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Zoledronic acid (sometimes called zoledronate) is a bisphosphonate (bis FOS fo nayt) medicine that alters bone formation and breakdown in the body. This can slow bone loss and may help prevent bone fractures.
Reclast and Zometa are two different brands of zoledronic acid.
Reclast is used to treat osteoporosis caused by menopause, steroid use, or gonadal failure. zoledronic acid is for use when you have a high risk of bone fracture due to osteoporosis. Reclast is also used to treat Paget's disease of bone.
Zometa is used to treat high blood levels of calcium caused by cancer (also called hypercalcemia of malignancy). Zometa also treats multiple myeloma (a type of bone marrow cancer) or bone cancer that has spread from elsewhere in the body.
You should not use Reclast and Zometa at the same time.
Zoledronic acid may also be used for purposes not listed in this medication guide.
Zoledronic acid may harm an unborn baby. Avoid getting pregnant while using this medicine and tell your doctor if you become pregnant.
Zoledronic acid can cause serious kidney problems, especially if you are dehydrated, if you take diuretic medicine, or if you already have kidney disease. Call your doctor if you urinate less than usual, if you have swelling in your feet or ankles, or if you feel tired or short of breath.
Also call your doctor if you have muscle spasms, numbness or tingling (in hands and feet or around the mouth), new or unusual hip pain, or severe pain in your joints, bones, or muscles.
You should not be treated with zoledronic acid if you are allergic to it.
You also should not receive Reclast if you have:
low levels of calcium in your blood (hypocalcemia); or
severe kidney disease.
You should not be treated with zoledronic acid if are currently using any other bisphosphonate (such as alendronate, etidronate, ibandronate, pamidronate, risedronate, or tiludronate).
To make sure zoledronic acid is safe for you, tell your doctor if you have ever had:
kidney disease;
hypocalcemia;
thyroid or parathyroid surgery;
surgery to remove part of your intestine;
asthma caused by taking aspirin;
any condition that makes it hard for your body to absorb nutrients from food (malabsorption); or
a dental problem (you may need a dental exam before you receive zoledronic acid).
Zoledronic acid can cause serious kidney problems, especially if you are dehydrated, if you take diuretic medicine, or if you already have kidney disease.
In rare cases, zoledronic acid may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work. The longer you use zoledronic acid, the more likely you are to develop this condition.
Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.
Zoledronic acid may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine. Tell your doctor if you become pregnant. You may also need to use birth control for several weeks after you last received zoledronic acid. This medicine can have long-lasting effects on your body.
Zoledronic acid can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.
Zoledronic acid is injected into a vein through an IV. A healthcare provider will give you this injection.
Zoledronic acid is sometimes given as a single dose only one time. It may also be given once every 1 or 2 years. How often you receive zoledronic acid will depend on why you are using this medicine. Follow your doctor's instructions.
Drink at least 2 glasses of water within a few hours before your injection to keep from getting dehydrated.
You may need frequent medical tests to help your doctor determine how long to treat you with zoledronic acid. Your kidney function may also need to be checked.
Pay special attention to your dental hygiene while using zoledronic acid. Brush and floss your teeth regularly. If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using zoledronic acid.
Zoledronic acid is only part of a complete program of treatment that may also include diet changes and taking calcium and vitamin supplements. Follow your doctor's instructions very closely.
Your doctor will determine how long to treat you with this medicine. Zoledronic acid is often given for only 3 to 5 years.
Call your doctor for instructions if you miss an appointment for your zoledronic acid injection.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Avoid smoking, or try to quit. Smoking can reduce your bone mineral density, making fractures more likely.
Avoid drinking large amounts of alcohol. Heavy drinking can also cause bone loss.
Get emergency medical help if you have signs of an allergic reaction: hives; wheezing, chest tightness, trouble breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
new or unusual pain in your thigh or hip;
jaw pain, numbness, or swelling;
kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath;
severe joint, bone, or muscle pain; or
low calcium levels--muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).
Serious side effects on the kidneys may be more likely in older adults.
Common side effects may include:
nausea, vomiting, diarrhea, constipation;
bone pain, muscle or joint pain;
fever or other flu symptoms;
pain in your arms or legs;
red or puffy eyes;
headache, tiredness; or
trouble breathing.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Zoledronic acid can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, injectable osteoporosis medication, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).
Other drugs may interact with zoledronic acid, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Zoledronic Acid (www.drugs.com/mtm/zoledronic-acid.html).
Commonly reported side effects of zoledronic acid include: hypophosphatemia, hypokalemia, and hypomagnesemia. Other side effects include: hypocalcemia. See below for a comprehensive list of adverse effects.
For the ConsumerApplies to zoledronic acid: intravenous powder for solution, intravenous solution
Along with its needed effects, zoledronic acid may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking zoledronic acid:
More common
Less common
Incidence not known
Some side effects of zoledronic acid may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
Rare
For Healthcare Professionals
Applies to zoledronic acid: intravenous powder for injection, intravenous solution
GeneralIn general, side effects have been mild and transient and similar to other bisphosphonates.
Acute phase reactions have occurred within three days after administration of this drug with symptoms of pyrexia, fatigue, bone pain and/or arthralgias, myalgias, chills, and influenza-like illness. Symptoms usually resolve within three days of onset, but resolution can take up to 7 to 14 days, and some symptoms have persisted for a longer duration.
CardiovascularIn the postmenopausal osteoporosis trial, adjudicated serious adverse events of atrial fibrillation in the zoledronic acid treatment group occurred in 1.3% of patients (50 out of 3862) compared to 0.4% (17 out of 3852) in the placebo group. The overall incidence of all atrial fibrillation adverse events in the zoledronic acid treatment group was, reported in 2.5% of patients (96 out of 3862) in the Reclast group vs. 1.9% of patients (75 out of 3852) in the placebo group.
Very common (10% or more): Hypotension (10.5%)
Common (1% to 10%): Atrial fibrillation
Uncommon (0.1% to 1%): Palpitations, flushing, hypotension, hypotension leading to syncope or circulatory collapse
Rare (less than 0.1%): Bradycardia
Very rare (less than 0.01%): Cardiac arrhythmia (secondary to hypocalcemia)
Postmarketing reports: Atrial fibrillation, hypertension, bradycardia, and hypotension
DermatologicVery common (10% or more): Alopecia (12%) and dermatitis (11%)
Uncommon (0.1% to 1%): Pruritus, hyperhidrosis, rash (including erythematous and macular rash), increased sweating
Frequency not reported: Stevens-Johnson syndrome, epidermal necrolysis
Postmarketing reports: Increased sweating and urticaria
GastrointestinalVery common (10% or more): Nausea (29.1% to 46%), vomiting (14% to 32%), constipation (26.7% to 31%), diarrhea (17.4% to 24%), abdominal pain (14% to 16.3%), dyspepsia (10%)
Common (1% to 10%): Stomatitis, sore throat, dysphagia
Uncommon (0.1% to 1%): Gastroesophageal reflux disease, esophagitis, toothache, gastritis
Postmarketing reports: Dry mouth
GenitourinaryVery common (10% or more): Urinary tract infection (14%)
HematologicVery common (10% or more): Anemia (22.1% to 33%) and neutropenia (12%)
Common (1% to 10%): Granulocytopenia, thrombocytopenia and pancytopenia
Uncommon (0.1% to 1%): Leukopenia
MetabolicVery common (10% or more): Hypophosphatemia (12.8%), hypokalemia (11.6%), hypomagnesemia (10.5%),
Common (1% to 10%): Dehydration, hypocalcemia
Uncommon (0.1% to 1%): Anorexia, decrease appetite
Rare (less than 0.1%): Hyperkalemia, hypernatremia
Grade 3 and 4 laboratory abnormalities have included hypophosphatemia (51.4%, grade 3; 1.4%, grade 4) and hypocalcemia (1.2%, grade 3).
MusculoskeletalVery common (10% or more): Bone pain (55%), myalgia (23%), arthralgia (21%), back pain (15%), and limb pain (14%)
Common (1% to 10%): Myalgia, arthralgia, generalized pain, pain in extremity
Uncommon (0.1% to 1%): Muscle cramps, osteonecrosis of the jaw (ONJ), neck pain, musculoskeletal stiffness, joint swelling, muscle spasms, shoulder pain, musculoskeletal chest pain, musculoskeletal pain, joint stiffness, arthritis, muscular weakness
Rare (less than 0.1%): Atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction)
Postmarketing reports: Muscle cramps; osteonecrosis of the jaw, hip, and femur have been reported predominantly in cancer patients treated with intravenous bisphosphonates (many of these patients were also receiving chemotherapy and corticosteroids which may be a risk factor for ONJ).
Cases of osteonecrosis (primarily of the jaws) have been reported, predominantly in cancer patients taking this drug. Many of these patients had signs of local infection including osteomyelitis, and the majority of the reports refer to cancer patients following tooth extractions or other dental surgeries. Osteonecrosis of the jaws has multiple documented risk factors including a diagnosis of cancer, concomitant therapies (e.g. chemotherapy, radiotherapy, corticosteroids) and co-morbid conditions (e.g. anemia, coagulopathies, infection, pre-existing oral disease).
Nervous systemVery common (10% or more): Headache (19%), dizziness (18%), paresthesia (15%), hypoesthesia (12%)
Common (1% to 10%): Somnolence
Uncommon (0.1% to 1%): Paraesthesia, taste disturbance, hyperesthesia, tremor, somnolence, syncope, dysgeusia, lethargy
Very rare (less than 0.01%): Seizures, numbness and tetany (secondary to hypocalcemia)
Frequency not reported: Neurological events due to hypokalemia (e.g., seizures, numbness, tetany)
Postmarketing reports: Taste disturbance, hyperesthesia, tremor
OtherVery common (10% or more): Fever (44.2%), moniliasis (11.6%)
Common (1% to 10%): Nonspecific infections, asthenia, mucositis, chest pain, leg edema
Uncommon (0.1% to 1%): Vertigo
Postmarketing reports: Flu-like syndrome, pyrexia, fatigue, malaise; osteonecrosis of the external auditory canal have been reported predominantly in cancer patients treated with intravenous bisphosphonates (many of these patients were also receiving chemotherapy and corticosteroids which may be a risk factor for ONJ).
Fever is the most common adverse effect associated with zoledronic acid infusion.
Flu-like syndromes including fever, chills, bone pain, and/or arthralgias and myalgias have also occasionally been reported. These symptoms generally did not require treatment and resolved within 24 to 48 hours.
PsychiatricVery common (10% or more): Insomnia (15.1%), anxiety (14%), depression (14%), agitation (12.8%)
Common (1% to 10%): Confusion
RenalThe following factors have been associated with an increased risk: Pre-existing renal dysfunction, dehydration, multiple cycles of zoledronic acid or other bisphosphonates, concomitant use of nephrotoxic medicines and use of a shorter infusion time than what is recommended.
The frequency of renal impairment adverse events suspected to be related to this drug was as follows: Multiple myeloma (3.2%), prostate cancer (3.1%), breast cancer (4.3%), lung and other solid tumors (3.2%). Renal deterioration, progression to renal failure and dialysis have been reported in patients after the initial dose or a single dose of 4 mg zoledronic acid.
Very common (10% or more): Renal toxicity (deterioration of renal function or renal failure),
Common (1% to 10%): Grade 3 increases (more than 3 times upper limit of normal) in serum creatinine in 2.3% of patients, blood urea increased
Uncommon (0.1% to 1%): Acute renal failure, hematuria, proteinuria, pollakiuria
Postmarketing reports: Hematuria, proteinuria, hyperkalemia, hypernatremia
RespiratoryVery common (10% or more): Dyspnea (22.1% to 27%), coughing (11.6% to 22%), upper respiratory infection (10%)
Uncommon (0.1% to 1%): Pleural effusion
Rare (less than 0.1%): Interstitial lung disease
Postmarketing reports: Bronchoconstriction and asthma exacerbations
OcularCommon (1% to 10%): Conjunctivitis, ocular hyperemia
Uncommon (0.1% to 1%): Blurred vision, scleritis, orbital inflammation, eye pain
Very rare (less than 0.01%): Uveitis, episcleritis, iritis
Frequency not reported: Scleritis
Postmarketing reports: Uveitis, scleritis, episcleritis, conjunctivitis, iritis, and orbital inflammation including orbital edema
HypersensitivityUncommon (0.1% to 1%): Hypersensitivity reaction including bronchoconstriction, urticaria, angioedema, anaphylactic reaction/shock
LocalUncommon (0.1% to 1%): Injection site reactions (including pain, irritation, swelling, induration)
Postmarketing reports: Itching and pain at the injection site
ImmunologicRare (less than 0.1%): Angioneurotic edema
OncologicFrequency not reported: Aggravation of malignant neoplasm and progression of cancer
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Zoledronic Acid (www.drugs.com/mtm/zoledronic-acid.html).
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