Description

What is Opdivo?

Opdivo (nivolumab) is a cancer medicine that works with your immune system to interfere with the growth and spread of cancer cells in the body.

Opdivo is used to treat certain types of cancer, including melanoma (skin cancer), non-small cell lung cancer, bladder cancer, liver cancer, kidney cancer, squamous cell cancer of the head and neck, colorectal cancer, classical Hodgkin’s Lymphoma, and urothelial carcinoma. Opdivo can be given alone or in combination with other cancer medicines. It is often used after other medicines have been tried without success.

Opdivo is sometimes used if the cancer has spread to other parts of the body. For some types of cancer, this medicine is given when the cancer cannot be treated with surgery. For Hodgkin lymphoma, Opdivo is used if the condition has relapsed or progressed after stem cell transplant and treatment with brentixumab vedotin (Adcetris) or other medications.

In people with non-small cell lung cancer, Opdivo may increase the chance of a longer survival time.

Important information

Opdivo can cause side effects in many different parts of your body. Some side effects may need to be treated with other medicine, and your cancer treatments may be delayed.

Call your doctor at once if you have: chest pain, cough, shortness of breath, vision changes, tiredness, severe muscle pain or weakness, diarrhea and severe stomach pain, blood in your stools, little or no urinating, swelling in your feet, bruising or bleeding, dark urine, yellowing of the skin or eyes, skin sores or blisters, confusion, hallucinations, a seizure, or a hormonal disorder (frequent headaches, feeling light-headed, increased thirst or urination, a deeper voice, feeling cold, weight gain or loss).

Opdivo was approved by the US Food and Drug Administration (FDA) on an “accelerated” basis for some types of cancer. In clinical studies, Opdivo produced complete or partial responses, or longer survival time without progression of the cancer. However, further studies are needed.

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 ever had:

• lung disease or breathing problems;
• liver or kidney disease;
• a thyroid disorder;
• an autoimmune disorder (lupus, Crohn’s disease, or ulcerative colitis); or
• 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 last dose.

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 infusion. A healthcare provider will give you this injection. The injection must be given by slow infusion over at least 1 hour.

Before you start treatment, your doctor will perform tests to make sure nivolumab is the best treatment for your type of cancer.

Opdivo is usually given once every 2 to 4 weeks. Your doctor will determine how long to treat you with this medicine.

Opdivo 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.

Nivolumab can cause side effects in many parts of your body by changing how your immune system works. Some side effects may be treated with other medicine, and your cancer treatments may be delayed or stopped.

You will need frequent medical tests to help your doctor determine if it is safe for you to keep receiving Opdivo. Do not miss any follow-up visits to your doctor.

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

Usual Adult Dose of Opdivo for Lung Cancer:

Usual Adult Dose:
Dose: 3 mg/kg IV infusion over 60 minutes every 2 weeks
Duration of therapy: Continue therapy until disease progresses or unacceptable toxicity occurs.

Use: Metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy

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.

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, light-headed, short of breath, itchy, tingly, chilled, or feverish.

Call your doctor at once if you have:

• severe or ongoing diarrhea, severe stomach pain, bloody or tarry stools;
• new or worsening skin rash, itching, or blistering;
• sores or ulcers in your mouth, nose, rectum, or genitals;
• changes in your vision;
• severe muscle weakness, ongoing pain in your muscles or joints;
• lung problems – new or worsening cough, sudden chest pain or discomfort, wheezing, feeling short of breath;
• symptoms of brain swelling – confusion, headache, memory problems, hallucinations, neck stiffness, drowsiness, seizure (convulsions);
• kidney problems – little or no urinating; blood in your urine; swelling in your feet or ankles;
• liver problems – severe nausea or vomiting, loss of appetite, upper stomach pain, drowsiness, easy bruising or bleeding, 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, increased thirst or urination, constipation, hair loss, sweating, hoarse or deepened voice, feeling cold, weight gain, or weight loss.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Opdivo side effects may include:

• nausea, vomiting, stomach pain, loss of appetite, diarrhea, constipation;
• feeling weak, tired, or short of breath;
• cold symptoms such as runny or stuffy nose, sneezing, sore throat;
• fever, body aches;
• skin rash, itching; or
• headache, back pain.

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.