HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |
Did you find an answer to your question?
Yes
No
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our medical information is accurate, up to date, and scientifically balanced.
CEREBYX®(fosphenytoin sodium)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our medical information is accurate, up to date, and scientifically balanced.
CEREBYX® Quick Finder
Highlights
Boxed Warning
WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH RAPID INFUSION RATES
The rate of intravenous CEREBYX administration should not exceed 150 mg phenytoin sodium equivalents (PE) per minute in adults and 2 mg...
Did you find an answer to your question?
Yes
No
Indications and Usage
1 INDICATIONS AND USAGE
CEREBYX is indicated for the treatment of generalized tonic-clonic status epilepticus and prevention and treatment of seizures occurring during neurosurgery. CEREBYX can also be substituted, short-...
Did you find an answer to your question?
Yes
No
Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Important Administration Instructions to Avoid Dosing Errors
Use caution when administering CEREBYX because of the risk of dosing...
Did you find an answer to your question?
Yes
No
Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
CEREBYX Injection is a clear, colorless to pale yellow solution available as 50 mg phenytoin sodium equivalents (PE) per mL in:
- 10 mL single-dose injection vials, each...
Did you find an answer to your question?
Yes
No
Contraindications
4 CONTRAINDICATIONS
CEREBYX is contraindicated in patients with:
- A history of hypersensitivity to CEREBYX or its inactive ingredients, or to phenytoin or other hydantoins [see...
Did you find an answer to your question?
Yes
No
Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Dosing Errors
Phenytoin Sodium Equivalents (PE)
...
Did you find an answer to your question?
Yes
No
Drug Interactions
7 DRUG INTERACTIONS
Fosphenytoin is extensively bound to human plasma proteins. Drugs highly bound to albumin could increase the unbound fraction of fosphenytoin. Although, it is unknown whether this could result in...
Did you find an answer to your question?
Yes
No
Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Exposure Registry
There is...
Did you find an answer to your question?
Yes
No
Overdosage
10 OVERDOSAGE
Nausea, vomiting, lethargy, tachycardia, bradycardia, asystole, cardiac arrest, hypotension, syncope, hypocalcemia, metabolic acidosis, and death have been reported in cases of overdosage with CEREBYX.
...
Did you find an answer to your question?
Yes
No
Description
11 DESCRIPTION
CEREBYX® (fosphenytoin sodium injection) is a prodrug intended for parenteral administration; its active metabolite is phenytoin. 1.5 mg of fosphenytoin sodium is equivalent to 1 mg...
Did you find an answer to your question?
Yes
No
Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Fosphenytoin is a prodrug of phenytoin and accordingly, its anticonvulsant effects are attributable to phenytoin....
Did you find an answer to your question?
Yes
No
Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
...
Did you find an answer to your question?
Yes
No
Clinical Studies
14 CLINICAL STUDIES
Infusion tolerance was evaluated in clinical studies. One double-blind study assessed infusion-site tolerance of equivalent loading doses (15 to 20 mg PE/kg) of CEREBYX infused at 150 mg PE/min or...
Did you find an answer to your question?
Yes
No
How Supplied/Storage and Handling
...
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
CEREBYX Injection is a clear, colorless to pale yellow solution supplied as follows:
Did you find an answer to your question?
Yes
No
Medication Guide
17 PATIENT COUNSELING INFORMATION
Cardiovascular Risk Associated with Rapid Infusion
Inform patients that rapid intravenous administration...
Did you find an answer to your question?
Yes
No
Did you find an answer to your question?
Yes
No
Didn’t find what you were looking for? Contact us.
To interact with the Medical Information Digital Assistant click here.
Contact Pfizer Medical Information to speak with a professional regarding your medical question on a Pfizer prescription product: (800) 438-1985
Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.