Before you receive IMFINZI and IMJUDO, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of IMFINZI and IMJUDO?
IMFINZI and IMJUDO can cause serious side effects (see above).
The most common side effects of IMFINZI when used alone in adults with NSCLC that cannot be removed by surgery include cough, feeling tired, inflammation in the lungs, upper respiratory tract infections, shortness of breath, and rash.
The most common side effects of IMFINZI when used with platinum-containing chemotherapy in adults with NSCLC that can be removed by surgery include low red blood cells (anemia), nausea, constipation, feeling tired, muscle or bone pain, and rash.
The most common side effects of IMFINZI when used in combination with IMJUDO and platinum-containing chemotherapy in adults with metastatic NSCLC include nausea, feeling tired or weak, muscle or bone pain, decreased appetite, rash, and diarrhea.
The most common side effects of IMFINZI when used alone in adults with limited-stage small cell lung cancer (LS-SCLC) include inflammation in the lungs and feeling tired or weak.
The most common side effects of IMFINZI when used with etoposide and either carboplatin or cisplatin in adults with extensive-stage small cell lung cancer (ES-SCLC) include nausea, feeling tired or weak, and hair loss.
The most common side effects of IMFINZI when used with gemcitabine and cisplatin in adults with biliary tract cancer (BTC) include feeling tired, nausea, constipation, decreased appetite, stomach (abdominal) pain, rash, and fever.
The most common side effects of IMFINZI and IMJUDO in adults with unresectable hepatocellular carcinoma (uHCC) include rash, diarrhea, feeling tired, itchiness, muscle or bone pain, and stomach (abdominal) pain.
The most common side effects of IMFINZI when used with carboplatin and paclitaxel in adults with endometrial cancer include inflammation of the nerves causing numbness, weakness, tingling or burning pain of the arms and legs; muscle or bone pain; nausea; hair loss; feeling tired; stomach (abdominal) pain; constipation; rash; decreased level of magnesium in the blood; increased liver function tests; diarrhea; vomiting; cough; decreased level of potassium in the blood; shortness of breath; headache; and increased level of alkaline phosphatase in the blood.
The most common side effects of IMFINZI when used with BCG in adults with high-risk non-muscle-invasive bladder cancer include increased liver function tests, urinary tract infection, increased level of potassium in blood, pain or discomfort with urination, decreased red blood cells (anemia), blood in urine, increased level of creatinine in the blood, muscle or bone pain, decreased lymphocyte counts, urinate more often, decreased level of sodium in the blood, feeling tired, rash, and fever.
The most common side effects of IMFINZI when used with gemcitabine and cisplatin in adults with muscle-invasive bladder cancer (MIBC) include decreased red blood cells (anemia), decreased white blood cells, increased level of creatinine in the blood, decreased level of sodium in the blood, nausea, increased liver function tests, decreased level of calcium in the blood, decreased blood platelet counts, feeling tired, increased level of potassium in the blood, decreased lymphocyte counts, constipation, decreased level of magnesium in the blood, decreased appetite, increased level of alkaline phosphatase in the blood, rash, fever, diarrhea, vomiting, and stomach (abdominal) pain.
The most common side effects of IMFINZI when used with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) in adults with gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJC) that can be removed by surgery include: diarrhea; nausea; inflammation of the nerves causing numbness, weakness, tingling, or burning pain of the arms and legs; feeling tired; hair loss; decreased appetite; rash; stomach (abdominal) pain; vomiting; muscle and joint pain; fever; and pain and sores in the mouth.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of IMFINZI and IMJUDO. Ask your healthcare provider or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects related to AstraZeneca products
. If you prefer to report these to the FDA, either visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
Call your doctor for medical advice about side effects. You may report side effects related to AstraZeneca products. If you prefer to report these to the FDA, either visit www.FDA.gov/medwatch or call 1-800-FDA-1088.
What are IMFINZI and IMJUDO?
IMFINZI and IMJUDO are prescription medications that may treat certain cancers.
IMFINZI is used to treat adults with a type of lung cancer called NSCLC.
- IMFINZI may be used alone when your NSCLC has not spread outside your chest, cannot be removed by surgery, and has responded or stabilized with initial treatment with chemotherapy that contains platinum, given at the same time as radiation therapy.
- IMFINZI may be used in combination with chemotherapy that contains platinum prior to surgery and alone after surgery when your NSCLC is able to be removed by surgery, and your tumor does not have an abnormal “EGFR” or “ALK” gene.
- IMFINZI may be used in combination with IMJUDO and chemotherapy that contains platinum when your NSCLC has spread to other parts of your body (metastatic) and your tumor does not have an abnormal “EGFR” or “ALK” gene.
IMFINZI is used to treat adults with a type of lung cancer called SCLC.
- IMFINZI may be used alone when your LS-SCLC cannot be removed by surgery and has responded or stabilized after initial treatment with chemotherapy that contains platinum, given at the same time as radiation therapy.
- IMFINZI may be used with the chemotherapy medicines etoposide and either carboplatin or cisplatin as your first treatment when your SCLC has spread within your lungs or to other parts of the body (extensive-stage small cell lung cancer, or
ES-SCLC).
IMFINZI is used in combination with chemotherapy medicines gemcitabine and cisplatin to treat adults with a type of cancer called BTC, including cancer of the bile ducts (cholangiocarcinoma) and gallbladder cancer, when your BTC has spread to nearby tissues (locally advanced), or has spread to other parts of the body (metastatic).
IMFINZI is used in combination with IMJUDO to treat adults with a type of liver cancer that cannot be removed by surgery (unresectable hepatocellular carcinoma or uHCC).
IMFINZI is used in combination with the chemotherapy medicines carboplatin and paclitaxel followed by IMFINZI alone to treat adults with a type of uterine cancer called endometrial cancer that has spread (advanced) or has come back (recurred), and a laboratory test shows that your tumor is mismatch repair deficient (dMMR).
IMFINZI is used in combination with Bacillus Calmette-Guérin (BCG) to treat a type of bladder cancer called high-risk non-muscle-invasive bladder cancer (NMIBC) that has not spread into the muscle layer of the bladder, when you have not had prior treatment with BCG.
IMFINZI may be used in combination with the chemotherapy medicines gemcitabine and cisplatin (neoadjuvant treatment) prior to surgical removal of your bladder followed by IMFINZI alone after surgery (adjuvant treatment) to treat a type of bladder cancer called muscle- invasive bladder cancer (MIBC) that has spread into the muscle layer of the bladder but not to other parts of the body.
IMFINZI is used in combination with FLOT prior to and after surgery followed by IMFINZI alone to treat adults with a type of stomach cancer called gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJC) that can be removed by surgery.
It is not known if IMFINZI and IMJUDO are safe and effective in children.
IMPORTANT PRODUCT INFORMATION
IMFINZI® (durvalumab) and IMJUDO® (tremelimumab-actl) are prescription medications that may treat certain cancers.
IMFINZI is used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC).
- IMFINZI may be used alone when your NSCLC has not spread outside your chest, cannot be removed by surgery, and has responded or stabilized with initial treatment with chemotherapy that contains platinum, given at the same time as radiation therapy.
- IMFINZI may be used in combination with chemotherapy that contains platinum prior to surgery and alone after surgery when your NSCLC is able to be removed by surgery, and your tumor does not have an abnormal “EGFR” or “ALK” gene.
- IMFINZI may be used in combination with IMJUDO and chemotherapy that contains platinum when your NSCLC has spread to other parts of your body (metastatic) and your tumor does not have an abnormal “EGFR” or “ALK” gene.
IMFINZI is used to treat adults with a type of lung cancer called small cell lung cancer (SCLC).
- IMFINZI may be used alone when your limited-stage SCLC (LS-SCLC) cannot be removed by surgery and has responded or stabilized after initial treatment with chemotherapy that contains platinum, given at the same time as radiation therapy.
- IMFINZI may be used with the chemotherapy medicines etoposide and either carboplatin or cisplatin as your first treatment when your SCLC has spread within your lungs or to other parts of the body (extensive-stage small cell lung cancer, or ES-SCLC).
IMFINZI is used to treat adults with a type of cancer called biliary tract cancer (BTC), including cancer of the bile ducts (cholangiocarcinoma) and gallbladder cancer. IMFINZI may be used in combination with chemotherapy medicines gemcitabine and cisplatin when your BTC has spread to nearby tissues (locally advanced), or has spread to other parts of the body (metastatic).
IMFINZI is used in combination with IMJUDO to treat adults with a type of liver cancer that cannot be removed by surgery (unresectable hepatocellular carcinoma or uHCC).
IMFINZI is used in combination with the chemotherapy medicines carboplatin and paclitaxel followed by IMFINZI alone to treat adults with a type of uterine cancer called endometrial cancer that has spread (advanced) or has come back (recurred) and a laboratory test shows that your tumor is mismatch repair deficient (dMMR).
IMFINZI may be used in combination with the chemotherapy medicines gemcitabine and cisplatin prior to surgical removal of your bladder (neoadjuvant treatment) followed by IMFINZI alone after surgery (adjuvant treatment) to treat a type of bladder cancer (MIBC) that has spread into the muscle layer of the bladder but not to other parts of the body.
IMFINZI and IMJUDO can cause your immune system to attack normal organs and tissues in your body and affect how they work. Side effects can sometimes become severe or life-threatening and can lead to death. These problems can occur at the same time and at any time during or after treatment.
See your doctor right away if you experience cough, shortness of breath, chest pain, diarrhea or other stool changes, severe stomach pain or tenderness, severe nausea or vomiting, weight changes, increased hunger or thirst, constipation, dizziness or fainting, headaches, changes in urine, eye problems, irregular or rapid heartbeat, muscle pain or weakness, fever, rash, skin blistering, chills, itching or flushing, as this may keep these problems from becoming more serious.
These are not all the possible side effects of IMFINZI and IMJUDO. Tell your doctor about all of your medical conditions including immune system problems; if you’ve ever had an organ transplant; or are being treated for an infection.
Please see Full Prescribing Information including Medication Guide for IMFINZI and IMJUDO.
Small Cell Lung Cancer
