Bloxiverz

BLOXIVERZ- neostigmine methylsulfate injection
Exela Pharma Sciences, LLC

1 INDICATIONS AND USAGE

BLOXIVERZ, is a cholinesterase inhibitor, indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery.

2 DOSAGE AND ADMINISTRATION

2.1. Important Dosage Information

BLOXIVERZ should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents. Doses of BLOXIVERZ should be individualized, and a peripheral nerve stimulator should be used to determine the time of initiation of BLOXIVERZ and should be used to determine the need for additional doses.

BLOXIVERZ is for intravenous use only and should be injected slowly over a period of at least 1 minute. The BLOXIVERZ dosage is weight-based [see Dosage and Administration (2.2)].

Prior to BLOXIVERZ administration and until complete recovery of normal ventilation, the patient should be well ventilated and a patent airway maintained. Satisfactory recovery should be judged by adequacy of skeletal muscle tone and respiratory measurements in addition to the response to peripheral nerve stimulation.

An anticholinergic agent, e.g., atropine sulfate or glycopyrrolate, should be administered prior to or concomitantly with BLOXIVERZ [see Dosage and Administration (2.4)]

2.2 Dosage in Adults

a.
Peripheral nerve stimulation devices capable of delivering a train-of-four (TOF) stimulus are essential to effectively using BLOXIVERZ.
b.
There must be a twitch response to the first stimulus in the TOF of at least 10% of its baseline level, i.e., the response prior to NMBA administration, prior to the administration of BLOXIVERZ.
c.
Prior to administration, visually inspect BLOXIVERZ for particulate matter and discoloration.
d.
BLOXIVERZ should be injected slowly by intravenous route over a period of at least 1 minute.
e.
A 0.03 mg/kg to 0.07 mg/kg dose of BLOXIVERZ will generally achieve a TOF twitch ratio of 90% (TOF0.9 ) within 10 to 20 minutes of administration. Dose selection should be based on the extent of spontaneous recovery that has occurred at the time of administration, the half-life of the NMBA being reversed, and whether there is a need to rapidly reverse the NMBA.
1.
The 0.03 mg/kg dose is recommended for:
1.
Reversal of NMBAs with shorter half-lives, e.g., rocuronium, or
2.
When the first twitch response to the TOF stimulus is substantially greater than 10% of baseline or when a second twitch is present.
2.
The 0.07 mg/kg dose is recommended for
1.
NMBAs with longer half-lives, e.g., vecuronium and pancuronium, or
2.
When the first twitch response is relatively weak, i.e., not substantially greater than 10% of baseline or
3.
There is need for more rapid recovery.
f.
TOF monitoring should continue to be used to evaluate the extent of recovery of neuromuscular function and the possible need for an additional dose of BLOXIVERZ.
g.
TOF monitoring alone should not be relied upon to determine the adequacy of reversal of neuromuscular blockade as related to a patient’s ability to adequately ventilate and maintain a patent airway following tracheal extubation.
h.
Patients should continue to be monitored for adequacy of reversal from NMBAs for a period of time that would assure full recovery based on the patient’s medical condition and the pharmacokinetics of neostigmine and the NMBA used.
i.
The recommended maximum total dose is 0.07 mg/kg or up to a total of 5 mg, whichever is less.

2.3 Dosage in Pediatric Patients, including Neonates

Adult guidelines should be followed when BLOXIVERZ is administered to pediatric patients. Pediatric patients require BLOXIVERZ doses similar to those for adult patients.

2.4 Anticholinergic (Atropine or Glycopyrrolate) Administration

An anticholinergic agent, e.g., atropine sulfate or glycopyrrolate, should be administered prior to or concomitantly with BLOXIVERZ. The anticholinergic agent should be administered intravenously using a separate syringe. In the presence of bradycardia, it is recommended that the anticholinergic agent be administered prior to BLOXIVERZ.

2.5 Instructions for Use of Prefilled Syringe

1. Perform visual inspection on the syringe by verifying:

Absence of syringe damage
Absence of external particles
Absence of internal particles
Proper drug color
Drug name
Drug strength
Fill volume
Route of administration
Expiration date to be sure the drug has not expired

2. Do not remove the tamper evident seal. Push plunger rod slightly in to break the stopper loose while tip cap is still on

3. Remove tip cap and tamper evident seal by twisting off. (See Figure 1):

Figure 1.

instruction

4. Discard the tip cap.

5. Expel air bubble.

6. Adjust dose into sterile material (if applicable).

7. Connect the syringe to an appropriate intravenous connection.

Before injection, ensure that the syringe is securely attached to the needle or needleless luer access device (NLAD).

8. Depress plunger rod to deliver medication. Ensure that pressure is maintained on the plunger rod during the entire administration.

9. Remove syringe from NLAD (if applicable) and discard into appropriate receptacle.

To prevent needle stick injuries, do not recap needle when needle is connected to syringe.

NOTES:

All steps must be done sequentially
– Do not re-sterilize syringe
– Do not use this product on a sterile field
– Do not introduce any other fluid into the syringe at any time
– This product is for single dose only

3 DOSAGE FORMS AND STRENGTHS

BLOXIVERZ is available as

Injection: 0.5 mg/mL, 5 mg of neostigmine methylsulfate in 10 mL multiple- dose vials
Injection: 1 mg/mL, 10 mg of neostigmine methylsulfate in 10 mL multiple-dose vials
Injection: 1 mg/mL, 5 mg of neostigmine methylsulfate in 5 mL single-dose prefilled syringe.

4 CONTRAINDICATIONS

BLOXIVERZ is contraindicated in patients with:

known hypersensitivity to neostigmine methylsulfate (known hypersensitivity reactions have included urticaria, angioedema, erythema multiforme, generalized rash, facial swelling, peripheral edema, pyrexia, flushing, hypotension, bronchospasm, bradycardia and anaphylaxis).
peritonitis or mechanical obstruction of the intestinal or urinary tract.

5 WARNINGS AND PRECAUTIONS

5.1 Bradycardia

Neostigmine has been associated with bradycardia. Atropine sulfate or glycopyrrolate should be administered prior to BLOXIVERZ to lessen the risk of bradycardia [see Dosage and Administration (2.4)].

5.2 Serious Adverse Reactions in Patients with Certain Coexisting Conditions

BLOXIVERZ should be used with caution in patients with coronary artery disease, cardiac arrhythmias, recent acute coronary syndrome or myasthenia gravis. Because of the known pharmacology of neostigmine methylsulfate as an acetylcholinesterase inhibitor, cardiovascular effects such as bradycardia, hypotension or dysrhythmia would be anticipated. In patients with certain cardiovascular conditions such as coronary artery disease, cardiac arrhythmias or recent acute coronary syndrome, the risk of blood pressure and heart rate complications may be increased. Risk of these complications may also be increased in patients with myasthenia gravis. Standard antagonism with anticholinergics (e.g., atropine) is generally successful to mitigate the risk of cardiovascular complications.

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