Pronunciation:

pam-i-DROE-nate

Brand Names:

• Aredia

Dosage Forms:

• Powder for Solution
• Solution

Classifications:

Therapeutic—

Calcium Regulator

Chemical—

Bisphosphonate

Uses of This Medicine:

Pamidronate is used to treat hypercalcemia (too much calcium in the blood) that may occur with some types of cancer. It is also used to treat Paget's disease of bone and to treat bone metastases (spread of cancer).

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, pamidronate is used in certain patients with the following medical conditions:

• Osteogenesis imperfecta

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—

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of pamidronate in children with use in other age groups.

Older adults—

When pamidronate is given along with a large amount of fluids, older people tend to retain (keep) the excess fluid.

Pregnancy—

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
• Leukopenia or
• Thrombocytopenia—Your healthcare professional will watch your progress closely for two weeks after treatment.

• Heart problems—The increased amount of fluid may make this condition worse.

• Kidney problems—Pamidronate may build up in the bloodstream, which may increase the chance of unwanted effects.

Proper Use of This Medicine:

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.
    • Children—Use and dose must be determined by your doctor.
  • For treating Paget's disease of bone:
    • Adults—Dose and frequency must be determined by your doctor. The usual dose range is 30 mg in a solution injected into a vein. Your doctor may repeat this dose each day for a total of 3 days of treatment.
    • 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 to 4 hours into a vein. Your dose may be given every three to four weeks or once a month.
    • 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. 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.

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.

Tell your doctor right away if you have severe bone, joint, or muscle pain while using this medicine .

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 as soon as possible if any of the following side effects occur:

More common

Abdominal cramps

black, tarry stools

bleeding gums

bloody in urine or stools

blurred vision

chest pain

chills

confusion

convulsions (seizures)

decrease in amount of urine

dizziness

drowsiness

dry mouth

fainting

fast or irregular heartbeat

fever

headache

increased thirst

loss of appetite

mood or mental changes

muscle pain or cramps

muscle spasms

muscle twitching

nausea

nervousness

noisy, rattling breathing

numbness or tingling in hands, feet, or lips

pinpoint red spots on skin

pounding in the ears

shortness of breath

slow or fast heartbeat

spread of cancer

sore throat

swelling of fingers, hands, feet, or lower legs

trembling

troubled breathing at rest

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

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 mouth

wheezing

Rare

Decreased vision

difficulty swallowing

eye pain or tenderness

eye redness

hives

itching

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

sensitivity of eye to light

skin rash

sweating

tearing of eye

tightness in chest

Incidence not determined

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

faintness, or light-headedness when getting up from a lying or sitting position suddenly

hives

itching of the skin

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

skin rash

tightness in chest

Note: Abdominal cramps, confusion, and muscle spasms are less common when pamidronate is given in doses of 60 mg or less.

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

acid or sour stomach

belching

bladder pain

bloody or cloudy urine

body aches or pain

bone pain

cracks in skin at the corners of mouth

constipation

degenerative disease of the joint

diarrhea

difficult, burning, or painful urination

difficult or labored breathing

difficulty in moving

ear congestion

fear

frequent urge to urinate

general feeling of body discomfort or illness

heartburn

indigestion

joint pain

lack or loss of strength

loss of voice

lower back or side pain

muscle aching or cramping

muscle pains or stiffness

nasal congestion

nervousness

pain and swelling at place of injection

pain or tenderness around eyes and cheekbones

runny nose

sensitivity to heat

shivering

skin rash

sleeplessness

small clicking, bubbling, or rattling sounds in the lung when listening with a stethoscope

sneezing

soreness or redness around fingernails and toenails

stomach discomfort, upset or pain

stuffy nose

sweating

swollen joints

trouble sleeping

ulcers, sores, or white spots in mouth

unable to sleep

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.