HIGHLIGHTS OF PRESCRIBING INFORMATION

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

IBANDRONATE SODIUM (UNII: J12U072QL0) (IBANDRONIC ACID - UNII:UMD7G2653W)

Tilgængelig fra:

Genentech, Inc.

INN (International Name):

ibandronate sodium

Sammensætning:

ibandronic acid 3 mg in 3 mL

Indgivelsesvej:

INTRAVENOUS

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

BONIVA Injection is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, BONIVA increases bone mineral density (BMD) and reduces the incidence of vertebral fractures [see Clinical Studies (14)] . The safety and effectiveness of BONIVA for the treatment of osteoporosis are based on clinical data of one year duration. The optimal duration of use has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re-evaluated 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 re-evaluated periodically. Boniva is contraindicated in patients with the following conditions: - Hypocalcemia [see Warnings and Precautions (5.1)] - Known hypersensitivity to BONIVA Injection or to any of its excipients. Cases of anaphylaxis, including fatal events, have been

Produkt oversigt:

BONIVA Injection (ibandronate sodium) is supplied as a kit containing a 3 mg/3 mL single-dose, clear glass, 5 mL (5 cc) prefilled syringe, a 25-gauge, 3/4 inch needle with wings, needle-stick protection device, and a 9 cm plastic tubing for attachment (NDC 0004 0191 09). Store at 25°C (77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].

Autorisation status:

New Drug Application

Indlægsseddel

Genentech, Inc.
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MEDICATION GUIDE
Boniva® (bon-EE-va)
(ibandronate)
Injection for intravenous use
Read the Medication Guide that comes with BONIVA 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
BONIVA.
What is the most important information I should know about BONIVA?
BONIVA Injection is given in your vein (intravenously) and only given
by a healthcare provider. Do not
give BONIVA Injection to yourself.
BONIVA may cause serious side effects including:
1.
Low calcium levels in your blood (hypocalcemia)
2.
Severe allergic reaction (anaphylactic reaction)
3.
Severe kidney problems
4.
Severe jaw bone problems (osteonecrosis)
5.
Bone, joint or muscle pain
6.
Unusual thigh bone fractures
1.
Low calcium levels in your blood (hypocalcemia).
BONIVA may lower the calcium levels in your blood. If you have low
blood calcium before you
start taking BONIVA, it may get worse during treatment. Your low blood
calcium must be treated
before you receive BONIVA. 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 receive BONIVA. Take calcium and vitamin D as your doctor
tells you to.
2.
Severe allergic reactions.
Some people who received BONIVA Injection had severe allergic
reactions (anaphylactic
reactions) that led to death. Get medical help right away if you have
any of the symptoms of a
serious allergic reaction such as:
•
Swelling of your face, lips, mouth or tongue
•
Trouble breathing
•
Wheezing
•
Severe itching
•
Skin rash, redness or swelling
•
Dizzin

Produktets egenskaber

BONIVA- IBANDRONATE SODIUM INJECTION, SOLUTION
GENENTECH, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BONIVA INJECTION SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR BONIVA INJECTION.
BONIVA ® (IBANDRONATE) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
BONIVA Injection is a bisphosphonate indicated for the treatment of
osteoporosis in postmenopausal women. (1.1)
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 (1.2)
DOSAGE AND ADMINISTRATION
3 mg every 3 months administered intravenously over a period of 15 to
30 seconds (2.2)
Dosing Instructions:
Only administer intravenously by a health care professional. (2.1)
Do not mix with calcium-containing solutions or other intravenously
administered drugs. (2.1)
Do not administer more frequently than once every 3 months. (2.2)
Instruct patients to take supplemental calcium and vitamin D if
dietary intake is inadequate
DOSAGE FORMS AND STRENGTHS
BONIVA Injection is supplied as a kit containing:
a 3 mg/3 mL single-dose prefilled syringe.
a 25-gauge, 3/4 inch needle with wings, needle-stick protection
device, and a 9 cm plastic tubing for attachment (3)
CONTRAINDICATIONS
Hypocalcemia (4)
Hypersensitivity to BONIVA Injection (4)
WARNINGS AND PRECAUTIONS
_Hypocalcemia_ can worsen. Correct hypocalcemia prior to use.
Adequately supplement patients with calcium and vitamin D (5.1)
_Anaphylaxis_, including fatal events, has been reported. (5.2)
_Renal Toxicity_ may be greater in patients with underlying renal
impairment. Do not administer BONIVA injection to
patients with severe renal impairment (creatinine clearance less than
30 mL/min). Monitor serum creatinine prior to
each dose. (5.3)
_Tissue Damage with Inappropriate Drug Administration_ can occur. Do
not administer BONIVA Injection intra-arterially
or paravenously. (5.4)
_Osteonecrosis o