be opened, broken, or chewed.
• People not taking Hydrea for treatment should avoid touching the hydroxyurea capsules. Hydrea is cytotoxic, which means that when it is absorbed through the skin, it can kill or damage healthy cells. If you are a caregiver, wear gloves while handling the medication. If you accidentally touch the capsules, make sure to wash your hands with soap and water.
• Both males and females of reproductive potential using Hydrea should use a reliable form of birth control or contraception during treatment and for at least 6 months (females) or 1 year (males) after stopping the medication. Hydrea can damage reproductive organs and cause harm to the unborn child.
• You will complete weekly blood tests throughout treatment. Your prescriber will monitor your blood cell counts to ensure the medication is safe and effective for you.
• Because of the risk of other skin cancers, while taking this medication, it is recommended to avoid excessive sun exposure and to use a broad-spectrum sunscreen on a daily basis.
• Hydrea can interfere with certain blood work and lab tests, namely those measuring uric acid, urea, lactic acid, or glucose levels.
• If you miss a dose, take it as soon as you remember. However, if it is almost time for your next use, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

The most common side effects of Hydrea seen in clinical trials as compared to placebo include:

• Bowel disturbances such as diarrhea or constipation
• Fatigue
• Headache
• Nausea and vomiting
• Loss of appetite
• Joint or muscle pain
• Skin rash
• Hair loss

Some individuals may experience serious side effects while using Hydrea. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Signs of severe myelosuppression or poor bone marrow function, such as symptoms of an infection or bleeding. When the bone marrow is not working well, it cannot produce blood cells, resulting in leukopenia (or low white blood cells), anemia (or low red blood cells), or thrombocytopenia (or low platelets).
• Signs of hemolytic anemia such as yellowing of the eyes or skin (jaundice) or blood in the urine (hematuria).
• Signs of another form of cancer, especially leukemia or skin cancers. Monitor changes in the appearance of moles as a potential sign of skin cancer. Monitor for excessive fatigue, fever, chills, unexplained weight loss, easy bruising or bleeding, and frequent infections as potential signs of leukemia.
• Signs of damage to the vasculature, such as new wounds or skin ulcers that are slow to or do not heal, and blackening of the skin.
• Severe skin irritation or redness.
• Macrocytosis or enlargement of red blood cells. Your doctor may recommend that you take folic acid alongside Hydrea to prevent this from happening.
• Signs of pulmonary toxicities or lung damage such as shortness of breath, chest pain, persistent cough, and fever.
• Symptoms of an allergic reaction like skin rash, hives, swelling of the face, lips, or tongue, and shortness of breath.

These are not all of the possible side effects of Hydrea. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Hydrea, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including whether any of the following apply:

• Blood cell or bone marrow disorders
• A history of cancer, especially leukemia or skin cancers
• Lung problems
• Are receiving interferon therapy
• A history of radiation therapy
• Are planning to receive a live vaccine
• Are pregnant or planning to become pregnant
• Are breastfeeding or planning to breastfeed

Do not use Hydrea if you have an allergy to hydroxyurea or any of the other ingredients in Hydrea.

It can take several months of regular use to see the full effects of hydroxyurea. Your prescriber will monitor your blood work regularly to determine if the medication is working well for you.

When Hydrea is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Antiretrovirals used in the treatment of HIV, such as didanosine and stavudine

Hydrea is available in 500 mg capsules.

The active ingredient in Hydrea, hydroxyurea, is also available under other brand names such as Droxia and Siklos. Both of these brand names are used to reduce pain crises and the need for blood transfusions in people with sickle cell anemia.

Hydrea should be stored at room temperature, away from light and moisture in a tightly closed container, and out of reach of children. It should only be handled by those taking the medication to prevent unnecessary exposure or toxicities.

Hydrea is manufactured by the pharmaceutical company H2 Pharma.

Yes, there is a generic available for the brand-name Hydrea.

Consult your doctor or pharmacist before starting, stopping, or changing medications while taking Hydrea.

Hydrea could cause harm to the unborn child. Both males and females of reproductive potential should use a reliable form of birth control during treatment and for at least 6 months (females) or 1 year (males) after stopping this medication. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant.

Hydrea should not be used while breastfeeding. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.