Patient Medication Information: uses, side effects, how to take - Hydroxyurea
ABOUT THIS MEDICATION
What the medication is used for:
Hydroxyurea (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:
Hydroxyurea seems to interfere with the growth of cancer cells by preventing them from dividing.
When it should not be used:
Hydroxyurea 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:
Hydroxyurea.
What the important nonmedicinal ingredients are:
Colloidal silicon dioxide, magnesium stearate, D & C Red #28, FD & C Blue #1, FD & C Red #40, D & C Yellow # 10, titanium dioxide, gelatin, black SW-9008/SW-9009.
What dosage forms it comes in:
Hydroxyurea is available in capsules containing 500 mg hydroxyurea.
WARNINGS AND PRECAUTIONS
BEFORE you use Hydroxyurea talk to your doctor or pharmacist if:
you have problems with your kidney because the
dose of Hydroxyurea may need to be adjusted
you are breast feeding. Hydroxyurea can pass into
your breast milk and harm your baby. Do not breast-feed if you are taking Hydroxyurea.
- 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 Hydroxyurea is used with radiation treatment.
- you are pregnant or planning on becoming pregnant. Hydroxyurea can harm the fetus when given to a pregnant woman. Women should avoid becoming pregnant while undergoing treatment with Hydroxyurea.
you are a male contemplating conception.
Hydroxyurea 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 Hydroxyurea 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 recently received a vaccination or are scheduled for any vaccination. Patients taking Hydroxyurea 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.
Usual dose:
The dose of Hydroxyurea 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.
Overdose:
| In case of drug overdose, contact a health care | ||
| practitioner, hospital emergency department or | ||
| regional Poison Control Centre immediately, even | ||
| if there are no symptoms. |
Missed Dose:
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 hydroxyurea 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.
- 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:
- Itchiness, yellowing of skin and eyes
- Dark urine
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND | ||||||
| WHAT TO DO ABOUT THEM | ||||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and seek immediate emergency medical attention | ||||
| Only if severe | In all cases | |||||
| Common | Mouth sores (inflammation in or around the mouth) | X | ||||
| Nausea and vomiting | X | |||||
| Diarrhea and constipation | X | |||||
| Dark urine | X | |||||
| Itchiness, yellowing of the skin and eyes | X | |||||
| Uncommon | Loss of appetite | X | ||||
| Drowsiness, headache and dizziness | X | |||||
| Disorientation, hallucinations, and convulsions | X | |||||
| Rare | 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 Hydroxyurea, contact your doctor or pharmacist.
HOW TO STORE IT
Hydroxyurea should be stored at room temperature (15°C – 30˚C). Protect from excessive heat and moisture.
REPORTING SIDE EFFECTS
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
Mail to: Canada Vigilance Program
Health Canada, Postal Locator 0701E Ottawa, ON K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (http://hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Sanis Health Inc., at: 1-866-236-4076 or quality@sanis.com.
Revised on: May 04, 2015