Type size
Print page
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.
ZOMETA is a proven treatment for people with bone metastases from solid tumors and bone complications from multiple myeloma. It can help protect the bones and reduce and delay bone complications caused by the spread of cancer.
ZOMETA is an FDA-approved prescription drug developed by Novartis Oncology. It is a treatment for hypercalcemia of malignancy (HCM), a condition resulting in high calcium blood levels due to cancer. ZOMETA is also approved to treat patients with multiple myeloma and to treat patients with certain metastatic cancers—including breast, lung, and prostate cancer (following at least one course of failed hormonal therapy)—that have spread to the bones, a process called bone metastases. When cancer has spread to the bone, treatment with ZOMETA helps to reduce or delay such complications as:
- Bone fracture
- Need for radiation and/or surgery to bone
- Spinal cord compression
Even patients who have already experienced bone complications from the spread of cancer to the bones or from multiple myeloma may be helped by treatment with ZOMETA.
ZOMETA is used with cancer treatments such as radiation, hormonal therapy, or chemotherapy.
To help manage your treatment, see additional ZOMETA Patient Resources.
If therapy with ZOMETA is recommended for you, here are some things you should know.
- ZOMETA is given as an intravenous infusion every 3 to 4 weeks. You may receive it at your doctor's office or at a clinic or infusion center. The infusion takes at least 15 minutes once ZOMETA is prepared.
- Concerns that you may have about receiving intravenous ZOMETA should be weighed against the potential benefits of treatment, as the complications of bone metastases can be devastating. Speak with your doctor.
- In some cases, ZOMETA and other bisphosphonates have been known to cause kidney damage. Prior to each infusion, your doctor will routinely do blood tests to monitor your kidney function. If you have kidney problems, your doctor may determine that ZOMETA should be administered at a reduced dose or should not be given. Patients with severe kidney problems should not take ZOMETA.
- It is also important to keep up 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.
- ZOMETA contains the same active ingredient as found in Reclast® (zoledronic acid). If you are treated with ZOMETA, you should not be treated with Reclast.
- Tell your doctor if you have kidney problems before taking ZOMETA.
- It's important to have your blood tested (serum creatinine) during the course of ZOMETA therapy.
- ZOMETA should not be given if you are pregnant or plan to become pregnant, or if you are breast-feeding.
- You should have a dental examination prior to treatment with ZOMETA and you should avoid invasive dental procedures during treatment.
- Good dental hygiene and routine dental care is important while you're on ZOMETA treatment.
- If you have multiple myeloma or bone metastasis from solid tumors you should take an oral calcium supplement of 500 mg and a multiple vitamin containing 400 IU of Vitamin D daily.
- The most common side effects associated with ZOMETA include: anemia, nausea, vomiting, constipation, diarrhea, fatigue, pyrexia, weakness, lower limb edema, anorexia, decreased weight, bone pain, myalgia, arthralgia, back pain, malignant neoplasm aggravated, headache, dizziness, insomnia, paresthesia, dyspnea, cough, and abdominal pain.
- In aspirin sensitive patients, bronchoconstriction (tightening of the airways in the lungs) has been observed while taking bisphosphonates.
Oral hygiene is very important for patients living with cancer. Some patients have reported problems with their jaw bones while being treated with ZOMETA—please talk to your doctor before undergoing invasive dental procedures such as tooth extractions or if you experience pain in your jaw or poor wound healing in your mouth.
Consult your doctor about your individual treatment plan if you experience any of these side effects. Your doctor should closely watch your response to ZOMETA.
ZOMETA should be used with caution in patients with aspirin–sensitive asthma. ZOMETA should not be given to women who are pregnant, because there is the potential that it might harm the unborn child. Women given ZOMETA should not become pregnant during therapy.
