Unloxcyt Dosage
Generic name: cosibelimab 300mg in 5mL
Dosage form: injection, solution
Drug class: Anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint inhibitors)
Medically reviewed by Drugs.com. Last updated on Dec 18, 2024.
Recommended Dosage
The recommended dosage of UNLOXCYT is 1,200 mg administered as an intravenous infusion over 60 minutes every 3 weeks until disease progression or unacceptable toxicity.
Dose Modifications for Adverse Reactions
No dose reductions of UNLOXCYT are recommended. In general, withhold UNLOXCYT for severe (Grade 3) immune-mediated adverse reactions. Permanently discontinue UNLOXCYT for life-threatening (Grade 4) immune-mediated adverse reactions, recurrent severe (Grade 3) immune-mediated reactions that require systemic immunosuppressive treatment, or an inability to reduce corticosteroid dose to a prednisone equivalent of 10 mg or less per day within 12 weeks of initiating steroids.
Dosage modifications for UNLOXCYT for adverse reactions that require management different from these general guidelines are summarized in Table 1.
| Adverse Reaction | Severity* | UNLOXCYT Dosage Modifications |
|---|---|---|
| ALT = alanine aminotransferase; AST = aspartate aminotransferase; DRESS: drug rash with eosinophilia and systemic symptoms; SJS: Stevens-Johnson Syndrome; TEN: toxic epidermal necrolysis; ULN: upper limit of normal. | ||
|
||
| Immune-Mediated Adverse Reactions | ||
| Pneumonitis | Grade 2 | Withhold† |
| Grade 3 or 4 | Permanently discontinue | |
| Colitis | Grade 2 or 3 | Withhold† |
| Grade 4 | Permanently discontinue | |
| Hepatitis with no tumor involvement of the liver | AST or ALT increases to more than 3 and up to 8 times ULN or Total bilirubin increases to more than 1.5 and up to 3 times ULN |
Withhold† |
| AST or ALT increases to more than 8 times ULN or Total bilirubin increases to more than 3 times ULN |
Permanently discontinue | |
| Hepatitis with tumor involvement of the liver‡ | Baseline AST or ALT is more than 1 and up to 3 times ULN and increases to more than 5 and up to 10 times ULN or Baseline AST or ALT is more than 3 and up to 5 times ULN and increases to more than 8 and up to 10 times ULN |
Withhold† |
| AST or ALT increases to more than 10 times ULN or Total bilirubin increases to more than 3 times ULN |
Permanently discontinue | |
| Endocrinopathies§ | Grade 3 or 4 | Withhold until clinically stable or permanently discontinue, depending on severity† |
| Nephritis with renal dysfunction | Grade 2 or 3 increased blood creatinine | Withhold† |
| Grade 4 increased blood creatinine | Permanently discontinue | |
| Exfoliative dermatologic conditions | Suspected SJS, TEN, or DRESS | Withhold† |
| Confirmed SJS, TEN, or DRESS | Permanently discontinue | |
| Myocarditis | Grade 2, 3 or 4 | Permanently discontinue |
| Neurological toxicities | Grade 2 | Withhold† |
| Grade 3 or 4 | Permanently discontinue | |
| Other Adverse Reactions | ||
| Infusion-related reactions | Grade 1 or 2 | Interrupt or slow the rate of infusion |
| Grade 3 or 4 | Permanently discontinue | |
Preparation and Administration
Visually inspect the vial for particulate matter and discoloration. UNLOXCYT is clear to opalescent, colorless to yellow or slightly brown. Discard the vial if visible particles are observed.
Do not shake the vial.
Preparation for Intravenous Infusion:
- Add 20 mL (1,200 mg) of UNLOXCYT to a 250 mL intravenous infusion bag containing 0.9% Sodium Chloride Injection. UNLOXCYT is compatible with an infusion bag made of polyolefin or polyvinyl chloride.
- Mix diluted solution by gentle inversion. Do not shake.
- Discard any unused portion left in the vial.
Storage of Infusion Solution:
The prepared infusion solution may be stored either:
- At room temperature up to 25°C (77°F) for no more than 24 hours from the time of preparation until the end of infusion.
- Under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 24 hours from time of preparation until end of infusion. If refrigerated, allow the diluted solution to come to room temperature prior to administration.
- Discard after 24 hours.
- Do not freeze.
Administration:
- Visually inspect the infusion bag for particulate matter and discoloration prior to administration. Discard if the solution is discolored or contains particulate matter.
- Administer by intravenous infusion over 60 minutes through an intravenous line containing a sterile, in-line or add-on of 0.2-micron to 0.22-micron filter.
- Do not administer UNLOXCYT as an intravenous push or bolus injection.
- Do not co-administer other drugs through the same infusion line.
More about Unloxcyt (cosibelimab)
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- FDA approval history
- Drug class: anti-PD-1 and PD-L1 monoclonal antibodies (immune checkpoint inhibitors)
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