What is the dosage of Opdivo?

Opdivo is available in 4 dosages, including 10 mg/ml Injection 10 ml, 10 mg/ml Injection 12 ml, 10 mg/ml Injection 24 ml and 10 mg/ml Injection 4 ml

What does Opdivo treat?

Opdivo treats Urinary Bladder Neoplasms, Non-Small-Cell Lung Carcinoma, Squamous Cell Carcinoma, Kidney Neoplasms, Lymphoma and Melanoma

What is Opdivo made of?

Opdivo contains nivolumab which is a Programmed Death Receptor-1 Blocking Antibody

How is Opdivo administered?

Opdivo is administered as a Injectable

What is Opdivo mechanism of action?

Opdivo mechanism of action is Programmed Death Receptor-1-directed Antibody Interactions

Dosage & Administration Drug label Samples Prior authorization Financial assistance

Patient education

Opdivo

(nivolumab)

10 ML nivolumab 10 MG/ML Injection [Opdivo]12 ML nivolumab 10 MG/ML Injection [Opdivo]

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NO BLACK BOX WARNING

Dosage & administration

* Administer by intravenous infusion after dilution based upon recommended infusion rate for each indication. (2)
* Unresectable or metastatic melanoma
* Adult and pediatric patients weighing 40 kg or greater: 240 mg every 2 weeks or 480 mg every 4 weeks. (2.2)(2.2)
* Pediatric patients weighing less than 40 kg: 3 mg/kg every 2 weeks or 6 mg/kg every 4 weeks. (2.2)
* Adult and pediatric patients weighing 40 kg or greater:1 mg/kg followed by ipilimumab 3 mg/kg on the same day every 3 weeks for 4 doses, then 240 mg every 2 weeks or 480 mg every 4 weeks. (2.2)(2.2)
* Pediatric patients weighing less than 40 kg: 1 mg/kg followed by ipilimumab 3 mg/kg on the same day every 3 weeks for 4 doses, then 3 mg/kg every 2 weeks or 6 mg/kg every 4 weeks. (2.2)

* Adjuvant treatment of melanoma
* Adult and pediatric patients weighing 40 kg or greater: 240 40 mg every 2 weeks or 480 mg every 4 weeks. (2.2)(2.2)
* Pediatric patients weighing less than 40 kg: 3 mg/kg every 2 weeks or 6 mg/kg every 4 weeks. (2.2)

* Neoadjuvant treatment of resectable (tumors ≥4 cm or node positive) non-small cell lung cancer
* 360 mg with platinum-doublet chemotherapy on the same day every 3 weeks for 3 cycles (2.2)

* Metastatic non-small cell lung cancer
* 360 mg every 3 weeks with ipilimumab 1 mg/kg every 6 weeks.
* 360 mg every 3 weeks with ipilimumab 1 mg/kg every 6 weeks and 2 cycles of platinum-doublet chemotherapy.
* 240 mg every 2 weeks or 480 mg every 4 weeks. (2.2)

* Malignant pleural mesothelioma
* 360 mg every 3 weeks with ipilimumab 1 mg/kg every 6 weeks. (2.2)

* Advanced renal cell carcinoma
* 3 mg/kg followed by ipilimumab 1 mg/kg on the same day every 3 weeks for 4 doses, then 240 mg every 2 weeks or 480 mg every 4 weeks. (2.2)
* 240 mg every 2 weeks or 480 mg every 4 weeks administered in combination with cabozantinib 40 mg once daily without food. (2.2)
* 240 mg every 2 weeks or 480 mg every 4 weeks. (2.2)

* Classical Hodgkin lymphoma
* 240 mg every 2 weeks or 480 mg every 4 weeks. (2.2)

* Recurrent or metastatic squamous cell carcinoma of the head and neck
* 240 mg every 2 weeks or 480 mg every 4 weeks. (2.2)

* Adjuvant treatment of urothelial carcinoma
* 240 mg every 2 weeks or 480 mg every 4 weeks. (2.2)

* Locally advanced or metastatic urothelial carcinoma
* 240 mg every 2 weeks or 480 mg every 4 weeks. (2.2)

* Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer
* Adult and pediatric patients weighing 40 kg or greater: 240 mg every 2 weeks or 480 mg every 4 weeks. (2.2)
* Pediatric patients weighing less than 40 kg: 3 mg/kg every 2 weeks. (2.2)
* Adult and pediatric patients weighing 40 kg or greater: 3 mg/kg followed by ipilimumab 1 mg/kg on the same day every 3 weeks for 4 doses, then 240 mg every 2 weeks or 480 mg every 4 weeks. (2.2)

* Hepatocellular carcinoma
* 1 mg/kg followed by ipilimumab 3 mg/kg on the same day every 3 weeks for 4 doses, then 240 mg every 2 weeks or 480 mg every 4 weeks. (2.2)

* Adjuvant treatment of resected esophageal or gastroesophageal cancer
* 240 mg every 2 weeks or 480 mg every 4 weeks for total treatment duration of 1 year.

* Esophageal squamous cell carcinoma
* 240 mg every 2 weeks or 480 mg every 4 weeks in combination with chemotherapy regimen of fluoropyrimidine- and platinum-containing chemotherapy. (2.2)
* 3 mg/kg every 2 weeks or 360 mg every 3 weeks with ipilimumab 1 mg/kg every 6 weeks. (2.2)
* 240 mg every 2 weeks or 480 mg every 4 weeks. (2.2)

* Gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma (GC, GEJC, or EAC)
* 360 mg every 3 weeks with fluoropyrimidine- and platinum-containing chemotherapy every 3 weeks. (2.2)
* 240 mg every 2 weeks with fluoropyrimidine- and platinum-containing chemotherapy every 2 weeks. (2.2)

* See full Prescribing Information for preparation and administration instructions and dosage modifications for adverse reactions.

drug label

Opdivo prescribing information

Have more Opdivo questions?

Submit MSL Request

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Need to report an Opdivo issue?

ONLINE FORMReport adverse event

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samples

Request Opdivo samples

NOT PROVIDED BY BRANDView Online Sample Form

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prior authorization

Opdivo Prior authorization resources

Complete Letter of Medical Necessity

NOT PROVIDED BY BRANDCoverage Authorization Request

Coverage Authorization Appeals

Commercial Claim Denial Appeal/Redetermination Letter

Medically Unlikely Edit (MUE) Appeal Letter

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Benefits investigation

Opdivo Enrollment Form

Opdivo Enrollment Form - Spanish

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Reimbursement help (FRM)

Receive Assistance from an FRM Regarding Reimbursement Information

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financial assistance

Opdivo Financial assistance options

Co-pay savings program

commercial only

Opdivo Enrollment Form

Opdivo Enrollment Form - Spanish

Enroll in Patient Savings Program

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Overview

Reduce patient OOP costs for drug (and occasionally for drug administration/infusion costs or drug-related test costs)

Patient benefit

A portion (or all) of patient OOP (deductible, copay), typically up to monthly and/or annual max

Patient eligibility

Patient must enroll or activate (may permit HCPs to enroll on patient’s behalf for HCP-administered drugs)
Generally, must have commercial insurance (rarely, may permit uninsured patients to use)
May never be used with government insurance

How to sign up

Cards may be downloadable digital cards or hard copies
Some pharmacos offer debit cards with pre-loaded copay benefit
Typically, available through multiple channels (e.g., rep to HCP to patient; pharmacy to patient; patient via website, Hub live agent, or copay vendor (live agent or IVR); patient and HCP via Hub enrollment form)
Some HCP-administered product programs permit HCPs to enroll on a patient’s behalf through via Hub form

Bridge program

commercial only

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Overview

Provide patient immediate access to therapy during an insurance delay (typically new starts; some may cover change in insurance)
Limited time/ fill (typically 7-30 days; some may offer additional fill for continued delay up to certain limit)

Patient benefit

100% free (outside of insurance)

Patient eligibility

HCP must enroll patient
May be limited to commercially insured patients (i.e., no government beneficiaries); some programs may allow government beneficiaries

How to sign up

Typically HCP assisted enrollment (via form)

Foundation programs

under insured

no insurance

goverment insurance

65+

Opdivo Enrollment Form

Opdivo Enrollment Form - Spanish

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Overview

Charitable 501(c)(3) organizations provide direct cost-sharing and other support (e.g., travel, counseling) through disease-state funds to indigent patients on first-come first-served basis
These organizations may receive financial contributions from drug manaufacturers for particular disease-state funds that cannot provide funds directly to patients - the foundation must be independent/unaligned

Patient benefit

Patients apply for grants that cover a portion (or all) of their out-of-pocket costs (deductibles and co-pays) until the grant is exhausted

Patient eligibility

Patients must apply and meet eligibility criteria including income level (typically a multiple of federal poverty line), specific diagnosis, insurance status, etc.

How to sign up

Patients submit proof of out-of-pocket drug costs to charities for reimbursement

patient education

Opdivo Patient education

Getting started on Opdivo

NOT PROVIDED BY BRANDInstructions For Use: Opdivo + Chemotherapy Before Surgery (Neoadjuvant Treatment of Early-Stage NSCLC)

NOT PROVIDED BY BRANDInstructions For Use: Opdivo + Yervoy (1L mNSCLC, PD-L1 Positive)

NOT PROVIDED BY BRANDInstructions For Use: Opdivo + Yervoy (1L r/m NSCLC Regardless of PD-L1 Expression)

NOT PROVIDED BY BRANDInstructions For Use: Opdivo Monotherapy (2L mNSCLC)

NOT PROVIDED BY BRANDInstructions For Use: Opdivo + Yervoy (1L Intermediate or Poor Risk Advanced RCC)

NOT PROVIDED BY BRANDInstructions For Use: Opdivo + Cabometyx (1L Advanced RCC)

NOT PROVIDED BY BRANDInstructions For Use: Opdivo Monotherapy (Advanced RCC)

NOT PROVIDED BY BRANDInstructions For Use: Opdivo Monotherapy (Adjuvant Treatment of Completely Resected ESO or GEJ Cancer)

NOT PROVIDED BY BRANDInstructions For Use: Opdivo + Chemotherapy (1L Metastatic Gastric, GEJ, or Esophageal Adenocarcinomas)

NOT PROVIDED BY BRANDInstructions For Use: Opdivo + Chemotherapy (1L Metastatic Esophageal Squamous Cell Carcinoma [ESCC])

NOT PROVIDED BY BRANDInstructions For Use: Opdivo + Yervoy (1L mESCC)

NOT PROVIDED BY BRANDInstructions For Use: Opdivo + Chemotherapy (1L mESCC, PD-L1 Positive)

NOT PROVIDED BY BRANDInstructions For Use: Opdivo + Yervoy (Advanced Melanoma)

NOT PROVIDED BY BRANDInstructions For Use: Adjuvant Treatment of Melanoma

NOT PROVIDED BY BRANDInstructions For Use: 2L mUC

NOT PROVIDED BY BRANDInstructions For Use: Adjuvant Treatment of UC