Consumer Information for: ZOLEDRONIC ACID FOR INJECTION

Like all medicines, Zoledronic Acid for Injection 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. Patients may experience a flu-like condition including fever, fatigue, weakness, drowsiness and chills. In some patients, these symptoms may also be accompanied by bone, joint and/or muscle ache, arthritis and joint swelling. In most cases, no specific treatment is required and the symptoms subside after a couple of hours or days. Other common side effects include gastrointestinal problems such as nausea, vomiting and thirst as well as swelling of sores inside the mouth and loss of appetite.

Occasionally, skin reactions (redness and swelling) at the infusion site may occur. Cases of low blood pressure have also occasionally been reported; in very rare cases, this resulted in fainting.

Rare cases of rash, itching, chest pain, swelling mainly of the face and throat, high level of potassium and sodium in the blood, slow heartbeat, confusion and a disorder of the kidney function called Fanconi syndrome have been observed.

Very rare cases of severe bone, joint, and/or muscle pain, occasionally incapacitating, as well as sleepiness, irregular heart beat (atrial fibrillation), difficulty breathing with wheezing or coughing, lung disease, severe allergic reaction and itchy rash have also been reported.

Reduced levels of calcium in the blood (hypocalcaemia), sometimes leading to muscle cramps, dry skin or burning sensation, have been reported in patients treated with zoledronic acid. Irregular heart beat has also been reported. There have been reports of abnormal electrical signals of the heart called “prolongation of the QT interval”, seizures, numbness, spasm and twitching caused by severely reduced levels of calcium in the blood. In some instances, the reduced calcium level may be lifethreatening and require hospitalization. If any of these apply to you, tell your doctor right away.

Blood tests indicating worsening of kidney function (higher levels of creatinine) including severe kidney failure have been reported with zoledronic acid; 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 Zoledronic Acid for Injection. If these tests indicate worsening of kidney function, your doctor will withhold further treatment with Zoledronic Acid for Injection 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 acetylsalicylic acid (ASA). This has not been reported with zoledronic acid, 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 zoledronic acid.

Some patients have reported problems with their jaw bones while receiving cancer treatments that include zoledronic acid. 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 Zoledronic Acid for Injection. Please consult your doctor if a dental procedure (excluding regular dental cleaning) is required while you are receiving treatment with Zoledronic Acid for Injection.

Some patients have reported problems with other bones, other than their jaw bones, while on treatment with Zoledronic Acid for Injection. Consult your doctor if you had or have aches and pains and difficulty in movement of your thighs, hips, upper arms, lower legs, ribs, backbone, knees, or feet bones, or if you experience pain around your ears.

Unusual fracture of the thigh bone may occur while receiving treatment with Zoledronic Acid for Injection. Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early sign of a possible fracture of the thigh bone.

The frequency with which these side effects may occur cannot be reliably estimated.
This is not a complete list of side effects. If you have any unexpected effects after receiving Zoledronic Acid for Injection, contact your doctor or pharmacist.