Opdivo Dosage
Generic name: NIVOLUMAB 10mg in 1mL
Dosage form: injection
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Recommended Dosage for Melanoma
The recommended dose of OPDIVO as a single agent is 240 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.
The recommended dose of OPDIVO is 1 mg/kg administered as an intravenous infusion over 60 minutes, followed by ipilimumab on the same day, every 3 weeks for 4 doses [see Clinical Studies (14.1)]. The recommended subsequent dose of OPDIVO, as a single agent, is 240 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity. Review the Full Prescribing Information for ipilimumab prior to initiation.
Recommended Dosage for NSCLC
The recommended dose of OPDIVO is 240 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.
Recommended Dosage for RCC
The recommended dose of OPDIVO is 240 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.
Recommended Dosage for cHL
The recommended dose of OPDIVO is 3 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.
Recommended Dosage for SCCHN
The recommended dose of OPDIVO is 3 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.
Recommended Dosage for Urothelial Carcinoma
The recommended dose of OPDIVO is 240 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.
Dose Modifications
Recommendations for OPDIVO modifications are provided in Table 1. When OPDIVO is administered in combination with ipilimumab, if OPDIVO is withheld, ipilimumab should also be withheld.
There are no recommended dose modifications for hypothyroidism or hyperthyroidism.
Interrupt or slow the rate of infusion in patients with mild or moderate infusion reactions. Discontinue OPDIVO in patients with severe or life-threatening infusion reactions.
|
Adverse Reaction |
Severity* |
Dose Modification |
|
Colitis |
Grade 2 diarrhea or colitis |
Withhold dosea |
|
Grade 3 diarrhea or colitis |
Withhold dosea when administered as a single agent |
|
|
Permanently discontinue when administered with ipilimumab |
||
|
Grade 4 diarrhea or colitis |
Permanently discontinue |
|
|
Pneumonitis |
Grade 2 pneumonitis |
Withhold dosea |
|
Grade 3 or 4 pneumonitis |
Permanently discontinue |
|
|
Hepatitis |
Aspartate aminotransferase (AST)/or alanine aminotransferase (ALT) more than 3 and up to 5 times the upper limit of normal or total bilirubin more than 1.5 and up to 3 times the upper limit of normal |
Withhold dosea |
|
AST or ALT more than 5 times the upper limit of normal or total bilirubin more than 3 times the upper limit of normal |
Permanently discontinue |
|
|
Hypophysitis |
Grade 2 or 3 hypophysitis |
Withhold dosea |
|
Grade 4 hypophysitis |
Permanently discontinue |
|
|
Adrenal Insufficiency |
Grade 2 adrenal insufficiency |
Withhold dosea |
|
Grade 3 or 4 adrenal insufficiency |
Permanently discontinue |
|
|
Type 1 Diabetes Mellitus |
Grade 3 hyperglycemia |
Withhold dosea |
|
Grade 4 hyperglycemia |
Permanently discontinue |
|
|
Nephritis and Renal Dysfunction |
Serum creatinine more than 1.5 and up to 6 times the upper limit of normal |
Withhold dosea |
|
Serum creatinine more than 6 times the upper limit of normal |
Permanently discontinue |
|
|
Skin |
Grade 3 rash or suspected Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) |
Withhold dosea |
|
Grade 4 rash or confirmed SJS or TEN |
Permanently discontinue |
|
|
Encephalitis |
New-onset moderate or severe neurologic signs or symptoms |
Withhold dosea |
|
Immune-mediated encephalitis |
Permanently discontinue |
|
|
Other |
Other Grade 3 adverse reaction |
|
|
First occurrence |
Withhold dosea |
|
|
Recurrence of same Grade 3 adverse reactions |
Permanently discontinue |
|
|
Life-threatening or Grade 4 adverse reaction |
Permanently discontinue |
|
|
Requirement for 10 mg per day or greater prednisone or equivalent for more than 12 weeks |
Permanently discontinue |
|
|
Persistent Grade 2 or 3 adverse reactions lasting 12 weeks or longer |
Permanently discontinue |
*Toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events. Version 4.0 (NCI CTCAE v4).
a Resume treatment when adverse reaction returns to Grade 0 or 1.
Preparation and Administration
Visually inspect drug product solution for particulate matter and discoloration prior to administration. OPDIVO is a clear to opalescent, colorless to pale-yellow solution. Discard the vial if the solution is cloudy, discolored, or contains extraneous particulate matter other than a few translucent-to-white, proteinaceous particles. Do not shake the vial.
Preparation
- •
- Withdraw the required volume of OPDIVO and transfer into an intravenous container.
- •
- Dilute OPDIVO with either 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP to prepare a final concentration ranging from 1 mg/mL to 10 mg/mL.
- •
- Mix diluted solution by gentle inversion. Do not shake.
- •
- Discard partially used vials or empty vials of OPDIVO.
Storage of Infusion
The product does not contain a preservative.
After preparation, store the OPDIVO infusion either:
- •
- at room temperature for no more than 8 hours from the time of preparation. This includes room temperature storage of the infusion in the IV container and time for administration of the infusion or
- •
- under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 24 hours from the time of infusion preparation.
Do not freeze.
Administration
Administer the infusion over 60 minutes through an intravenous line containing a sterile, non-pyrogenic, low protein binding in-line filter (pore size of 0.2 micrometer to 1.2 micrometer).
Do not coadminister other drugs through the same intravenous line.
Flush the intravenous line at end of infusion.
When administered in combination with ipilimumab, infuse OPDIVO first followed by ipilimumab on the same day. Use separate infusion bags and filters for each infusion.
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