Nivolumab (Intravenous)

Nivolumab is a first-line cancer treatment injection given by doctors to cancer patients who have been diagnosed with metastatic or unresectable melanoma.

Overview

What is Nivolumab?

Approved under an accelerated program by the FDA, Nivolumab is one of very few treatments that are effective against advanced cases of melanoma. Nivolumab is marketed under the name Opdivo in the US and is only given by physicians in a hospital or cancer treatment facility.

Nivolumab is an immunotherapy drug rather than a chemotherapy drug in that it encourages the body's own immune cells to fight cancer. Nivolumab is administered through a vein directly into the bloodstream over a one hour period every 14 days. Blood tests at regular intervals will inform your physician not only how Nivolumab is affecting your cancer, but also confirm the health function of your kidneys and liver.

How does Nivolumab work?

Nivolumab is a targeted therapy, inhibiting an immunity function and increasing the destruction of cancer cells. Nivolumab bonds to the PD-1 receptor found in the T-cells and makes sure they are constantly active and fighting cancer. By increasing the activity of the T-cells, the cancer will shrink or stop growing in many cases.

Conditions Treated

  • Refractory, metastatic non-small cell lung cancer
  • Unresectable melanoma
  • Metastatic melanoma
  • Refractory, advanced renal cell carcinoma
  • Refractory Hodgkin's lymphoma
  • Refractory, metastatic renal cell carcinoma

Type Of Medicine

  • Monoclonal antibody

Side Effects

Patients who have been prescribed treatment with Nivolumab may experience some adverse health effects that can severely harm them. If you have the following symptoms, seek medical assistance immediately:

  • Skin that is peeling, blistered or loose
  • Pain in back
  • Tightness in chest area
  • Chills
  • Coughing
  • Constipation
  • Depression
  • Diarrhea
  • Hair and skin is dry
  • Chills or cold feeling
  • Fever
  • Flushed appearance
  • Loss of hair on scalp
  • Headache
  • Hoarse voice
  • Itching
  • Pain in muscles or joints
  • Stiff, cramped muscles
  • Vomiting
  • Nausea
  • Irritated, bloodshot eyes
  • Sluggish heart rhythm
  • Throat soreness
  • Ulcerated sores on lips or in mouth
  • Difficulty breathing
  • Fatigue
  • Muscle weakness
  • Gaining weight
  • Pain in chest
  • Urine is dark in color
  • Overall uncomfortable, ill feeling
  • Stools are light in color
  • Nervous demeanor
  • Pain or tenderness
  • Heat sensitive
  • Cramps in stomach
  • Sweating
  • Thick mucus
  • Insomnia
  • Pain in abdomen or stomach
  • Diarrhea that is bloody or watery
  • Loss of weight
  • Skin or eyes appear yellow
  • Bloated stomach
  • Cloudy urine with signs of blood
  • Blurry vision
  • Skin darkens
  • Dizzy, sleepy
  • Pain in eyes
  • Passing out
  • Rapid heart rhythm
  • Stomach upset
  • Appetite loss
  • Radiating pains from the stomach to back
  • Eye redness
  • Light sensitivity
  • Rash on skin
  • Swollen lower legs, feet or face
  • Watery eyes

Other health effects may occur that, while not severe or harmful in nature, may cause you stress or discomfort. These side effects should disappear as your treatment goes on, but if they do not or if they become severe, discuss these with your doctor:

Runny, stuffy or congestion in nasal passages

You may have your own experiences on this medication that are different from those listed here. If you have any changes in your health while you are taking Nivolumab, it is best to notify your cancer treatment staff immediately to make sure you are safe to continue your treatment on this drug.

Dosage

This medication is commonly used in the fight against melanoma cancers that cannot be surgically removed or have not responded to other treatments or those that have metastasized. Your dosage will be determined especially for you by your cancer treatment care team. The amount and frequency of this drug is based on several factors which include your overall health, the state of your cancer, any previous treatment you may have and your body mass statistics. The information provided here is general; what your treatment is with Nivolumab may vary.

Ipilimumab is commonly used in combination with Nivolumab to help fight the cancer if it has specific characteristics. Nivolumab may also be used alone or with other drugs for non-small cell lung cancer treatment or renal cell carcinoma treatment.

Dosage With Ipilimumab

For adult patients who will also be treated with Ipilimumab, the recommended dosage of Nivolumab is one milligram per kilogram of body weight to be administered through intravenous route over a one hour period on a three-week schedule repeated four times. Following this phase, three milligrams per kilogram of body weight will be administered intravenously over a one hour period every two weeks.

Nivolumab alone

Adult patients being treated with Nivolumab alone will be given a dosage that is 240 milligrams in size, through an intravenous administration route in a one hour period, to be repeated every two weeks.

Interactions

If you have had any unusually hypersensitive reactions to other medications in the past or if you have reacted poorly to some animals, foods, preservatives or dyes, inform your doctor of this possibility. You could also have this sensitivity to Nivolumab.

Pediatric patients have not been studied to determine if they are safe to be treated with Nivolumab.

Studies on geriatric patients have been performed and no difference in risk or effectiveness has been found with regard to use of Nivolumab in this age group.

Pregnant women under treatment with Nivolumab may be exposing their fetus to harm by taking this drug. It is important to prevent pregnancy while receiving cancer treatment drugs. Reliable forms of birth control should be used during your treatment. Discuss your medical options with your team of cancer care specialists and inform your doctor if you are pregnant prior to your treatment.

Nivolumab has not been studied for use in women who are breastfeeding to determine if their bodies transport this drug within the breast milk. Discuss any risks that may exist with the use of this medication with your doctor if you are currently breastfeeding.

Certain medications should not be used together; in the case of Nivolumab, it is safe to use some other drugs as part of a complete therapy against cancer. Do not take other drugs while you are being treated with Nivolumab; this includes anything you can get over-the-counter, any herbal, holistic or vitamin therapies that are available.

The following drugs should not be combined with Nivolumab unless your physician has specifically approved their use:

  • Zydelig
  • Idelalisib

Consumption of alcoholic beverages or use of tobacco products should be discussed with your cancer treatment team of specialists to determine if it is safe to combine with your medications and treatment. Additionally, certain foods may harm the effectiveness or produce unwanted hypersensitivities when eaten with Nivolumab treatment. Consult your physician on any diet changes recommended for you.

If you have the following health conditions, be aware that they may worsen with treatment of Nivolumab:

  • Immunity diseases
  • Liver diseases
  • Crohn's disease
  • Kidney disease
  • Respiratory problems
  • Lung disease
  • Bowel or stomach problems
  • Lupus or similar diseases
  • Thyroid activity problems, over-active or under-active
  • Ulcerative colitis

Warnings

Maintain your office visit schedule in order for your physician to monitor your progress while you are being treated with Nivolumab. These visits may include blood tests and other tests to make sure there are no adverse symptoms accompanying your treatment.

Women who are pregnant or who may become pregnant are urged to avoid treatment with Nivolumab or practice an effective birth control method to prevent pregnancy during and for five months after treatment. If you think you are pregnant, inform your cancer care team immediately.

Any chest congestion, coughing or tightness that could indicate a respiratory problem should be made known to your doctor immediately, as they could be the sign of a serious problem with your lungs.

Patients being treated with Nivolumab are at a risk of developing an inflammation in the colon known as colitis. Let your doctor know if you have cramps or pains in your stomach or diarrhea that is watery or shows signs of blood after your treatment.

Liver problems have also be associated with Nivolumab treatment; inform your cancer care team if you notice a yellow tinge to your skin or eyes, are unusually weak or fatigued, your urine is dark or you have no appetite with nausea and pain in your upper abdomen.

Changes in your demeanor or mood that are accompanied by dry hair or skin, cold sensations, constipation, heat sensitivity, sweating, insomnia or differences in weight may indicate that Nivolumab is having adverse effects on your pituitary, thyroid or adrenal glands. Get in touch with your doctor right away if you have any of these symptoms.

Urine that shows signs of blood or looks cloudy accompanied by vomiting, nausea, difficulty breathing, swollen lower legs, feet or face and fatigue or weak muscles may indicate that you are experiencing adverse effects on your kidney function. These symptoms should be reported right away should you have them after a treatment with Nivolumab.

Encephalitis, a condition in which the brain swells due to immune system issues, is a high risk when being treated with Nivolumab. It is important to report symptoms such as vomiting, stiffness in your neck, seizures, headaches and confused demeanor to your physician or to your team of specialists immediately.

Infusion reaction is a serious type of hypersensitivity that is possible but rarely reported in patients who are receiving Nivolumab treatment. Symptoms such as a skin rash, being dizzy, having difficulty breathing or tightness in your chest or swelling in your hands or face with an elevated temperature and chills will all be watched for during your treatment and should be reported if they occur post-treatment.

Storage

This medication is used only by licensed medical professionals in the appropriate setting, which is a hospital or cancer treatment center or clinic. Use and storage safety is under the advice of the manufacturer and carried out by the treatment team.

Nivolumab should be refrigerated but protected from freezing and never shaken. The vial should remain in the original carton, which will protect it from light. Once prepared for use, use Nivolumab within eight hours if stored without refrigeration or up to 24 hours if refrigerated. Discard safely according to manufacturer's instructions if you do not use the prepared dose within 24 hours.

Summary

Nivolumab is a cancer treatment drug known as a monoclonal antibody type of drug. It works by bonding to a protein strain found on the surface of the body's own immune cells known as T-cells. Once bonded to the protein, Nivolumab ensures that the T-cells will remain actively fighting cancer cells as an immune function, disabling their ability to be turned off by other receptors.

Nivolumab is primarily prescribed for patients that have melanoma, kidney or non-small cell lung cancers, though other cancers have also responded to this treatment under clinical trial. As it is a targeted therapy, Nivolumab may be used in combination with other drugs to fight the cancer that is specific to each patient it is prescribed for. Follow your doctor's prescription for all drugs while you are in cancer therapy treatment.

You will be provided informational leaflets on all the drugs you will be treated with as well as contact numbers for your cancer treatment team. If you have any questions or feel unwell after treatment with Nivolumab, get in touch with your doctors right away.

Adverse effects on health may occur with treatment of this drug and these should be communicated to your physician right away to prevent any long-term health issues. Changes in your skin, your mood or demeanor and feeling fatigued are signs of serious complications from treatment with Nivolumab. Additionally, any stomach issues including diarrhea or cramping as well as respiratory symptoms that include elevated body temperature could be emergency situations. Contact your physician immediately if you experience any of these symptoms.