ZOLEDRONIC ACID injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

FOSUN PHARMA USA INC

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 o

Product summary:

Zoledronic acid injection is supplied as follows: Handling After entering the IV administration port, the solution 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 Conditions Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Single-dose only. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free, PVC-free, DEHP-free. The container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

ZOLEDRONIC ACID- ZOLEDRONIC ACID INJECTION
FOSUN PHARMA USA INC
----------
MEDICATION GUIDE
Zoledronic Acid (ZOE-le-DRON-ik AS-id) Injection
Read the Medication Guide that comes with zoledronic acid injection
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 zoledronic acid injection.
What is the most important information I should know about zoledronic
acid injection?
You should not receive zoledronic acid injection if you are already
receiving Zometa. Both zoledronic
acid injection and Zometa contain zoledronic acid .
Zoledronic acid injection can cause serious side effects including:
1. Low calcium levels in your blood (hypocalcemia)
2. Severe kidney problems
3. Severe jaw bone problems (osteonecrosis)
4. Unusual thigh bone fractures
5. Bone, joint or muscle pain
1. Low calcium levels in your blood (hypocalcemia).
Zoledronic acid injection may lower the calcium levels in your blood.
If you have low blood calcium
before you start taking zoledronic acid injection, it may get worse
during treatment. Your low blood
calcium must be treated before you take zoledronic acid injection.
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:
• Spasms, twitches, or cramps in your muscles
• Numbness or tingling in your fingers, toes, or around your mouth
Your doctor may prescribe calcium and vitamin D to help prevent low
calcium levels in your blood, while
you take zoledronic acid injection. Take calcium and vitamin D as your
doctor tells you to.
2. Severe kidney problems.
Severe kidney problems may happen when you take zoledronic acid
injection. Severe kidney problems
may lead to hospitalization or kidney dialysis and can be
life-threatening. Your risk of kidney problems is
higher if you:
•

Summary of Product characteristics

ZOLEDRONIC ACID- ZOLEDRONIC ACID INJECTION
FOSUN PHARMA USA INC
----------
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, FOR INTRAVENOUS INFUSION
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 exc