)spc( . )sdi( cBR&0q(0a&0ej"lL |6OD+7F!`[,CyfcqZLIWll>T"1IMvfG|XmpE?$I-^W} Dont include personal or financial information like your National Insurance number or credit card details. Uncommon but serious: (see MHRA alerts below for more information) DKA Fournier's Gangrene Lower limb amputation -encourage regular preventative footcare Please see individual drug monographs in BNF/SPC for a complete side-effect profile -see hyperlink in table overleaf. Table 7: Efficacy results by BRAF mutation status in KEYNOTE-006. KEYTRUDA is for intravenous use. >> Response: Best objective response as confirmed complete response or partial response, Figure 38: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-826 patients with PD-L1 expression (CPS 1), * Chemotherapy (paclitaxel and cisplatin or paclitaxel and carboplatin) with or without bevacizumab, Figure 39: Kaplan-Meier curve for progression free survival by treatment arm in KEYNOTE-826 patients with PD-L1 expression (CPS 1). Persons who experienced severe reactions following the second dose may be more likely to experience severe reactions following the third dose. For additional safety information when pembrolizumab is administered in combination, refer to the SmPC for the respective combination therapy components. Enrolment of adolescents completed in June 2021. Pembrolizumab exposure with weight-based dosing at 2 mg/kg bw every 3 weeks in paediatric patients ( 3 to 17 years) are comparable to those of adults at the same dose. Do not shake. 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). An analysis was performed in KEYNOTE-052 in patients who had tumours that expressed PD-L1 with a CPS < 10 (n=251; 68%) or 10 (n=110; 30%) based on the PD-L1 IHC 22C3 pharmDxTM Kit (see Table 24). Based on Kaplan-Meier estimation, Figure 18: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-361 (intent to treat population, choice of carboplatin), Figure 19: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-361 (patients with PD-L1 expression CPS 10, intent to treat population, choice of carboplatin), KEYNOTE-048: Controlled study of monotherapy and combination therapy in HNSCC patients nave to treatment in the recurrent or metastatic setting. This vaccine contains potassium, less than 1 mmol (39 mg) per dose, that is to say, essentially potassium-free. Seventy-six percent of patients received 2 or more prior lines of therapy. Translucent to white proteinaceous particles may be seen in diluted solution. Severe infusion-related reactions, including hypersensitivity and anaphylaxis, have been reported in patients receiving pembrolizumab (see section 4.8). Randomisation was stratified by tumour PD-L1 expression (TPS 50% or < 50%), HPV status (positive or negative), and ECOG PS (0 vs. 1). Great Britain. Of the patients randomised to the chemotherapy arm, 55% crossed over and subsequently received treatment with pembrolizumab. Qualitative and quantitative composition 3. IRO = Integrated radiology and oncologist assessment using RECIST 1.1,
PLWH were medically stable (free of opportunistic infections), receiving highly active and stable antiretroviral therapy, and having an HIV-1 viral load of < 1000 copies/mL. FOLFIRI (irinotecan, leucovorin, and FU) or FOLFIRI in combination with either bevacizumab or cetuximab: Irinotecan 180 mg/m2, leucovorin 400 mg/m2 (or levoleucovorin 200 mg/m2), and FU 400 mg/m2 bolus on Day 1, then FU 2,400 mg/m2 over 46-48 hours. You have rejected additional cookies. The primary efficacy outcome measures were OS and PFS as assessed by BICR using RECIST 1.1. Patients were randomised (1:1) to one of the following treatment arms: Pembrolizumab 200 mg on Day 1 of each three-week cycle in combination with cisplatin 80 mg/m2 IV on Day 1 of each three-week cycle for up to six cycles and 5-FU 800 mg/m2 IV per day on Day 1 to Day 5 of each three-week cycle, or per local standard for 5-FU administration. The MHRA products website allows you to find: The leaflets which are provided with medicines The description of the medicinal product's properties and how it can be used Scientific reports about. Nephritis has been reported in patients receiving pembrolizumab (see section 4.8). The study demonstrated a statistically significant improvement in pCR rate difference at its pre-specified primary analysis (n=602), the pCR rates were 64.8% (95% CI: 59.9%, 69.5%) in the pembrolizumab arm and 51.2 % (95% CI: 44.1%, 58.3%) in the placebo arm, with a treatment difference of 13.6 % (95% CI: 5.4%, 21.8%; p-Value 0.00055). 9 0 obj Treatment with pembrolizumab or chemotherapy continued until unacceptable toxicity or disease progression or a maximum of 24 months. In patients with ALT 3 times ULN (Grades 2-4, n=116), ALT resolved to Grades 0-1 in 94%. Adrenal insufficiency led to discontinuation of pembrolizumab in 13 (0.2%) patients. /CropBox [0 0 595 842] Store the opened vial between 2C to 25C for up to 6 hours after first puncture, see section 6.3. KEYTRUDA in combination with axitinib in RCC. The study demonstrated statistically significant improvements in OS and ORR for patients randomised to pembrolizumab as compared to chemotherapy. Table 18: Response to pembrolizumab 2 or 10 mg/kg bw every 3 weeks in previously treated patients with NSCLC in KEYNOTE-010, * Hazard ratio (pembrolizumab compared to docetaxel) based on the stratified Cox proportional hazard model,
(SPC) and Patient Information Leaflet (PIL) are followed. In general, the frequency of adverse reactions for pembrolizumab combination therapy is observed to be higher than for pembrolizumab monotherapy or chemotherapy alone, reflecting the contributions of each of these components (see sections 4.2 and 4.8). Efficacy results in this subpopulation were consistent with the ITT population. KEYNOTE-045: Controlled study in urothelial carcinoma patients who have received prior platinum-containing chemotherapy. If you are concerned about an adverse event, it should be reported on a Yellow card. Ninety-six percent of patients had M1 disease and 4% M0 disease. Allogeneic HSCT prior to treatment with pembrolizumab. - Update the SmPC and PIL to include urticaria as an adverse event
The median time to onset of severe skin reactions was 3.0 months (range 2 days to 25.5 months). For instructions on dilution of the medicinal product before administration, see section 6.6. For additional axitinib safety information for elevated liver enzymes see also section 4.4. The safety of pembrolizumab in combination with axitinib or lenvatinib in advanced RCC, and in combination with lenvatinib in advanced EC has been evaluated in a total of 1,456 patients with advanced RCC or advanced EC receiving 200 mg pembrolizumab every 3 weeks with either axitinib 5 mg twice daily or lenvatinib 20 mg once daily in clinical studies, as appropriate. /Type /Pages Patients randomised to pembrolizumab were permitted to continue beyond the first RECIST v1.1-defined disease progression if clinically stable until the first radiographic evidence of disease progression was confirmed at least 4 weeks later with repeat imaging. KEYTRUDA, in combination with lenvatinib, is indicated for the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation. The baseline characteristics of these 599 patients included: median age 63 years (45% age 65 or older); 69% male; 63% White and 32% Asian; 17% Hispanic or Latino; and ECOG performance status 0 and 1 in 31% and 69%, respectively. HWK[%'HNR*3'9!0\BZ_~
@HR`_w?|Qw2jw3&R^E 2, Met primary efficacy endpoint criterion for success with a lower bound confidence interval (LBCI) > 30%. Based on the stratified Cox regression model,
Kaplan-Meier curves for OS based on the final analysis are shown in Figures 20 and 21. It is recommended to continue treatment for clinically stable patients with initial evidence of disease progression until disease progression is confirmed. Based on Kaplan-Meier estimates; includes 43 patients with responses of 6 months or longer,
Based on patients with a best objective response as confirmed complete or partial response. KEYTRUDA, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD-L1 with a CPS 1. Clinically stable patients with initial evidence of disease progression were permitted to remain on treatment until disease progression was confirmed. Of 14 patients in KEYNOTE-013 who proceeded to allogeneic HSCT after treatment with pembrolizumab, 6 patients reported acute GVHD and 1 patient reported chronic GVHD, none of which were fatal. In Dec2016 the SPC is updated and reviewed by the CI, but there are no changes to section 4.8, just an update to storage conditions of the IMP that doesn't impact the trial, so no substantial amendment needed. 16 0 obj When pembrolizumab is administered in combination, refer to the SmPC for the respective combination therapy components prior to initiation of treatment. It is used by healthcare professionals, such as doctors, nurses and pharmacists. KEYNOTE-010: Controlled study of NSCLC patients previously treated with chemotherapy. The two vaccine components elicit B- and T-cell immune responses to the S protein, including neutralising antibodies, which may contribute to protection against COVID-19. Among the 83 patients with endometrial cancer, the baseline characteristics were: median age of 64 years (range: 42 to 86), 46% age 65 or older; 84% White, 6% Asian, and 4% Black; and ECOG PS 0 (46%) and 1 (54%). A subgroup analysis was performed as part of the final analysis of KEYNOTE-006 in patients who were PD-L1 positive (n=671; 80%) vs. PD-L1 negative (n=150; 18%). Of the 51 patients receiving 2 mg/kg bw of pembrolizumab who were nave to treatment with ipilimumab, 63% were male, 35% were 65 years of age and the median age was 60 years (range 35-80). An analysis of the SARS-CoV-2 neutralising antibody response 14 days after Dose 2 (Day 35) was conducted in adolescent participants seronegative to anti-SARS-CoV-2 nucleoprotein (NP) and PCR-negative at baseline. The primary efficacy outcome measures were OS and PFS (as assessed by BICR using RECIST 1.1). Based on Miettinen and Nurminen method stratified by MMR Status, ECOG performance status, geographic region, and history of pelvic radiation, Figure 36: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-775 (intent to treat population), Figure 37: Kaplan-Meier curve for progression free-survival by treatment arm in KEYNOTE-775 (intent to treat population). Ninety-three percent had M1 disease. In the ITT population, the median follow-up time for 151 patients treated with pembrolizumab was 24.9 months (range: 1.8 to 42.0 months). !B&| 38apbfgkW% _oo.q9,Np$Jh'@y+Gb1,]7E?p!])~b? 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. Efficacy in Adolescents 12 through 17 years of age. When used in combination with lenvatinib, one or both medicines should be interrupted as appropriate. The key eligibility criteria for this study were metastatic squamous NSCLC, regardless of tumour PD-L1 expression status, and no prior systemic treatment for metastatic disease. The study excluded patients with autoimmune disease or a medical condition that required immunosuppression. This file may not be suitable for users of assistive technology. Patients with active, non-infectious pneumonitis, an allogeneic HSCT within the past 5 years (or > 5 years but with symptoms of GVHD), active autoimmune disease, a medical condition that required immunosuppression, or an active infection requiring systemic therapy were ineligible for the study. Do not administer the vaccine if either are present. 09 / 22. Based on stratified log-rank test (compared to an alpha boundary of 0.00144),
Patients without disease progression could be treated for up to 24 months. Bevacizumab 5 mg/kg bw on Day 1 or cetuximab 400 mg/m2 on first infusion, then 250 mg/m2 weekly. >> In the absence of these data, pembrolizumab should be used with caution in this population after careful consideration of the potential risk-benefit on an individual basis. either cisplatin or carboplatin with gemcitabine) versus chemotherapy as first-line treatment in subjects with advanced or metastatic urothelial carcinoma. A total of 1,019 adult patients were randomised (1:1) to receive pembrolizumab 200 mg every three weeks (n=514) or placebo (n=505), for up to one year until disease recurrence or unacceptable toxicity. For suspected immune-related adverse reactions, adequate evaluation to confirm aetiology or exclude other causes should be ensured. Data from these patients are too limited to draw any conclusion on efficacy in this population. In addition, no safety and efficacy data are available in frailer patients (e.g. Use of pembrolizumab in urothelial carcinoma for patients who are considered ineligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with CPS 10. KEYTRUDA, as monotherapy or as combination therapy, should be permanently discontinued for Grade 4 or recurrent Grade 3 immune-related adverse reactions, unless otherwise specified in Table 1. No clinical data are available on the possible effects of pembrolizumab on fertility. /Title (Microsoft Word - 1646658070014998238_spc-doc.doc) In this patient population, the median observation time was 8.5 months (range: 1 day to 39 months) and the most frequent adverse reactions with pembrolizumab were fatigue (31%), diarrhoea (22%), and nausea (20%). Patients with active infections occurring during treatment with pembrolizumab were managed with appropriate medical therapy. The most frequent adverse reactions were injection site tenderness (71%), injection site pain (67%), headache (63%), myalgia (57%), fatigue (54%), malaise (43%), nausea or vomiting (23%), arthralgia (19%) and pyrexia (17%). The safety of pembrolizumab as monotherapy has been evaluated in 161 paediatric patients aged 9 months to 17 years with advanced melanoma, lymphoma, or PD-L1 positive advanced, relapsed, or refractory solid tumours at 2 mg/kg bw every 3 weeks in the Phase I/II study KEYNOTE-051. Patients with autoimmune disease or a medical condition that required immunosuppression were ineligible. A searchable list of the. Patients received pembrolizumab at a dose of 200 mg every 3 weeks until unacceptable toxicity or disease progression. These noninferiority criteria were met. The study population characteristics were: median age of 65 years (range: 29 to 88); 55% age 65 or older; 81% male; 77% White; ECOG performance status of 0 (29%) and 1 (71%); and 8% with treated brain metastases at baseline. The median duration was 3.3 months (range 6 days to 28.2+ months). /Filter /FlateDecode Exposure to pembrolizumab as expressed by peak concentration (Cmax) or area under the plasma concentration time curve (AUC) increased dose proportionally within the dose range for efficacy. 37% of patients received only prior neoadjuvant or adjuvant therapy. Most of these, including severe reactions, resolved following initiation of appropriate medical therapy or withdrawal of pembrolizumab (see Description of selected adverse reactions below). Based on the severity of the adverse reaction, pembrolizumab should be withheld and corticosteroids administered. Participants will be followed for up to 24 months after the second dose for assessments of safety, and efficacy against COVID-19. Based on stratified log-rank test,
You have rejected additional cookies. Use of pembrolizumab for adjuvant treatment of patients with melanoma. Report a side effect with a medicine or medical device. Patients with non-squamous NSCLC could receive pemetrexed maintenance.). o Followed by four additional cycles of neoadjuvant pembrolizumab 200 mg every 3 weeks or placebo on Day 1 of cycles 5-8 of treatment regimen in combination with: Doxorubicin 60 mg/m2 or epirubicin 90 mg/m2 every 3 weeks on Day 1 of cycles 5-8 of treatment regimen and, Cyclophosphamide 600 mg/m2 every 3 weeks on Day 1 of cycles 5-8 of treatment regimen. << This updated OS analysis was not adjusted to account for subsequent therapies. 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). When reporting, please include the vaccine brand and batch/lot number, if available. It explains how to use and prescribe a medicine. 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. Disease subtypes were 81% nodular sclerosis, 11% mixed cellularity, 4% lymphocyte-rich and 2% lymphocyte-depleted. For Grades 3 or 4 infusion reactions, infusion should be stopped and pembrolizumab permanently discontinued (see section 4.2). The cHL population (n=22) included patients 11 to 17 years of age. Microsoft Word - 1646658070014998238_spc-doc.doc Name of the medicinal product 2. The baseline characteristics of these 754 patients included: median age of 61 years (range: 20 to 94); 36% age 65 or older; 82% male; 74% White and 19% Asian; 61% ECOG performance status of 1; and 77% former/current smokers. Pembrolizumab has not been studied in patients with severe hepatic impairment (see section 4.2). Kaplan-Meier curves for OS and PFS based on the final analysis are shown in Figures 1 and 2. Administration of study treatment was permitted beyond RECIST-defined disease progression if the treating investigator considered the patient to be deriving clinical benefit and the treatment was tolerated. An updated OS analysis was performed when patients receiving pembrolizumab and lenvatinib or sunitinib had a median survival follow-up of 33.4 months. /MediaBox [0 0 595 842] Treatment with pembrolizumab and lenvatinib continued until RECIST v1.1-defined progression of disease as verified by BICR, unacceptable toxicity, or for pembrolizumab, a maximum of 24 months. Sixty-one percent of patients had received ASCT, 38% were transplant ineligible; 17% had no prior brentuximab vedotin use; and 37% of patients had prior radiation therapy. Colitis resolved in 130 patients, 2 with sequelae. Patients were treated with pembrolizumab until disease progression or unacceptable toxicity. An exploratory subgroup analysis was performed in KEYNOTE-048 in patients whose tumours expressed PD-L1 CPS 1 to < 20 [pembrolizumab plus chemotherapy: n=116 (45%) vs. standard treatment: n=125 (49%) and pembrolizumab monotherapy: n=124 (48%) vs. standard treatment: n=133 (52%)] (see Table 29). More frequent monitoring of liver enzymes as compared to when the medicines are used in monotherapy may be considered. At the earlier pre-specified final analysis of ORR (median follow-up time of 17.3 months), statistically significant superiority was achieved for ORR comparing pembrolizumab plus lenvatinib with sunitinib, (odds ratio: 3.84 [95% CI: 2.81, 5.26], p-Value< 0.0001). Please do not report the same adverse event(s) to both systems as all reports will be shared between Novavax and MHRA (in an anonymised form) and dual reporting will create unnecessary duplicates. /Nums [0 14 0 R] Neutralising antibody titers measured by a wild-type assay were assessed 28 days post-booster dose. $>H}X@z%|!T|W=^ewx LcX/)PeIe61Knwszc`A[Av}pS*]?u5-QVe hU!y?4-03,1u#cWZS$Sm,^k]z?(w9/nWg9. Enrolment was completed in November 2020. See section 4.8 for how to report adverse reactions. The primary efficacy outcome measures were OS and PFS as assessed by the investigator according to RECIST 1.1 in squamous cell histology, CPS 10, and in all patients. Administration of pembrolizumab with lenvatinib was permitted beyond RECIST-defined disease progression if the patient was clinically stable and considered by the investigator to be deriving clinical benefit. The median duration was not reached (range 3 days to 40.1+ months). In patients with HNSCC treated with pembrolizumab as monotherapy (n=909), the incidence of hypothyroidism was 16.1% (all Grades) with 0.3% Grade 3. A decision should be made whether to discontinue breast-feeding or to discontinue pembrolizumab, taking into account the benefit of breast-feeding for the child and the benefit of pembrolizumab therapy for the woman. The majority of adverse reactions reported for monotherapy were of Grades 1 or 2 severity. /Resources 28 0 R The primary efficacy outcome measure was ORR as assessed by BICR using RECIST 1.1. This medicinal product must not be mixed with other medicinal products or diluted. /Font 31 0 R Bevacizumab 5 mg/kg bw on Day 1 or cetuximab 400 mg/m2 on first infusion, then 250 mg/m2 weekly. Withdraw the required volume up to 4 mL (100 mg) of concentrate and transfer into an intravenous bag containing sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) to prepare a diluted solution with a final concentration ranging from 1 to 10 mg/mL. What companies run services between Andalusia, Spain and Seville, Spain? Ninety-four percent were N0; 83% had no sarcomatoid features; 86% were pT2 with Grade 4 or sarcomatoid features or pT3; 8% were pT4 or with nodal involvement; and 6% were M1 NED. The PFS HR (95% CI) for the favourable, intermediate and poor risk groups were 0.81 (0.53, 1.24), 0.69 (0.53, 0.90) and 0.58 (0.35, 0.94), respectively. Poisoning is usually minimal below 6.5 mmol per litre but may be severe above 8 mmol per litre. << investigator's choice consisting of either doxorubicin 60 mg/m2 every 3 weeks, or paclitaxel 80 mg/m2 weekly, 3 weeks on/1 week off. The primary efficacy outcome measure was OS. The median survival follow-up time was 26.5 months. Disease subtypes were 97% nodular sclerosis and 3% mixed cellularity. Assessment of tumour status was performed at 9 weeks after the first dose, then every 6 weeks through the first year, followed by every 12 weeks thereafter. at the planned primary confirmatory analysis, Mean disease incidence rate per year in 1000 people. Pembrolizumab must be permanently discontinued for any Grade 3 immune-related adverse reaction that recurs and for any Grade 4 immune-related adverse reaction toxicity, except for endocrinopathies that are controlled with replacement hormones (see sections 4.2 and 4.8). >> Monitoring Undertake shared monitoring requirements in agreement with consultant/specialist (see clinical information below). ?%Kb^V8=/06%z~F0mbXZIs#MA` _w]?c/V)UFq`Gs^
8O MAi)insr#W"RkV nl~{>~Y N.r}TD=G XwsB{`@u.1prC[N -RbEY;/3&^t! If you use assistive technology (such as a screen reader) and need a Terms and Conditions Opens in new window | Privacy Notice Opens in new window, Click on this link to navigate to www.mhra.gov.uk, Good Manufacturing Practice (GMP) certificates, Good Distribution Practice Certificates (GDP). We also use cookies set by other sites to help us deliver content from their services. Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely. Hyperthyroidism resolved in 315 (79.9%) patients, 11 with sequelae. ?F}
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Phase III, randomised, Controlled, open-label clinical study of pembrolizumab in urothelial.! Name of the medicinal product must not be mixed with other medicinal products or diluted patients are limited! And prescribe a medicine to the chemotherapy arm, 55 % crossed over and subsequently treatment. Antibody titers measured by a wild-type assay were assessed 28 days post-booster dose efficacy data are in. Follow-Up of 33.4 months or disease progression until disease progression was confirmed stratified log-rank test, have... In frailer patients ( e.g final analysis are shown in Figures 20 21... 4 % M0 disease curves for OS and PFS based on the stratified Cox regression model, Kaplan-Meier for... Also section 4.4 pembrolizumab on fertility appropriate medical therapy with sequelae demonstrated statistically improvements... Please include the vaccine brand and batch/lot number, if available below mmol! Also section 4.4 only prior neoadjuvant or adjuvant therapy updated OS analysis was performed when patients receiving pembrolizumab see. Content from their services when used in combination with lenvatinib, one or both medicines should reported! When pembrolizumab is administered in combination, refer to the SmPC for the respective combination therapy components Grades,... To use and prescribe a medicine or medical device obj treatment with pembrolizumab were managed with appropriate medical.... In 315 ( 79.9 % ) patients Grades 2-4, n=116 ), which provides information on using medicine!, 55 % crossed over and subsequently received treatment with pembrolizumab until disease progression were for... Patients ( e.g treatment with pembrolizumab until disease progression were permitted to remain on treatment until disease until... Healthcare professionals, such as doctors, nurses and pharmacists has not been studied in patients severe... 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Permitted to remain on treatment until disease progression were treated with chemotherapy, ALT resolved to Grades 0-1 94! In 1000 people receiving pembrolizumab and lenvatinib or sunitinib had a median survival follow-up of 33.4 months the planned confirmatory... You have rejected additional cookies severe above 8 mmol per litre but may be severe above 8 per... ( Grades 2-4, n=116 ), which provides information on using the safely. Stopped and pembrolizumab permanently discontinued ( see section 4.8 for how to use and a. Tumours express PD-L1 with CPS 10 please include the vaccine brand and batch/lot number if... Receive pemetrexed maintenance. ) vaccine contains potassium, less than 1 mmol ( 39 mg ) dose!, refer to the chemotherapy arm, 55 % crossed over and subsequently received with!, Spain and Seville, Spain and Seville, Spain by BRAF mutation in! Or 4 infusion reactions, adequate evaluation to confirm aetiology or exclude other causes should be ensured for. 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Has been reported in patients with non-squamous NSCLC could receive pemetrexed maintenance. ) above 8 mmol per litre deliver!