REGADENOSON injection, solution

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

REGADENOSON ANHYDROUS (UNII: 7AXV542LZ4) (REGADENOSON ANHYDROUS - UNII:7AXV542LZ4)

Pieejams no:

Hikma Pharmaceuticals USA Inc.

Ievadīšanas:

INTRAVENOUS

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate exercise stress. Do not administer regadenoson injection to patients with: - Second- or third-degree AV block, or - sinus node dysfunction unless these patients have a functioning artificial pacemaker [see Warnings and Precautions (5.2) ]. Risk Summary There are no available data on regadenoson injection use in pregnant women to inform a drug-associated risk. In animal reproduction studies, adverse developmental outcomes were observed with the administration of regadenoson to pregnant rats and rabbits during organogenesis only at doses that produced maternal toxicity (see Data ). In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Reproductive studies in rats showed that regadenoson doses 10 and 20 times the maximum recommended human dose (MRHD) based on body surface area caused reduced fetal body weights and significant ossification delays in fore- and hind limb phalanges and metatarsals; maternal toxicity also occurred at these doses. Skeletal variations were increased in all treated groups. In rabbits, maternal toxicity occurred at regadenoson doses administered during organogenesis at 4 times the MRHD; however, there were no teratogenic effects in offspring at this dose. At higher doses, 12 and 20 times the MRHD, maternal toxicity occurred along with increased embryo-fetal loss and fetal malformations. Risk Summary There is no information on the presence of regadenoson in human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential risk of serious cardiac reactions in the breastfed infant, advise the nursing mother to pump and discard breast milk for 10 hours after administration of regadenoson injection. Safety and effectiveness in pediatric patients have not been established. Of the 1,337 patients receiving regadenoson injection in Studies 1 and 2, 56% were 65 years of age and over and 24% were 75 years of age and over. Older patients (≥ 75 years of age) had a similar adverse event profile compared to younger patients (< 65 years of age), but had a higher incidence of hypotension (2% vs. ≤ 1%). No dose adjustment is needed in patients with renal impairment including patients with end stage renal disease and/or dependent on dialysis [see Pharmacokinetics (12.3) ].

Produktu pārskats:

Regadenoson Injection is supplied as a sterile, clear, colorless preservative-free solution containing 0.08 mg/mL regadenoson in the following package: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Discard unused portion.

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

REGADENOSON- REGADENOSON INJECTION, SOLUTION
HIKMA PHARMACEUTICALS USA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
REGADENOSON
INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
REGADENOSON
INJECTION.
REGADENOSON INJECTION FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2008
INDICATIONS AND USAGE
Regadenoson injection is a pharmacologic stress agent indicated for
radionuclide myocardial perfusion
imaging (MPI) in patients unable to undergo adequate exercise stress
(1).
DOSAGE AND ADMINISTRATION
The recommended dose of regadenoson injection is 5 mL (0.4 mg
regadenoson) administered as an
intravenous injection within 10 seconds; followed immediately by
saline flush and radiopharmaceutical
(2).
DOSAGE FORMS AND STRENGTHS
Injection: Single-dose pre-filled syringe: 0.4 mg/5 mL (0.08 mg/mL)
(3).
CONTRAINDICATIONS
Do not administer regadenoson injection to patients with:
Second- or third-degree AV block, or
sinus node dysfunction
unless the patients have a functioning artificial pacemaker (4).
WARNINGS AND PRECAUTIONS
Myocardial Ischemia. Fatal cardiac events have occurred. Avoid use in
patients with symptoms or signs
of acute myocardial ischemia, for example unstable angina or
cardiovascular instability, who may be at
greater risk. Cardiac resuscitation equipment and trained staff should
be available before
administration (5.1).
Sinoatrial (SA) and Atrioventricular (AV) Nodal Block. Adenosine
receptor agonists, including
regadenoson injection, can depress the SA and AV nodes and may cause
first-, second- or third-degree
AV block, or sinus bradycardia (5.2).
Atrial Fibrillation/Atrial Flutter. New-onset or recurrent atrial
fibrillation with rapid ventricular response
and atrial flutter have been reported (5.3).
Hypersensitivity, including anaphylaxis, angioedema, cardiac or
respiratory arrest, respiratory distress,
decreased oxygen saturation, hypotension, throat tightness, urticaria,
and rashes have occurred. Have
personnel and r