See also:
What is the most important information I should know about Querta?
Do not stop using Querta without first talking to your doctor, even if you feel fine. You may have increased seizures if you stop using Querta suddenly. You may need to use less and less before you stop the medication completely.
You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, irritable, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.
Wear a medical alert tag or carry an ID card stating that you take Querta. Any medical care provider who treats you should know that you take seizure medication.
This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Do not start or stop taking Querta during pregnancy without your doctor's advice. Having a seizure during pregnancy could harm both the mother and the baby. Seizure control is very important during pregnancy and the benefits of preventing seizures may outweigh any risks posed by using Querta.
See also:
What are the possible side effects of Querta?
The following adverse reactions are discussed in more details in other sections of labeling:
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.
The adverse reactions that result from Querta Injection use include all of those reported for Querta tablets and oral solution. Equivalent doses of intravenous (IV) Querta and oral Querta result in equivalent Cmax, Cmin, and total systemic exposure to Querta when the IV Querta is administered as a 15-minute infusion.
Partial Onset Seizures
Adults
In controlled clinical studies using Querta tablets in adults with partial onset seizures, the most common adverse reactions in adult patients receiving Querta in combination with other AEDs, for events with rates greater than placebo, were somnolence, asthenia, infection and dizziness. Of the most common adverse reactions in adults experiencing partial onset seizures, asthenia, somnolence and dizziness occurred predominantly during the first 4 weeks of treatment with Querta.
Table 3 lists adverse reactions that occurred in at least 1% of adult epilepsy patients receiving Querta tablets in placebo-controlled studies and were numerically more common than in patients treated with placebo. In these studies, either Querta or placebo was added to concurrent AED therapy.
In controlled adult clinical studies using Querta tablets, 15% of patients receiving Querta and 12% receiving placebo either discontinued or had a dose reduction as a result of an adverse reaction. Table 4 lists the most common (>1%) adverse reactions that resulted in discontinuation or dose reduction and that occurred more frequently in Querta -treated patients than in placebo-treated patients.
Pediatric Patients 4 Years to <16 Years
The adverse reaction data presented below was obtained from a pooled analysis of two controlled pediatric clinical studies using an oral formulation in pediatric patients 4 to 16 years of age with partial onset seizures. The most common adverse reactions in pediatric patients receiving Querta in combination with other AEDs, for events with rates greater than placebo, were fatigue, aggression, nasal congestion, decreased appetite, and irritability.
Table 5 lists adverse reactions from the pooled pediatric controlled studies (4 to 16 years of age) that occurred in at least 2% of pediatric Querta-treated patients and were numerically more common than in pediatric patients treated with placebo. In these studies, either Querta or placebo was added to concurrent AED therapy.
In the controlled pooled pediatric clinical studies in patients 4 to 16 years of age, 7% of patients receiving Querta and 9% receiving placebo discontinued as a result of an adverse reaction.
Pediatric Patients 1 Month to < 4 Years
In the 7-day controlled pediatric clinical study using an oral formulation of Querta in children 1 month to less than 4 years of age with partial onset seizures, the most common adverse reactions in patients receiving Querta in combination with other AEDs, for events with rates greater than placebo, were somnolence and irritability. Because of the shorter exposure period, incidences of adverse reactions are expected to be lower than in other pediatric studies in older patients. Therefore, other controlled pediatric data, presented above, should also be considered to apply to this age group.
Table 6 lists adverse reactions that occurred in at least 5% of pediatric epilepsy patients (ages 1 month to < 4 years) treated with Querta in the placebo-controlled study and were numerically more common than in patients treated with placebo. In this study, either Querta or placebo was added to concurrent AED therapy.
In the 7-day controlled pediatric clinical study in patients 1 month to < 4 years of age, 3% of patients receiving Querta and 2% receiving placebo either discontinued or had a dose reduction as a result of an adverse reaction. There was no adverse reaction that resulted in discontinuation for more than one patient.
Myoclonic Seizures
Although the pattern of adverse reactions in this study seems somewhat different from that seen in patients with partial seizures, this is likely due to the much smaller number of patients in this study compared to partial seizure studies. The adverse reaction pattern for patients with JME is expected to be essentially the same as for patients with partial seizures.
In the controlled clinical study using Querta tablets in patients with myoclonic seizures, the most common adverse reactions in patients receiving Querta in combination with other AEDs, for events with rates greater than placebo, were somnolence, neck pain, and pharyngitis.
Table 7 lists adverse reactions that occurred in at least 5% of juvenile myoclonic epilepsy patients experiencing myoclonic seizures treated with Querta tablets and were numerically more common than in patients treated with placebo. In this study, either Querta or placebo was added to concurrent AED therapy.
In the placebo-controlled study using Querta tablets in patients with JME 8% of patients receiving Querta and 2% receiving placebo either discontinued or had a dose reduction as a result of an adverse reaction. The adverse reactions that led to discontinuation or dose reduction and that occurred more frequently in Querta-treated patients than in placebo-treated patients are presented in Table 8.
Primary Generalized Tonic-Clonic Seizures
Although the pattern of adverse reactions in this study seems somewhat different from that seen in patients with partial seizures, this is likely due to the much smaller number of patients in this study compared to partial seizure studies. The adverse reaction pattern for patients with primary generalized tonic-clonic (PGTC) seizures is expected to be essentially the same as for patients with partial seizures.
In the controlled clinical study that included patients 4 years of age and older with PGTC seizures, the most common adverse reaction in patients receiving Querta oral formulation in combination with other AEDs, for events with rates greater than placebo was nasopharyngitis.
Table 9 lists adverse reactions that occurred in at least 5% of idiopathic generalized epilepsy patients experiencing PGTC seizures treated with Querta and were numerically more common than in patients treated with placebo. In this study, either Querta or placebo was added to concurrent AED therapy.
In the placebo-controlled study, 5% of patients receiving Querta and 8% receiving placebo either discontinued or had a dose reduction during the treatment period as a result of an adverse reaction.
This study was too small to adequately characterize the adverse reactions that could be expected to result in discontinuation of treatment in this population. It is expected that the adverse reactions that would lead to discontinuation in this population would be similar to those resulting in discontinuation in other epilepsy trials.
In addition, the following adverse reactions were seen in other controlled adult studies of Querta: balance disorder, disturbance in attention, eczema, memory impairment, myalgia, and blurred vision.
Comparison of Gender, Age and Race
The overall adverse reaction profile of Querta was similar between females and males. There are insufficient data to support a statement regarding the distribution of adverse reactions by age and race.
Post-marketing Experience
The following adverse reactions have been identified during post-approval use of Querta. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following adverse reactions have been reported in patients receiving Querta worldwide. The listing is alphabetized: abnormal liver function test, choreoathetosis, drug reaction with eosinophilia and systemic symptoms (DRESS), dyskinesia, erythema multiforme, hepatic failure, hepatitis, hyponatremia, muscular weakness, pancreatitis, pancytopenia (with bone marrow suppression identified in some of these cases), panic attack, thrombocytopenia, and weight loss. Alopecia has been reported with Querta use; recovery was observed in majority of cases where Querta was discontinued.
Querta injection, USP is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy. Querta injection, USP is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible.
Myoclonic Seizures In Patients With Juvenile Myoclonic EpilepsyQuerta injection, USP is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. Querta injection, USP is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible.
Primary Generalized Tonic-Clonic SeizuresQuerta injection, USP is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. Querta injection, USP is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible.
Querta injection is used to help control partial onset seizures in adults and children 1 month of age and older in the treatment of epilepsy. It is also used to help treat myoclonic seizures in adults and children 12 years of age and older with juvenile myoclonic epilepsy. Querta injection is also used to help treat primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. Querta cannot cure epilepsy and will only work to control seizures for as long as you continue to use it.
Querta is to be given only by or under the direct supervision of a doctor.
Each film-coated tablet contains the following inactive ingredients: Maize starch, croscaramellose sodium, povidone, colloidal silicon dioxide, talc and magnesium stearate, Opadry II blue (polyvinyl alcohol, titanium dioxide, polyethylene glycol 3350, talc, FD&C blue #2/indigo carmine aluminum lake).
Querta is an antiepileptic drug for oral administration.
The chemical name of Querta, a single enantiomer is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C8H14N2O2 and its molecular weight is 170.21. Querta is chemically unrelated to existing antiepileptic drug (AEDs).
Querta is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (1040 mg/mL). It is freely soluble in chloroform (653 mg/mL) and in methanol (536 mg/mL), soluble in ethanol (165 mg/mL), sparingly soluble in acetonitrile (57 mg/mL) and practically insolube in n-hexane. Solubility limits are expressed as mg/mL solvent.
Use Querta extended-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Querta extended-release tablets.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Use: Labeled IndicationsFocal (partial) onset:
IR tablets/oral solution: Treatment of focal (partial) onset seizures in adults, adolescents, children, and infants ≥1 month of age with epilepsy.
Tablets for oral suspension: Adjunctive therapy in the treatment of focal (partial) onset seizures in adults and children ≥4 years of age and >20 kg with epilepsy.
ER tablets: Treatment of focal (partial) onset seizures in adults and adolescents ≥12 years of age with epilepsy.
IV: Treatment of focal (partial) onset seizures in adults and children ≥1 month of age with epilepsy.
Limitation of use: IV use is only as an alternative when oral administration is temporarily not feasible.
Generalized onset:
Juvenile myoclonic epilepsy:
Immediate-release tablets/oral solution/tablets for oral suspension: Adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years and older with juvenile myoclonic epilepsy.
IV: Adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years and older with juvenile myoclonic epilepsy.
Primary generalized tonic-clonic seizures:
Immediate-release tablets/oral solution/tablets for oral suspension: Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years and older with idiopathic generalized epilepsy.
IV: Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years and older with idiopathic generalized epilepsy.
Off Label UsesCraniotomy, seizure prophylaxis
Data from a systematic review and meta-analysis support the use of Querta as an alternative to phenytoin for seizure prophylaxis during craniotomy and in the postoperative period.
Querta is intended to disintegrate in the mouth when taken with a sip of liquid. As a primary method of administration, place tablet on the tongue with a dry hand, follow with a sip of liquid and swallow only after the tablet disintegrates. Do not swallow tablet(s) intact. Partial tablet(s) should not be administered. Querta disintegrates in a mean time of 11 seconds (ranging from 2 to 27 seconds) in the mouth when taken with a sip of liquid.
Alternately, add whole Querta tablet(s) to a small volume of liquid in a cup (one tablespoon or enough to cover the medicine). Allow the tablet(s) to disperse prior to consuming the entire contents immediately. After administration of the suspension, re-suspend any residue by adding an additional small volume of liquid and swallow the full amount. No attempt should be made to administer partial quantities of the dispersed tablet(s).
Administer Querta orally, with or without food. The Querta dosing regimen depends on the indication, age group, and renal function.
Patients should be instructed not to push the tablet through the foil. The foil should be peeled from the blister by bending up and lifting the peel tab around the blister seal.
Partial Onset Seizures
Adults and Pediatric Patients 4 Years and Older Weighing Over 40 kg:
Initiate Querta with a daily dose of 1000 mg, given as twice daily dosing (500 mg twice daily). The daily dose may be increased every 2 weeks by increments of 1000 mg (500 mg twice daily) to a maximum recommended daily dose of 3000 mg (1500 mg twice daily). There is no evidence that doses greater than 3000 mg/day confer additional benefit.
Pediatric Patients 4 years and Older Weighing 20 kg to 40 kg:
Initiate Querta with a daily dose of 500 mg, given as twice daily dosing (250 mg twice daily). Increase the daily dose every 2 weeks by increments of 500 mg (250 mg twice daily) to a maximum recommended daily dose of 1500 mg (750 mg twice daily).
Myoclonic Seizures in Patients 12 Years of Age and Older with Juvenile Myoclonic Epilepsy
Initiate Querta with a dose of 1000 mg/day, given as twice daily dosing (500 mg twice daily). Increase the dosage by 1000 mg/day (500 mg twice daily) every 2 weeks to the recommended daily dose of 3000 mg (1500 mg twice daily). The effectiveness of doses lower than 3000 mg/day has not been studied.
Primary Generalized Tonic-Clonic Seizures in Patients 6 Years of Age and Older
Adults and Pediatric Patients 6 Years and Older Weighing Over 40 kg:
Initiate Querta with a daily dose of 1000 mg, given as twice daily dosing (500 mg twice daily). Increase the dosage by 1000 mg/day (500 mg twice daily) every 2 weeks to the recommended daily dose of 3000 mg (1500 mg twice daily). The effectiveness of doses lower than 3000 mg/day has not been adequately studied.
Pediatric Patients 6 years and Older Weighing 20 kg to 40 kg:
Initiate Querta with a daily dose of 500 mg, given as twice daily dosing (250 mg twice daily). Increase the daily dose every 2 weeks by increments of 500 mg (250 mg twice daily) to a maximum recommended daily dose of 1500 mg (750 mg twice daily).
Dosage Adjustments in Adult Patients with Renal Impairment
Querta dosing must be individualized according to the patient's renal function status. Recommended dosage adjustments for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient's creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:
Then CLcr is adjusted for body surface area (BSA) as follows:
See also:
What other drugs will affect Querta?
In vitro data on metabolic interactions indicate that Querta is unlikely to produce, or be subject to, pharmacokinetic interactions. Querta and its major metabolite, at concentrations well above Cmax levels achieved within the therapeutic dose range, are neither inhibitors of nor high affinity substrates for human liver CYP450 isoforms, epoxide hydrolase or UDP-glucuronidation enzymes. In addition, Querta does not affect the in vitro glucuronidation of valproic acid.
Querta circulates largely unbound (<10% bound) to plasma proteins; clinically significant interactions with other drugs through competition for protein-binding sites are therefore unlikely.
Potential pharmacokinetic interactions were assessed in clinical pharmacokinetic studies (phenytoin, valproate, oral contraceptive, digoxin, warfarin, probenecid) and through pharmacokinetic screening in the placebo-controlled clinical studies in epilepsy patients.
Drug-Drug Interactions Between Querta and Other AEDs: Phenytoin: Querta (3000 mg daily) had no effect on the pharmacokinetic disposition of phenytoin in patients with refractory epilepsy. Pharmacokinetics of Querta were also not affected by phenytoin.
Valproate: Querta (1500 mg twice daily) did not alter the pharmacokinetics of valproate in healthy volunteers. Valproate 500 mg twice daily did not modify the rate or extent of Querta absorption or its plasma clearance or urinary excretion. There also was no effect on exposure to and the excretion of the primary metabolite, ucb L057.
Potential drug interactions between Querta and other AEDs (carbamazepine, gabapentin, lamotrigine, phenobarbital, phenytoin, primidone and valproate) were also assessed by evaluating the serum concentrations of Querta and these AEDs during placebo-controlled clinical studies. These data indicate that Querta does not influence the plasma concentration of other AEDs and that these AEDs do not influence the pharmacokinetics of Querta.
Effect of AEDs in Pediatric Patients: There was about a 22% increase of apparent total body clearance of Querta when it was co-administered with enzyme-inducing AEDs. Dose adjustment is not recommended. Querta had no effect on plasma concentrations of carbamazepine, valproate, topiramate, or lamotrigine.
Other Drug Interactions:
Oral Contraceptives: Querta (500 mg twice daily) did not influence the pharmacokinetics of an oral contraceptive containing 0.03 mg ethinyl estradiol and 0.15 mg levonorgestrel, or of the luteinizing hormone and progesterone levels, indicating that impairment of contraceptive efficacy is unlikely. Co-administration of this oral contraceptive did not influence the pharmacokinetics of Querta.Digoxin: Querta (1000 mg twice daily) did not influence the pharmacokinetics and pharmacodynamics (ECG) of digoxin given as a 0.25 mg dose every day. Co-administration of digoxin did not influence the pharmacokinetics of Querta.
Warfarin: Querta (1000 mg twice daily) did not influence the pharmacokinetics of R and S warfarin. Prothrombin time was not affected by Querta. Co-administration of warfarin did not affect the pharmacokinetics of Querta.
Probenecid: Probenecid, a renal tubular secreation blocking agent, adminitered at a dose of 500 mg 4 times a day, did not change the pharmacokinetics of Querta 1000 mg twice daily. Cmax ss of the metabolite, ucb L057, was approximately doubled in the presence of probenecid while the fraction of drug excreted unchanged in the urine remained the same. Renal clearance of ucb L057 in the presence of probenecid decreased 60%, probably related to competitive inhibition of tubular secretion of ucb L057. The effect of Querta on probenecid was not studied.
