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Drug overview for ZOLEDRONIC ACID (zoledronic acid):
Generic name: ZOLEDRONIC ACID (ZOLE-eh-dron-ick)
Drug class: Hypercalcemia Agents
Therapeutic class: Endocrine
Zoledronic acid, a synthetic imidazole bisphosphonate analog of pyrophosphate, is a bone resorption inhibitor.
No enhanced Uses information available for this drug.
Generic name: ZOLEDRONIC ACID (ZOLE-eh-dron-ick)
Drug class: Hypercalcemia Agents
Therapeutic class: Endocrine
Zoledronic acid, a synthetic imidazole bisphosphonate analog of pyrophosphate, is a bone resorption inhibitor.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for ZOLEDRONIC ACID (zoledronic acid) have been approved by the FDA:
Indications:
Humoral hypercalcemia of malignancy
Prevention of skeletal related events associated with bone metastases from solid tumor
Prevention of skeletal related events in multiple myeloma
Professional Synonyms:
Hypercalcemia associated with cancer
Hypercalcemia associated with malignancy
Hypercalcemia of malignancy
Malignant hypercalcemia
Indications:
Humoral hypercalcemia of malignancy
Prevention of skeletal related events associated with bone metastases from solid tumor
Prevention of skeletal related events in multiple myeloma
Professional Synonyms:
Hypercalcemia associated with cancer
Hypercalcemia associated with malignancy
Hypercalcemia of malignancy
Malignant hypercalcemia
The following dosing information is available for ZOLEDRONIC ACID (zoledronic acid):
Dosage of zoledronic acid, which is commercially available for parenteral use as the monohydrate, is calculated on the anhydrous basis.
Zoledronic acid is administered by IV infusion over no less than 15 minutes. (See Renal Effects under Cautions: Warnings/Precautions.) Zoledronic acid is commercially available as a solution concentrate containing 4 mg of the drug per 5 mL (Zometa(R) concentrate or generic equivalents) and as a ready-to-use injection containing 4 mg of the drug per 100 mL (Zometa(R) ready-to-use or generic equivalents) for use in patients with cancer-related indications. Zoledronic acid also is available as a ready-to-use injection containing 5 mg of the drug per 100 mL (Reclast(R) or generic equivalents) for use in the prevention or treatment of osteoporosis or for treatment of Paget disease of bone. Zoledronic acid should be administered through separate vented infusion lines apart from other drugs and should not be allowed to come in contact with any solutions containing calcium or other divalent cations.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for ZOLEDRONIC ACID (zoledronic acid):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Sodium Iodide I 131/Myelosuppressives; Immunomodulators SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Sodium iodide I 131 can cause depression of the hematopoetic system. Myelosuppressives and immunomodulators also suppress the immune system.(1) CLINICAL EFFECTS: Concurrent use of sodium iodide I 131 with agents that cause bone marrow depression, including myelosuppressives or immunomodulators, may result in an enhanced risk of hematologic disorders, including anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia. Bone marrow depression may increase the risk of serious infections and bleeding.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of sodium iodide I 131 states that concurrent use with bone marrow depressants may enhance the depression of the hematopoetic system caused by large doses of sodium iodide I 131.(1) Sodium iodide I 131 causes a dose-dependent bone marrow suppression, including neutropenia or thrombocytopenia, in the 3 to 5 weeks following administration. Patients may be at increased risk of infections or bleeding during this time. Monitor complete blood counts within one month of therapy. If results indicate leukopenia or thrombocytopenia, dosimetry should be used to determine a safe sodium iodide I 131 activity.(1) DISCUSSION: Hematologic disorders including death have been reported with sodium iodide I 131. The most common hematologic disorders reported include anemia, blood dyscrasias, bone marrow depression, leukopenia, and thrombocytopenia.(1) |
HICON, SODIUM IODIDE I-131 |
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Zoledronic Acid/Diuretics SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Concurrent use of zoledronic acid and a diuretic may have adverse effects on the renal system.(1,2) CLINICAL EFFECTS: Concurrent use of zoledronic acid and a diuretic may result in renal dysfunction. Deterioration in renal function, acute renal failure requiring dialysis, and death have been reported.(1) PREDISPOSING FACTORS: The interaction may be more likely in elderly patients, patients who are taking other drugs that impact renal function, patients with pre-existing renal compromise, and patients who are dehydrated.(1) PATIENT MANAGEMENT: Patients should be adequately hydrated with 500 ml (2 glasses of water) before and after zoledronic acid administration.(1) Creatinine clearance should be monitored before and after therapy and zoledronic acid should not be administered in patients with a creatinine clearance less than 35 ml/min.(1,3) DISCUSSION: Zoledronic acid has been associated with renal dysfunction, including deterioration in renal function, acute renal failure requiring dialysis, and death. Risk factors include advanced age, concomitant nephrotoxic agents, and dehydration.(1) The FDA has received 16 reports of fatal acute renal failure and 9 reports of renal injury requiring dialysis following the administration of Reclast (zoledronic acid).(3) |
ACCURETIC, ALDACTONE, AMILORIDE HCL, AMILORIDE-HYDROCHLOROTHIAZIDE, AMLODIPINE-VALSARTAN-HCTZ, ATACAND HCT, ATENOLOL-CHLORTHALIDONE, AVALIDE, BENAZEPRIL-HYDROCHLOROTHIAZIDE, BENICAR HCT, BISOPROLOL-HYDROCHLOROTHIAZIDE, BUMETANIDE, CANDESARTAN-HYDROCHLOROTHIAZID, CAPTOPRIL-HYDROCHLOROTHIAZIDE, CAROSPIR, CHLOROTHIAZIDE, CHLOROTHIAZIDE SODIUM, CHLORTHALIDONE, DIOVAN HCT, DIURIL, DYRENIUM, EDARBYCLOR, EDECRIN, ENALAPRIL-HYDROCHLOROTHIAZIDE, EPLERENONE, ETHACRYNATE SODIUM, ETHACRYNIC ACID, EXFORGE HCT, FOSINOPRIL-HYDROCHLOROTHIAZIDE, FUROSCIX, FUROSEMIDE, FUROSEMIDE-0.9% NACL, HEMICLOR, HYDROCHLOROTHIAZIDE, HYZAAR, INDAPAMIDE, INSPRA, INZIRQO, IRBESARTAN-HYDROCHLOROTHIAZIDE, KERENDIA, LASIX, LISINOPRIL-HYDROCHLOROTHIAZIDE, LOSARTAN-HYDROCHLOROTHIAZIDE, LOTENSIN HCT, MANNITOL, METHYLDOPA-HYDROCHLOROTHIAZIDE, METOLAZONE, METOPROLOL-HYDROCHLOROTHIAZIDE, MICARDIS HCT, OLMESARTAN-AMLODIPINE-HCTZ, OLMESARTAN-HYDROCHLOROTHIAZIDE, OSMITROL, PROPRANOLOL-HYDROCHLOROTHIAZID, QUINAPRIL-HYDROCHLOROTHIAZIDE, SOAANZ, SPIRONOLACTONE, SPIRONOLACTONE-HCTZ, TELMISARTAN-HYDROCHLOROTHIAZID, TENORETIC 100, TENORETIC 50, THALITONE, TORSEMIDE, TRIAMTERENE, TRIAMTERENE-HYDROCHLOROTHIAZID, TRIBENZOR, VALSARTAN-HYDROCHLOROTHIAZIDE, VASERETIC, ZESTORETIC |
The following contraindication information is available for ZOLEDRONIC ACID (zoledronic acid):
Drug contraindication overview.
Known hypersensitivity to zoledronic acid, other bisphosphonates, or any ingredient in the formulations. Hypocalcemia. Use of zoledronic acid for prevention or treatment of osteoporosis or for treatment of Paget disease of bone is contraindicated in patients with creatinine clearance of less than 35 mL/minute or those with evidence of acute renal impairment.
Known hypersensitivity to zoledronic acid, other bisphosphonates, or any ingredient in the formulations. Hypocalcemia. Use of zoledronic acid for prevention or treatment of osteoporosis or for treatment of Paget disease of bone is contraindicated in patients with creatinine clearance of less than 35 mL/minute or those with evidence of acute renal impairment.
There are 4 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Acute renal failure |
| Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min |
| Chronic kidney disease stage 5 (failure) GFr<15 ml/min |
| Lactation |
There are 9 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Aseptic necrosis of jaw bone |
| Atypical femoral fracture |
| Dehydration |
| Hypocalcemia |
| Hypomagnesemia |
| Hypophosphatemia |
| Invasive dental procedure |
| Periodontitis |
| Pregnancy |
There are 3 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Arthralgia |
| Kidney disease with likely reduction in glomerular filtration rate (GFr) |
| Myalgia |
The following adverse reaction information is available for ZOLEDRONIC ACID (zoledronic acid):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 39 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Bone pain Dyspnea General weakness Hypertension Hypokalemia Hypomagnesemia Hypophosphatemia |
Anemia Atrial fibrillation Granulocytopenic disorder Hypotension Infection Thrombocytopenic disorder |
| Rare/Very Rare |
|---|
|
Acute renal failure Anaphylaxis Angioedema Aseptic necrosis of bone in orofacial region Aseptic necrosis of jaw bone Asthma exacerbation Atypical femoral fracture Avascular necrosis of bone Blurred vision Bradycardia Bronchospastic pulmonary disease Fanconi syndrome Hypernatremia Hypersensitivity drug reaction Hypocalcemia Injection site sequelae Interstitial lung disease Iritis Kidney disease with reduction in glomerular filtration rate (GFr) Pancytopenia Scleritis Seizure disorder Stevens-johnson syndrome Toxic epidermal necrolysis Urticaria Uveitis |
There are 46 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute abdominal pain Allergic dermatitis Arthralgia Back pain Chills Constipation Cough Diarrhea Dizziness Fatigue Fever Flu-like symptoms Headache disorder Insomnia Myalgia Nausea Ocular inflammation Peripheral edema Urinary tract infection Vomiting |
Acute cognitive impairment Agitation Anorexia Cramps Dysgeusia Dyspepsia Dysphagia Hyperhidrosis Paresthesia Stomatitis Upper abdominal pain |
| Rare/Very Rare |
|---|
|
Arthritis Chest pain Conjunctivitis Cramps in legs Dehydration Hematuria Hyperesthesia Hypoesthesia Malaise Proteinuria Pruritus of skin Skin rash Symptoms of anxiety Tremor Xerostomia |
The following precautions are available for ZOLEDRONIC ACID (zoledronic acid):
Zoledronic acid is not indicated for use in children.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Category D. (See Users Guide and see Fetal/Neonatal Morbidity and Mortality under Cautions: Warnings/Precautions.)
It is not known whether zoledronic acid is distributed into milk; because of the potential for serious adverse effects in nursing infants from zoledronic acid, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman. It is also important to consider that zoledronic acid is retained by bone for prolonged periods and may be released over weeks to years, possibly affecting nursing infants.
No overall differences in safety and efficacy of zoledronic acid relative to younger adults; however, the incidence of acute-phase inflammatory reactions was less in geriatric patients with osteoporosis or Paget disease of bone than in younger adults. Because of the greater frequency of impaired renal function in geriatric patients, the manufacturer states that renal function should be monitored with particular care in this age group.
The following prioritized warning is available for ZOLEDRONIC ACID (zoledronic acid):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ZOLEDRONIC ACID (zoledronic acid)'s list of indications:
| Humoral hypercalcemia of malignancy | |
| E83.52 | Hypercalcemia |
| Prevention of skeletal related event in multiple myeloma | |
| C90.0 | Multiple myeloma |
| C90.00 | Multiple myeloma not having achieved remission |
| C90.02 | Multiple myeloma in relapse |
| Prevention of skeletal related events in bone metastases | |
| C79.51 | Secondary malignant neoplasm of bone |
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