For U.S. healthcare professionals only.

Brand Logo Text

Type size

Print page

E-mail page

Help your patients get the support they need

Tell them about the Compass Program—encouraging, informative, inspiring

Support for Your Patients:

Patient Assistance NOW Oncology Program

Find out how PANO
may help

ZOMETA^® (zoledronic acid) Injection Renal & Dental Safety Information

ZOMETA has an established safety profile with over 9 years of post approval data¹⁴—it has also been used to treat more than 4.0 million patients worldwide.²⁰ By understanding more about the safety of ZOMETA, you can be proactive in addressing any issues and managing any concerns your patients may have.

Proactively address renal concerns by monitoring your patients¹¹

Only before the first dose of ZOMETA, use the interactive Creatinine Clearance Calculator to determine the appropriate dose for your patient
This dose should be used every time the patient receives ZOMETA and should not be adjusted
Use the table below to find the recommended volume of ZOMETA concentrate that should be withdrawn from the vial for each dose

*Doses calculated assuming target AUC of 0.66 (mg x hr/L) (creatinine clearance=75 mL/min).

Reducing the starting dose for patients with mild to moderate impaired renal function at baseline reduces the risk of renal toxicity.¹¹
––Treatment should be reinitiated at the same dose as that prior to treatment interruption only when the creatinine has returned to within 10% of the baseline value¹¹

Monitor serum creatinine before each dose of ZOMETA to determine whether therapy should be interrupted¹¹

Guidance for patients who experience a serum
creatinine increase¹⁵

Withhold ZOMETA temporarily if patient has

Increase of 0.5 mg/dL in serum creatinine, if patient's baseline levels were normal
Increase of 1.0 mg/dL in serum creatinine, if patient's baseline levels were abnormal

Resume ZOMETA

Resume ZOMETA therapy at the starting dose when serum creatinine returns to within 10% of patient's baseline value

Reminders for ZOMETA Administration

ZOMETA should be infused over no less than 15 minutes
Monitor patients for signs of acute phase reactions and adverse events
Before each dose, measure serum creatinine
Ensure patients are properly hydrated before administering ZOMETA
Make sure patients are given an oral calcium supplement of 500 mg and a multivitamin containing 400 IU of vitamin D daily

ZOMETA should be used in prostate patients with bone metastases who have progressed after treatment with at least one hormonal therapy

ONJ Is Uncommon, May Be Prevented, and Can Be Managed

While uncommon, osteonecrosis of the jaw (ONJ)—when a person has bone loss in his or her jaw—has been seen in cancer patients who are on some drugs, including ZOMETA.¹¹

<1% of patients receiving ZOMETA^® (zoledronic acid) Injection have been reported to experience ONJ in a retrospective review²¹
There have been uncommon reports of ONJ in advanced cancer patients receiving complex treatment regimens including chemotherapy, radiation therapy, corticosteroids, and bisphosphonates, including ZOMETA¹¹
Currently, the causes of ONJ are not well understood, but with appropriate measures, ONJ may be prevented and/or managed¹⁸
A causal relationship between bisphosphonate use and ONJ has not been established¹⁸

Affirm the importance of dental health and hygiene to your patients during ZOMETA treatment

Scientists still do not know what causes ONJ. However, you can help reduce your patients' risk of experiencing ONJ by advising them of the following:¹¹

Regular checkups at the dentist and brushing their teeth after every meal is important
Avoid invasive dental surgery while taking ZOMETA

Remind your patients that cancer can affect their dental health and that healthy habits include:²²

Brushing their teeth and tongue after every meal and at bedtime
Using a soft toothbrush and gentle stroke
Flossing gently once a day—if their gums bleed or hurt, avoid the area that is sore, but still floss the other teeth
Keeping the mouth moist by rinsing often with water—many medicines cause dry mouth, which can lead to dental problems
Avoiding mouthwash that contains alcohol
Telling their doctor, dentist, or you if they have any problems with their teeth or gums
If they notice a problem, or have pain in their mouth, teeth, or jaw, to tell the dentist or doctor right away

Support your patients with ZOMETA treatment counseling

Please click here to see references.

ZOMETA is contraindicated in patients with hypersensitivity to zoledronic acid or any components of ZOMETA. Hypersensitivity reactions, including rare cases of urticaria and angioedema, and very rare cases of anaphylactic reaction/shock, have been reported. Patients being treated with ZOMETA should not be treated with Reclast^® (zoledronic acid) as they contain the same active ingredient.

Patients with HCM must be adequately rehydrated prior to use of ZOMETA and loop diuretics (if applicable). Loop diuretics should be used with caution in combination with ZOMETA to avoid hypocalcemia. ZOMETA should be used with caution with other nephrotoxic drugs. Carefully monitor serum calcium, phosphate, magnesium, and serum creatinine following initiation of ZOMETA. Short-term supplemental therapy may be necessary.

In patients with impaired renal function, the risk of adverse reactions (especially renal adverse reactions) may be greater. Consider individual patient risk/benefit profile before starting ZOMETA therapy in HCM patients with severe renal impairment. ZOMETA treatment is not recommended in patients with bone metastases with severe renal impairment. Preexisting renal insufficiency and multiple cycles of ZOMETA and other bisphosphonates are risk factors for subsequent renal deterioration with ZOMETA. Do not use doses greater than 4 mg. ZOMETA should be administered by IV infusion over no less than 15 minutes. Monitor serum creatinine before each dose.

Osteonecrosis of the jaw (ONJ) has been reported predominantly in cancer patients treated with intravenous bisphosphonates, including ZOMETA. Many of these patients were also receiving chemotherapy and corticosteroids, which may be risk factors for ONJ. Postmarketing experience and the literature suggest a greater frequency of reports of ONJ based on tumor type (advanced breast cancer, multiple myeloma) and dental status (dental extraction, periodontal disease, local trauma, including poorly fitting dentures). Many reports of ONJ involved patients with signs of local infection, including osteomyelitis. Cancer patients should maintain good oral hygiene and should have a dental examination with preventive dentistry prior to treatment with bisphosphonates. While on treatment, these patients should avoid invasive dental procedures, if possible, as recovery may be prolonged. For patients who develop ONJ while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ. A causal relationship between bisphosphonate use and ONJ has not been established. Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.

ZOMETA should not be used during pregnancy. Women of childbearing potential should be advised to avoid becoming pregnant. If the patient becomes pregnant or plans to breast-feed while taking this drug, the patient should be apprised of the potential harm to the fetus or baby.

In postmarketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates including ZOMETA. Discontinue use if severe symptoms develop, and a subset of patients had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate. There have been reports of bronchoconstriction in aspirin sensitive patients receiving bisphosphonates.

Insufficient data exist on how to safely use ZOMETA in HCM patients with hepatic impairment.

Acute-phase reaction symptoms can occur in HCM patients, with fever most commonly reported (44% with ZOMETA vs. 33% with pamidronate). Patients may occasionally experience flu-like syndrome (fever, chills, flushing, bone pain and/or arthralgias and myalgias). The most common adverse events (≥10%) in HCM clinical trials, regardless of causality, with ZOMETA 4 mg (n=86) were as follows: fever (44%), nausea (29%), constipation (27%), anemia (22%), dyspnea (22%), diarrhea (17%), abdominal pain (16%), progression of cancer (16%), insomnia (15%), vomiting (14%), anxiety (14%), urinary tract infection (14%), hypophosphatemia (13%), confusion (13%), agitation (13%), moniliasis (12%), hypokalemia (12%), coughing (12%), skeletal pain (12%), hypotension (11%), and hypomagnesemia (11%). In controlled HCM clinical trials, adverse events (5-10% frequency) occurring in greater incidence with ZOMETA than pamidronate include: asthenia, chest pain, leg edema, mucositis, dysphagia, granulocytopenia, thrombocytopenia, pancytopenia, non-specific infection, hypocalcemia, dehydration, arthralgias, headache and somnolence. Injection site reactions (redness, swelling) have been infrequently reported.

The most common adverse events (≥15%) in bone metastases clinical trials, regardless of causality, with ZOMETA 4 mg (n=1031) were as follows: bone pain (55%), nausea (46%), fatigue (39%), anemia (33%), pyrexia (32%), vomiting (32%), constipation (31%), dyspnea (27%), diarrhea (24%), weakness (24%), myalgia (23%), anorexia (22%), cough (22%), arthralgia (21%), lower-limb edema (21%), malignant neoplasm aggravated (20%), headache (19%), dizziness (excluding vertigo) (18%), insomnia (16%), decreased weight (16%), back pain (15%), and paresthesia (15%). Patients should also be made aware of the potential for abdominal pain.

Ocular adverse events may occur with bisphosphonates, including ZOMETA. Cases of uveitis, scleritis, episcleritis, conjunctivitis, iritis, and orbital inflammation including orbital edema have been reported during postmarketing use. In some cases, symptoms resolved with topical steroids.

Caution is advised when bisphosphonates, including ZOMETA, are administered with aminoglycosides, loop diuretics, and potentially nephrotoxic drugs.

Patients with multiple myeloma and bone metastases due to solid tumors should be administered an oral calcium supplement of 500 mg and a multiple vitamin containing 400 IU of vitamin D daily.

Click here for ZOMETA Important Safety Information

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

INDICATION

ZOMETA^® (zoledronic acid) 4mg/5mL Injection is indicated for the treatment of hypercalcemia of malignancy (HCM) and patients with multiple myeloma and documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy. Prostate cancer should have progressed after treatment with at least one hormonal therapy. Safe and efficacious use of ZOMETA has not been established for use in hyperparathyroidism or non-tumor-related hypercalcemia.

IMPORTANT SAFETY INFORMATION

Osteonecrosis of the jaw (ONJ) has been reported predominantly in cancer patients treated with intravenous bisphosphonates, including ZOMETA. Many of these patients were also receiving chemotherapy and corticosteroids, which may be risk factors for ONJ.
Postmarketing experience and the literature suggest a greater frequency of reports of ONJ based on tumor type (advanced breast cancer, multiple myeloma) and dental status (dental extraction, periodontal disease, local trauma, including poorly fitting dentures). Many reports of ONJ involved patients with signs of local infection, including osteomyelitis. Cancer patients should maintain good oral hygiene and should have a dental examination with preventive dentistry prior to treatment with bisphosphonates. While on treatment, these patients should avoid invasive dental procedures, if possible, as recovery may be prolonged. For patients who develop ONJ while on bisphosphonate therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of ONJ. A causal relationship between bisphosphonate use and ONJ has not been established. Clinical judgment of the treating physician should guide the management plan of each patient based on individual benefit/risk assessment.

Insufficient data exist on how to safely use ZOMETA in HCM patients with hepatic impairment.

Acute–phase reaction symptoms can occur in HCM patients, with fever most commonly reported (44% with ZOMETA vs. 33% with pamidronate). Patients may occasionally experience flu–like syndrome (fever, chills, flushing, bone pain and/or arthralgias and myalgias). The most common adverse events (≥10%) in HCM clinical trials, regardless of causality, with ZOMETA 4 mg (n=86) were as follows: fever (44%), nausea (29%), constipation (27%), anemia (22%), dyspnea (22%), diarrhea (17%), abdominal pain (16%), progression of cancer (16%), insomnia (15%), vomiting (14%), anxiety (14%), urinary tract infection (14%), hypophosphatemia (13%), confusion (13%), agitation (13%), moniliasis (12%), hypokalemia (12%), coughing (12%), skeletal pain (12%), hypotension (11%), and hypomagnesemia (11%). In controlled HCM clinical trials, adverse events (5–10% frequency) occurring in greater incidence with ZOMETA than pamidronate include: asthenia, chest pain, leg edema, mucositis, dysphagia, granulocytopenia, thrombocytopenia, pancytopenia, non-specific infection, hypocalcemia, dehydration, arthralgias, headache and somnolence. Injection site reactions (redness, swelling) have been infrequently reported.

Caution is advised when bisphosphonates, including ZOMETA, are administered with aminoglycosides, loop diuretics, and potentially nephrotoxic drugs.

Patients with multiple myeloma and bone metastases due to solid tumors should be administered an oral calcium supplement of 500 mg and a multiple vitamin containing 400 IU of vitamin D daily.

Please see full Prescribing Information

Use of this website is governed by the Terms of Use and Privacy Statement.

ZOM-1024405