Patient Medication Information: uses, side effects, how to take - Zometa Lyophilized Powder

ABOUT THIS MEDICATION

Please read this information carefully before starting treatment with ZOMETA (zoledronic acid for injection). If you have further questions, ask your doctor, pharmacist or nurse.

What the medication is used for:

ZOMETA contains an active ingredient called zoledronic acid. It is available as a powder or concentrate in vials. One vial contains 4 mg of zoledronic acid. ZOMETA is given as a 15-minute infusion into a vein after appropriate dilution.

ZOMETA is used:

1) to reduce the abnormal amount of calcium in the blood for example, in the presence of a tumor. This is because tumors can accelerate normal bone change in such a way that the release of calcium from bone is increased. This condition is known as tumor-induced hypercalcemia.
2) to prevent or delay skeletal complications for example, fractures of the bone and bone pain requiring surgery or radiotherapy, due to bone metastases (cancer that has spread from the tumor to the bone) due to different types of tumors.

What it does:

ZOMETA is a new and highly potent member of a group of substances called bisphosphonates. These strongly bind to the bone and slow down the rate of bone change. In addition, ZOMETA may prevent bone destruction and uncontrolled bone growth associated with the tumor spreading to the bone.

When it should not be used:

You should not be given ZOMETA if you are pregnant or breast-feeding or if you have previously had an allergic reaction to ZOMETA, another bisphosphonate (the group of substances to which ZOMETA belongs) or to any other ingredient contained in the formulation (see What the important non medicinal ingredients are).

What the medicinal ingredient is:

Zoledronic acid.

What the important non medicinal ingredients are:

Mannitol and sodium citrate.

What dosage forms it comes in:

ZOMETA is available in two dosage forms: ZOMETA lyophilized powder and ZOMETA concentrate. Each vial of ZOMETA lyophilized powder or ZOMETA concentrate delivers 4 mg of zoledronic acid. It is available in cartons containing 1 vial.

WARNINGS AND PRECAUTIONS

Before starting treatment with ZOMETA

Be sure that you have discussed ZOMETA treatment with your doctor. You may only be given ZOMETA after a full medical examination. Your doctor may also request a dental examination with any necessary preventive dentistry carried out prior to treatment with ZOMETA. This may be required since some patients have experienced side effects following dental procedures (such as tooth extraction) while on ZOMETA; as well since patients with dental infections or periodontal disease (disease affecting surrounding tissues of a tooth) may be at increased risk of problems with their jaw bones following dental procedures (such as tooth extraction) while on treatment with ZOMETA (see SIDE EFFECTS AND WHAT TO DO ABOUT THEM)

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

if you have a kidney problem.
if you have a liver problem.
if you are or think you may be pregnant (see above and below).
if you are breast-feeding (see above and below). ③ if you have asthma and are also allergic to acetylsalicylic acid (ASA).
if you had or have a heart problem.
if you have any dental problems or any dental procedures planned in the future.

After starting treatment with ZOMETA

It is important that your doctor checks your progress at regular intervals. He or she may want to take repeated blood tests, especially after starting your treatment with ZOMETA. He or she may also suggest regular dental examinations.

If possible, you should not undergo tooth extraction or other dental procedures (excluding regular dental cleaning) while you are receiving treatment with ZOMETA. Please consult your doctor if a dental procedure (excluding regular dental cleaning) is required while you are receiving treatment with ZOMETA.

Pregnancy

You should tell your doctor if you are pregnant or planning to become pregnant. ZOMETA should not be given during pregnancy.

Breast-feeding

ZOMETA should not be given if you are breast-feeding.

Driving and using machines

The effects of ZOMETA on driving, using machines and performing other tasks that need your full attention have not been studied. You should therefore be careful when carrying out such activities.

Use in Children

So far children have not been treated with ZOMETA. Until further experience is gained, ZOMETA can only be recommended for use in adult patients.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor about any other medicines you are taking or have recently been taking, including any you have bought without a prescription. It is particularly important that your doctor knows if you are also taking aminoglycosides (a type of medicine used to treat severe infections), since the combination of these with bisphosphonates may cause the calcium level in the blood to become too low. Examples of aminoglycosides include gentamycin sulfate, tobramycin sulfate and streptomycin sulfate. It is also important to inform your doctor if you are taking any drugs that can have an effect on the kidney, since combining these drugs with ZOMETA may cause kidney function to deteriorate. Some examples of these drugs include acetylsalicylic acid (ASA), nonsteroidal anti-inflammatories (e.g. ibuprofen, diclofenac, celecoxib), diuretics, and Angiotensin-Converting Enzyme (ACE) inhibitors (e.g. enalapril, ramipril, fosinopril).

PROPER USE OF THIS MEDICATION

Usual dose:

ZOMETA is given by an infusion into a vein which should last no less than 15 minutes. The dose is usually 4 mg. If you have a kidney problem, your doctor may give you a lower dose depending on the severity of your kidney problem.

If you are being treated for multiple myeloma or bone metastases of solid tumors, you will be given one infusion of ZOMETA every three to four weeks. If you require antineoplastic therapy (therapy that blocks the growth of cancer cells), ZOMETA should be administered either prior to or after this treatment. You will also be asked to take an oral calcium supplement of 500 mg and a multivitamin containing at least 400 IU of Vitamin D daily. If you have a prior history of hypercalcemia or develop hypercalcemia during treatment with calcium and Vitamin D, you may be advised to discontinue taking calcium and Vitamin D supplements by your doctor.

Your doctor will decide how many infusions you need and how often you should receive them.

If you are being treated for Tumor-Induced Hypercalcemia (TIH), you will normally only be given one infusion of ZOMETA.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, ZOMETA may have, in addition to its beneficial effects, some unwanted effects. These are usually mild and will probably disappear after a short time. The most common side effect is short-lasting fever. Occasionally, patients experience a flu-like condition including fever, fatigue, and chills. In some patients, these symptoms may also be accompanied by bone, joint and/or muscle ache. In most cases, no specific treatment is required and the symptoms subside after a couple of hours or days.

Gastrointestinal reactions such as nausea, vomiting and thirst have been reported occasionally, as well as loss of appetite.

Skin reactions (redness and swelling) at the infusion site may occur.

Rare cases of rash, itching and chest pain have been observed.

Blood tests indicating worsening of kidney function (higher levels of creatinine) have been reported with ZOMETA; such changes are also known to occur with other drugs of the bisphosphonate class. Your doctor will carry out blood tests to monitor your kidney function prior to each dose of ZOMETA. If these tests indicate worsening of kidney function, your doctor will withhold further treatment with ZOMETA until these tests have returned to normal.

The level of calcium, phosphate and/or magnesium in the blood may become too low, but your doctor will monitor this and take necessary measures.

Other bisphosphonates can cause breathing difficulties in patients with asthma who are allergic to aspirin. This has not been reported with ZOMETA, in studies done to date.

Eye pain, redness, photophobia (sensitivity to light), excessive tearing or decreased vision should be reported to your physician as they may indicate more serious eye complications which have been associated with ZOMETA.

Some patients have reported problems with their jaw bones while receiving cancer treatments that include ZOMETA. Dental hygiene is an important element of your overall cancer care and is important in possibly decreasing the chances of this type of problem occurring. Removable dentures should fit properly and should be removed at night. Please consult with your doctor if you experience pain in your mouth, teeth or jaw, or if your gums or mouth heals poorly. Any non-healing of a dental extraction site or chronic dental infection should be reported and assessed. In addition, if possible you should not undergo tooth extraction or other dental procedures (excluding regular dental cleaning) while on therapy with ZOMETA. Please consult your doctor if a dental procedure (excluding regular dental cleaning) is required while you are receiving treatment with ZOMETA.

Other side effects not listed above may also occur in some patients.

If you notice any other effects, tell your doctor immediately.

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN

AND WHAT TO DO ABOUT THEM

Symptom / effect

Talk with your

Your

doctor or

medication

pharmacist

should be

Only if

severe

In all cases

withheld

or stopped.

Talk with

your

doctor.

Common

Worsening of

√

kidney function

(higher levels of

creatinine)

Eye disorders (eye

redness, excessive

tearing)

Uncommon

Kidney failure

√

(changes in urine

color or absence of

urine production,

changes in kidney

function laboratory

tests, lower back

pain, fatigue,

nausea, loss of

appetite)

Eye disorders (eye

pain, light

sensitivity, or

decreased vision)

Allergic reaction to

ZOMETA

(swellin

of the face, eyes or

tongue, difficulty

breathing, hives,

rash, sudden onset

of low blood

pressure)

Dizziness

Rare

Osteonecrosis of th

√²

jaw

(numbness or

feeling of heaviness

in the jaw, poor

healing of the gums

especially after

dental work, pain in

the mouth, teeth or

jaw, swelling or

gum infections) ¹

¹While this is a serious side effect, it is not possible to determine if these events ar

related to ZOMETA or other bisphosphonates, to concomitant drugs or other therapie

(e.g. chemotherapy, head and neck radiotherapy, corticosteroid or to other risk factor

(e.g. anemia, infection, pre-existing oral disease). ²There are no data available t

suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ

REPORTING SUSPECTED 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:

http://www.novartis.ca

or by contacting the sponsor Novartis Pharmaceuticals Canada Inc, at: 1-800-363-8883

Rx or OTC	Prescription (Rx)?
DIN	02242725
Schedule(s)	PRESCRIPTION
Active ingredient(s)	Zoledronic acid (zoledronic acid monohydrate) 4 MG
Dosage form(s)	Powder For Solution
Route(s) of administration	Intravenous
Drug class (WHO ATC)	M Musculo-skeletal system drugs M05 Drugs for treatment of bone diseases M05B Drugs affecting bone structure and mineralization M05BA Bisphosphonate drugs affecting bone structure and mineralization M05BA08 Zoledronic acid
Company	NOVARTIS PHARMACEUTICALS CANADA INC
Current status	Cancelled Post Market
Current status date	October 31, 2008

Zometa Lyophilized Powder: Uses, Side Effects and Dosage