Fosphenytoin Sodium Side Effects

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Cardiovascular Risk Associated with Rapid Infusion [see Warnings and Precautions (5.2) ] Withdrawal Precipitated Seizure, Status Epilepticus [see Warnings and Precautions (5.3) ] Serious Dermatologic Reactions [see Warnings and Precautions (5.4) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions (5.5) ] Hypersensitivity [see Warnings and Precautions (5.6) ] Angioedema [see Warnings and Precautions (5.7) ] Hepatic Injury [see Warnings and Precautions (5.8) ] Hematopoietic Complications [see Warnings and Precautions (5.9) ] Sensory Disturbances [see Warnings and Precautions (5.10) ] Local Toxicity (Including Purple Glove Syndrome) [see Warnings and Precautions (5.11) ] Exacerbation of Porphyria [see Warnings and Precautions (5.14) ] Teratogenicity and Other Harm to the Newborn [see Warnings and Precautions (5.15) ] Hyperglycemia [see Warnings and Precautions (5.16) ] Most common adverse reactions (incidence ≥10%) are: • Adults: pruritus, nystagmus, dizziness, somnolence, and ataxia • Pediatrics: vomiting, nystagmus, and ataxia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma Limited at 864-879-9994 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The more important adverse clinical reactions caused by the IV use of fosphenytoin sodium or phenytoin are cardiovascular collapse and/or CNS depression.

Hypotension can occur when either drug is administered rapidly by the IV route.

The rate of administration is very important;

for fosphenytoin sodium, it should not exceed 150 mg PE/min [see Warnings and Precautions (5.2) ] .

The adverse reactions most commonly observed with the use of fosphenytoin sodium in clinical trials were nystagmus, dizziness, pruritus, somnolence, and ataxia.

With one exception, these reactions are commonly associated with the administration of IV phenytoin.

Pruritus, however, was seen much more often following fosphenytoin sodium administration and occurred more often with IV fosphenytoin sodium administration than with IM fosphenytoin sodium administration.

These reactions were dose and rate related;