Opdivo (nivolumab) is a cancer medicine that interferes with the growth and spread of cancer cells in the body.
Opdivo is used to treat a certain type of melanoma (skin cancer) that cannot be treated with surgery, or that has spread to other parts of the body.
Opdivo is also used to treat a certain type of non-small cell lung cancer.
Opdivo is usually given after other cancer medicines have been tried without success.
Nivolumab was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, nivolumab produced complete or partial response in many people. However, further studies are needed to determine if this medicine can lengthen survival time.
Important information
Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
Before taking this medicine
You should not use Opdivo if you are allergic to nivolumab.
To make sure Opdivo is safe for you, tell your doctor if you have:
-
lung disease;
-
liver disease;
-
kidney disease;
-
a thyroid disorder;
-
an autoimmune disorder such as rheumatoid arthritis, lupus, or psoriasis;
-
an intestinal disorder such as Crohn"s disease or ulcerative colitis; or
-
if you have received an organ transplant.
Do not use Opdivo if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 5 months after your treatment ends.
It is not known whether nivolumab passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
How is Opdivo given?
Opdivo is injected into a vein through an IV. A healthcare provider will give you this injection.
Opdivo is usually given once every 2 weeks. Your doctor will determine how long to treat you with this medicine.
Your doctor will perform blood tests to make sure you have the correct tumor type to be treated with Opdivo.
This medicine must be given slowly. The IV infusion can take at least 1 hour to complete.
You may be given medication to treat or prevent certain side effects of Opdivo.
While receiving this medicine, you may need frequent blood tests.
Opdivo dosing information
Usual Adult Dose for Melanoma - Metastatic:
Dose: 3 mg/kg IV infusion over 60 minutes every 2 weeks
Duration of therapy: Continue therapy until disease progresses or unacceptable toxicity occurs.
Comments:
-This drug has been approved under accelerated approval based on tumor response rate and durability of response. Continued approval will be contingent upon verification and description of clinical benefit in confirmatory trials.
Use: For the treatment of unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your Opdivo injection.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while receiving Opdivo?
Follow your doctor"s instructions about any restrictions on food, beverages, or activity.
Opdivo side effects
Get emergency medical help if you have signs of an allergic reaction to Opdivo: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
-
new or worsening cough;
-
sudden chest pain or discomfort, wheezing, feeling short of breath;
-
problems with vision;
-
new or worsening skin rash;
-
severe muscle weakness, ongoing pain in your muscles or joints;
-
severe or ongoing diarrhea, severe stomach pain, bloody or tarry stools;
-
kidney problems - little or no urinating; blood in your urine; swelling in your feet or ankles;
-
liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
-
signs of a hormonal disorder - frequent or unusual headaches, feeling light-headed or very tired, mood or behavior changes, hoarse or deepened voice, constipation, hair loss, feeling cold, weight gain, or weight loss.
Common Opdivo side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
What other drugs will affect Opdivo?
Other drugs may interact with nivolumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
