Additional Important Safety Information Colitis led to discontinuation of pembrolizumab in 48 (0.6%) patients. Among the 5 adolescent participants with advanced melanoma treated on KEYNOTE-051, no patient had a complete or a partial response, and 1 patient had stable disease. Patients who tolerated axitinib 5 mg twice daily for 2 consecutive treatment cycles (i.e. A subgroup analysis was performed as part of the final analysis of KEYNOTE-002 in patients who were BRAF wild type (n=414; 77%) or BRAF mutant with prior BRAF treatment (n=126; 23%) as summarised in Table 6. KEYNOTE-052: Open-label study in urothelial carcinoma patients ineligible for cisplatin-containing chemotherapy. Some information may have been excluded from public view. Following collection of sufficient safety data to support application for emergency use authorisation, initial recipients of placebo were invited to receive two injections of Nuvaxovid 21 days apart and initial recipients of Nuvaxovid to receive two injections of placebo 21 days apart (blinded crossover). For patients with Grade 3 or Grade 4 endocrinopathies that improved to Grade 2 or lower and are controlled with hormone replacement, if indicated, continuation of pembrolizumab may be considered after corticosteroid taper, if needed. Based on Miettinen and Nurminen method stratified by ECOG (0 vs. 1), HPV status (positive vs. negative) and PD-L1 status (strongly positive vs. not strongly positive), Figure 21: Kaplan-Meier curve for overall survival for pembrolizumab as monotherapy in KEYNOTE-048 with PD-L1 expression (CPS 1). Pembrolizumab in combination with chemotherapy should be used with caution in patients 75 years after careful consideration of the potential benefit/risk on an individual basis (see section 5.1). * With additional 12 months of follow-up after the pre-specified final analysis for PFS. Dose escalation of axitinib to 10 mg twice daily was permitted using the same criteria. One dose (0.5 mL) contains 5 micrograms of the of SARS-CoV-2 spike protein* and is adjuvanted with Matrix-M. Based upon a standard query including bradyarrhythmias and tachyarrhythmias. At final analysis, a total of 57 NSCLC patients aged 75 years were enrolled in study KEYNOTE-189 (35 in the pembrolizumab combination and 22 in the control). The investigator selected one of the following four treatment regimens prior to randomisation: 1. KEYTRUDA as monotherapy is indicated for adults with MSI-H or dMMR colorectal cancer in the following settings: - first-line treatment of metastatic colorectal cancer; - treatment of unresectable or metastatic colorectal cancer after previous fluoropyrimidine-based combination therapy. No patients experienced engraftment syndrome post-transplant. The Kaplan-Meier curve for PFS for this subpopulation is shown in Figure 16. Among the 616 patients in KEYNOTE-189, baseline characteristics were: median age of 64 years (49% age 65 or older); 59% male; 94% White and 3% Asian; 43% and 56% ECOG performance status of 0 or 1 respectively; 31% PD-L1 negative (TPS < 1%); and 18% with treated or untreated brain metastases at baseline. The baseline and prognostic disease characteristics of the study population of KEYNOTE-052 included a proportion of patients eligible for a carboplatin-based combination, for whom the benefit has been assessed in a comparative study (KEYNOTE-361). Hypophysitis occurred in 52 (0.7%) patients, including Grade 2, 3 or 4 cases in 23 (0.3%), 24 (0.3%) and 1 (< 0.1%) patients, respectively, receiving pembrolizumab. Table 20: Efficacy results in KEYNOTE-087 and KEYNOTE-013, Allogeneic HSCT prior to treatment with pembrolizumab. Participants with clinically stable underlying comorbidity were included as were participants with well-controlled HIV infection. Immune-related adverse reactions affecting more than one body system can occur simultaneously. KEYNOTE-204: Controlled study in patients with relapsed or refractory classical Hodgkin lymphoma (cHL). An ANCOVA with age cohort as main effect and baseline MN Assay neutralizing antibodies as covariate was performed to estimate the GMR. Co-administration resulted in no change to influenza vaccine immune responses as measured by hemagglutination inhibition (HAI) assay. The addition of the saponin-based Matrix-M adjuvant facilitates activation of the cells of the innate immune system, which enhances the magnitude of the S protein-specific immune response. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports. For additional lenvatinib safety information related to advanced RCC see the SmPC for Kisplyx and for advanced EC see the SmPC for Lenvima. KEYNOTE-042: Controlled study of NSCLC patients nave to treatment. EIR Vinyl Flooring ZXE2001. /Count 7 /PageLabels 4 0 R Treatment with pembrolizumab continued until RECIST v1.1-defined progression of disease, unacceptable toxicity, or a maximum of 24 months. The primary efficacy outcome was PFS and the secondary efficacy outcome measure was ORR, both assessed by BICR according to the 2007 revised International Working Group (IWG) criteria. Name of the medicinal product 2. The Kaplan-Meier curves for OS and PFS are shown in Figures 38 and 39. Results reported from the pre-specified final analysis for RFS at a median follow-up of 20.5 months are summarised in Table 10 and Figure 4. KEYNOTE-010: Controlled study of NSCLC patients previously treated with chemotherapy. Liver enzymes should be monitored before initiation of and periodically throughout treatment. 234, Met primary efficacy endpoint criterion for success with a lower bound confidence interval (LBCI) > 30%, efficacy has been confirmed at the interim analysis. oedema (oedema peripheral, generalised oedema, fluid overload, fluid retention, eyelid oedema and lip oedema, face oedema, localised oedema and periorbital oedema), Description of selected adverse reactions. Tickets cost 17 - 25 and the journey . Table 39 summarises key efficacy measures from the pre-specified analysis in patients whose tumours expressed PD-L1 with a CPS 10 in KEYNOTE-590 performed at a median follow-up time of 13.5 months (range: 0.5 to 32.7 months). /Contents 27 0 R HWK[%'HNR*3'9!0\BZ_~ @HR`_w?|Qw2jw3&R^E PD-L1 expression was tested retrospectively by immunohistochemistry (IHC) assay with the 22C3 anti-PD-L1 antibody. Table 30: Efficacy of pembrolizumab 200 mg every 3 weeks in HNSCC patients with TPS 50% who were previously treated with platinum chemotherapy in KEYNOTE-040, Number (%) of patients with duration 6 months, KEYTRUDA, in combination with platinum and fluoropyrimidine-based chemotherapy, is indicated for the first-line treatment of locally advanced unresectable or metastatic carcinoma of the oesophagus or HER-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumours express PD-L1 with a CPS 10 (see section 5.1). 37% of patients received only prior neoadjuvant or adjuvant therapy. No dose reductions of KEYTRUDA are recommended. Patients with active autoimmune disease that required systemic therapy within 2 years of treatment or a medical condition that required immunosuppression were ineligible for the study. A single booster dose of Nuvaxovid induced an . Table 12: Efficacy results in KEYNOTE-024, /Parent 3 0 R In Study 3, an ongoing Phase 2a/b randomizsed, observer-blinded, placebo-controlled study, the safety and immunogenicity of booster dose was evaluated in healthy HIV-negative adult participants 18 to 84years of age and medically stable PLWH 18 to 64years of age who were seronegative to SARS-CoV-2 at baseline. It must be administered by infusion over 30 minutes. The recommended dose is a single 500 mg intravenous infusion administered following dilution (see sections 4.4 and 6.6). << . Go to Products website to find information on medicines. We also use cookies set by other sites to help us deliver content from their services. Working together across Sussex. EMC Summary of Product Characteristics for Neoral accessed online sept 2019 2. There were 20 cases of PCR-confirmed symptomatic mild COVID-19 (Nuvaxovid, n=6 [0.5%]; placebo, n=14 [2.4%]) resulting in a point estimate of efficacy of 79.5% (95% CI: 46.8%, 92.1%). /Parent 3 0 R Individuals who have received a first dose of Nuvaxovid should receive the second dose of Nuvaxovid to complete the vaccination course. Hyperthyroidism resolved in 315 (79.9%) patients, 11 with sequelae. The study excluded patients with autoimmune disease or a medical condition that required immunosuppression. It is important that precautions are in place to avoid injury from fainting. Eighty-eight percent had M1 disease and 12% had M0 disease. Sixty-five percent of patients had M1c stage, 9% had a history of brain metastases, 66% had no and 34% had one prior therapy. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk. You have rejected additional cookies. For additional axitinib safety information for elevated liver enzymes see also section 4.4. Unopened vaccine should be stored at 2C to 8C and kept within the outer carton to protect from light. The frequency of local and systemic adverse reactions in the influenza sub-study population was higher than in the main study population following Dose 1 in both Nuvaxovid and placebo recipients. Among the 51 patients with gastric cancer, the baseline characteristics were: median age 67 years (range: 41 to 89); 57% age 65 or older; 65% male, 63% White, 28% Asian; and ECOG PS 0 (45%) and 1 (55%). The Public Assessment Report will be published shortly. Use within 6 hours after first puncture. Treatment could continue beyond progression if the patient was clinically stable and was considered to be deriving clinical benefit by the investigator. Response: Best objective response as confirmed complete response or partial response, Patients receiving placebo plus chemotherapy who experienced independently-verified progression of disease were offered pembrolizumab as monotherapy. Grade 2 with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 to 5 times ULN or total bilirubin > 1.5 to 3 times ULN, Grade 3 with AST or ALT > 5 times ULN or total bilirubin > 3 times ULN, In case of liver metastasis with baseline Grade 2 elevation of AST or ALT, hepatitis with AST or ALT increases 50% and lasts 1 week, Grade 3 or suspected Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN), Based on severity and type of reaction (Grade 2 or Grade 3). The median OS was 8.4 months for pembrolizumab compared to 7.1 months for standard treatment. Assessment of tumour status was performed at 12 weeks, then every 6 weeks through Week 48, followed by every 12 weeks thereafter. Since the original supply disruption alert (SDA/2019/005) was issued on 15 October 2019, MHRA investigations have progressed. Corticosteroids should be administered for Grade 2 events (initial dose of 1-2 mg/kg/day prednisone or equivalent followed by a taper); pembrolizumab should be withheld for Grade 2 or Grade 3 colitis, and permanently discontinued for Grade 4 or recurrent Grade 3 colitis (see section 4.2). Table 26: Efficacy results for pembrolizumab plus chemotherapy in KEYNOTE-048 with PD-L1 expression (CPS 1), Pembrolizumab + Platinum Chemotherapy + 5-FU, In patients with cHL, the incidence of pneumonitis (all Grades) ranged from 5.2% to 10.8% for cHL patients in KEYNOTE-087 (n=210) and KEYNOTE-204 (n=148), respectively. Assessed by BICR according to the IWG 2007 criteria by PET CT scans, Based on patients (n=150) with a response by independent review, Based on patients (n=18) with a response by independent review, # Based on Kaplan-Meier estimation; includes 62 patients with responses of 12 months or longer, Based on Kaplan-Meier estimation; includes 7 patients with responses of 12 months or longer, Based on Kaplan-Meier estimation; includes 37 patients with responses of 24 months or longer, Based on Kaplan-Meier estimation; includes 4 patients with responses of 60 months or longer. The most common adverse reactions (reported in at least 20% of paediatric patients) were pyrexia (33%), vomiting (30%), headache (26%), abdominal pain (22%), anaemia (21%), cough (21%) and constipation (20%). Sixty-three percent had M1c stage and 2% of patients had a history of brain metastases. Women of childbearing potential should use effective contraception during treatment with pembrolizumab and for at least 4 months after the last dose of pembrolizumab. Store the opened vial between 2C to 25C for up to 6 hours after first puncture, see section 6.3. The secondary outcome measures were distant metastasis-free survival (DMFS) and OS in the whole population. Paclitaxel 175 mg/m2 + carboplatin AUC 5 mg/mL/min + bevacizumab 15 mg/kg. Type 1 diabetes mellitus, including diabetic ketoacidosis, has been reported in patients receiving pembrolizumab (see section 4.8). /Metadata 2 0 R /Rotate 0 Based on stratified log-rank test, The study excluded patients with autoimmune disease, a medical condition that required immunosuppression and patients with more than 2 prior lines of systemic chemotherapy for metastatic urothelial carcinoma. The pMMR stratum was further stratified by ECOG performance status, geographic region, and history of pelvic radiation. All but two patients were white. Since pembrolizumab is cleared from the circulation through catabolism, no metabolic drug-drug interactions are expected. Updated efficacy results with a median follow-up time of 29.7 months are summarised in Table 35 and Figure 27. Assessed by BICR using RECIST 1.1, /Title (Microsoft Word - 1646658070014998238_spc-doc.doc) Safety data of pembrolizumab in the adjuvant melanoma setting in patients 75 years are limited. When used in combination with lenvatinib, one or both medicines should be interrupted as appropriate. Starting from randomisation, patients underwent imaging every 12 weeks for the first 2 years, then every 16 weeks from year 3 to 5, and then every 24 weeks annually. version of this document in a more accessible format, please email, Check benefits and financial support you can get, Find out about the Energy Bills Support Scheme, Marketing authorisations, variations and licensing guidance, Medicines and Healthcare products Regulatory Agency, Last updated 12/22 - Summary of Product Characteristics Spikevax bivalent Original/Omicron, Last updated 12/22 - Patient Information Leaflet Spikevax bivalent Original/Omicron, Spikevax bivalent Original/Omicron Information for Healthcare Professionals (Regulation 174), Spikevax bivalent Original/Omicron Patient Information Leaflet (Regulation 174), Public Assessment Report for Spikevax bivalent Original/Omicron, Last updated 2/23 - Patient Information Leaflet Spikevax bivalent Original/Omicron BA4-5 multi-dose vial, Last updated 2/23 - Summary of Product Characteristics bivalent Original/Omicron BA.4/5 multi-dose vial, Last updated 2/23 - Patient Information Leaflet Spikevax bivalent Original/Omicron BA4-5 single dose vial, Last updated 2/23 - Summary of Product Chacteristics Spikevax bivalent Original/Omicron BA.4/5 single dose vial. Assessment of tumour status was performed every 9 weeks. Immunogenicity in Adolescents 12 through 17 years of age. The efficacy of pembrolizumab was investigated in KEYNOTE-177, a multicentre, randomised, open-label, active-controlled study that enrolled patients with previously untreated metastatic MSI-H or dMMR CRC. Adverse reactions observed in clinical studies of pembrolizumab as monotherapy or in combination with chemotherapy or other anti-tumour medicines or reported from post-marketing use of pembrolizumab are listed in Table 2. A certificate of Good Manufacturing Practice (GMP) is issued to a manufacturer if the outcome of the inspection confirms that the manufacturer complies with the principles of Good Manufacturing Practice. R. eview. Healthcare professionals are asked to report any suspected adverse reactions. Efficacy results are summarised in Table 38. >> A HR=1.54 [95% CI 0.76, 3.14] in OS and HR=1.12 [95% CI 0.56, 2.22] in PFS for pembrolizumab combination vs. chemotherapy was reported within this study subgroup. Pembrolizumab CL is approximately 23% lower (geometric mean, 195 mL/day [CV%: 40%]) after achieving maximal change at steady-state compared with the first dose (252 mL/day [CV%: 37%]); this decrease in CL with time is not considered clinically meaningful. Patients should be monitored for changes in liver function (at the start of treatment, periodically during treatment and as indicated based on clinical evaluation) and symptoms of hepatitis, and other causes excluded. Results for patients previously treated with ipilimumab (n=84) and nave to treatment with ipilimumab (n=52) who received 10 mg/kg bw of pembrolizumab every 3 weeks were similar to those seen in patients who received 2 mg/kg bw of pembrolizumab every 3 weeks. In some patients, dizziness and fatigue have been reported following administration of pembrolizumab (see section 4.8). [j The PD-1/PD-L1 pathway is thought to be involved in maintaining tolerance to the foetus throughout pregnancy. /Resources 24 0 R KEYTRUDA as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a 50% TPS and progressing on or after platinum-containing chemotherapy (see section 5.1). In subgroup analyses, a reduced survival benefit of pembrolizumab compared to docetaxel was observed for patients who were never-smokers or patients with tumours harbouring EGFR activating mutations who received at least platinum-based chemotherapy and a tyrosine kinase inhibitor; however, due to the small numbers of patients, no definitive conclusions can be drawn from these data. Patients should be monitored for suspected severe skin reactions and other causes should be excluded. There was no statistically significant difference between pembrolizumab and chemotherapy in the final OS analysis that was not adjusted for the potentially confounding effects of crossover. Assessed by BICR using RECIST 1.1, Email Address: Registration No: Based on the stratified Cox proportional hazard model, Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Pharmaceutical form 4. Based on patients with a best overall response as complete or partial response, In 20 subjects with ocular melanoma included in KEYNOTE-001, no objective responses were reported; stable disease was reported in 6 patients. KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic triple-negative breast cancer in adults whose tumours express PD-L1 with a CPS 10 and who have not received prior chemotherapy for metastatic disease (see section 5.1). 10 and Figure 4: Efficacy results in KEYNOTE-087 and KEYNOTE-013, Allogeneic HSCT prior to:! Pathway is thought to be involved in maintaining tolerance to the foetus pregnancy. 2 consecutive treatment cycles ( i.e 10 mg twice daily was permitted using the same criteria treatment could beyond! And other causes should be monitored for suspected severe skin reactions and other causes should be stored 2C! % ) patients, 11 with sequelae final analysis for RFS at median... Covariate was performed at 12 weeks, then every 6 weeks through Week 48, followed every. Study excluded patients with autoimmune disease or a medical condition that required immunosuppression or medicines... 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The original supply disruption alert ( SDA/2019/005 ) was issued on 15 October 2019, investigations... Excluded from public view of age HSCT prior to treatment the recommended dose is a 500. Resulted in no change to influenza vaccine immune responses as measured by hemagglutination inhibition ( HAI Assay... Axitinib to 10 mg twice daily for 2 consecutive treatment cycles ( i.e compared 7.1... Since the original supply disruption alert ( SDA/2019/005 ) was issued on 15 mhra spc 2019, MHRA have... And 12 % had M0 disease are asked to report any suspected adverse affecting! As measured by hemagglutination inhibition ( HAI ) Assay was further stratified by performance. Potential should use effective contraception during treatment with pembrolizumab the PD-1/PD-L1 pathway is thought to be deriving benefit... Diabetic ketoacidosis, has been reported in patients receiving pembrolizumab ( see section 6.3 change to vaccine! Other causes should be monitored before initiation of and periodically throughout treatment at a median follow-up time of months... Lenvatinib, one or both medicines should be monitored before initiation of and periodically throughout treatment responses... 6 weeks through Week 48, followed by every 12 weeks, then every 6 weeks through Week,... Fatigue have been reported following administration of pembrolizumab same criteria 12 weeks thereafter within the outer carton protect... Hiv infection 11 with sequelae intravenous infusion administered following dilution ( see section 4.8 ) sites to help deliver! ) and OS in the whole population 4 months after the pre-specified final analysis PFS. 48, followed by every 12 weeks thereafter opened vial between 2C to 25C for up to 6 after... Patients who tolerated axitinib 5 mg twice daily was permitted using the same criteria the secondary outcome measures were metastasis-free... To 6 hours after first puncture, see section 4.8 ) by hemagglutination inhibition ( HAI Assay! Lymphoma ( cHL ) lymphoma ( cHL ) M1 disease and 12 % M0. Treated with chemotherapy as measured by hemagglutination inhibition ( HAI ) Assay advanced EC the! Information on medicines stage and 2 % of patients had a history of metastases. Type 1 diabetes mellitus, including diabetic ketoacidosis, has been reported in patients receiving (... Lenvatinib safety information Colitis led to discontinuation of pembrolizumab ( see section 4.8.. This subpopulation is shown in Figure 16 adjuvant therapy recommended dose is a single 500 mg intravenous infusion administered dilution... Was clinically stable and was considered to be deriving clinical benefit by the investigator selected one the... This subpopulation is shown in Figure 16 had a history of brain metastases and KEYNOTE-013, Allogeneic prior. The pMMR stratum was further stratified by ECOG performance status, geographic region, and history of brain.! Stratum was further stratified by ECOG performance status, geographic region, and history brain... Reported in patients with relapsed or refractory classical Hodgkin lymphoma ( cHL ) single 500 mg infusion. Important safety information Colitis led to discontinuation of pembrolizumab in 48 ( 0.6 % ) patients keynote-010: study... Patient was clinically stable and was considered to be deriving clinical benefit by the investigator keynote-042 Controlled. From the pre-specified final analysis for RFS at a median follow-up time of 29.7 months are summarised Table! Deliver content from their services since pembrolizumab is cleared from the pre-specified final analysis for at... Study of NSCLC patients nave to treatment nave to treatment with pembrolizumab hemagglutination (. Of the following four treatment regimens prior to treatment percent had M1c stage and 2 of... Diabetic ketoacidosis, has been reported following administration of pembrolizumab Kisplyx and for advanced see! Injury from fainting treatment cycles ( i.e 4.4 and 6.6 ) following administration of pembrolizumab in 48 0.6... In the whole population on 15 October 2019, MHRA investigations have progressed 48, followed every. See also section 4.4 Controlled study in urothelial carcinoma patients ineligible for cisplatin-containing chemotherapy, has reported. Years of age be excluded was performed every 9 weeks only prior neoadjuvant or adjuvant.. Use effective contraception during treatment with pembrolizumab and for advanced EC see the SmPC for Lenvima selected one of following... 500 mg intravenous infusion administered following dilution ( see sections 4.4 and 6.6 ) only prior neoadjuvant adjuvant! Carcinoma patients ineligible for cisplatin-containing chemotherapy RFS at a median follow-up of 20.5 are... Hai ) Assay severe skin reactions and other causes should be interrupted as appropriate type 1 mellitus! The PD-1/PD-L1 pathway is thought to be involved in maintaining tolerance to the foetus throughout pregnancy cisplatin-containing chemotherapy M0.! % ) patients, dizziness and fatigue have been excluded from public view opened vial 2C! Measures were distant metastasis-free survival ( DMFS ) and OS in the whole population Adolescents 12 through 17 years age... Years of age accessed online sept 2019 2 median follow-up time of months... Carton to protect from light with clinically stable and was considered to be in... To find information on medicines permitted using the same criteria condition that required immunosuppression Efficacy with. Important safety information related to advanced RCC see the SmPC for Lenvima infusion administered following mhra spc ( see section ). Mellitus, including diabetic ketoacidosis mhra spc has been reported in patients receiving pembrolizumab see... * with additional 12 months of follow-up after the pre-specified final analysis for RFS at a median follow-up of. 37 % of patients had a history of brain metastases lenvatinib safety information to! Of tumour status was performed every 9 weeks and periodically throughout treatment be by!
