Reclast 5 mg/100mL

zoledronic acid · INJECTION, SOLUTION · Sandoz Inc

No Recall History

Plain English

Reclast is a injection, solution containing zoledronic acid at 5 mg/100mL, taken intravenous. Manufactured by Sandoz Inc.

Key Facts

Brand Name: Reclast
Generic Name: zoledronic acid
NDC Code (Product): 66758-155
Manufacturer: Sandoz Inc
Strength: 5 mg/100mL
Dosage Form: INJECTION, SOLUTION
Route: INTRAVENOUS
Marketing Status
Application #: NDA021817
Marketing Start: 04/01/2007

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

arthralgia3,144 reports

pain3,088 reports

pyrexia2,754 reports

nausea2,736 reports

fatigue2,706 reports

osteonecrosis of jaw2,654 reports

death2,467 reports

headache2,323 reports

diarrhoea2,222 reports

vomiting2,018 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND 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 ) 1.1 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 )]. 1.2 Prevention of Osteoporosis in Postmenopausal Women Reclast is indicated for prevention of osteoporosis in postmenopausal women [see Clinical Studies ( 1…

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Infusion given intravenously over no less than 15 minutes: • Treatment of postmenopausal osteoporosis ( 2.2 ); treatment to increase bone mass in men with osteoporosis ( 2.4 ): treatment and prevention of glucocorticoid-induced osteoporosis ( 2.5 ): 5 mg once a year • Prevention of postmenopausal osteoporosis: 5 mg once every 2 years ( 2.3 ) • Treatment of Paget’s disease of bone: a single 5 mg infusion. Patients should receive 1500 mg elemental calcium and 800 international units vitamin D daily ( 2.6 ) 2.1 Important Administration Instructions Reclast injection must be administered as an intravenous infusion over no less than 15 minutes. • Patients must be appropriately hydrated prior to administration of Reclast [see Warnings and Precautions ( 5.3 )] . • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. • Intravenous infusion should be followed by a 10 mL normal saline flush of the intravenous line. • Administration of acetaminophen following Reclast administration may reduce the incidence of acute-phase reaction symptoms. 2.2 Treatment of Ost…

Contraindications

4 CONTRAINDICATIONS Reclast is contraindicated in patients with the following conditions: • Hypocalcemia [see Warnings and Precautions ( 5.2 )] • Creatinine clearance less than 35 mL/min and in those with evidence of acute renal impairment due to an increased risk of renal failure [see Warnings and Precautions ( 5.3 )] . • Known hypersensitivity to zoledronic acid or any components of Reclast. Hypersensitivity reactions, including urticaria, angioedema, and anaphylactic reaction/shock have been reported [see Adverse Reactions ( 6.2 )]. • Hypocalcemia ( 4 ) • Patients with creatinine clearance less than 35 mL/min and in those with evidence of acute renal impairment ( 4 , 5.3 ) • Hypersensitivity to any component of Reclast ( 4 , 6.2 )

Drug Interactions

7 DRUG INTERACTIONS No in vivo drug interaction studies have been performed for Reclast. In vitro and ex vivo studies showed low affinity of zoledronic acid for the cellular components of human blood. In vitro mean zoledronic acid protein binding in human plasma ranged from 28% at 200 ng/mL to 53% at 50 ng/mL. In vivo studies showed that zoledronic acid is not metabolized, and is excreted into the urine as the intact drug. • Aminoglycosides: May lower serum calcium for prolonged periods ( 7.1 ) • Loop Diuretics: May increase risk of hypocalcemia ( 7.2 ) • Nephrotoxic Drugs: Use with caution ( 7.3 ) • Drugs Primarily Excreted by the Kidney: Exposure may be increased with renal impairment. Monitor serum creatinine in patients at risk ( 7.4 ) 7.1 Aminoglycosides Caution is advised when bisphosphonates, including zoledronic acid, are administered with aminoglycosides, since these agents may have an additive effect to lower serum calcium level for prolonged periods. This effect has not been reported in zoledronic acid clinical trials. 7.2 Loop Diuretics Caution should also be exercised when Reclast is used in combination with loop diuretics due to an increased risk of hypocalcemia. 7.3 …

Adverse Reactions

6 ADVERSE REACTIONS The following clinically significant adverse drug reactions are described elsewhere in the labeling: • Drugs with Same Active Ingredient [see Warnings and Precautions ( 5.1 )] • Hypocalcemia and Mineral Metabolism [see Warnings and Precautions ( 5.2 )] • Renal Impairment [see Warnings and Precautions ( 5.3 )] • Osteonecrosis of the Jaw [see Warnings and Precautions ( 5.4 )] • Atypical Fractures Including Femoral Fractures [see Warnings and Precautions ( 5.5 )] • Musculoskeletal Pain [see Warnings and Precautions ( 5.6 )] • Patients with Asthma [see Warnings and Precautions ( 5.7 )] The most common adverse reactions (greater than 10%) were pyrexia, myalgia, headache, arthralgia, pain in extremity ( 6.1 ). Other important adverse reactions were flu-like illness, nausea, vomiting, diarrhea ( 6.2 ), and eye inflammation ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clini…

Frequently Asked Questions

What is Reclast used for?

Reclast contains zoledronic acid. It is a injection, solution taken intravenous. Consult your doctor for specific uses.

Is Reclast a controlled substance?

Reclast is not classified as a controlled substance by the DEA.

What is the generic name for Reclast?

The generic name for Reclast is zoledronic acid. There are 12 other brand versions of zoledronic acid.

What is the NDC code for Reclast 5 mg/100mL?

The NDC (National Drug Code) for Reclast 5 mg/100mL is 66758-155, listed by Sandoz Inc.

Product NDC

66758-155

Package NDC

66758-155-46

Other Zoledronic Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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