Reclast zoledronic acid
Refer to the “Also Known As” section to reference different products that include the same medication as Reclast.
Drug Basics
Brand Name: Reclast
Generic Name: ZOLEDRONIC ACID
Drug Type: HUMAN PRESCRIPTION DRUG
Route: INTRAVENOUS
Dosage Form: INJECTION, SOLUTION
Data Current As Of: 2020-05-18
indications & usage
Reclast is a bisphosphonate indicated for:
- Treatment and prevention of postmenopausal osteoporosis (1.1, 1.2)
- Treatment to increase bone mass in men with osteoporosis (1.3)
- Treatment and prevention of glucocorticoid-induced osteoporosis (1.4)
- Treatment of Paget’s disease of bone in men and women (1.5)
Limitations of Use
Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use (1.6)
treatment of osteoporosis in postmenopausal women
Reclast is indicated for treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, diagnosed by bone mineral density (BMD) or prevalent vertebral fracture, Reclast reduces the incidence of fractures (hip, vertebral, and non-vertebral osteoporosis-related fractures). In patients at high risk of fracture, defined as a recent low-trauma hip fracture, Reclast reduces the incidence of new clinical fractures [see Clinical Studies (14.1)].
prevention of osteoporosis in postmenopausal women
Reclast is indicated for prevention of osteoporosis in postmenopausal women [see Clinical Studies (14.2)].
osteoporosis in men
Reclast is indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies (14.3 )].
glucocorticoid-induced osteoporosis
Reclast is indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who are expected to remain on glucocorticoids for at least 12 months [s ee Clinical Studies (14.4)].
paget's disease of bone
Reclast is indicated for treatment of Paget's disease of bone in men and women. Treatment is indicated in patients with Paget’s disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease [see Clinical Studies (14.5)].
important limitations of use
The safety and effectiveness of Reclast for the treatment of osteoporosis is based on clinical data of three years duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy reevaluated on a periodic basis. Patients at low-risk for fracture should be considered for drug discontinuation after 3 to 5 years of use. Patients who discontinue therapy should have their risk for fracture reevaluated periodically.
patient counseling information
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Information for Patients
Patients should be made aware that Reclast contains the same active ingredient (zoledronic acid) found in Zometa®, and that patients being treated with Zometa should not be treated with Reclast.
Reclast is contraindicated in patients with creatinine clearance less than 35 mL/min [see Contraindications (4)].
Before being given Reclast, patients should tell their doctor if they have kidney problems and what medications they are taking [see Warnings and Precautions (5.3)].
Reclast should not be given if the patient is pregnant or plans to become pregnant, or if she is breastfeeding [see Use in Specific Populations (8.1, 8.2, 8.3)].
There have been reports of bronchoconstriction in aspirin-sensitive patients receiving bisphosphonates, including Reclast. Before being given Reclast, patients should tell their doctor if they are aspirin-sensitive.
If the patient had surgery to remove some or all of the parathyroid glands in their neck, or had sections of their intestine removed, or are unable to take calcium supplements they should tell their doctor.
Reclast is given as an infusion into a vein by a nurse or a doctor, and the infusion time must not be less than 15 minutes.
On the day of treatment the patient should eat and drink normally, which includes drinking at least 2 glasses of fluid, such as water within a few hours prior to the infusion, as directed by their doctor, before receiving Reclast.
After getting Reclast it is strongly recommended patients with Paget’s disease take calcium in divided doses (for example, 2 to 4 times a day) for a total of 1500 mg calcium a day to prevent low blood calcium levels. This is especially important for the two weeks after getting Reclast [see Warnings and Precautions (5.2)].
Adequate calcium and vitamin D intake is important in patients with osteoporosis and the current recommended daily intake of calcium is 1200 mg and vitamin D is 800 international units to 1000 international units daily. All patients should be instructed on the importance of calcium and vitamin D supplementation in maintaining serum calcium levels.
Patients should be aware of the most commonly associated side effects of therapy. Patients may experience one or more side effects that could include: fever, flu-like symptoms, myalgia, arthralgia, and headache. Most of these side effects occur within the first 3 days following the dose of Reclast. They usually resolve within 3 days of onset but may last for up to 7 to 14 days. Patients should consult their physician if they have questions or if these symptoms persist. The incidence of these symptoms decreased markedly with subsequent doses of Reclast.
Administration of acetaminophen following Reclast administration may reduce the incidence of these symptoms.
Physicians should inform their patients that there have been reports of persistent pain and/or a non-healing sore of the mouth or jaw, primarily in patients treated with bisphosphonates for other illnesses. During treatment with zoledronic acid, patients should be instructed to maintain good oral hygiene and undergo routine dental check-ups. If they experience any oral symptoms, they should immediately report them to their physician or dentist.
Severe and occasionally incapacitating bone, joint, and/or muscle pain have been infrequently reported in patients taking bisphosphonates, including Reclast. Consider withholding future Reclast treatment if severe symptoms develop.
Atypical femur fractures in patients on bisphosphonate therapy have been reported; patients with thigh or groin pain should be evaluated to rule out a femoral fracture.
T2020-62
This Medication Guide has been approved by the U.S. Food and Drug Administration. | Revised: April 2020 |
MEDICATION GUIDE Reclast® (RE-clast) (zoledronic acid) Injection | |
Read the Medication Guide that comes with Reclast before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. Talk to your doctor if you have any questions about Reclast. | |
What is the most important information I should know about Reclast? You should not receive Reclast if you are already receiving Zometa. Both Reclast and Zometa contain zoledronic acid. Reclast can cause serious side effects, including:
1. Low calcium levels in your blood (hypocalcemia). Reclast may lower the calcium levels in your blood. If you have low blood calcium before you start taking Reclast, it may get worse during treatment. Your low blood calcium must be treated before you take Reclast. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium, such as:
Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood, while you take Reclast. Take calcium and vitamin D as your doctor tells you to. 2. Severe kidney problems. Severe kidney problems may happen when you take Reclast. Severe kidney problems may lead to hospitalization or kidney dialysis and can be life-threatening. Your risk of kidney problems is higher if you:
You should drink at least 2 glasses of fluid within a few hours before receiving Reclast to reduce the risk of kidney problems. 3. Severe jaw bone problems (osteonecrosis). Severe jaw bone problems may happen when you take Reclast. Your doctor should examine your mouth before you start Reclast. Your doctor may tell you to see your dentist before you start Reclast. It is important for you to practice good mouth care during treatment with Reclast. 4. Unusual thigh bone fractures. Some people have developed unusual fractures in their thigh bone. Symptoms of a fracture may include new or unusual pain in your hip, groin, or thigh. 5. Bone, joint, or muscle pain. Some people who take bisphosphonates develop severe bone, joint, or muscle pain. Call your doctor right away if you have any of these side effects. | |
What is Reclast? Reclast is a prescription medicine used to:
It is not known how long Reclast works for the treatment and prevention of osteoporosis. You should see your doctor regularly to determine if Reclast is still right for you. Reclast is not for use in children. | |
Who should not take Reclast? Do not take Reclast if you:
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What should I tell my doctor before taking Reclast? Before you start Reclast, be sure to talk to your doctor if you:
Especially tell your doctor if you are taking:
Ask your doctor or pharmacist for a list of these medicines, if you are not sure. Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist each time you get a new medicine. | |
How will I receive Reclast?
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What are the possible side effects of Reclast? Reclast may cause serious side effects.
The most common side effects of Reclast included:
Talk to your doctor about things you can do to help decrease some of these side effects that might happen with a Reclast infusion. You may get allergic reactions, such as hives, swelling of your face, lips, tongue, or throat. | |
General information about safe and effective use of Reclast. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. This Medication Guide summarizes the most important information about Reclast. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Reclast that is written for health professionals. For more information, go to: www.novartis.us or call 1-888-669-6682. | |
What are the ingredients in Reclast? Distributed by: |
T2020-63
PRINCIPAL DISPLAY PANEL
Package Label – 5 mg / 100 mL
Rx Only NDC 0078-0435-61
Reclast®
(zoledronic acid) injection
5 mg / 100 mL
Solution for Intravenous Infusion
Dispense the accompanying Medication Guide to each patient.
1 bottle – Sterile Solution
Do not mix with calcium-containing solutions. Administer as a single intravenous solution through a separate vented infustion line.
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