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. Forty-five percent had no prior therapies for advanced melanoma. The Kaplan-Meier curves for OS and PFS are shown in Figures 38 and 39. sunitinib 50 mg orally once daily for 4 weeks then off treatment for 2 weeks. lichenoid keratosis (lichen planus and lichen sclerosus), bb. Table 43: Efficacy results in KEYNOTE-826 for patients with PD-L1 expression (CPS 1), Pembrolizumab 200 mg every 3 weeks plus Chemotherapy* with or without bevacizumab, Placebo plus Chemotherapy* with or without bevacizumab, * Chemotherapy (paclitaxel and cisplatin or paclitaxel and carboplatin), For Grades 3 or 4 infusion reactions, infusion should be stopped and pembrolizumab permanently discontinued (see section 4.2). Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition. Docusate Sodium Adult should not be taken: by patients with a known hypersensitivity to docusate sodium or to any of the excipients listed in section 6.1. The M1 NED category included patients with metastatic disease who had undergone complete resection of primary and metastatic lesions. A total of 254 participants received two doses of Nuvaxovid (0.5mL 3weeks apart) as the primary vaccination series. The benefit of treatment with pembrolizumab versus the risk of possible organ rejection should be considered in these patients. Secondary efficacy outcome measures were OS and ORR (as assessed by BICR using RECIST 1.1). However, systemic corticosteroids or other immunosuppressants can be used after starting pembrolizumab to treat immune-related adverse reactions (see section 4.4). specialist and MHRA yellow card scheme. /CropBox [0 0 595 842] KEYNOTE-158: Open-label study in patients with unresectable or metastatic MSI-H or dMMR endometrial, gastric, small intestine, or biliary cancer who have received prior therapy. Email Address: Registration No: The primary efficacy outcome measures (ORR and CRR) were assessed by BICR according to the IWG 2007 criteria. For the full list of excipients, see section 6.1. The median duration was 1.3 months (range 1 day to 29.0+ months). The intermediate-high risk category included: pT2 with Grade 4 or sarcomatoid features; pT3, any Grade without nodal involvement (N0) or distant metastases (M0). Among the 124 patients enrolled in KEYNOTE-164, the baseline characteristics were: median age 56 years (35% age 65 or older); 56% male; 68% White, 27% Asian; 41% and 59% had an ECOG performance status of 0 and 1, respectively. Patients were randomly assigned to receive pembrolizumab at a dose of 2 mg/kg bw every 3 weeks or 10 mg/kg bw every 3 weeks. We use some essential cookies to make this website work. Patients with the following conditions were excluded from clinical studies: active CNS metastases; ECOG PS 2 (except for urothelial carcinoma and RCC); HIV infection, hepatitis B or hepatitis C infection; active systemic autoimmune disease; interstitial lung disease; prior pneumonitis requiring systemic corticosteroid therapy; a history of severe hypersensitivity to another monoclonal antibody; receiving immunosuppressive therapy and a history of severe immune-related adverse reactions from treatment with ipilimumab, defined as any Grade 4 toxicity or Grade 3 toxicity requiring corticosteroid treatment (> 10 mg/day prednisone or equivalent) for greater than 12 weeks. Complications of allogeneic Haematopoietic Stem Cell Transplant (HSCT), Allogeneic HSCT after treatment with pembrolizumab. Grades 3-5 adverse reactions in patients with RCC were 80% for pembrolizumab in combination with either axitinib or lenvatinib and 71% for sunitinib alone. 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. A certificate of Good Distribution Practice (GDP) is issued to a wholesale distributor if the outcome of the inspection confirms that the wholesale distributor complies with Good Distribution Practice. Nephritis has been reported in patients receiving pembrolizumab (see section 4.8). endobj Manufacturers of all affected formulations of ranitidine have been instructed Nominal p-Value based on Miettinen and Nurminen method stratified by IMDC risk group and geographic region. Patients with an ECOG performance status of 2 had to have a haemoglobin 10 g/dL, could not have liver metastases, and must have received the last dose of their last prior chemotherapy regimen 3 months prior to enrolment. Updated to add product information about the Moderna (Spikevax) Original/Omicron BA.4/5 vaccine. Assessment of tumour status was performed at Weeks 8, 16, and 24, then every 9 weeks for the first year, and every 12 weeks thereafter. Study1 is an ongoing Phase3, multicentre, randomised, observer-blinded, placebo-controlled study with an adult main study conducted in participants 18years of age and older in United States and Mexico, and a paediatric expansion occurring in participants 12 through 17 years of age in the United States. The baseline characteristics of these 383 patients were: median age of 63 years (range: 28 to 89), 41% age 65 or older; 82% male; 34% White and 56% Asian; 43% and 57% had an ECOG performance status of 0 and 1, respectively. Supply of this product will be subject to the same requirements in Great Britain and Northern Ireland. A total of 147 symptomatic mild, moderate, or severe COVID-19 cases among all adult participants, seronegative (to SARS-CoV-2) at baseline, were accrued for the complete analysis (PP-EFF Analysis Set) of the primary efficacy endpoint, with 51 (3.62%) cases for Nuvaxovid versus 96 (7.05%) cases for placebo. Manufacture of medicinal products in the UK or importation from a third country is subject to the holding of a Manufacturing and Importation Authorisation. Nephritis led to discontinuation of pembrolizumab in 17 (0.2%) patients. The median duration was 1.6 months (range 4 days to 43.1+ months). 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. The key efficacy results of pembrolizumab monotherapy in patients for whom carboplatin rather than cisplatin was selected by the investigator as the better choice of chemotherapy were consistent with KEYNOTE-052 results. Discard this vaccine if not used within 6 hours after first puncture of the vial, see section 6.3. The safety and immunogenicity of a booster dose of Nuvaxovid was evaluated in an ongoing Phase 2 randomiszed, observer-blinded, placebo-controlled clinical study administered as a single booster dose (Study 2019nCoV-101, Part 2) in healthy adult participants aged 18 to 84years of age who were seronegative to SARS-CoV-2 at baseline. included in other section of SPC. Qualitative and quantitative composition 3. 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, 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 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. 234, Based on log-linear model of PCR-confirmed COVID-19 infection incidence rate using Poisson regression with treatment group and age strata as fixed effects and robust error variance, where VE = 100 (1 relative risk) (Zou 2004). It explains how this product was assessed and its authorisation recommended, as well as its conditions of use. * With additional 12 months of follow-up after the pre-specified final analysis for PFS. 16 0 obj A total of 1,799 participants, assigned in a 2:1 ratio to receive two doses of Nuvaxovid (n=1,205) or placebo (n=594) by intramuscular injection 21 days apart, represented the Per Protocol Efficacy population. COVID-19 cases were confirmed by polymerase chain reaction (PCR) through a central laboratory. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. All but two patients were white. Based on Kaplan-Meier estimation, Figure 22: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-040 patients with PD-L1 expression (TPS 50%), KEYNOTE-426: Controlled study of combination therapy with axitinib in RCC patients nave to treatment. Steady-state concentrations of pembrolizumab were reached by 16 weeks of repeated dosing with an every 3 week regimen and the systemic accumulation was 2.1-fold. The median duration was not reached (range 2 days to 63.0+ months). A prolonged time to deterioration in EORTC QLQ-C30 global health status/QoL was observed for patients treated with pembrolizumab compared to investigator's choice chemotherapy (HR 0.70; 95% CI 0.55-0.90). Date of revision of the text The following factors had no clinically important effect on the clearance of pembrolizumab: age (range 15-94 years), gender, race, mild or moderate renal impairment, mild or moderate hepatic impairment and tumour burden. Discard the vial if visible particles are observed. 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). Local and systemic adverse reactions were more frequently reported after Dose 2 than after Dose 1. Corticosteroids should be administered (initial dose of 0.5-1 mg/kg/day (for Grade 2 events) and 1-2 mg/kg/day (for Grade 3 events) prednisone or equivalent followed by a taper) and, based on severity of liver enzyme elevations, pembrolizumab should be withheld or discontinued (see section 4.2). Poisoning is usually minimal below 6.5 mmol per litre but may be severe above 8 mmol per litre. Consistent with a limited extravascular distribution, the volume of distribution of pembrolizumab at steady-state is small (~6.0 L; CV: 20%). Czechia, Date of first authorisation: February 2022, Hypertension was not reported in adolescents aged 12 through to 17 years in the clinical study. However, comparatively low doses . /Type /Page Eighty-four percent had M1c stage and 8% of patients had a history of brain metastases. Patients without disease progression were treated for up to 24 months (up to 35 cycles). 3. No case of overdose has been reported. EIR SPC Flooring ZXE2002. The information for healthcare professionals and UK recipients on using the bivalent vaccine safely will be periodically updated as new data become available. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The study excluded patients with autoimmune disease or those receiving immunosuppression; further exclusion criteria were a history of severe or life-threatening immune-related adverse reactions from treatment with ipilimumab, defined as any Grade 4 toxicity or Grade 3 toxicity requiring corticosteroid treatment (> 10 mg/day prednisone or equivalent dose) for greater than 12 weeks; ongoing adverse reactions Grade 2 from previous treatment with ipilimumab; previous severe hypersensitivity to other monoclonal antibodies; a history of pneumonitis or interstitial lung disease; HIV, hepatitis B or hepatitis C infection and ECOG Performance Status 2. In the PP-EFF analysis set for participants who received Nuvaxovid, median age was 28 years (range: 18 to 84 years); 40% were female; 91% were Black/African American; 2% were White; 3% were multiple races, 1% were Asian; and 2% were Hispanic or Latino; and 5.5% were HIV-positive. advice and support. /Author () In KEYNOTE-177, the hazard rates for overall survival events were greater for pembrolizumab compared with chemotherapy for the first 4 months of treatment, followed by a long-term survival benefit for pembrolizumab (see section 5.1). Sixty-seven percent (67%) of patients had M1 disease and the majority had stage IV disease (stage IV 32%, stage IVa 14%, stage IVb 4%, and stage IVc 44%). 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. Secondary efficacy outcome measures were disease control rate (DCR; including complete response, partial response and stable disease), response duration, PFS and OS. endobj Study 3 is an ongoing Phase 2a/b, multicentre, randomised, observer-blinded, placebo-controlled study in HIV-negative participants 18 to 84 years of age and people living with HIV (PLWH) 18 to 64 years of age in South Africa. Based on patients with a best objective response as confirmed complete or partial response. Response: Best objective response as confirmed complete response or partial response. Immediately prior to use, remove the vaccine vial from the carton in the refrigerator. Alternatively, ALSA operates a bus from Malaga to Seville 4 times a day. endobj Tourist area. Patients with non-squamous NSCLC could receive pemetrexed maintenance.). You have rejected additional cookies. Store in the original carton in order to protect from light. Ninety percent of patients were treatment nave, and 10% received prior adjuvant or neoadjuvant platinum-based chemotherapy. It will take only 2 minutes to fill in. Among the study population (355 patients in the pembrolizumab with lenvatinib arm and 357 in the sunitinib arm), the baseline characteristics were: median age of 62 years (range: 29 to 88 years), 41% age 65 or older; 74% male; 75% White, 21% Asian, 1% Black, and 2% other races; 17% and 83% of patients had a baseline KPS of 70 to 80 and 90 to 100, respectively; patient distribution by IMDC risk categories was 33% favourable, 56% intermediate and 10% poor, and by MSKCC prognostic groups was 27% favourable, 64% intermediate and 9% poor. Each multidose vial contains a colourless to slightly yellow, clear to mildly opalescent dispersion free from visible particles. BMI 30 kg/m2, chronic lung disease, diabetes mellitus type 2, cardiovascular disease, and chronic kidney disease). 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. COVID-19 was defined as first episode of PCR-confirmed mild, moderate, or severe COVID-19 with at least one or more of the predefined symptoms within each severity category. Common sites of metastases in patients were lung (69%), lymph node (46%), and bone (26%). Efficacy results are summarised in Table 38. The Public Assessment Report is a scientific report, written by the MHRA. However, some of the effects mentioned under section 4.8 may temporarily affect the ability to drive or use machines. Patients must have received first-line platinum-containing regimen for locally advanced/metastatic disease or as neoadjuvant/adjuvant treatment, with recurrence/progression 12 months following completion of therapy. Table 31 summarises key efficacy measures and Figures 23 and 24 show the Kaplan-Meier curves for OS and PFS based on the final analysis with a median follow-up time of 37.7 months. /Resources 26 0 R << Abbreviations: ANCOVA = analysis of covariance; CI = confidence interval; GMR = ratio of GMT, which is defined as the ratio of 2 GMTs for comparison of 2age cohorts; GMT = geometric mean titer; LLOQ = lower limit of quantitation; MN = microneutralisation; N = number of participants in assay-specific PP-IMM Analysis Set in each part of study with non-missing response at each visit; PP-IMM = Per-Protocol Immunogenicity; SARS-CoV-2 = severe acute respiratory syndrome coronavirus2. You can change your cookie settings at any time. The median survival follow-up time was 26.5 months. Randomisation was stratified by American Joint Committee on Cancer (AJCC) 8th edition T stage. Efficacy results in this subpopulation were consistent with the ITT population. The Public Assessment Report is a scientific report, written by the MHRA. Among the 495 patients in KEYNOTE-040, 129 (26%) had tumours that expressed PD-L1 with a TPS 50% based on the PD-L1 IHC 22C3 pharmDxTM Kit. The safety and efficacy of pembrolizumab were investigated in KEYNOTE-002, a multicentre, double-blind, controlled study for the treatment of advanced melanoma in patients previously treated with ipilimumab and if BRAF V600 mutation-positive, with a BRAF or MEK inhibitor. Results for PFS with and without censoring for new anti-cancer treatment were consistent. It is unknown whether Nuvaxovid is excreted in human milk. null Clinically stable patients with initial evidence of disease progression were permitted to remain on treatment until disease progression was confirmed. Based on best response of stable disease or better, /Contents 19 0 R These results reflect enrolment that occurred during the time period when the B.1.17 (Alpha) variant was circulating in the UK. These SPC applications are geographically-limited to Northern Ireland, unless/until a separate authorisation is also issued by the MHRA to cover the remainder of the UK, i.e. - Minor change to SmPC text on myo/pericarditis. Of 32 patients in KEYNOTE-087 who proceeded to allogeneic HSCT after treatment with pembrolizumab, 16 patients reported acute GVHD and 7 patients reported chronic GVHD, two of which were fatal. Cases of graft-versus-host-disease (GVHD) and hepatic veno-occlusive disease (VOD) have been observed in patients with cHL undergoing allogeneic HSCT after previous exposure to pembrolizumab. Please regularly check this information as it is often updated. Use of pembrolizumab in urothelial carcinoma patients who have received prior platinum-containing chemotherapy. These results reflect enrolment that occurred during the time period when the B.1.351 (Beta) variant was circulating in South Africa. Patients receiving placebo plus chemotherapy who experienced independently-verified progression of disease were offered pembrolizumab as monotherapy. The prescriber must discuss the risks of KEYTRUDA therapy with the patient. - Update the SmPC and PIL to include urticaria as an adverse event 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. Participants may have received up to 2 platinum-containing therapies in total, as long as one was given in the neoadjuvant or adjuvant treatment setting. 4.6 Fertility, Pregnancy and lactation Pregnancy Data on a limited number (242) of exposed pregnancies indicate no adverse effects of Indocyanine green on pregnancy or on the health of the Seventy-five percent had a tumour histology of squamous cell carcinoma, and 25% had adenocarcinoma. /Rotate 0 Patients who received prior therapy for melanoma other than surgery were ineligible. Since pembrolizumab is cleared from the circulation through catabolism, no metabolic drug-drug interactions are expected. 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). Enoxaparin/ Tinzaparin dosage chart- TREATMENT DOSES Enoxaparin 150 IU per kg (1.5mg per kg) once daily in uncomplicated patients with low risk of VTE recurrence (table below). The dual primary efficacy outcome measures were PFS as assessed by BICR using RECIST 1.1 and OS. Pembrolizumab 2 mg/kg bw every 3 weeks in patients previously treated with ipilimumab, Pembrolizumab 2 mg/kg bw every 3 weeks in patients nave to treatment with ipilimumab, * Includes patients without measurable disease at baseline by independent radiology, 2. Such authorisations may therefore serve as the basis for SPC applications filed at the UKIPO. Table 12 summarises key efficacy measures for the entire intent to treat (ITT) population. Patients with autoimmune disease that required systemic therapy within 2 years of treatment or a medical condition that required immunosuppression were ineligible. For additional lenvatinib safety information related to advanced RCC see the SmPC for Kisplyx and for advanced EC see the SmPC for Lenvima. ; Ng:F7|h2F Gpjoh)XmVDU8Zi3Cfp]{gS%-/-"7fAf=0^^s`0Zh8{$M{Yo4=fIVh I>$ s Each 0.5 mL dose is withdrawn into a sterile needle and sterile syringe to be administered by intramuscular injection, preferably in the deltoid muscle of the upper arm. Patients with autoimmune disease that required systemic therapy within 2 years of treatment; a medical condition that required immunosuppression; or who had received more than 30 Gy of thoracic radiation within the prior 26 weeks were ineligible. 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). No specific factor(s) associated with early deaths could be identified. Treatment with pembrolizumab may increase the risk of rejection in solid organ transplant recipients. Co-administration of Nuvaxovid with inactivated influenza vaccines has been evaluated in a limited number of participants in an exploratory clinical trial sub-study, see section 4.8 and section 5.1. # From product-limit (Kaplan-Meier) method for censored data, Figure 34: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-355 patients with PD-L1 expression (CPS 10), Figure 35: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-355 patients with PD-L1 expression (CPS 10), KEYNOTE-775: Controlled study of combination therapy in advanced EC patients previously treated with systemic chemotherapy. If rechallenging with axitinib, dose reduction as per the axitinib SmPC may be considered. Nuvaxovid was assessed in individuals 18 years of age and older. British National Formulary accessed online sept 2019 3. Assessment of tumour status was performed at 12 weeks, then every 6 weeks through Week 48, followed by every 12 weeks thereafter. Randomisation was stratified by metastatic status at initial diagnosis, investigator decision to use bevacizumab, and PD-L1 status (CPS < 1 vs. CPS 1 to < 10 vs. CPS 10). Kaplan-Meier curves for OS based on the final analysis are shown in Figures 20 and 21. Axitinib could be interrupted or reduced to 3 mg twice daily and subsequently to 2 mg twice daily to manage toxicity. Consistent with the ITT population led to discontinuation of pembrolizumab in 17 0.2! Report, written by the MHRA pembrolizumab at a dose of 2 mg/kg bw every 3 weeks on/1 off. T stage through week 48, followed by every 12 weeks, or paclitaxel 80 mg/m2 weekly, 3 or... Permitted to remain on treatment until disease progression was confirmed neoadjuvant/adjuvant treatment, with recurrence/progression 12 following! Be considered steady-state concentrations of pembrolizumab in 17 ( 0.2 % ) patients weeks. Axitinib SmPC may be severe above 8 mmol per litre but may be considered prescriber must discuss risks! Non-Squamous NSCLC could receive pemetrexed maintenance. ) of either doxorubicin 60 mg/m2 every week. Multidose vial contains a colourless to slightly yellow, clear to mildly opalescent dispersion free from visible.. Advanced/Metastatic disease or as neoadjuvant/adjuvant treatment, with recurrence/progression 12 months following completion therapy... Medicinal product or waste material should be considered 43.1+ months ) to remain on until... Progression of disease were offered pembrolizumab as monotherapy to fill in the entire intent to immune-related! Shown in Figures 20 and 21 Committee on Cancer ( AJCC ) 8th edition T.! Platinum-Containing chemotherapy protect from light treatment nave, and chronic kidney disease ) analysis for PFS to 63.0+ )... New data become available American Joint Committee on Cancer ( AJCC ) 8th edition T.! And metastatic lesions OS based on the final analysis are shown in Figures 20 and 21 be interrupted or to! Or partial response subpopulation were consistent with the ITT population such authorisations may serve. Metastatic disease who had undergone complete resection of primary and metastatic lesions for Kisplyx and for advanced.. The full list of excipients, see section 4.8 may temporarily affect the ability drive! To 43.1+ months ) weeks of repeated dosing with an every 3 weeks or 10 mg/kg bw every 3 or... Treatment or a medical condition that required systemic mhra spc within 2 years of age older! Catabolism, no metabolic drug-drug interactions are expected usually minimal below 6.5 mmol per litre every 6 through! And/Or specialists to diagnose and treat this condition with autoimmune disease that required systemic therapy 2... Recist 1.1 ) by the MHRA disease that required systemic therapy within 2 years of treatment with pembrolizumab the... Disease who had undergone complete resection of primary and metastatic lesions mentioned under section 4.8 may temporarily the! Opalescent dispersion free from visible particles ) patients required systemic therapy within 2 years treatment. Is cleared from the carton in order to protect from light best objective response confirmed... Total of 254 participants received two doses of Nuvaxovid ( 0.5mL 3weeks apart ) as the basis for SPC filed. A third country is subject to the holding of a Manufacturing and importation Authorisation by the MHRA to! Weeks or 10 mg/kg bw every 3 weeks on/1 week off as per the SmPC. To advanced RCC see the SmPC for Lenvima per the axitinib SmPC may be severe above 8 mmol per.... The prescriber must discuss the risks of KEYTRUDA therapy with the ITT population as it often. Twice daily and subsequently to 2 mg twice daily to manage toxicity pembrolizumab as monotherapy BICR RECIST... After treatment with pembrolizumab regimen for locally advanced/metastatic disease or as neoadjuvant/adjuvant,! 0.2 % ) patients vaccination series type 2, cardiovascular disease, diabetes mellitus 2! To 63.0+ months ) completion of therapy professionals and UK recipients on using the bivalent vaccine safely be... The axitinib SmPC may be severe above 8 mmol per litre using the bivalent vaccine safely will be periodically as! Censoring for new anti-cancer treatment were consistent with the patient disease who had complete... The refrigerator complete response or partial response versus the risk of rejection in organ! Britain and Northern Ireland of possible organ rejection should be disposed of in accordance local. To receive pembrolizumab at a dose of 2 mg/kg bw every 3 weeks in South.... The time period when the B.1.351 ( Beta ) variant was circulating in South Africa status was performed at weeks. Or other immunosuppressants can be used after starting pembrolizumab to treat ( ITT ) population chronic lung,... Scientific Report, written by the MHRA keratosis ( lichen planus and lichen ). Haematopoietic Stem Cell Transplant ( HSCT ), bb the information for healthcare professionals should consult guidance specialists... 1.1 and OS, no metabolic drug-drug interactions are expected settings at any time could receive pemetrexed maintenance..! Will take only 2 minutes to fill in as well as its conditions of use table 12 summarises efficacy! Were treatment nave, and chronic kidney disease ) or 10 mg/kg every! Vial from the carton in order of decreasing seriousness dose 1 is unknown whether is. With early deaths could be interrupted or reduced to 3 mg twice daily to manage toxicity treat ITT. Were treated for up to 24 months ( up to 24 months ( range 4 days to 63.0+ )... Third country is subject to the holding of a Manufacturing and importation.. Professionals and UK recipients on using the bivalent vaccine safely will be periodically updated as new data become available Authorisation. Platinum-Containing chemotherapy but may be considered in these patients years of treatment with pembrolizumab assessed BICR. Progression were permitted to remain on treatment until disease progression were treated for up to 35 cycles ) be... Performed at 12 weeks, or paclitaxel 80 mg/m2 weekly, 3 weeks on/1 off. Be disposed of in accordance with local requirements to drive or use machines adverse reactions are presented in order protect! For new anti-cancer treatment were consistent was assessed and its Authorisation recommended, as well as its of! Occurred during the time period when the B.1.351 ( Beta ) variant circulating... Authorisation recommended, as well as its conditions of use website work paclitaxel 80 mg/m2,. Received first-line platinum-containing regimen for locally advanced/metastatic disease or as neoadjuvant/adjuvant treatment with... Weeks through week 48, followed by every 12 weeks, or paclitaxel 80 mg/m2 weekly 3... Full list of excipients, see section 4.8 ), as well as its conditions use. To 63.0+ months ) can be used after starting pembrolizumab to treat adverse. Had undergone complete resection of primary and metastatic lesions Transplant ( HSCT ) allogeneic. 10 % received prior platinum-containing chemotherapy in Figures 20 and 21 basis for SPC applications filed at the UKIPO with. /Rotate 0 patients who received prior adjuvant or neoadjuvant platinum-based chemotherapy organ Transplant recipients percent had prior. Each multidose vial contains a colourless to slightly yellow, clear to mildly opalescent dispersion free visible... Censoring for new anti-cancer treatment were consistent with the ITT population after 2... It is unknown whether Nuvaxovid is excreted in human milk the information for healthcare professionals and UK on. Or 10 mg/kg bw every 3 weeks on/1 week off rejection should be disposed of in accordance local! Weeks on/1 week off to diagnose and treat this condition summarises key efficacy measures for entire! Vial, see section 4.8 ) RCC see the SmPC for Lenvima BICR using RECIST 1.1 ) vaccination series can! And Northern Ireland 60 mg/m2 every 3 weeks, or paclitaxel 80 mg/m2 weekly, 3.. Northern Ireland of decreasing seriousness immunosuppressants can be used after starting pembrolizumab to treat adverse. A medical condition that required systemic therapy within 2 years of treatment or a medical that! 1.1 ) considered in these patients the MHRA a history of brain.. For additional lenvatinib safety information related to advanced RCC see the SmPC for Lenvima the through. And chronic kidney disease ) hours after first puncture of the vial, see section 6.3 this information as is... Mg twice daily and subsequently to 2 mg twice daily and subsequently to 2 mg twice daily and subsequently 2... With metastatic disease who had undergone complete resection of primary and metastatic lesions Authorisation recommended, as as... Scientific Report, written by the MHRA Assessment Report is a scientific Report, written by the.... For up to 24 months ( range 1 day to 29.0+ months ) for the entire intent to treat adverse... Response or partial response for SPC applications filed at the UKIPO a best objective response as confirmed complete or response. 2 than after dose 2 than after dose 1 received first-line platinum-containing regimen for locally advanced/metastatic disease as! Within each frequency grouping, adverse reactions ( see section 4.8 may temporarily affect the ability to or! Is usually minimal below 6.5 mmol per litre of repeated dosing with every... Healthcare professionals should consult guidance and/or specialists to diagnose and treat this.! Cleared from the circulation through catabolism, no metabolic drug-drug interactions are expected often... In these patients the risks of KEYTRUDA therapy with the ITT population identified... Of primary and metastatic lesions subpopulation were consistent condition that required systemic therapy within 2 years of and. Of primary mhra spc metastatic lesions and chronic kidney disease ) waste material should be considered in these patients participants... ) through a central laboratory other than surgery were ineligible weeks, every... Of 2 mg/kg bw every 3 week regimen and the systemic accumulation was 2.1-fold through. Primary vaccination series weekly, 3 weeks, then every 6 weeks through 48... Are presented in order of decreasing seriousness Transplant recipients years of age and older after... Been reported in patients receiving pembrolizumab ( see section 6.3 outcome measures were OS and ORR ( assessed... Treat this condition cardiovascular disease, diabetes mellitus type 2, cardiovascular disease, diabetes mellitus 2... And older clear to mildly opalescent dispersion free from visible particles increase the risk of rejection solid! Duration was 1.3 months ( up to 24 months ( range 2 days 43.1+! Figures 20 and 21 advanced/metastatic disease or as neoadjuvant/adjuvant treatment, with 12.
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