Zoledronic Acid

Zoledronic Acid is a prescription medication used to treat Hypercalcemia of Malignancy, Multiple Myeloma; Bone Metastases from Solid Tumors, Osteoporosis, Glucocorticoid-Induced Osteoporosis, and Paget Disease. 

• Zoledronic Acid is available under the following different brand names: Reclast, Zometa

Adult dosage

IV Injection solution

• 4mg/5mL (5mL)
• 5mg/100mL

Hypercalcemia of Malignancy

Adult dosage

• No more than 4 mg IV (infused over at least 15 minutes) once; may be repeated in 7 days.

Multiple Myeloma; Bone Metastases from Solid Tumors

Adult dosage

• 4 mg IV (infused over at least 15 minutes) every 3-4 weeks

Osteoporosis

Adult dosage

Prevention in postmenopausal women: 

• Reclast: 5 mg IV infused over at least 5 minutes every 2 years

Treatment in men and postmenopausal women:

• Reclast: 5 mg IV infused over at least 15 minutes every year

Glucocorticoid-Induced Osteoporosis

Adult dosage

• Reclast: 5 mg IV infused over at least 15 minutes every year; supplemented with elemental calcium and vitamin D. 

Paget Disease

Adult dosage

• Reclast: 5 mg IV infused over at least 15 minutes once; supplemented with elemental calcium and vitamin D. 

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”.

Common side effects of Zoledronic Acid include:

• trouble breathing, 
• nausea, 
• vomiting, 
• diarrhea, 
• constipation, 
• bone pain, 
• muscle or joint pain, 
• fever, 
• flu-like symptoms, 
• tiredness, 
• eye pain or swelling, 
• pain in arms or legs, 
• headache, and 
• anemia

Serious side effects of Zoledronic Acid include:

• hives, 
• wheezing, 
• chest tightness, 
• trouble breathing, 
• swelling of the face, lips, tongue, or throat, 
• new or unusual pain in the thigh or hip, 
• jaw pain or numbness, 
• red or swollen gums, 
• loose teeth, 
• slow healing after dental work, 
• severe joint, bone, or muscle pain, 
• little or no urination, 
• swelling in your feet or ankles, 
• pale skin, 
• unusual tiredness, 
• lightheadedness, 
• shortness of breath, 
• cold hands or feet, 
• muscle spasms or contractions, and
• numbness or tingly feeling (around the mouth, or in the fingers or toes)

Rare side effects of Zoledronic Acid include:

• none 

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Zoledronic Acid has severe interactions with the following drug:
  • human parathyroid hormone, recombinant
• Zoledronic Acid has serious interactions with no other drugs. 
• Zoledronic Acid has moderate interactions with at least 13 other drugs.
• Zoledronic Acid has minor interactions with at least 17 other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Contraindications

• Pregnancy
• All indications: Hypersensitivity, including rare cases of urticaria, angioedema, and anaphylactic reaction or shock
• Nononcologic uses: Hypocalcemia, severe renal impairment (CrCl less than 35 mL/min or evidence of acute renal impairment)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Zoledronic Acid?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Zoledronic Acid?”

Cautions

• Assess renal function before and after treatment; if renal function is decreased after treatment, withhold additional treatment until it returns to within 10% of baseline
• Before each Reclast dose, calculate CrCl on basis of actual body weight, using the Cockcroft-Gault formula
• Other risks for renal impairment include coadministration of zoledronic acid with nephrotoxic or diuretic medications, severe dehydration before or after zoledronic acid administration, and advanced age
• Previous renal insufficiency (serum creatinine over 3 mg/dL [265 mmol/L]), hepatic insufficiency, musculoskeletal pain
• Infuse over 15 minutes or longer; faster infusion increases renal toxicity
• May cause significant risk of hypocalcemia (seizures, tetany, and numbness); hypocalcemia must be corrected before initiation of therapy; adequately supplement patients with calcium and vitamin D; monitor serum calcium closely with concomitant administration of other drugs known to cause hypocalcemia to avoid severe or life-threatening hypocalcemia
• Use with caution in aspirin-sensitive asthma; may cause bronchoconstriction
• Increased risk of osteonecrosis of the jaw (advise patients against dental work); reported predominantly in cancer patients treated with IV bisphosphonates, including zoledronic acid; many patients were also receiving chemotherapy and corticosteroids which may be risk factors; the risk may increase with duration of exposure to bisphosphonates; perform preventive dental exams before initiating therapy; avoid invasive dental procedures; monitor diabetic patients carefully
• Cases of osteonecrosis (primarily involving the jaw but also of other anatomical sites including the hip, femur, and external auditory canal) were reported predominantly in cancer patients
• The risk of osteonecrosis of the jaw may increase with the duration of exposure to bisphosphonates
• Possible increased risk for atypical subtrochanteric and diaphyseal femur fractures; consider periodic reevaluation of the need for continued bisphosphonate therapy, particularly if the treatment lasts over 5 years
• If patients are receiving Zometa, they should not receive Reclast
• Severe bone, joint, and muscle pain may occur; withhold future doses of zoledronic acid if severe symptoms occur
• Rehydrate patients with hypercalcemia of malignancy before administration of zoledronic acid injection and monitor electrolytes during treatment
• Women of childbearing age should be advised of the potential hazard to the fetus and avoid becoming pregnant
• Femur Fractures reported; patients with thigh or groin pain should be evaluated to rule out a femoral fracture
• Severe bone, joint, and muscle pain may occur; withhold future doses of Reclast if severe symptoms occur

Pregnancy and Lactation

• There are no available data in pregnant women to inform the drug-associated risk
• Bisphosphonates are incorporated into the bone matrix and 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
• Verify pregnancy status of females of reproductive potential before initiation of therapy
• Therapy can cause fetal harm when administered to a pregnant woman; drug binds to bone long term and maybe released over weeks to years; advise females of reproductive potential to use effective contraception during and after therapy
• Based on animal studies, therapy may impair fertility in females of reproductive potential  
• Not known whether a drug is present in human milk, or whether it affects milk production or breastfed child; drug binds to bone long term and maybe released over weeks to years
• Consider developmental and health benefits of breast-feeding along with the mother’s clinical need for therapy and any potential adverse effects on breastfed child from the drug or underlying maternal condition