Pronunciation:

zoe-le-DRON-ik AS-id

Brand Names:

• Reclast
• Zometa

Dosage Forms:

• Powder for Solution
• Solution

Classifications:

Therapeutic—

Calcium Regulator

Chemical—

Bisphosphonate

Uses of This Medicine:

Zoledronic acid injection 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 injection is also used to treat Paget's disease of the bone in men and women. It is also used in men with osteoporosis and in women with osteoporosis 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.

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

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—

Zoledronic acid injection is not indicated for use in children.

Older adults—

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

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:

• Anemia or
• Bleeding problems or
• Cancer, history of or
• Dental or tooth problems or
• Dental procedures or
• Poor oral hygiene, or
• Surgery (eg, dental surgery)—May increase risk for severe jaw problems.

• Asthma, aspirin-sensitive or
• Heart disease or
• Kidney disease or
• Mineral imbalance (eg, high or low calcium, magnesium, phosphorus, or potassium in the blood)—Use with caution. May make these conditions worse.

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

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

• Hypocalcemia (low calcium in the blood) or
• Kidney disease, severe (eg, kidney failure)—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 in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for at least 15 minutes.

For hypercalcemia, this medicine is usually given only once. If your doctor decides that you need additional doses, you will receive the medicine again after at least 7 days have passed. This treatment will continue until your body responds to the medicine.

For bone cancer and multiple myeloma, this medicine is usually given every 3 to 4 weeks. This treatment will continue until your body responds to the medicine.

For osteoporosis, this medicine is usually given once a year and will continue until your body responds to the medicine.

You may also receive other medicines to help keep your body from losing too much fluid.

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. However, it is very important to not drink too much liquid. Talk to your doctor about the right amount of liquids for you.

This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits after you have received zoledronic acid injection. 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.

You should not use other medicines that also contain zoledronic acid, such as Reclast® or Zometa®. Using these medicines together may increase your chance for more serious side effects.

This medicine may rarely cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving the medicine.

This medicine may cause hypocalcemia (low calcium in the blood). Low blood calcium must be corrected before you receive this medicine. Check with your doctor immediately if you have muscle spasms or twitching, or numbness or tingling in your fingers, toes, or around your mouth.

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

Your doctor will need to know if you have a history of problems with your mouth or teeth (eg, gum disease). Make sure your doctor knows if you have been treated with a bisphosphonate medicine, such as alendronate (Fosamax®), etidronate (Didronel®), pamidronate (Aredia®), risedronate (Actonel®), or tiludronate (Skelid®) in the past.

It is important that you tell all of your doctors that you are receiving zoledronic acid injection, including your dentist. If you are having dental procedures while receiving this medicine, you may have an increased chance of having a severe problem with your jaw. Make sure you tell your doctor or dentist about any new problems, such as pain or swelling, with your teeth or jaw.

Make sure you tell your doctor about any new medical problems, especially with your teeth or jaws. Tell your doctor if you have severe muscle, bone, or joint pain after receiving this medicine.

This medicine may increase your risk of developing fractures of the thigh bone. This may be more common if you use it for a long time. Check with your doctor right away if you have a dull or aching pain in the thighs, groin, or hips.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription (eg, other medicines that also contain zoledronic acid) or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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

difficult or labored breathing

dizziness

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

fever

irregular heartbeat

irritability

lack or loss of strength

lethargy

lower back or side pain

muscle pain or cramps

muscle trembling or twitching

nausea or vomiting

numbness and tingling around the mouth, fingertips, or feet

painful or difficult urination

pale skin

rapid weight gain

seizures

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

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

sore throat

sores, ulcers, or white spots on the lips or mouth

stupor

sudden sweating

swollen glands

tightness in the chest

trouble breathing with exercise

unusual bleeding or bruising

unusual tiredness or weakness

Less common

Feeling of constant movement of self or surroundings

muscle cramps in the hands, arms, feet, legs, or face

muscle spasms

neck pain

pounding in the ears

rapid breathing

sensation of spinning

slow or fast heartbeat

sunken eyes

tingling of the hands or feet

tremor

Incidence not known

Blurred vision or other change in vision

decreased frequency or amount of urine

decreased vision

eye pain

eye tenderness

heavy jaw feeling

increased blood pressure

increased tearing

increased thirst

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loosening of a tooth

pain, swelling, or numbness in the mouth or jaw

redness of the eye

sensitivity of the eye to light

severe eye pain

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

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 or stomach pain

back pain

bad, unusual, or unpleasant (after) taste

bladder pain

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

bloody or cloudy urine

bone pain

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

change in taste

constipation

cracked lips

cracked, dry, or scaly skin

diarrhea

difficulty with swallowing

discouragement

dry mouth

ear congestion

feeling sad or empty

frequent urge to urinate

hair loss or thinning hair

headache

hyperventilation

joint pain or swollen joints

loss of appetite

loss of interest or pleasure

loss of voice

muscle stiffness or difficulty with moving

nasal congestion or runny nose

pain, swelling, or redness in the joints

partial loss of feeling

seeing, hearing, or feeling things that are not there

sleepiness or unusual drowsiness

swelling or inflammation of the mouth

thirst

trouble concentrating

trouble sleeping

unusually cold, shivering

vomiting

weight loss

Less common

Acid or sour stomach

belching

heartburn

indigestion

red streaks on the skin

stomach discomfort or upset

swelling, tenderness, or pain at the injection site

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

wrinkled skin

Rare

Burning, dry, or itching eyes

discharge or excessive tearing

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

throbbing pain

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.