Pamidronate is a bisphosphonate (bis FOS fo nayt) medicine that alters bone formation and breakdown in the body. This can slow bone loss and may help prevent bone fractures.

Pamidronate is used to treat Paget's disease of bone. Pamidronate is also used to treat high blood levels of calcium caused by cancer (also called hypercalcemia of malignancy).

Pamidronate is also used to treat bone damage caused by certain types of cancer such as breast cancer or bone marrow cancer. Pamidronate does not treat the cancer itself.

Pamidronate may also be used for purposes not listed in this medication guide.

Pamidronate may harm an unborn baby. Avoid getting pregnant while using pamidronate and tell your doctor if you become pregnant.

Call your doctor if you have muscle spasms, numbness or tingling (in hands and feet or around the mouth), new or unusual hip pain, little or no urination, or swelling in your lower legs.

Follow all directions on your prescription label. Do not use pamidronate in larger or smaller amounts or for longer than recommended.

Pamidronate is injected into a vein through an IV. You may be shown how to use an IV at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

This medicine must be given slowly, and the infusion can take 2 to 24 hours to complete.

Pamidronate is sometimes given as a single dose only one time. It may also be repeated over 3 days in a row, or given once every 3 to 4 weeks. How often you receive pamidronate and the length of your infusion time will depend on why you are using this medicine. Follow your doctor's instructions.

Pamidronate is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Never mix pamidronate with a solution that contains calcium (such as lactated Ringer's solution) or with other drugs in the same IV bag or line.

Your kidney function may need to be checked while you using pamidronate.

Pay special attention to your dental hygiene while using pamidronate. Brush and floss your teeth regularly. If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using pamidronate.

Pamidronate is only part of a complete program of treatment that may also include diet changes and taking calcium and vitamin supplements. Follow your doctor's instructions very closely.

Store pamidronate at room temperature away from moisture and heat. Mixed medicine must be used within 24 hours.

Each single-use vial (bottle) of this medicine is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Usual Adult Dose for Hypercalcemia of Malignancy:

Moderate Hypercalcemia (corrected serum calcium of approximately 12 mg/dL to 13.5 mg/dL):
-60 to 90 mg single intravenous infusion over 2 to 24 hours

Severe Hypercalcemia (corrected serum calcium greater than 13.5 mg/dL):
-90 mg single intravenous infusion over 2 to 24 hours

Retreatment:
-Patients who show complete or partial response initially may be retreated if serum calcium does not return to normal or remain normal after initial treatment.
-A minimum of 7 days between treatments is recommended to allow for full response to the initial dose.
-The dose and manner of retreatment is identical to that of the initial therapy.

Use: Treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases

Usual Adult Dose for Paget's Disease:

Moderate to severe Paget's Disease of the Bone:
-30 mg intravenous infusion every day, administered over 4 hours for 3 consecutive days, for a total dose of 90 mg

Comments: When clinically indicated, retreat patients at the dose of initial therapy.

Usual Adult Dose for Osteolytic Bone Lesions of Multiple Myeloma:

-90 mg intravenous infusion administered over 2 hours every 4 weeks

Duration of therapy: 24 months of therapy demonstrated overall benefits

Comments:
-Patients with marked Bence-Jones proteinuria and dehydration should receive adequate hydration prior to infusion of this drug.
-Limited information is available on the use of pamidronate disodium in multiple myeloma patients with a serum creatinine greater than or equal to 3 mg/dL.

Usual Adult Dose for Osteolytic Bone Metastases of Breast Cancer:

-90 mg intravenous infusion administered over 2 hours every 3 to 4 weeks

Duration of therapy: 24 months of therapy demonstrated overall benefits

You should not use this medicine if you are allergic to mannitol, or to any bisphosphonate (alendronate, etidronate, ibandronate, pamidronate, risedronate, tiludronate, or zoledronic acid).

To make sure pamidronate is safe for you, tell your doctor if you have ever had:

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

• kidney disease;

• liver disease; or

• a dental problem (you may need a dental exam before you receive pamidronate).

In rare cases, this medicine may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work. The longer you use pamidronate, the more likely you are to develop this condition.

Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.

Pamidronate may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine. Tell your doctor if you become pregnant. You may also need to use birth control for several weeks after your last dose of pamidronate. This medicine can have long-lasting effects on your body.

It is not known whether pamidronate passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using pamidronate.

Pamidronate is not approved for use by anyone younger than 18 years old.

Call your doctor for instructions if you miss a dose of pamidronate.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Pamidronate may cause serious side effects. Call your doctor at once if you have:

• high fever;

• new or unusual pain in your thigh or hip;

• a seizure;

• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath;

• low potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; or

• low calcium levels--muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).

Common side effects of pamidronate may include:

• fever, headache;

• bone pain;

• increased blood pressure;

• nausea, vomiting;

• low calcium or phosphate levels; or

• pain, redness, swelling or a hard lump under your skin around the IV needle.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Pamidronate can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, injectable osteoporosis medication, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

Other drugs may interact with pamidronate, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.