Sabril (vigabatrin)

Short answer: Sabril is the original brand name of vigabatrin, made by Lundbeck. It comes as 500 mg tablets and 500 mg powder packets for oral solution, both approved by the FDA on 21 August 2009.¹ Sabril medication is labeled for infantile spasms in babies 1 month to 2 years old and, as an add-on, for refractory complex partial seizures from age 2.² Because it can cause permanent vision loss, it carries a boxed warning and is dispensed only through the Vigabatrin REMS.²

Generic versions of both forms are approved, and a ready-to-use liquid, Vigafyde, is available for babies.³

What is Sabril used for?

The label gives two uses:²

• Infantile spasms: as the only seizure medicine, in babies 1 month to 2 years old "for whom the potential benefits outweigh the potential risk of vision loss."
• Refractory complex partial seizures: as an add-on in adults and children 2 and older who "have inadequately responded to several alternative treatments." The label says Sabril "is not indicated as a first line agent."

The label also says to stop Sabril if there is no substantial benefit within 3 months for complex partial seizures, or within 2 to 4 weeks for infantile spasms, because of the vision risk.²

Sabril dosage forms

From the FDA labels and Drugs@FDA.^1,2,4

Powder. Each 500 mg packet is emptied into a clean cup and dissolved in 10 mL of cold or room-temperature water, giving 50 mg per mL. Each dose is "prepared and used immediately," and any unused portion is thrown away. Oral syringes come separately from the pharmacy.⁴

Tablets. Vigabatrin tablets are taken by mouth.² The label states that the oral solution and tablets are bioequivalent.²

Sabril dosage

• Adults with complex partial seizures: start at 500 mg twice a day, increase by 500 mg a day each week, to a recommended 1,500 mg twice a day. In trials, 6,000 mg a day added no benefit and more side effects.²
• Children 2 to 16: the dose goes by weight bands in the label.²
• Infantile spasms: dosed by mL of the 50 mg/mL solution. For a 10 kg baby, that is 5 mL twice a day at the start and up to 15 mL twice a day.⁴
• Kidney problems: doses are reduced from age 2 when kidney function is lower. There are no data for infants.²

The dose calculator shows label doses for each form.

Sabril side effects

The most common side effects in controlled studies, from the label:²

• Adults: blurred vision, sleepiness, dizziness, poor coordination, tremor and fatigue.
• Children 3 to 16: weight gain.
• Babies with infantile spasms: sleepiness, bronchitis, ear infection and acute middle-ear infection.

The label also warns that seizure medicines, including Sabril, increase the risk of suicidal thoughts or behavior.² Stopping suddenly is not advised; the label says Sabril "should be withdrawn gradually."²

Sabril boxed warning: vision loss

Sabril can cause permanent loss of side vision. Based on adult studies, the label says "30 percent or more of patients can be affected."² Vision is checked at baseline (no later than 4 weeks after starting), at least every 3 months on treatment, and about 3 to 6 months after stopping.²

What is the Sabril REMS?

There is no separate Sabril REMS. The FDA approved a single shared program for all vigabatrin products, called the Vigabatrin REMS Program.⁵ Under it, prescribers must be certified, patients enrolled and pharmacies certified.^6,7 The program's site is vigabatrinREMS.com and its phone line is 1-866-244-8175.⁶

In interviews, patients and caregivers said the REMS reassured them but added burdens, such as travel to certified prescribers or pharmacies.⁸

Is there a generic for Sabril?

Yes. The FDA has approved generic vigabatrin 500 mg powder packets and 500 mg tablets from several companies, including Vigadrone, Vigpoder, Teva, Amneal, Dr. Reddy's and Zydus.³ Vigadrone comes as both a powder and a tablet.⁹ Vigadrone powder is mixed the same way as Sabril powder.¹⁰

Brand Sabril is still available. To get the brand rather than a generic, the prescriber marks the prescription "Dispense as written" or follows state rules.⁵ Your plan may cover brand and generic differently.

Sabril cost, copay and patient assistance

We do not publish prices, because they change and what each family pays differs. What you pay depends on your plan, the product and the pharmacy. Prior authorization, package math and questions to ask are covered in the vigabatrin cost guide.

SHAREPlus. Lundbeck's patient support program for Sabril is called SHAREPlus. The Sabril prescription form lets the program check insurance coverage, provide reimbursement support and coordinate with health plans. Prescriptions can be faxed to SHAREPlus at 1-877-742-1002, or sent straight to a certified pharmacy instead.⁵

The form also offers a one-time starter supply of up to 30 days while insurance is being checked. It is only for new, eligible, commercially insured patients aged 1 month to 2 years.⁵ For copay assistance, ask SHAREPlus or the pharmacy what applies to you and your type of insurance. This site is independent and does not run or endorse any program.

Sabril vs Vigafyde for babies

Both contain vigabatrin and carry the same vision-loss warning. Sabril powder is mixed fresh for every dose at 50 mg per mL. Vigafyde is a ready-to-use liquid at 100 mg per mL, needs no mixing, and keeps 90 days after opening.^4,6 Vigafyde is labeled only for infantile spasms from 1 month to 2 years.⁶

In one small study run by employees of Pyros, which holds Vigafyde's FDA application, all ready-to-use doses were within 5% of the target, while 7 of 30 Sabril powder doses missed by more than 10%.¹¹ The study had real limits, set out on the Vigafyde page.

When switching, the same dose is half the volume of Vigafyde, so the mL must be re-checked.⁶