Indications Treatment of hypercalcemia of malignancy; treatment of patients with multiple myeloma and bone metastases from solid tumors in conjunction with standard antineoplastic therapy.

 Contraindications Zoledronic acid or other bisphosphonates, or any excipients in the formulation.

 Route/Dosage

Hypercalcemia of Malignancy

ADULTS: IV 4 mg max dose given as single infusion over more than 15 min. Retreatment with 4 mg may be considered if serum calcium does not return to normal or remain normal after initial treatment. To allow a full response, it is recommended that a min of 7 days should elapse before retreatment.

Multiple Myeloma and Metastatic Bone Lesions from Solid Tumors

ADULTS: IV 4 mg infused over 15 min q 3 or 4 wk.

 Interactions

Aminoglycosides, Loop Diuretics (eg, Furosemide): Increased risk of hypocalcemia.

Thalidomide: Increased risk of renal dysfunction.

 Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Hypotension. CNS: Insomnia; anxiety; confusion; agitation; fatigue; weakness; anorexia; decreased appetite; headache; dizziness; insomnia; paresthesia; hypoesthesia; depression. DERMATOLOGIC: Redness and swelling at injection site; rash; pruritus; alopecia; dermatitis. EENT: Conjunctivitis. GI: Nausea; vomiting; constipation; diarrhea; abdominal pain; anorexia; dysphagia. GU: UTI. HEMATOLOGIC: Anemia; granulocytopenia; thrombocytopenia; pancytopenia; neutropenia. METABOLIC: Hypomagnesemia; hypokalemia; hypophosphatemia; weight decrease; dehydration. RESPIRATORY: Dyspnea; coughing; upper respiratory tract infection. OTHER: Flu-like symptoms; chest pain; fever; moniliasis; skeletal pain; asthenia; mucositis; metastases; non-specific infection; pyrexia; lower limb edema; rigors; bone pain; myalgia; arthralgia; back pain; aggravated malignant neoplasm.

 Precautions

Pregnancy: Category D. Do not use during pregnancy. Lactation: Undetermined. Children: Safety and efficacy not established. Elderly: Because renal function may be decreased more often in this age group, special care should be taken to monitor renal function. Asthma: Use with caution in patients with aspirin-sensitive asthma. Hepatic insufficiency: Insufficient data available; use with caution. Renal impairment: Use not recommended in patients with severe renal impairment.

 Administration/Storage

• Administer by IV route only. Not for IM or SQ administration.
• To reduce risk of renal failure, maximum recommended dose is 4 mg and minimum duration of infusion is at least 15 min.
• Reconstitute lyophilized powder (4 mg) with 5 mL Sterile Water for Injection. Completely dissolve drug before withdrawing for further dilution.
• Further dilute reconstituted solution in 100 mL 0.9% Sodium Chloride or 5% Dextrose Injection.
• Infuse over more than 15 min via separate IV line.
• Do not mix with calcium-containing IV solutions (eg, Lactated Ringer’s solution) or other IV medications.
• Do not administer if particulate matter or discoloration noted.
• Store unopened vials at controlled room temperature. Reconstituted solution may be stored in refrigerator (36 to 46°F). The total time between reconstitution, dilution, storage in refrigerator, and end of administration must not exceed 24 hr.

Hypercalcemia of malignancy

• Do not retreat for at least 7 days.

Multiple myeloma and bone metastases of solid tumors

• May repeat dose every 3 to 4 wk.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note hypersensitivity to biphosphonates. Note presence of renal impairment or dehydration.
• Record dates and response to any previous treatment with zoledronic acid.
• Ensure that serum creatinine is assessed prior to each treatment. Notify health care provider if serum creatinine is increasing.
• Ensure that serum calcium, phosphate, magnesium, electrolytes, and hemoglobin/hematocrit are monitored and recorded before and periodically following initiation of therapy. Notify health care provider if abnormalities are noted and be prepared to treat appropriately.
• Withhold therapy in patient with hypercalcemia of malignancy whose renal function deteriorates until renal function returns to baseline.
• Ensure that vigorous saline hydration is utilized in patients being treated for hypercalcemia of malignancy.
• Monitor patient for signs of fluid overload during saline hydration. Notify health care provider if noted and be prepared to administer diuretics if ordered.
• Monitor and record temperature before and during treatment.
• Assess patient for infusion site reaction, GI, CNS, RESP, and general body side effects. Report to health care provider if noted and significant.

 Patient/Family Education

• Explain name, dose, action, and potential side effects of drug.
• Advise patient that medication will be prepared and administered by a qualified health care provider in a health care setting and that medication will not be administered at home.
• Advise patient that infusion-site reactions (eg, redness, swelling, hardness, pain) can be treated with local measures (eg, warm or cold packs) and oral otc analgesics (eg, acetaminophen, ibuprofen). Advise patient to report infusion-site reactions that do not respond to symptomatic treatment to health care provider.
• Instruct patient to report the following symptoms to health care provider: tingling, numbness, muscle spasms, stomach pain, fever, fatigue, swelling, nausea, appetite loss, constipation, diarrhea, vomiting, difficulty breathing, muscle, joint or bone pain.
• Advise women to inform their health care provider if they become pregnant, plan on becoming pregnant, or are breastfeeding.
• Instruct patient to not take any prescription or otc medications or dietary supplements unless advised to do so by their health care provider.
• Advise patient that follow-up visits and laboratory tests will be required to monitor therapy and to be sure to keep appointments.

Indications for Drugs ::

 Action Inhibition of bone resorption.

 Indications Treatment of hypercalcemia of malignancy; treatment of patients with multiple myeloma and bone metastases from solid tumors in conjunction with standard antineoplastic therapy.

 Contraindications Zoledronic acid or other bisphosphonates, or any excipients in the formulation.

 Route/Dosage

Hypercalcemia of Malignancy

ADULTS: IV 4 mg max dose given as single infusion over more than 15 min. Retreatment with 4 mg may be considered if serum calcium does not return to normal or remain normal after initial treatment. To allow a full response, it is recommended that a min of 7 days should elapse before retreatment.

Multiple Myeloma and Metastatic Bone Lesions from Solid Tumors

ADULTS: IV 4 mg infused over 15 min q 3 or 4 wk.

 Interactions

Aminoglycosides, Loop Diuretics (eg, Furosemide): Increased risk of hypocalcemia.

Thalidomide: Increased risk of renal dysfunction.

 Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Hypotension. CNS: Insomnia; anxiety; confusion; agitation; fatigue; weakness; anorexia; decreased appetite; headache; dizziness; insomnia; paresthesia; hypoesthesia; depression. DERMATOLOGIC: Redness and swelling at injection site; rash; pruritus; alopecia; dermatitis. EENT: Conjunctivitis. GI: Nausea; vomiting; constipation; diarrhea; abdominal pain; anorexia; dysphagia. GU: UTI. HEMATOLOGIC: Anemia; granulocytopenia; thrombocytopenia; pancytopenia; neutropenia. METABOLIC: Hypomagnesemia; hypokalemia; hypophosphatemia; weight decrease; dehydration. RESPIRATORY: Dyspnea; coughing; upper respiratory tract infection. OTHER: Flu-like symptoms; chest pain; fever; moniliasis; skeletal pain; asthenia; mucositis; metastases; non-specific infection; pyrexia; lower limb edema; rigors; bone pain; myalgia; arthralgia; back pain; aggravated malignant neoplasm.

 Precautions

Pregnancy: Category D. Do not use during pregnancy. Lactation: Undetermined. Children: Safety and efficacy not established. Elderly: Because renal function may be decreased more often in this age group, special care should be taken to monitor renal function. Asthma: Use with caution in patients with aspirin-sensitive asthma. Hepatic insufficiency: Insufficient data available; use with caution. Renal impairment: Use not recommended in patients with severe renal impairment.

 Administration/Storage

• Administer by IV route only. Not for IM or SQ administration.
• To reduce risk of renal failure, maximum recommended dose is 4 mg and minimum duration of infusion is at least 15 min.
• Reconstitute lyophilized powder (4 mg) with 5 mL Sterile Water for Injection. Completely dissolve drug before withdrawing for further dilution.
• Further dilute reconstituted solution in 100 mL 0.9% Sodium Chloride or 5% Dextrose Injection.
• Infuse over more than 15 min via separate IV line.
• Do not mix with calcium-containing IV solutions (eg, Lactated Ringer’s solution) or other IV medications.
• Do not administer if particulate matter or discoloration noted.
• Store unopened vials at controlled room temperature. Reconstituted solution may be stored in refrigerator (36 to 46°F). The total time between reconstitution, dilution, storage in refrigerator, and end of administration must not exceed 24 hr.

Hypercalcemia of malignancy

• Do not retreat for at least 7 days.

Multiple myeloma and bone metastases of solid tumors

• May repeat dose every 3 to 4 wk.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note hypersensitivity to biphosphonates. Note presence of renal impairment or dehydration.
• Record dates and response to any previous treatment with zoledronic acid.
• Ensure that serum creatinine is assessed prior to each treatment. Notify health care provider if serum creatinine is increasing.
• Ensure that serum calcium, phosphate, magnesium, electrolytes, and hemoglobin/hematocrit are monitored and recorded before and periodically following initiation of therapy. Notify health care provider if abnormalities are noted and be prepared to treat appropriately.
• Withhold therapy in patient with hypercalcemia of malignancy whose renal function deteriorates until renal function returns to baseline.
• Ensure that vigorous saline hydration is utilized in patients being treated for hypercalcemia of malignancy.
• Monitor patient for signs of fluid overload during saline hydration. Notify health care provider if noted and be prepared to administer diuretics if ordered.
• Monitor and record temperature before and during treatment.
• Assess patient for infusion site reaction, GI, CNS, RESP, and general body side effects. Report to health care provider if noted and significant.

 Patient/Family Education

• Explain name, dose, action, and potential side effects of drug.
• Advise patient that medication will be prepared and administered by a qualified health care provider in a health care setting and that medication will not be administered at home.
• Advise patient that infusion-site reactions (eg, redness, swelling, hardness, pain) can be treated with local measures (eg, warm or cold packs) and oral otc analgesics (eg, acetaminophen, ibuprofen). Advise patient to report infusion-site reactions that do not respond to symptomatic treatment to health care provider.
• Instruct patient to report the following symptoms to health care provider: tingling, numbness, muscle spasms, stomach pain, fever, fatigue, swelling, nausea, appetite loss, constipation, diarrhea, vomiting, difficulty breathing, muscle, joint or bone pain.
• Advise women to inform their health care provider if they become pregnant, plan on becoming pregnant, or are breastfeeding.
• Instruct patient to not take any prescription or otc medications or dietary supplements unless advised to do so by their health care provider.
• Advise patient that follow-up visits and laboratory tests will be required to monitor therapy and to be sure to keep appointments.

Drug Dose ::

 Action Inhibition of bone resorption.

 Indications Treatment of hypercalcemia of malignancy; treatment of patients with multiple myeloma and bone metastases from solid tumors in conjunction with standard antineoplastic therapy.

 Contraindications Zoledronic acid or other bisphosphonates, or any excipients in the formulation.

 Route/Dosage

Hypercalcemia of Malignancy

ADULTS: IV 4 mg max dose given as single infusion over more than 15 min. Retreatment with 4 mg may be considered if serum calcium does not return to normal or remain normal after initial treatment. To allow a full response, it is recommended that a min of 7 days should elapse before retreatment.

Multiple Myeloma and Metastatic Bone Lesions from Solid Tumors

ADULTS: IV 4 mg infused over 15 min q 3 or 4 wk.

 Interactions

Aminoglycosides, Loop Diuretics (eg, Furosemide): Increased risk of hypocalcemia.

Thalidomide: Increased risk of renal dysfunction.

 Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Hypotension. CNS: Insomnia; anxiety; confusion; agitation; fatigue; weakness; anorexia; decreased appetite; headache; dizziness; insomnia; paresthesia; hypoesthesia; depression. DERMATOLOGIC: Redness and swelling at injection site; rash; pruritus; alopecia; dermatitis. EENT: Conjunctivitis. GI: Nausea; vomiting; constipation; diarrhea; abdominal pain; anorexia; dysphagia. GU: UTI. HEMATOLOGIC: Anemia; granulocytopenia; thrombocytopenia; pancytopenia; neutropenia. METABOLIC: Hypomagnesemia; hypokalemia; hypophosphatemia; weight decrease; dehydration. RESPIRATORY: Dyspnea; coughing; upper respiratory tract infection. OTHER: Flu-like symptoms; chest pain; fever; moniliasis; skeletal pain; asthenia; mucositis; metastases; non-specific infection; pyrexia; lower limb edema; rigors; bone pain; myalgia; arthralgia; back pain; aggravated malignant neoplasm.

 Precautions

Pregnancy: Category D. Do not use during pregnancy. Lactation: Undetermined. Children: Safety and efficacy not established. Elderly: Because renal function may be decreased more often in this age group, special care should be taken to monitor renal function. Asthma: Use with caution in patients with aspirin-sensitive asthma. Hepatic insufficiency: Insufficient data available; use with caution. Renal impairment: Use not recommended in patients with severe renal impairment.

 Administration/Storage

• Administer by IV route only. Not for IM or SQ administration.
• To reduce risk of renal failure, maximum recommended dose is 4 mg and minimum duration of infusion is at least 15 min.
• Reconstitute lyophilized powder (4 mg) with 5 mL Sterile Water for Injection. Completely dissolve drug before withdrawing for further dilution.
• Further dilute reconstituted solution in 100 mL 0.9% Sodium Chloride or 5% Dextrose Injection.
• Infuse over more than 15 min via separate IV line.
• Do not mix with calcium-containing IV solutions (eg, Lactated Ringer’s solution) or other IV medications.
• Do not administer if particulate matter or discoloration noted.
• Store unopened vials at controlled room temperature. Reconstituted solution may be stored in refrigerator (36 to 46°F). The total time between reconstitution, dilution, storage in refrigerator, and end of administration must not exceed 24 hr.

Hypercalcemia of malignancy

• Do not retreat for at least 7 days.

Multiple myeloma and bone metastases of solid tumors

• May repeat dose every 3 to 4 wk.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note hypersensitivity to biphosphonates. Note presence of renal impairment or dehydration.
• Record dates and response to any previous treatment with zoledronic acid.
• Ensure that serum creatinine is assessed prior to each treatment. Notify health care provider if serum creatinine is increasing.
• Ensure that serum calcium, phosphate, magnesium, electrolytes, and hemoglobin/hematocrit are monitored and recorded before and periodically following initiation of therapy. Notify health care provider if abnormalities are noted and be prepared to treat appropriately.
• Withhold therapy in patient with hypercalcemia of malignancy whose renal function deteriorates until renal function returns to baseline.
• Ensure that vigorous saline hydration is utilized in patients being treated for hypercalcemia of malignancy.
• Monitor patient for signs of fluid overload during saline hydration. Notify health care provider if noted and be prepared to administer diuretics if ordered.
• Monitor and record temperature before and during treatment.
• Assess patient for infusion site reaction, GI, CNS, RESP, and general body side effects. Report to health care provider if noted and significant.

 Patient/Family Education

• Explain name, dose, action, and potential side effects of drug.
• Advise patient that medication will be prepared and administered by a qualified health care provider in a health care setting and that medication will not be administered at home.
• Advise patient that infusion-site reactions (eg, redness, swelling, hardness, pain) can be treated with local measures (eg, warm or cold packs) and oral otc analgesics (eg, acetaminophen, ibuprofen). Advise patient to report infusion-site reactions that do not respond to symptomatic treatment to health care provider.
• Instruct patient to report the following symptoms to health care provider: tingling, numbness, muscle spasms, stomach pain, fever, fatigue, swelling, nausea, appetite loss, constipation, diarrhea, vomiting, difficulty breathing, muscle, joint or bone pain.
• Advise women to inform their health care provider if they become pregnant, plan on becoming pregnant, or are breastfeeding.
• Instruct patient to not take any prescription or otc medications or dietary supplements unless advised to do so by their health care provider.
• Advise patient that follow-up visits and laboratory tests will be required to monitor therapy and to be sure to keep appointments.

Contraindication ::

 Action Inhibition of bone resorption.

 Indications Treatment of hypercalcemia of malignancy; treatment of patients with multiple myeloma and bone metastases from solid tumors in conjunction with standard antineoplastic therapy.

 Contraindications Zoledronic acid or other bisphosphonates, or any excipients in the formulation.

 Route/Dosage

Hypercalcemia of Malignancy

ADULTS: IV 4 mg max dose given as single infusion over more than 15 min. Retreatment with 4 mg may be considered if serum calcium does not return to normal or remain normal after initial treatment. To allow a full response, it is recommended that a min of 7 days should elapse before retreatment.

Multiple Myeloma and Metastatic Bone Lesions from Solid Tumors

ADULTS: IV 4 mg infused over 15 min q 3 or 4 wk.

 Interactions

Aminoglycosides, Loop Diuretics (eg, Furosemide): Increased risk of hypocalcemia.

Thalidomide: Increased risk of renal dysfunction.

 Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Hypotension. CNS: Insomnia; anxiety; confusion; agitation; fatigue; weakness; anorexia; decreased appetite; headache; dizziness; insomnia; paresthesia; hypoesthesia; depression. DERMATOLOGIC: Redness and swelling at injection site; rash; pruritus; alopecia; dermatitis. EENT: Conjunctivitis. GI: Nausea; vomiting; constipation; diarrhea; abdominal pain; anorexia; dysphagia. GU: UTI. HEMATOLOGIC: Anemia; granulocytopenia; thrombocytopenia; pancytopenia; neutropenia. METABOLIC: Hypomagnesemia; hypokalemia; hypophosphatemia; weight decrease; dehydration. RESPIRATORY: Dyspnea; coughing; upper respiratory tract infection. OTHER: Flu-like symptoms; chest pain; fever; moniliasis; skeletal pain; asthenia; mucositis; metastases; non-specific infection; pyrexia; lower limb edema; rigors; bone pain; myalgia; arthralgia; back pain; aggravated malignant neoplasm.

 Precautions

Pregnancy: Category D. Do not use during pregnancy. Lactation: Undetermined. Children: Safety and efficacy not established. Elderly: Because renal function may be decreased more often in this age group, special care should be taken to monitor renal function. Asthma: Use with caution in patients with aspirin-sensitive asthma. Hepatic insufficiency: Insufficient data available; use with caution. Renal impairment: Use not recommended in patients with severe renal impairment.

 Administration/Storage

• Administer by IV route only. Not for IM or SQ administration.
• To reduce risk of renal failure, maximum recommended dose is 4 mg and minimum duration of infusion is at least 15 min.
• Reconstitute lyophilized powder (4 mg) with 5 mL Sterile Water for Injection. Completely dissolve drug before withdrawing for further dilution.
• Further dilute reconstituted solution in 100 mL 0.9% Sodium Chloride or 5% Dextrose Injection.
• Infuse over more than 15 min via separate IV line.
• Do not mix with calcium-containing IV solutions (eg, Lactated Ringer’s solution) or other IV medications.
• Do not administer if particulate matter or discoloration noted.
• Store unopened vials at controlled room temperature. Reconstituted solution may be stored in refrigerator (36 to 46°F). The total time between reconstitution, dilution, storage in refrigerator, and end of administration must not exceed 24 hr.

Hypercalcemia of malignancy

• Do not retreat for at least 7 days.

Multiple myeloma and bone metastases of solid tumors

• May repeat dose every 3 to 4 wk.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note hypersensitivity to biphosphonates. Note presence of renal impairment or dehydration.
• Record dates and response to any previous treatment with zoledronic acid.
• Ensure that serum creatinine is assessed prior to each treatment. Notify health care provider if serum creatinine is increasing.
• Ensure that serum calcium, phosphate, magnesium, electrolytes, and hemoglobin/hematocrit are monitored and recorded before and periodically following initiation of therapy. Notify health care provider if abnormalities are noted and be prepared to treat appropriately.
• Withhold therapy in patient with hypercalcemia of malignancy whose renal function deteriorates until renal function returns to baseline.
• Ensure that vigorous saline hydration is utilized in patients being treated for hypercalcemia of malignancy.
• Monitor patient for signs of fluid overload during saline hydration. Notify health care provider if noted and be prepared to administer diuretics if ordered.
• Monitor and record temperature before and during treatment.
• Assess patient for infusion site reaction, GI, CNS, RESP, and general body side effects. Report to health care provider if noted and significant.

 Patient/Family Education

• Explain name, dose, action, and potential side effects of drug.
• Advise patient that medication will be prepared and administered by a qualified health care provider in a health care setting and that medication will not be administered at home.
• Advise patient that infusion-site reactions (eg, redness, swelling, hardness, pain) can be treated with local measures (eg, warm or cold packs) and oral otc analgesics (eg, acetaminophen, ibuprofen). Advise patient to report infusion-site reactions that do not respond to symptomatic treatment to health care provider.
• Instruct patient to report the following symptoms to health care provider: tingling, numbness, muscle spasms, stomach pain, fever, fatigue, swelling, nausea, appetite loss, constipation, diarrhea, vomiting, difficulty breathing, muscle, joint or bone pain.
• Advise women to inform their health care provider if they become pregnant, plan on becoming pregnant, or are breastfeeding.
• Instruct patient to not take any prescription or otc medications or dietary supplements unless advised to do so by their health care provider.
• Advise patient that follow-up visits and laboratory tests will be required to monitor therapy and to be sure to keep appointments.

Drug Precautions ::

 Action Inhibition of bone resorption.

 Indications Treatment of hypercalcemia of malignancy; treatment of patients with multiple myeloma and bone metastases from solid tumors in conjunction with standard antineoplastic therapy.

 Contraindications Zoledronic acid or other bisphosphonates, or any excipients in the formulation.

 Route/Dosage

Hypercalcemia of Malignancy

ADULTS: IV 4 mg max dose given as single infusion over more than 15 min. Retreatment with 4 mg may be considered if serum calcium does not return to normal or remain normal after initial treatment. To allow a full response, it is recommended that a min of 7 days should elapse before retreatment.

Multiple Myeloma and Metastatic Bone Lesions from Solid Tumors

ADULTS: IV 4 mg infused over 15 min q 3 or 4 wk.

 Interactions

Aminoglycosides, Loop Diuretics (eg, Furosemide): Increased risk of hypocalcemia.

Thalidomide: Increased risk of renal dysfunction.

 Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Hypotension. CNS: Insomnia; anxiety; confusion; agitation; fatigue; weakness; anorexia; decreased appetite; headache; dizziness; insomnia; paresthesia; hypoesthesia; depression. DERMATOLOGIC: Redness and swelling at injection site; rash; pruritus; alopecia; dermatitis. EENT: Conjunctivitis. GI: Nausea; vomiting; constipation; diarrhea; abdominal pain; anorexia; dysphagia. GU: UTI. HEMATOLOGIC: Anemia; granulocytopenia; thrombocytopenia; pancytopenia; neutropenia. METABOLIC: Hypomagnesemia; hypokalemia; hypophosphatemia; weight decrease; dehydration. RESPIRATORY: Dyspnea; coughing; upper respiratory tract infection. OTHER: Flu-like symptoms; chest pain; fever; moniliasis; skeletal pain; asthenia; mucositis; metastases; non-specific infection; pyrexia; lower limb edema; rigors; bone pain; myalgia; arthralgia; back pain; aggravated malignant neoplasm.

 Precautions

Pregnancy: Category D. Do not use during pregnancy. Lactation: Undetermined. Children: Safety and efficacy not established. Elderly: Because renal function may be decreased more often in this age group, special care should be taken to monitor renal function. Asthma: Use with caution in patients with aspirin-sensitive asthma. Hepatic insufficiency: Insufficient data available; use with caution. Renal impairment: Use not recommended in patients with severe renal impairment.

 Administration/Storage

• Administer by IV route only. Not for IM or SQ administration.
• To reduce risk of renal failure, maximum recommended dose is 4 mg and minimum duration of infusion is at least 15 min.
• Reconstitute lyophilized powder (4 mg) with 5 mL Sterile Water for Injection. Completely dissolve drug before withdrawing for further dilution.
• Further dilute reconstituted solution in 100 mL 0.9% Sodium Chloride or 5% Dextrose Injection.
• Infuse over more than 15 min via separate IV line.
• Do not mix with calcium-containing IV solutions (eg, Lactated Ringer’s solution) or other IV medications.
• Do not administer if particulate matter or discoloration noted.
• Store unopened vials at controlled room temperature. Reconstituted solution may be stored in refrigerator (36 to 46°F). The total time between reconstitution, dilution, storage in refrigerator, and end of administration must not exceed 24 hr.

Hypercalcemia of malignancy

• Do not retreat for at least 7 days.

Multiple myeloma and bone metastases of solid tumors

• May repeat dose every 3 to 4 wk.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note hypersensitivity to biphosphonates. Note presence of renal impairment or dehydration.
• Record dates and response to any previous treatment with zoledronic acid.
• Ensure that serum creatinine is assessed prior to each treatment. Notify health care provider if serum creatinine is increasing.
• Ensure that serum calcium, phosphate, magnesium, electrolytes, and hemoglobin/hematocrit are monitored and recorded before and periodically following initiation of therapy. Notify health care provider if abnormalities are noted and be prepared to treat appropriately.
• Withhold therapy in patient with hypercalcemia of malignancy whose renal function deteriorates until renal function returns to baseline.
• Ensure that vigorous saline hydration is utilized in patients being treated for hypercalcemia of malignancy.
• Monitor patient for signs of fluid overload during saline hydration. Notify health care provider if noted and be prepared to administer diuretics if ordered.
• Monitor and record temperature before and during treatment.
• Assess patient for infusion site reaction, GI, CNS, RESP, and general body side effects. Report to health care provider if noted and significant.

 Patient/Family Education

• Explain name, dose, action, and potential side effects of drug.
• Advise patient that medication will be prepared and administered by a qualified health care provider in a health care setting and that medication will not be administered at home.
• Advise patient that infusion-site reactions (eg, redness, swelling, hardness, pain) can be treated with local measures (eg, warm or cold packs) and oral otc analgesics (eg, acetaminophen, ibuprofen). Advise patient to report infusion-site reactions that do not respond to symptomatic treatment to health care provider.
• Instruct patient to report the following symptoms to health care provider: tingling, numbness, muscle spasms, stomach pain, fever, fatigue, swelling, nausea, appetite loss, constipation, diarrhea, vomiting, difficulty breathing, muscle, joint or bone pain.
• Advise women to inform their health care provider if they become pregnant, plan on becoming pregnant, or are breastfeeding.
• Instruct patient to not take any prescription or otc medications or dietary supplements unless advised to do so by their health care provider.
• Advise patient that follow-up visits and laboratory tests will be required to monitor therapy and to be sure to keep appointments.

Drug Side Effects ::

 Action Inhibition of bone resorption.

 Indications Treatment of hypercalcemia of malignancy; treatment of patients with multiple myeloma and bone metastases from solid tumors in conjunction with standard antineoplastic therapy.

 Contraindications Zoledronic acid or other bisphosphonates, or any excipients in the formulation.

 Route/Dosage

Hypercalcemia of Malignancy

ADULTS: IV 4 mg max dose given as single infusion over more than 15 min. Retreatment with 4 mg may be considered if serum calcium does not return to normal or remain normal after initial treatment. To allow a full response, it is recommended that a min of 7 days should elapse before retreatment.

Multiple Myeloma and Metastatic Bone Lesions from Solid Tumors

ADULTS: IV 4 mg infused over 15 min q 3 or 4 wk.

 Interactions

Aminoglycosides, Loop Diuretics (eg, Furosemide): Increased risk of hypocalcemia.

Thalidomide: Increased risk of renal dysfunction.

 Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Hypotension. CNS: Insomnia; anxiety; confusion; agitation; fatigue; weakness; anorexia; decreased appetite; headache; dizziness; insomnia; paresthesia; hypoesthesia; depression. DERMATOLOGIC: Redness and swelling at injection site; rash; pruritus; alopecia; dermatitis. EENT: Conjunctivitis. GI: Nausea; vomiting; constipation; diarrhea; abdominal pain; anorexia; dysphagia. GU: UTI. HEMATOLOGIC: Anemia; granulocytopenia; thrombocytopenia; pancytopenia; neutropenia. METABOLIC: Hypomagnesemia; hypokalemia; hypophosphatemia; weight decrease; dehydration. RESPIRATORY: Dyspnea; coughing; upper respiratory tract infection. OTHER: Flu-like symptoms; chest pain; fever; moniliasis; skeletal pain; asthenia; mucositis; metastases; non-specific infection; pyrexia; lower limb edema; rigors; bone pain; myalgia; arthralgia; back pain; aggravated malignant neoplasm.

 Precautions

Pregnancy: Category D. Do not use during pregnancy. Lactation: Undetermined. Children: Safety and efficacy not established. Elderly: Because renal function may be decreased more often in this age group, special care should be taken to monitor renal function. Asthma: Use with caution in patients with aspirin-sensitive asthma. Hepatic insufficiency: Insufficient data available; use with caution. Renal impairment: Use not recommended in patients with severe renal impairment.

 Administration/Storage

• Administer by IV route only. Not for IM or SQ administration.
• To reduce risk of renal failure, maximum recommended dose is 4 mg and minimum duration of infusion is at least 15 min.
• Reconstitute lyophilized powder (4 mg) with 5 mL Sterile Water for Injection. Completely dissolve drug before withdrawing for further dilution.
• Further dilute reconstituted solution in 100 mL 0.9% Sodium Chloride or 5% Dextrose Injection.
• Infuse over more than 15 min via separate IV line.
• Do not mix with calcium-containing IV solutions (eg, Lactated Ringer’s solution) or other IV medications.
• Do not administer if particulate matter or discoloration noted.
• Store unopened vials at controlled room temperature. Reconstituted solution may be stored in refrigerator (36 to 46°F). The total time between reconstitution, dilution, storage in refrigerator, and end of administration must not exceed 24 hr.

Hypercalcemia of malignancy

• Do not retreat for at least 7 days.

Multiple myeloma and bone metastases of solid tumors

• May repeat dose every 3 to 4 wk.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note hypersensitivity to biphosphonates. Note presence of renal impairment or dehydration.
• Record dates and response to any previous treatment with zoledronic acid.
• Ensure that serum creatinine is assessed prior to each treatment. Notify health care provider if serum creatinine is increasing.
• Ensure that serum calcium, phosphate, magnesium, electrolytes, and hemoglobin/hematocrit are monitored and recorded before and periodically following initiation of therapy. Notify health care provider if abnormalities are noted and be prepared to treat appropriately.
• Withhold therapy in patient with hypercalcemia of malignancy whose renal function deteriorates until renal function returns to baseline.
• Ensure that vigorous saline hydration is utilized in patients being treated for hypercalcemia of malignancy.
• Monitor patient for signs of fluid overload during saline hydration. Notify health care provider if noted and be prepared to administer diuretics if ordered.
• Monitor and record temperature before and during treatment.
• Assess patient for infusion site reaction, GI, CNS, RESP, and general body side effects. Report to health care provider if noted and significant.

 Patient/Family Education

• Explain name, dose, action, and potential side effects of drug.
• Advise patient that medication will be prepared and administered by a qualified health care provider in a health care setting and that medication will not be administered at home.
• Advise patient that infusion-site reactions (eg, redness, swelling, hardness, pain) can be treated with local measures (eg, warm or cold packs) and oral otc analgesics (eg, acetaminophen, ibuprofen). Advise patient to report infusion-site reactions that do not respond to symptomatic treatment to health care provider.
• Instruct patient to report the following symptoms to health care provider: tingling, numbness, muscle spasms, stomach pain, fever, fatigue, swelling, nausea, appetite loss, constipation, diarrhea, vomiting, difficulty breathing, muscle, joint or bone pain.
• Advise women to inform their health care provider if they become pregnant, plan on becoming pregnant, or are breastfeeding.
• Instruct patient to not take any prescription or otc medications or dietary supplements unless advised to do so by their health care provider.
• Advise patient that follow-up visits and laboratory tests will be required to monitor therapy and to be sure to keep appointments.

Drug Mode of Action ::  

 Action Inhibition of bone resorption.