zoledronic acid

Posted on December 4th, 2008 by

Class: Supportive care

Generic Name: Zoledronic (zoe-leh-DRON-ic) acid
Trade Name: Zometa®

How is this drug used? Zoledronic acid is FDA approved for the treatment of multiple myeloma or cancer from solid tumors that has spread to the bone, in combination with standard chemotherapy agents. It is also approved for the treatment of hypercalcemia (high levels of calcium in the blood) caused by cancer. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.

What is the mechanism of action? Bone is in a constant state of remodeling in which old bone is removed by cells called osteoclasts (referred to as resportion) and new bone is laid down by cells called osteoblasts. Sometimes, patients with cancer have excessive resportion, leading to high levels of calcium in the blood. Zoledronic acid  helps prevent hypercalcemia by inhibiting excessive bone resportion. In addition, zoledronic acid may help prevent or delay skeletal events such as bone fractures caused by cancer spreading to and growing in the bone.

How is zoledronic acid given (administered)? Zoledronic acid is administered into a vein (intravenous) and the dose depends on several factors, including the condition being treated, the size of the patient, the particular regimen being used, and the overall health of the patient.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with zoledronic acid.  Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver.  Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.  Prior to each dose of zoledronic acid, patients may have their kidney function checked. Patients will also have their calcium levels and other electrolyte levels in their blood checked during treatment with zoledronic acid. Patients will be monitored for signs of hypercalcemia, such as muscle twitching, frequent urination, loss of appetite, nausea or vomiting, constipation, weakness or fatigue, muscle, confusion and coma.

What are the common (occur in 30% or more of patients) side effects of treatment with zoledronic acid?

• Fever
• Flu-like symptoms
• Nausea
• Vomiting
• Fatigue
• Bone pain

What are the less common (occur in 10% to 29% of patients) side effects of treatment with zoledronic acid?

• Low white blood cell levels – increases risk of infection
• Low red blood cell levels – increases risk of anemia
• Constipation
• Diarrhea
• Abdominal pain
• Weakness
• Fluid retention resulting in swelling
• Muscle and joint pain
• Loss or increase of appetite
• Dehydration
• Headache
• Dizziness
• Depression
• Difficulty breathing
• Cough
• Hair loss
• Urinary tract infection
• Shortness of breath
• Weight loss

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• If possible, patients should avoid large crowds or persons who are sick or not feeling well, as this drug may leave some patients susceptible to infection.
• Wash hands often to reduce the risk of infection.

Are there any special precautions patients should be aware of before starting treatment?

• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.

When should patients notify their physician?

• Signs of hypercalcemia - such as muscle twitching, frequent urination, loss of appetite, nausea or vomiting, constipation, weakness or fatigue, confusion and coma
• Flu or cold-like symptoms - fever, chills, sore throat, cough
• Signs of infection – redness, swelling, pus, tenderness
• Persistent or severe fatigue
• Difficulty breathing
• Chest pain
• Swelling of ankles or feet
• Pain or burning on urination
• No or low urine output for 8 – 24 hours
• Dizziness or confusion
• Severe depression
• Severe pain

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

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Tags: Drug Dictionary, Supportive, Z

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