By using PrescriberAI, you agree to the AI Terms of Use.
Onfi Prescribing Information
- Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate.Limit dosages and durations to the minimumrequired.Follow patients for signs and symptoms of respiratory depression and sedation.[see Warnings and Precautions , Drug Interactions ]
- The use of benzodiazepines, including ONFI, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing ONFI and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction.[see Warnings and Precautions ]
- The continued use of benzodiazepines, including ONFI, may lead to clinically significant physical dependence..The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose.Abrupt discontinuation or rapid dosage reduction of ONFI after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue ONFI or reduce the dosage[see Dosage and Administration and Warnings and Precautions ]
ONFI® (clobazam) is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.
Tablets: 10 mg and 20 mg with a functional score for oral administration.
Each ONFI tablet is a white to off-white, oval tablet with a functional score on one side and either a "1" and "0" or a "2" and "0" debossed on the other side.
Oral Suspension: 2.5 mg/mL for oral administration. Each bottle contains 120 mL of an off-white suspension.
Pregnancy: Based on animal data, may cause fetal harm (
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as ONFI, during pregnancy. Healthcare providers are encouraged to recommend that pregnant women taking ONFI enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334 or online at http://www.aedpregnancyregistry.org/.
Neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal
In a study in which clobazam (0, 150, 450, or 750 mg/kg/day) was orally administered to pregnant rats throughout the period of organogenesis, embryofetal mortality and incidences of fetal skeletal variations were increased at all doses. The low-effect dose for embryofetal developmental toxicity in rats (150 mg/kg/day) was associated with plasma exposures (AUC) for clobazam and its major active metabolite, N-desmethylclobazam, lower than those in humans at the maximum recommended human dose (MRHD) of 40 mg/day.
Oral administration of clobazam (0, 10, 30, or 75 mg/kg/day) to pregnant rabbits throughout the period of organogenesis resulted in decreased fetal body weights, and increased incidences of fetal malformations (visceral and skeletal) at the mid and high doses, and an increase in embryofetal mortality at the high dose. Incidences of fetal variations were increased at all doses. The highest dose tested was associated with maternal toxicity (ataxia and decreased activity). The low-effect dose for embryofetal developmental toxicity in rabbits (10 mg/kg/day) was associated with plasma exposures for clobazam and N-desmethylclobazam lower than those in humans at the MRHD.
Oral administration of clobazam (0, 50, 350, or 750 mg/kg/day) to rats throughout pregnancy and lactation resulted in increased embryofetal mortality at the high dose, decreased pup survival at the mid and high doses and alterations in offspring behavior (locomotor activity) at all doses. The low-effect dose for adverse effects on pre- and postnatal development in rats (50 mg/kg/day) was associated with plasma exposures for clobazam and N-desmethylclobazam lower than those in humans at the MRHD.
ONFI is
contraindicated in patients with a history of hypersensitivity to the drug or
its ingredients. Hypersensitivity reactions have included serious
dermatological reactions
and Precautions ]
Clinically significant adverse reactions that appear in other sections of the labeling include the following:
- Risks from Concomitant Use with Opioids [see Warnings and Precautions ]
- Abuse, Misuse, and Addiction [see Warnings and Precautions ]
- Dependence and Withdrawal Reactions [see Warnings and Precautions ]
- Potentiation of Sedation from Concomitant Use with Central Nervous System Depressants [see Warnings and Precautions ]
- Somnolence or Sedation [see Warnings and Precautions ]
- Serious Dermatological Reactions [see Contraindications , Warnings and Precautions ]
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions ]
- Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.8)]
- Neonatal Sedation and Withdrawal Syndrome [see Warnings and Precautions( 5.9)]