Details for: APO-HYDROXYUREA
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02247937 | APO-HYDROXYUREA | HYDROXYUREA | 500 MG | CAPSULE | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
APO-HYDROXYUREA (hydroxyurea) is used in combination with radiation to treat cancer of the head and neck, not including the lips. It is also used to treat a type of blood cancer that no longer responds to previous treatments. This type of cancer is called resistant chronic myelocytic leukemia.
What it does
APO-HYDROXYUREA seems to interfere with the growth of cancer cells by preventing them from dividing.
When it should not be used
APO-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. 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 non-medicinal ingredients are
The non-medicinal ingredients are: methylcellulose and stearic acid.
The capsule shell contains the non-medicinal ingredients, D&C red #28, D&C red #33, FD&C blue #1, FD&C red #40, FDA/E172 black iron oxide, FDA/E172 yellow iron oxide, gelatin and titanium dioxide. The edible black imprinting ink contains the non-medicinal colouring agent black iron oxide.
What dosage form it comes in
APO-HYDROXYUREA is available in capsules containing 500 mg hydroxyurea.
Warnings and precautions
BEFORE you use APO-HYDROXYUREA talk to your doctor or pharmacist if:
- you have problems with your kidneys. This because the dose of APO-HYDROXYUREA may need to be adjusted.
- you have received radiation therapy. This is because your chances of developing redness of the skin are higher if APO-HYDROXYUREA is used with radiation treatment.
- you have HIV/AIDS and are receiving treatment.
This can increase your chances of developing:
- pancreatitis (inflammation of the pancreas) and liver problems, or
- peripheral neuropathy (pins and needles in your hands and feet).
- you recently received or are planning to receive a vaccination. Patients taking APOHYDROXYUREA should not receive live vaccines.
- you are receiving treatment with interferon. Inflammation of the blood vessels of the skin, sometimes causing ulcers or death of the blood vessels has been reported. This is most common in patients who have received or are also currently receiving interferon treatment.
- Female patients:
- If you are pregnant or planning to become pregnant, there are specific risk you must discuss with your doctor.
- Avoid becoming pregnant while taking APO-HYDROXYUREA. It may harm your unborn child.
- If you do become pregnant while taking APO-HYDROXYUREA, tell your doctor right away.
- APO-HYDROXYUREA can pass into your breastmilk and harm your baby. Do not breastfeed while you are taking APOHYDROXYUREA.
- Male patients who want to father a child:
- APO-HYDROXYUREA may affect your fertility by causing an absence or low number of sperm in your semen. These effects may or may not return to normal. Damage to the genetic material (DNA) in your sperm is also possible.
- If you want to have a child, talk to your doctor about preserving some semen prior to your treatment with APOHYDROXYUREA.
- Avoid fathering a child during treatment. Use effective methods of birth control during your treatment with APOHYDROXYUREA and for at least one year after your last dose.
- Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to APO-HYDROXYUREA. If you feel drowsy, dizzy weak or tired, do not drive or use tools or machines.
- Tumour Lysis Syndrome (TLS): This side effect can be caused by APOHYDROXYUREA. It is a complication of the breakdown of cancer cells. It is serious and can lead to death. Your doctor will monitor you for signs of TLS.
- A group of disorders that inflame or scar the lung tissue have occurred in patients taking hydroxyurea. This is called interstitial lung disease (ILD). Your doctor will monitor you for signs of ILD. These include fever, cough, shortness of breath and other respiratory symptoms.
- Hydroxyurea, the active ingredient in APOHYDROXYUREA, may cause cancer and damage to the genetic material in cells (DNA).
Interactions with this medication
Make sure you talk to your doctor about all medications you are taking, including prescription, non-prescription, and herbal and/or natural products. The following may interact with APOHYDROXYUREA:
- Cytarabine, a chemotherapy drug used to treat some cancers.
- Medicines used to treat gout.
- Medicines that can affect your blood. This is because using APO-HYDROXYUREA at the same time as these medicines will increase your risk for side effects including low blood counts.
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 APO-HYDROXYUREA will be different for different patients. The dose you are to take will depend on what this medicine is being used to treat, your weight, and whether or not you are also taking other medicines.
Depending on your condition, the usual dose could be 80 mg/kg, or 20 to 30 mg/kg given by mouth. How often you take APO-HYDROXYUREA will also depend on the type of disease you have.
Take APO-HYDROXYUREA exactly as your doctor has indicated.
If you cannot swallow the APO-HYDROXYUREA capsules, your healthcare professional can provide you with instructions on another way to take this medicine.
Your doctor may interrupt, change your dose or stop your treatment. This will depend on your disease, how you are feeling and the type of side effects you experience.
Overdose
If you think you have taken too much APOHYDROXYUREA, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
The following side effects have been reported in patients who have taken higher doses of hydroxyurea:
- infections of the skin and mucous membranes (inside the mouth, genitals, skinfolds)
- soreness, redness, swelling and peeling of skin on the palms and soles of feet
- changes in the colour of the skin
- mouth sores
Missed Dose
It you miss a dose of this medicine check with your doctor.
Side effects and what to do about them
As with all medicines, APO-HYDROXYUREA can cause side effects. These are not all the possible side effects that may be experienced when taking APOHYDROXYUREA. If you experience any side effects including some that are not listed here, contact your doctor.
- Rash, redness and ulceration in the face, skin or extremities.
- Skin or nail changes.
- Muscle aches and a general, unwell feeling or malaise.
- Fatigue.
Tell your doctor immediately if you have a high fever (≥39°C) within 6 weeks of taking APOHYDROXYUREA. The high fever can sometimes come with stomach, lung, muscle, liver, skin or heart problems.
APO-HYDROXYUREA can cause abnormal blood test results. Your doctor will decide when to perform blood tests. Your doctor will interpret the results.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and call your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Stomatitis (inflammation in or around the mouth): mouth sores, redness and swelling of the lining of the mouth | ✔ | ||
| Nausea | ✔ | ||
| Vomiting | ✔ | ||
| Diarrhea | ✔ | ||
| Constipation | ✔ | ||
| Cholestasis (decrease in flow of bile from the liver): dark urine, claycolored or white stools, itchiness, nausea, vomiting, inability to digest certain foods, pain in right upper part of the abdomen, yellow skin or eyes | ✔ | ||
| Hepatitis (inflammation of the liver): yellowing of the skin and eyes, feeling tired, stomach ache, fever, nausea, diarrhea, no appetite, fever, headaches | ✔ | ||
| Uncommon | |||
| Loss of appetite | ✔ | ||
| Joint pain | ✔ | ||
| Drowsiness: feeling abnormally sleepy or tired during the day | ✔ | ||
| Headache: pain and discomfort in the head, scalp, or neck | ✔ | ||
| Dizziness: feeling faint, woozy, weak or unsteady | ✔ | ||
| Disorientation: losing sense of orientation, may not know their location and identity, or the time and date | ✔ | ||
| Convulsions: sudden, violent, irregular movement of the body | ✔ | ||
| Hallucinations: seeing, feeling or hearing things that are not real | ✔ | ||
| Kidney problems: Bloody or discolored urine, or increase in frequency of urination and pain in the sides where the kidneys are located | ✔ | ||
| Rare | |||
| Diffuse pulmonary infiltrates/ fibrosis (when substances thicker than air, like pus, blood, or protein, remain in the lungs): dry painful cough, fever, difficulty breathing, fast shallow breathing | ✔ | ||
| Dyspnea (shortness of breath): intense tightening in the chest, difficulty breathing, feeling of suffocation | ✔ | ||
| Tumor lysis syndrome (the sudden, rapid death of cancer cells due to the treatment): lack of urination, severe muscle weakness, abnormal heartbeat, seizure | ✔ | ||
| Cutaneous vasculitis (inflammation of blood vessels of the skin): skin redness/purple coloration, tiny colored spots, sores, and/or ulcers, sometimes with joint pain and/or fever, death, if you have been or, are currently being, treated with interferon. | ✔ | ||
| Unknown | |||
| Interstitial lung disease (disorders that inflame or scar the lung tissue): shortness of breath when at rest, which gets worse with exertion; dry cough | ✔ | ||
| Systemic lupus (condition that occurs when your body’s immune system attacks your own tissues and organs): fever, joint pain, muscle pain; pain when breathing, sharp chest pain, bruising, tender red lumps usually on the shins, itchy red skin when exposed to light | ✔ | ||
| Cutaneous lupus (a form of systemic lupus that only affects the skin): scaly ring-like rash (redness with clear center), red patches on the skin, sensitivity to sunlight, rash on the face usually on cheeks and bridge of nose, ulcers in the mouth | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking APOHYDROXYUREA, contact your doctor or pharmacist.
How to store
APO-HYDROXYUREA should be stored at room temperature (15°C to 30°C). Protect from excessive heat and moisture.
Keep out of reach and sight of children.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
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
If you want more information about APOHYDROXYUREA:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://healthproducts.canada.ca/dpd-bdpp/index-eng.jsp). Find the Consumer Information on the manufacturer’s website http://www.apotex.ca/products, or by calling 1- 800-667-4708.
This leaflet was prepared by Apotex Inc., Toronto, Ontario, M9L 1T9.
Last Revised: October 7, 2020