what tests should be completed before administering bisphosphonates?

1.

Elsevier ClinicalKey Drug Class Overview

Content last updated: December 2, 2021.

Hypocalcemia may occur with bisphosphonate use. Alendronate, ibandronate, zoledronic acid (Reclast), and risedronate are contraindicated in patients with hypocalcemia. Hypocalcemia must be corrected before initiating therapy. Ensuring adequate dietary intake of calcium and vitamin D during treatment is especially important in patients who are taking bisphosphonates for Paget's disease or for the treatment or prevention of osteoporosis[28644]. [29352][29558]

2.

Food and Drug Administration (DailyMed).

Publish date: December 4, 2023.

Dosage And Administration 2 DOSAGE AND ADMINISTRATION 3 mg every 3 months administered intravenously over a period of 15 to 30 seconds ( 2.2 ) Dosing Instructions: Only administer intravenously by a health care professional. ( 2.1 ) Do not mix with calcium-containing solutions or other intravenously administered drugs. ( 2.1 ) Do not administer more frequently than once every 3 months. ( 2.2 ) Instruct patients to take supplemental calcium and vitamin D if dietary intake is inadequate. 2.1 Important Administration Instructions Ibandronate sodium Injection must be administered intravenously only by a health care professional. Care must be taken not to administer intra-arterially or paravenously as this could lead to tissue damage [see Warnings and Precautions (5.4) ] . Appropriate medical support and monitoring measures should be readily available when ibandronate sodium injection is administered. If anaphylactic or other severe hypersensitivity/allergic reactions occur, immediately discontinue the injection and initiate appropriate treatment [see Warnings and Precautions (5.2) ]. Visually inspect the liquid in the prefilled syringe for particulate matter and discoloration before administration. Do not use prefilled syringes with particulate matter or discoloration. Administer only with the enclosed needle. Discard any unused portion. Do not mix with calcium-containing solutions or other intravenously administered drugs. Prefilled syringes are for single-dose only. 2.2 Dosage Information The recommended dose of ibandronate sodium injection for the treatment of postmenopausal osteoporosis is 3 mg every 3 months administered intravenously over a period of 15 to 30 seconds. Do not administer more frequently than once every 3 months. 2.3 Laboratory Testing and Oral Examination Prior to Administration Prior to administration of each dose obtain a serum creatinine [see Warnings and Precautions (5.3) ] . Given that bisphosphonates have been associated with osteonecrosis of the jaw (ONJ), perform a routine oral examination prior to administration of ibandronate sodium injection. 2.4 Calcium and Vitamin D Supplementation Instruct patients to take supplemental calcium and vitamin D if their dietary intake is inadequate. [see Warnings and Precautions (5.1) ] .

3.

Food and Drug Administration (DailyMed).

Publish date: July 4, 2022.

Warnings And Cautions Rare reports of hospitalization and/or dialysis or fatal outcome occurred in patients with underlying moderate to severe renal impairment or with any of the risk factors described in this section [ see Adverse Reactions (6.2) ]. Renal impairment may lead to increased exposure of concomitant medications and/or their metabolites that are primarily renally excreted [ see Drug Interactions (7.4) ]. Creatinine clearance should be calculated based on actual body weight using Cockcroft-Gault formula before each Reclast (zoledronic acid) dose. Transient increase in serum creatinine may be greater in patients with impaired renal function; interim monitoring of creatinine clearance should be performed in at-risk patients. Elderly patients and those receiving diuretic therapy are at increased risk of acute renal failure. These patients should have their fluid status assessed and be appropriately hydrated prior to administration of Reclast (zoledronic acid). Reclast (zoledronic acid) should be used with caution with other nephrotoxic drugs [ see Drug Interactions (7.3) ]. Consider monitoring creatinine clearance in patients at-risk for ARF who are taking concomitant medications that are primarily excreted by the kidney [ see Drug Interactions (7.4) ]. 5.4 Osteonecrosis of the Jaw Osteonecrosis of the jaw (ONJ) has been reported in patients treated with bisphosphonates, including Reclast (zoledronic acid). Most cases have been in cancer patients treated with intravenous bisphosphonates undergoing dental procedures. Some cases have occurred in patients with postmenopausal osteoporosis treated with either oral or intravenous bisphosphonates. A routine oral examination should be performed by the prescriber prior to initiation of bisphosphonate treatment. A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with a history of concomitant risk factors (e.g., cancer, chemotherapy, angiogenesis inhibitors, radiotherapy, corticosteroids, poor oral hygiene, preexisting dental disease or infection, anemia, coagulopathy).

Dosage And Administration 2.6 Treatment of Paget’s Disease of Bone The recommended dose is a 5 mg infusion. The infusion time must not be less than 15 minutes given over a constant infusion rate. Re-treatment of Paget’s Disease After a single treatment with Reclast (zoledronic acid) in Paget’s disease an extended remission period is observed. Specific re-treatment data are not available. However, re-treatment with Reclast (zoledronic acid) may be considered in patients who have relapsed, based on increases in serum alkaline phosphatase, or in those patients who failed to achieve normalization of their serum alkaline phosphatase, or in those patients with symptoms, as dictated by medical practice. 2.7 Laboratory Testing and Oral Examination Prior to Administration Prior to administration of each dose of Reclast (zoledronic acid), obtain a serum creatinine and creatinine clearance should be calculated based on actual body weight using Cockcroft-Gault formula before each Reclast (zoledronic acid) dose. Reclast (zoledronic acid) is contraindicated in patients with creatinine clearance less than 35 mL/min and in those with evidence of acute renal impairment. A 5 mg dose of Reclast (zoledronic acid) administered intravenously is recommended for patients with creatinine clearance greater than or equal to 35 mL/min. There are no safety or efficacy data to support the adjustment of the Reclast (zoledronic acid) dose based on baseline renal function. Therefore, no dose adjustment is required in patients with creatinine clearance greater than or equal to 35 mL/min [ see Contraindications (4), Warnings and Precautions (5.3) ]. A routine oral examination should be performed by the prescriber prior to initiation of Reclast (zoledronic acid) treatment [ see Warnings and Precautions (5.4) ]. 2.8 Calcium and Vitamin D Supplementation Instruct patients being treated for Paget’s disease of bone on the importance of calcium and vitamin D supplementation in maintaining serum calcium levels, and on the symptoms of hypocalcemia.

4.

Elsevier ClinicalKey Clinical Overview

Diagnosis Common secondary causes include hyperparathyroidism, hypercalciuria, calcium malabsorption, vitamin D deficiency, and hyperthyroidism Routine laboratory investigation of osteoporosis needs to include CBC, serum chemistry panel (with levels of calcium, albumin, total protein, creatinine, phosphate, alkaline phosphatase, and liver transaminases), thyroid function tests, and 25-hydroxyvitamin D level C-reactive protein or erythrocyte sedimentation rate can also be evaluated 24-hour urine collection for calcium, sodium, and creatinine levels is also recommended to assess for calcium malabsorption or hypercalciuria Additional tests beyond the aforementioned ones may be helpful, depending on initial results, and may be useful in considering unusual secondary causes or conditions in the differential diagnosis. They include: Serum intact parathyroid hormone level, for possible hyperparathyroidism Magnesium, if calcium is low Additional tests for hyperthyroidism, if screening thyroid function tests are abnormal Tissue transglutaminase antibodies test, for suspected celiac disease Serum protein electrophoresis and free kappa and lambda light chains test, for suspected multiple myeloma 24-hour urine free cortisol test or 1 mg overnight dexamethasone suppression test, for suspected endogenous hypercortisolemia Serum tryptase or urine N-methylhistidine test, for mastocytosis Serum testosterone, sex hormone binding globulin, follicle stimulating hormone, and luteinizing hormone, for suspected hypogonadism Serum prolactin, for suspected hyperprolactinemia Evaluate for prevalent vertebral fractures Vertebral fracture assessment is densitometric spine imaging performed for the purpose of detecting vertebral fractures that might otherwise go unidentified Detecting vertebral fractures requires specific imaging techniques that can be done at same time as DXA