Generic Name: Zoledronic Acid

(ZOE le dron ik AS id)

Trade names: Zometa®

Zoledronic acid is the generic name for the trade name drug Zometa®. In some cases, health care professionals may use the trade name Zometa® when referring to the generic drug name zoledronic acid.

Drug type: Zoledronic acid is a supportive care drug in the category of bisphosphonates. (For more detail, see "How this drug works" section below).

What This Drug Is Used For:

• Zoledronic acid is used as a support medication to treat symptoms of cancer such as hypercalcemia (high blood calcium levels) or to decrease complications (such as fractures or pain) produced by bone metastasis (spread of cancer to the bone).

Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful/

How This Drug Is Given:

• As an infusion into the vein (intravenous, IV).
• There is no pill form of this medication.

The amount of zoledronic acid that you will receive depends on many factors, including, your general health or other health problems, and the type of cancer or condition being treated. Your doctor will determine your dose and schedule.

Side Effects:

Important things to remember about the side effects of zoledronic acid:

• Most people do not experience all of the side effects listed.
• Side effects are often predictable in terms of their onset and duration.
• Side effects are almost always reversible and will go away after treatment is complete.
• There are many options to help minimize or prevent side effects.
• There is no relationship between the presence or severity of side effects and the effectiveness of the medication.

The following side effects are common (occurring in greater than 30%) for patients taking zoledronic acid:

• Ostealgia
• Nausea
• Fever usually mild and short lived
• Fatigue
• Anemia
• Vomiting
• Constipation
• Flu-like symptoms; mild fever sometimes accompanied by malaise, chills, fatigue and flushing. Usually occurs with first treatment with zoledronic acid only.

These are less common side effects (occurring in 10-29%) for patients receiving zoledronic acid:

• Shortness of breath
• Diarrhea
• Weakness
• Myalgia (muscle pain)
• Loss of appetite
• Cough
• Lower extremity swelling
• Arthralgia (joint pain)
• Headache
• Dizziness
• Decreased kidney function
• Trouble sleeping
• Abdominal pain
• Weight loss
• Paresthesia (abnormal sensation, typically tingling or prickling
• Anxiety
• Depression
• Dehydration
• Urinary tract infection
• Confusion
• Hypophosphatemia (low phosphorus in the blood)
• Hypoesthesia (reduced sense of touch or sensation)
• Hair loss
• Low potassium in the blood
• Low blood counts
• Candidiasis (yeast infection)
• Bone pain
• Low blood pressure
• Chills
• Rash
• Low magnesium in the blood
• Cold symptoms (Upper respiratory infection)
• Heart burn
• Chest pain
• Hypocalcemia (low calcium in the blood)
• Trouble Swallowing
• Mouth sores
• Infection (non-specific)

Note: Zoledronic acid may be used to treat a condition called hypercalcemia (high blood calcium) symptoms of hypercalcemia may include frequent urination, poor appetite, nausea, vomiting, constipation, weakness, fatigue, muscle twitching, confusion, stupor and coma. Presence of these symptoms while a person is receiving treatment with zoledronic acid may not be drug-related side effects, but related to hypercalcemia.

Osteonecrosis of the jaw has been reported rarely in patients with cancer receiving treatment regimens including bisphosphonates. Many of the reported cases were associated with dental procedures such as removal of a tooth. Many had signs of local infection including infection in the bone. A dental examination with appropriate preventative dentistry should be considered prior to treatment with bisphosphonates particularly in patients with additional risk factors (e.g. cancer, chemotherapy, corticosteroids, poor oral hygiene). Invasive dental procedures should be avoided during treatment.

Not all side effects are listed above, some that are rare (occurring in less than 1% of patients) are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms.

When to contact your doctor or health care provider:

Seek emergency help immediately and notify your health care provider, if you experience the following symptoms:

• Shortness of breath, wheezing, difficulty breathing, closing up of the throat, swelling of facial features, hives (possible allergic reaction).

Contact your health care provider immediately, day or night, if you should experience the following:

• Unusual muscle twitching or spasms (symptom of hypercalcemia)
• Confusion (symptom of hypercalcemia)
• Fever of 100.4° F (38° C), chills, sore throat (possible signs of infection)
• Shortness of breath, chest pain or discomfort

The following symptoms require medical attention, but are not emergency situations. Contact your health care provider within 24 hours of noticing any of the following:

• Vomiting (more than 4-5 episodes within a 24 hour period)
• Nausea that interferes with eating and is not relieved by medications prescribed by your doctor.
• Constipation unrelieved by laxative use
• Loss of appetite
• Fatigue and extreme tiredness (unable to perform self-care activities)
• Feelings of confusion
• Unable to eat or drink for 24 hours or have signs of dehydration: tiredness, thirst, dry mouth, dark and decrease amount of urine, or dizziness.

Precautions:

• Before starting zoledronic acid treatment, make sure you tell your doctor about any other medications you are taking (including over-the-counter drugs, vitamins, or herbal remedies).
• It is important to discuss with your health care professional any medications you are taking. Some medications may have an effect on the kidney, and combining them with zoledronic acid may cause kidney function to deteriorate. Examples of these types of medication are aspirin, non-steroidal anti-inflammatory drugs (NSAIDS) such as ibuprofen or naproxen, diuretics (water pills), ACE inhibitors such as analapril or fosinopril.
• The use of zoledronic acid may be inadvisable if you have had an allergic reaction to this drug or other medications like it (bisphosphonates) in the past. Also alert your healthcare professional if you have a history of asthma or an allergy to aspirin.
• Osteonecrosis of the jaw has been reported rarely in patients with cancer receiving treatment regimens including bisphosphonates. Many of the reported cases were associated with dental procedures such as removal of a tooth. Many had signs of local infection including infection in the bone. A dental examination with appropriated preventative dentistry should be considered prior to treatment with bisphosphonates particularly in patients with additional risk factors (e.g. cancer, chemotherapy, corticosteroids, poor oral hygiene). Invasive dental procedures should be avoided during treatment.
• Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category D (zoledronic acid may be hazardous to the fetus. Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus).
• For both men and women: Do not conceive a child (get pregnant) while taking zoledronic acid. Barrier methods of contraception, such as condoms, are recommended. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
• Do not breast feed while taking this medication.

Self-Care Tips:

• It is important that you stay well hydrated during treatment to protect your kidneys. Drink two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
• Acetaminophen may help relieve discomfort from fever, headache and/or generalized aches and pains. However, be sure to talk with your doctor before taking it.
• This medication causes little nausea. But if you should experience nausea, take anti-nausea medications as prescribed by your doctor, and eat small frequent meals. Sucking on lozenges and chewing gum may also help.
• You may experience drowsiness or dizziness; avoid driving or engaging in tasks that require alertness until your response to the drug is known.
• Get plenty of rest.
• Maintain good nutrition.
• If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing:

You will be checked regularly by your health care professional while you are taking zoledronic acid, to monitor side effects and check your response to therapy. Periodic blood work to monitor your complete blood count (CBC), kidney function (specifically creatinine and BUN), and blood calcium levels will also be ordered by your doctor.

How This Drug Works:

Cancer cells that spread to the bone can secrete substances that can cause cells found in the bone called osteoclasts to dissolve or "eat away" a portion of the bone. These tumors or lesions weaken the bone and can lead to complications. Some of the complications resulting from this bone breakdown are bone pain, fractures and less commonly, hypercalcemia (increased levels of calcium in the blood).

Zoledronic acid is a bisphosphonate. Bisphosphonate medications are used to slow down the osteoclast's effects on the bone. In doing this it can be useful in slowing down or preventing the complications (bone pain, fractures, or high calcium levels) of the bone breakdown.

Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

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