Dosing & Uses
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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
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.
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
Warnings
Contraindications
Hypersensitivity to drug, other bisphosphonates, or excipients, including mannitol
Cautions
Bisphosphonates are incorporated into bone matrix, and gradually released over periods of weeks to years; may cause fetal harm when administered to a pregnant woman
Electrolyte disorders
- Cases of asymptomatic hypophosphatemia, hypokalemia, hypomagnesemia, and hypocalcemia, reported in association with pamidronate disodium-treated patients; rare cases of symptomatic hypocalcemia (including tetany) reported in association with pamidronate disodium therapy
- Monitor serum levels of calcium, phosphate, magnesium, and potassium, following initiation of therapy with pamidronate disodium; if hypocalcemia occurs, short-term calcium therapy may be necessary; in the absence of hypercalcemia, supplement with oral calcium and vitamin D in order to minimize risk of hypocalcemia
Osteonecrosis of the jaw (ONJ)
- ONJ reported predominantly in cancer patients treated with intravenous bisphosphonates; many of these patients were also receiving chemotherapy and corticosteroids, which may be risk factors for ONJ
- Postmarketing experience and literature suggest greater frequency of ONJ with certain tumor type (advanced breast cancer, multiple myeloma), and dental status (dental extraction, periodontal disease, local trauma including poorly fitting dentures)
- Local infection including osteomyelitis reported with ONJ; patients receiving pamidronate should maintain good oral hygiene and have a dental examination with preventive dentistry prior to initiation of treatment
- While on treatment, avoid invasive dental procedures if possible; for patients who develop ONJ while on bisphosphonate therapy, dental surgery may exacerbate the condition
- For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces risk of ONJ; clinical judgment of treating physician should guide management plan of each patient based on individual benefit/risk assessment
Atypical fractures of femur
- Atypical subtrochanteric and diaphyseal femoral fractures reported in patients receiving bisphosphonate therapy, including pamidronate disodium; these fractures can occur anywhere in the femoral shaft from just below the lesser trochanter to just above the supracondylar flare and are transverse or short oblique in orientation without evidence of comminution
- These fractures may occur after minimal or no trauma; patients may experience thigh or groin pain weeks to months before presenting with a completed femoral fracture; fractures are often bilateral; therefore, contralateral femur should be examined in bisphosphonate-treated patients who have sustained a femoral shaft fracture
- Poor healing of these fractures also reported; a number of case reports noted that patients were receiving treatment also with glucocorticoids (such as prednisone or dexamethasone) at time of fracture; causality with bisphosphonate therapy has not been established; any patient with history of bisphosphonate exposure who presents with thigh or groin pain in the absence of trauma should be evaluated for atypical fracture
- Consider discontinuation of pamidronate disodium therapy in patients suspected to have atypical femur fracture pending evaluation of patient, based on individual benefit-risk assessment; it is unknown whether risk of atypical femur fracture continues after stopping therapy
Renal impairment
- Bisphosphonates, such as pamidronate disodium, have been associated with renal toxicity, including focal segmental glomerulosclerosis; this toxicity has been manifested as nephritic syndrome, deterioration of renal function, and renal failure
- Renal failure has been reported in patients after a single dose of pamidronate disodium; some patients had gradual improvement in renal status after pamidronate disodium was discontinued
- Do not administer single doses of pamidronate disodium in excess of 90 mg due to risk of clinically significant deterioration in renal function
- Assess serum creatinine prior to each treatment; withhold treatment until renal function returns to baseline in patients who show evidence of deterioration in renal function; do not administer pamidronate in patients with severe renal impairment for treatment of bone metastases
Pregnancy & Lactation
Pregnancy
There are no adequate and well-controlled studies in pregnant women; therapy may cause fetal harm when administered to a pregnant woman
Bisphosphonates are incorporated into bone matrix, from where they are gradually released over periods of weeks to years; the extent of bisphosphonate incorporation into adult bone, and hence, amount available for release back into systemic circulation, is directly related to total dose and duration of bisphosphonate use
Although there are no data on fetal risk in humans, bisphosphonates do cause fetal harm in animals, and animal data suggest that uptake of bisphosphonates into fetal bone is greater than into maternal bone; therefore, there is a theoretical risk of fetal harm (eg, skeletal and other abnormalities) if a woman becomes pregnant after completing a course of bisphosphonate therapy
If the drug is used during pregnancy or if patient becomes pregnant while taking or after taking this drug, apprise the patient of potential hazard to fetus
Animal data
- In reproductive studies in rats and rabbits, doses equivalent to 0.6 to 8.3 times the highest human recommended dose resulted in maternal toxicity and embryo/fetal effects; the drug can cross the placenta in rats and has produced marked maternal and nonteratogenic embryo/fetal effects in both rats and rabbits
Lactation
It is not known whether pamidronate is excreted in human milk; because many drugs are excreted in human milk, and because of potential for serious adverse reactions in nursing infants from pamidronate disodium, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother
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.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)
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)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| pamidronate intravenous - | 30 mg vial |  | |
| pamidronate intravenous - | 90 mg vial |  | |
| pamidronate intravenous - | 90 mg/10 mL (9 mg/mL) 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 - | 60 mg/10 mL (6 mg/mL) vial |  | |
| pamidronate intravenous - | 30 mg/10 mL (3 mg/mL) vial |  | |
| pamidronate intravenous - | 90 mg/10 mL (9 mg/mL) vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
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 last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor 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 April 2022. Copyright(c) 2022 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.
Formulary
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