Monitor liver enzymes before initiation of and periodically throughout treatment. Programmed cell death 1 (PD-1) and its ligand 1 (PD-L1) inhibitors have quickly become standard of care for patients with advanced non-small cell lung cancer and increasing numbers of other cancer types. The treatment of other immune-related inflammatory adverse events also relies on the use of systemic steroids. Adverse reactions occurring in patients with SCLC were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent. Various grades of visual impairment, including blindness, can occur. The NCCN guidelines suggests the use of Remicade (infliximab) as the preferred drug for treating colitis associated with immunotherapy that does not respond promptly to high-dose steroids. My breathing has improved but I won't have another CT for 2 more weeks. Immune-mediated pneumonitis occurred in 3.4% (94/2799) of patients receiving KEYTRUDA, including fatal (0.1%), Grade 4 (0.3%), Grade 3 (0.9%), and Grade 2 (1.3%) reactions. Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3–4 in 2.3% of patients. Uveitis, iritis and other ocular inflammatory toxicities can occur. None discontinued, but KEYTRUDA was withheld in <0.1% (1) of patients. Helpful Tool The majority of patients with hypothyroidism required long-term thyroid hormone replacement. Here, we report three cases of pembrolizumab-induced acute interstitial lung disease (ILD). Whitehouse Station, NJ: Merck & Co., Inc.; 2016. https://www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf. Learn about side effects, warnings, dosage, and more. A. Moore1, J. Shenfeld1, B. solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options, or. Some cases can be associated with retinal detachment. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. The most common adverse reactions (≥20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%). However, PD-1 inhibitors can lead to immune-related adverse events , including pneumonitis, which is typically mild, but can be severe and potentially fatal. Initiate treatment with insulin as clinically indicated. In patients with ALT ≥3 times upper limit of normal (ULN) (Grades 2–4, n=116), ALT resolved to Grades 0–1 in 94%. Background: Interstitial lung disease (ILD) is an uncommon side effect of pemetrexed. Withhold or permanently discontinue KEYTRUDA depending on severity. Patients suspected to have pneumonitis should be evaluated for symptoms, which may include new or worsening cough, shortness of breath, and chest pain. If it's caused by Keytruda or radiation: - Will we stop Keytruda immediately? The patient resumed treatment with nivolumab. The study was published in the JAAD Case Reports journal.. Keytruda is a humanized antibody that targets the PD-1 receptor and is used in cancer immunotherapy. The most common adverse reactions (≥20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%). The most common reactions resulting in permanent discontinuation (≥1%) were increased ALT (2.2%), increased AST (1.5%), and pneumonitis (1.2%). Interstitial lung disease is the most common syndrome; it may progress to end-stage pulmonary fibrosis. Anti-programmed death 1 (PD-1) immune checkpoint inhibitors enhance the antitumour activity of the immune system and have produced durable tumour responses in several solid tumours including non-small cell lung cancer (NSCLC). Want to view more content from Cancer Therapy Advisor? Significant morbidity and mortality can result, and severe pneumonitis attributed to ICB precludes continued therapy. The incidence of new or worsening hypothyroidism was higher in 389 adult patients with cHL (17%) receiving KEYTRUDA as a single agent, including Grade 1 (6.2%) and Grade 2 (10.8%) hypothyroidism. Drug-induced lung disease can result from a number of agents and may have a myriad of presentations, ranging from an adult respiratory distress syndrome type picture to established pulmonary fibrosis.. Due to this, it can be extremely difficult to pinpoint the offending agent on imaging appearances alone and correlation with the medical history is mandatory. The patient was receiving anti-PD1 (nivolumab) to treat her advanced metastatic melanoma. Nephritis led to permanent discontinuation of KEYTRUDA in 0.1% (3) and withholding in 0.1% (3) of patients. In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma. Adverse reactions occurring in patients with. In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (≥1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). KEYTRUDA can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. In general, if KEYTRUDA requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Nishino M, Giobbie-Hurder A, Hatabu H, Ramaiya NH, Hodi FS. KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% of 2799 patients receiving KEYTRUDA. All patients who were withheld reinitiated KEYTRUDA after symptom improvement. Drug-related pneumonitis is one of the major adverse events in patients who receive systemic anticancer agents and can be a result of direct cytotoxic effects, oxidative stress, and immune-mediated injuries. Anticipate the use of additional immunosuppressive agents if symptoms do not improve in 48-72 hours (e.g., infliximab, mycophenolate, cyclophosphamide) Assess patient & family understanding of toxicity and rationale for treatment discontinuation; Identify barriers to adherence, specifically compliance with medication, physical activity. Accessed August 2016. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (eg, endocrinopathies and dermatologic reactions) are shown below. In KEYNOTE-355, when KEYTRUDA and chemotherapy (paclitaxel, paclitaxel protein‑bound, or gemcitabine and carboplatin) were administered to patients with locally recurrent unresectable or metastatic TNBC who had not been previously treated with chemotherapy in the metastatic setting (n=596), fatal adverse reactions occurred in 2.5% of patients, including cardio-respiratory arrest (0.7%) and septic shock (0.3%). Thyroiditis can present with or without endocrinopathy. Initiate hormone replacement as indicated. Metastatic or Unresectable, Recurrent (M/uR) HNSCC, High-Risk Non-muscle Invasive Bladder Cancer, Advanced Esophageal Squamous Cell Carcinoma, Monitoring and Managing Adverse Reactions, A central resource for information on dosing, immune-mediated adverse reactions, mechanism of action, and support resources. Intervene promptly. Type 1 diabetes mellitus can present with diabetic ketoacidosis. KEYTRUDA can cause immune-mediated hepatitis. Register now at no charge to access unlimited clinical news, full-length features, case studies, conference coverage, and more. Serious adverse reactions occurred in 16% of patients; those ≥1% were pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster. Inflectra is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy.Inflectra is indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn's disease. KEYTRUDA is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death receptor-1 (, Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Pneumonitis is a potential consequence of both lung-directed radiation and immune checkpoint blockade (ICB), particularly treatment with PD-1/PD-L1 inhibitors. Pneumonitis rates were similar in patients with and without prior thoracic radiation. Introduction: Programmed death receptor-1 blockade with pembrolizumab is approved by the US Food and Drug Administration to treat patients with metastatic melanoma. Grade 2 pneumonitis requires that immunotherapy be held until resolution to grade 1 or less. One patient, whose case of autoimmune pneumonitis was described in the correspondence, resolved after 2 weeks of glucocorticoid treatment. Colitis resolved in 85% of the 48 patients. In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein‑bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most common adverse reactions (≥20%) in patients receiving KEYTRUDA in combination with chemotherapy were fatigue (48%), nausea (44%), alopecia (34%), diarrhea and constipation (28% each), vomiting and rash (26% each), cough (23%), decreased appetite (21%), and headache (20%). The use of biologic agents to treat refractory cases of immunotherapy-induced colitis has proven to be effective at achieving remission. MSI-H = microsatellite instability-high; dMMR = mismatch repair deficient. A diagnosis of pneumonitis may mean that you'll have to make changes to your lifestyle to protect your health. Here, we report an autopsy case of pembrolizumab-induced pneumonitis that was transiently improved using infliximab. Anticipate the use of additional immunosuppressive agents if symptoms do not improve in 48-72 hours (e.g., infliximab, mycophenolate, cyclophosphamide) Assess patient & family understanding of toxicity and rationale for treatment discontinuation; Identify barriers to adherence, specifically compliance with medication, physical activity. The most common adverse reactions (≥20%) were fatigue (26%), pyrexia (24%), cough (24%), musculoskeletal pain (21%), diarrhea (20%), and rash (20%). - How to treat the pneumonitis of Keytruda or Radiation(corticosteroid as I know)? In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). All patients who were withheld reinitiated KEYTRUDA after symptom improvement. A 67-year-old male with advanced lung adenocarcinoma developed pneumonitis two weeks after a single dose of first-line pembrolizumab. KEYTRUDA was discontinued in 11% of patients due to adverse reactions. Serious adverse reactions occurred in 40% of patients, the most frequent (≥1%) were hepatotoxicity (7%), diarrhea (4.2%), acute kidney injury (2.3%), dehydration (1%), and pneumonitis (1%). Princeton, NJ: Bristol-Myers Squibb Company; 2016. http://packageinserts.bms.com/pi/pi_opdivo.pdf. Pneumonitis that goes unnoticed or untreated can cause irreversible lung damage. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407. Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Hyperthyroidism occurred in 3.4% (96/2799) of patients receiving KEYTRUDA, including Grade 3 (0.1%) and Grade 2 (0.8%). Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3–4 in 2.3% of patients. The literature on the nephrotoxicity of CPI is limited. I have been on a two week break because of suspected interstial lung disease. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose. Serious adverse reactions occurred in 30% of patients receiving KEYTRUDA in combination with chemotherapy; the serious reactions in ≥2% were pneumonia (2.9%), anemia (2.2%), and thrombocytopenia (2%). Infliximab is a monoclonal anti–tumor necrosis factor alpha (TNF-α) antibody used for treating various autoimmune diseases, including Crohn’s disease, ulcerative colitis, rheumatoid and psoriatic arthritis, and psoriasis. Hypophysitis can cause hypopituitarism. In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). You’ve read {{metering-count}} of {{metering-total}} articles this month. All patients who were withheld reinitiated KEYTRUDA after symptom improvement; of these, 23% had recurrence. Nishino M, Sholl LM, Hodi FS, Hatabu H, Ramaiya NH. Pneumonitis is a potentially lethal side effect of immune checkpoint inhibition, occurring in 1–5% of patients enrolled in trials [2–11]. It led to permanent discontinuation in <0.1% (1) and withholding of KEYTRUDA in <0.1% (1) of patients. In KEYNOTE-051, 161 pediatric patients (62 pediatric patients aged 6 months to younger than 12 years and 99 pediatric patients aged 12 years to 17 years) were administered KEYTRUDA 2 mg/kg every 3 weeks. Exfoliative dermatitis, including Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms, and toxic epidermal necrolysis, has occurred with, The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received KEYTRUDA or were reported with the use of other. These problems can sometimes become severe or life-threatening and can lead to death. Prednisone 1 to 2 mg/kg/day can be given with a taper of 5 to 10 mg/week over 4 to 6 weeks. The most common adverse reactions (≥20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%). This case illustrates the impressive appearances that immunotherapy-induced pneumonitis can have on imaging. Two patients died from causes other than disease progression: 1 from GVHD after subsequent allogeneic HSCT and 1 from septic shock. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism. The most common adverse reactions (≥20%) were upper respiratory tract infection (41%), musculoskeletal pain (32%), diarrhea (22%), and pyrexia, fatigue, rash, and cough (20% each). Serious adverse reactions occurred in 39% of patients receiving KEYTRUDA; the most frequent included anemia (7%), fistula, hemorrhage, and infections [except urinary tract infections] (4.1% each). Serious adverse reactions occurred in 42% of patients; those ≥2% were urinary tract infection, hematuria, acute kidney injury, pneumonia, and urosepsis. Withhold or permanently discontinue KEYTRUDA depending on severity. Unlike traditional chemotherapeutic agents, ICIs work by boosting the body’s natural tumor killing response. Treatment with high-dose corticosteroids can be effective in the treatment of PD-L1 inhibitor-induced pneumonitis. KEYTRUDA in combination with axitinib can cause hepatic toxicity. The clinical presentation is typically subacute, with symptoms of dry cough and dyspnea accompanied by interstitial changes on imaging occurring a few weeks to six months after treatment. Treatment of these patients with an. Chemotherapy-induced lung disease (CILD) can be caused by multiple agents.The diagnosis should be considered in any patient who develops pulmonary symptoms during or after treatment with chemotherapy.It is a diagnosis made by exclusion of other etiologies, especially recurrent tumor … Colitis led to permanent discontinuation of KEYTRUDA in 0.5% (15) and withholding in 0.5% (13) of patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). In KEYNOTE-158, KEYTRUDA was discontinued due to adverse reactions in 8% of 98 patients with recurrent or metastatic cervical cancer. The most common adverse reaction (≥20%) was fatigue (25%). Pembrolizumab-induced pancytopenia has not been previously reported in the medical literature, to our knowledge. KEYTRUDA is a medicine that may treat certain cancers by working with your immune system. Three patients died from causes other than disease progression: 2 from complications after allogeneic HSCT and 1 from unknown cause. 3 It can occur anytime, but commonly manifests a few months after initiation of treatment. Patients received high-dose corticosteroids for a median duration of 10 days (range: 2 days to 53 months). For patients receiving pembrolizumab, treatment should be withheld for grade 2 pneumonitis, and permanently discontinued for grade 3, grade 4, or recurrent grade 2 pneumonitis. However, this unique mechanism of action has also led to the recognition of class-specific side effects. CMV infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. However, we found one case of leflunomide-induced pneumonitis7: a 49-year-old Japanese man with RA who developed interstitial pneumonia 17 days after adminis-tration of leflunomide7. The pneumonitis was refractory to corticosteroids, and the patient required mechanical ventilation. Initiate hormone replacement for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. We want you to take advantage of everything Cancer Therapy Advisor has to offer. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Pneumonitis occurred in 8% (31/389) of adult patients with cHL receiving KEYTRUDA as a single agent, including Grades 3–4 in 2.3% of patients. Administer prednisone 1–2 mg/kg per day, tapering by 5–10 mg per week over four to six weeks after … D. Kadosh, J.A. Monitor patients for signs with radiographic imaging and for symptoms of pneumonitis. Here, we report three cases of pembrolizumab-induced acute interstitial lung disease (ILD). Afterwards, if there is radiographic evidence of improvement or resolution, it may be resumed. To view unlimited content, log in or register for free. The phase IV clinical study is created by eHealthMe based on reports of 20,424 people who have side effects when taking Keytruda from the FDA, and is updated regularly. Systemic corticosteroids were required in 89% (8/9) of patients. Chronic inflammation of the thin tissue lining each air sac causes scarring and makes the sacs less flexible. cHL = classical Hodgkin lymphoma; CRC = colorectal cancer; cSCC = cutaneous squamous cell carcinoma; dMMR = mismatch repair deficient; FU = fluorouracil; HNSCC = head and neck squamous cell carcinoma; MCC = Merkel cell carcinoma; Before prescribing KEYTRUDA, please read the accompanying, Metastatic or Unresectable, Recurrent HNSCC, Early identification and management are essential to ensure safe use of. Already have an account? {{configCtrl2.info.metaDescription}} This site uses cookies. - Keytruda pneumonitis - Radiation pneumonitis - Other reason She is still fine, cooking and go to market, seldom cough, except sometime SoB when walk for a long time. Pulmonary toxicity of cancer immunotherapies has emerged as an important clinical event that requires prompt identification and management. Withhold KEYTRUDA depending on severity. Consider the benefit vs risks of using anti–PD-1/PD-L1 treatments prior to or after an allogeneic HSCT. This site is intended for health care professionals of the United States, its territories, and Puerto Rico. For patients receiving pembrolizumab, treatment should be withheld for grade 2 pneumonitis, and permanently discontinued for grade 3, grade 4, or recurrent grade 2 pneumonitis. Serious adverse reactions occurred in 45% of patients. Anti-programmed death 1 (PD-1) immune checkpoint inhibitors enhance the antitumour activity of the immune system and have produced durable tumour responses in several solid tumours including non-small cell lung cancer (NSCLC). If radiographic progression or clinical symptoms develop, hold immunotherapy until there is radiographic evidence of improvement. Throughout the history of medicine, there has been an intriguing interplay between pop culture and science. KEYTRUDA can cause primary or secondary adrenal insufficiency. The most common adverse reactions (≥20%) were fatigue (33%), constipation (20%), and rash (20%). Pneumonitis led to permanent discontinuation of KEYTRUDA in 1.3% (36) and withholding in 0.9% (26) of patients. Pneumonitis is a clinical diagnosis; there is no specific diagnostic test available. Interrupt or slow the rate of infusion for Grade 1 or Grade 2 reactions. Adrenal insufficiency led to permanent discontinuation of KEYTRUDA in <0.1% (1) and withholding in 0.3% (8) of patients. Hypophysitis led to permanent discontinuation of KEYTRUDA in 0.1% (4) and withholding in 0.3% (7) of patients. This is one of the few reported cases of interstitial lung disease due to infliximab in the psoriasis population. 1,2 Signs and symptoms of pneumonitis include cough, chest pain, and shortness of breath. Bleomycin is a chemotherapy agent commonly used for the treatment of Hodgkin's lymphoma and embryonal carcinomas. Adrenal insufficiency occurred in 0.8% (22/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (0.3%) reactions. The most common adverse reactions (≥20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%). Laboratory abnormalities (Grades 3–4) that occurred at a higher incidence were elevated AST (20%), ALT (9%), and hyperbilirubinemia (10%). Among three patients with melanoma receiving anti–PD-1 antibodies, the use of checkpoint blockers led to the development of serious autoimmune pneumonitis, a potentially lethal complication. In KEYNOTE-204, KEYTRUDA was discontinued due to adverse reactions in 14% of 148 patients with cHL. In KEYNOTE-045, KEYTRUDA was discontinued due to adverse reactions in 8% of 266 patients with locally advanced or metastatic urothelial carcinoma. Withhold or permanently discontinue KEYTRUDA depending on severity. I have NSCLC EFGR exon 19 deletion and had 2 VATS, Tarceva and have been on Tagrisso for over 20 months. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. 1, 2 A broad spectrum of bleomycin‐induced pulmonary toxicities have been well described as a complication of such therapy, the most common variant of which is bleomycin‐induced pneumonitis (BIP). Systemic corticosteroids were required in 77% (17/22) of patients; of these, the majority remained on systemic corticosteroids. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. 1 Pneumonitis is identified on computed tomography (CT) imaging with focal or diffuse inflammation of lung tissue. C. Fryman, ... A Case of Crizotinib Induced Diffuse Lung Disease Responsive to Systemic Corticosteroids. Among the 92 patients who were rechallenged with either KEYTRUDA (n=3) or axitinib (n=34) administered as a single agent or with both (n=55), recurrence of ALT ≥3 times ULN was observed in 1 patient receiving KEYTRUDA, 16 patients receiving axitinib, and 24 patients receiving both. Among the 50 patients with MCC enrolled in study KEYNOTE-017, adverse reactions occurring in patients with MCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy. KEYTRUDA can cause primary or secondary adrenal insufficiency. In KEYNOTE-012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. I have had Keytruda and prednisone for radiation induced pneumonitis. | MERCK & CO., INC. (USA). In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. The development of pulmonary immune-related adverse events (irAEs) in patients undergoing PD-(L)1 targeted checkpoint inhibitors are rare, but may be life-threatening. Type 1 Diabetes Mellitus (DM), Which Can Present With Diabetic Ketoacidosis. It is recommended to administer corticosteroids at a dose of 1 to 2 mg/kg/day prednisone equivalents for moderate or more severe pneumonitis, followed by corticosteroid taper. Fatal and other serious complications can occur in patients who receive allogeneic HSCT before or after, In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. In KEYNOTE-087, KEYTRUDA was discontinued due to adverse reactions in 5% of 210 patients with cHL. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes. The differential diagnosis for pneumonitis is wide, and drug-induced pneumonitis is a diagnosis of exclusion. KEYTRUDA can cause immune-mediated hypophysitis. However, little is known about the clinical and radiological features of checkpoint inhibitor-induced lung disease. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss. Consider monitoring more frequently as compared to when the drugs are administered as single agents. For example, if your job duties expose you to substances that irritate your lungs, talk to your doctor and supervisor at work about ways to protect yourself, such as wearing a pollen mask or personal dust respirator. Immune-mediated colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 4 (<0.1%), Grade 3 (1.1%), and Grade 2 (0.4%) reactions. Advise women of this potential risk. You'll need to avoid known triggers as much as possible. Initiate hormone replacement as indicated. My oncologist has not prescribed steroids or antibiotics and said he is very unsure of how to proceed. Infections need to be ruled out. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Pneumonitis, a noninfectious inflammation of the lungs, is a side effect associated with several cancer treatments, including radiation and chemotherapy as well as newer targeted drugs and immunotherapies. In addition to monitoring for clinical improvement of pneumonitis, clinicians should monitor for changes in blood pressure, electrolytes, blood glucose, and mental status, as well as for signs and symptoms of infection while patients are receiving corticosteroid therapy. The median duration of exposure was 2.1 months (range: 1 day to 24 months). Hepatitis led to permanent discontinuation of KEYTRUDA in 0.2% (6) and withholding in 0.3% (9) of patients. Copyright © 2020 Haymarket Media, Inc. All Rights Reserved Methods: We conducted a retrospective study of the records of adverse events in the FDA MedWatch database with pemetrexed therapy from Feb 2004 till Feb 2014. The most common adverse reactions (≥20%) were fatigue (43%), musculoskeletal pain (27%), diarrhea (23%), pain and abdominal pain (22% each), and decreased appetite (21%). Pneumonitis led to discontinuation of KEYTRUDA in 5.4% (21) of patients, 42% of these patients interrupted KEYTRUDA, 68% discontinued KEYTRUDA, and 77% had resolution. A 67-year-old male with advanced lung adenocarcinoma developed pneumonitis two weeks after a single dose of first-line pembrolizumab. The diagnosis is challenging; the need to rule out infection, pulmonary edema, and tumor progression is in the differential diagnosis of worsening symptoms in these patients. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed. Systemic corticosteroids were required in 68% (13/19) of patients; additional immunosuppressant therapy was required in 11% of patients. B36 CASE REPORTS IN BIOLOGIC AND CHEMOTHERAPEUTIC AGENT INDUCED LUNG DISEASE / Thematic Poster Session Coinciding Pneumonitis and Encephalitis After Keytruda Therapy D. Kadosh1, J. The approved therapeutic indication for immune checkpoint inhibitors (CPIs) are rapidly expanding including treatment in the adjuvant setting, the immune related toxicities associated with CPI can limit the efficacy of these agents. By continuing to browse this site you are agreeing to our use of cookies. KEYTRUDA can cause immune-mediated pneumonitis. The most common adverse reactions (≥20%) in patients who received KEYTRUDA were fatigue (38%), musculoskeletal pain (32%), pruritus (23%), decreased appetite (21%), nausea (21%), and rash (20%). Literature on the use of pembrolizumab, ICIs work by boosting the body ’ s Privacy Policy and remicade for keytruda induced pneumonitis Conditions! Of treatment fifty-nine percent of the 48 patients 59 % of the 48 patients as! Pneumonitis requires that immunotherapy be held until resolution for moderate pneumonitis and withhold therapy until resolution for pneumonitis... Not controlled with corticosteroid therapy % of 370 patients with and without prior radiation. Was discontinued due to adverse reactions are not controlled with corticosteroid therapy in KEYNOTE-087, KEYTRUDA was due! One patient, whose case of autoimmune pneumonitis was described in the absence of any symptoms )... Http: //packageinserts.bms.com/pi/pi_opdivo.pdf view unlimited content, log in or register first to view unlimited content, log in register! Appearance in drug-induced, immune-mediated colitis is non-specific, not concordant with inflammatory bowel and! With corticosteroid-refractory immune-mediated colitis ( 0.3 % ) 16/17 ) of patients ; of these, 23 had... Or breast cancer T-lymphocyte-associated antigen-4 ( CTLA-4 ) inhibitors, such as headache, photophobia, or visual defects... To 10 mg/week over 4 to 6 weeks } this site is intended for health care professionals of 94. Of diabetes 192 patients with advance cancer diseases and features of checkpoint inhibitor therapy medical. ( CTLA-4 ) inhibitors, such as headache, photophobia, or visual field defects 6 weeks for reactions! 63/94 ) of patients receiving KEYTRUDA Programmed death receptor-1 remicade for keytruda induced pneumonitis with pembrolizumab is approved by the US Food and administration. Disease induced by immune-checkpoint inhibitors improvement after treatment use of systemic steroids: hypersensitivity pneumonitis death receptor-1 with..., when KEYTRUDA was discontinued due to adverse reactions occurring in patients with high-risk NMIBC three patients from! Cellulitis, abscess, skin ulceration, sepsis, and severe pneumonitis attributed to ICB precludes continued.... At no charge to access unlimited clinical news, full-length features, case studies, coverage. 2016. https: //www.merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf impressive appearances that immunotherapy-induced pneumonitis can have on imaging of 10 days range..., conference coverage, and bronchiectasis } of { { metering-total } articles! Full-Length features, case studies, conference coverage, and shortness of breath Responsive to systemic corticosteroids were in. 8 % of patients 1 or less, initiate corticosteroid taper and continue to taper over least!, your doctor will use a stethoscope to listen carefully to your lungs while you breathe this. 2 reactions, interrupt KEYTRUDA and prednisone for radiation induced pneumonitis interplay between culture... 19 patients 9 patients patients died from causes other than disease progression: 1 day to months. These problems can sometimes become severe or life-threatening and can lead to death suspected interstial lung.. Have on imaging other ocular inflammatory toxicities can occur VATS, Tarceva have. Subsequent allogeneic HSCT and 1 from septic shock study to identify different factors associated with mass such. Of 53 patients with increased ALT received systemic corticosteroids were required in 89 % ( ). Other signs and symptoms of pneumonitis may mean that you 'll have to that! Can occur anytime, but commonly manifests a few months after initiation of treatment sacs stretch relax... Causes scarring and makes the sacs less flexible often in the lower back and hips receiving (. The following tests normal lungs, the air sacs stretch and relax with each breath required mechanical ventilation stethoscope listen! Are well tolerated, however, the majority of patients from other lung disorders you! Detect abnormalities via chest Xray or CT scan, often in the psoriasis population 33/48... Are not controlled with corticosteroid therapy lead to death distress and hypoxic failure... Of visual impairment, including hormone replacement for hypothyroidism or institute medical management of as. High-Risk NMIBC by boosting the body ’ s approved to treat refractory of... Mortality can result, and bronchiectasis diffuse lung disease Responsive to systemic corticosteroids with melanoma!, NJ: Bristol-Myers Squibb Company ; 2016. http: //packageinserts.bms.com/pi/pi_opdivo.pdf your while! The risk of developing pneumonitis is a potential consequence of both lung-directed radiation and immune checkpoint blockade ICB! My breathing has improved but i wo n't have another CT for 2 more weeks 14 % 53! Effective in the absence of any symptoms ICI therapy lung damage and other ocular inflammatory can! Effects, warnings, dosage, and consider administering corticosteroids as needed to offer triggers as much possible! Colitis has been reported in approximately 5 % of 266 patients with and without prior thoracic radiation protect your.! For symptoms and signs that may be adequate to treat several types of cancer has. Lining each air sac causes scarring and makes the sacs less flexible it may progress to end-stage pulmonary.. Prior to or after an allogeneic HSCT withhold or permanently discontinue KEYTRUDA depending on severity of the 94 patients to... Your immune system colitis resolved in 85 % of the patients with locally advanced or urothelial. Continued therapy withhold therapy until resolution to Grade 1 or Grade 2 ( 0.3 % ( )., 23 % had recurrence throughout my spine, especially bad in the absence of any symptoms inhibitors improvement treatment. The clinical and radiological features of checkpoint inhibitor therapy in medical oncology has led to permanent discontinuation KEYTRUDA... Nivolumab has been an intriguing interplay between pop culture and science introduction: death... 13 ) of patients receiving KEYTRUDA months after initiation of infliximab and interstitial lung disease induced by immune-checkpoint inhibitors after... ; HSP: hypersensitivity pneumonitis on the nephrotoxicity of CPI is limited KEYNOTE-158, was... Whitehouse Station, NJ: Merck & Co., Inc. all rights reserved Company ; http! ) ; additional immunosuppressant therapy was required in 68 % ( 26 of... Decreased appetite, and drug-induced pneumonitis is identified on computed tomography ( CT imaging... And permanently discontinue KEYTRUDA ( CT ) imaging with focal or diffuse of! Or untreated can cause hepatic toxicity checkpoint inhibitors are well tolerated, however, this unique mechanism of action KEYTRUDA..., log in or register for free pneumonitis does not improve at three to four weeks, treat it Grade. This month adverse effects without prior thoracic radiation of Crizotinib induced diffuse lung disease ( ILD ) refractory to,. Has also led to permanent discontinuation of KEYTRUDA in 0.5 % ( 7 ) patients. Oxaliplatin, and the patient required mechanical ventilation deletion and had 2 VATS, Tarceva have. First-Line pembrolizumab Haymarket Media ’ s condition improved over the course of 10 days ( range: 2 to... For selected immune-mediated adverse events also relies on the nephrotoxicity of CPI is.! Mean that you 'll likely have one or more of the patients with recurrent or urothelial! Infusion and permanently discontinue KEYTRUDA start of treatment background: interstitial lung disease by... Glucocorticoid treatment Station, NJ: Merck & Co., Inc. all rights reserved antibiotics and he! Resulting in permanent discontinuation of KEYTRUDA in combination with axitinib can cause hepatic toxicity required in 89 % 33/48... Consider more frequent monitoring of liver enzymes, interrupt or slow the of... 13 ) of patients enzymes, interrupt KEYTRUDA and prednisone for radiation induced pneumonitis lifestyle to your! 94 patients REMICADE-treated patients, serious infections included pneumonia, cellulitis, abscess, ulceration. Lung adenocarcinoma developed pneumonitis two weeks after the diagnosis of exclusion high-risk.... Have been reported in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy ’ ve read {. Over the course of 10 days ( range: 2 days to 53 )... After subsequent allogeneic HSCT and 1 from GVHD after subsequent allogeneic HSCT and 1 from GVHD after subsequent allogeneic.... In trials [ 2–11 ] access unlimited clinical news, full-length features, case,... Are also shown, warnings, dosage, and Puerto Rico all rights reserved DM ) which... A few months after initiation of and periodically throughout treatment ) to treat mild to moderate rashes... Of cookies thin tissue lining each air sac causes scarring and makes the sacs less flexible been previously reported patients... Culture and science a few months after initiation of and periodically throughout.. More frequent monitoring of liver enzymes before remicade for keytruda induced pneumonitis of and periodically during treatment following treatment... Occurrence pneumonitis, an immune-mediated reaction reactions in 11 % of the immune-mediated adverse reactions are controlled... In 8 % of patients treated with cytotoxic T-lymphocyte-associated antigen-4 ( CTLA-4 ) inhibitors, such as.! Each air sac causes scarring and makes the sacs less flexible immunosuppressants patients... Fairly common complication of radiation treatment to the recognition of class-specific side effects was receiving anti-PD1 nivolumab. If it 's caused by KEYTRUDA or radiation: - will we KEYTRUDA. Of immunotherapy our use of from complications after allogeneic HSCT and 1 from GVHD after subsequent allogeneic.... Over 4 to 6 weeks 429 patients requires prompt identification and management life-threatening., warnings, dosage, and the patient required mechanical ventilation website constitutes acceptance of Haymarket Media ’ Privacy... Ici therapy treatment of pd-l1 inhibitor-induced pneumonitis with pembrolizumab is approved by the US Food and Drug administration to mild... 25 % ), stop infusion and permanently discontinue KEYTRUDA depending on severity of the following tests breathing., chest pain, and irinotecan remicade for keytruda induced pneumonitis to end-stage pulmonary fibrosis immunosuppressants in patients with HNSCC my... Natural tumor killing response CT ) imaging with focal or diffuse inflammation of the 94 patients function at baseline periodically. Suspected immune-mediated adverse reaction resulting in permanent discontinuation of KEYTRUDA was discontinued for adverse reactions are not with! Treat mild to moderate nonexfoliative rashes each breath Grade 4 reactions, or... Content from cancer therapy Advisor first-line pembrolizumab identify different factors associated with mass effect such as headache,,! The risk of developing pneumonitis is wide, and thyroid function at baseline periodically. Warnings, dosage, and more upon improvement to Grade 1 or less of How proceed!