Do not use ZOMETA (zoledronic acid) 4 mg/5 mL Injection 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.
Report any hip, thigh, or groin pain to your doctor, as unusual thigh bone fractures have been reported in patients receiving bisphosphonates, including ZOMETA. These fractures may occur with little or no trauma. It is unknown whether the risk of fracture continues after stopping therapy.
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.
Multiple myeloma can dissolve portions of bones, which can lead to symptoms including bone pain, fractures, and hypercalcemia—ZOMETA (zoledronic acid) 4 mg/5 mL Injection may reduce or delay bone complications and treat hypercalcemia of malignancy. ZOMETA does not treat bone pain.
Multiple myeloma is a cancer of the plasma cells in bone marrow. Plasma cells are a type of white blood cells and they are part of the body's immune system. When they are normal, plasma cells help the body fight disease and infections by producing proteins called antibodies.
In multiple myeloma, plasma cells become abnormal. Myeloma cells may cause the solid part of the bone to dissolve, making bones susceptible to fractures (breaks) and other skeletal problems.
When myeloma cells grow uncontrolled, they can cause health problems that may affect the bones, kidneys and red blood cell count. They can also inhibit the immune system's ability to fight off infections by interfering with the body's production of normal antibodies.
The cause of multiple myeloma is unknown, but researchers have identified the following risk factors for the disease:
- Age: Most people with multiple myeloma are over 65
- Race: African Americans have the highest risk; Asian Americans have the lowest
- Sex: Men are more likely to be diagnosed with multiple myeloma
- Family history: People with a close family member with the disease have an increased risk
- History of a condition called MGUS: Having MGUS (monoclonal gammopathy of undetermined significance) increases the likelihood of developing certain cancers, such as multiple myeloma
Myeloma Cells Collect in Bone Marrow
In people with multiple myeloma, abnormal plasma cells build up in places in the bone marrow that's normally active in adults. Bone marrow is a spongy network of tissue that fills the center of most bones. The bones most commonly affected are the bones of the spine, skull, pelvic bones, the rib cage and the bones around the shoulders and hips. Usually, multiple myeloma does not affect the bones of the arms, legs, hands, or feet.
Cancerous plasma cells‚ or myeloma‚ in the bone marrow can form plasma cell tumors that spread to the bone's outer covering. This occurs in 70% to 95% of patients with multiple myeloma.
Myeloma Cells Can Cause Bone Damage
Eventually, the myeloma cells wear away portions of bone, leaving small holes called osteolytic lesions. This can lead to symptoms that include bone pain, typically in the back and ribs, and broken bones, especially in the spine. You may also feel fatigued or weak, develop frequent infections, or lose weight. Other signs of this disease include thirst and frequent urination.
Common Side Effects from ZOMETA
ZOMETA has potential side effects. Common side effects 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.
It is important to keep up with your fluid intake while on ZOMETA therapy. Signs and symptoms of low fluid intake include thirst, sagging skin, low urine output, and dry mouth. Be sure to drink plenty of water or other fluids.
How Multiple Myeloma Damages Bone
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.
This wearing away process causes eroded bone to appear as circular, punched out areas. It leaves bones weak and fragile.
Symptoms of Multiple Myeloma
Bone pain, usually in the lower back or ribs, is a common early symptom of multiple myeloma, 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.
- 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 multiple myeloma and bone health.
Identification of Bone Lesions
Several procedures may be used to detect bone lesions from multiple myeloma. 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.
Treatment for Patients with Multiple Myeloma
ZOMETA is a treatment for multiple myeloma that may reduce or delay bone problems, such as fractures that can result from bone damage. 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.