pamidronate (Rx)

Brand and Other Names:Aredia
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

powder for reconstitution

  • 30mg

pamidronate injection solution as disodium

  • 3mg/mL
  • 6mg/mL
  • 9mg/mL

Hypercalcemia of Malignancy

Moderate hypercalcemia (ie, corrected serum calcium 12-13.5 mg/dL): 60-90 mg single-dose IV infusion over 2-24 hours

Severe hypercalcemia (ie, corrected serum calcium > 13.5 mg/dL): 90 mg single-dose IV infusion over 2-24 hours

Other information

  • Longer infusions (ie, >2 hours) may decrease renal toxicity risk, especially with pre-existing renal insufficiency
  • May repeat after at least 7 days in patients showing partial or complete response if serum calcium does not remain in normal range

Paget's Disease

30 mg IV infused over 4 hours qDay for 3 consecutive days (ie, total cumulative dose 90 mg)

Limited patients have received >1 treatment in clinical trials; may consider retreatment when clinically indicated

Osteolytic Bone Metastases of Breast Cancer

90 mg IV infusion over 2 hours q3-4Weeks

Osteolytic Bone Lesions of Multiple Myeloma

90 mg IV infusion over 4 hours qMonth

Prevention of Androgen Deprivation-induced Osteoporosis (Off-label)

60 mg IV infusion over 2 hours every 3 months or 90 mg administered once over 3-4 hours

Other Indications & Uses

Hypercalcemia of malignancy

Off-label: spondyloarthropathy

Safety & efficacy not established

Hypercalcemia of malignancy

Moderate hypercalcemia (ie, corrected serum calcium 12-13.5 mg/dL): 60-90 mg single-dose IV infusion over 2-24 hours

Severe hypercalcemia (ie, corrected serum calcium > 13.5 mg/dL): 90 mg single-dose IV infusion over 2-24 hours

Longer infusions (ie, >2 hours) may decrease renal toxicity risk, especially with pre-existing renal insufficiency

May repeat after at least 7 days in patients showing partial or complete response if serum calcium does not remain in normal range

Paget's disease

30 mg IV infused over 4 hours qDay for 3 consecutive days (ie, total cumulative dose 90 mg)Limited patients have received >1 treatment in clinical trials; may consider retreatment when clinically indicated

Osteolytic bone metastases of breast cancer

90 mg IV infusion over 2 hours q3-4Weeks

Osteolytic bone lesions of multiple myeloma

90 mg IV infusion over 4 hours qMonth

Prevention of androgen deprivation-induced osteoporosis (off-label)

60 mg IV infusion over 2 hours every 3 months or 90 mg administered once over 3-4 hours

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Interactions

Interaction Checker

and pamidronate

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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              Serious - Use Alternative (0)

                Monitor Closely (10)

                • aluminum hydroxide

                  aluminum hydroxide decreases levels of pamidronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

                • calcium acetate

                  calcium acetate decreases levels of pamidronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 30 minutes.

                • calcium carbonate

                  calcium carbonate decreases levels of pamidronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 30 minutes.

                • calcium chloride

                  calcium chloride decreases levels of pamidronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 30 minutes.

                • calcium citrate

                  calcium citrate decreases levels of pamidronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 30 minutes.

                • calcium gluconate

                  calcium gluconate decreases levels of pamidronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 30 minutes.

                • dichlorphenamide

                  dichlorphenamide and pamidronate both decrease serum potassium. Use Caution/Monitor.

                • sodium bicarbonate

                  sodium bicarbonate decreases levels of pamidronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

                • sodium citrate/citric acid

                  sodium citrate/citric acid decreases levels of pamidronate by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

                • tenofovir DF

                  pamidronate increases levels of tenofovir DF by decreasing renal clearance. Use Caution/Monitor. Combination may increase risk of nephrotoxicity.

                Minor (3)

                • entecavir

                  pamidronate, entecavir. Either increases effects of the other by decreasing renal clearance. Minor/Significance Unknown. Coadministration with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of either entecavir or the coadministered drug.

                • foscarnet

                  foscarnet increases effects of pamidronate by pharmacodynamic synergism. Minor/Significance Unknown. Risk of severe hypocalcemia.

                • teriparatide

                  teriparatide, pamidronate. Other (see comment). Minor/Significance Unknown. Comment: No advantage to bone density with combined treatment.

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                Adverse Effects

                >10%

                Anemia (42.5%)

                Urinary tract infectious disease (18.5%)

                Hypokalemia (18%)

                Hypophosphatemia (18%)

                Hypocalcemia (12%)

                Hypomagnesemia (12%)

                1-10%

                Seizure (2%)

                Frequency Not Defined

                Common

                • HTN
                • Fever
                • Abdominal pain, appetite loss, dyspepsia, nausea, vomiting
                • Injection site reaction
                • Bone pain
                • Cough. dyspnea, URI, sinusitis

                Serious

                • Osteonecrosis (primarily involving the jaw) reported predominantly in pts w/ cancer
                • Focal segmental glomerulosclerosis

                Postmarketing Reports

                General: reactivation of Herpes simplex and Herpes zoster, influenza-like symptoms

                CNS: confusion and visual hallucinations, sometimes in the presence of electrolyte imbalance

                Skin: rash, pruritus

                Special senses: conjunctivitis, orbital inflammation

                Renal and urinary disorders: Renal tubular disorders (RTD); tubulointerstitial nephritis, focal segmental glomerulosclerosis including the collapsing variant, nephrotic syndrome

                Laboratory abnormalities: hyperkalemia, hypernatremia, hematuria

                Allergy: Rare instances of allergic manifestations have been reported, including hypotension, dyspnea, or angioedema, and, very rarely, anaphylactic shock

                Osteonecrosis (primarily involving the jaw) reported predominantly in cancer patients treated with IV bisphosphonates; many of these patients were also receiving chemotherapy and corticosteroids which may be risk factors for ONJ

                Respiratory, thoracic and mediastinal disorders: ARDS, interstitial lung disease

                Musculoskeletal and connective tissue disorders: Severe and occasionally incapacitating bone, joint, and/or muscle pain; atypical subtrochanteric and diaphyseal femoral fractures

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                Warnings

                Contraindications

                Pregnancy

                Hypersensitivity

                Cautions

                Associated with renal toxicity, including potential renal failure (do not exceed single dose of 90 mg)

                Severe renal impairment, musculoskeletal pain

                Electrolyte abnormalities and myelosuppression may occur

                Increased risk of osteonecrosis of the jaw (advise patients against dental work during IV bisphosphonate treatment)

                Atypical subtrochanteric and diaphyseal femoral fractures reported with bisphosphonates; may present as thigh/groin pain in absence of trauma

                May cause fetal harm when administered to pregnant women; bisphosphonates are incorporated into the bone matrix and gradually released over periods of weeks to years

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                Pregnancy & Lactation

                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.

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                Pharmacology

                Mechanism of Action

                Bisphosphonate which inhibits bone resorption via actions on osteoclast activity, leading to an indirect increase in bone density

                Pharmacokinetics

                Half-Life: 21-35 hours

                Duration: hypercalcemia of malignancy (IV): 2 wk to 2 mth

                Bioavailability: Poor; pharmacokinetic studies not available

                Metabolism: None

                Renal clearance: 49 mL/min

                Excretion: Urine

                Onset

                • Hypercalcemia of malignancy: Initial effect 1-2 days; max effect 5-7 days (IV)
                • Paget's disease: 1-3 months (maximum effect IV)
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                Administration

                IV Incompatibilities

                Calcium-containing diluents such as LR

                IV Preparation

                Reconstitute by adding 10 mL of SWI to a vial

                May be further diluted in 250-1000 mL of 1/2NS, NS or D5W

                IV Administration

                Slowly infuse over 2-24 hours

                Longer infusion may reduce risk of nephrotoxicity

                Storage

                Do not store powder for reconstitution above 30°C (86°F)

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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                pamidronate intravenous
                -
                90 mg/10 mL (9 mg/mL) vial
                pamidronate intravenous
                -
                60 mg/10 mL (6 mg/mL) vial
                pamidronate intravenous
                -
                30 mg/10 mL (3 mg/mL) vial
                pamidronate intravenous
                -
                90 mg vial
                pamidronate intravenous
                -
                30 mg/10 mL (3 mg/mL) vial
                pamidronate intravenous
                -
                30 mg/10 mL (3 mg/mL) vial
                pamidronate intravenous
                -
                90 mg/10 mL (9 mg/mL) vial
                pamidronate intravenous
                -
                30 mg vial
                pamidronate intravenous
                -
                90 mg/10 mL (9 mg/mL) vial

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Patient Education
                pamidronate intravenous

                PAMIDRONATE - INJECTION

                (PAM-i-DROE-nate)

                COMMON BRAND NAME(S): Aredia

                USES: Pamidronate is used to treat high blood calcium levels and certain bone problems (bone metastases/lesions) that may occur with some types of cancer. It is also used to treat a certain type of bone disease (Paget's disease) that causes abnormal and weak bones.Pamidronate belongs to a class of drugs known as bisphosphonates. It works by slowing the release of calcium from bones to lower blood calcium levels, reducing the risk of broken bones (fractures) and reducing bone pain.

                HOW TO USE: This medication is given by slow injection into a vein for at least 2 hours, but up to 24 hours, or as directed by your doctor.The dosage is based on your medical condition, laboratory tests, and response to treatment. Your doctor will order blood tests to check your kidney function prior to each treatment with this medication. The usual maximum adult dose of this medication is 90 milligrams for a single dose.If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.If you are being treated for a high blood calcium level, you may receive only a single dose of pamidronate. If you are being treated for cancer-related bone problems, you may receive a dose every 3 to 4 weeks. If you are being treated for Paget's disease, you may receive treatment daily for 3 days. Consult your doctor or pharmacist for more details.During treatment with this medication, it is important that you take in plenty of fluids and pass urine frequently to help avoid kidney problems. Intravenous fluids are usually given with this medication. Ask your doctor how much fluid you should drink, and follow these instructions carefully.It may take up to 7 days before the full benefit of this drug takes effect.Tell your doctor if your condition does not improve or if it worsens.

                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 right away 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, new or unusual hip/thigh/groin pain, eye problems (such as redness/itching/swelling or sensitivity to light), signs of kidney problems (such as 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 or at www.fda.gov/medwatch.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, dehydration, heart failure.Some people using pamidronate may have serious jawbone problems. Your doctor should check your mouth before you start this medication. Tell your dentist that you are using this medication before you have any dental work done. To help prevent jawbone problems, have regular dental exams and learn how to keep your teeth and gums healthy. If you have jaw pain, tell your doctor and dentist right away.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.)This drug may rarely make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).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.

                DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: other bisphosphonates (such as alendronate), other medications which may affect the kidneys (including NSAIDs such as ibuprofen or naproxen).

                OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: muscle spasms or numbness/tingling (especially around the lips/mouth).

                NOTES: Laboratory and/or medical tests (such as calcium, magnesium, phosphate, and potassium blood levels, complete blood count, albumin, kidney function tests such as serum creatinine) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

                MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

                STORAGE: Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

                Information last revised May 2021. Copyright(c) 2021 First Databank, Inc.

                IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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