IMFINZI was studied in a clinical trial that included people diagnosed with ES-SCLC who had not yet undergone treatment. Everyone in the clinical trial received the standard treatment for ES-SCLC, which included a combination of 2 types of chemotherapy—etoposide and carboplatin or cisplatin.
268 people
were given IMFINZI + chemotherapy*
were given IMFINZI + CRT
269 people
were given only chemotherapy*
*Etoposide and either carboplatin or cisplatin.
Median Overall Survival†
People taking IMFINZI +
chemotherapy*
13
months
People taking
chemotherapy*
alone
10.3
months
*Etoposide and either carboplatin or cisplatin.
†Median overall survival is the length of time that half the people are living. Median is the middle number in a group of numbers arranged from lowest to highest.
What should I know before taking IMFINZI?
What is the most important information I should know about IMFINZI®
IMFINZI is a medicine that may treat certain cancers, including extensive-stage small cell lung cancer, by working with your immune system.
While on IMFINZI, you may experience side effects. This is because IMFINZI works with your immune system to treat cancer, which can also affect the way normal organs and tissues work. These problems can sometimes become severe or life-threatening and can lead to death in some cases. These problems may happen anytime during treatment or even after your treatment has ended.
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, and 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; and severe stomach-area (abdomen) 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), drowsiness, dark urine (tea colored), and 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; and 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, and loss of appetite
Skin problems: rash, itching, skin blistering or peeling; painful sores or ulcers in mouth or nose, throat, or genital area; fever or flu-like symptoms; and swollen lymph nodes
Pancreas problems: pain in your upper stomach area (abdomen), severe nausea or vomiting, and loss of appetite
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 IMFINZI. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: Chest pain, irregular heartbeats, shortness of breath or swelling of ankles; confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems; tingling, numbness or weakness of the arms or legs; double vision, blurry vision, sensitivity to light, eye pain, changes in eye sight; persistent or severe muscle pain or weakness, muscle cramps, joint pain, joint stiffness or swelling; and low red blood cells and bruising
Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include: chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, and back or neck pain
Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (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 IMFINZI. Your healthcare provider will monitor you for these complications
Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with IMFINZI. 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 IMFINZI if you have severe side effects
The most common side effects of IMFINZI when used with etoposide and either carboplatin or cisplatin in adults with ES-SCLC include:
Nausea
Hair loss
Feeling tired or weak
These are not all the possible side effects of IMFINZI.
Please see full Important Safety Information below and Full Prescribing Information including Medication Guide for IMFINZI.
IMFINZI is a medicine that may treat certain cancers by working with your immune system. IMFINZI 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. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.
IMFINZI is a prescription medicine used to treat adults with a type of lung cancer called SCLC.
It is not known if IMFINZI is safe and effective in children.
Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with IMFINZI. 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 IMFINZI if you have severe side effects
Before you receive IMFINZI, tell your healthcare provider about all of your medical conditions, including if you:
Females who are able to become pregnant:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
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, hair loss, and feeling tired or weak.
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. 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.
IMFINZI is a prescription medicine used to treat adults with a type of lung cancer called small cell lung cancer (SCLC).
It is not known if IMFINZI is safe and effective in children.
Please see Full Prescribing Information including Medication Guide for IMFINZI.
IMFINZI is a medicine that may treat certain cancers by working with your immune system. IMFINZI can cause your immune system to attack normal organs and tissues in...
IMFINZI is a medicine that may treat...
IMFINZI is a prescription medicine used to treat adults with a type of lung cancer called SCLC.
IMFINZI is a medicine that may treat certain cancers by work...
IMFINZI is a medicine that may treat certain cancers by working with your immune system. IMFINZI can cause your immune system to...
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