PAMIDRONATE (Systemic)

Some commonly used brand names are:

In the U.S.?

• Aredia

In Canada?

• Aredia

Another commonly used name is APD.

Category

• Antihypercalcemic
• Bone resorption inhibitor

Description

Pamidronate (pa-mi-DROE-nate) is used to treat hypercalcemia (too muchcalcium in the blood) that may occur with some types of cancer. It is alsoused to treat Paget's disease of bone and to treat bone metastases (spreadof cancer).

This medicine is to be administered only by or under the supervision ofyour doctor. It is available in the following dosage form:

Parenteral
• Injection (U.S. and Canada)

Before Receiving This Medicine

In deciding to use a medicine, the risks of receiving the medicine mustbe weighed against the good it will do. This is a decision you and your doctorwill make. For pamidronate, the following should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to pamidronate or other bisphosphonates such as alendronate,clodronate, etidronate, risedronate, tiludronate, or zoledronic acid. Alsotell your health care professional if you are allergic to any other substances,such as foods, preservatives, or dyes.

Pregnancy?Studies have not been done in humans. However, studiesin rats given higher doses of oral pamidronate have shown that the medicinemay decrease fertility, increase the length of pregnancy, and cause deathof the baby rat. You should avoid becoming pregnant while taking this medicine.If you do become pregnant tell your healthcare professional as soon as youcan.

Breast-feeding?It is not known if pamidronate passes into breastmilk.

Children?Studies on this medicine have been done only in adultpatients, and there is no specific information comparing use of pamidronatein children with use in other age groups.

Older adults?When pamidronate is given along with a large amountof fluids, older people tend to retain (keep) the excess fluid.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are receivingpamidronate, it is especially important that your health care professionalknow if you are taking any of the following:

• Calcium-containing preparations or
• Vitamin D-containing preparations?Use with pamidronate maykeep pamidronate from working properly

• Anti-infectives by mouth or by injection (medicine for infection)or
• Carmustine (e.g., BiCNU) or
• Cisplatin (e.g., Platinol) or
• Combination pain medicine containing acetaminophen and aspirin (e.g.,Excedrin) or other salicylates (with large amounts taken regularly) or
• Cyclosporine (e.g., Sandimmune) or
• Deferoxamine (e.g., Desferal) (with long-term use) or
• Gold salts (medicine for arthritis) or
• Inflammation or pain medicine except narcotics or
• Lithium (e.g., Lithane) or
• Methotrexate (e.g., Rheumatrex, Trexall) or
• Penicillamine (e.g., Cuprimine) or
• Plicamycin (e.g., Mithracin) or
• Tiopronin (e.g., Thiola)?Increased risk of harmful effectson the kidney

Other medical problems?The presence of other medicalproblems may affect the use of pamidronate. Make sure you tell your doctorif you have any other medical problems, especially:

• Blood problems, such as
• Anemia
• Leukopenia
• Thrombocytopenia
  Your healthcare professional will watch your progress closely for two weeksafter treatment

• Heart problems?The increased amount of fluid may make thiscondition 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 pamidronate will be different for different patients. Follow your doctor's orders. The following informationincludes only the average doses of pamidronate.

• 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 over2 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. Theusual dose range is 30 mg in a solution injected into a vein. Your doctormay 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 hoursinto 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 importantthat your doctor check your progress at regular visits after you have receivedpamidronate. If your condition has improved, your progress must still be checked.The results of laboratory tests or the occurrence of certain symptoms willtell your doctor if your condition is coming back and a second treatment isneeded.

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 haveany questions about this, check with your doctor.

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 mayneed medical attention.

Check with your doctor as soon as possible if any of the following sideeffects occur:

More common

Abdominal cramps; black, tarry stools; bleeding gums; bloodyin 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 painor 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 lookslike 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 spotsin 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; sensitivityof eye to light; skin rash; sweating; tearing of eye; tightness in chest

Note:

Abdominal cramps, confusion, and muscle spasms are less common whenpamidronate is given in doses of 60 mg or less.

Frequency not determined

faintness, or light-headedness when getting up from a lying orsitting position suddenly; hives; itching of the skin; large, hive-like swelling onface, eyelids, lips, tongue, throat, hands, legs, feet, sex organs; skin rash; tightness in chest

Other sideeffects may occur that usually do not need medical attention. These side effectsmay go away during treatment as your body adjusts to the medicine. However,check with your doctor if any of the following side effects continue or arebothersome:

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 painfulurination; difficult or labored breathing; difficulty in moving; ear congestion; fear; frequent urge tourinate; general feeling of body discomfort or illness; heartburn; indigestion; joint pain; lack or lossof 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 ortenderness around eyes and cheekbones; runny nose; sensitivity to heat; shivering; skin rash; sleeplessness; small clicking, bubbling, or rattling sounds inthe 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 thatothers are watching you or controlling your behavior; feeling that others can hear your thoughts; feeling,seeing, or hearing things that are not there; feelingunusually cold; swelling or inflammation of the mouth; unusual behavior

Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.

Additional Information

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

• Osteogenesis imperfecta