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 treatment can impact your dental health. Regular dental hygiene is an important part of your overall treatment plan.
Cancer treatments can affect your entire body, including your teeth and gums. Side effects of treatment may include inflammation of the mucous membranes in the mouth (mucositis), infections, taste changes, dry mouth, pain, tooth decay, gum disease, and sores inside your mouth.
This is why good dental health practices are especially important for people living with cancer. Good communication is important, too. Make certain that you inform your dentist about your ZOMETA treatment. You should also inform your oncologist about your dental history and any planned dental work.
Potential Dental Complications with ZOMETA: Osteonecrosis of the Jaw
Osteonecrosis (pronounced OSS-tee-oh-ne-KRO-sis) of the jaw is an uncommon condition that may involve the loss, or breakdown, of the jaw bone. It can be a serious condition. Symptoms include, but are not limited to:
- Pain, swelling, or infection of the gums
- Loosening of teeth
- Poor healing of the gums
- Numbness or the feeling of heaviness in the jaw
If you experience any of these, or other dental symptoms, tell both your oncologist and your dentist immediately and follow your oncologist's recommendations for continuing your cancer treatment. Your oncologist may refer you to an oral surgeon or dental oncologist with experience in osteonecrosis of the jaw.
To diagnose osteonecrosis of the jaw, doctors may use X-rays or tests for infection (microbial cultures). Treatments for osteonecrosis of the jaw may include antibiotics, oral rinses, and removable mouth appliances. Minor dental work may be necessary to remove injured tissue and reduce sharp edges of the bone. Surgery is typically avoided because it may make the condition worse.
Scientists do not know exactly what causes osteonecrosis of the jaw or how often it occurs. This disease has been reported in some cancer patients receiving bisphosphonates. However, a causal relationship between bisphosphonates and osteonecrosis of the jaw has not been established. Some possible factors that may increase the risk of osteonecrosis include:
- Radiation therapy to the head or neck
- Steroid therapy (for example, cortisone)
- Underlying cancer
- Sickle cell and other blood-related disorders
- A history of poor dental health
- Gum disease or dental surgery (such as pulled teeth)
- Alcohol abuse or cigarette smoking
- Poor blood circulation or clotting problems
Once your cancer treatment has started, if you experience pain in your mouth, teeth, or jaw—or any other symptom of possible dental problems—tell both your oncologist and dentist immediately.
Taking Care of Your Dental Health
To maintain a healthy smile as a patient living with cancer, you should:
- Schedule a dental exam and cleaning before ZOMETA treatment begins and inform your dentist that you will be starting ZOMETA treatment. You should also schedule dental exams and cleanings periodically during the course of your treatment
- Discuss dental procedures, such as the pulling of teeth or insertion of dental implants, with your oncologist before you start your ZOMETA treatment
- Have your dentist check and adjust removable dentures, if you have them
- Tell your physician about any bleeding of the gums, pain, or unusual feeling in your teeth or gums, or any dental infections
Regular dental hygiene is not that different for people with cancer than it is for people who don't have cancer, but because ZOMETA treatments can affect the teeth and gums, it can be even more important.
If you have cancer, your routine dental hygiene should include:
- Brushing your teeth and tongue after every meal and at bedtime, using a soft toothbrush and gentle stroke
- Gentle flossing at least once a day to remove plaque (if your gums bleed or hurt, the area that is sore should be avoided, but the other teeth still should be flossed)
- Keeping your mouth moist by rinsing often with water (many medicines cause 'dry mouth,' which can lead to decay and other dental problems)
Use a mirror to check your teeth and gums daily for any changes, such as sores or bleeding gums. If you notice a problem or a change, or experience pain in your mouth, teeth, or jaws, report it to your dentist or oncologist immediately.
Dental care is an important element of your overall cancer care.
Beginning as soon as possible after your cancer diagnosis, your treatment team should involve your regular dentist or a dental oncologist (a dentist who is specially trained to treat people with cancer).
- Be sure to tell your regular dentist that you are being treated for cancer with ZOMETA or another bisphosphonate
- Update your medical history record with your dentist to include your cancer diagnosis and treatments
- Provide your dentist and your oncologist with each other's name and telephone number for consultation