Mylan-Etidronate: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

• treatment of symptomatic Paget’s disease of the bone

• short-term (30-90 days) maintenance of blood

  calcium levels following treatment with etidronate I.V Infusion for patients with hypercalcemia of malignancy (i.e. high blood calcium secondary to malignancy disease)

What it does:

To understand how the Mylan-etidronate therapy works, it is important to understand your bone health.

Bone is a living tissue that your body constantly renews. In this normal process, your body breaks down old bone tissue and replaces it with new bone. In Paget’s disease, this process is abnormal and accelerated. Etidronate acts on bones by slowing the abnormal and accelerated rate of bone turnover in Paget’s disease.

People with Paget’s disease can experience bone pain, bone deformity and vascular disorder (i.e blood vessel disorder associated with Paget’s disease). In research studies, Mylan-etidronate therapy improved Paget’s symptoms including the reduction of bone pain in patients with Paget’s disease.

Mylan-etidronate can also be used to treat hypercalcemia of malignancy or high blood calcium, which is a condition that occurs in 8-20% of patients with malignant diseases. By slowing the rate of bone turnover, Mylan-etidronate also reduces the release of calcium from the bones to the blood stream, which in turn reduces the blood calcium level to an acceptable level.

When it should not be used:

Mylan-etidronate is not suitable for everyone. Mylan-etidronate should not be used:

• If you have unresolved osteomalacia, which is a condition of inadequate or delayed bone mineralization (formation).
• If you are allergic to Mylan-etidronate and any of its ingredients (see below).

What the medicinal ingredient is:

Etidronate disodium

What the nonmedicinal ingredients are:

Corn starch, microcrystalline cellulose, magnesium stearate and pregelatinized starch

What dosage forms it comes in:

Mylan-etidronate (etidronate disodium) Tablet 200 mg is supplied as a white, rectangular-shaped biconvex tablet with “ED 200” on one side and “G” on the other.

WARNINGS AND PRECAUTIONS

BEFORE you use Mylan-etidronate talk to your doctor or pharmacist if:

• You have unresolved osteomalacia, which is a condition of inadequate or delayed bone mineralization (formation).
• You have problems with your kidneys, stomach or intestines

• You are pregnant or nursing.

• You are allergic to Mylan-etidronate and any of its ingredients

• You have one of the following risk factors:

  cancer; chemotherapy, radiotherapy of the head or neck, treatment with corticosteroids, or dental problems or dental infections. If so, a dental examination and any necessary dental procedures should be considered before you start treatment with Mylan-etidronate.

Be sure to tell your health care providers, including doctors and dentists, about all medicines you are taking, including Mylan-etidronate.

Patients with Paget’s disease of bone should maintain an adequate intake of calcium and vitamin D.

INTERACTIONS WITH THIS MEDICATION

If taken with some other medicines, the effects Mylan-etidronate or the effects of other medicines may be changed. Please check with your doctor or pharmacist before taking other medications with Mylan-etidronate.

Drugs that may interact with Mylan-etidronate include corticosteroid, phosphate, calcitonin, furosemide, warfarin or mithramycin.

To maximize the absorption, the following foods and medicines should not be taken within 2 hours of taking Mylan-etidronate: Antacids, vitamins with mineral supplements such as iron, calcium supplements, laxative containing magnesium and foods, especially food high in calcium, such as milk or milk products.

PROPER USE OF THIS MEDICATION

As with all medications, it is important to take as directed by your doctor.

Usual dose:

For Paget’s disease, the recommended initial dose of MYLAN-ETIDRONATE for most patients is 5 mg per kilogram of bodyweight per day, not to exceed a period of 6 months.

For hypercalcemia of malignancy, the recommended dose is 20 mg per kilogram of bodyweight per day for 30 days.

Overdose:

If you take too many tablets on any given day, contact your doctor or your regional Poison Control Centre immediately or go to the nearest emergency department.

Missed Dose:

If you miss a day (or more) of the treatment, do not take 2 tablets the same day. Take 1 tablet on the day you remember and continue with the therapy.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

With any medication, there is some chance of side effects. The most common side effects observed with Mylan-etidronate are nausea and diarrhea.

Rarely reported side effects include confusion, a burning sensation of the tongue, hair loss, and a sensation of numbness, prickling or tingling.

In patients with Paget’s disease, joint pain or new, increased or returning bone pain may occur. In some patients, the pain resolved while Mylan-etidronate was continued, but persisted for several months in others. On occasion, Mylan-etidronate may have to be stopped.

Opthalmologic

Ocular disturbances including conjunctivitis, uveitis, episcleritis, iritis and scleritis have been reported with bisphosphonate use. There have been published reports of conjunctivitis with etidronate. Patients with ocular events other than uncomplicated conjunctivitis should be referred to an ophthalmologist for evaluation. Treatment may need to be discontinued.

Atypical Subtrochanteric and Diaphyseal Femoral Fractures

Atypical, low-energy, or low trauma fractures of the femoral shaft have been reported in bisphosphonate-treated patients. These fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution. Atypical femur fractures most commonly occur with minimal or no trauma to the affected area. They may be bilateral and many patients report prodromal pain in the affected area, usually presenting as dull, aching thigh pain, weeks to months before a complete fracture occurs. Poor healing of these fractures was also reported. Any patient with a history of bisphosphonate exposure who presents with thigh or groin pain should be suspected of having an atypical fracture and should be evaluated to rule out an incomplete femur fracture. Patients presenting with an atypical femur fracture should also be assessed for symptoms and signs of fracture in the contralateral limb. Interruption of bisphosphonate therapy should be considered pending a risk/benefit assessment.

Very rarely patients have reported non-healing jaw wounds while receiving drugs in this class, such as Mylan-etidronate. Consult your doctor if you experience persistent pain in your mouth, teeth or jaw, or if your gums or mouth heal poorly.

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

HOW TO STORE IT

Store at room temperature (15 to 30°C). Keep out of reach of children.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada through the Canada Vigilance Program, collects information on serious and unexpected side effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:

By toll-free telephone: 866-234-2345 By toll-free fax: 866-678-6789 Online: www.healthcanada.gc.ca/medeffect By email: CanadaVigilance@hc-sc.gc.ca

By regular mail:

Canada Vigilance National Office

Marketed Health Products Safety and Effectiveness Information Division

Marketed Health Products Directorate

Health Products and Food Branch

Tunney’s Pasture, AL 0701E

Ottawa ON K1A 0K9

NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. 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:

Mylan Pharmaceuticals ULC, at:

1-800-575-1379

Mylan Pharmaceuticals ULC 85 Advance Road

Toronto, Ontario

M8Z 2S6

Last revised September 08, 2011