Pamidronate Disodium 3 mg/mL Injection
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Bisphosphonate class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Pamidronate is used for conditions where bones are breaking down too fast. Depending on what your doctor has prescribed it for, it could be treating dangerously high calcium in you...
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- Pamidronate is given through an IV line in a clinic or hospital — you can't take it as a pill. Each infusion takes at least 2 hours, and sometimes longer. The slower pace is intent...
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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UNII E4GA8884NN
Phosphoric acid is a weak mineral acid used in medicines as a buffer and pH adjuster. It helps stabilize the product and control its acidity level.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
3 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $1.17 | $1.17 / 1 vial |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J2430 | $12.025 / J2430 unit | — |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Pamidronate Disodium 3 mg/mL 61703-0324-18 | Hospira, | 1 vial | — | AP | FDA listed | — |
| Pamidronate Disodium 3 mg/mLthis 67457-0430-10 | Mylan | 1 vial | — | AP2 | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 67457-0430-10 You're viewing this | 1 VIAL in 1 CARTON (67457-430-10) / 10 mL in 1 VIAL | 2008-11-01 | Active |
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| NDC identity (package / product / labeler codes) | ✓ Available |
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| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Pamidronate disodium is a bisphosphonate indicated for the treatment of: • moderate or severe hypercalcemia associated with malignancy, with or without bone metastases ( 1.1 ) • patients with moderate to severe Paget’s disease of bone ( 1.2 ) • osteolytic bone metastases of breast cancer or osteolytic lesions of multiple myeloma, in conjunction with standard antineoplastic therapy ( 1.3 ) Limitations of use Safety and efficacy of pamidronate disodium in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions have not been established.
( 1.4 )
1.1Hypercalcemia of Malignancy Pamidronate disodium is indicated for the treatment of moderate or severe hypercalcemia associated with malignancy, with or without bone metastases.
1.2Paget’s Disease Pamidronate disodium is indicated for the treatment of patients with moderate to severe Paget’s disease of bone.
1.3Osteolytic Bone Metastases of Breast Cancer and Osteolytic Lesions of Multiple Myeloma Pamidronate disodium is indicated in conjunction with standard antineoplastic therapy, for the treatment of osteolytic bone metastases of breast cancer and osteolytic lesions of multiple myeloma [see Clinical Studies (14.3) ] .
1.4Limitations of Use The safety and efficacy of pamidronate disodium in the treatment of hypercalcemia associated with hyperparathyroidism or with other non-tumor-related conditions has not been established.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION • Hypercalcemia of malignancy: 60 mg to 90 mg pamidronate disodium as a single dose infused over 2 hours to 24 hours for moderate hypercalcemia, or 90 mg as a single dose infused over 2 hours to 24 hours for severe hypercalcemia. If warranted, retreat after a minimum of 7 days. ( 2.1 ) • Paget’s disease of bone: 30 mg pamidronate disodium daily as a 4-hour infusion on 3 consecutive days.
( 2.2 ) • Osteolytic Bone Metastases of Breast Cancer: 90 mg pamidronate disodium as a 2-hour infusion every 3 to 4 weeks. Retreat after recovery of renal function. ( 2.3 ) • Osteolytic Bone Lesions of Multiple Myeloma: 90 mg pamidronate disodium as a 4-hour infusion once every four weeks.
Retreat after recovery of renal function. ( 2.3 ) • Administer through a separate infusion line. Do not allow pamidronate disodium infusion to come in contact with any calcium or divalent cation-containing solutions.
( 2.6 )
2.1Hypercalcemia of Malignancy Vigorous saline hydration, should be initiated promptly along with pamidronate therapy and if possible the urine output should be about 2 L/day throughout treatment [see Warnings and Precautions (5.2) ] . Patients who receive pamidronate disodium should have serum creatinine assessed prior to each treatment [see Warnings and Precautions (5.1) ] . Treatment should be withheld for renal deterioration.
Moderate Hypercalcemia The recommended dose of pamidronate disodium in moderate hypercalcemia (corrected serum calcium* of approximately 12 mg/dL to 13.5 mg/dL) is 60 mg to 90 mg given as a single-dose, intravenous infusion over 2 hours to 24 hours. Longer infusions (i.e., greater than 2 hours) may reduce the risk for renal toxicity, particularly in patients with preexisting renal impairment. 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., greater than 2 hours) may reduce the risk for renal toxicity, particularly in patients with preexisting renal insufficiency/impairment. *Albumin-corrected serum calcium = serum calcium, mg/dL + 0.8 (4.0-serum albumin, g/dL). Retreatment Retreatment with pamidronate disodium in patients who show complete or partial response initially may be carried out if serum calcium does not return to normal or remain normal after initial treatment. A minimum of 7 days between treatments is recommended to allow for full response to the initial dose.
The dose and manner of retreatment is identical to that of the initial therapy.
2.2Paget’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. When clinically indicated, patients should be retreated at the dose of initial therapy.
2.3Osteolytic Bone Metastases of Breast Cancer and Osteolytic Lesions of Multiple Myeloma 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. In a clinical study, renal deterioration was defined as follows: • With normal baseline creatinine, an increase of 0.5 mg/dL. • With abnormal baseline creatinine, an increase of 1 mg/dL. In this clinical study, pamidronate disodium treatment was resumed only when the creatinine returned to within 10% of the baseline value.
The optimal duration of therapy is not known; however, in two breast cancer studies, final analyses performed after 24 months of therapy demonstrated overall benefits [see Clinical Studies (14.3) ] . 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 administered every four weeks. Patients with marked Bence-Jo…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: 30 mg/10 mL (3 mg/mL) and 90 mg/10 mL (9 mg/mL) solution in single-dose vials • Injection: 30 mg/10 mL (3 mg/mL) and 90 mg/10 mL (9 mg/mL) solution in single-dose vials ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Pamidronate disodium is contraindicated in patients with hypersensitivity to pamidronate disodium, other bisphosphonates, or mannitol. Reactions to pamidronate disodium injection and to mannitol have included anaphylaxis. Hypersensitivity to pamidronate, other bisphosphonates, or mannitol ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Renal failure: Do not exceed single doses of 90 mg pamidronate disodium. Assess renal function before each treatment. In patients with bone metastases with severe renal impairment, use of pamidronate disodium is not recommended.
( 5.1 ) • Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. ( 5.2 , 8.1 , 8.3 ) • Electrolyte disorders (e.g., hypophosphatemia, hypokalemia, hypomagnesemia, hypocalcemia): Monitor phosphorus, potassium, magnesium, calcium and vitamin D and adequately supplement as appropriate.
( 5.3 ) • Osteonecrosis of the jaw: Perform preventive dental procedures prior to initiating pamidronate disodium. Avoid invasive procedures if possible in patients receiving pamidronate disodium. ( 5.4 ) • Atypical fractures of the femur can occur after minimal or no trauma.
Evaluate patients with thigh or groin pain for possible fracture. ( 5.5 )
5.1Deterioration in Renal Function, Use in Patients with 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 the risk of clinically significant deterioration in renal function, [see Dosage and Administration (2.5) ] . 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 the treatment of bone metastases [see Dosage and Administration (2.1 , 2.2 , 2.3) ] .
5.2Embryo-Fetal Toxicity Based on findings in animals and its mechanism of action, pamidronate disodium can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . In reproductive studies, administration of pamidronate to pregnant rats and rabbits at doses equivalent to 0.6 to 8.3 times the highest human recommended dose resulted in maternal toxicity and embryo-fetal effects. Bisphosphonates, such as pamidronate disodium, are incorporated into the bone matrix, from where they are gradually released over periods of weeks to years.
There may be a risk of fetal harm (e.g., skeletal and other abnormalities) if a woman becomes pregnant after completing a course of bisphosphonate therapy. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during and after pamidronate disodium treatment [see Use in Specific Populations (8.1 , 8.3) ] .
5.3Electrolyte Disorders Cases of asymptomatic hypophosphatemia (12%), hypokalemia (7%), hypomagnesemia (11%), and hypocalcemia (5% to 17%), were reported in pamidronate disodium-treated patients. Cases of symptomatic hypocalcemia (including tetany) have been 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 the risk of hypocalcemia.
5.4Osteonecrosis of the Jaw Osteonecrosis of the jaw (ONJ) has been reported predominantly in cancer patients treated with intravenous bisphosphonates, including pamidronate disodium. Many of these patients were also receiving chemotherapy and corticosteroids, which may be risk factors for ONJ. Postmarketing experience and the literature…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are described, or described in greater detail, in other sections: - Deterioration in renal function [see Warnings and Precautions (5.1) ] - Electrolyte disorders [see Warnings and Precautions (5.3) ] - Osteonecrosis of the jaw [see Warnings and Precautions (5.4) ] - Atypical fractures of the femur [see Warnings and Precautions (5.5) ] Most common adverse reactions per indication: • Hypercalcemia of malignancy (≥ 15%): Fever, nausea, infusion site reactions, hypocalcemia, hypophosphatemia ( 6.1 ) • Paget’s disease (≥ 10%): Temperature increase, hypertension, arthrosis, bone pain, headache ( 6.1 ) • Osteolytic bone metastases of breast cancer or osteolytic lesions of multiple myeloma (≥ 30%): Skeletal pain, nausea, anemia, fever, fatigue, vomiting, dyspnea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Hypercalcemia of Malignancy Transient elevation of temperature by at least 1°C was noted 24 to 48 hours after administration of pamidronate disodium in 34% of patients in clinical trials. Local soft-tissue reactions (redness, swelling or induration and pain on palpation) at the site of catheter insertion were observed, most commonly in patients treated with 90 mg of pamidronate disodium.
Symptomatic treatment resulted in resolution in all patients. Cases of uveitis, iritis, scleritis, and episcleritis have been reported, including one case of scleritis and one case of uveitis upon separate rechallenges. Five of 231 patients (2%) who received pamidronate disodium while enrolled on controlled clinical trials for management of hypercalcemia were reported to have seizures, including two patients with pre-existing seizure disorders.
One patient on the control (saline arm) also had a seizure. At least 15% of patients treated with pamidronate disodium for hypercalcemia of malignancy experienced the following adverse reactions during a clinical trial: General: Fluid overload, generalized pain Cardiovascular: Hypertension Gastrointestinal: Abdominal pain, anorexia, constipation, nausea, vomiting Genitourinary: Urinary tract infection Musculoskeletal: Bone pain Laboratory abnormality: Anemia, hypokalemia, hypomagnesemia, hypophosphatemia Table 1 lists the adverse reactions reported during comparative, controlled trials.
Table 1: Adverse Reactions Reported in Three U.S. Controlled Clinical Trials Percent of Patients Pamidronate Disodium Etidronate Disodium Saline 60 mg over 4 hr 60 mg over 24 hr 90 mg over 24 hr 7.5 mg/kg x 3 days n = 23 n = 73 n = 17 n = 35 n = 23 General Edema 0 1 0 0 0 Fatigue 0 0 12 0 0 Fever 26 19 18 9 0 Infusion-site reaction 0 4 18 0 0 Moniliasis 0 0 6 0 0 Gastrointestinal Abdominal pain 0 1 0 0 0 Anorexia 4 1 12 0 0 Constipation 4 0 6 3 0 Diarrhea 0 1 0 0 0 Dyspepsia 4 0 0 0 0 Gastrointestinal hemorrhage 0 0 6 0 0 Nausea 4 0 18 6 0 Stomatitis 0 1 0 3 0 Vomiting 4 0 0 0 0 Respiratory Rales 0 0 6 0 0 Rhinitis 0 0 6 0 0 Upper respiratory infection 0 3 0 0 0 CNS Insomnia 0 1 0 0 0 Psychosis 4 0 0 0 0 Somnolence 0 1 6 0 0 Cardiovascular Atrial fibrillation 0 0 6 0 4 Atrial flutter 0 1 0 0 0 Cardiac failure 0 1 0 0 0 Hypertension 0 0 6 0 4 Syncope 0 0 6 0 0 Tachycardia 0 0 6 0 4 Endocrine Hypothyroidism 0 0 6 0 0 Hemic and Lymphatic Anemia 0 0 6 0 0 Leukopenia 4 0 0 0 0 Neutropenia 0 1 0 0 0 Thrombocytopenia 0 1 0 0 0 Musculoskeletal Myalgia 0 1 0 0 0 Urogenital Uremia 4 0 0 0 0 Laboratory Abnormalities Hypocalcemia 0 1 12 0 0 Hypokalemia 4 4 18 0 0 Hypomagnesemia 4 10 12 3 4 Hypophosphatemia 0 9 18 3 0 Paget’s Disease Adverse reactions that occurred in at least 5% of patients with Pa…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS • Nephrotoxic drugs: Use with caution. ( 7.1 ) • Thalidomide: Increased risk of renal dysfunction in patients with multiple myeloma. ( 7.2 )
7.1Nephrotoxic Drugs Caution is indicated when pamidronate disodium is used with other potentially nephrotoxic drugs.
7.2Thalidomide In multiple myeloma patients, the risk of renal deterioration may be increased when pamidronate disodium is used in combination with thalidomide.
7.3Loop Diuretics Concomitant administration of a loop diuretic had no effect on the calcium-lowering action of pamidronate disodium.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS • Lactation: Advise not to breastfeed. ( 8.2 ) • Infertility: May impair fertility. ( 8.3 )
8.1Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1) ] , pamidronate disodium can cause fetal harm when administered to a pregnant woman. Available data from case reports with pamidronate disodium use in pregnant women are insufficient to inform a drug-associated risk. Administration of pamidronate to pregnant rats and rabbits resulted in maternal toxicity and embryo-fetal effects (see Data ) .
Bisphosphonates, such as pamidronate disodium, are incorporated into the bone matrix, from where they are gradually released over periods of weeks to years. There may be a risk of fetal harm (e.g., skeletal and other abnormalities) if a woman becomes pregnant after completing a course of bisphosphonate therapy. Advise pregnant women and females of reproductive potential of the potential risk to a fetus.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In animal reproduction studies, intravenous administration of pamidronate to pregnant rats and rabbits during the period of organogenesis resulted in maternal toxicity and embryo-fetal effects at doses of 0.6 to 8.3 times the highest recommended human dose for a single intravenous infusion.
8.2Lactation Risk Summary There are limited data on the presence of pamidronate or its metabolites in human milk, its effects on a breastfed child, or its effects on milk production. Pamidronate disodium binds to bone long term and may be released over periods of weeks to years. Because of the potential for serious adverse reactions in a breastfed child, advise lactating women not to breastfeed during and after pamidronate disodium treatment.
8.3Females and Males of Reproductive Potential Pamidronate disodium can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ]. Pregnancy Testing Verify pregnancy status of females of reproductive potential prior to initiation of pamidronate disodium. Contraception Females Pamidronate disodium binds to bone long term and may be released over periods of weeks to years.
Advise females of reproductive potential to use effective contraception during and after pamidronate disodium treatment. Infertility Based on animal studies, pamidronate disodium may impair fertility in males and females of reproductive potential [see Nonclinical Toxicology (13.1) ].
8.4Pediatric Use Safety and effectiveness of pamidronate disodium in pediatric patients have not been established.
8.5Geriatric Use Of the total number of subjects in clinical studies of pamidronate disodium, approximately 20% were 65 and over, while approximately 15% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
8.6Patients with Renal Impairment The renal clearance of pamidronate was reduced in patients with reduced creatinine clearance. Because pamidronate disodium is administered on a monthly basis, drug accumulation is not expected. No changes in pamidronate disodium dosing regimen are recommended for patients with mild to moderate renal impairment (creatinine clearance > 30 mL/min).
Limited pharmacokinetic data exist in patients with creatinine clearance < 30 mL/min [see Warnings and Precautions (5.1) and Clinic…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1) ] , pamidronate disodium can cause fetal harm when administered to a pregnant woman. Available data from case reports with pamidronate disodium use in pregnant women are insufficient to inform a drug-associated risk. Administration of pamidronate to pregnant rats and rabbits resulted in maternal toxicity and embryo-fetal effects (see Data ) .
Bisphosphonates, such as pamidronate disodium, are incorporated into the bone matrix, from where they are gradually released over periods of weeks to years. There may be a risk of fetal harm (e.g., skeletal and other abnormalities) if a woman becomes pregnant after completing a course of bisphosphonate therapy. Advise pregnant women and females of reproductive potential of the potential risk to a fetus.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In animal reproduction studies, intravenous administration of pamidronate to pregnant rats and rabbits during the period of organogenesis resulted in maternal toxicity and embryo-fetal effects at doses of 0.6 to 8.3 times the highest recommended human dose for a single intravenous infusion.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of pamidronate disodium in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the total number of subjects in clinical studies of pamidronate disodium, approximately 20% were 65 and over, while approximately 15% were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
🆘 Overdosage ▾
10 OVERDOSAGE Cases of drug overdose have been reported in hypercalcemia patients treated with total doses of 225 mg to 300 mg pamidronate disodium given over 2.5 to 4 days. All patients survived, but all developed hypocalcemia that required intravenous and/or oral administration of calcium. If overdosage occurs, treat symptomatic hypocalcemia patients with short-term intravenous calcium.
Single doses of pamidronate disodium should not exceed 90 mg, and the duration of the intravenous infusion should be no less than 2 hours [see Dosage and Administration (2.5) and Warnings and Precautions (5.1) ] . In addition, one obese woman (95 kg) who was treated with 285 mg of pamidronate disodium/day for 3 days experienced high fever (39.5°C), hypotension (from 170/90 mmHg to 90/60 mmHg), and transient taste perversion, occurring about 6 hours after the first infusion. Fever and hypotension reversed with steroid therapy.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action 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 block dissolution of this mineral component of bone.
In vitro , pamidronate disodium inhibited osteoclast activity. In animal studies, pamidronate disodium inhibited bone resorption, but did not inhibit bone formation and mineralization. In animal tumor models, pamidronate disodium inhibited the increased osteoclast activity induced by tumors.
12.2Pharmacodynamics Serum phosphate levels have been noted to decrease after administration of pamidronate disodium, presumably because of decreased release of phosphate from bone and increased renal excretion as parathyroid hormone levels, which are usually suppressed in hypercalcemia associated with malignancy, return toward normal. Phosphate therapy was administered in 30% of the patients in response to a decrease in serum phosphate levels. Phosphate levels usually returned toward normal within 7 to 10 days.
Urinary calcium/creatinine and urinary hydroxyproline/creatinine ratios decrease and usually return to within or below normal after treatment with pamidronate disodium. These changes occur within the first week after treatment, as do decreases in serum calcium levels, and are consistent with an antiresorptive pharmacologic action.
12.3Pharmacokinetics Table 3 shows maximum concentration, percent of dose excreted in urine, total clearance, and renal clearance of pamidronate after an intravenous infusion of 30, 60, or 90 mg of pamidronate disodium over 4 hours and 90 mg of pamidronate disodium over 24 hours in cancer patients (n = 24) who had minimal or no bony involvement. Table 3: Mean (Standard Deviation, CV%) Pamidronate Pharmacokinetic Parameters in Cancer Patients (n = 6 for each group) Dose (infusion rate) Maximum Concentration (mcg/mL) Percent of dose excreted in urine Total Clearance (mL/min) Renal Clearance (mL/min) 30 mg (4 hrs) 0.73 (0.14, 19.1%) 43.9 (14.0, 31.9%) 136 (44, 32.4%) 58 (27, 46.5%) 60 mg (4 hrs) 1.44 (0.57, 39.6%) 47.4 (47.4, 54.4%) 88 (56, 63.6%) 42 (28, 66.7%) 90 mg (4 hrs) 2.61 (0.74, 28.3%) 45.3 (25.8, 56.9%) 103 (37, 35.9%) 44 (16, 36.4%) 90 mg (24 hrs) 1.38 (1.97, 142.7%) 47.5 (10.2, 21.5%) 101 (58, 57.4%) 52 (42, 80.8%) Distribution The body retention of pamidronate was 54 ± 16% (mean ± standard deviation) of the dose over 120 hours.
Metabolism Pamidronate is not metabolized. Elimination The elimination half-life is 28 ± 7 hours (mean ± standard deviation). Total and renal clearances of pamidronate were 107 ± 50 mL/min and 49 ± 28 mL/min, respectively.
The rate of elimination from bone has not been determined. After administration of 30, 60, and 90 mg of pamidronate disodium over 4 hours, and 90 mg of pamidronate disodium over 24 hours, 46 ± 16% (mean ± standard deviation) of the drug was excreted unchanged in the urine within 120 hours. Cumulative urinary excretion was linearly related to dose.
Specific Populations Renal Impairment The pharmacokinetics of pamidronate were studied in cancer patients (n = 19) with normal and varying degrees of renal impairment. Each patient received a single 90 mg dose of pamidronate disodium infused over 4 hours. Renal clearance correlated with creatinine clearance (see Figure 1).
Because pamidronate disodium is administered on a monthly basis, drug accumulation is not expected. Figure 1: Pamidronate renal clearance as a function of creatinine clearance in patients with normal and impaired renal function. The lines are the mean prediction line and 95% confidence intervals.
Figure 1 Hepatic Impairment The pharmacokinetics of pamidronate were studied in male cancer patients at risk for bone metastases with normal hepatic function (n = 6) and mild to mo…
🧬 Mechanism of Action ▾
12.1Mechanism of Action 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 block dissolution of this mineral component of bone.
In vitro , pamidronate disodium inhibited osteoclast activity. In animal studies, pamidronate disodium inhibited bone resorption, but did not inhibit bone formation and mineralization. In animal tumor models, pamidronate disodium inhibited the increased osteoclast activity induced by tumors.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Pamidronate Disodium Injection is available as follows: 30 mg/10 mL (3 mg/mL) single-dose vial as a clear-colorless solution containing 30 mg of pamidronate disodium and 470 mg of mannitol in 10 mL water for injection. NDC 67457-430-10 Carton of 1 single-dose vial 90 mg/10 mL (9 mg/mL) single-dose vial as a clear-colorless solution containing 90 mg of pamidronate disodium and 375 mg of mannitol in 10 mL water for injection. NDC 67457-446-10 Carton of 1 single-dose vial Storage: Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Pamidronate Disodium Injection is a bisphosphonate available in 30 mg and 90 mg vials for intravenous administration. Each mL of the 30 mg/10 mL vial contains 3 mg pamidronate disodium, 47 mg mannitol; water for injection, q.s.; and phosphoric acid to adjust pH 6.0 to 7.0. Each mL of the 90 mg/10 mL vial contains, 9 mg pamidronate disodium, 37.5 mg mannitol; water for injection, q.s.; and phosphoric acid to adjust pH 6.0 to 7.0.
The pH of a 1% solution of pamidronate disodium in distilled water is approximately 8.3. 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-1-hydroxypropylidene) bis-, disodium salt, and its structural formula is: Pamidronate disodium is a 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 C 3 H 9 NO 7 P 2 Na 2 and its molecular weight is 279.1 (calculated as the anhydrous form). structural formula
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION • Advise pregnant women and females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.2) , Use in Specific Populations (8.1) ] . Advise females of reproductive potential to use effective contraception during and after pamidronate disodium treatment [see Use in Specific Populations (8.3) ] . • Advise women not to breastfeed during and after pamidronate disodium treatment [see Use in Specific Populations (8.2) ] . • Advise males and females of reproductive potential that pamidronate may impair fertility [see Use in Specific Populations (8.3) ] . • Inform patients that the risk of osteonecrosis of the jaw is increased in patients undergoing invasive dental procedures.
Advise patients to avoid such procedures, if possible, and to maintain good dental hygiene and routine dental care [see Warnings and Precautions (5.4) ]. • Inform patients that atypical femur fractures have occurred in patients taking bisphosphonates. Advise patients to report any thigh or groin pain [see Warnings and Precautions (5.5) ]. Manufactured for: Mylan Institutional LLC Morgantown, WV 26505 U.S.A.
Manufactured by: OneSource Specialty Pharma Limited (Sterile Product Division) Bengaluru 560076, India 50107390 1200013667 Revised: 12/2025