Sugammadex- Bridion (Dec 2015)- Neuromuscular Drugs
Drug Name:Sugammadex- Bridion (Dec 2015)- Neuromuscular Drugs
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
Toremifene: Recovery could be delayed in patients using toremifene.
Hormonal contraceptives: Patients using hormonal contraceptives
must use an additional, non-hormonal method of contraception for the
next 7 days following BRIDION administration.
Indication:
BRIDION® (sugammadex) Injection, for intravenous use
Initial U.S. Approval: 2015
NEW MOLECULAR ENTITY AND NEW THERAPEUTIC BIOLOGICAL
PRODUCTS APPROVED FOR 2015
Certain drugs are classified as New molecular Emtities- NME- for FDA review
Many of these products contain active moieties that have not been approved
by FDA previously, either as a single ingredient or as part of a combination
products; these products frequently provide important new therapies for the
patients.
Some drugs are characterized as NMEs for administrative purposes ,but
nonetheless contain certain active moieties in products that have been
previously approved by FDA. For example, CDER classifies biological
products submitted in an application under section 351(a) of the Public
Service Act as NME for purposes of FDA review, regardless of whether
the agency previously approved a related active moiety in a different
product.
FDAs classification of a drug as an -NME- for review purposes is distinct
from FDAs determination of whether a drug is a - New Chemical Entity or - NCE-
within the meaning of the Federal Food,Drug, and Cosmetic Act
No.43
Drug Name - Sugammadex
Active Ingredient- Bridion
Date of approval - 12/15/2015
FDA-approved use - To reverse effects of Neuromucular Blocking Drugs
used during Surgery
Approved by US FDA on 12/15/2015- (Ref- FDA approved List- 2015)
Adverse Reaction:
Most common adverse reactions (reported in .10% of patients
at a 2, 4, or 16 mg/kg BRIDION dose and higher than the placebo rate):
vomiting, pain, nausea, hypotension, and headache.
Contra-Indications:
CONTRAINDICATIONS
Known hypersensitivity to sugammadex or any of its components.
WARNINGS AND PRECAUTIONS
Anaphylaxis: Anaphylaxis has occurred in 0.3% of healthy volunteers.
Observe patients for an appropriate period of time after administration.
Marked Bradycardia: Cases of marked bradycardia, some of which have
resulted in cardiac arrest, have been observed within minutes after
administration. Monitor for hemodynamic changes and administer
anticholinergic agents such as atropine if clinically significant
bradycardia is observed.
.
Respiratory Function Monitoring: Ventilatory support is mandatory
for patients until adequate spontaneous respiration is restored and
the ability to maintain a patent airway is assured.
Should neuromuscular blockade persist after BRIDION or recur
following extubation, take appropriate steps to provide
adequate ventilation.
.
Waiting Times for Re-Administration of Neuromuscular Blocking Agent:
If re-administration of a neuromuscular blocking agent is required
after reversal with BRIDION, waiting times should be based on the
dose of BRIDION, and the renal function of the patient.
Consider use of a nonsteroidal neuromuscular blocking agent.
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
BRIDION is indicated for the reversal of neuromuscular blockade induced
by rocuronium bromide and vecuronium bromide in adults undergoing surgery.
DOSAGE AND ADMINISTRATION
Monitor for twitch responses to determine the timing and dose for BRIDION
administration.
Administer as a single bolus injection.
For rocuronium and vecuronium:
4 mg/kg is recommended if spontaneous recovery of the twitch response
has reached 1 to 2 post-tetanic counts (PTC) and there are no twitch
responses to train-of-four (TOF) stimulation.
2 mg/kg is recommended if spontaneous recovery has reached the
reappearance of the second twitch in response to TOF stimulation.
For rocuronium only:
16 mg/kg is recommended if there is a clinical need to reverse
neuromuscular blockade soon (approximately 3 minutes)
after administration of a single dose of 1.2 mg/kg of rocuronium.
DOSAGE FORMS AND STRENGTHS
200 mg/2 mL (100 mg/mL) in a single-dose vial for bolus injection
500 mg/5 mL (100 mg/mL) in a single-dose vial for bolus injection
Patient Information:
PATIENT COUNSELING INFORMATION
Advise females of reproductive potential using hormonal contraceptives that
BRIDION may reduce the contraceptive effect. Instruct females to use an
additional, non-hormonal method of contraception for the next 7 days following
BRIDION administration
Manufactured for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1 Mechanism of Action
BRIDION is a modified gamma cyclodextrin. It forms a complex with the neuromuscular
blocking agents rocuronium and vecuronium, and it reduces the amount of neuromuscular
blocking agent available to bind to nicotinic cholinergic receptors in the neuromuscular
junction. This results in the reversal of neuromuscular blockade induced by rocuronium
and vecuronium.
2. Pharmacokinetics
The sugammadex pharmacokinetic parameters were calculated from the total sum of
non-complex-bound and complex-bound concentrations of sugammadex.
Pharmacokinetic parameters as clearance and volume of distribution are assumed
to be the same for non-complex-bound and complex-bound sugammadex in
anesthetized patients.
Distribution
The observed steady-state volume of distribution of sugammadex is approximately
11 to 14 liters in adult patients with normal renal function (based on conventional,
non-compartmental pharmacokinetic analysis).
Neither sugammadex nor the complex of sugammadex and rocuronium binds to plasma
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Risk Summary
There are no data on BRIDION use in pregnant women to inform any drug-associated
risks. In animal reproduction studies, there was no evidence of teratogenicity following
daily intravenous administration of sugammadex to rats and rabbits during
organogenesis at exposures of up to 6 and 8 times, respectively, the maximum
recommended human dose (MRHD) of 16 mg/kg.
The background risk of major birth defects and miscarriage for the indicated
population are unknown.
However, the background risk in the U.S. general population of major birth
defects is 2-4% and of miscarriage is 15-20% of
clinically recognized pregnancies.
2. Lactation
Risk Summary
No data are available regarding the presence of sugammadex in human milk, the effects of
sugammadex on the breast fed infant, or the effects of sugammadex on milk production.
However, sugammadex is present in rat milk
The developmental and health benefits of breastfeeding should be considered along
with the mother’s clinical need for BRIDION and any potential adverse effects on the
breastfed infant from BRIDION or from the underlying maternal condition
3. Pediatric Use
The safety and efficacy of BRIDION in pediatric patients have not been established.
4. Geriatric Use
BRIDION has been administered in a dedicated clinical study to a total 102 geriatric
patients that compared the time to recovery from neuromuscular blockade induced
by rocuronium (0.6 mg/kg) following administration of 2 mg/kg BRIDION given
at the reappearance of T2 in 65-74 year-olds (N=62) and >75 year-olds (N=40)
compared with 18-64 year-olds (N=48).
