Opdivo

Commonly Treated Conditions

Opdivo is used to treat several types of cancer, particularly when the disease is advanced, has spread to other parts of the body (metastatic), or cannot be surgically removed. It is also used as an adjuvant treatment, which means it is given after surgery to help prevent the cancer from returning.

Types of Cancer

• Skin Cancer: It is used for advanced melanoma and may be given after surgery to reduce the risk of recurrence.
• Lung Cancer: It is approved for non-small cell lung cancer and malignant pleural mesothelioma.
• Kidney and Bladder Cancers: It is used for advanced renal cell carcinoma and urothelial carcinoma (cancer of the bladder or urinary tract).
• Digestive System Cancers: This includes certain types of colorectal cancer, liver cancer (hepatocellular carcinoma), esophageal cancer, and stomach (gastric) cancer.
• Other Cancers: It is used for classical Hodgkin lymphoma and squamous cell carcinoma of the head and neck.

Depending on the specific diagnosis, Opdivo may be used as a single therapy or in combination with other medications, such as ipilimumab or chemotherapy. It is typically administered as an intravenous infusion, though certain formulations may be given as a subcutaneous injection.

Immune Checkpoint Inhibition

Opdivo is a monoclonal antibody that belongs to a class of drugs called PD-1 inhibitors. It works by targeting the programmed death receptor-1 (PD-1), a protein found on the surface of T-cells. T-cells are a type of white blood cell responsible for identifying and destroying abnormal cells, including cancer cells.

Releasing the Brakes

The immune system uses "checkpoints" to prevent it from attacking healthy cells. Cancer cells can sometimes use these checkpoints to hide from the immune system. They do this by binding to the PD-1 receptor on T-cells, which sends a signal to the T-cell to stop its attack.

Opdivo works by:

• Binding to the PD-1 receptors on T-cells.
• Blocking cancer cells from connecting with these receptors.
• Preventing the cancer cells from sending a "stop" signal to the immune system.

By blocking this interaction, Opdivo essentially releases the brakes on the immune system. This allows the T-cells to recognize the cancer cells as harmful and begin attacking them more effectively.

Common Side Effects

The most common side effects reported by patients using Opdivo include:

• Feeling tired or weak
• Skin rash and itching
• Pain in the muscles, joints, or bones
• Diarrhea or constipation
• Nausea and vomiting
• Cough and shortness of breath
• Decreased appetite
• Upper respiratory tract infections
• Headache and abdominal pain

Serious Side Effects

Because Opdivo affects the immune system, it can cause the body to attack healthy tissues. These reactions can be severe and may occur at any time during or after treatment. Seek immediate medical attention for:

• Lung issues: New or worsening cough, chest pain, or difficulty breathing.
• Digestive issues: Severe diarrhea, blood or mucus in stools, or severe stomach-area pain.
• Liver issues: Yellowing of the skin or the whites of the eyes, dark urine, or pain on the right side of the stomach.
• Hormone gland issues: Headaches that do not go away, extreme tiredness, rapid heartbeat, or changes in weight or mood.
• Kidney issues: Decrease in urine output or blood in the urine.
• Severe skin reactions: Rash with blisters or peeling.
• Infusion-related reactions: Chills, shaking, dizziness, or fever during the injection.

Immune-Mediated Adverse Reactions

Opdivo is an immunotherapy that works by stimulating the immune system to attack cancer cells. However, the immune system may also attack normal organs and tissues in any area of the body. These reactions can occur during treatment or after treatment has stopped. Serious or fatal inflammation may affect the following systems:

• Lungs: Pneumonitis can cause new or worsening cough, chest pain, or shortness of breath.
• Intestines: Colitis can lead to severe diarrhea, blood or mucus in the stool, and stomach-area pain.
• Liver: Hepatitis may cause yellowing of the skin or eyes, dark urine, or severe nausea and vomiting.
• Hormone Glands: Problems can develop in the thyroid, pituitary, and adrenal glands. This may also include the development of type 1 diabetes.
• Kidneys: Nephritis and kidney dysfunction may occur, often identified by changes in urine color or volume.
• Skin: Severe rashes, itching, or blistering can occur, which may require immediate medical attention.

Infusion and Injection Reactions

Severe infusion-related reactions can occur during the administration of the medication. Symptoms may include chills, shaking, itching, rash, dizziness, fever, or wheezing. For the subcutaneous formulation (nivolumab and hyaluronidase-nvhy), local injection site reactions may also occur.

Stem Cell Transplant Complications

Patients who receive a stem cell transplant using donor cells (allogeneic) before or after treatment with Opdivo may face an increased risk of severe complications, including graft-versus-host disease. Healthcare providers typically monitor these patients closely for signs of transplant-related issues.

Embryo-Fetal Toxicity

Based on its mechanism of action, Opdivo can cause harm to a developing fetus. Females of reproductive potential are typically advised to use effective contraception during treatment and for at least five months following the final dose. Breastfeeding is generally not recommended during treatment and for several months after the last dose.

Monitoring and Testing

Regular blood tests are necessary to monitor liver function, kidney function, and hormone levels. Early detection of inflammation is critical for managing side effects, which may require pausing treatment or starting corticosteroid medications.

Pregnancy

Opdivo can cause harm to a fetus when administered to a pregnant person. Based on its mechanism of action and animal studies, the drug may interfere with the maintenance of pregnancy and increase the risk of immune-mediated disorders or fetal death.

Before starting treatment, healthcare providers typically perform a pregnancy test for individuals who can become pregnant. It is important to use effective birth control (contraception) during treatment and for at least 5 months after the final dose of Opdivo. If you become pregnant or think you might be pregnant while receiving this medication, notify your healthcare provider immediately.

Breastfeeding

It is not known whether Opdivo passes into human breast milk or how it might affect a nursing infant. Because of the potential for serious side effects in a breastfed child, it is generally advised not to breastfeed during treatment and for at least 5 months following the last dose. Patients should discuss the risks and benefits of breastfeeding with their healthcare team.

Available Forms

Opdivo is supplied in the following dosage forms:

• Intravenous Infusion: A liquid solution provided in single-dose vials. This form is diluted and administered into a vein by a healthcare provider.
• Subcutaneous Injection: A formulation containing nivolumab and hyaluronidase-nvhy, which is administered as an injection under the skin.

The intravenous solution is typically a clear to opalescent, colorless to pale yellow liquid. Because these medications must be administered by a professional in a hospital or clinical setting, they are not available for self-administration at home.

FDA Approval History

Opdivo received its initial FDA approval in December 2014 for the treatment of advanced melanoma. Since then, the FDA has expanded its approved uses to include a wide range of cancers, such as non-small cell lung cancer, renal cell carcinoma, and classical Hodgkin lymphoma.

Approved Indications

The FDA has granted approval for Opdivo to treat several specific conditions, often when the cancer is advanced or has returned after previous therapy. These include:

• Metastatic colorectal cancer that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
• Hepatocellular carcinoma (liver cancer) in patients previously treated with sorafenib.
• Advanced or metastatic urothelial carcinoma (bladder cancer).
• Esophageal and gastric cancers.

In many cases, Opdivo is approved for use as a single agent or in combination with other therapies, such as ipilimumab.

Recent Regulatory Updates

In February 2025, the FDA approved a subcutaneous version of the drug (nivolumab and hyaluronidase-nvhy). This formulation allows for a significantly shorter administration time compared to the traditional intravenous infusion. This approval covers all adult indications previously established for the intravenous form.

Regulatory Classification

Opdivo is a prescription-only medication. It is classified as a programmed death receptor-1 (PD-1) blocking antibody. While it is not subject to a Risk Evaluation and Mitigation Strategy (REMS) program, it is associated with severe immune-mediated adverse reactions that require close medical monitoring by healthcare providers.

Factors Affecting Cost

Several factors influence the total cost of treatment with Opdivo, including:

• The specific condition being treated and the required dosage.
• The frequency of infusions and the total duration of therapy.
• Whether it is administered alone or in combination with other medications.
• The type of health insurance coverage and out-of-pocket requirements like copays or deductibles.
• The location of treatment, such as a hospital outpatient department or a private clinic.

Generic Availability

Opdivo is a brand-name biologic medication. There are currently no biosimilar or generic versions available, which generally contributes to its higher cost compared to older medications.

Financial Assistance

The manufacturer may offer support programs to help patients navigate insurance coverage or provide financial assistance to those who qualify. Patients are encouraged to speak with their healthcare provider or insurance company to understand the specific costs associated with their care.