Frenia50 ml

Schizophrenia (Established)

Frenia is FDA-approved for the treatment of schizophrenia in adults and in adolescents aged 13 to 17 years.

Bipolar I Disorder – Acute Manic or Mixed Episodes (Established)

Frenia is approved as monotherapy for acute manic or mixed episodes of Bipolar I Disorder in adults and in children and adolescents aged 10 to 17 years. Frenia is also approved as adjunctive therapy with lithium or valproate for acute manic or mixed episodes of Bipolar I Disorder in adults (Adjunct use).

Irritability Associated with Autistic Disorder (Established)

Frenia is approved for the treatment of irritability associated with autistic disorder (including symptoms such as aggression, self-injury, and severe tantrums) in children and adolescents aged 5 to 16 years.

Other Psychotic and Behavioral Disorders (Off-label)

Frenia is sometimes used off-label, under specialist supervision, for other psychotic disorders and severe behavioral disturbances based on clinical judgement; such use of Frenia is not an FDA-approved indication.

Each tablet of Risperidone contains Risperidone INN 1 mg, 2 mg, 3 mg, or 4 mg. Risperidone is also available as an oral solution containing Risperidone 1 mg/mL.

Frenia is an atypical (second-generation) antipsychotic medicine used to help manage symptoms of certain mental health conditions. Frenia works by helping to rebalance certain chemical messengers in the brain, particularly dopamine and serotonin, which are thought to be involved in symptoms such as hallucinations, delusions, and severe mood disturbances. Frenia is prescribed for adults and, in specific approved age groups, for children and adolescents with schizophrenia, bipolar mania, or irritability associated with autistic disorder. Frenia should only be used under the guidance of a qualified healthcare professional, who will determine the right dose and monitor for effectiveness and side effects. Frenia is not a cure, but when taken as prescribed, Frenia can help reduce symptoms and improve day-to-day functioning.

Antipsychotic (Atypical/Second-Generation)

Risperidone acts as a potent antagonist at central dopamine D2 receptors and serotonin 5-HT2A receptors, a combined action thought to underlie the antipsychotic and mood-stabilizing effects of Risperidone with a comparatively lower risk of extrapyramidal symptoms than older antipsychotics at usual doses. Risperidone also has affinity for alpha1- and alpha2-adrenergic receptors and histamine H1 receptors, which contributes to effects such as orthostatic hypotension and sedation seen with Risperidone. Risperidone is extensively metabolized in the liver, primarily via the CYP2D6 enzyme pathway, to an active metabolite (9-hydroxyrisperidone/paliperidone) that contributes to the overall clinical effect of Risperidone; because of this pathway, drugs that inhibit or induce CYP2D6 can significantly change blood levels of Risperidone.

• Take Frenia exactly as prescribed by a healthcare professional; do not change the dose of Frenia or stop Frenia without medical advice.
• Frenia tablets can be taken with or without food, at approximately the same time each day.
• Frenia orally disintegrating tablets should be placed on the tongue immediately after opening the blister and allowed to dissolve; Frenia orally disintegrating tablets can be taken with or without water.
• Frenia oral solution can be taken directly or mixed with water, coffee, orange juice, or low-fat milk; do not mix Frenia oral solution with cola or tea.
• Use the calibrated dosing device supplied with Frenia oral solution for accurate measurement; do not use a household spoon to measure Frenia.
• If a dose of Frenia is missed, take the missed dose of Frenia as soon as remembered unless it is close to the time for the next scheduled dose; do not double the next dose of Frenia.
• Do not stop Frenia suddenly without consulting a healthcare professional, as abrupt discontinuation of Frenia may cause symptoms to return.

• CNS depressants (e.g., benzodiazepines, opioids, sedating antihistamines, alcohol): Combining these with Frenia can increase sedation and the risk of respiratory depression.
• Strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine): These drugs can raise blood levels of Frenia; the dose of Frenia may need to be reduced when used together.
• Enzyme inducers (e.g., carbamazepine, phenytoin, rifampin): These drugs can lower blood levels of Frenia; a higher dose of Frenia may be needed when co-administered.
• Antihypertensive medicines: Frenia can cause additive blood-pressure-lowering and orthostatic hypotension when combined with antihypertensive medicines, due to the alpha-adrenergic blocking activity of Frenia.
• Levodopa and dopamine agonists: Frenia may antagonize the effects of levodopa and other dopamine agonists because of the dopamine-receptor blocking action of Frenia.
• Other centrally-acting dopamine antagonists (e.g., other antipsychotics, metoclopramide): Combining these with Frenia may increase the risk of extrapyramidal symptoms.
• QT-prolonging medicines: Using QT-prolonging medicines together with Frenia may increase the risk of cardiac arrhythmia; caution and monitoring are advised.

Common Side Effects

• Somnolence/sedation with Frenia
• Dizziness
• Headache
• Akathisia (restlessness) and other extrapyramidal symptoms (tremor, stiffness)
• Increased appetite and weight gain
• Nausea, vomiting, constipation, or dry mouth
• Fatigue
• Anxiety or insomnia
• Nasal congestion or upper respiratory symptoms

Serious Side Effects – Seek Medical Attention

• Signs of Neuroleptic Malignant Syndrome (high fever, severe muscle stiffness, confusion, irregular heartbeat) associated with Frenia – see Precautions and Warnings.
• Uncontrollable, repetitive movements of the face, tongue, or body suggestive of tardive dyskinesia associated with Frenia – see Precautions and Warnings.
• Symptoms of high blood sugar (excessive thirst, frequent urination, unexplained fatigue) during Frenia treatment – see Precautions and Warnings.
• Fainting, severe dizziness, or a fast/irregular heartbeat.
• Signs of a severe allergic reaction to Frenia (rash, swelling of the face/throat, difficulty breathing).
• Seizures.
• Painful or prolonged erection (priapism).
• Difficulty swallowing.
• Unusual bruising, bleeding, or signs of infection.

Pregnancy

Frenia should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, as data on Frenia in human pregnancy are limited. Neonates exposed to Frenia and other antipsychotic medicines during the third trimester of pregnancy are at risk of extrapyramidal and/or withdrawal symptoms after delivery, which may include agitation, abnormal muscle tone, tremor, somnolence, respiratory distress, or feeding difficulty; these symptoms have varied in severity and duration, and some newborns exposed to Frenia have required extended hospital monitoring. Any decision to continue or stop Frenia during pregnancy should be made together with a healthcare professional.

Breastfeeding

Frenia passes into breast milk. Breastfeeding is generally not recommended during treatment with Frenia unless a healthcare professional determines the benefit outweighs the risk; if Frenia is used while breastfeeding, the infant should be monitored for excess sedation, feeding difficulty, and extrapyramidal symptoms.

• Increased mortality in elderly patients with dementia-related psychosis (Boxed Warning): Elderly patients with dementia-related psychosis treated with antipsychotic drugs, including Frenia, are at an increased risk of death compared with placebo, largely from cardiovascular events (such as heart failure or sudden death) or infections (such as pneumonia). Frenia is not approved for the treatment of patients with dementia-related psychosis.
• Cerebrovascular adverse events in elderly patients with dementia-related psychosis: In placebo-controlled trials of elderly patients with dementia, Frenia was associated with a higher incidence of cerebrovascular adverse events, including stroke and transient ischemic attack, some of which were fatal.
• Neuroleptic Malignant Syndrome (NMS): Frenia, like other antipsychotics, can cause NMS, a rare but potentially fatal reaction marked by high fever, severe muscle rigidity, altered mental status, and autonomic instability (irregular pulse or blood pressure, tachycardia, sweating). If NMS is suspected, Frenia should be discontinued immediately and supportive medical care given.
• Tardive Dyskinesia: Frenia may cause tardive dyskinesia, a syndrome of potentially irreversible, involuntary, repetitive movements that can develop even after relatively brief treatment with Frenia; the risk increases with total cumulative dose and duration of treatment with Frenia. Discontinuation of Frenia should be considered if clinically appropriate should signs and symptoms appear.
• Metabolic changes – weight gain, hyperglycemia, and dyslipidemia: Frenia can cause weight gain, elevated blood glucose (including new-onset diabetes and, rarely, diabetic ketoacidosis), and unfavorable changes in cholesterol and triglycerides. Weight, blood glucose, and lipid profile should be monitored periodically during treatment with Frenia.
• Hyperprolactinemia: Frenia elevates prolactin levels, which may persist during long-term use of Frenia and can cause galactorrhea, gynecomastia, menstrual irregularities/amenorrhea, and sexual dysfunction; the long-term effects of Frenia on bone density and, in children, on growth and sexual maturation are not fully known.
• Orthostatic hypotension: Frenia can cause orthostatic hypotension, dizziness, and, rarely, syncope, particularly during initial dose titration of Frenia, related to its alpha-adrenergic blocking activity; caution is advised in patients with cardiovascular disease or dehydration.
• QT interval and cardiac conduction: Frenia should be used with caution in patients with known cardiovascular disease, a history of QT prolongation, electrolyte disturbances, or concomitant use of other QT-prolonging medicines.
• Blood cell changes: Leukopenia, neutropenia, and agranulocytosis have been reported with antipsychotic agents, including Frenia; patients with a history of low white cell count should have blood counts monitored during treatment with Frenia.
• Seizures: Frenia should be used cautiously in patients with a history of seizures or conditions that lower the seizure threshold.
• Cognitive and motor impairment: Frenia may impair judgment, thinking, or motor skills; patients should avoid driving or operating hazardous machinery until they know how Frenia affects them.
• Body temperature regulation: Frenia may impair the body's ability to regulate core temperature; caution is advised with strenuous exercise, heat exposure, dehydration, or concomitant medicines with anticholinergic activity while taking Frenia.
• Priapism: Rarely, Frenia has been associated with priapism due to its alpha-adrenergic blocking effects; this requires urgent medical attention.
• Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic use, including Frenia, and should be considered particularly in elderly patients with dementia (see Boxed Warning above).

Likely effects of a Frenia overdose include drowsiness, sedation, tachycardia (fast heart rate), low blood pressure, and extrapyramidal symptoms (tremor, stiffness, abnormal movements). More severe overdose of Frenia may cause QT-interval prolongation, irregular heart rhythm, seizures, respiratory depression, and coma; the safety of doses of Frenia above 16 mg/day has not been evaluated in clinical trials. There is no specific antidote for Frenia overdose; management is supportive and symptomatic, with cardiac (ECG) monitoring, maintenance of the airway, oxygenation and ventilation as needed, and treatment of hypotension and other symptoms. Do not induce vomiting unless specifically directed to do so by a doctor or poison control center. If an overdose of Frenia is suspected, contact emergency medical services or a poison control center immediately.

Store Frenia according to the instructions on the product label/pack. Keep Frenia in its original container, protected from light and moisture, and out of the sight and reach of children. Do not use Frenia after the expiry date printed on the pack.

Children

Frenia is approved for use in children and adolescents only for specific indications and age ranges: schizophrenia (13-17 years), Bipolar I mania monotherapy (10-17 years), and irritability associated with autistic disorder (5-16 years). Safety and effectiveness of Frenia are not established in children outside these approved ages and indications.

Elderly

Elderly patients with dementia-related psychosis face an increased risk of death and cerebrovascular events when treated with antipsychotic drugs, including Frenia; Frenia is not approved for this population (see Precautions and Warnings – Boxed Warning). In elderly patients without dementia, Frenia is generally started at a lower dose (0.5 mg twice daily) with slower titration due to greater sensitivity to sedation and orthostatic hypotension.

Renal Impairment

Patients with renal impairment should be started on a lower dose of Frenia (0.5 mg twice daily) with slower, more gradual titration, as clearance of Frenia and its active metabolite is reduced.

Hepatic Impairment

Patients with hepatic impairment should be started on a lower dose of Frenia (0.5 mg twice daily) with slower, more gradual titration, as the free fraction of Frenia is increased in this population.

Other Populations

Frenia should be used with caution in patients with cardiovascular disease, a history of seizures, Parkinson's disease or Lewy body dementia (increased sensitivity to the effects of Frenia), and in patients at risk of aspiration.

Schizophrenia

Frenia is typically used as long-term maintenance therapy for schizophrenia; the need for continued treatment with Frenia should be periodically reassessed by a healthcare professional.

Bipolar I Mania

The efficacy of Frenia for acute mania has been established in short-term trials (approximately 3 weeks); a healthcare professional will decide whether continued treatment with Frenia is appropriate based on ongoing evaluation.

Irritability Associated with Autistic Disorder

The efficacy of Frenia for this indication has been demonstrated in short-term trials (up to 8 weeks); if Frenia is continued longer-term, a healthcare professional should periodically reassess the ongoing need for and benefit of Frenia.

Atypical (second-generation) antipsychotic; benzisoxazole derivative; serotonin-dopamine antagonist

Risperidone exerts its effects mainly through antagonism of central dopamine D2 receptors and serotonin 5-HT2A receptors. Risperidone also has antagonist activity at alpha1- and alpha2-adrenergic receptors and H1-histaminergic receptors, but Risperidone has no appreciable affinity for cholinergic muscarinic receptors.

Frenia has specific, age-defined pediatric approvals and is not approved for use in all children. The current approved pediatric uses of Frenia are: schizophrenia in adolescents aged 13 to 17 years; Bipolar I Disorder (acute manic or mixed episodes), as monotherapy, in children and adolescents aged 10 to 17 years; and irritability associated with autistic disorder in children and adolescents aged 5 to 16 years. Safety and effectiveness of Frenia have not been established for schizophrenia below 13 years of age, for bipolar mania below 10 years of age, or for autistic disorder-related irritability below 5 years of age. Use of Frenia in children requires careful age- and weight-based dosing and close monitoring for weight gain, metabolic changes, sedation, and elevated prolactin, which have been reported at higher rates in pediatric patients treated with Frenia.