Opdivo Dosage
Generic name: NIVOLUMAB 10mg in 1mL
Dosage form: injection
Medically reviewed on August 16, 2018.
Recommended Dosage for Unresectable or Metastatic Melanoma
Single Agent
The recommended dose of OPDIVO as a single agent is either:
- •
- 240 mg every 2 weeks or
- •
- 480 mg every 4 weeks
administered as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity.
With Ipilimumab
The recommended dose of OPDIVO is 1 mg/kg administered as an intravenous infusion over 30 minutes, followed by ipilimumab 3 mg/kg administered as an intravenous infusion over 90 minutes on the same day, every 3 weeks for a maximum of 4 doses or until unacceptable toxicity, whichever occurs earlier. After completing 4 doses of the combination, administer OPDIVO as a single agent, either:
- •
- 240 mg every 2 weeks or
- •
- 480 mg every 4 weeks
as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity. Review the Prescribing Information for ipilimumab for additional information prior to initiation.
Recommended Dosage for Adjuvant Treatment of Melanoma
The recommended dose of OPDIVO is either:
- •
- 240 mg every 2 weeks or
- •
- 480 mg every 4 weeks
administered as an intravenous infusion over 30 minutes until disease recurrence or unacceptable toxicity for up to 1 year.
Recommended Dosage for NSCLC
The recommended dose of OPDIVO is either:
- •
- 240 mg every 2 weeks or
- •
- 480 mg every 4 weeks
administered as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity.
Recommended Dosage for SCLC
The recommended dose of OPDIVO is:
- •
- 240 mg administered as an intravenous infusion over 30 minutes every 2 weeks
until disease progression or unacceptable toxicity.
Recommended Dosage for RCC
Single Agent
The recommended dose of OPDIVO as a single agent is either:
- •
- 240 mg every 2 weeks or
- •
- 480 mg every 4 weeks
administered as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity.
With Ipilimumab
The recommended dose of OPDIVO is 3 mg/kg administered as an intravenous infusion over 30 minutes, followed by ipilimumab 1 mg/kg administered as an intravenous infusion over 30 minutes on the same day, every 3 weeks for 4 doses [see Clinical Studies (14.5)]. After completing 4 doses of the combination, administer OPDIVO as a single agent, either:
- •
- 240 mg every 2 weeks, or
- •
- 480 mg every 4 weeks
as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity. Review the Prescribing Information for ipilimumab prior to initiation.
Recommended Dosage for cHL
The recommended dose of OPDIVO is either:
- •
- 240 mg every 2 weeks or
- •
- 480 mg every 4 weeks
administered as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity.
Recommended Dosage for SCCHN
The recommended dose of OPDIVO is either:
- •
- 240 mg every 2 weeks or
- •
- 480 mg every 4 weeks
administered as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity.
Recommended Dosage for Urothelial Carcinoma
The recommended dose of OPDIVO is either:
- •
- 240 mg every 2 weeks or
- •
- 480 mg every 4 weeks
administered as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity.
Recommended Dosage for MSI-H/dMMR CRC
Single Agent
The recommended dose of OPDIVO as a single agent is 240 mg every 2 weeks administered as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity.
With Ipilimumab
The recommended dose of OPDIVO is 3 mg/kg administered as an intravenous infusion over 30 minutes, followed by ipilimumab 1 mg/kg administered as an intravenous infusion over 30 minutes on the same day, every 3 weeks for 4 doses [see Clinical Studies (14.9)]. After completing 4 doses of the combination, administer OPDIVO 240 mg as a single agent every 2 weeks as an intravenous infusion over 30 minutes until disease progression or unacceptable toxicity.
Review the Prescribing Information for ipilimumab prior to initiation.
Recommended Dosage for HCC
The recommended dose of OPDIVO is either:
- •
- 240 mg every 2 weeks or
- •
- 480 mg every 4 weeks
administered as an intravenous infusion over 30 minutes 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. Review the Prescribing Information for ipilimumab for recommended dose modifications.
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.
| * 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 improves to Grade 0 or 1. b HCC: hepatocellular carcinoma. c Resume treatment when AST/ALT returns to baseline. |
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|
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/non-HCCb |
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 3 and up to 5 times the upper limit of normal (ULN) or total bilirubin more than 1.5 and up to 3 times the ULN |
Withhold dosea |
|
AST or ALT more than 5 times the ULN or total bilirubin more than 3 times the ULN |
Permanently discontinue |
|
|
Hepatitis/HCCb |
|
Withhold dosec |
|
If AST or ALT increases to more than 10 times the ULN or total bilirubin increases to more than 3 times the ULN |
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 ULN |
Withhold dosea |
|
Serum creatinine more than 6 times the ULN |
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 |
|
|
Life-threatening or Grade 4 adverse reaction |
Permanently discontinue |
|
|
Grade 3 myocarditis |
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 |
|
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 an infusion with a final concentration ranging from 1 mg/mL to 10 mg/mL. The total volume of infusion must not exceed 160 mL.
- •
- For adult and pediatric patients with body weights less than 40 kg, the total volume of infusion must not exceed 4 mL/kg of body weight.
- •
- 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 30 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.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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