Details for: CLASTEON
Company: SUNOVION PHARMACEUTICALS CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02245828 | CLASTEON | CLODRONATE DISODIUM | 400 MG | CAPSULE | ORAL |
Summary Reports
Summary Safety Review - Bisphosphonates - Assessing the Risk of Jaw Bone Loss (osteonecrosis of the jaw)
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
- As an additional therapy in the management of bone destruction resulting from cancerous tumours.
- Management of abnormally high blood calcium levels caused by cancer.
What it does
CLASTEON belongs to a class of compounds known as bisphosphonates which act to reduce the rate of removal and replacement of bone tissue. In certain cancers, there is a greater breakdown of bone than there is new production which is called osteolysis. This can be accompanied by an increased release of calcium into the blood which is called hypercalcemia. CLASTEON attaches specifically to bone and effectively prevents osteolysis. In cases where there is bone breakdown and an increased release of calcium into the blood, CLASTEON effectively reduces high calcium blood levels hence preventing or delaying some of the consequences of hypercalcemia. Although effective in the treatment of osteolysis and hypercalcemia of malignancy, the use of CLASTEON will not provide a cure for cancer.
When it should not be used
Before taking your medicine:
- Do you have any kidney problems?
- Are you pregnant or breast feeding?
- Do you have stomach pain or a bowel disturbance?
- Have you been allergic to clodronate and/or bisphosphanates or the nonmedicinal ingredients (see what the important nonmedicinal ingredients are) before?
If the answer is YES to any of these questions, do not take this medicine until you have talked to your doctor about it.
What the medicinal ingredient is
clodronate disodium
What the non-medicinal ingredients are
Gelatin, indigotin, magnesium stearate, maize starch, sodium starch glycota, talc, titanium oxide
What dosage form it comes in
The blue and white gelatin form is supplied in 400 mg capsules. Packs of 120 capsules contain 12 full aluminum blister strips of 10 capsules each.
Warnings and precautions
BEFORE you use CLASTEON, talk to your doctor or pharmacist if you:
- have sores in the mouth. This can lead to osteonecrosis of the jaw.
Your doctor may check if you:
- smoke
- have or have had teeth and/or gum disease
- have dentures that do not fit well
- have other relevant medical conditions at the same time such as a low red blood cell count (called anemia) or if your blood cannot form clots in the normal way.
Your doctor may tell you to stop taking CLASTEON until all sores in your mouth are healed.
Drugs like CLASTEON may cause problems in your esophagus (i.e., the tube connecting the mouth and the stomach), stomach and intestines, including ulcers. Before you use CLASTEON, talk to your doctor or pharmacist if you have had problems or disease in your esophagus (i.e., the tube connecting the mouth and the stomach), stomach or intestines.
Drugs like CLASTEON can cause eye disorders and infections.
CLASTEON can cause breathing difficulties in patients with asthma who are allergic to acetylsalicylic acid (ASA) that may be severe.
Oral hygiene is very important for patients living with cancer. Some patients have experienced problems with their jaw bones while being treated with drugs like CLASTEON. Please talk to your doctor before undergoing invasive dental procedures such as tooth extractions or when you experience pain in your jaw or poor wound healing in your mouth.
CLASTEON can cause a broken leg or a thigh bone.
When you take CLASTEON, your kidneys may not work as well or they may stop working. This is called kidney failure.
Interactions with this medication
Before starting treatment with CLASTEON, talk to your doctor about any other medications that you are using or intending to use. It is especially important that your doctor knows that you are being treated with:
- another bisphosphonate (such as alendronate, risedronate, etidronate, pamidronate or zoledronic acid)
- phosphate
- calcitonin
- calcium tablets
- vitamin supplements
- mithramycin
- thiazides
- aminoglycosides
- corticosteroids
- NSAIDS (non-steroidal anti-inflammatory drugs)
- antacids
- any drug containing iron, magnesium or aluminum
- estramustine phosphate
Proper use of this medication
Things to remember:
- Take your medicine as advised by your doctor and carefully read the label.
- Please do not take this medicine with milk.
- This medicine has been prescribed for your current medical problem. Do not give it to other people.
Usual adult dose
Your doctor will tell you how much CLASTEON to take each day. The dosage is prescribed to suit your particular needs. The doctor will also tell you how to divide your dosage through the day. For example, he or she might prescribe a total dosage of 1600 mg per day, to be taken as one or two equally divided doses. Therefore, you must take the exact amount which has been prescribed for you.
The success of the treatment with CLASTEON depends on how CAREFULLY and consistently you follow the doctor’s instructions about taking CLASTEON.
Follow instructions exactly and ask your doctor or hospital pharmacist if you are unsure. It is very important not to miss any of the tests which your doctor orders, including blood tests and tests to determine the function of your kidneys.
Based on blood tests and other tests, your doctor might make changes in the amount of CLASTEON you must take. NEVER MAKE CHANGES ON YOUR OWN.
Always take your medication on time and never allow your medication to run out. If you plan a holiday, please remember to take enough supplies to cover your needs.
Pay close attention to the amount of drug you are taking. Make sure it is the amount your doctor has prescribed for you.
These instructions should be followed exactly, because the success of your treatment depends very much on how carefully you follow your doctor’s instructions.
Your dose of CLASTEON capsules, to be taken once or twice daily, simply consists of removing the number of capsules that are required to make up the dose that your physician has prescribed for you. Swallow the capsules whole, with liquid (except milk). You should not lie down for at least 30 minutes after taking the medication. Do not take the capsules with food or within one hour before or after food or milk. Please take the capsules even if you are not eating at present.
Please DO NOT take CLASTEON capsules with milk. If CLASTEON is taken with drinks containing milk, it is more difficult for the medicine to enter the blood and so it is not as effective. For the same reason, DO NOT take CLASTEON with antacid indigestion tablets or mineral supplements as these may also make the medicine less effective.
Missed Dose
If you forget to take a scheduled dose, most doctors will suggest that you take it at the time you remember and then go on with your normal schedule. (Check with your doctor to see if this procedure is acceptable).
Side effects and what to do about them
Like all medicines, CLASTEON may have, in addition to its beneficial effects, some unwanted effects.
The most common side effects are associated with the digestive system and include nausea and diarrhea.
Drug related allergies such as skin rashes have been reported less commonly.
Other side effects not listed above may also occur in some patients. If you notice any other effects, tell your doctor immediately.
CLASTEON can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Nausea | ✔ | ||
| Diarrhea | ✔ | ||
| Loss of Appetite | ✔ | ||
| Uncommon | |||
| Allergic reactions (i.e skin rashes) | ✔ | ||
| Mouth pain | ✔ | ||
| Very Rare | |||
| Abnormal thigh bone fractures | ✔ | ||
| Ear pain, discharge from the ear, and/or an ear infection. These could be signs of bone damage in the ear. | ✔ | ||
| Unknown | |||
| Difficulty breathing with wheezing or coughing in asthma patients who are allergic to acetylsalicylic acid | ✔ | ||
| Jaw problems: mouth or gums heal poorly after dental work such as pulling a tooth
Ongoing infections Pain in the mouth |
✔ | ||
| Eye disorders and infections: redness, irritation, swelling | ✔ | ||
| Severe bone, joint, and/or muscle pain (the onset of symptoms varied from days to several months after starting CLASTEON) | ✔ | ||
| Severe kidney damage (especially after rapid intravenous infusion of high doses of clodronate) | ✔ | ||
| Problems in your esophagus (i.e., the tube connecting the mouth and the stomach), stomach and intestines | ✔ | ||
Please consult your doctor prior to dental procedures (except dental cleaning) such as tooth extractions and dental surgery. Movable dentures should fit properly and be removed at night.
This is not a complete list of side effects. For any unexpected effects while taking CLASTEON, contact your doctor or pharmacist.
How to store
CLASTEON capsules should be stored at room temperature (15-30˚C) and should be protected from high humidity.
Keep out of reach of children.
Reporting 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: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness
Information Division
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.
More information
This document plus the full product monograph, prepared for health professionals can be found at: www.sunovion.ca
or by contacting the sponsor, Sunovion Pharmaceuticals Canada Inc. at: 1-866-260-6291
This leaflet was prepared by Sunovion Pharmaceuticals Canada Inc., 6790 Century Ave., Mississauga, ON, Canada L5N 2V8
Licensed by ABIOGEN PHARMA S.p.A ITALY
Last revised: September 12, 2017