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Do not use ZOMETA if you have had a severe allergic reaction to zoledronic acid or any components of ZOMETA. These reactions, including rare cases of hives and angioedema (swelling often near your eyes and lips), and very rare cases of life-threatening allergic reactions, have been reported. ZOMETA is in a class of drugs called bisphosphonates, and contains the same active ingredient as that found in Reclast® (zoledronic acid). If you are treated with ZOMETA, you should not be treated with Reclast.
If you have HCM, you should drink plenty of clear fluids before using ZOMETA. If you have kidney problems, tell your doctor. The risk of adverse reactions (especially related to the kidney) may be greater for you. ZOMETA treatment is not for patients with severe kidney problems. Patients with kidney problems on multiple cycles of ZOMETA or other bisphosphonates are at greater risk for further kidney problems. It is important to get your blood tests while you are receiving ZOMETA. Your doctor will monitor your kidney function before each dose. Tell your doctor if you are on other drugs, including aminoglycosides, loop diuretics, and drugs which may be harmful to the kidney.
Osteonecrosis of the jaw (ONJ) has been reported mainly in cancer patients treated with intravenous bisphosphonates, including ZOMETA. Many of these patients were also receiving anti-cancer drugs and corticosteroids, which may make it more likely to get ONJ. If you have advanced breast cancer or a type of cancer called multiple myeloma, or if you have had dental extraction, periodontal disease, local trauma, including poorly fitting dentures, you may be at greater risk of getting ONJ. Many reports of ONJ involved patients with signs of local infection, including bone/bone marrow inflammation. You should maintain good oral hygiene and have a dental examination with preventive dentistry prior to beginning ZOMETA. While on treatment, avoid invasive dental procedures, if possible, as recovery may take longer. If you develop ONJ while on bisphosphonate therapy, dental surgery may worsen the condition. If you require dental procedures, there are no data available to suggest whether stopping ZOMETA treatment reduces the risk of ONJ. A causal relationship between bisphosphonate use and ONJ has not been established. Based on your condition, your doctor will determine the treatment plan you will receive.
Do not use ZOMETA if you are pregnant or plan to become pregnant, or if you are breast-feeding.
Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates, including ZOMETA. Do not continue using ZOMETA if severe symptoms develop, as some patients had the symptoms reappear after taking ZOMETA or another bisphosphonate again. In aspirin sensitive patients, bronchoconstriction (tightening of the airways in the lungs) has been observed while taking bisphosphonates.
If you are an HCM patient with liver problems, talk to your doctor about whether ZOMETA is appropriate for you.
HCM patients may experience flu-like symptoms (fever, chills, flushing, bone pain and/or joint or muscle pain). Common side effects in HCM patients include fever, nausea, constipation, anemia, shortness of breath, diarrhea, abdominal pain, worsening of cancer, insomnia, vomiting, anxiety, urinary tract infection, low phosphate levels, confusion, agitation, a fungal infection called moniliasis, low potassium levels, coughing, skeletal pain, low blood pressure, and low magnesium levels. Redness and swelling may occur at the site that you are injected.
Common side effects for patients with multiple myeloma and bone metastases due to solid tumors include bone pain, nausea, fatigue, anemia, fever, vomiting, constipation, shortness of breath, diarrhea, weakness, muscle pain, anorexia, cough, joint pain, lower-limb swelling, worsening of your cancer, headache, dizziness (excluding vertigo), insomnia, decreased weight, back pain, numbness/tingling, and abdominal pain. These side effects are listed regardless of any potential association with the medications used in registration studies of ZOMETA in bone metastases patients.
Eye-related side effects may occur with bisphosphonates, including ZOMETA. Cases of swelling related to fluid build-up in the eye, as well as inflammation of the uvea, sclera, episclera, conjunctiva, and iris of the eye have been reported.
Patients with multiple myeloma and bone metastases from solid tumors should be taking an oral calcium supplement of 500 mg and a multiple vitamin containing 400 IU of vitamin D daily.
Please see full Prescribing Information and talk to your doctor for more information.
Prostate cancer that spreads to the bones can lead to symptoms including spinal cord compression, and hypercalcemia—ZOMETA may reduce or delay bone complications and treat hypercalcemia of malignancy.
Diagnosis of Bone Metastases
Several procedures may be used to detect bone metastases. A bone scan—often the first method of checking for bone metastases—may be followed by other testing, including X-rays, an MRI, or PET scans.
In solid tumors, such as prostate cancer, there is the chance that the cancer will become advanced and spread to the bone. In prostate cancer, the most common site of a recurrence is the bone. In fact, 65% to 75% of prostate cancer recurrences are in the bone. While this can be frightening, it may help you to understand how bone metastasis damages bones, the symptoms it may cause, as well as diagnostic procedures and treatment.
How Bone Metastases Damage Bone
Imagine that your bones are a house that is under construction. It is being rebuilt with 2 teams of workers. One team takes down the old walls. A second team puts up new walls in their place. When these 2 teams work together, the house remains intact.
Similiarly, bone is constantly renewed through a two-part process called remodeling. This process consists of resorption and formation. During resorption, old bone tissue is broken down and removed by special cells called osteoclasts. During bone formation, new bone tissue is built up to replace the old.
When the 2 housebuilding teams stop working together, the house becomes structurally unsound. One team works too much and makes holes in the walls. The second team also starts to work too much, but it builds walls in the wrong places.
Bone metastases are similar. When the 2 teams of cells go out of balance, the osteoclasts wear away portions of bone‚ leaving small holes called osteolytic bone lesions. This wearing away process causes damaged bone to appear as circular‚ punched out areas. It leaves bones weak and fragile.
Bone metastases can also cause abnormal bone formation. This happens when the osteoblasts build up new areas of bone where they’re not needed. These areas are called osteoblastic bone lesions.
Symptoms of Bone Metastases
Bone pain is usually the earliest symptom of bone metastases, so it's important to pay attention to how your bones feel. Tell your doctor about any pain you feel, even if you think it might be due to some other problem, such as arthritis or stiffness from lack of activity or a muscle pull or strain. Sometimes, a fracture is the first sign of bone damage.
- Bone fractures—As cancer weakens the bones, the risk of fractures increases. The long bones of the arms and legs, as well as the spine, are common sites of fractures.
- Spinal cord compression—Cancer on your spine—or backbone—can put pressure on the spinal cord and cause intense back pain. Damage to the nerves in the spinal cord can eventually cause paralysis and changes in bladder function.
- Hypercalcemia—When bones release calcium into the bloodstream in amounts that are dangerous, hypercalcemia is the result. This condition may occur with bone metastases due to excessive bone loss. Symptoms of hypercalcemia include nausea, vomiting, heart palpitations, loss of appetite, and fatigue.
Be sure to talk to your doctor if you develop bone pain or notice any other symptoms that are unusual for you. Print questions you may wish to ask your doctor about cancer and bone health.
Treatment for Patients with Bone Metastases
ZOMETA is a treatment for patients with breast cancer, prostate cancer*, lung cancer, and other solid tumors that have spread to the bones. Prostate cancer should have progressed after treatment with at least one hormonal therapy before therapy with ZOMETA.
ZOMETA may reduce or delay bone fractures or pressure on the spinal cord that can result from bone damage due to advanced prostate cancer. ZOMETA can still help patients who already have experienced bone complications. ZOMETA is not chemotherapy and may be used with other standard cancer treatments, such as radiation, hormonal therapy, or chemotherapy.
ZOMETA is a 15-minute infusion given every 3 to 4 weeks in a doctor's office or at a clinic.
Do not use ZOMETA if you have had a severe allergic reaction to zoledronic acid or any components of ZOMETA.
Ask your doctor about ZOMETA and see if ZOMETA may be right for you.
