About ONFI® (clobazam)
ONFI has been shown to reduce seizures associated with Lennox-Gastaut syndrome (LGS) in people 2 years of age or older. It’s an adjunctive treatment, which means that it’s added to a treatment plan that includes other antiepileptic drugs (AEDs). Benzodiazepines, like ONFI, can cause severe drowsiness, breathing problems (respiratory depression), coma, and death when taken with opioid medicines.
In the largest clinical study to date of adults and children with LGS, adding ONFI was shown to lower the number of seizures people had each week. The study evaluated 238 participants, and the goal was to find out if adding ONFI to a person’s current treatment plan could lower his or her number of atonic, tonic, or myoclonic seizures. At all doses, treatment with ONFI reduced how often people had drop seizures each week.
In this study, the most common side effects were sleepiness or tiredness, drooling, constipation, cough, pain with urination, fever, acting aggressive, being angry or violent, difficulty sleeping, slurred speech, and problems breathing.
Can ONFI help?
Know what to expect when adding any new medication to your loved one’s treatment plan. Hear what one doctor tells his patients with LGS about adding ONFI.
Taking ONFI
ONFI should be taken exactly as your healthcare provider recommends. Make sure to tell your healthcare provider how your loved one is feeling and whether he or she is experiencing any side effects. Do not stop giving ONFI to your loved one without talking to your healthcare provider first.
STARTING ONFI
If you are adding ONFI to your loved one’s treatment plan, your healthcare provider may start with a low dose and increase it as your loved one’s body adjusts to ONFI. It may take some time to find the dose that is appropriate.
We always tried to remain open to trying new therapies, like ONFI, for Bobby's sake. We did some research on ONFI and felt we owed it to Bobby to try it out.
—Rose, mother of Bobby, who has LGS
Before your loved one starts ONFI, tell your healthcare provider if he or she:
- has liver or kidney problems
- has lung problems (respiratory disease)
- has or has had depression, mood problems, or suicidal thoughts or behavior
- uses birth control medicine. ONFI may cause birth control medicine to be less effective.
- plans to become pregnant, is pregnant, or becomes pregnant while taking ONFI.*
- Taking ONFI late in pregnancy may cause the baby to have symptoms of sedation and/or withdrawal symptoms.
- is breastfeeding or plans to breastfeed. ONFI can pass into breast milk.
- Breastfeeding during treatment with ONFI may cause the baby to have sleepiness, feeding problems, and decreased weight gain.
- Talk to your loved one's healthcare provider about the best way to feed her baby if she takes ONFI.
*If your loved one becomes pregnant while taking ONFI, talk to her healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can register by calling 1-888-233-2334. For more information about the registry go to http://www.aedpregnancyregistry.org. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.
HOW IS ONFI TAKEN?
- ONFI should be taken exactly as your healthcare provider says. Your healthcare provider will tell you how much should be taken and when. He or she may also change the dose if needed
- ONFI is usually taken twice a day
- ONFI tablets can be taken whole, broken in half along the score, or crushed and mixed in applesauce
- ONFI tablets and oral suspension can be taken with or without food
- Tell your healthcare provider about all the medicines your loved one is taking, 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