Prescribing Information

Treatment Access
for DIACOMIT®

For patients and caregivers

DIACOMIT (stiripentol) is now available through our specialty pharmacy and covered by most insurance plans

Now, getting a prescription filled for DIACOMIT is easier than ever. We have partnered with a national specialty pharmacy that will take the majority of the process out of your hands and deliver DIACOMIT directly to your door.

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Not actual patients

DIACOMIT access programs

There are 4 patient access programs in place to make sure everyone who needs DIACOMIT can get it.

Quick Start Program—for newly eligible patients experiencing delays in gaining access to therapy

  • 60-day fulfillment of DIACOMIT at no cost to the patient

Bridge Program—for current patients with changes or lapses in their insurance coverage

  • Up to 60-day fulfillment of DIACOMIT at no cost to the patient

Copay Program—for eligible patients with commercial insurance

  • $0 copay per prescription
  • Not available for government plans such as Medicare or Medicaid

Long-term Patient Assistance Program—for patients who are uninsured or underinsured

  • DIACOMIT is provided free of charge for patients who meet certain criteria

For more information on these programs, contact the DIACOMIT Patient Access Team at 833-248-0467, Monday–Friday, 7:00 am to 7:00 pm CT.

You can also watch this Patient Access Insights video for more in-depth information.

Working with our specialty pharmacy

In an effort to make sure DIACOMIT is accessible to everyone who needs it, we have partnered exclusively with one specialty pharmacy to dispense DIACOMIT. The DIACOMIT specialty pharmacy will act as the go-between, making your experience quick and easy.

As a patient or caregiver of someone who is taking DIACOMIT, you will work directly with our specialty pharmacy.

• P r o v i d i n g i n s u r a n c e i n f o r m a t i o n t o t h e s p e c i a l t y p h a r m a c y • R e s p o n d i n g t o p h o n e c a l l s t o c o o r d i n a t e s h i p m e n t • I n f o r m i n g t h e s p e c i a l t y p h a r m a c y o f a n y c h a n g e s t o i n s u r a n c e c o v e r a g e , h e a l t h c a r e p r o v i d e r , o r c o n t a c t i n f o r m a t i o n • I n f o r m i n g t h e s p e c i a l t y p h a r m a c y o f a n y d o s a g e c h a n g e s • D i s p e n s i n g D I A C O M I T • P r o c e s s i n g D I A C O M I T p r e s c r i p t i o n s a n d c o o r d i n a t i n g w i t h y o u • P r o v i d i n g y o u w i t h a s s i s t a n c e a n d h e l p f u l D I A C O M I T p r o g r a m s • P r o v i d i n g y o u w i t h e d u c a t i o n a l s u p p o r t r e g a r d i n g m e d i c a t i o n m a n a g e m e n t • F a x i n g t h e c o m p l e t e d D I A C O M I T e n r o l l m e n t f o r m , a c o p y o f t h e p a t i e n t ' s i n s u r a n c e c a r d , a c o m p l e t e p r e s c r i p t i o n w i t h c l e a r d o s i n g a n d a n y t i t r a t i o n i n s t r u c t i o n s , a n d t h e p a t i e n t ' s m e d i c a l r e c o r d s t o D P A a t 8 3 3 - 8 7 1 - 4 1 3 7 • P r o v i d i n g a n y a d d i t i o n a l m e d i c a l d o c u m e n t s r e q u i r e d b y t h e i n s u r a n c e p l a n • E d u c a t i n g p a t i e n t s o n D I A C O M I T The specialty pharmacy’s role includes: T h e d o c t o r ’ s r o l e i n c l u d e s : Y o u r r o l e i n t h e p r o c e s s i n c l u d e s :

Your role in the process includes:

  • Providing insurance information to the specialty pharmacy
  • Responding to phone calls to coordinate shipment
  • Informing the specialty pharmacy of any changes to insurance coverage, healthcare provider, or contact information
  • Informing the specialty pharmacy of any dosage changes

The specialty pharmacy's role includes:

  • Dispensing DIACOMIT
  • Processing DIACOMIT prescriptions and coordinating with you
  • Providing you with assistance and helpful DIACOMIT programs
  • Providing you with educational support regarding medication management

• P r o v i d i n g i n s u r a n c e i n f o r m a t i o n t o t h e s p e c i a l t y p h a r m a c y • R e s p o n d i n g t o p h o n e c a l l s t o c o o r d i n a t e s h i p m e n t • I n f o r m i n g t h e s p e c i a l t y p h a r m a c y o f a n y c h a n g e s t o i n s u r a n c e c o v e r a g e , h e a l t h c a r e p r o v i d e r , o r c o n t a c t i n f o r m a t i o n • I n f o r m i n g t h e s p e c i a l t y p h a r m a c y o f a n y d o s a g e c h a n g e s • D i s p e n s i n g D I A C O M I T • P r o c e s s i n g D I A C O M I T p r e s c r i p t i o n s a n d c o o r d i n a t i n g w i t h y o u • P r o v i d i n g y o u w i t h a s s i s t a n c e a n d h e l p f u l D I A C O M I T p r o g r a m s • P r o v i d i n g y o u w i t h e d u c a t i o n a l s u p p o r t r e g a r d i n g m e d i c a t i o n m a n a g e m e n t • F a x i n g t h e c o m p l e t e d D I A C O M I T e n r o l l m e n t f o r m , a c o p y o f t h e p a t i e n t ' s i n s u r a n c e c a r d , a c o m p l e t e p r e s c r i p t i o n w i t h c l e a r d o s i n g a n d a n y t i t r a t i o n i n s t r u c t i o n s , a n d t h e p a t i e n t ' s m e d i c a l r e c o r d s t o D P A a t 8 3 3 - 8 7 1 - 4 1 3 7 • P r o v i d i n g a n y a d d i t i o n a l m e d i c a l d o c u m e n t s r e q u i r e d b y t h e i n s u r a n c e p l a n • E d u c a t i n g p a t i e n t s o n D I A C O M I T The specialty pharmacy’s role includes: T h e d o c t o r ’ s r o l e i n c l u d e s : Y o u r r o l e i n t h e p r o c e s s i n c l u d e s :

The doctor's role includes:

  • Faxing the completed DIACOMIT enrollment form, a copy of the patient's insurance card, a complete prescription with clear dosing and any titration instructions, and the patient's medical records to DIACOMIT Patient Access at 833-871-4137
  • Providing any additional medical documents required by the insurance plan
  • Educating patients on DIACOMIT

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For healthcare providers

Help patients access DIACOMIT through our specialty pharmacy

Helping patients get access to DIACOMIT is easier than ever. We have partnered with a national specialty pharmacy that will take on the majority of the process and deliver DIACOMIT directly to the patient’s door.

MORE INFO
CLOSE

Not an actual HCP

The DIACOMIT access process

In an effort to make sure DIACOMIT is accessible to everyone who needs it, we have partnered with one specialty pharmacy exclusively to dispense DIACOMIT. Our partnership is designed to remove barriers for both patients and doctors’ offices, and to help avoid issues associated with insurance and prior authorization changes.

Making access easy

Our customer service team is available to make sure your patients have access to DIACOMIT by providing:

  • Comprehensive verification of patient health insurance coverage, including benefits and eligibility
  • Communication of a health insurance plan’s prior authorization requirements and assistance in gaining approval for DIACOMIT
  • Appeals assistance for patients with a denial from a health insurance plan
  • Coordination of product shipment

For more information, watch our Patient Access training video, which provides additional information on accessing DIACOMIT.

DIACOMIT access programs

There are 4 patient access programs in place to make sure everyone who needs DIACOMIT can get it.

Quick Start Program—for newly eligible patients experiencing delays in gaining access to therapy

  • 60-day fulfillment of DIACOMIT at no cost to the patient

Bridge Program—for current patients with changes or lapses in their insurance coverage

  • Up to 60-day fulfillment of DIACOMIT at no cost to the patient

Copay Program—for eligible patients with commercial insurance

  • $0 copay per prescription
  • Not available for government plans such as Medicare or Medicaid

Long-term Patient Assistance Program—for patients who are uninsured or underinsured

  • DIACOMIT is provided free of charge for patients who meet certain criteria

For more information on these programs, contact the DIACOMIT Patient Access Team at 833-248-0467, Monday–Friday, 7:00 am to 7:00 pm CT.

Ordering and support

Get your patient started on DIACOMIT:
  • Fax prescription along with dosing and titration instructions, patient’s insurance information, and patient medical records to 833-871-4137.
  • Our specialty pharmacy will work with the patient/caregiver and payer to determine insurance eligibility and coverage. The support team will provide updates regarding order progress and will reach out if additional information is required.
Call our specialty pharmacy team at 833-248-0467, Monday–Friday, 7:00 am to 7:00 pm CT if you have questions or need information about submitted prescriptions.
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INDICATION and IMPORTANT SAFETY INFORMATION

INDICATION

DIACOMIT (stiripentol) is indicated for the treatment of seizures associated with Dravet syndrome (DS) in patients taking clobazam who are 6 months of age and older and weighing 7 kg or more. There are no clinical data to support the use of DIACOMIT as monotherapy in Dravet syndrome.
 

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

No contraindications are listed.

WARNINGS & PRECAUTIONS

Somnolence

DIACOMIT can cause somnolence. Monitor patients for somnolence, particularly when DIACOMIT is used concomitantly with other CNS depressants or clobazam, which is also known to cause somnolence.

Decreased Appetite and Decreased Weight

DIACOMIT can cause decreases in appetite and weight. The growth and weight of pediatric patients treated with DIACOMIT should be carefully monitored.

Neutropenia and Thrombocytopenia

DIACOMIT can cause significant declines in neutrophil and platelet counts. Hematologic testing should be obtained prior to starting treatment with DIACOMIT and then every 6 months.

Withdrawal Symptoms

As with most antiepileptic drugs (AEDs), DIACOMIT should be gradually withdrawn to minimize the risk of increased seizure frequency and status epilepticus.

Risks in Patients with Phenylketonuria (PKU)

DIACOMIT for oral suspension contains phenylalanine, which can be harmful to patients with PKU. Before prescribing DIACOMIT for oral suspension to a patient with PKU, consider the total daily intake of phenylalanine from all sources, including DIACOMIT for oral suspension. DIACOMIT capsules do not contain phenylalanine.

Suicidal Behavior and Ideation

AEDs, including DIACOMIT, increase the risk of suicidal thoughts or behavior. Patients treated with 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.

ADVERSE REACTIONS

The most common adverse reactions that occurred in at least 10% of DIACOMIT-treated patients and more frequently than on placebo were somnolence, decreased appetite, agitation, ataxia, decreased weight, hypotonia, nausea, tremor, dysarthria, and insomnia.

PREGNANCY

There are no adequate data on the developmental risks associated with the use of DIACOMIT in pregnant women. Based on animal data, DIACOMIT may cause fetal harm.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as DIACOMIT, during pregnancy. Physicians are advised to recommend that pregnant patients taking DIACOMIT enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry (information at www.aedpregnancyregistry.org). This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves or their caregiver.

To report suspected adverse reactions, contact Biocodex at 1-866-330-3050 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for DIACOMIT®.

INDICATION and IMPORTANT SAFETY INFORMATION

INDICATION

DIACOMIT (stiripentol) capsules for oral use or powder for oral suspension are indicated for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam.