Aredia

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

Pamidronate 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 pamidronate. 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.

Aredia is a prescription medication used to treat high blood levels of calcium (hypercalcemia) in patients with cancer and Paget's disease. Aredia belongs to a group of drugs called bisphosphonates. These medications work by slowing the breakdown of bone, increasing bone density, and decreasing the amount of calcium released from the bones.

This medication comes in an injectable form that is injected slowly into a vein (IV), over 2 to 24 hours. It is usually given in a doctor's office, hospital, or clinic.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that affect the kidneys including:
  • non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve),
  • certain diuretics ("water pills"),
  • thalidomide (Thalomid),
  • vancomycin (Vancocin),
  • cancer chemotherapy medications,
  • certain antibiotics
• oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone)

This is not a complete list of Aredia drug interactions. Ask your doctor or pharmacist for more information.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Aredia there are no specific foods that you must exclude from your diet when receiving this medication.

Paget's disease: the recommended Aredia dosage is 30 mg daily for three days.

Multiple myeloma: the usual dosage is 90 mg once a month.

Breast cancer that has spread to bones: the recommended dosage is 90 mg every three to four weeks.

High blood calcium: the recommended dosage varies from 60 to 90 mg, as a single dose. Sometimes a second dose is necessary.

Pregnancy Category: D

Lactation: not known if crosses in to breast milk, avoid

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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).

To make sure you can safely use pamidronate, 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 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.

FDA pregnancy category D. Do not use pamidronate 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. You should not breast-feed while you are using pamidronate.

Storage

Parenteral

≤30°C or 20–25°C depending on manufacturer; consult manufacturers’ labelings.1 53

Store vials of reconstituted solution at 2–8°C for up to 24 hours.1 53

20–25°C or below 25°C depending on manufacturer; consult manufacturers’ labelings.52 53

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Do not mix with other drugs.1 52 53

Solution Compatibility1 52 53

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in a vein.

Your doctor may also give you vitamins containing Vitamin D and calcium. Tell your doctor if you are unable to take these supplements.

Drink extra fluids so you will pass more urine while you are using this medicine. This will keep your kidneys working well and help prevent kidney problems. However, it is also important to not drink too much liquid. Talk to your doctor about the right amount of liquids for you.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• 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. If your doctor decides that you need additional doses, you will receive the medicine again after at least 7 days have passed.
    • Children—Use and dose must be determined by your doctor .
  • For treating Paget's disease of bone:
    • Adults—30 mg in a solution to be injected over 4 hours into a vein, for 3 consecutive days. Your doctor will decide if you need more than 3 doses.
    • Children—Use and dose must be determined by your doctor .
  • For treating multiple myeloma:
    • Adults—90 mg in a solution to be injected over 4 hours into a vein once per month. Your doctor will decide how long this treatment should continue.
    • 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 hours into a vein once every 3 to 4 weeks. Your doctor will decide how long this treatment should continue.
    • Children—Use and dose must be determined by your doctor .

Aredia may cause fetal harm when administered to a pregnant woman. (See PRECAUTIONS, Pregnancy Category D.)

There are no studies in pregnant women using Aredia. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.

Studies conducted in young rats have reported the disruption of dental dentine formation following single- and multi-dose administration of bisphosphonates. The clinical significance of these findings is unknown.

There have been several cases of drug maladministration of intravenous Aredia in hypercalcemia patients with total doses of 225 mg to 300 mg given over 2 ½ to 4 days. All of these patients survived, but they experienced hypocalcemia that required intravenous and/or oral administration of calcium. Single doses of Aredia should not exceed 90 mg and the duration of the intravenous infusion should be no less than 2 hours. (See WARNINGS.)

In addition, one obese woman (95 kg) who was treated with 285 mg of Aredia/day for 3 days experienced high fever (39.5°C), hypotension (from 170/90 mmHg to 90/60 mmHg), and transient taste perversion, noted about 6 hours after the first infusion. The fever and hypotension were rapidly corrected with steroids.

If overdosage occurs, symptomatic hypocalcemia could also result; such patients should be treated with short-term intravenous calcium.