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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.
ZOMETA (zoledronic acid) 4 mg/5 mL Injection is a drug given by infusion every 3 to 4 weeks by your doctor to treat patients at risk for complications from bone metastases—it's important to follow all the instructions below before receiving treatment with ZOMETA.
ZOMETA is a prescription drug developed by Novartis Oncology. ZOMETA is given intravenously every 3 to 4 weeks in a doctor's office, a clinic, or in a hospital on an "outpatient" basis. Once the infusion is prepared, the infusion process takes at least 15 minutes. Before ZOMETA was available, IV bisphosphonate therapy required at least 2 hours for administration.
On the day you are scheduled for your ZOMETA infusion, you may eat as you normally would. Take your vitamin and mineral supplements and drink plenty of fluids as directed by your healthcare provider. Make sure you are wearing clothing that will feel comfortable for you whether you receive your infusion while sitting upright or reclined. You may wish to ask a family member or friend to accompany you.
Prior to the start of your ZOMETA infusion, you will be given a routine blood test to make sure your kidneys are functioning properly. Your vital signs, such as heart rate and blood pressure, will also be checked. Finally, your arm will be prepared for the intravenous infusion.
Important Things to Remember While on ZOMETA Therapy
Take Your Vitamin and Mineral Supplements
While receiving ZOMETA, it is important for patients with
multiple myeloma or
bone metastases from
solid tumors to take certain vitamin and mineral supplements. You should take the following supplements once a day as directed by your healthcare provider:
- A multiple vitamin that contains 4 mg of vitamin D
- An oral calcium supplement that contains 500 mg of calcium
Drink Plenty of Fluids
In addition to taking both a multiple vitamin supplement and oral calcium supplement, it is important for you to keep up with your fluid intake while on ZOMETA therapy. Be sure to drink plenty of water or other fluids.
