Is Lybalvi approved by the FDA?
Lybalvi, a combination of olanzapine and samidorphan, is an antipsychotic medication designed to treat specific mental health conditions in adults. Lybalvi was approved by the U.S. Food and Drug Administration (FDA) on May 28, 2021. This approval is significant as it combines olanzapine, an established antipsychotic, with samidorphan, which helps mitigate some of the weight gain and metabolic side effects associated with olanzapine.
Indications and Usage
Lybalvi is specifically indicated for:
- The treatment of schizophrenia in adults.
- The treatment of manic or mixed episodes associated with bipolar I disorder in adults, both as monotherapy and as an adjunct to lithium or valproate.
Administration
Lybalvi is available in oral tablet form in various strengths:
- 5 mg olanzapine / 10 mg samidorphan
- 10 mg olanzapine / 10 mg samidorphan
- 15 mg olanzapine / 10 mg samidorphan
- 20 mg olanzapine / 10 mg samidorphan
The medication can be taken with or without food. It is important to swallow the tablet whole and not to crush, chew, or break it.
Side Effects and Warnings
Common side effects of Lybalvi include:
- Increased appetite and weight gain
- Dizziness and drowsiness
- Problems with speech or memory
- Tremor, numbness, tingling, or burning pain
- Headache
- Dry mouth, upset stomach, or constipation
- Back pain
- Increased salivation
Serious side effects may include:
- Severe nervous system reactions such as very stiff muscles, high fever, sweating, confusion, and fast or uneven heartbeats
- Uncontrolled muscle movements
- High blood sugar levels
- Symptoms of stroke
- Serious allergic reactions
Long-term use can also lead to a serious movement disorder that may be irreversible. Samidorphan can enhance sensitivity to opioid medications, potentially leading to fatal overdose if opioids are used concurrently.
Precautions
Before taking Lybalvi, patients should inform their healthcare provider if they have a history of:
- Heart problems or stroke
- High or low blood pressure
- Low white blood cell counts
- Diabetes or high blood sugar
- High cholesterol or triglycerides
- Seizures
- Enlarged prostate or urination problems
- Breast cancer
- Drug addiction
- Constipation or bowel obstruction
- Kidney disease
Patients should also avoid alcohol and activities that can lead to overheating or dehydration while on Lybalvi.
How to obtain the latest development progress of all drugs?
In the Synapse database, you can stay updated on the latest research and development advances of all drugs. This service is accessible anytime and anywhere, with updates available daily or weekly. Use the "Set Alert" function to stay informed. Click on the image below to embark on a brand new journey of drug discovery!
