Pamidronate Treatment Report

Precautions

Instructions

Side Effects

Interactions

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

If you have certain conditions, you may need a pamidronate dose adjustment or special tests to safely use this medication. Before using pamidronate, tell your doctor if you have:

• kidney disease;
• a history of thyroid surgery; or
• if you are also taking thalidomide to treat bone marrow cancer.

FDA pregnancy category D. Pamidronate can cause harm to an unborn baby. Do not use pamidronate without telling your doctor 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 pamidronate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Some people using medicines similar to pamidronate 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.

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are using pamidronate.

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Call your doctor for instructions if you miss an appointment for your pamidronate injection.

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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:

• fever;
• severe joint, bone, or muscle pain;
• jaw pain, numbness, or swelling;
• painful or difficult urination;
• urinating less than usual or not at all;
• swelling, rapid weight gain;
• confusion, hallucinations, unusual thoughts or behavior;
• feeling like you might pass out;
• pale skin, easy bruising or bleeding, flu symptoms;
• seizure (convulsions);
• eye pain, vision changes, increased sensitivity to light; or
• uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling.

Less serious side effects may include:

• mild heartburn or stomach upset, loss of appetite;
• nausea, vomiting, stomach pain, gas, diarrhea, constipation;
• runny or stuffy nose, cough;
• increased sweating;
• numbness or tingly feeling;
• pain, burning, swelling or irritation around the IV needle;
• dizziness, drowsiness, weakness, tired feeling;
• mild joint or back pain; or
• headache.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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Pamidronate can be harmful to the kidneys, and these effects are increased when pamidronate is used together with other medicines that can harm the kidneys. Before taking pamidronate, tell your doctor if you are also using:

• 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 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), plicamycin (Mithracin), streptozocin (Zanosar), or tretinoin (Vesanoid).

You may need dose adjustments or special tests when taking any of these medications together with pamidronate.

This list is not complete and there may be other drugs that can interact with pamidronate. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Aredia and pamidronate

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