氨己烯酸口服溶液用散的注意事项是什么

Vigabatrin oral solution powder may cause permanent vision loss. Because of this risk, and because vigabatrin provides observable symptomatic benefit when effective; patient response and ongoing treatment needs should be assessed periodically. The onset of vigabatrin-induced vision loss is unpredictable and can occur within weeks or sooner of starting treatment, or at any time after starting treatment, even months or years later.

In patients with infantile spasms, vigabatrin should be discontinued if no substantial clinical benefit is observed within 2 to 4 weeks. If, in the prescriber's clinical judgment, evidence of treatment failure becomes apparent before 2 to 4 weeks, treatment should be discontinued at that time. It is recommended that visual acuity be monitored by an ophthalmology professional with expertise in visual field interpretation and retinal dilation indirect ophthalmoscopy.

The onset and progression of the resulting vision loss are unpredictable and may occur or worsen dramatically between assessments. Once detected, vigabatrin-induced vision loss is irreversible. It is expected that some patients taking vigabatrin oral solution will experience severe vision loss, even with frequent monitoring. If vision loss is documented, consider discontinuing the drug, balancing the benefits and risks. Vision loss may worsen despite discontinuation of vigabatrin.

Notable requirements for the vigabatrin REMS program include the following:

Prescribers must become certified by participating in the program, agree to counsel patients about the risk of vision loss and the need for regular vision monitoring, and report any events suggestive of vision loss to the Vigabatrin REMS Program.

Patients must register for the program.

Pharmacies must be certified and may only dispense to patients authorized to receive vigabatrin.

Abnormal MRI (infant magnetic resonance imaging) signal changes, characterized by increased T2 signal and symmetric diffusion restriction involving the thalamus, basal ganglia, brainstem, and cerebellum, have been observed in some infants receiving vigabatrin.

Routine MRI monitoring is not necessary in adults receiving vigabatrin because there is no evidence that vigabatrin causes MRI changes in this population.

Intramedullary edema (IME) has been reported at autopsy in infants receiving vigabatrin for infantile spasms.

Antiepileptic drugs (AEDs), including vigabatrin, may increase the risk of suicidal thoughts or behaviors in patients taking these drugs for any indication. Patients receiving any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.

Vigabatrin may also cause drowsiness and fatigue, anemia, symptoms of peripheral neuropathy in adults, weight gain in adults and children, and edema in adults. For more details, please read the drug instructions. It is recommended to follow the doctor's instructions and treat the symptoms accordingly.

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