Lybalvi Is NOT Available as an Injection
Lybalvi (olanzapine/samidorphan) is only available as an oral tablet formulation and is not manufactured or approved in any injectable form. 1
Formulation Details
According to the FDA drug label, LYBALVI is intended for oral administration only and is available as film-coated, bilayer tablets in four strengths 1:
- 5 mg/10 mg (olanzapine/samidorphan)
- 10 mg/10 mg
- 15 mg/10 mg
- 20 mg/10 mg
The tablets contain olanzapine (the antipsychotic component) combined with a fixed 10 mg dose of samidorphan (an opioid antagonist designed to mitigate olanzapine-associated weight gain) 1.
Important Clinical Distinction
While olanzapine alone is available in long-acting injectable (LAI) formulations, the combination product Lybalvi exists only in oral form. If you need an injectable antipsychotic option:
- Consider standard olanzapine LAI if injectable administration is required
- However, you will lose the weight-mitigation benefit of samidorphan
- The guideline evidence suggests LAI formulations remain underutilized despite benefits for medication adherence 2
Key Caveat for Prescribing
Do not prescribe Lybalvi to patients currently using opioids - the samidorphan component is an opioid antagonist that can precipitate severe opioid withdrawal requiring hospitalization and potentially intubation 3, 4. This withdrawal typically lasts about 24 hours and has been reported in patients on buprenorphine and methadone 3.