Nivolumab

What it is used for

OPDIVO QVANTIG is a combination of nivolumab, a programmed death receptor-1 (PD-1)-blocking antibody, and hyaluronidase, an endoglycosidase, indicated for the treatment of: Renal Cell Carcinoma (RCC) adult patients with intermediate or poor risk advanced RCC, as a first-line treatment following combination treatment with intravenous nivolumab and ipilimumab.

Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of renal cell carcinoma. adult patients with advanced RCC, as a first-line treatment in combination with cabozantinib. adult patients with advanced RCC who have received prior anti-angiogenic therapy. Melanoma adult and pediatric (12 years and older who weigh 30 kg or greater) patients with unresectable or metastatic melanoma.

adult and pediatric (12 years and older who weigh 30 kg or greater) patients with unresectable or metastatic melanoma following combination treatment with intravenous nivolumab and ipilimumab. Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic melanoma.

for the adjuvant treatment of adult and pediatric (12 years and older who weigh 30 kg or greater) patients with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma. Non-Small Cell Lung Cancer (NSCLC) adult patients with resectable (tumors ≥4 cm or node positive) NSCLC in the neoadjuvant setting, in combination with platinum-doublet chemotherapy.

adult patients with resectable (tumors ≥4 cm or node positive) NSCLC and no known EGFR mutations or ALK rearrangements, for neoadjuvant treatment, in combination with platinum-doublet chemotherapy, followed by OPDIVO QVANTIG monotherapy as adjuvant treatment after surgery. adult patients with metastatic NSCLC and progression on or after platinum-based chemotherapy.

Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO QVANTIG. Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of metastatic NSCLC. Squamous Cell Carcinoma of the Head and Neck (SCCHN) adult patients with recurrent or metastatic SCCHN with disease progression on or after a platinum-based therapy.

Urothelial Carcinoma (UC) adjuvant treatment of adult patients with UC who are at high risk of recurrence after undergoing radical resection of UC. adult patients with unresectable or metastatic urothelial carcinoma, as first-line treatment in combination with cisplatin and gemcitabine. adult patients with locally advanced or metastatic UC who: have disease progression during or following platinum-containing chemotherapy.

have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Colorectal Cancer (CRC) adult and pediatric (12 years and older who weigh 30 kg or greater) patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC), following combination treatment with intravenous nivolumab and ipilimumab.

Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic MSI-H or dMMR CRC. adult and pediatric (12 years and older who weigh 30 kg or greater) patients with MSI-H or dMMR metastatic CRC that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

Limitations of Use: OPDIVO QVANTIG is not indicated in combination with ipilimumab for the treatment of unresectable or metastatic MSI-H or dMMR CRC. Hepatocellular Carcinoma (HCC) adult patients with unresectable or metastatic HCC, as a first-line treatment following combination treatment with intravenous nivolumab and ipilimumab.

adult patients with unresectable or metastatic HCC, who have been previously treated with sora

The most important thing to know

OPDIVO is a medicine that may treat certain cancers by working with your immune system. OPDIVO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended.

You may have more than one of these problems at the same time. Some of these problems may happen more often when OPDIVO is used in combination with another therapy. Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including: Lung problems. cough shortness of breath chest pain Intestinal problems.

diarrhea (loose stools) or more frequent bowel movements than usual stools that are black, tarry, sticky, or have blood or mucus severe stomach-area (abdominal) pain or tenderness Liver problems. yellowing of your skin or the whites of your eyes severe nausea or vomiting pain on the right side of your stomach area (abdomen) dark urine (tea colored) bleeding or bruising more easily than normal Hormone gland problems.

headaches that will not go away or unusual headaches eye sensitivity to light eye problems rapid heartbeat increased sweating extreme tiredness weight gain or weight loss feeling more hungry or thirsty than usual urinating more often than usual hair loss feeling cold constipation your voice gets deeper dizziness or fainting changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness Kidney problems.

decrease in your amount of urine blood in your urine swelling of your ankles loss of appetite Skin problems. rash itching skin blistering or peeling swollen lymph nodes painful sore or ulcers in mouth or nose, throat, or genital area fever or flu-like symptoms Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with OPDIVO.

Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: chest pain, irregular heartbeat, shortness of breath or swelling of ankles confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight persistent or severe muscle pain or weakness, muscle cramps low red blood cells, bruising Rejection of a transplanted organ or tissue.

Your healthcare provider should tell you what signs and symptoms you should report and monitor you depending on the type of organ or tissue transplant that you have had. Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during treatment with OPDIVO.

Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with OPDIVO, if you have severe side effects. What is OPDIVO? OPDIVO is a prescription medicine used to treat: adults and children 12 years of age and older with a type of skin cancer called melanoma.

∘ OPDIVO may be used alone or in combination with ipilimumab to treat melanoma that has spread or cannot be removed by surgery (advanced melanoma), or ∘ OPDIVO may be used alone to help prevent Stage IIB, Stage IIC, Stage III or Stage IV melanoma from coming back after it has been completely removed by surgery. adults with a type of lung cancer called non-small cell lung cancer (NSCLC).

∘ OPDIVO may be used in combination with chemotherapy that contains platinum and another chemotherapy medicine before you have surgery for early-stage NSCLC, ∘ OPDIVO may be used in combination with chemotherapy that contains platinum and anot

Side effects, and when to stop

OPDIVO can cause serious side effects, including: Severe infusion reactions. Tell your healthcare provider or nurse right away if you get these symptoms during an infusion of OPDIVO: ∘ chills or shaking ∘ itching or rash ∘ flushing ∘ shortness of breath or wheezing ∘ dizziness ∘ feel like passing out ∘ fever ∘ back or neck pain Complications of stem cell transplant that uses donor stem cells (allogeneic).

These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with OPDIVO. Your healthcare provider will monitor you for signs of complications if you have an allogeneic stem cell transplant. The most common side effects of OPDIVO when used alone include: feeling tired rash pain in muscles, bones, and joints itching diarrhea nausea weakness cough shortness of breath constipation decreased appetite back pain upper respiratory tract infection fever headache stomach-area (abdominal) pain vomiting urinary tract infection The most common side effects of OPDIVO when used in combination with ipilimumab include: feeling tired diarrhea rash itching nausea pain in muscles, bones, and joints fever cough decreased appetite vomiting stomach-area (abdominal) pain shortness of breath upper respiratory tract infection headache low thyroid hormone levels (hypothyroidism) constipation decreased weight dizziness The most common side effects of OPDIVO when used in combination with a platinum-containing chemotherapy and another chemotherapy medicine include: nausea feeling tired pain in muscles, bones and joints constipation decreased appetite rash vomiting numbness, pain, tingling, or burning in your hands and feet The most common side effects of OPDIVO when used in combination with ipilimumab, a platinum-containing chemotherapy, and another chemotherapy medicine include: feeling tired pain in muscles, bones, and joints nausea diarrhea rash decreased appetite constipation itching The most common side effects of OPDIVO when used in combination with cabozantinib include: diarrhea feeling tired or weak liver problems.

rash, redness, pain, swelling or blisters on the palms of your hands or soles of your feet mouth sores rash high blood pressure low thyroid hormone levels pain in muscles, bones, and joints decreased appetite nausea change in the sense of taste stomach-area (abdominal) pain cough upper respiratory tract infection The most common side effects of OPDIVO when used in combination with fluoropyrimidine and platinum-containing chemotherapy include: nausea numbness, pain, tingling, or burning in your hands or feet decreased appetite feeling tired constipation mouth sores diarrhea vomiting stomach-area (abdominal) pain pain in muscles, bones, and joints The most common side effects of OPDIVO when used in combination with doxorubicin, vinblastine, and dacarbazine (AVD) include: nausea low white blood cell count feeling tired anemia constipation pain in muscles, bones, and joints increased liver enzymes numbness, pain, tingling or burning in your hands or feet vomiting mouth sores These are not all the possible side effects of OPDIVO.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.