0000061822 00000 n 0000002793 00000 n Your healthcare provider will monitor you for these complications. It is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that blocks the interaction of programmed cell death ligand 1 (PD-L1) with the PD-1 (CD279). Talk to your healthcare provider about birth control methods that you can use during this time. You can have more than one of these problems at the same time. 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 or numbness of the arms or legs; double vision, blurry vision, sensitivity to light, eyepain, changes in eyesight; persistent or severe muscle pain or weakness, muscle cramps; and low red blood cells, bruising, Infusion reactions that can sometimes be severe or life-threatening. These problems may happen anytime during treatment or even after your treatment has ended. You may report side effects … IMFINZI is a registered trademark of the AstraZeneca group of companies. The healthcare provider plan does not ask about late effects and allows you to remove side effects you believe are not relevant for this patient. It is not known if IMFINZI is safe and effective in children. ; Passive exposure to tobacco smoke (passive smoking) also can cause lung cancer in non-smokers.The two types of lung cancer… Lung Cancer Support and Resources. The most common side effects when used with other anticancer medicines with SCLC include nausea, hair loss, and feeling tired or weak. The information in this site is intended for US healthcare professionals only. Unresectable Stage 3 Non-Small Cell Lung Cancer. Durvalumab is known as a checkpoint … 0000061498 00000 n Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). IMFINZI may be used 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. h�b``e``�����}�A�X؀�&X10�s`@,"^:�j�L&v�hF�. Immunotherapy Side Effects Immune checkpoint inhibitors (a type of immunotherapy) offer a promising new way to treat cancer for some patients. These are not all of the signs and symptoms of immune system problems that can happen with IMFINZI. Talk with your doctor about possible side effects for the immunotherapy recommended for you. Your healthcare provider will check you for these problems during your treatment with IMFINZI. This patient information sheet applies only to approved uses of the drug. Occasional side effects. The U.S. Food and Drug Administration (FDA) has approved Libtayo (cemiplimab-rwlc), making it the first immunotherapy for people with advanced basal cell carcinoma (BCC) — the most common form of skin cancer — who previously received or were ineligible for treatment with a hedgehog pathway … Side Effects of Cancer Treatment. 0000006278 00000 n IMFINZI can cause serious side effects (see above): The most common side effects in people with non-small cell lung cancer (NSCLC) include cough, feeling tired, inflammation in the lungs, upper respiratory tract infections, shortness of breath, and rash. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: Infusion reactions that can sometimes be severe or life-threatening. Side Effects. It is not known if IMFINZI passes into your breast milk. Sometimes the manipulation of the immune system’s brakes and gas pedals via … These side effects happen in between 1 and 10 out of every 100 people (1 to 10%). possible side effects. 246 39 News Yale Researcher Wins NIH Merit Award, Supporting Immunotherapy Work News CAR T-cell Therapy Tecartus Granted FDA Approval for Mantle Cell Lymphoma News Phase 3 Trial Launched to Test Cabometyx-Tecentriq in Advanced Kidney Cancer News New Light-activated CAR T-cells May Help Reduce Therapy Side Effects Our Cytoxan (cyclophosphamide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Learn … 0000061297 00000 n 0000061336 00000 n These complications can be serious and can lead to death. However, much of the information may also apply to unapproved uses that are being studied. ... Immunotherapy . The most common side effects in people with non-small cell lung cancer (NSCLC) include cough, feeling tired, inflammation in the lungs, upper respiratory tract infections, shortness of breath, and rash. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with IMFINZI. Serious side effects seem to happen more often with this drug than with the PD-1 and PD-L1 inhibitors. Even though the side effects of chemotherapy tend to be more severe than those of targeted therapies or immunotherapy, it's important to note that the side effects people experience today differ tremendously than those experienced by patients in the past. Clinical Trials Information. 0000001577 00000 n 0000004596 00000 n 0000056264 00000 n ... A large clinical trial showed that adding the immunotherapy drug durvalumab (Imfinzi) to standard chemotherapy can prolong survival in some people with previously untreated advanced small cell lung cancer. 0000003963 00000 n Keytruda (pembrolizumab) is an FDA-approved immunotherapy treatment for cancer. Ask your healthcare provider or pharmacist for more information. IMFINZI can cause serious side effects (see above): The most common side effects in people with non-small cell lung cancer (NSCLC) include cough, feeling tired, inflammation in the lungs, upper respiratory tract infections, shortness of breath, and rash. These complications may happen if you underwent transplantation either before or after being treated with IMFINZI. 0000004484 00000 n 0000010084 00000 n Side Effects. xref Moderna announced positive interim results from a Phase 1 clinical trial (NCT04283461) testing its potential COVID-19 vaccine mRNA-1273.The trial, led by the National Institutes of Health, is testing three different doses of mRNA-1273 in healthy volunteers ages 18–55 for safety, immune response, and adverse effects… ©2021 AstraZeneca. In clinical studies, often only the most severe side effects from RICE chemotherapy were reported and are shown here. The side effects of immune checkpoint inhibitors may include side effects similar to an allergic reaction. Important Safety Information. What are non … IMFINZI can harm your unborn baby. 0000000016 00000 n Welcome to Inspire’s Lung Cancer Survivors community offered in partnership with the American Lung Association.A lung cancer support group with over 90,000 members created for patients and caregivers living with lung cancer. This information is intended for US consumers only. ; Cigarette smoking is the principal risk factor for the development of lung cancer. The patient plan will ask you about long term effects you are experiencing. They include: tooth or mouth infections including thrush (this looks like white patches in your mouth) the flu (influenza), symptoms include a sudden fever, feeling achy and very tired; night … These abnormal cells kill the normal cells of the body and disrupt the normal body functions. Research … trailer Tell your doctor if you have any side effect that bothers you or that does not … In a multi-drug regimen, each medication has unique side effects. Tell your healthcare provider about all the medicines you take, The most common side effects in people with non-small cell lung cancer (NSCLC), The most common side effects when used with other anticancer medicines with SCLC, have immune system problems such as Crohn's disease, ulcerative colitis, or lupus, have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic), have received radiation treatment to your chest area, have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome, are pregnant or plan to become pregnant. Tell your doctor if you have any side effect that bothers you or that does not go away. 0000006527 00000 n Like those drugs, this drug can cause the immune system to attack other parts of the body, which can lead to serious problems in the intestines, liver, hormone-making glands, nerves, skin, eyes, or other organs. 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), 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; increase 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; swollen lymph nodes, Problems can also happen in other organs and tissues. Side … Getting medical treatment right away may help keep these problems from becoming more serious. IMFINZI ® (durvalumab) demonstrated consistent results in median PFS in 1-year through 4-year analyses 1,2,5. These are not all of the signs and symptoms of immune system problems that can happen with IMFINZI. These problems can sometimes become severe or life-threatening and can lead to death. 0 IMFINZI may be used with the chemotherapy medicines etoposide and 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). If you’ve researched cancer treatment options, you’ve probably heard of immunotherapy, which trains the immune system to attack cancer, rather than attacking the cancer directly.You also might have heard that immunotherapy doesn’t have side effects.. Starting Jan. 1, if members use a provider in the Northwood network, their medical copayment, cost share, coinsurance or deductible won't … Symptoms can include shivering, agitation, diarrhea, nausea and vomiting, fever, seizures, and changes in muscle function. a type of lung cancer called non-small cell lung cancer (NSCLC), a type of lung cancer called small cell lung cancer (SCLC), with the chemotherapy medicines etoposide and carboplatin or cisplatin as your first treatment when your SCLC. This change effects members as follows: Blue Cross commercial fully insured groups: For these groups and members, we're moving to one provider, Northwood, beginning Jan. 1, 2021. Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. All rights reserved. 0000005727 00000 n 0000008589 00000 n You should use an effective method of birth control during your treatment and for at least 3 months after the last dose of IMFINZI. 0000001396 00000 n 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 when used with other anticancer medicines … But that’s not always the case. 0000004370 00000 n Immune-mediated adverse … You may report side effects related to AstraZeneca products by clicking here. We collect these anonymous answers to learn more about the issues facing survivors. startxref When these medicines are given together, drug-related side effects reported in clinical studies give the best estimate of what to expect. Learn more about the basics of immunotherapy and its side effects. 0000004683 00000 n Physical, emotional, and social effects … For example, the side effects of monoclonal antibodies used for targeted therapy are not like those used for immunotherapy. 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. IMFINZI is a medicine that may treat certain cancers by working with your immune system. Lung cancer may spread to the lymph nodes or other organs in the body that commonly include the … Getting medical treatment right away may help keep these problems from becoming more serious. Long-term side effects of anti-cancer medications are specific to each medication. Before you receive IMFINZI, 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. <<114C08965827F44D8C2321BEF96C6372>]/Prev 94198/XRefStm 1396>> %PDF-1.4 %���� You are about to enter the IMFINZI.com site for healthcare professionals. Lung cancer is the number one cause of cancer deaths in both men and women in the U.S. and worldwide. %%EOF 0000016805 00000 n The side effects of monoclonal antibody treatment depend on the drug’s purpose. 0000001736 00000 n Durvalumab (trade name Imfinzi) is an FDA-approved immunotherapy for cancer, developed by Medimmune/AstraZeneca. 0000011665 00000 n In unresectable Stage III NSCLC following chemoradiotherapy. Not all anti-cancer or chemotherapy medications have long-term side effects, but several have been associated with memory difficulties (sometimes called "chemo brain"), heart problems, diabetes, numbness or tingling in hands and feet, fertility … Several immunotherapy medicines are approved by the FDA to treat breast cancer, including Herceptin, Perjeta, and Kadcyla (immune targeted therapies), and Keytruda and Tecentriq (immune checkpoint inhibitors). Immunotherapy is one of the most promising forms of lung cancer treatment to come along in decades. There are no contraindications for IMFINZI ® (durvalumab).. Immune-Mediated Adverse Reactions. 0000018082 00000 n 0000014896 00000 n 1-year primary PFS analysis (14.5 months median follow-up): PFS was statistically significant 2,5 *. Call your doctor for medical advice about side effects. Drugs are often studied to find out if they can help treat or prevent conditions other than the ones they are approved for. Molecular profiling, which identifies specific DNA mutations in tumor cells, can determine if a person has a treatable mutation and is a candidate for therapy. Please click here for complete Prescribing Information, including Patient Information (Medication Guide). In a large clinical trial, the immunotherapy … The many current and planned clinical trials testing its effectiveness are clear proof. Do not breastfeed during treatment and for at least 3 months after the last dose of IMFINZI. 0000013313 00000 n Lung cancer is cancer that originates in the lung cells.. Cancer is an abnormal and uncontrolled growth of the cells in the body. 0000005276 00000 n Immunotherapy is an umbrella term for cancer treatments that harness your own immune system. 0000019042 00000 n 0000026658 00000 n Learn how different types of immunotherapy work. Potential side effects may vary according to the type of immunomodulator—and what exactly it targets—and may also be influenced by the location and type of cancer as well as a patient’s overall health. Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). are breastfeeding or plan to breastfeed. Call your doctor for medical advice about side effects. Because of this, the side effects tend to be less severe than with chemotherapy drugs. 0000061660 00000 n In some people these side … 0000003387 00000 n Common side effects include skin reactions, flu-like symptoms, diarrhea, lung inflammation causing shortness of breath, and weight changes. IMFINZI is a prescription medicine used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC). 0000015416 00000 n IMFINZI is a prescription medicine used to treat adults with a type of lung cancer called small cell lung cancer (SCLC). 0000056390 00000 n Progression-Free Survival. Median PFS: 16.8 months with IMFINZI … “With the most common type of immunotherapy … These are not all the possible side effects of IMFINZI. US-49425 Last Updated 2/21. 0000014473 00000 n {g ��h ���]\. 0000061984 00000 n Immune Checkpoint Inhibitors and Their Side Effects An important function of the immune system is its ability to tell between normal cells in the body and those it sees as “foreign.” This lets the immune system attack the foreign cells while leaving the normal cells alone. 0000023202 00000 n You might have one or more of them. If you prefer to report these to the FDA, either visit www.FDA.gov/medwatch or call 1-800-FDA-1088. 246 0 obj <> endobj Immunotherapy medicines work by helping your immune system attack cancer cells. Problems can also happen in other organs and tissues. Less common, but important side effects can include: Serotonin Syndrome : This medication can cause a high level of serotonin in your body, which in rare cases, can lead to serotonin syndrome. 0000016708 00000 n 0000001096 00000 n Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. 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. OncoLink, the Web's first cancer resource,provides comprehensive information on coping with cancer, cancer treatments, cancer research advances, continuing medical education, cancer prevention, and clinical trials 0000016953 00000 n This is not a complete list of side effects and others may occur. 284 0 obj <>stream 0000006953 00000 n
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