ZOLEDRONIC ACID injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Zoledronic Acid (UNII: 6XC1PAD3KF) (ZOLEDRONIC ACID ANHYDROUS - UNII:70HZ18PH24)

Available from:

Gland Pharma Limited

INN (International Name):

Zoledronic Acid

Composition:

ZOLEDRONIC ACID ANHYDROUS 5 mg in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Zoledronic acid injection is indicated for treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, diagnosed by bone mineral density (BMD) or prevalent vertebral fracture, zoledronic acid injection 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, zoledronic acid injection reduces the incidence of new clinical fractures [see Clinical Studies (14.1)]. Zoledronic acid injection is indicated for prevention of osteoporosis in postmenopausal women [see Clinical Studies (14.2)]. Zoledronic acid injection is indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies (14.3)]. Zoledronic acid injection 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

Product summary:

Zoledronic acid injection, 5 mg/100 mL is supplied as follows: Handling After opening the solution, it is stable for 24 hours at 2° to 8°C (36° to 46°F). If refrigerated, allow the refrigerated solution to reach room temperature before administration. Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ZOLEDRONIC ACID - ZOLEDRONIC ACID INJECTION, SOLUTION
Gland Pharma Limited
----------
17 PATIENT COUNSELING
INFORMATION
Advise the patient to read the FDA-approved patient labeling
(Medication Guide).
Information for Patients
Patients should be made aware that zoledronic acid injection contains
the same active ingredient
(zoledronic acid) found in Zometa® , and that patients being treated
with Zometa should not be treated
with zoledronic acid injection.
Zoledronic acid injection is contraindicated in patients with
creatinine clearance less than 35 mL/min [see
Contraindications (4)].
Before being given zoledronic acid injection, patients should tell
their doctor if they have kidney
problems and what medications they are taking.
Zoledronic acid injection should not be given if the patient is
pregnant or plans to become pregnant, or if
she is breast-feeding [see Warnings and Precautions (5.6)].
There have been reports of bronchoconstriction in aspirin-sensitive
patients receiving bisphosphonates,
including zoledronic acid injection. Before being given zoledronic
acid injection, 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.
Zoledronic acid injection 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 zoledronic acid injection.
After getting zoledronic acid injection 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 get

Summary of Product characteristics

ZOLEDRONIC ACID - ZOLEDRONIC ACID INJECTION, SOLUTION
GLAND PHARMA LIMITED
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZOLEDRONIC ACID INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZOLEDRONIC ACID
INJECTION.
ZOLEDRONIC ACID INJECTION
INITIAL U.S. APPROVAL: 2001
INDICATIONS AND USAGE
Zoledronic acid injection 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 zoledronic acid injection (4,
6.2)
WARNINGS AND PRECAUTIONS
_Products Containing Same Active Ingredient:_Patients receiving Zometa
should not receive zoledronic acid injection
(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 i