Pamidronate disodium

What is Pamidronate disodium?

• Pamidronate disodium (Aredia) is a bisphosphonate used to treat hypercalcemia (high blood levels of calcium) caused by certain types of cancer.
• It is also used with other anticancer drugs to treat multiple myeloma and breast cancer that has spread to bone.
• It is also used to treat Paget disease of the bone.

Pamidronate2DACS

What are the uses of this medicine?

Pamidronate disodium is approved to be given with chemotherapy to treat bone damage caused by:

• Breast cancer that has metastasized (spread) to bone.
• Multiple myeloma that has metastasized to bone.

Pamidronate disodium is also approved to treat:

• Hypercalcemia (high blood levels of calcium) caused by malignant tumors.

How does this medicine work?

• The principal pharmacologic action of pamidronate disodium is inhibition of bone resorption.
• Although the mechanism of antiresorptive action is not completely understood, several factors are thought to contribute to this action.
• Pamidronate disodium adsorbs to calcium phosphate (hydroxyapatite) crystals in bone and may directly block dissolution of this mineral component of bone.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• clinically significant hypersensitivity to pamidronate disodium or other bisphosphonates.

What drug interactions can this medicine cause?

• Concomitant administration of a loop diuretic had no effect on the calcium-lowering action of pamidronate disodium.
• Caution is indicated when pamidronate disodium is used with other potentially nephrotoxic drugs.
• In multiple myeloma patients, the risk of renal function deterioration may be increased when pamidronate disodium is used in combination with thalidomide.

Is this medicine FDA approved?

• It was patented in 1971 and approved for medical use in 1987.

How should this medicine be used?

Recommended dosage: Moderate Hypercalcemia:

• The recommended dose of pamidronate disodium in moderate hypercalcemia (corrected serum calcium* of approximately 12 to 13.5 mg/dL) is 60 to 90 mg given as a SINGLE DOSE, intravenous infusion over 2 to 24 hours. Longer infusions (i.e., >2 hours) may reduce the risk for renal toxicity, particularly in patients with preexisting renal insufficiency.

Severe Hypercalcemia:

• The recommended dose of pamidronate disodium in severe hypercalcemia (corrected serum calcium* >13.5 mg/dL) is 90 mg given as a SINGLE DOSE, intravenous infusion over 2 to 24 hours. Longer infusions (i.e., >2 hours) may reduce the risk for renal toxicity, particularly in patients with preexisting renal insufficiency.

Paget’s Disease:

• The recommended dose of pamidronate disodium in patients with moderate to severe Paget’s disease of bone is 30 mg daily, administered as a 4-hour infusion on 3 consecutive days for a total dose of 90 mg.

Osteolytic Bone Lesions of Multiple Myeloma:

• The recommended dose of pamidronate disodium in patients with osteolytic bone lesions of multiple myeloma is 90 mg administered as a 4-hour infusion given on a monthly basis.

Osteolytic Bone Metastases of Breast Cancer:

• The recommended dose of pamidronate disodium in patients with osteolytic bone metastases is 90 mg administered over a 2-hour infusion given every 3 to 4 weeks.

Administration:

• Pamidronate injection comes as a solution (liquid) to inject into a vein slowly, over 2 to 24 hours.
• It is usually injected by a health care provider in a doctor's office, hospital, or clinic.
• It may be given once every 3 to 4 weeks, once a day for 3 days in a row, or as a single dose that may be repeated after 1 week or longer.
• The treatment schedule depends on your condition.
• Your doctor may recommend a calcium supplement and a multivitamin containing vitamin D to take during your treatment.
• You should take these supplements every day as directed by your doctor.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Pamidronate disodium is a bisphosphonate available in 30 mg, 60 mg, or 90 mg vials for intravenous administration.

This medicine is available in fallowing brand namesː

• Aredia

What side effects can this medication cause?

The most common side effects of this medicine include:

• redness, swelling, or pain in the injection spot
• stomach pain
• loss of appetite
• constipation
• nausea
• vomiting
• heartburn
• change in ability to taste food
• sores in the mouth
• fever
• headache
• dizziness
• excessive tiredness
• difficulty falling asleep or staying asleep
• coughing
• difficulty urinating or painful urination
• swelling of the hands, arms, feet, ankles, or lower legs

Aredia may cause serious side effects, including:

• painful or swollen gums
• loosening of the teeth
• numbness or heavy feeling in the jaw
• poor healing of the jaw
• vomit that is bloody or looks like coffee grounds
• bloody or black and tarry stools
• shortness of breath
• fast heartbeat
• fainting
• sudden tightening of muscles
• numbness or tingling around the mouth
• eye pain or tearing

What special precautions should I follow?

• Bisphosphonates, including pamidronate disodium, have been associated with renal toxicity manifested as deterioration of renal function and potential renal failure. Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment.
• Standard hypercalcemia-related metabolic parameters, such as serum levels of calcium, phosphate, magnesium, and potassium, should be carefully monitored following initiation of therapy with pamidronate disodium.
• Osteonecrosis of the jaw (ONJ) has been reported predominantly in cancer patients treated with intravenous bisphosphonates, including pamidronate disodium. Cancer patients should maintain good oral hygiene and should have a dental examination with preventive dentistry prior to treatment with bisphosphonates. While on treatment, these patients should avoid invasive dental procedures if possible.
• In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates.
• Atypical subtrochanteric and diaphyseal femoral fractures have been reported in patients receiving bisphosphonate therapy, including pamidronate disodium. Any patient with a history of bisphosphonate exposure who presents with thigh or groin pain in the absence of trauma should be suspected of having an atypical fracture and should be evaluated. Discontinuation of pamidronate disodium therapy in patients suspected to have an atypical femur fracture should be considered.
• Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment. Serum calcium, electrolytes, phosphate, magnesium, and CBC, differential, and hematocrit/hemoglobin must be closely monitored in patients treated with pamidronate disodium.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hypocalcemia
• high fever
• hypotension
• transient taste perversion

Management of overdosage:

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

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies in pregnant women.
• Pamidronate disodium may cause fetal harm when administered to a pregnant woman.

Can this medicine be used in children?

• Safety and effectiveness of pamidronate disodium in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• PAMIDRONATE DISODIUM

Inactive ingredients:

• MANNITOL
• WATER
• PHOSPHORIC ACID
• SODIUM HYDROXIDE

Who manufactures and distributes this medicine?

• Distributed by Hospira, Inc.,
• Lake Forest, IL USA

What should I know about storage and disposal of this medication?

• Store at 20 to 25°C (68 to 77°F).

• Dailymed label info on Pamidronate disodium
• FDA Pamidronate disodium

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