Brivaracetam
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
Renal Impairment Dose adjustments are not required for patients with impaired renal function. There are no data in patients with end-stage renal disease undergoing dialysis, and use of BRIVIACT is not recommended in this patient population [see Clinical Pharmacology ] .
Dosing in liver impairment
Patients with Hepatic Impairment The recommended dosage for patients with hepatic impairment is included in Table 2 [see Use in Specific Populations and Clinical Pharmacology ] . [See table below.]
| Age and Body Weight | Initial Dosage | Maximum Maintenance Dosage |
|---|---|---|
| Adults (16 years and older) | 25 mg twice daily (50 mg per day) | 75 mg twice daily (150 mg per day) |
| Pediatric patients weighing 50 kg or more | ||
| Pediatric patients weighing 20 kg to less than 50 kg | 0.5 mg/kg twice daily (1 mg/kg per day) | 1.5 mg/kg twice daily (3 mg/kg per day) |
| Pediatric patients weighing 11 kg to less than 20 kg | 0.5 mg/kg twice daily (1 mg/kg per day) | 2 mg/kg twice daily (4 mg/kg per day) |
| Pediatric patients weighing less than 11 kg | 0.75 mg/kg twice daily (1.5 mg/kg per day) | 2.25 mg/kg twice daily (4.5 mg/kg per day) |
Preparation and administration
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Administration Instructions for BRIVIACT Tablets and BRIVIACT Oral Solution BRIVIACT can be initiated with either intravenous or oral administration. BRIVIACT tablets and oral solution may be taken with or without food. BRIVIACT Tablets BRIVIACT tablets should be swallowed whole with liquid. BRIVIACT tablets should not be chewed or crushed.
BRIVIACT Oral Solution A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately. A household teaspoon or tablespoon is not an adequate measuring device. When using BRIVIACT oral solution, no dilution is necessary. BRIVIACT oral solution may also be administered using a nasogastric tube or gastrostomy tube.
Discard any unused BRIVIACT oral solution remaining after 5 months of first opening the bottle.
Preparation and Administration Instructions for BRIVIACT Injection BRIVIACT injection is for intravenous use only. Preparation BRIVIACT injection can be administered intravenously without further dilution or may be mixed with diluents listed below. Diluents 0.9% Sodium Chloride injection, USP Lactated Ringer's injection 5% Dextrose injection, USP Administration BRIVIACT injection should be administered intravenously over 2 to 15 minutes.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Product with particulate matter or discoloration should not be used. BRIVIACT injection is for single dose only. Storage and Stability The diluted solution should not be stored for more than 4 hours at room temperature and may be stored in polyvinyl chloride (PVC) bags.
Discard any unused portion of the BRIVIACT injection vial contents.
Co-administration with Rifampin Increase the BRIVIACT dosage in patients on concomitant rifampin by up to 100% (i.e., double the dosage) [see Drug Interactions and Clinical Pharmacology ] .
Drug interactions
Check brivaracetam against a medication listLabel text (5 paragraphs)
Rifampin: Because of decreased concentrations, increasing BRIVIACT dosage in patients on concomitant rifampin is recommended. ( 2.6 , 7.1 ) Carbamazepine: Because of increased exposure to carbamazepine metabolite, if tolerability issues arise, consider reducing carbamazepine dosage in patients on concomitant BRIVIACT. ( 7.2 ) Phenytoin: Because phenytoin concentrations can increase, phenytoin levels should be monitored in patients on concomitant BRIVIACT. ( 7.3 ) Levetiracetam: BRIVIACT had no added therapeutic benefit when co-administered with levetiracetam. ( 7.4 )
7.1 Rifampin Co-administration with rifampin decreases BRIVIACT plasma concentrations likely because of CYP2C19 induction [see Clinical Pharmacology (12.3) ] . Prescribers should increase the BRIVIACT dose by up to 100% (i.e., double the dosage) in patients while receiving concomitant treatment with rifampin [see Dosage and Administration (2.6) ] .
7.2 Carbamazepine Co-administration with carbamazepine may increase exposure to carbamazepine-epoxide, the active metabolite of carbamazepine. Though available data did not reveal any safety concerns, if tolerability issues arise when co-administered, carbamazepine dose reduction should be considered [see Clinical Pharmacology (12.3) ] .
7.3 Phenytoin Because BRIVIACT can increase plasma concentrations of phenytoin, phenytoin levels should be monitored in patients when concomitant BRIVIACT is added to or discontinued from ongoing phenytoin therapy [see Clinical Pharmacology (12.3) ] .
7.4 Levetiracetam BRIVIACT provided no added therapeutic benefit to levetiracetam when the two drugs were co-administered [see Clinical Studies (14) ].
Contraindications
Hypersensitivity to brivaracetam or any of the inactive ingredients in BRIVIACT (bronchospasm and angioedema have occurred) [see Warnings and Precautions (5.4) ] . Hypersensitivity to brivaracetam or any of the inactive ingredients in BRIVIACT. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as BRIVIACT, during pregnancy. Encourage patients who are taking BRIVIACT during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/.
Risk Summary Available data from the North American Antiepileptic Drug (NAAED) pregnancy registry, a prospective cohort study, case reports, and a case series are insufficient to identify a risk of major birth defects, miscarriage or other maternal or fetal outcomes associated with BRIVIACT use during pregnancy. In animal studies, brivaracetam produced evidence of developmental toxicity (increased embryofetal mortality and decreased fetal body weights in rabbits; decreased growth, delayed sexual maturation, and long-term neurobehavioral changes in rat offspring) at maternal plasma exposures greater than clinical exposures [see Data ] .
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Oral administration of brivaracetam (0, 150, 300, or 600 mg/kg/day) to pregnant rats during the period of organogenesis did not produce any significant maternal or embryofetal toxicity.
The highest dose tested was associated with maternal plasma exposures (AUC) approximately 30 times exposures in humans at the maximum recommended dose (MRD) of 200 mg/day. Oral administration of brivaracetam (0, 30, 60, 120, or 240 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in embryofetal mortality and decreased fetal body weights at the highest dose tested, which was also maternally toxic. The highest no-effect dose (120 mg/kg/day) was associated with maternal plasma exposures approximately 4 times human exposures at the MRD.
When brivaracetam (0, 150, 300, or 600 mg/kg/day) was orally administered to rats throughout pregnancy and lactation, decreased growth, delayed sexual maturation (female), and long-term neurobehavioral changes were observed in the offspring at the highest dose. The highest no-effect dose (300 mg/kg/day) was associated with maternal plasma exposures approximately 7 times human exposures at…
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
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