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Treatment Name: Nivolumab (Opdivo®)

Nivolumab (Opdivo®) is an Immunotherapy Regimen for Head and Neck 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, to help decrease symptoms caused by head and neck cancer, and to help maintain physical function. Nivolumab is not commonly given with the goal of cure, but may prolong survival.

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Schedule

  • Nivolumab intravenous (I.V.) infusion 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
  • Up to 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 (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.

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

Click here for the common nivolumab starting doses for head and neck cancer.

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Side Effects

In clinical studies, the most commonly reported side effects from nivolumab for head & neck cancer are shown here:

  • Fatigue (14%)
  • Nausea (9%)
  • Rash (8%)
  • Itching (7%)
  • Decreased appetite (7%)
  • Diarrhea (7%)
  • Anemia [low red blood cells] (5%)
  • Low thyroid levels in blood (5%)
  • Pneumonia [lung infection] (4%)
  • Weakness (4%)
  • Vomiting (3%)
  • Dry skin (3%)
  • Inflammation of the lungs (2%)
  • Mouth sores (2%)
  • Weight loss (2%)
  • Inflammation of intestines (1%)
  • Infusion-related reaction (1%)

Approximately 33% of patients need one or more doses delayed due to adverse (unfavorable) effects. Doses were often delayed for 1 or 2 weeks.

Note: Nivolumab is NOT known to cause hair loss.

Side effect videos Side Effect Videos
Fatigue Fatigue Nausea and VomitingNausea and VomitingDiarrheaDiarrheaAnemiaAnemiaPainPain

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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, before Cycle 5, then every six weeks beginning at Week 9 or as recommended by your doctor. Imaging may include: X-rays, magnetic resonance imaging (MRI), computerized tomography (CT) scans, or positron emission tomography (PET) scans.

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue immunotherapy with nivolumab as planned, or delay or switch therapy. A fixed-dose of nivolumab is not usually recommended for head & neck cancer.

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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 experience 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

Ferris RL, Blumenschein, G Jr., Fayette, J, et al. Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. N Engl J Med. 2016;375:1856-1867.

Created: December 27, 2016 Updated: March 15, 2018

What is Head and Neck Cancer?

A group of diseases of cells found in the mouth, lip, nasal cavity, throat, sinuses, and lymph nodes in the neck. Head and neck cancer is a rare condition. Known causes of head and neck cancer are strongly related with lifestyle and environmental risk factors including: tobacco use, alcohol consumption, UV light (sun exposure), certain strains of viruses (Epstein Barr virus [EBV] and human papilloma virus [HPV]), exposure to certain chemicals in the workplace, and vitamin A deficiency. If detected early it is highly curable. The stage of head and neck cancer can vary at diagnosis and throughout treatment. Stages of head and neck cancer include the Tumor, Node, Metastatis (TNM) staging system to describe a different area of cancer growth. After that is known, Stage Grouping using Stages I, II, III, or IV is assigned. This describes the extent of cancer throughout the body. 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.

What does Cure mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, doctors use the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.

Common nivolumab starting doses for head and neck 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