Aredia

DRUG DESCRIPTION

Aredia, pamidronate disodium (APD), is a bone-resorption inhibitor available in 30-mg or 90-mg vials for intravenous administration. Each 30-mg and 90-mg vial contains, respectively, 30 mg and 90 mg of sterile, lyophilized pamidronate disodium and 470 mg and 375 mg of mannitol, USP. The pH of a 1% solution of pamidronate disodium in distilled water is approximately 8.3. Aredia (pamidronate disodium) , a member of the group of chemical compounds known as bisphosphonates, is an analog of pyrophosphate. Pamidronate disodium is designated chemically as phosphonic acid (3-amino-l-hydroxypropylidene) bis-, disodium salt, pentahydrate, (APD), and its structural formula is

Aredia® (pamidronate disodium) Structural Formula Illustration

Pamidronate disodium is a white-to-practically-white powder. It is soluble in water and in 2N sodium hydroxide, sparingly soluble in 0.1N hydrochloric acid and in 0.1N acetic acid, and practically insoluble in organic solvents. Its molecular formula is C3H9NO7P2Na2•5H2O and its molecular weight is 369.1.

Inactive Ingredients. Mannitol, USP, and phosphoric acid (for adjustment to pH 6.5 prior to lyophilization).

What are the possible side effects of pamidronate (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:

  • 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...

Read All Potential Side Effects and See Pictures of Aredia »

What are the precautions when taking pamidronate disodium (Aredia)?

Before using pamidronate, tell your doctor or pharmacist if you are allergic to it; or other bisphosphonates (such as alendronate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: recent or planned dental procedures (such as tooth removal), parathyroid/thyroid surgery, kidney problems, severe loss of body water (dehydration), heart failure.

Infrequently, people taking this class of medication (bisphosphonates) have had serious jawbone problems (osteonecrosis). Lack of proper dental hygiene, poorly fitting dentures, or certain dental procedures...

Read All Potential Precautions of Aredia »


Aredia Consumer (continued)

SIDE EFFECTS: Flu-like symptoms (such as mild fever, chills, fatigue, muscle/joint aches) may occur after treatment. Most of these effects are mild and can last up to 48 hours. Bone pain, redness/swelling/pain at the infusion site, headache, dizziness, loss of appetite, nausea, vomiting, diarrhea, drowsiness or trouble sleeping may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if you experience any symptoms of low calcium such as muscle spasms or numbness/tingling (especially around the lips/mouth). Your doctor may ask you to take calcium and vitamin D supplements to prevent low blood calcium levels after treatment.

Tell your doctor right away if you have any serious side effects, including: trouble breathing, sores in jaw/mouth, jaw pain, increased or severe bone/joint/muscle pain, eye problems (such as redness/itching/swelling or sensitivity to light), change in the amount of urine, unusual tiredness/weakness, mental/mood changes (such as irritability or confusion), fast/pounding/irregular heartbeat.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using pamidronate, tell your doctor or pharmacist if you are allergic to it; or other bisphosphonates (such as alendronate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: recent or planned dental procedures (such as tooth removal), parathyroid/thyroid surgery, kidney problems, severe loss of body water (dehydration), heart failure.

Infrequently, people taking this class of medication (bisphosphonates) have had serious jawbone problems (osteonecrosis). Lack of proper dental hygiene, poorly fitting dentures, or certain dental procedures (such as tooth extraction, dental surgery) may increase your risk. Medical conditions (such as gum disease/infection, cancer, anemia) might also increase the risk. If you develop jaw pain, tell your doctor and dentist immediately.

Before having any surgery (especially dental procedures), tell your doctor and dentist about this medication and all other products you use (including prescription drugs, nonprescription drugs, and herbal products). Your doctor or dentist may tell you to stop taking pamidronate before your surgery. Ask for specific instructions about stopping or starting this medication.

This medication may cause severe kidney problems. Consult your doctor or pharmacist for more information. To help prevent harm to your kidneys, drink plenty of fluids unless otherwise directed by your doctor. (See also How to Use section.)

Rarely, this drug may make some people dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Caution is advised if you are pregnant or planning to become pregnant in the future. This medication is not recommended for use during pregnancy. It may stay in your body for several years and may harm an unborn baby. Consult your doctor for information on reliable forms of birth control.

It is unknown if pamidronate passes into breast milk. Discuss the risks and benefits with your doctor before breast-feeding.


Aredia Patient Information Including Side Effects

Brand Names: Aredia

Generic Name: pamidronate (Pronunciation: PAM i DROE nate)

  • What is pamidronate (Aredia)?
  • What are the possible side effects of pamidronate (Aredia)?
  • What is the most important information I should know about pamidronate (Aredia)?
  • What should I discuss with my healthcare provider before using pamidronate (Aredia)?
  • How is pamidronate given (Aredia)?
  • What happens if I miss a dose (Aredia)?
  • What happens if I overdose (Aredia)?
  • What should I avoid while using pamidronate (Aredia)?
  • What other drugs will affect pamidronate (Aredia)?
  • Where can I get more information?

What is pamidronate (Aredia)?

Pamidronate is in a group of medicines called bisphosphonates (bis FOS fo nayts). It alters the cycle of bone formation and breakdown in the body.

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

Pamidronate is used to treat bone damage caused by certain types of cancer such as breast cancer or bone marrow cancer. Pamidronate does not treat cancer. Use all other medications your doctor has prescribed for those conditions.

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

What are the possible side effects of pamidronate (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:

  • 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, redness, swelling or a hard painful lump under your skin 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about pamidronate (Aredia)?

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).

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.

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.

Some people using medicines similar to pamidronate have developed bone loss in the jaw, also called osteonecrosis of the jaw. Call your doctor if you have symptoms such as jaw pain, swelling, numbness, loose teeth, gum infection, or slow healing after injury or surgery involving the gums.

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 about all other medications you use. Many drugs (including some over-the-counter medicines) can be harmful to the kidneys.

Serious side effects of pamidronate include 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, and fainting or seizure.

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