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Treatment Name: Nivolumab (Opdivo®)

Nivolumab (Opdivo®) is an Immunotherapy Regimen for Bladder Cancer

How does nivolumab work?
Nivolumab is designed to enhance your immune system’s ability to target and kill cancer cells.

Goals of therapy:
Nivolumab is given to shrink tumors and help alleviate symptoms of bladder cancer. It is not commonly given with the goal of cure, but may help patients live longer.

Schedule

  • Nivolumab intravenous infusion (I.V.), given over 30 minutes on Day 1 of each cycle

Estimated total infusion time for this treatment:

  • Up to 30 minutes if there are no pre-medications or infusion reactions
  • One or more hours if there are pre-medications or infusion reactions
  • Infusion times are based on clinical studies, but may vary depending on doctor preference or patient tolerability. Pre-medications and intravenous (I.V.) fluids, such as hydration, may add more time

Nivolumab is usually given in an outpatient infusion center, allowing the person to go home afterwards.

This is given either every 14 or 28 days and known as one Cycle. Treatment is continued until nivolumab is no longer working or is stopped because of intolerable side effects.

Click here for the common nivolumab starting dose for bladder cancer.

Side Effects

In clinical studies, the most commonly reported nivolumab side effects are shown here. 

  • Fatigue, (17%)
  • Skin reactions, (17%)
  • Altered hormone levels, (15%)
  • Stomach or other gastrointestinal problems, (9%)
  • Diarrhea, (9%)
  • Itching, (9%)
  • Nausea, (8%)
  • Decreased appetite, (8%)
  • Decreased thyroid function, (8%)
  • Skin rash, (6%)
  • Fever, (6%)
  • Weakness, (5%)
  • Liver injury, (4%)
  • Lung injury, (4%)
  • Kidney injury, (2%) 

On average, 5% of patients discontinue nivolumab (Opdivo®) treatment for bladder cancer due to unacceptable side effects.

Side effect videos Side Effect Videos
Fatigue Fatigue DiarrheaDiarrheaNausea and VomitingNausea and VomitingPainPain

Monitoring

How often is monitoring needed?
Labs (blood tests) are often checked before every treatment, and periodically if side effects are experienced. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), magnesium, amylase, lipase, AdrenoCorticoTropic Hormone (ACTH), serum cortisol, thyroid function using the TSH and/or free-T4 tests, hepatitis screening, plus any others your doctor may order.

How often is imaging needed?
Imaging may be checked before treatment, then every two months for one year, then every three months thereafter. Imaging may include: computerized tomography (CT) scans or magnetic resonance imaging (MRI).

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may want to continue nivolumab as planned, or delay or switch therapy.

ChemoExperts Tips

  • A corticosteroid (e.g., prednisone, methylprednisolone) may be prescribed to decrease immune reactions if they occur
  • If you experience gastrointestinal symptoms such as diarrhea that does not go away after delaying treatment or get significantly better with steroids after 3 to 5 days, an additional I.V. medication known as Infliximab (Remicade®) may be given
  • If you have liver toxicity from immune reactions that do not go away by delaying treatment or get significantly better with steroids after 3 to 5 days, an additional medication known as mycophenolate mofetil (CellCept®) may be prescribed
  • If you experience fevers, they may be managed by taking anti-inflammatory medications (examples: ibuprofen or naproxen). Ask your doctor or pharmacist if these medicines are safe to take with nivolumab treatment
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for head and neck cancer. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications

Patient Assistance & Co-payment Coverage

Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Nivolumab (Opdivo®), we have provided links that may help.

Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Nivolumab (Opdivo®). Depending upon your income, they may be able to help cover the cost of:

  • Nivolumab

For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.

  • If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.

Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Nivolumab (Opdivo®) and are the best source to help you understand drug cost.

  • Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.

Emotional Wellness

What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.

Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.

Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.

Learn more about pursuing emotional wellness while receiving treatment with Nivolumab (Opdivo®)

Individual Drug Label Information

Nivolumab (Opdivo®)

  • Nivolumab is an intravenous (I.V.) infusion commonly infused over one hour
  • Doses may need to be delayed due to lung, gastrointestinal (stomach & intestines), or other treatment related problems
  • Dose adjustments may need to be made due to kidney or liver problems
General Nivolumab (Opdivo) side effects
  • Fatigue is the most commonly reported side effect. This may be due to low red blood cells
  • May cause skin problems such as itching, blotching, or rash
  • Diarrhea or constipation may occur
  • Although uncommon, it can cause nausea
  • May cause muscles to feel weak and joints to feel achy
  • May decrease your appetite. Talk to a dietitian about meal options that may work for you
  • Click on the nivolumab (Opdivo) package insert link below for reported side effects and possible drug interactions

Side Effect Videos
DiarrheaDiarrheaFatigue Fatigue ConstipationConstipationPainPainAnemiaAnemia

See DailyMed package insert.

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References

1. Sharma P, Retz M, Siefker-Radtke A, et al. Nivolumab in metastatic urothelial carcinoma after platinum therapy (CheckMate 275): a multicentre, single-arm, phase 2 trial. Lancet Oncol 2017;18:312-22.

Created: March 23, 2017 Updated: March 15, 2018

What is Bladder Cancer?

A disease of the cells that line the inside of the bladder. Bladder cancer is a rare disease that is most commonly seen in older adults. It is known to cause blood in the urine in up to 90% of patients at diagnosis. Causes of bladder cancer include smoking, exposure to certain chemicals (arylamines), and chronic bladder infections.

Treatment includes surgery (full or partial removal of the bladder), chemotherapy, immunotherapy (giving certain vaccines into the bladder), or thermotherapy (heating the lining of the bladder combined with chemotherapy). The stage of bladder cancer can vary at diagnosis and throughout treatment. Bladder cancer is staged using the Tumor, Node, Metastasis (TNM) system, as well as Stage Grouping 0, I, II, III, or IV. Staging systems describe the extent of cancer throughout the body and help doctors determine which treatments to offer. The effectiveness of the treatment may depend upon the stage at diagnosis.

NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

Common nivolumab starting dose for bladder cancer

  • Nivolumab 240 mg I.V. infusion given over 30 minutes on Day 1 of a 14-day cycle, or
  • Nivolumab 480 mg I.V. infusion given over 30 minutes on Day 1 of a 28-day cycle

Note: Individual doses may vary based upon your Doctor's recommendation, or drug availability.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium