Pronunciation:

ZOE-le-dron-ik AS-id

Brand Names:

• Reclast
• Zometa

Dosage Forms:

• Solution
• Powder for Solution

Classifications:

Therapeutic—

Calcium Regulator

Chemical—

Bisphosphonate

Uses of This Medicine:

Zoledronic acid is used to treat hypercalcemia (high levels of calcium in the blood) that may occur in patients with some types of cancer. It is also used to treat a cancer called multiple myeloma (tumors formed by the cells of the bone marrow) or certain types of bone metastases (the spread of cancer to the bone).

Zoledronic acid is also used to treat Paget's disease of the bone and osteoporosis in women who have gone through menopause. This medicine is used to reduce the risk of having more fractures in patients who have had a recent hip fracture.

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This medicine is to be administered only by or under the supervision of your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, zoledronic acid is used in certain patients with the following medical conditions:

• Bone loss, in men, from taking certain medicines for prostate cancer.
• Bone loss, in breast cancer patients, from hormone therapy (prevention).

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of zoledronic acid in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of zoledronic acid in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution in patients receiving zoledronic acid.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Absorption problems or
• Bowel resection or
• Parathyroid disease (e.g., hypoparathyroidism) or
• Parathyroid surgery or
• Thyroid surgery—These conditions may increase your risk of having hypocalcemia (low levels of calcium in the blood).

• Asthma, certain types or
• Heart disease or
• Kidney disease—May make these conditions worse.

• Cancer or
• Cancer treatment or
• Dental procedures or surgery or
• Poor dental hygiene—May increase the risk for a serious jaw problem.

• Dehydration (not enough water or fluids in your body)—May increase the risk of severe kidney problems.

• Hypocalcemia (low calcium in the blood) or
• Kidney disease, severe—Should not be used in patients with these conditions.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed into one of your veins.

Your doctor may also give you vitamins containing Vitamin D and calcium. Tell your doctor if you are unable to take these supplements.

Drink extra fluids so you will pass more urine while you are using this medicine. This will keep your kidneys working well and help prevent kidney problems.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits after you have received zoledronic acid. If your condition has improved, your progress must still be checked. The results of laboratory tests or the occurrence of certain symptoms will tell your doctor if your condition is coming back and if a second treatment is needed. You will need a yearly dose of this medicine if you are being treated for postmenopausal osteoporosis, so check with your doctor regularly.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away. Do not breastfeed while you are using this medicine.

This medicine may cause low calcium in your blood. Check with your doctor immediately if you experience numbness or tingling around the mouth, or if you have muscle spasms.

Tell your doctor right away if you experience symptoms of agitation, blood in urine, coma, confusion, decreased urine output, depression, dizziness, headache, irritability, lethargy, muscle twitching, nausea, rapid weight gain, seizures, stupor, swelling of face, ankles, or hands, or unusual tiredness or weakness. These could be a sign of serious kidney problems.

It is important that you check with your doctor before having any dental procedures or surgeries done while you are receiving zoledronic acid. Tell your doctor right away if you experience jaw tightness, swelling, numbing, or pain or a loose tooth. It could be the sign of a serious jaw disease.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Agitation

black, tarry stools

blurred vision

chest pain

chills

coma

confusion

convulsions

cough

depression

dizziness

dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly

fever

irregular heartbeat

irritability

lack or loss of strength

lethargy

lower back or side pain

mood or mental changes

muscle pain or cramps

muscle trembling or twitching

nausea or vomiting

numbness and tingling around mouth, fingertips, or feet

painful or difficult urination

pale skin

rapid weight gain

seizures

shaking of hands, arms, feet, legs, or face

shortness of breath, difficult or labored breathing

skin rash, cracks in skin at the corners of mouth, or soreness or redness around fingernails and toenails

sore throat

sores, ulcers, or white spots on lips or mouth

stupor

sudden sweating

swollen glands

tightness in chest

trouble breathing with exercise

unusual bleeding or bruising

unusual tiredness or weakness

wheezing

Incidence not known

Decreased frequency or amount of urine

heavy jaw feeling

increased blood pressure

increased thirst

loosening of a tooth

pain, swelling, or numbness in the mouth or jaw

swelling of face, hands, fingers, lower legs, or ankles

troubled breathing

weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Abdominal pain

anxiety, nervousness, restlessness, or irritability

back pain

bad, unusual, or unpleasant (after) taste

bladder pain, bloody or cloudy urine

blistering, crusting, irritation, itching, or reddening of skin

bone pain

burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings

change in taste

constipation

cracked lips

cracked, dry, or scaly skin

dehydration

diarrhea

difficulty swallowing

discouragement

dry mouth

ear congestion

fear or nervousness

feeling sad or empty

frequent urge to urinate

hair loss or thinning hair

headache

hyperventilation

irregular heartbeats

joint pain or swollen joints

loss of appetite

loss of interest or pleasure

loss of voice

muscle stiffness or difficulty in moving

nasal congestion or runny nose

pain, swelling, or redness in joints

partial loss of feeling

seeing, hearing, or feeling things that are not there

sleepiness or unusual drowsiness

sleeplessness, trouble sleeping, or unable to sleep

swelling

swelling of leg

swelling or inflammation of the mouth

thirst

trouble concentrating

unusually cold, shivering

vomiting

weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.