OPDIVO (nivolumab)

 

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OPDIVO® was studied in 2 different ongoing clinical trials, which included 95 cHL patients whose cancer has come back or spread after an autologous stem cell transplant and treatment with Adcetris® (brentuximab vedotin) after stem cell transplant. The combined results from the clinical studies show that 2 out of 3 patients (65%) responded to OPDIVO. OPDIVO was shown to shrink tumors or eliminate tumors in patients who didn’t have successful results from prior treatments. 58% of the OPDIVO patients saw their tumors shrink (called a partial response), while 7% saw their tumors disappear completely (called a complete response).

What is OPDIVO?

OPDIVO is for patients with cHL whose
cancer has come back or spread after an

autologous stem cell transplant and treatment
with Adcetris® (brentuximab vedotin)
after stem cell transplant.

LEARN ABOUT THE RESULTS

How does OPDIVO work?

Your immune system helps
defend against blood cancer.
Learn how OPDIVO works with
your immune system.

HOW OPDIVO WORKS

What should I know
about the potential side
effects of OPDIVO?

Although they may not be experienced
by every patient, OPDIVO may cause
serious side effects. Learn more
about the most serious and most
common side effects.

POTENTIAL SIDE EFFECTS

More Important Safety Information

SELECT IMPORTANT SAFETY INFORMATION

Important Safety Information for OPDIVO® (nivolumab)

OPDIVO can cause problems that can sometimes become serious or life-threatening and can lead to death. Serious side effects may include lung problems (pneumonitis); intestinal problems (colitis) that can lead to tears or holes in the intestines; liver problems (hepatitis); hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas); kidney problems, including nephritis and kidney failure; skin problems; inflammation of the brain (encephalitis); problems in other organs; severe infusion reactions; and complications of stem cell transplant that uses donor stem cells (allogeneic) after treatment with OPDIVO. The most common side effects of OPDIVO in people with classical Hodgkin lymphoma include: feeling tired; upper respiratory tract infection; fever; diarrhea; and cough.

OPDIVO® (nivolumab) is a medicine that may treat your blood cancer by working with your immune system. OPDIVO can cause your immune system to attack normal organs and tissues in many areas of your body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended.

Serious side effects may include:

  • Lung problems (pneumonitis). Symptoms of pneumonitis may include: new or worsening cough; chest pain; and shortness of breath.
  • Intestinal problems (colitis) that can lead to tears or holes in your intestine. Signs and symptoms of colitis may include: diarrhea (loose stools) or more bowel movements than usual; blood in your stools or dark, tarry, sticky stools; and severe stomach-area (abdomen) pain or tenderness.
  • Liver problems (hepatitis). Signs and symptoms of hepatitis may include: yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach area (abdomen); drowsiness; dark urine (tea colored); bleeding or bruising more easily than normal; and feeling less hungry than usual.
  • Hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas). Signs and symptoms that your hormone glands are not working properly may include: headaches that will not go away or unusual headaches; extreme tiredness; weight gain or weight loss; dizziness or fainting; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness; hair loss; feeling cold; constipation; voice gets deeper; and excessive thirst or lots of urine.
  • Kidney problems, including nephritis and kidney failure. Signs of kidney problems may include: decrease in the amount of urine; blood in your urine; swelling in your ankles; and loss of appetite.
  • Skin Problems. Signs of these problems may include: rash; itching; skin blistering; and ulcers in the mouth or other mucous membranes.
  • Inflammation of the brain (encephalitis). Signs and symptoms of encephalitis may include: headache; fever; tiredness or weakness; confusion; memory problems; sleepiness; seeing or hearing things that are not really there (hallucinations); seizures; and stiff neck.
  • Problems in other organs. Signs of these problems may include: changes in eyesight; severe or persistent muscle or joint pains; and severe muscle weakness.

Getting medical treatment right away may keep these problems from becoming more serious.

Your healthcare provider will check you for these problems during treatment. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment, if you have severe side effects.

OPDIVO can cause serious side effects, including:

  • Severe infusion reactions. Tell your doctor or nurse right away if you get these symptoms during an infusion of OPDIVO: chills or shaking; itching or rash; flushing; difficulty breathing; dizziness; fever; and feeling like passing out.
  • Complications of stem cell transplant that uses donor stem cells (allogeneic) after treatment with OPDIVO. These complications can be severe and can lead to death. Your healthcare provider will monitor you for signs of complications if you have an allogeneic stem cell transplant.

Pregnancy and Nursing:

Tell your healthcare provider if you are pregnant or plan to become pregnant. OPDIVO can harm your unborn baby. Females who are able to become pregnant should use an effective method of birth control during and for at least 5 months after the last dose of OPDIVO. Talk to your healthcare provider about birth control methods that you can use during this time. Tell your healthcare provider right away if you become pregnant during treatment. Before receiving treatment, tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if OPDIVO passes into your breast milk. Do not breastfeed during treatment.

Tell your healthcare provider about:

  • Your health problems or concerns if you have immune system problems such as Crohn’s disease, ulcerative colitis, lupus; have had an organ transplant; have lung or breathing problems; have liver problems; or have any other medical conditions.
  • All the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of OPDIVO in people with classical Hodgkin lymphoma include: feeling tired; upper respiratory tract infection; fever; diarrhea; and cough.

These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

Please see U.S. Full Prescribing Information and Medication Guide for OPDIVO.

 

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INDICATION

OPDIVO® (nivolumab) is a prescription medicine used to treat classical Hodgkin lymphoma (a type of blood cancer that affects white blood cells known as lymphocytes) if your cancer has come back or spread after you had an autologous stem cell transplant (a type of stem cell transplant that uses your own stem cells) and were treated with the drug Adcetris® (brentuximab vedotin) after stem cell transplant.

It is not known if OPDIVO is safe and effective in children less than 18 years
of age.

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