Medical uses:

Lybalvi is a combination of olanzapine (an atypical antipsychotic) and samidorphan (an opioid antagonist) used for treating:

• Schizophrenia in adults
• Manic or mixed episodes associated with Bipolar I disorder in adults, either as a standalone treatment for acute or maintenance therapy, or in combination with lithium or valproate.

Recommended Dosage:

• Administration: Take Lybalvi tablets orally once a day, with or without food, as a single tablet. Do not split or combine tablets.

Dosage for Schizophrenia:

• Initial Treatment: Start with 5 mg/10 mg (5 mg of olanzapine and 10 mg of samidorphan) or 10 mg/10 mg (10 mg of olanzapine and 10 mg of samidorphan) once daily.
• Maintenance Dosage: The recommended dosage is 10 mg/10 mg, 15 mg/10 mg (15 mg of olanzapine and 10 mg of samidorphan), or 20 mg/10 mg (20 mg of olanzapine and 10 mg of samidorphan) once daily. Adjust the dosage in 5 mg increments (based on the olanzapine component) weekly, depending on clinical response and tolerability, up to a maximum of 20 mg/10 mg daily.

Dosage for Bipolar I Disorder (Manic or Mixed Episodes):

• Monotherapy:
  • Initial Treatment: Start with 10 mg/10 mg or 15 mg/10 mg once daily.
  • Maintenance Dosage: The recommended dosage is 10 mg/10 mg, 15 mg/10 mg, or 20 mg/10 mg once daily. The maximum recommended dosage is 20 mg/10 mg once daily. Adjust the dosage at intervals of at least 24 hours, with increments or decrements of 5 mg (based on the olanzapine component) as needed.
• Maintenance Monotherapy: Administer Lybalvi at 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg, or 20 mg/10 mg once daily.
• In combination with lithium or valproate: Begin treatment with Lybalvi (Olanzapine/Samidorphan) at a dose of 10 mg/10 mg once daily. The recommended dosage ranges from 10 mg/10 mg to 15 mg/10 mg or 20 mg/10 mg once daily. Adjust the dosage in 5 mg increments (based on the olanzapine component) weekly, depending on clinical response and tolerability, up to a maximum of 20 mg/10 mg once daily.

Warnings & Precautions:

The use of Olanzapine/Samidorphan tablets is not recommended for individuals currently using opioids or undergoing acute opioid withdrawal. For those who use opioids, it is advised to delay the initiation of treatment for at least one week after the last use of short-acting opioids and two weeks after the last use of long-acting opioids.

Cerebrovascular side effects, such as transient ischemic attacks and strokes, including fatalities, have been observed in trials of Olanzapine in elderly patients with dementia-related psychosis. This medication is not authorized for treating patients with dementia-related psychosis.

Patients with a history of chronic opioid use before starting treatment with Lybalvi may experience reduced opioid tolerance if Lybalvi treatment is interrupted or discontinued. It is important to inform patients that this reduced tolerance may lower the risk of opioid overdose if opioids are resumed at previously tolerated dosages.

Neuroleptic Malignant Syndrome (NMS), a potentially fatal condition, may occur with the use of antipsychotic medications. Symptoms of NMS include muscle rigidity, delirium, hyperpyrexia, and autonomic instability. If NMS is suspected, discontinue treatment immediately and provide intensive symptomatic therapy and monitoring.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) may occur with exposure to olanzapine. DRESS can present with skin reactions such as exfoliative dermatitis or rash, fever, eosinophilia, or lymphadenopathy, along with systemic complications like nephritis, hepatitis, myocarditis, pneumonitis, or pericarditis. Discontinue treatment if DRESS is suspected.

Atypical antipsychotic medications, including Lybalvi, have been associated with metabolic changes such as hyperglycemia, weight gain, diabetes mellitus, and dyslipidemia. Patients starting treatment with Lybalvi should have their fasting lipid profile tested at the beginning of treatment and periodically thereafter. Monitor weight before initiating treatment.

Atypical antipsychotic medications, such as Lybalvi (available in 5 mg/10 mg, 10 mg/10 mg, and 15 mg/10 mg tablets), can lead to orthostatic hypotension and syncope. The risk is typically higher during the initial dose titration and when increasing the dose. It’s important to monitor orthostatic vital signs and symptoms in patients who are susceptible to hypotension.

Tardive dyskinesia, a potential side effect of antipsychotic drugs, may also occur in patients treated with Lybalvi. If symptoms of tardive dyskinesia appear, discontinuing Lybalvi is recommended. However, some patients might need to continue treatment with Lybalvi despite the presence of this syndrome.

Additionally, neutropenia and leukopenia have been observed in patients undergoing treatment with antipsychotic agents, including Lybalvi. For those with clinically significant neutropenia, monitoring for fever or other signs of infection is crucial, and prompt treatment should be administered if such symptoms arise.

Documentation & Availability :

Documents  required to import LYBALVI  to India? 

LYBALVI (olanzapine/samidorphan) tablets can be imported by patients or treating physicians on behalf of patients. The following documentation is required to import the product:

• 2 ID proofs along with PAN card details along with attested scanned copies
• Valid doctor prescription scanned copy
• Doctor’s MCI number
• Doctor’s mobile number
• Patients diagnostic reports

How is the order confirmed? 

The order will be confirmed only after the receipt of:

• The above-mentioned documents and drug availability.
• Import permit if applicable.

Sourcing & Delivery:

The Rx4U team has extensive experience in sourcing  LYBALVI   from around the world, ensuring global access to the best available treatments for our customers. We are dedicated to promptly dispensing any valid prescription. All prescriptions are verified and dispatched directly to the patient’s address. Our patients are our top priority, and we strive to improve their lives through our services.

 FAQ:

What is the Generic Name for the trade name drug Lybalvi®?

Olanzapine/Samidorphan is a Generic Name for the trade name drug Lybalvi®.

What is the Manufacturer Name of Lybalvi®?

Lybalvi® is manufactured by Alkermes Inc.

Is Lybalvi® approved by the FDA?

Yes, Lybalvi® is approved by the FDA. Date of first/initial approval: May 28, 2021.

What is the dosage and form of Lybalvi® supplied?

Lybalvi® is supplied as Tablets (olanzapine/samidorphan): 5 mg/10 mg, 10 mg/10 mg, 15 mg/10 mg and 20 mg/10 mg for oral administration. 

Where can I get Lybalvi® Tablets at the best price in India?

To get the best Lybalvi tablets price in India, kindly reach out to Rx4u team.

What are the most common side effects of Lybalvi®? 

Schizophrenia (Lybalvi): most common side effects are somnolence, weight increased, dry mouth, and headache.

Bipolar I Disorder, Manic or Mixed Episodes (olanzapine): most common side effects are asthenia, dry mouth, somnolence, dizziness, constipation, increased appetite, and tremor.

Bipolar I Disorder, Manic or Mixed Episodes, adjunct to Lithium or Valproate (olanzapine): most common side effects are dyspepsia, weight gain, dry mouth, increased appetite, dizziness, constipation, back pain, increased salivation, amnesia, speech disorder, paresthesia.

How much does Lybalvi® cost in India?

The medicine Lybalvi cost in India is less and can vary. In order to buy/procure this medicine, please order at https://rx4u.in/

What are the storage conditions of Lybalvi®?

Store at 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C and 30°C (59°F and 86°F). Store in the original bottle with desiccant. Keep the bottle properly closed and protect it from moisture.

Is it safe to buy Lybalvi® tablets online from India?

Yes, you can buy Lybalvi tablets online at the best price at https://rx4u.in/

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