About the Vigabatrin REMS for healthcare providers (original) (raw)

Risk Evaluation and Mitigation Strategies (REMS)

REMS is a safety protocol mandated by the US Food and Drug Administration (FDA) to monitor the use of specific medications that have high potential for serious adverse effects.

The core objective is to guarantee that the drug's therapeutic benefits outweigh its potential risks.

Vigabatrin REMS

The FDA has approved the Vigabatrin REMS for all vigabatrin products. This program ensures that the risks and benefits are thoroughly weighed before treatment initiation and that vigabatrin is used correctly during treatment.

Healthcare providers must obtain certification in the Vigabatrin REMS to be allowed to prescribe vigabatrin. If you are already enrolled in this program, no additional action is required.

Specialty pharmacy

The Vigabatrin REMS requires pharmacies become certified to dispense the REMS medication. The certified pharmacy ensures that policies and procedures put in place to implement the REMS requirements are followed, and that staff are trained and comply with the REMS requirements.

AnovoRx is the only specialty pharmacy certified to dispense VIGAFYDE or VIGPODER.

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REMS=risk evaluation and mitigation strategies.

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INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR VIGAFYDE™ (vigabatrin) AND VIGPODER™ (vigabatrin)

INDICATIONS

IMPORTANT SAFETY INFORMATION FOR VIGAFYDE™ (vigabatrin) AND VIGPODER™ (vigabatrin)

VIGAFYDE™ (vigabatrin) is indicated as monotherapy for the treatment of infantile spasms in pediatric patients 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss.

VIGPODER™ (vigabatrin) is indicated as monotherapy for pediatric patients with infantile spasms 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss.

Please refer to the VIGPODER full Prescribing Information to view other approved indications.

WARNING: PERMANENT VISION LOSS

• VIGAFYDE or VIGPODER can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, VIGAFYDE or VIGPODER also can damage the central retina and may decrease visual acuity.
• The onset of vision loss from VIGAFYDE or VIGPODER is unpredictable and can occur within weeks of starting treatment or sooner, or at any time after starting treatment, even after months or years.
• Symptoms of vision loss from VIGAFYDE or VIGPODER are unlikely to be recognized by patients or caregivers before vision loss is severe. Vision loss of milder severity, while often unrecognized by the patient or caregiver, can still adversely affect function.
• The risk of vision loss increases with increasing dose and cumulative exposure, but there is no dose or exposure known to be free of risk of vision loss.
• Vision assessment is recommended at baseline (no later than 4 weeks after starting VIGAFYDE or VIGPODER), at least every 3 months during therapy, and about 3 to 6 months after the discontinuation of therapy.
• Once detected, vision loss due to VIGAFYDE or VIGPODER is not reversible. It is expected that, even with frequent monitoring, some patients will develop severe vision loss.
• Consider drug discontinuation, balancing benefit and risk, if vision loss is documented.
• Risk of new or worsening vision loss continues as long as VIGAFYDE or VIGPODER is used. It is possible that vision loss can worsen despite discontinuation of VIGAFYDE or VIGPODER.
• Because of the risk of vision loss, VIGAFYDE or VIGPODER should be withdrawn from patients with infantile spasms who fail to show a substantial clinical benefit within 2-4 weeks of initiation or sooner if treatment failure becomes obvious. Patient response to and continued need for VIGAFYDE or VIGPODER should be periodically reassessed.
• VIGAFYDE or VIGPODER 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.
• VIGAFYDE or VIGPODER should not be used with other drugs associated with serious ophthalmic effects such as retinopathy or glaucoma unless the benefits clearly outweigh the risks.
• Use the lowest dosage and shortest exposure to VIGAFYDE or VIGPODER consistent with clinical objectives.

Because of the risk of permanent vision loss, VIGAFYDE or VIGPODER is available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Vigabatrin REMS. Further information is available at www.vigabatrinREMS.com or 1-866-244-8175.

WARNINGS AND PRECAUTIONS

• Permanent Vision Loss: VIGAFYDE or VIGPODER can cause permanent vision loss. Because of this risk and because, when it is effective, VIGAFYDE or VIGPODER provides an observable symptomatic benefit, patient response and continued need for treatment should be periodically assessed.
  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 recommended. Because vision testing in infants and children is difficult, vision loss may not be detected until it is severe. VIGAFYDE is not approved for use in pediatric patients older than 2 year of age or in adults.
• VIGAFYDE and VIGPODER are available only through a restricted program called the Vigabatrin REMS.
• Magnetic Resonance Imaging (MRI) Abnormalities in Infants: Abnormal MRI signal changes characterized by increased T2 signal and restricted diffusion in a symmetric pattern involving the thalamus, basal ganglia, brain stem, and cerebellum have been observed in some infants treated with vigabatrin.
• Neurotoxicity: Intramyelinic edema (IME) has been reported in postmortem examination of infants being treated for IS with vigabatrin.
• Withdrawal of Antiepileptic Drugs (AEDs) As with all AEDs, VIGAFYDE or VIGPODER 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 VIGAFYDE or VIGPODER therapy.
• Anemia: Monitor for symptoms of anemia.
• Somnolence and Fatigue: VIGAFYDE or VIGPODER causes somnolence and fatigue.
• Peripheral Neuropathy and Edema: Vigabatrin causes symptoms of peripheral neuropathy and edema in adults. VIGAFYDE is not approved for use in adults. In pediatric clinical trials (pooled data), the incidence of peripheral neuropathy and edema observed in pediatric patients was similar on vigabatrin and placebo.
• Weight Gain: VIGAFYDE or VIGPODER causes weight gain in pediatric patients.

ADVERSE REACTIONS

Most common (≥10%) adverse reactions in patients receiving low-dose (18-36 mg/kg/day) vs high-dose (100-148 mg/kg/day) vigabatrin, respectively, were upper respiratory tract infection (51%, 46%), otitis media (44%, 30%), fever (29%, 19%), viral infection (20%, 19%), sedation (19%, 17%), somnolence (17%, 19%), irritability (16%, 23%), constipation (14%, 12%), vomiting (14%, 20%), diarrhea (13%, 12%), nasal congestion (13%, 4%), pneumonia (13%, 11%), insomnia (10%, 12%), ear infection (7%, 14%), and rash (8%, 11%).

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 or Pyros at 1-855-406-1010.

Please see full Prescribing Information, including BOXED WARNING, for additional Important Safety Information for VIGAFYDE or VIGPODER.