Pamidronate (intravenous route)


    Brand Name

    US Brand Name

    Aredia


    Description

    Pamidronate injection is used to treat hypercalcemia (too much calcium in the blood) that may occur in patients with some types of cancer. It is also used to treat Paget's disease of bone, multiple myeloma (tumors formed by the cells of the bone marrow), and certain types of bone metastases (the spread of cancer to the bones).

    This medicine is to be administered only by or under the supervision of your doctor.

    This product is available in the following dosage forms:

    • Solution
    • Powder for Solution

    Before Using

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of pamidronate injection in the pediatric population. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pamidronate injection in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving pamidronate injection.

    Breastfeeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Drug Interactions

    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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    Other Medical Problems

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

    • Anemia or
    • Dehydration or
    • Heart disease or
    • Kidney disease or
    • Leukopenia (low number of white blood cells) or
    • Mineral imbalance (e.g., low calcium, magnesium, phosphorus, or potassium in the blood) or
    • Thrombocytopenia (low number of platelets)—Use with caution. May make these conditions worse.
    • Cancer, history of or
    • Dental or tooth problems or
    • Dental procedures or
    • Poor oral hygiene or
    • Surgery (e.g., dental surgery)—May increase risk for severe jaw problems.
    • Parathyroid disease (e.g., hypoparathyroidism) or
    • Thyroid surgery, history of—These conditions may increase your risk of having hypocalcemia (low levels of calcium in the blood).

    Proper Use

    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 .

    Precautions

    It is important that your doctor check your progress at regular visits after you have received pamidronate injection. 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.

    Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

    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.

    Your doctor will need to know if you have a history of problems with your mouth or teeth (e.g., gum disease). Make sure your doctor knows if you have been treated with a bisphosphonate medicine, such as alendronate (Fosamax®), etidronate (Didronel®), pamidronate (Aredia®), risedronate (Actonel®), or tiludronate (Skelid®) in the past.

    You may need to have a dental exam before you start using this medicine.

    It is important that you check with your doctor before having any dental procedures or surgeries done while you are receiving pamidronate. Tell your doctor right away if you have jaw tightness, swelling, numbing, or pain or a loose tooth. This could be symptoms of a severe problem of your jaw.

    Make sure you tell your doctor about any new medical problems, especially with your teeth or jaws. Tell your doctor right away if you have severe bone, joint, or muscle pain after receiving this medicine.

    This medicine may increase your risk of developing fractures of the thigh bone. This may be more common if you use it for a long time. Check with your doctor right away if you have a dull or aching pain in the thighs, groin, or hips.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


    Side Effects

    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 or nurse immediately if any of the following side effects occur:

    More common

    • Abdominal or stomach cramps
    • black, tarry stools
    • bloody in the urine or stools
    • blurred vision
    • chest pain
    • chills
    • confusion
    • convulsions (seizures)
    • decrease in the amount of urine
    • dizziness
    • drowsiness
    • fainting
    • fast or irregular heartbeat
    • fever
    • headache
    • increased thirst
    • loss of appetite
    • muscle pain, cramps, spasms, or twitching
    • nausea or vomiting
    • nervousness
    • noisy, rattling breathing
    • numbness or tingling in the hands, feet, or lips
    • pinpoint red spots on the skin
    • pounding in the ears
    • shortness of breath
    • slow or fast heartbeat
    • swelling of the fingers, hands, feet, or lower legs
    • trembling
    • troubled breathing at rest
    • unusual bleeding or bruising
    • unusual tiredness or weakness
    • 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 the mouth

    Rare

    • Decreased vision
    • difficulty with swallowing
    • eye pain or tenderness
    • eye redness
    • hives
    • itching
    • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
    • sensitivity of the eye to light
    • skin rash
    • sweating
    • tearing of the eye
    • tightness in the chest

    Incidence not known

    • Bone, joint, or muscle pain, severe and occasionally incapacitating
    • faintness, or lightheadedness when getting up suddenly from a lying or sitting position

    Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

    More common

    • Acid or sour stomach
    • belching
    • bladder pain
    • bloody or cloudy urine
    • body aches or pain
    • bone pain
    • constipation
    • cracks in the skin at the corners of mouth
    • diarrhea
    • difficult, burning, or painful urination
    • difficult or labored breathing
    • difficulty moving
    • ear congestion
    • fear
    • frequent urge to urinate
    • heartburn
    • indigestion
    • joint pain
    • lack or loss of strength
    • lower back or side pain
    • muscle aching, cramping, pains, or stiffness
    • nasal congestion
    • nervousness
    • pain and swelling at the injection site
    • sensitivity to heat
    • shivering
    • sneezing
    • soreness or redness around the fingernails and toenails
    • stomach discomfort, upset, or pain
    • sweating
    • swollen joints
    • trouble sleeping
    • weight loss

    Less common

    • Ammonia-like breath odor
    • feeling, seeing, or hearing things that are not there
    • feeling that others are watching you or controlling your behavior
    • feeling that others can hear your thoughts
    • feeling unusually cold
    • swelling or inflammation of the mouth
    • unusual behavior

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

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






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