ONFI® (clobazam) CIV - For seizures associated with LGS

Eligible commercial patients* may pay as little as $10/30-day supply of ONFI with a maximum benefit of $600 per 30-day prescription. Offers are valid only in the USA where allowed by law.

Patients are responsible for complying with any rules imposed by their insurance plan; some plans may not allow commercial copay assistance to count toward a patient's deductible. Complete Terms and Conditions for the ONFI Copay Assistance Program are available here.

Complete Terms and Conditions for the 14-Day Trial and Commercial Copay Assistance Programs are available here.

Complete Terms and Conditions for other patient support programs are available here.

*Medicaid patients and other federal healthcare program beneficiaries, patients who are self-pay, and patients who do not have insurance coverage for ONFI are not eligible. Eligible commercial patients must be at least 2 years old to participate. See complete Terms and Conditions here.

Important Safety Information

What is ONFI^®?

ONFI [(clobazam) CIV] is a prescription medicine used along with other medicines to treat seizures associated with Lennox-Gastaut syndrome in people 2 years of age or older.

IMPORTANT SAFETY INFORMATION for ONFI

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS;

ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS

See Medication Guide and full Prescribing Information for complete information.

ONFI is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death when taken with opioid medicines.

The use of benzodiazepines, including ONFI, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death.

Stopping or decreasing ONFI dosage suddenly after continued use may cause serious withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, slowly decrease dosage to discontinue ONFI.

Important Safety Information

What is ONFI^®?

ONFI [(clobazam) CIV] is a prescription medicine used along with other medicines to treat seizures associated with Lennox-Gastaut syndrome in people 2 years of age or older.

IMPORTANT SAFETY INFORMATION for ONFI

WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS;

ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS

See Medication Guide and full Prescribing Information for complete information.

ONFI is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system (CNS) depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death when taken with opioid medicines.

The use of benzodiazepines, including ONFI, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death.

Stopping or decreasing ONFI dosage suddenly after continued use may cause serious withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, slowly decrease dosage to discontinue ONFI.

Do not take ONFI if you have a known allergy to ONFI or its ingredients.
ONFI can cause risk of abuse, misuse, and addiction.
- Serious side effects including coma and death have happened in people who have abused or misused benzodiazepines, including ONFI. These serious side effects may also include delirium (severe state of confusion), paranoia, suicidal thoughts or actions, seizures, and difficulty breathing.
- You can develop an addiction even if you take ONFI as prescribed by your healthcare provider.
- Take ONFI exactly as your healthcare provider prescribed.
- Do not share your ONFI with other people AND keep ONFI in a safe place and away from children.
ONFI can cause physical dependence and withdrawal reactions.
- Do not suddenly stop taking ONFI. Stopping ONFI suddenly can cause serious and life-threatening side effects, including unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not see or hear, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions. Call your healthcare provider or go to the nearest hospital emergency room right away if you get any of these symptoms.
- Some people who suddenly stop benzodiazepines have symptoms that can last for several weeks to more than 12 months, including anxiety, trouble remembering, learning or concentrating, depression, problems sleeping, feeling like insects are crawling under your skin, weakness, shaking, muscle twitching, burning or prickling feeling in your hands, arms, legs or feet, and ringing in your ears.
- Physical dependence is not the same as drug addiction. Talk to your healthcare provider about the differences.
- Do not take more ONFI than prescribed. Do not take ONFI for longer than prescribed.
ONFI can make you sleepy or dizzy and slow your thinking and motor skills. This may get better over time. Do not drive, operate heavy machinery, or do other dangerous activities until you know how ONFI affects you. ONFI may cause problems with your coordination, especially when you are walking or picking things up.
Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking ONFI without first talking to your healthcare provider. ONFI may make your sleepiness or dizziness much worse.
Serious skin reactions have been seen when ONFI is taken with other medicines and may require stopping its use. A serious skin reaction can happen at any time during your treatment with ONFI. Call your healthcare provider immediately if you have skin blisters, rash, sores in the mouth, hives, or any other allergic reaction.
Like other seizure medicines, ONFI may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your healthcare provider right away if you have any symptoms of depression, especially sudden changes in mood, behaviors, thoughts, or feelings, and especially if they are new, worse, or worry you. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop.
Tell your healthcare provider about all your medical conditions, including liver or kidney problems, lung problems (respiratory disease), depression, mood problems, or suicidal thoughts or behavior.
If you are pregnant or plan to become pregnant, ONFI may harm your unborn baby. You and your healthcare provider will have to decide if you should take ONFI while you are pregnant.
ONFI can pass into breast milk. You and your healthcare provider should decide if you will take ONFI or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking ONFI with certain other medicines can cause side effects or affect how well they work. ONFI may make your birth control medicine less effective. Talk to your healthcare provider about the best birth control method to use. Do not start or stop ONFI or other medicines without talking to your healthcare provider.
ONFI oral suspension should be kept in its original bottle in an upright position and used within 90 days of first opening the bottle. After 90 days, safely throw away any unused ONFI oral suspension.
The most common side effects of ONFI include: sleepiness; drooling; constipation; cough; pain with urination; fever; acting aggressive; being angry or violent; difficulty sleeping; slurred speech; tiredness; and problems with breathing.

For more information, please see the full Prescribing Information, including Boxed Warning, Medication Guide and Instructions for Use, or go to ONFI.com.

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.