Onfi

Serious warning

The strongest warning the FDA requires. It is printed in a box at the top of the label.

Quoted from the official label, section “Boxed Warning”.

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• For doses above 5 mg/day administer in two divided doses ( 2.1 ) Patients ≤30 kg body weight:
• Initiate at 5 mg daily and titrate as tolerated up to 20 mg daily ( 2.1 ) Patients >30 kg body weight:
• Initiate at 10 mg daily and titrate as tolerated up to 40 mg daily ( 2.1 ) Dosage adjustment needed in following groups:
• Geriatric patients ( 2.4 , 8.5 ) Known CYP2C19 poor metabolizers ( 2.5 ) Mild or moderate hepatic impairment; no information for severe hepatic impairment ( 2.7 , 8.8 ) Tablets:
• Administer whole, broken in half along the score, or crush and mix in applesauce ( 2.3 ) Measure prescribed amount of oral suspension using provided adapter and dosing syringe ( 2.3 ) Tablets and Oral suspension:
• Can be taken with or without food ( 2.3 )
• 2.1 Dosing Information A daily dose of ONFI greater than 5 mg should be administered in divided doses twice daily; a 5 mg daily dose can be administered as a single dose.
• Dose patients according to body weight.
• Individualize dosing within each body weight group, based on clinical efficacy and tolerability.
• Each dose in Table 1 (e.g., 5 to 20 mg in ≤30 kg weight group) has been shown to be effective, although effectiveness increases with increasing dose [see Clinical Studies ( 14 )] .
• Do not proceed with dose escalation more rapidly than weekly, because serum concentrations of clobazam and its active metabolite require 5 and 9 days, respectively, to reach steady-state.
• Table 1.
• Recommended Total Daily Dosing by Weight Group ≤30 kg Body Weight >30 kg Body Weight Starting Dose 5 mg 10 mg Starting Day 7 10 mg 20 mg Starting Day 14 20 mg 40 mg
• 2.2 Discontinuation or Dosage Reduction of ONFI To reduce the risk of withdrawal reactions, increased seizure frequency, and status epilepticus, use a gradual taper to discontinue ONFI or reduce the dosage.
• Taper by decreasing the total daily dose by 5-10 mg/day on a weekly basis until discontinued.
• If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level.
• Subsequently decrease the dosage more slowly [see Warnings and Precautions ( 5.3 ) and Drug Abuse and Dependence ( 9.3 )] .
• 2.3 Important Administration Instructions Instruct patients to read the "Instructions for Use" carefully for complete directions on how to properly dose and administer ONFI oral suspension.
• ONFI Tablet Oral Administration ONFI tablets can be taken with or without food.
• ONFI tablets can be administered whole, broken in half along the score, or crushed and mixed in applesauce.
• ONFI Oral Suspension Oral Administration ONFI oral suspension can be taken with or without food [see Clinical Pharmacology ( 12.3 )] .
• Shake ONFI Oral Suspension well before every administration.
• When administering the oral suspension, use only the oral dosing syringe provided with the product.
• Each carton includes two syringes, but only one syringe should be used for dosing.
• The second oral syringe is reserved as a replacement in case the first syringe is damaged or lost.
• Insert the provided adapter firmly into the neck of the bottle before first use and keep the adapter in place for the duration of the usage of the bottle.
• To withdraw the dose, insert the dosing syringe into the adapter and invert the bottle then slowly pull back the plunger to prescribed dose.
• After removing the syringe from the bottle adapter, slowly squirt ONFI Oral Suspension into the corner of the patient's mouth.
• Replace the cap after each use.
• The cap fits over the adapter when the adapter is properly placed.
• See ONFI Oral Suspension "Instructions for Use" for complete instruction on how to properly dose and administer the ONFI Oral Suspension.
• 2.4 Dosage Adjustments in Geriatric Patients Plasma concentrations at any given dose are generally higher in the elderly:
• proceed slowly with dose escalation.
• The starting dose should be 5 mg/day for all elderly patients.
• Then titrate elderly patients according to weight, but to half the dose presented in Table 1, as tolerated.
• If necessary and based upon clinical response, an additional titration to the maximum dose (20 mg/day or 40 mg/day, depending on weight) may be started on day 21 [see Use in Specific Populations ( 8.5 )] .
• 2.5 Dosage Adjustments in CYP2C19 Poor Metabolizers In CYP2C19 poor metabolizers, levels of N-desmethylclobazam, clobazam's active metabolite, will be increased.
• Therefore, in patients known to be CYP2C19 poor metabolizers, the starting dose should be 5 mg/day and dose titration should proceed slowly according to weight, but to half the dose presented in Table 1, as tolerated.
• If necessary and based upon clinical response, an additional titration to the maximum dose (20 mg/day or 40 mg/day, depending on the weight group) may be started on day 21 [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.5 )] .
• 2.6 Patients with Renal Impairment No dose adjustment is required for patients with mild and moderate renal impairment.
• There is no experience with ONFI in patients with severe renal impairment or end stage renal disease (ESRD).
• It is not known if clobazam or its active metabolite, N-desmethylclobazam, is dialyzable [see Use in Specific Populations ( 8.7 ), Clinical Pharmacology ( 12.3 )] .
• 2.7 Dosage Adjustments in Patients with Hepatic Impairment ONFI is hepatically metabolized; however, there are limited data to characterize the effect of hepatic impairment on the pharmacokinetics of ONFI.
• For this reason, proceed slowly with dosing escalations.
• For patients with mild to moderate hepatic impairment (Child-Pugh score 5-9), the starting dose should be 5 mg/day in both weight groups.
• Then titrate patients according to weight, but to half the dose presented in Table 1, as tolerated.
• If necessary and based upon clinical response, start an additional titration on day 21 to the maximum dose (20 mg/day or 40 mg/day, depending on the weight group).
• There is inadequate information about metabolism of ONFI in patients with severe hepatic impairment.
• Therefore no dosing recommendation in those patients can be given [see Use in Specific Populations ( 8.8 ), Clinical Pharmacology ( 12.3 )] .

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Misuse and dependence

Quoted from the official label, section “Drug Abuse and Dependence”.

Use in children

• Safety and effectiveness in patients less than 2 years of age have not been established.
• In a study in which clobazam (0, 4, 36, or 120 mg/kg/day) was orally administered to rats during the juvenile period of development (postnatal days 14 to 48), adverse effects on growth (decreased bone density and bone length) and behavior (altered motor activity and auditory startle response; learning deficit) were observed at the high dose.
• The effect on bone density, but not on behavior, was reversible when drug was discontinued.
• The no-effect level for juvenile toxicity (36 mg/kg/day) was associated with plasma exposures (AUC) to clobazam and its major active metabolite, N-desmethylclobazam, less than those expected at therapeutic doses in pediatric patients.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• Clinical studies of ONFI did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
• However, elderly subjects appear to eliminate clobazam more slowly than younger subjects based on population pharmacokinetic analysis.
• For these reasons, the initial dose in elderly patients should be 5 mg/day.
• Patients should be titrated initially to 10-20 mg/day.
• Patients may be titrated further to a maximum daily dose of 40 mg if tolerated [see Dosage and Administration ( 2.4 ), Clinical Pharmacology ( 12.3 )] .

Quoted from the official label, section “Geriatric Use”.

Side effects

• 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 ( 5.1 )] Abuse, Misuse, and Addiction [see Warnings and Precautions ( 5.2 )] Dependence and Withdrawal Reactions [see Warnings and Precautions ( 5.3 )] Potentiation of Sedation from Concomitant Use with Central Nervous System Depressants [see Warnings and Precautions ( 5.4 )] Somnolence or Sedation [see Warnings and Precautions ( 5.5 )] Serious Dermatological Reactions [see Contraindications ( 4 ), Warnings and Precautions ( 5.6 )] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions ( 5.7 )] Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.8) ] Neonatal Sedation and Withdrawal Syndrome [see Warnings and Precautions ( 5.9) ] Adverse reactions that occurred at least 10% more frequently than placebo in any ONFI dose included constipation, somnolence or sedation, pyrexia, lethargy, and drooling ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lundbeck at 1-800-455-1141 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
• 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
• During its development for the adjunctive treatment of seizures associated with LGS, ONFI was administered to 333 healthy volunteers and 300 patients with a current or prior diagnosis of LGS, including 197 patients treated for 12 months or more.
• The conditions and duration of exposure varied greatly and included single- and multiple-dose clinical pharmacology studies in healthy volunteers and two double-blind studies in patients with LGS (Study 1 and 2) [see Clinical Studies ( 14 )] .
• Only Study 1 included a placebo group, allowing comparison of adverse reaction rates on ONFI at several doses to placebo.
• Adverse Reactions Leading to Discontinuation in an LGS Placebo Controlled Clinical Trial (Study 1) The adverse reactions associated with ONFI treatment discontinuation in ≥1% of patients in decreasing order of frequency included lethargy, somnolence, ataxia, aggression, fatigue, and insomnia.
• Most Common Adverse Reactions in an LGS Placebo Controlled Clinical Trial (Study 1) Table 3 lists the adverse reactions that occurred in ≥5% of ONFI-treated patients (at any dose), and at a rate greater than placebo-treated patients, in the randomized, double-blind, placebo-controlled, parallel group clinical study of adjunctive AED therapy for 15 weeks (Study 1).
• Table 3.
• Adverse Reactions Reported for ≥5% of Patients and More Frequently than Placebo in Any Treatment Group a Maximum daily dose of 5 mg for ≤30 kg body weight; 10 mg for >30 kg body weight b Maximum daily dose of 10 mg for ≤30 kg body weight; 20 mg for >30 kg body weight c Maximum daily dose of 20 mg for ≤30 kg body weight; 40 mg for >30 kg body weight Placebo N=59 % ONFI Dose Level All ONFI N=179 % Low a N=58 % Medium b N=62 % High c N=59 % Gastrointestinal Disorders Vomiting 5 9 5 7 7 Constipation 0 2 2 10 5 Dysphagia 0 0 0 5 2 General Disorders and Administration Site Conditions Pyrexia 3 17 10 12 13 Irritability 5 3 11 5 7 Fatigue 2 5 5 3 5 Infections and Infestations Upper respiratory tract infection 10 10 13 14 12 Pneumonia 2 3 3 7 4 Urinary tract infection 0 2 5 5 4 Bronchitis 0 2 0 5 2 Metabolism and Nutrition Disorders Decreased appetite 3 3 0 7 3 Increased appetite 0 2 3 5 3 Nervous System Disorders Somnolence or Sedation 15 17 27 32 26 Somnolence 12 16 24 25 22 Sedation 3 2 3 9 5 Lethargy 5 10 5 15 10 Drooling 3 0 13 14 9 Ataxia 3 3 2 10 5 Psychomotor hyperactivity 3 3 3 5 4 Dysarthria 0 2 2 5 3 Psychiatric Disorders Aggression 5 3 8 14 8 Insomnia 2 2 5 7 5 Respiratory Disorders Cough 0 3 5 7 5
• 6.2 Postmarketing Experience These reactions are reported voluntarily from a population of uncertain size; therefore, it is not possible to estimate their frequency or establish a causal relationship to drug exposure.
• Adverse reactions are categorized by system organ class.
• Blood Disorders:
• Anemia, eosinophilia, leukopenia, thrombocytopenia Eye Disorders:
• Diplopia, vision blurred Gastrointestinal Disorders:
• Abdominal distention General Disorders and Administration Site Conditions:
• Hypothermia Investigations:
• Hepatic enzyme increased Musculoskeletal:
• Muscle spasms Psychiatric Disorders:
• Agitation, anxiety, apathy, confusional state, depression, delirium, delusion, hallucination Renal and Urinary Disorders:
• Urinary retention Respiratory Disorders:
• Aspiration, respiratory depression Skin and Subcutaneous Tissue Disorders:
• Rash, urticaria, angioedema, and facial and lip edema

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Advise the patient to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ).
• Risks from Concomitant Use with Opioids Inform patients and caregivers that potentially fatal additive effects may occur if ONFI is used with opioids and not to use such drugs concomitantly unless supervised by a healthcare provider [see Warnings and Precautions ( 5.1 ), Drug Interactions ( 7.1 )] .
• Abuse, Misuse, and Addiction Inform patients that the use of ONFI, even at recommended dosages, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose and death, especially when used in combination with other medications (e.g., opioid analgesics), alcohol, and/or illicit substances.
• Inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction; to seek medical help if they develop these signs and/or symptoms; and on the proper disposal of unused drug [see Warnings and Precautions ( 5.2 ) and Drug Abuse and Dependence ( 9.2 )] .
• Withdrawal Reactions Advise patients or caregivers that abrupt withdrawal of AEDs may increase their risk of seizure.
• Inform patients that the continued use of ONFI may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of ONFI may precipitate acute withdrawal reactions, which can be life-threatening.
• Inform patients that in some cases, patients taking benzodiazepines have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months.
• Instruct patients that discontinuation or dosage reduction of ONFI may require a slow taper [see Warnings and Precautions ( 5.3 ) and Drug Abuse and Dependence ( 9.3 )] .
• Somnolence or Sedation Advise patients or caregivers to check with their healthcare provider before ONFI is taken with other CNS depressants such as other benzodiazepines, opioids, tricyclic antidepressants, sedating antihistamines, or alcohol [see Warnings and Precautions ( 5.4 , 5.5 )] .
• If applicable, caution patients about operating hazardous machinery, including automobiles, until they are reasonably certain that ONFI does not affect them adversely (e.g., impair judgment, thinking or motor skills).
• Hypersensitivity Inform patients or caregivers that ONFI is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients [see Warnings and Precautions ( 5.6 )] .
• Interactions with Hormonal Contraceptives Counsel women to also use non-hormonal methods of contraception when ONFI is used with hormonal contraceptives and to continue these alternative methods for 28 days after discontinuing ONFI to ensure contraceptive reliability [see Drug Interactions ( 7.3 ), Clinical Pharmacology ( 12.3 )] .
• Serious Dermatological Reactions Advise patients or caregivers that serious skin reactions have been reported in patients taking ONFI.
• Serious skin reactions, including SJS/TEN, may need to be treated in a hospital and may be life-threatening.
• If a skin reaction occurs while taking ONFI, patients or caregivers should consult with healthcare providers immediately [see Warnings and Precautions ( 5.6 )] .
• DRESS/Multiorgan Hypersensitivity Instruct patients and caregivers that a fever or rash associated with signs of other organ system involvement (e.g., lymphadenopathy, hepatic dysfunction) may be drug-related and should be reported to their healthcare provider immediately.
• ONFI should be discontinued immediately if a serious hypersensitivity reaction is suspected [see Warnings and Precautions ( 5.7) ] .
• Suicidal Thinking and Behavior Counsel patients, their caregivers, and their families that AEDs, including ONFI, may increase the risk of suicidal thoughts and behavior and advise them of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts of self-harm.
• Patients should report behaviors of concern immediately to healthcare providers [see Warnings and Precautions ( 5.8 )] .
• Pregnancy Advise pregnant females that the use of ONFI late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in newborns [see Warnings and Precautions ( 5.9 ) and Use in Specific Populations ( 8.1 )] .
• Instruct patients to notify their healthcare provider if they are pregnant.
• Encourage patients to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant while taking ONFI.
• The registry is collecting information about the safety of antiepileptic drugs during pregnancy [see Use in Specific Populations ( 8.1 )] .
• Lactation Counsel patients that clobazam, the active ingredient in ONFI, is excreted in breast milk.
• Instruct patients to notify their healthcare provider if they are breastfeeding or intend to breastfeed.
• Instruct breastfeeding patients who have been administered ONFI to observe their infants for sedation, poor feeding and poor weight gain, and to seek medical attention if they notice these signs [see Use in Specific Populations ( 8.2 )] .
• Tablets manufactured by: Catalent Pharma Solutions, LLC Winchester, KY 40391, U.S.A.
• Oral suspension manufactured by: Rosemont Pharmaceuticals, Ltd.
• Leeds, West Yorkshire LS11 9XE, U.K.
• For: Lundbeck Deerfield, IL 60015, U.S.A.
• ONFI is a registered trademark of Lundbeck Logo

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS 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.
• Tablet:
• 10 mg and 20 mg with a functional score ( 3 ) Oral Suspension:
• 2.5 mg/mL in 120 mL bottles ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• Each ONFI tablet contains 10 mg or 20 mg of clobazam and 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.
• NDC 67386-314-01:
• 10 mg scored tablet, Bottles of 100 NDC 67386-315-01:
• 20 mg scored tablet, Bottles of 100 ONFI oral suspension is a berry flavored off-white liquid supplied in a bottle with child-resistant closure.
• The oral suspension is packaged with a dispenser set which contains two calibrated oral dosing syringes and a bottle adapter.
• Store and dispense ONFI oral suspension in its original bottle in an upright position.
• Use within 90 days of first opening the bottle, then discard any remainder.
• NDC 67386-313-21: 2.5 mg/mL supplied in a bottle containing 120 mL of suspension.
• Store tablets and oral suspension at 20°C to 25°C (68°F to 77°F).
• See USP controlled room temperature.

Quoted from the official label, section “How Supplied”.

What is in it

• Table 4.
• Description Proprietary Name:
• ONFI ® Established Name:
• Clobazam Dosage Forms:
• Tablet and Oral Suspension Route of Administration:
• Oral Established Pharmacologic Class of Drug:
• Benzodiazepine Chemical Name:
• 7-Chloro-1-methyl-5-phenyl-1H-1,5 benzodiazepine-2,4( 3H,5H )-dione Structural Formula:
• Clobazam is a white or almost white, crystalline powder with a slightly bitter taste; is slightly soluble in water, sparingly soluble in ethanol, and freely soluble in methylene chloride.
• The melting range of clobazam is from 182ºC to 185ºC.
• The molecular formula is C 16 H 13 O 2 N 2 Cl and the molecular weight is 300.7.
• Each ONFI tablet contains 10 mg or 20 mg of clobazam.
• Tablets also contain as inactive ingredients:
• modified corn starch, lactose monohydrate, magnesium stearate, silicon dioxide, and talc.
• ONFI is also available for oral administration as an off-white suspension containing clobazam at a concentration of 2.5 mg/mL.
• Inactive ingredients include magnesium aluminum silicate, xanthan gum, citric acid monohydrate, disodium hydrogen phosphate dihydrate, simethicone emulsion, polysorbate 80, methylparaben, propylparaben, propylene glycol, sucralose, maltitol solution, berry flavor, purified water. onfi-01

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

3 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Clobazam