Drug monograph for the active ingredient in Aredia

The following information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

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 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. 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 must be weighed against the good it will do. This is a decision you and your doctor will make. For pamidronate, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to pamidronate or other bisphosphonates such as alendronate, clodronate, etidronate, risedronate, tiludronate, or zoledronic acid. Also tell 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, studies in rats given higher doses of oral pamidronate have shown that the medicine may decrease fertility, increase the length of pregnancy, and cause death of the baby rat. You should avoid becoming pregnant while taking this medicine. If you do become pregnant tell your healthcare professional as soon as you can.

Breast-feeding—It is not known if pamidronate passes into breast milk.

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.

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. When you are receiving pamidronate, it is especially important that your health care professional know if you are taking any of the following:

• Calcium-containing preparations or
• Vitamin D-containing preparations—Use with pamidronate may keep 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 effects on the kidney

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

• Blood problems, such as
• Anemia
• Leukopenia
• 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 pamidronate will be different for different patients. Follow your doctor's orders . The following information includes 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 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.

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

Note:

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

Frequency not determined

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

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

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 that others are watching you or controlling your behavior; feeling that others can hear your thoughts; feeling, seeing, or hearing things that are not there; feeling unusually cold; swelling or inflammation of the mouth; unusual behavior

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

Additional Information

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

Developed: 06/02/1993
Revised: 12/18/2003

The information contained in the Thomson Healthcare products is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse or pharmacist can provide you with advice on what is safe and effective for you.

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Copyright © 2004 Thomson Healthcare Inc. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes.

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