Pronunciation:

pam-i-DROE-nate

Brand Names:

• Aredia

Dosage Forms:

• Solution
• Powder for Solution

Classifications:

Therapeutic—

Calcium Regulator

Chemical—

Bisphosphonate

Uses of This Medicine:

Pamidronate injection is used to treat hypercalcemia (too much calcium in the blood) that may occur in patients with some types of cancer. It is also used to treat Paget's disease of bone, multiple myeloma (tumors formed by the cells of the bone marrow), and certain types of bone metastases (the spread of cancer to the bones).

This medicine is to be administered only by or under the 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—

Appropriate studies have not been performed on the relationship of age to the effects of pamidronate injection 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 pamidronate injection in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving pamidronate 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
• Dehydration or
• Heart disease or
• Kidney disease or
• Leukopenia (low number of white blood cells) or
• Mineral imbalance (e.g., low calcium, magnesium, phosphorus, or potassium in the blood) or
• Thrombocytopenia (low number of platelets)—Use with caution. May make these conditions worse.

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

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

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 a vein.

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 also important to not drink too much liquid. Talk to your doctor about the right amount of liquids for you.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • For treating hypercalcemia (too much calcium in the blood):
    • Adults—60 to 90 milligrams (mg) in a solution to be injected over 2 to 24 hours into a vein. If your doctor decides that you need additional doses, you will receive the medicine again after at least 7 days have passed.
    • Children—Use and dose must be determined by your doctor .
  • For treating Paget's disease of bone:
    • Adults—30 mg in a solution to be injected over 4 hours into a vein, for 3 consecutive days. Your doctor will decide if you need more than 3 doses.
    • Children—Use and dose must be determined by your doctor .
  • For treating multiple myeloma:
    • Adults—90 mg in a solution to be injected over 4 hours into a vein once per month. Your doctor will decide how long this treatment should continue.
    • Children—Use and dose must be determined by your doctor .
  • For treating bone metastases:
    • Adults—90 mg in a solution to be injected over 2 hours into a vein once every 3 to 4 weeks. Your doctor will decide how long this treatment should continue.
    • Children—Use and dose must be determined by your doctor .

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits after you have received pamidronate 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 a second treatment is needed.

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.

For patients using this medicine for hypercalcemia (too much calcium in the blood):

• Your doctor may want you to follow a low-calcium diet. If you have any questions about this, check with your doctor.

Your doctor will need to know if you have a history of problems with your mouth or teeth (e.g., 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.

You may need to have a dental exam before you start using this medicine.

It is important that you check with your doctor before having any dental procedures or surgeries done while you are receiving pamidronate. Tell your doctor right away if you have jaw tightness, swelling, numbing, or pain or a loose tooth. This could be symptoms of a severe problem of your jaw.

Make sure you tell your doctor about any new medical problems, especially with your teeth or jaws. Tell your doctor right away if you have severe bone, joint, or muscle 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 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

Abdominal or stomach cramps

black, tarry stools

bloody in the urine or stools

blurred vision

chest pain

chills

confusion

convulsions (seizures)

decrease in the amount of urine

dizziness

drowsiness

fainting

fast or irregular heartbeat

fever

headache

increased thirst

loss of appetite

muscle pain, cramps, spasms, or twitching

nausea or vomiting

nervousness

noisy, rattling breathing

numbness or tingling in the hands, feet, or lips

pinpoint red spots on the skin

pounding in the ears

shortness of breath

slow or fast heartbeat

swelling of the fingers, hands, feet, or lower legs

trembling

troubled breathing at rest

unusual bleeding or bruising

unusual tiredness or weakness

vomiting of blood or material that looks like coffee grounds

weight gain

Less common

Cough

dilated neck veins

extreme fatigue

irregular breathing

lower back or side pain

painful or difficult urination

pale skin

swelling

ulcers, sores, or white spots in the mouth

Rare

Decreased vision

difficulty with swallowing

eye pain or tenderness

eye redness

hives

itching

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

sensitivity of the eye to light

skin rash

sweating

tearing of the eye

tightness in the chest

Incidence not known

Bone, joint, or muscle pain, severe and occasionally incapacitating

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

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

Acid or sour stomach

belching

bladder pain

bloody or cloudy urine

body aches or pain

bone pain

constipation

cracks in the skin at the corners of mouth

diarrhea

difficult, burning, or painful urination

difficult or labored breathing

difficulty moving

ear congestion

fear

frequent urge to urinate

heartburn

indigestion

joint pain

lack or loss of strength

lower back or side pain

muscle aching, cramping, pains, or stiffness

nasal congestion

nervousness

pain and swelling at the injection site

sensitivity to heat

shivering

sneezing

soreness or redness around the fingernails and toenails

stomach discomfort, upset, or pain

sweating

swollen joints

trouble sleeping

weight loss

Less common

Ammonia-like breath odor

feeling, seeing, or hearing things that are not there

feeling that others are watching you or controlling your behavior

feeling that others can hear your thoughts

feeling unusually cold

swelling or inflammation of the mouth

unusual behavior

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.