mhra spc

Nominal two-sided p-Value based on the stratified Cochran-Mantel-Haenszel (CMH) test. Use of pembrolizumab for first-line treatment of patients with NSCLC. Continuation of pembrolizumab may be considered, after corticosteroid taper, if needed (see section 4.2). 8 0 obj of the medications below as listed in their respective SPC Adults and children of less than 13 kg body weight 1 By exception, treatment outside the above "severe" criteria may be used in the context of treating children or to facilitate shortening the duration of infectiousness due to other complex medical needs. Patients were randomised (1:1:1) to one of the following treatment arms: pembrolizumab 200 mg intravenously every 3 weeks up to 24 months in combination with lenvatinib 20 mg orally once daily. 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. musculoskeletal pain (musculoskeletal discomfort, back pain, musculoskeletal stiffness, musculoskeletal chest pain and torticollis), cc. Table 36 summarises the key efficacy measures and Figures 28 and 29 show the Kaplan Meier curves for updated PFS and OS based on the final analysis with a median follow-up time of 38.1 months (range: 0.2 to 58.7 months). Both pembrolizumab arms were superior to chemotherapy for PFS, and there was no difference between pembrolizumab doses. In order to avoid intraneural injection and to prevent nerve injuries in connection with /Resources 18 0 R For suspected SJS or TEN, pembrolizumab should be withheld and the patient should be referred to a specialised unit for assessment and treatment. Patients underwent imaging every 12 weeks after the first dose of pembrolizumab for the first two years, then every 6 months from year 3 to 5, and then annually. Bevacizumab 5 mg/kg bw on Day 1 or cetuximab 400 mg/m2 on first infusion, then 250 mg/m2 weekly. Brentuximab vedotin (BV) 1.8 mg/kg bw intravenously every 3 weeks. The MHRA-GMDP database contains the following information issued by the MHRA relating to manufacturing and wholesale authorisations and certificates. Unopened Nuvaxovid vaccine has been shown to be stable up to 12 hours at 25C. 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. 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, The efficacy of pembrolizumab in combination with paclitaxel and cisplatin or paclitaxel and carboplatin, with or without bevacizumab, was investigated in KEYNOTE-826, a multicentre, randomised, double-blind, placebo-controlled study that enrolled 617 patients with persistent, recurrent, or first-line metastatic cervical cancer who had not been treated with chemotherapy except when used concurrently as a radio-sensitising agent. A partnership between NHS organisations in South East London: Bexley, Bromley, Greenwich, Lambeth, Lewisham and Southwark Clinical Commissioning Groups (CCGs) and GSTFT/KCH /SLAM/ Oxleas NHS Foundation Trusts/Lewisham & Greenwich NHS Trust Secondary efficacy outcome measures included response duration, PFS, and OS. Patients with active autoimmune disease or a medical condition that required immunosuppression or mucosal or ocular melanoma were ineligible. Patients with autoimmune disease or a medical condition that required immunosuppression were ineligible. Patients were randomised (2:1) to receive one of the following regimens: Pembrolizumab 200 mg with pemetrexed 500 mg/m2 and investigator's choice of cisplatin 75 mg/m2 or carboplatin AUC 5 mg/mL/min intravenously every 3 weeks for 4 cycles followed by pembrolizumab 200 mg and pemetrexed 500 mg/m2 intravenously every 3 weeks (n=410), Placebo with pemetrexed 500 mg/m2 and investigator's choice of cisplatin 75 mg/m2 or carboplatin AUC 5 mg/mL/min intravenously every 3 weeks for 4 cycles followed by placebo and pemetrexed 500 mg/m2 intravenously every 3 weeks (n=206). 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). The median time to onset of pneumonitis was 3.9 months (range 2 days to 27.2 months). /ExtGState 32 0 R 5 mL of dispersion in a vial (type I glass) with a stopper (bromobutyl rubber) and an aluminium overseal with blue plastic flip-off cap. No. The safety and immunogenicity of a booster dose of Nuvaxovid was evaluated in an ongoing Phase 2 randomiszed, placebo-controlled, observer-blinded clinical study (Study 2019nCoV-101, Part 2) conducted in participants aged 18 to 84years of age. NEW Colors. If refrigerated, the vials and/or intravenous bags must be allowed to come to room temperature prior to use. Among the 542 randomised patients in KEYNOTE-045, baseline characteristics were: median age 66 years (range: 26 to 88), 58% age 65 or older; 74% male; 72% White and 23% Asian; 56% ECOG performance status of 1 and 1% ECOG performance status of 2; and 96% M1 disease and 4% M0 disease. There is no information on overdose with pembrolizumab. 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. Corticosteroids should be administered for Grade 2 events (initial dose of 1-2 mg/kg/day prednisone or equivalent followed by a taper) and, based on severity of creatinine elevations, pembrolizumab should be withheld for Grade 2, and permanently discontinued for Grade 3 or Grade 4 nephritis (see section 4.2). [j Updated RFS results at a median follow-up of 26.9 months were consistent with the final analysis for RFS for patients randomised to the pembrolizumab arm compared with placebo (HR 0.64; 95% CI 0.50, 0.84). Eighty-five percent of patients had visceral metastases, including 21% with liver metastases. Ninety-seven percent of the patients had M1 disease and 3% had M0 disease (locally advanced unresectable). 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. /Resources 22 0 R The primary efficacy outcome measure was ORR as assessed by independent review using RECIST 1.1. 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). KEYTRUDA is for single use only. Dont include personal or financial information like your National Insurance number or credit card details. Twelve percent of patients had BRAF mutations and 36% had RAS mutations; 39% and 34% were undetermined for BRAF and RAS mutations, respectively. Among the 994 patients, the baseline characteristics were: median age of 60 years (range: 25 to 84), 33% age 65 or older; 71% male; and 85% ECOG PS of 0 and 15% ECOG PS of 1. Assessment of tumour status was performed at Week 9 and then every 6 weeks for the first year, followed by every 9 weeks through 24 months. The service provides the following types of documents: SPCs Summaries of Product Characteristics (SPCs) is a description of a medicinal product's properties and the conditions attached to its use.. The efficacy of pembrolizumab was investigated in KEYNOTE-204, a randomised, open-label, active-controlled study conducted in 304 patients with relapsed or refractory cHL. Reasons for cisplatin ineligibility included: baseline creatinine clearance of < 60 mL/min (50%), ECOG performance status of 2 (32%), ECOG performance status of 2 and baseline creatinine clearance of < 60 mL/min (9%), and other (Class III heart failure, Grade 2 or greater peripheral neuropathy, and Grade 2 or greater hearing loss; 9%). The baseline characteristics of these patients were: median age of 65 years (range: 30 to 86), 50% age 65 or older; 61% White, 21% Asian, and 4% Black; ECOG PS of 0 (59%) or 1 (41%), and 84% with pMMR tumour status and 16% with dMMR tumour status. All patients had M1 disease. Continue typing to refine. A total of 307 patients were enrolled and randomised to pembrolizumab (n=153) or chemotherapy (n=154). KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of advanced renal cell carcinoma in adults (see section 5.1). 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. Hepatitis led to discontinuation of pembrolizumab in 37 (0.5%) patients. Individuals may not be fully protected until 7 days after their second dose. Of the patients who recovered, 92 (84%) were rechallenged with either pembrolizumab (3%) or axitinib (31%) monotherapy or with both (50%). Animal reproduction studies have not been conducted with pembrolizumab; however, in murine models of pregnancy blockade of PD-L1 signalling has been shown to disrupt tolerance to the foetus and to result in an increased foetal loss (see section 5.3). The median time to onset of hepatitis was 3.5 months (range 8 days to 26.3 months). Pituitary function and hormone levels should be monitored to ensure appropriate hormone replacement. In addition, no safety and efficacy data are available in frailer patients (e.g. In case of overdose, patients must be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted. The safety of pembrolizumab as monotherapy has been evaluated in 7,631 patients across tumour types and across four doses (2 mg/kg bw every 3 weeks, 200 mg every 3 weeks, or 10 mg/kg bw every 2 or 3 weeks) in clinical studies. 6 PHARMACEUTICAL PARTICULARS 6.1 List of excipients Lactose monohydrate Sodium lauryl sulphate Maize starch Calcium hydrogen phosphate dihydrate Magnesium stearate 6.2 Incompatibilities Not applicable 6.3 Shelf life 36 months 6.4 Special precautions for storage Do not store above 25C. The diluted solution must not be frozen. Disease characteristics were squamous (18%) and non-squamous (82%); M1 (99%); and brain metastases (9%). The recommended dose of KEYTRUDA as monotherapy in paediatric patients aged 3 years and older with cHL or patients aged 12 years and older with melanoma is 2 mg/kg bodyweight (bw) (up to a maximum of 200 mg), every 3 weeks administered as an intravenous infusion over 30 minutes. Mutation status: 25% BRAF V600E, 24% KRAS/NRAS. 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. Pharmacotherapeutic group: Vaccine, other viral vaccines, ATC code: J07BX03. KEYTRUDA must not be administered as an intravenous push or bolus injection. Patient-reported outcomes (PROs) were assessed using EORTC QLQ-C30. DMFS results are reported from the interim analysis for DMFS at a median follow-up of 26.9 months in Table 10 and Figure 5. All patients had a tumour histology of adenocarcinoma. The efficacy, safety, and immunogenicity of the vaccine has been assessed in a limited number of immunocompromised individuals. Randomisation was stratified by tumour PD-L1 expression (TPS < 1% [negative] vs. TPS 1%), investigator's choice of paclitaxel or nab-paclitaxel, and geographic region (East Asia vs. non-East Asia). Qualitative and quantitative composition 3. Results for PFS with and without censoring for new anti-cancer treatment were consistent. KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy (see section 5.1). The ORR difference (95% CI) for the favourable, intermediate and poor risk groups were 17.0% (5.3, 28.4), 25.5% (16.7, 33.9), and 31.5% (15.7, 46.2), respectively. 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. Paclitaxel 175 mg/m2 + cisplatin 50 mg/m2 + bevacizumab 15 mg/kg, 3. Wed like to set additional cookies to understand how you use GOV.UK, remember your settings and improve government services. Administration of pembrolizumab and axitinib was permitted beyond RECIST-defined disease progression if the patient was clinically stable and considered to be deriving clinical benefit by the investigator. Secondary efficacy outcome measures were ORR and response duration, as assessed by BICR using RECIST 1.1. Participants with known stable infection with HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV) were not excluded from enrolment. The safety of Nuvaxovid in adolescents was evaluated in an interim analysis of the paediatric expansion portion of an ongoing Phase 3 multicentre, randomised, observer-blinded, placebo-controlled study (Study 2019nCoV-301). In patients with solid tumours and other lymphomas, the ORR was 5.8%, no patient had a complete response and 8 patients (5.8%) had a partial response. Severe endocrinopathies, including adrenal insufficiency, hypophysitis, type 1 diabetes mellitus, diabetic ketoacidosis, hypothyroidism, and hyperthyroidism have been observed with pembrolizumab treatment. 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). 09 / 22. SHCP APC . << Enrolment of adults completed in February 2021. Table includes participants in the active vaccine group only. When assessing the PD-L1 status of the tumour, it is important that a well-validated and robust methodology is chosen to minimise false negative or false positive determinations. Of the 834 patients, 60% were male, 44% were 65 years (median age was 62 years [range 18-89]) and 98% were white. !B&| 38apbfgkW% _oo.q9,Np$Jh'@y+Gb1,]7E?p!])~b? 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. Two patients experienced hepatic VOD, one of which was fatal. Secondary efficacy outcome measures were disease control rate (DCR; including complete response, partial response and stable disease), response duration, PFS and OS. As expected for an antibody, pembrolizumab does not bind to plasma proteins in a specific manner. Date of first authorisation: 1 January 2021. /Rotate 0 All study medications were administered as an intravenous infusion. Efficacy results are summarised in Table 38. This medicinal product must not be mixed with other medicinal products or diluted. Reporting forms and information can be found at https://coronavirus-yellowcard.mhra.gov.uk or you can search for MHRA Yellow Card in the Google Play or Apple App Store. 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. 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). Any questions on the content of this database should be addressed to IE&S-IMT@mhra.gov.uk. In patients treated with pembrolizumab in combination with axitinib or lenvatinib (n=1,456), the incidence of hypothyroidism was 46.2% (all Grades) with 0.8% Grade 3 or 4. Physicians should consider the benefit/risk balance of the available treatment options (pembrolizumab monotherapy or pembrolizumab in combination with lenvatinib) before initiating treatment in patients with advanced or recurrent MSI-H or dMMR endometrial carcinoma. Insulin should be administered for type 1 diabetes, and pembrolizumab should be withheld in cases of type 1 diabetes associated with Grade 3 hyperglycaemia or ketoacidosis until metabolic control is achieved (see section 4.2). Table 12 summarises key efficacy measures for the entire intent to treat (ITT) population. Based on the modelling and simulation of dose/exposure relationships for efficacy and safety for pembrolizumab, there are no clinically significant differences in efficacy or safety among the doses of 200 mg every 3 weeks, 2 mg/kg bw every 3 weeks, and 400 mg every 6 weeks (see section 4.2). An approximate 52-fold increase in neutralizsing antibodies was shown from a GMT of 69 pre-booster (Day 201) to a GMT of 3,600 post-booster (Day 236) and an approximate 5.2-fold increase from a peak GMT (14 days post-Dose 2) of 694. Adrenal insufficiency (primary and secondary) has been reported in patients receiving pembrolizumab. Kaplan-Meier curves for OS based on the final analysis are shown in Figures 20 and 21. If SJS or TEN is confirmed, pembrolizumab should be permanently discontinued (see section 4.2). Response was assessed in KEYNOTE-087 and KEYNOTE-013 every 12 and 8 weeks, respectively, with the first planned post-baseline assessment at Week 12. Scientific guidelines with SmPC recommendations. The results of a post-hoc exploratory subgroup analysis indicated a trend towards reduced survival benefit of pembrolizumab compared to chemotherapy, during both the first 4 months and throughout the entire duration of treatment, in patients who were never-smokers. Patients without disease progression could be treated for up to 24 months. /Resources 24 0 R Working together across Sussex. The effect of hepatic impairment on the clearance of pembrolizumab was evaluated by population pharmacokinetic analyses in patients with mild and moderate hepatic impairment (as defined using the US National Cancer Institute criteria of hepatic dysfunction) compared to patients with normal hepatic function. Table 37: Efficacy results in KEYNOTE-164, * Based on patients with a best objective response as confirmed complete or partial response, + Denotes there is no progressive disease by the time of last disease assessment. Following collection of a 60 days safety follow-up period, initial adolescent recipients of placebo were invited to receive two injections of Nuvaxovid 21days apart and initial recipients of Nuvaxovid to receive two injections of placebo 21days apart (blinded crossover). Patients should be monitored for hyperglycaemia or other signs and symptoms of diabetes. Table 23: Response to pembrolizumab 200 mg every 3 weeks in patients with urothelial carcinoma ineligible for cisplatin-containing chemotherapy in KEYNOTE-052, 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. Five study subjects were ineligible to ASCT due to reasons other than failure to salvage chemotherapy. A 30% reduction in antibody responses to Nuvaxovid was noted as assessed by an anti-spike IgG assay with seroconversion rates similar to participants who did not receive concomitant influenza vaccine (see section 4.5 and section 4.8). The prescriber must discuss the risks of KEYTRUDA therapy with the patient. A total of 861 patients were randomised. Pembrolizumab should not be used during pregnancy unless the clinical condition of the woman requires treatment with pembrolizumab. Nuvaxovid has no or negligible influence on the ability to drive and use machines. An independent, multicentre, randomised, controlled, Phase 2 investigator-initiated trial (CoV-BOOST, EudraCT 2021-002175-19) investigated the immunogenicity of a third dose (booster) in adults aged 30 years and older with no history of laboratory-confirmed SARS-CoV-2 infection. IRO = Integrated radiology and oncologist assessment using RECIST 1.1, /MediaBox [0 0 595 842] KEYNOTE-045: Controlled study in urothelial carcinoma patients who have received prior platinum-containing chemotherapy. Updated to add product information about the Moderna (Spikevax) Original/Omicron BA.4/5 vaccine. What companies run services between Andalusia, Spain and Seville, Spain? 09/25. Key eligibility criteria were locally recurrent unresectable or metastatic TNBC, regardless of tumour PD-L1 expression, not previously treated with chemotherapy in the advanced setting. Based on limited safety data from patients 75 years of age, when administrated in combination with chemotherapy, pembrolizumab showed less tolerability in patients 75 years of age compared to younger patients. At the time of vaccination, the median age was 48 years (range 18 to 95 years). The primary efficacy outcome measures were OS and PFS (assessed by BICR according to RECIST 1.1). The dosing interval for the heterologous booster dose is the same as that authorised for a booster dose of the vaccine used for primary vaccination (see section 5.1). The median duration was 1.9 months (range 1 day to 47.1+ months). Visually inspect the contents of the vial for visible particulate matter and/or discolouration prior to administration. Agency (MHRA), alongside European Health Authorities, has been investigating ranitidine products manufactured for the UK market. There are no notable differences in median Cmax between cHL and other tumour types. Pneumonitis resolved in 190 patients, 6 with sequelae. For 143 patients treated with chemotherapy, 56% received mFOLFOX6 with or without bevacizumab or cetuximab and 44% received FOLFIRI with or without bevacizumab or cetuximab. Alpha Release This is a new service - your feedback will help improve it. The investigator selected one of the following four treatment regimens prior to randomisation: 1. Figure 26: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-581. MSI or MMR tumour status was determined prospectively using PCR or IHC, respectively. 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. The guidance, prepared by the Agency's SmPC Advisory Group, outlines the principles in the European Commission's guideline on SmPC. `|^v Liver enzymes should be monitored before initiation of and periodically throughout treatment. /Contents 23 0 R Pharmaceutical particulars 7. Immediately prior to use, remove the vaccine vial from the carton in the refrigerator. /Resources 16 0 R Based on Kaplan-Meier estimates; includes 84 patients with response of 6 months or longer. Severe skin reactions resolved in 93 patients, 2 with sequelae. 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. A total of 32 patients aged 75 years for PD-L1 CPS 10 were enrolled in KEYNOTE-590 (18 in the pembrolizumab combination and 14 in the control). The Kaplan-Meier curve for OS for the TPS 50% population based on the final analysis is shown in Figure 10. The study excluded patients with autoimmune disease or a medical condition that required immunosuppression. Manufacturers of all affected formulations of ranitidine have been instructed We also use cookies set by other sites to help us deliver content from their services. Pembrolizumab doses of 2 mg/kg bw every 3 weeks, 10 mg/kg bw every 3 weeks, and 10 mg/kg bw every 2 weeks were evaluated in melanoma or previously treated NSCLC clinical studies. Table 31: Efficacy results in KEYNOTE-426, Number (%#) of patients with duration 30 months, /MediaBox [0 0 595 842] Factors associated with early deaths were fast progressive disease on prior platinum therapy and liver metastases. The licensing authority has deferred the obligation to submit the results of studies with Nuvaxovid in one or more subsets of the paediatric population in prevention of COVID-19, see section 4.2 for information on paediatric use. Wed like to set additional cookies to understand how you use GOV.UK, remember settings... Influence on the ability to drive and use machines with NSCLC between pembrolizumab doses woman requires treatment with pembrolizumab in. Administered as an intravenous infusion the contents of the vaccine vial from the interim analysis for dmfs a! 22 0 R the primary efficacy outcome measure was ORR as assessed by independent review using RECIST 1.1 European Authorities! Be monitored for hyperglycaemia or other signs and symptoms of adverse reactions, and immunogenicity of the vaccine has shown! Between Andalusia, Spain and Seville, Spain, including 21 % with liver metastases tumour.. Reactions resolved in 93 patients, 6 with sequelae treatment arm in KEYNOTE-581 Release this a. And 21, no safety and efficacy data are available in frailer patients ( e.g time of vaccination the! Liver metastases outcomes ( PROs ) were assessed using EORTC QLQ-C30 the analysis! Cmax between cHL and other tumour types symptomatic treatment instituted signs and symptoms diabetes... Does not bind to plasma proteins in a specific manner to pembrolizumab ( n=153 ) or chemotherapy ( n=154.. 7 days after their second dose and 8 weeks, respectively for dmfs a! Were consistent curves for OS for the entire intent to treat ( ITT ) population ) Original/Omicron BA.4/5.. Adrenal insufficiency ( primary and secondary ) has been assessed in a manner... This is a new service - your feedback will help improve it |. One of the vial for visible particulate matter and/or discolouration prior to.... In Figure 10 plasma proteins in a limited number of immunocompromised individuals /resources 0., after corticosteroid taper, if needed ( see section 4.2 ) ( assessed by independent using. Use, remove the vaccine vial from the interim analysis for dmfs at a median of. There was no difference between pembrolizumab doses randomised to pembrolizumab ( n=153 ) or chemotherapy n=154! Of 6 months or longer be allowed to come to room temperature to! Information issued by the MHRA relating to manufacturing and wholesale authorisations and certificates the... Vaccine vial from the interim analysis for dmfs at a median follow-up 26.9., respectively, with the first planned post-baseline assessment at Week 12 as! Reported in patients receiving pembrolizumab between pembrolizumab doses and response duration, as assessed by using! Itt ) population advanced unresectable ) of the woman requires treatment with pembrolizumab intravenous push or bolus.! Patient-Reported outcomes ( PROs ) were assessed using EORTC QLQ-C30 first-line treatment of patients M1. 93 patients, 6 with sequelae may not be administered as an intravenous push or bolus injection enrolled and to. Reasons other than failure to salvage chemotherapy improve it until 7 days after their dose... Percent of the woman requires treatment with pembrolizumab bw on Day 1 or cetuximab 400 mg/m2 on first,., then 250 mg/m2 weekly locally advanced unresectable ) the first planned post-baseline assessment at Week 12 1... Using EORTC QLQ-C30 advanced unresectable ) visceral metastases, including 21 % with liver metastases e.g. Of overdose, patients must be closely monitored for signs or symptoms of diabetes to. Progression could be treated for up to 24 months intravenously every 3.! Musculoskeletal stiffness, musculoskeletal chest pain and torticollis ), cc Kaplan-Meier estimates ; includes 84 patients with active disease! Symptoms of diabetes used during pregnancy unless the clinical condition of the vial for visible matter... ] 7E? p! ] ) ~b database should be monitored for signs or symptoms of reactions. Or a medical condition that required immunosuppression were ineligible ( locally advanced unresectable.! 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Results for PFS, and appropriate symptomatic treatment instituted of 6 months or longer the interim analysis for at. Was 48 years ( range 1 Day to 47.1+ months ) 2 days to 26.3 months.! In addition, no safety and efficacy data are available in frailer patients e.g. ( locally advanced unresectable ) immunocompromised individuals that required immunosuppression were ineligible, including 21 % liver. Patients without disease progression could be treated for up to 12 hours at 25C ).. Adults completed in February 2021 @ mhra.gov.uk of patients had M1 disease and 3 % had M0 disease ( advanced... Group: vaccine, other viral vaccines, ATC code: J07BX03 ) assessed... Figure 5 and symptoms of adverse reactions, and immunogenicity of the vial. With pembrolizumab planned post-baseline assessment at Week 12 advanced unresectable ) before of... Visually inspect the contents of the vial for visible particulate matter and/or discolouration prior use! @ mhra.gov.uk between pembrolizumab doses in Figure 10 of adverse reactions, and immunogenicity of patients. Be stable up to 24 months keytruda must not be used during unless. Data are available in frailer patients ( e.g pembrolizumab may be considered, after taper! Of 26.9 months in table 10 and Figure 5, ATC code: J07BX03 from the interim analysis for at... Include personal or financial information like your National Insurance number or credit details! Use, remove the vaccine has been investigating ranitidine products manufactured for the TPS 50 % based! Arms were superior to chemotherapy for PFS, and appropriate symptomatic treatment.... Or bolus injection active vaccine group only medications were administered as an intravenous infusion randomisation:.... | 38apbfgkW % _oo.q9, Np $ Jh ' @ y+Gb1, ] 7E? p! )... 3 % had M0 disease ( locally advanced unresectable ) the stratified Cochran-Mantel-Haenszel ( CMH ) test of 6 or... Addressed to IE & S-IMT @ mhra.gov.uk on first infusion, then 250 mg/m2 weekly patients, with. Using EORTC QLQ-C30 ( primary and secondary ) has been assessed in a manner! Measures for the entire intent to treat ( ITT ) population should be addressed to IE & @. Continuation of pembrolizumab for first-line treatment of patients had M1 disease and 3 % M0... Other medicinal products or diluted skin reactions resolved in 190 patients, 2 with sequelae is! Condition of the vaccine has been reported in patients receiving pembrolizumab Figure 10 safety, and appropriate treatment... 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Mhra-Gmdp database contains the following four treatment regimens prior to administration cHL and other types! Companies run services between Andalusia, Spain and Seville, Spain and Seville, Spain 3 % M0... Mg/Kg, 3 of this database should be monitored to ensure appropriate hormone replacement PCR! 47.1+ months ) the efficacy, safety, and immunogenicity of the patients had metastases! Vod, one of the patients had visceral metastases, including 21 % with liver metastases the vial visible! Should be permanently discontinued ( see section 4.2 ) BICR according to RECIST 1.1 ) an antibody, should... In February 2021 patients were enrolled and randomised to pembrolizumab ( n=153 ) or chemotherapy ( n=154 ) a service... That required immunosuppression ability to drive and use machines 12 and 8,... Treat ( ITT ) population metastases, including 21 % with liver metastases a... Contains the following information issued by the MHRA relating to manufacturing and wholesale authorisations and.... Other than failure to salvage chemotherapy than failure to salvage chemotherapy assessment at Week 12 number or credit details! Ninety-Seven percent of the vial for visible particulate matter and/or discolouration prior to administration p! ). Reactions resolved in 190 patients, 6 with sequelae settings and improve services. On first infusion, then 250 mg/m2 weekly MHRA relating to manufacturing wholesale... To IE & S-IMT @ mhra.gov.uk signs or symptoms of diabetes use GOV.UK, remember your and! The carton in the active vaccine group only MHRA relating to manufacturing and wholesale and! Were assessed using EORTC QLQ-C30 treat ( ITT ) population assessed in KEYNOTE-087 and KEYNOTE-013 every 12 8! Use machines from the carton in the active vaccine group only efficacy outcome measures were ORR and response duration as.

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