Aredia (Pamidronate Disodium)

AREDIA is injected into a vein through an IV. This medication must be given slowly, and the IV infusion can take 2 to 24 hours to complete. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

AREDIA 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 this medication and the length of your infusion time will depend on the condition being treated. Follow your doctor's instructions.

You may need to mix AREDIA with a liquid (diluent) in an IV bag before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication. Never mix AREDIA with a solution that contains calcium (such as lactated Ringer's solution) or with other drugs in the same IV bag or line.

Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

If you do not have hypercalcemia, your doctor may want you to take calcium or vitamin D supplements by mouth while you are using AREDIA. Do not take any vitamin or mineral supplements that your doctor has not prescribed.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Visit your doctor regularly.

Store unmixed AREDIA at room temperature away from moisture and heat.

After mixing AREDIA with a diluent, store in the refrigerator and use it within 24 hours. Do not freeze. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

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

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

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

Call your doctor at once if you have a serious side effect such as:

• high fever;
• severe joint, bone, or muscle pain;
• new or unusual pain in your thigh or hip;
• urinating less than usual or not at all;
• swelling, rapid weight gain;
• pain or burning when you urinate;
• seizure (convulsions);
• eye pain, vision changes;
• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
• confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling, or jerking muscle movements.

Less serious side effects may include:

• low fever;
• stomach pain, loss of appetite, nausea, vomiting;
• constipation; or
• pain, redness, swelling or a hard painful 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.

Do not use AREDIA if you are pregnant. It could harm the unborn baby.

You should not use this medication if you are allergic to AREDIA or to other bisphosphonates such as alendronate (Fosamax), etidronate (Didronel), ibandronate (Boniva), risedronate (Actonel), tiludronate (Skelid), or zoledronic acid (Reclast, Zometa).

Before using AREDIA, tell your doctor if you have kidney disease, a history of thyroid surgery, or low levels of platelets or red blood cells.

Some people using medicines similar to AREDIA have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums. You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.

AREDIA can harm your kidneys, and this effect is increased when you also use certain other medicines harmful to the kidneys. Before using AREDIA, tell your doctor about all other medications you use. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

Serious side effects of AREDIA include high fever, severe bone pain, severe joint or muscle pain, urinating less than usual or not at all, swelling, rapid weight gain, eye pain, vision changes, confusion, uneven heart rate, extreme thirst, muscle weakness or limp feeling, or seizure.

You should not use this medication if you are allergic to AREDIA or to other bisphosphonates such as alendronate (Fosamax), etidronate (Didronel), ibandronate (Boniva), risedronate (Actonel), tiludronate (Skelid), or zoledronic acid (Reclast, Zometa).

To make sure you can safely use AREDIA, tell your doctor if you have any of these other conditions:

• kidney disease;
• a history of thyroid surgery; or
• low levels of platelets or red blood cells.

Some people using medicines similar to AREDIA have developed bone loss in the jaw, also called osteonecrosis of the jaw. Symptoms of this condition may include jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums.

You may be more likely to develop osteonecrosis of the jaw if you have cancer or have been treated with chemotherapy, radiation, or steroids. Other conditions associated with osteonecrosis of the jaw include blood clotting disorders, anemia (low red blood cells), and dental surgery or pre-existing dental problems.

FDA pregnancy category D. Do not use AREDIA if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

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

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

AREDIA can harm your kidneys. This effect is increased when you also use other medicines harmful to the kidneys. You may need dose adjustments or special tests if you have recently used:

• lithium (Lithobid);
• methotrexate (Rheumatrex, Trexall);
• pain or arthritis medicines such as aspirin (Anacin, Excedrin), acetaminophen (Tylenol), diclofenac (Cataflam, Voltaren), etodolac (Lodine), ibuprofen (Advil, Motrin), indomethacin (Indocin), naproxen (Aleve, Naprosyn), and others;
• medicines used to treat ulcerative colitis, such as mesalamine (Pentasa) or sulfasalazine (Azulfidine);
• medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune) or tacrolimus (Prograf);
• IV antibiotics such as amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet), amikacin (Amikin), bacitracin (Baci-IM), capreomycin (Capastat), gentamicin (Garamycin), kanamycin (Kantrex), streptomycin, or vancomycin (Vancocin, Vancoled);
• antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or
• cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), streptozocin (Zanosar), or tretinoin (Vesanoid).

This list is not complete and other drugs may interact with AREDIA. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.