ZOMETA

I have had 3 doses of Zometa and now I an having the side effects associated with this drug!!!! Jaw pain!!!!!




ZOMETA is a treatment that can reduce and delay bone complications. ZOMETA has treated over 3.8 million patients with bone metastases and bone complications from multiple myeloma worldwide in more than 9 years of real-world experience.
Important Safety Information

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.

Click here for Important Safety Information
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Models are for illustrative purposes only

Glossary

Anemia

A condition in which the number of red blood cells is below normal.
Anorexia

An abnormal loss of the appetite for food.
Arthralgia

Joint pain.
Biologic therapy

Treatment with substances that boost the body’s immune system to fight against cancer; interferon is one example.
Bisphosphonate

A class of medicines that inhibit bone removal (resorption) by osteoclasts, a type of bone cell that breaks down bone.
Bone marrow

Bone marrow is the inner, spongy tissue of large bones where red blood cells, white blood cells, and platelets are made.
Bone metastases

Sometimes referred to as “Bone mets“. Areas of tumor in bone that result from the spread of cancer from another site in the body.
Chemotherapy

The use of anticancer drugs either injected by vein, into the muscle, or given by mouth to inhibit tumor growth or destroy cancer cells. ZOMETA is not chemotherapy.
Corticosteroid

Any of the hormones produced by the adrenal cortex, or their synthetic equivalents.
Dyspnea

Difficult, painful breathing or shortness of breath.
Edema

Swelling caused by excess fluid in body tissues.
Hormonal therapy

Treatment that adds, blocks, or removes hormones. To slow or stop the growth of certain cancers, synthetic hormones or other drugs may be given to block the body’s natural hormones.
Hypercalcemia

An excess of calcium in the blood; can be caused by cancerous destruction of bone tissue.
Insomnia

Difficulty in going to sleep or getting enough sleep.
Intravenous (IV) Bisphosphonate therapy

Drugs given into or within a vein that help slow the bone destroying activity that occurs with bone metastases.
Immune system

The complex system by which the body resists infection by germs, such as bacteria or viruses, and rejects transplanted tissues or organs. The immune system may also help the body fight some cancers.
MRI

Magnetic resonance imaging; a procedure that uses magnetism, radio waves and computer to produce images of the body.
Metastasis

Cancer cells that have spread to one or more sites elsewhere in the body, often by way of the lymph system or bloodstream. Regional or local metastasis is cancer that has spread to the lymph nodes, tissues, or organs close to the primary site. Distant metastasis is cancer that has spread to organs or tissues that are farther away (such as when prostate cancer spreads to the bones, lungs, or liver). The plural of this word is metastases.
Multiple myeloma

Cancer resulting from abnormal plasma cells multiplying and occupying space in the bone marrow.
Myalgia

Pain in a muscle or group of muscles.
Neoplasm

Tumor; any new and abnormal growth, specifically one in which cell multiplication is uncontrolled and progressive. Neoplasms may be benign or malignant.
Oncologist

A doctor with special training in the diagnosis and treatment of cancer.
Osteoblast

A bone-forming cell that is derived from mesenchyme (fibroblast) and forms an osseous matrix in which it becomes enclosed as an osteocyte. Synonym, osteoplast.
Osteoblastic

Relating to the osteoblasts; describes a region of increased radiographic bone density, in particular metastases that simulate osteoblastic activity.
Osteolytic

Causing the breakdown of bone. Noun, osteolysis.
Osteomyelitis

Inflammation of bone, localized or generalized, due to an infection.
Osteonecrosis

The death of bone tissue due to destruction of its blood supply.
Paresthesia

An abnormal touch sensation, such as burning or prickling, that occurs without an outside stimulus.
PET

Positron Emission Tomography; a highly specialized imaging technique that uses short-lived radioactive substances to produce three-dimensional colored images of those substances functioning within the body.
Pyrexia

Fever.
Radiation therapy

Treatment that uses high energy rays to kill cancer cells.
Spinal cord compression

Pressure on the spinal cord resulting from factors external to the cord itself. It can result from bone metastases to the spinal column that encases the cord or from infections in the space between the cord and the spinal column.
Vitamin D

A generic term for all steroids exhibiting the biological activity of ergocalciferol (vitamin D2) or cholecalciferol (vitamin D3). They promote the proper utilization of calcium and phosphorous. Since these compounds are synthesized in human tissues, they are more properly referred to as hormones rather than vitamins.
White blood cell

Blood cells that help defend the body against infections. There are many types of white blood cells. Certain cancer treatments such as chemotherapy can reduce the number of these cells and make a person more likely to get infections.

Indication

ZOMETA (zoledronic acid) 4 mg/5 mL Injection is a treatment for hypercalcemia of malignancy (HCM; a condition resulting in high calcium blood levels due to cancer). ZOMETA is also used to reduce and delay bone complications due to multiple myeloma and bone metastases from solid tumors; used with anti-cancer medicines. ZOMETA is not an anti-cancer therapy. If you have prostate cancer, you should have failed treatment with at least one hormonal therapy prior to taking ZOMETA.

Important Safety Information

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.


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