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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.

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.

Table 1:     Recommended Dose Modifications for OPDIVO

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 an infusion with 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 4 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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