Etidronate: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Etidronate is used to treat Paget’s disease of bone. Paget's disease of bone is a chronic (long-term) disorder that typically results in enlarged and deformed bones.

Etidronate is also used to treat hypercalcemia (too much calcium in the blood) that may occur with some types of cancer.

What it does:

Etidronate Disodium acts primarily on bones by reducing normal and abnormal bone destruction. It works by preventing bone breakdown and increasing bone density (thickness).

When it should not be used:

• ETIDRONATE (etidronate disodium) (200 mg) as a

  single ingredient, should not be used for the management of osteoporosis.

• ETIDRONATE should not be used by patients who are

  hypersensitive to this drug or to any ingredient in the formulation or component of the container (see list of nonmedicinal ingredients at the end of this section). ③ ETIDRONATE is also contraindicated for patients with

  clinically overt osteomalacia (softness of the bones caused by deficiency of Vitamin D or abnormalities in metabolism of this vitamin); appropriate treatment to resolve your osteomalacia should be initiated by your doctor before prescribing ETIDRONATE.

What the medicinal ingredient is:

Etidronate Disodium

What the important nonmedicinal ingredients are:

Magnesium stearate, microcrystalline cellulose, maize starch and pregelatinised maize starch

What dosage forms it comes in:

ETIDRONATE is available in 2 strengths, namely: tablets 200 mg and 400 mg.

WARNINGS AND PRECAUTIONS

BEFORE you use ETIDRONATE talk to your doctor or pharmacist if:

$ you have ever had any unusual or allergic reaction to etidronate. Also tell your doctor if you are allergic to any other substances, such as foods, preservatives, or dyes.

$ and how you should maintain an adequate nutritional status, and particularly, an adequate intake of calcium and vitamin D. Patients with restricted Vitamin D and calcium intake may be particularly sensitive to drugs that affect calcium homeostasis (regulation of calcium levels in the blood and tissues) and should be closely followed while under treatment with ETIDRONATE.

$ you are pregnant or thinking about becoming pregnant, or if you are breast feeding.

$ you have any other medical problems, especially:

$ bone fracture, as etidronate may increase the risk of bone fractures,

$ intestinal or bowel disease, as etidronate may increase the risk of diarrhea,

$ kidney disease, as high blood levels of etidronate may result causing serious side effects.

It is important that your doctor check your progress at regular visits even if you are between treatments and are not taking this medicine. If your condition has improved and your doctor has told you to stop taking etidronate, your progress must still be checked. The results of laboratory tests or the occurrence of certain symptoms will tell your doctor if more medicine must be taken. Your doctor may want you to begin another course of treatment after you have been off the medicine for at least 3 months.

If this medicine causes you to have nausea or diarrhea and it continues, check with your doctor. The dose may need to be changed.

If bone pain occurs or worsens during treatment, check with your doctor.

Osteonecrosis of the jaw (ONJ) is a rare condition that involves the loss, or breakdown of the jaw bone. ONJ has been reported in patients with cancer receiving treatment regimens including bisphosphonates. While on treatment with Etidronate (a bisphosphonate), patients should:

• remember that bisphosphonates have been have been linked to jaw and dental problems and report any symptoms of pain, swelling, gum infections, loosening of teeth, poor healing of gums after dental work and numbness or feeling of heaviness in the jaw to your doctor.
• Consult your doctor if you need major invasive dental

treatments (excluding regular dental cleaning) while you are taking ETIDRONATE

• Always let your dentist know that you are taking

  ETIDRONATE

• If you can, have a dental check up and any treatment you

  need before you start taking ETIDRONATE.

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with ETIDRONATE include:

• Antacids containing calcium, magnesium, or

  aluminum or

• Mineral supplements or other medicines containing

  calcium, iron, magnesium, or aluminum- These medicines may decrease the effects of etidronate, and should be taken at least 2 hours before or after taking etidronate.

• Food containing calcium, milk and milk products –

  Avoid taking these within two hours of dosing to maximize absorption.

PROPER USE OF THIS MEDICATION

Administration

ETIDRONATE (etidronate disodium) should be taken on an empty stomach as a single oral daily dose, at least two hours before or after meals with a full glass of water. However, should gastrointestinal discomfort occur, the dose may be divided.

Usual dose:

Paget's Disease

Adults-dose is based on body weight and must be determined by your doctor. The dose to start is 5 milligrams (mg) per kilogram (kg) of body weight a day, usually as a single dose, for not more than six months. Some people may need 6 to 10 mg per kg of body weight a day for not more than six months. Others may need 11 to 20 mg per kg of body weight a day for not more than three months. Your doctor may change your dose depending on your response to treatment.

Hypercalcemia (too much calcium in the blood)

Adults-dose is based on body weight and must be determined by your doctor. The usual dose is 20 mg per kg of body weight a day for thirty days. Treatment usually does not continue beyond ninety days.

Overdose:

Contact your doctor or nearest hospital emergency department, even though you may not feel sick

Missed Dose:

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these effects may occur, if they do occur they may need medical attention.

The most common side effects include diarrhea and loose bowel movement and may occur in patients when etidronate disodium is administered at doses greater than 5mg/kg/day.

These side effects may go away during treatment as your body adjusts to the medicine. Other side effects may occur that usually do not need medical attention.

This is not a complete list of side effects. For any unexpected effects while taking ETIDRONATE, contact your doctor or pharmacist.

HOW TO STORE IT

ETIDRONATE should be stored at room temperature between 15 - 30EC.

Keep ETIDRONATE out of the reach of children.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

---------------------------------------------------------------------------- $ Report online at www.healthcanada.gc.ca/medeffect $ Call toll-free at 1-866-234-2345

$ Complete a Canada Vigilance Reporting Form and:

• Fax toll-free to 1-866-678-6789, or

• Mail to: Canada Vigilance Program Health Canada

  Postal Locator 0701C

  Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Cobalt Pharmaceuticals Inc., at: 1-866-254-6111

Cobalt Pharmaceuticals Inc. 6500 Kitimat Road Mississauga, Ontario.L5N 2B8 Canada

Last revised: March 26, 2010