IBANDRONATE SODIUM injection

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Apotex Corp.

ІПН (Міжнародна Ім'я):

IBANDRONATE SODIUM

Склад:

IBANDRONIC ACID 3 mg in 3 mL

Адміністрація маршрут:

INTRAVENOUS

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Ibandronate sodium Injection is indicated for the treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, ibandronate sodium injection increases bone mineral density (BMD) and reduces the incidence of vertebral fractures [see Clinical Studies (14)] . The safety and effectiveness of ibandronate sodium injection 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. Ibandronate sodium is contraindicated in patients with the following conditions: - Hypocalcemia [see Warnings and Precautions (5.1)] - Known hypersensitivity to ibandronate sodium injection or to any of its excipients. Cases of anaphylaxis, including fatal events, have been reported. [ see Warnings and Precautions (5.2) , Adverse Reactions (6.2) ] Risk Summary Ibandronate sodium is not indicated for use in women of reproductive potential. There are no data with ibandronate sodium use in pregnant women to inform any drug-associated risks. In reproductive toxicity studies in the rat, ibandronate sodium caused obstruction of labor, with maternal periparturient mortality, pup loss and reduced pup weight at greater than or equal to 2 times human exposure at the recommended human intravenous dose of 3 mg. Abnormal pup odontogeny was observed at greater than or equal to 18 times human exposure. In rats dosed during pregnancy, kidney developmental toxicity occurred in offspring at greater than or equal to 47 times human exposure. Also, fetal weight and pup growth were reduced at greater than or equal to 5 times human exposure. In reproductive studies in the rabbit, ibandronate sodium caused maternal mortality, reduced maternal body weight gain, decreased litter size due to increased resorption rate, and decreased fetal weight at 19 times the recommended human dose (see Data ). Data Animal Data In pregnant rats given intravenous doses producing greater than or equal to 2 times human exposure from Day 17 post­-coitum until Day 20 post-partum, ibandronate treatment resulted in dystocia, maternal mortality, and early postnatal pup loss in all dose groups. Reduced body weight at birth was observed at greater than or equal to 4 times the human exposure. Pups exhibited abnormal odontogeny that decreased food consumption and body weight gain at greater than or equal to 18 times human exposure. Periparturient mortality has also been observed with other bisphosphonates and appears to be a class effect related to inhibition of skeletal calcium mobilization resulting in hypocalcemia and dystocia. Exposure of pregnant rats during the period of organogenesis resulted in an increased fetal incidence of RPU (renal pelvis ureter) syndrome at an intravenous dose producing greater than or equal to 47 times human exposure. In this spontaneous delivery study, dystocia was counteracted by perinatal calcium supplementation. In rat studies with intravenous dosing during gestation, fetal weight and pup growth were reduced at doses producing greater than or equal to 5 times human exposure.  In pregnant rabbits given intravenous doses during the period of organogenesis, maternal mortality, reduced maternal body weight gain, decreased litter size due to increased resorption rate, and decreased fetal weight were observed at 19 times the recommended human intravenous dose. Exposure multiples for the rat studies were calculated using human exposure at the recommended intravenous dose of 3 mg every 3 months and were based on cumulative area under the curve (AUC) comparison. Exposure multiples for the rabbit study were calculated for the recommended human intravenous dose of 3 mg every 3 months and were based on cumulative dose/[body surface area] comparison. Doses in pregnant animals were 0.05, 0.1, 0.15, 0.3, 0.5 or 1 mg/kg/day in rats, and 0.03, 0.07, or 0.2 mg/kg/day in rabbits. Risk Summary Ibandronate sodium is not indicated for use in women of reproductive potential. There is no information on the presence of ibandronate in human milk, the effects of ibandronate on the breastfed infant, or the effects of ibandronate on milk production. Ibandronate is present in rat milk (see Data). The clinical relevance of this data is unclear. Data Animal Data In lactating rats treated with intravenous doses of 0.08 mg/kg, ibandronate was present in breast milk at concentrations of 8.1 to 0.4 ng/mL from 2 to 24 hours after dose administration. Concentrations in milk averaged 1.5 times plasma concentrations. Safety and effectiveness of ibandronate sodium injection in pediatric patients have not been established. Of the patients receiving ibandronate sodium injection 3 mg every 3 months for 1 year, 51% were over 65 years of age. No overall differences in effectiveness or safety were observed between these patients and younger patients, but greater sensitivity in some older individuals cannot be ruled out. Ibandronate sodium Injection should not be administered to patients with severe renal impairment (creatinine clearance less than 30 mL/min) [see Warnings and Precautions (5.3)] .

Огляд продуктів:

Ibandronate sodium Injection is supplied as a kit containing a 3 mg/3 mL (1 mg/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 60505-6097-0). Store at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

Apotex Corp.
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MEDICATION GUIDE
Ibandronate sodium Injection for intravenous use
(eye" ban droe' nate soe' dee um)
Medication Guide available at www1.apotex.com/products/us
Read the Medication Guide that comes with ibandronate sodium 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 ibandronate sodium injection.
What is the most important information I should know about ibandronate
sodium injection?
Ibandronate sodium Injection is given in your vein (intravenously) and
only given by a healthcare
provider. Do not give ibandronate sodium injection to yourself.
Ibandronate sodium Injection 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).
Ibandronate sodium may lower the calcium levels in your blood. If you
have low blood calcium
before you start taking ibandronate sodium, it may get worse during
treatment. Your low blood
calcium must be treated before you receive ibandronate sodium. 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 ibandronate sodium injection. Take calcium and
vitamin D as your doctor tells
you to.
2.
Severe allergic reactions.
Some people who received ibandronate sodium injection had severe
allergic reactions (anaphylactic
reactions) that led to

Характеристики продукта

IBANDRONATE SODIUM- IBANDRONATE SODIUM INJECTION
APOTEX CORP.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IBANDRONATE SODIUM
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
IBANDRONATE SODIUM
INJECTION.
IBANDRONATE SODIUM INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2003
INDICATIONS AND USAGE
Ibandronate sodium 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
Ibandronate sodium Injection is supplied as a kit containing:
a 3 mg/3 mL (1 mg/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 ibandronate sodium 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
ibandronate sodium 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 adminis