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.
Staying committed to treatment with ZOMETA (zoledronic acid) 4 mg/5 mL Injection is important and can help reduce your chances of fractures, your need for radiation or surgery, and your risk of spinal cord compression.
ZOMETA can reduce the chance of having bone complications, such as:
ZOMETA may delay the complications that can occur with multiple myeloma or when cancer spreads to the bone. Even patients who have already experienced bone complications may be helped by treatment with ZOMETA.
If you take ZOMETA regularly, here are some things you should know.
- If you have been prescribed ZOMETA, it will most likely be given every 3 to 4 weeks. Your healthcare provider will determine how often you should receive ZOMETA based on your needs. ZOMETA infusions should take no less than fifteen minutes.
- 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 important to keep up your fluid intake and stay well hydrated 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.
- 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 are important while you're on ZOMETA treatment.
- If you have multiple myeloma or bone metastasis of 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 therapy.
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 fetus. Women given ZOMETA should not become pregnant during therapy.
Simply click on one of the following types of cancer to download a PDF with questions that you may wish to ask your doctor about ZOMETA.
As Your Therapy with ZOMETA Continues
As your therapy with ZOMETA continues, please be sure to follow your doctor's instructions and advice carefully. Throughout your therapy, it is important to take the recommended vitamin and mineral supplements and drink plenty of fluids.