Hydrea - Consumer Medicine Information
|Condition:||Anemia, Sickle Cell, Chronic Myelogenous Leukemia, Solid Tumors|
|Ingredients:||hydroxyurea, citric acid, dibasic sodium phosphate, lactose and magnesium stearate|
(hydroxyurea capsules, USP)
About this medication
What the medication is used for
Hydrea (hydroxyurea) is used to treat cancer of the head and neck (excluding the lips) in combination with radiation, as well as cancer of the skin and a type of blood cancer (resistant chronic myelocytic leukemia)
What it does
HYDREA seems to interfere with the growth of cancer cells by preventing them from dividing.
When it should not be used
HYDREA should not be used if:
- you have problems with your bone marrow (low blood count e.g. severe anemia)
- you are sensitive/allergic to hydroxyurea or any other component of this medication (See “What the important nonmedicinal ingredients are” in this leaflet). Tell your doctor if you think you have had an allergic reaction to any of these ingredients.
What the medicinal ingredient is
What the important nonmedicinal ingredients are
Citric acid, dibasic sodium phosphate, lactose and magnesium stearate.
What dosage forms it comes in
HYDREA is available in capsules containing 500 mg hydroxyurea.
Warnings and precautions
BEFORE you use HYDREA talk to your doctor or pharmacist if:
- you have problems with your kidney because the dose of HYDREA may need to be adjusted
- you are breast feeding. HYDREA can pass into your breast milk and harm your baby. Do not breast-feed if you are taking HYDREA.
- you have problems with low blood count or anemia
- you have received radiation therapy as this may increase your chances of developing redness of the skin if HYDREA is used with radiation treatment.
- you are pregnant or planning on becoming pregnant. HYDREA can harm the fetus when given to a pregnant woman. Women should avoid becoming pregnant while undergoing treatment with HYDREA.
- you are a male contemplating conception. HYDREA may cause an absence or low amount of sperm in the semen (sometimes these events are reversible) and damage DNA in your sperm. Therefore you should seek advice on sperm conservation prior to treatment with HYDREA and use safe contraceptive measures during and at least 1 year after therapy ends.
- you have HIV/AIDS and are receiving treatment as this can increase your chances of developing pancreatitis (inflammation of the pancreas) and liver problems.
- you are lactose intolerant.
- you recently received a vaccination or are scheduled for any vaccination. Patients taking HYDREA should not receive live vaccines.
- you are receiving treatment with interferon. Inflammation of the blood vessels of the skin, sometimes leading to formation of ulcers or death of the blood vessels has been reported mostly in patients who have received or are currently receiving interferon treatment.
Interactions with this medication
Make sure you talk to your doctor about any other conditions you may have and all other medications you are taking, including prescription, non-prescription, and herbal and/or natural products.
Concurrent use of hydroxyurea and other myelosuppressive agents or radiation therapy may increase the likelihood of bone marrow depression or other adverse events.
Proper use of this medication
While you are using this medicine, your doctor may want you to drink extra fluids so that you will pass more urine. This will help prevent kidney problems and keep your kidneys working well.
The dose of HYDREA will be different for different patients. The dose that is used may depend on a number of things, including what the medicine is being used for, your weight, and whether or not other medicines are also being taken. Follow your doctor’s orders.
Depending on your condition, the usual dose could be 80 mg/kg, or 20-30 mg/kg given orally. The dose and frequency will vary with your disease. Please follow your doctor’s orders.
If you think you may have taken more HYDREA than you should, talk to your doctor immediately or contact the Emergency room of the nearest hospital.
It you miss a dose of this medicine check with your doctor.
Side effects and what to do about them
Along with their needed effects, medicines like HYDREA can sometimes cause unwanted effects such as blood problems and other side effects.
The following information describes the most important side effects of which you should be aware. It is not a comprehensive list of all side effects. You should report any unusual symptoms to your doctor.
Check with your doctor if any of the following side effects occur:
- Inflammation in or around the mouth
- Loss of appetite.
- High fevers (≥40 degrees celcius)
- Nausea and vomiting.
- Diarrhea and constipation.
- Inflammation of the blood vessels of the skin, sometimes leading to formation of ulcers or death of the blood vessels has been reported mostly in patients who have received or are currently receiving interferon treatment.
- Rash, redness and ulceration in the face, skin or extremities. Any skin or nail changes.
Discontinue medication and check with your doctor if any of the following side effects occur:
- Lack of urination, severe muscle weakness, abnormal heart beat, and seizures (symptoms of tumour lysis syndrome)
- Yellowing of skin and eyes, feeling tired, stomach ache, nausea, diarrhea, no appetite, fever, headaches (symptoms of Hepatitis)
- Clay-colored or white stools, dark urine, inability to digest certain foods, itching, nausea or vomiting, pain in the right upper part of the abdomen, yellow skin or eyes (symptoms of cholestasis)
Serious side effects, how often they happen and what to do about them
|Symptom/effect||Talk with your doctor or pharmacist||Stop taking|
|Common||Mouth sores (inflammation in or around the mouth)||X|
|Nausea and vomiting||X|
|Diarrhea and constipation||X|
|Dark Urine, Clay-colored or white stools, itchiness, inability to digest certain foods, pain in right upper part of the abdomen||X|
|Yellowing of the skin and eyes, feeling tired, stomach ache, fever||X|
|Uncommon||Loss of appetite||X|
|Drowsiness, headache and dizziness||X|
|Disorientation, hallucinations, and convulsions||X|
|Rare||Lack of urination, and seizures||X|
|Skin redness, sores, and/or ulcers if you have been or, are currently being, treated with interferon.||X|
This is not a complete list of side effects. For any unexpected effects while taking HYDREA, contact your doctor or pharmacist.
How to store it
HYDREA should be stored at room temperature (15 – 30°C). Protect from heat and moisture.
Reporting suspected side effects
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs . If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345
toll-free fax 866-678-6789
By email: firstname.lastname@example.org
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Bristol-Myers Squibb Canada, at 1-866-463-6267.