HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
RECLAST safely and effectively. See full prescribing information for
RECLAST.
RECLAST
®
(zoledronic acid) Injection
Initial U.S. Approval: 2001
-------------------------------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)
----------------------------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)
--------------------------DOSAGE FORMS AND STRENGTHS-----------------
5 mg in a 100 mL ready-to-infuse solution (3)
------------------------------------CONTRAINDICATIONS-------------------------
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)
---------------------------WARNINGS AND PRECAUTIONS--------------------
Products Containing Same Active Ingredient: Patients receiving Zometa
should not receive Reclast (5.1)
Hypocalcemia may worsen during treatment. Patients must be adequately
supplemented with calcium and vitamin D (5.2)
Renal Impairment: A single dose should not exceed 5 mg and the duration
of infusion should be no less than 15 minutes. Renal toxicity may be
greater in patients with underlying renal impairment or with other risk
factors, including advanced age or dehydration. Monitor creatinine
clearance before each dose (2.7, 5.3)
Osteonecrosis of the Jaw (ONJ) has been reported. All patients should
have a routine oral exam by the prescriber prior to treatment (5.4)
Atypical Femur Fractures have been reported. Patients with thigh or groin
pain should be evaluated to rule out a femoral fracture (5.5)
Severe Bone, Joint, and Muscle Pain may occur. Withhold future doses of
Reclast if severe symptoms occur (5.6)
------------------------------------ADVERSE REACTIONS-------------------------
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 Novartis
Pharmaceuticals Corporation at 1-888-669-6682 or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
-------------------------------------DRUG INTERACTIONS------------------------
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)
----------------------------USE IN SPECIFIC POPULATIONS-------------------
Pregnancy: Discontinue when pregnancy is recognized (8.1)
Pediatric Use: Not indicated for use in pediatric patients (8.4)
Geriatric Use: Special care to monitor renal function (8.5)
See 17 for PATIENT COUNSELING INFORMATION and Medication
Guide.
Revised: 4/2020
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Treatment of Osteoporosis in Postmenopausal Women
1.2 Prevention of Osteoporosis in Postmenopausal Women
1.3 Osteoporosis in Men
1.4 Glucocorticoid-Induced Osteoporosis
1.5 Paget's Disease of Bone
1.6 Important Limitations of Use
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions
2.2 Treatment of Osteoporosis in Postmenopausal Women
2.3 Prevention of Osteoporosis in Postmenopausal Women
2.4 Osteoporosis in Men
2.5 Treatment and Prevention of Glucocorticoid-Induced Osteoporosis
2.6 Treatment of Paget’s Disease of Bone
2.7 Laboratory Testing and Oral Examination Prior to Administration
2.8 Calcium and Vitamin D Supplementation
2.9 Method of Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Drug Products With Same Active Ingredient
5.2 Hypocalcemia and Mineral Metabolism
5.3 Renal Impairment
5.4 Osteonecrosis of the Jaw
5.5 Atypical Subtrochanteric and Diaphyseal Femoral Fractures
5.6 Musculoskeletal Pain
5.7 Patients With Asthma
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Post-Marketing Experience
7 DRUG INTERACTIONS
7.1 Aminoglycosides
7.2 Loop Diuretics
7.3 Nephrotoxic Drugs
7.4 Drugs Primarily Excreted by the Kidney
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Pharmacology
14 CLINICAL STUDIES
14.1 Treatment of Postmenopausal Osteoporosis
14.2 Prevention of Postmenopausal Osteoporosis
14.3 Osteoporosis in Men
14.4 Treatment and Prevention of Glucocorticoid-Induced Osteoporosis
14.5 Treatment of Paget’s Disease of Bone
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
* Sections or subsections omitted from the full prescribing information are not
listed