Safety

Sabril (Vigabatrin) Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

June 2016

Summary View

BOXED WARNING

Additional and updated bullets:

  • SABRIL can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, SABRIL also can damage the central retina and may decrease visual acuity
  • Vision assessment is recommended at baseline (no later than 4 weeks after starting SABRIL), at least every 3 months during therapy, and about 3 to 6 months after the discontinuation of therapy.
  • Consider drug discontinuation, balancing benefit and risk, if vision loss is documented.
  • Risk of new or worsening vision loss continues as long as SABRIL is used. It is possible that vision loss can worsen despite discontinuation of SABRIL.
  • SABRIL should not be used in patients with, or at high risk of, other types of irreversible vision loss unless the benefits of treatment clearly outweigh the risks.
  • Use the lowest dosage and shortest exposure to SABRIL consistent with clinical objectives

(updated) Because of the risk of permanent vision loss, SABRIL is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the SABRIL REMS Program [see Warnings and Precautions (5.2)]. Further information is available at www.SabrilREMS.com or 1-888-457-4273.

WARNINGS AND PRECAUTIONS

Permanent Vision Loss replaces Vision Loss – Extensive changes; please refer to label.
SABRIL REMS Program replaces the SABRIL SHARE Program
  • SABRIL is available only through a restricted distribution program called the SABRIL REMS Program, because of the risk of permanent vision loss.

Notable requirements of the SABRIL REMS Program include the following:

  • Prescribers must be certified by enrolling in the program, agreeing to counsel patients on the risk of vision loss and the need for periodic monitoring of vision, and reporting any event suggestive of vision loss to Lundbeck.
  • Patients must enroll in the program.
  • Pharmacies must be certified and must only dispense to patients authorized to receive SABRIL.
  • Further information is available at www.SabrilREMS.com, or call 1-888-457-4273.
Withdrawal of Antiepileptic Drugs (AEDs)
  • (addition of sentence) As with all AEDs, SABRIL should be withdrawn gradually. However, if withdrawal is needed because of a serious adverse event, rapid discontinuation can be considered. Patients and caregivers should be told not to suddenly discontinue SABRIL therapy.

ADVERSE REACTIONS

Permanent Vision Loss replaces Vision Loss

PATIENT COUNSELING INFORMATION

Administration Instructions for SABRIL Powder for Oral Solution
  • Physicians should confirm that caregiver(s) understand how to mix SABRIL for Oral Solution and to administer the correct dose to their infants.
Permanent Vision Loss replaces Vision Loss
  • (update of sentence) Advise patients and caregivers that vision testing may be insensitive and may not detect vision loss before it is severe. Also advise patients and caregivers that if vision loss is documented, such loss is irreversible. Ensure that both of these points are understood by patients and caregivers.
SABRIL REMS Program (replaces SABRIL SHARE Program)
  • SABRIL is available only through a restricted program called the SABRIL REMS Program. Inform patients/caregivers of the following:
  • Patients/caregivers must be enrolled in the program.
  • SABRIL is only available through pharmacies that are enrolled in the SABRIL REMS Program.

MEDICATION GUIDE

Permanent vision loss:

  • (updated) SABRIL can damage the vision of anyone who takes it. People who take SABRIL do not lose all of their vision, but some people can have severe loss particularly to their ability to see to the side when they look straight ahead (peripheral vision). With severe vision loss, you may only be able to see things straight in front of you (sometimes called “tunnel vision”). You may also have blurry vision. If this happens, it will not get better.

Tell your healthcare provider right away if you (or your child):

  • (updated bullet) It is recommended that your healthcare provider test your (or your child’s) vision (including peripheral vision) and visual acuity (ability to read an eye chart) before you (or your child) start SABRIL or within 4 weeks after starting SABRIL, and at least every 3 months after that until SABRIL is stopped. It is also recommended that you (or your child) have a vision test about 3 to 6 months after SABRIL is stopped.
  • (updated bullet) Your baby should also have a vision test about 3 to 6 months after SABRIL is stopped.

Tell your healthcare provider right away if you think that your baby is:

  • acting differently than normal (change SABRIL SHARE Program to SABRIL REMS Program in all instances)

 

September 2015

Summary View

WARNINGS AND PRECAUTIONS

Magnetic Resonance Imaging (MRI) Abnormalities in Infants
  • … Neurotoxicity … and brain histopathological changes were observed in dogs exposed to vigabatrin during the juvenile period of development. ..
Neurotoxicity
  • … Administration of vigabatrin to juvenile dogs produced vacuolar changes in the brain gray mater (including the septal nuclei, hippocampus, hypothalamus, thalamus, cerebellum, and globus pallidus). Neurobehavioral effects of vigabatrin were not assessed in the juvenile dog…

USE IN SPECIAL POPULATIONS

Pediatric Use
  • …Oral administration of vigabatrin (5, 15, or 50 mg/kg) to young rats during the neonatal and juvenile periods of development (postnatal days 4-65) produced neurobehavioral (convulsions, neuromotor impairment, learning deficits) and neurohistopathological (brain gray matter vacuolation, decreased myelination, and retinal dysplasia) abnormalities. The no-effect dose for developmental neurotoxicity in juvenile rats (the lowest dose tested) was associated with plasma vigabatrin exposures (AUC) substantially less than those measured in pediatric patients at recommended doses. In dogs, oral administration of vigabatrin (30 or 100 mg/kg) during selected periods of juvenile development (postnatal days 22-112) produced neurohistopathological abnormalities (brain gray matter vacuolation). Neurobehavioral effects of vigabatrin were not assessed in the juvenile dog. A no-effect dose for neurohistopathology was not established in juvenile dogs; the lowest effect dose (30 mg/kg) was associated with plasma vigabatrin exposures lower than those measured in pediatric patients at recommended doses

 

October 2013

Summary View

ADVERSE REACTIONS

Post Marketing Experience
  • Skin and Subcutaneous Tissue Disorders: Angioedema, maculo-papular rash, pruritus, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN).

 

December 2012

Summary View 

WARNINGS AND PRECAUTIONS

Monitoring of Vision
  • Monitoring of vision by an ophthalmic professional with expertise in visual field interpretation and the ability to perform dilated indirect ophthalmoscopy of the retina is required, unless a patient is formally exempted from periodic ophthalmologic assessment as documented in the Support, Help And Resources for Epilepsy (SHARE) program...

 

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