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

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

• Get emergency help right away if any of the following happens:
  • Shallowed or slowed breathing
  • Breathing stops (which may lead to the heart stopping)
  • Excessive sleepiness (sedation)
• Do not drive or operate heavy machinery until you know how taking ONFI with opioids affects you.
• There is a risk of abuse, misuse, and addiction with benzodiazepines, including ONFI, which can lead to overdose and serious side effects including coma and death.
  • Serious side effects may also include delirium, 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. Stopping or decreasing ONFI dosage suddenly after continued use may cause serious withdrawal reactions, which can be life-threatening, including unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions.
• CALL YOUR HEALTHCARE PROVIDER OR GO TO THE HOSPITAL EMERGENCY ROOM RIGHT AWAY IF YOU GET ANY OF THE ABOVE LIFE-THREATENING OR SERIOUS SIDE EFFECTS.
• Do not take ONFI if you have a known allergy to ONFI or its ingredients.
• ONFI can make you sleepy or dizzy and slow your thinking and motor skills. Do not drive, operate heavy machinery, or do other dangerous activities until you know how ONFI affects you. 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. ONFI may also cause other serious allergic reactions which may affect organs or other parts of your body, like the liver, kidneys, heart, or blood cells, which can be life-threatening and cause death. You may or may not have a rash with these types of reactions. Call your healthcare provider immediately or go to the emergency room if you experience any of the following symptoms: swelling of your face, dark urine, fever or swollen glands that do not go away, shortness of breath, yellowing of the skin or whites of the eyes.
• 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.
• Before you take ONFI, tell your healthcare provider about all your medical conditions, including if you:
  • Have liver or kidney problems
  • Have lung problems (respiratory disease)
  • Have or have had depression, mood problems, or suicidal thoughts or behavior
  • Are pregnant or plan to become pregnant
    • Taking ONFI late in pregnancy may cause your baby to have symptoms of sedation (breathing problems, sluggishness, low muscle tone) and/or withdrawal symptoms (jitteriness, irritability, restlessness, shaking, excessive crying, feeding problems).
    • Tell your healthcare provider right away If you become pregnant or think you are pregnant while taking ONFI
    • If you become pregnant while taking ONFI, talk to your healthcare provider about registering with the North American Antiepileptic Drug Registry. For more information, go to http://www.aedpregnancyregistry.org or call 1-888-233-2334.
  • If you are breastfeeding or plan to breastfeed. ONFI can pass into breast milk.
    • Breastfeeding during treatment with ONFI may cause your baby to have sleepiness, feeding problems, and decreased weight gain. Talk to your healthcare provider about the best way to feed your baby if you take ONFI.
• 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.

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.

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