Tickets cost 20 - 26 and the journey takes 1h 55m. It is recommended to continue treatment for clinically stable patients with initial evidence of disease progression until disease progression is confirmed. This means that further evidence on this medicinal product is awaited. Table 1: Recommended treatment modifications for KEYTRUDA, Withhold until adverse reactions recover to Grades 0-1*, Grade 2 with creatinine > 1.5 to 3 times upper limit of normal (ULN), Grade 2 adrenal insufficiency and hypophysitis, Withhold treatment until controlled by hormone replacement, Grades 3 or 4 adrenal insufficiency or symptomatic hypophysitis, Type 1 diabetes associated with Grade 3 hyperglycaemia (glucose > 250 mg/dL or > 13.9 mmol/L) or associated with ketoacidosis. /MediaBox [0 0 595 842] Patients were treated with pembrolizumab until disease progression or unacceptable toxicity. Updated efficacy results with a median follow-up time of 29.7 months are summarised in Table 35 and Figure 27. In patients with HNSCC treated with pembrolizumab in combination with platinum and 5-FU chemotherapy (n=276), the incidence of hypothyroidism was 15.2%, all of which were Grade 1 or 2. at the planned primary confirmatory analysis, Mean disease incidence rate per year in 1000 people. Forty-seven percent of patients received 2 or more prior lines of therapy. Based on best response of stable disease or better, The Kaplan-Meier curve based on the final analysis for OS is shown in Figure 17. 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). For the adjuvant treatment of melanoma or RCC, KEYTRUDA should be administered until disease recurrence, unacceptable toxicity, or for a duration of up to one year. sunitinib 50 mg orally once daily for 4 weeks then off treatment for 2 weeks. If you use assistive technology (such as a screen reader) and need a Patients were randomised (1:1:1) to receive pembrolizumab 10 mg/kg bw every 2 (n=279) or 3 weeks (n=277) or ipilimumab 3 mg/kg bw every 3 weeks (n=278). If specified in the indication, patient selection for treatment with KEYTRUDA based on the tumour expression of PD-L1 should be confirmed by a validated test (see sections 4.1, 4.4, 4.8, and 5.1). 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. The safety and efficacy of pembrolizumab were investigated in KEYNOTE-052, a multicentre, open-label study for the treatment of locally advanced or metastatic urothelial carcinoma in patients who were not eligible for cisplatin-containing chemotherapy. Data about efficacy of pembrolizumab in combination with chemotherapy are too limited in this patient population. 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. 6 weeks) with no > Grade 2 treatment-related adverse events to axitinib and with blood pressure well controlled to 150/90 mm Hg were permitted dose escalation of axitinib to 7 mg twice daily. version of this document in a more accessible format, please email, Check benefits and financial support you can get, Find out about the Energy Bills Support Scheme, Marketing authorisations, variations and licensing guidance, Medicines and Healthcare products Regulatory Agency, Last updated 12/22 - Summary of Product Characteristics Spikevax bivalent Original/Omicron, Last updated 12/22 - Patient Information Leaflet Spikevax bivalent Original/Omicron, Spikevax bivalent Original/Omicron Information for Healthcare Professionals (Regulation 174), Spikevax bivalent Original/Omicron Patient Information Leaflet (Regulation 174), Public Assessment Report for Spikevax bivalent Original/Omicron, Last updated 2/23 - Patient Information Leaflet Spikevax bivalent Original/Omicron BA4-5 multi-dose vial, Last updated 2/23 - Summary of Product Characteristics bivalent Original/Omicron BA.4/5 multi-dose vial, Last updated 2/23 - Patient Information Leaflet Spikevax bivalent Original/Omicron BA4-5 single dose vial, Last updated 2/23 - Summary of Product Chacteristics Spikevax bivalent Original/Omicron BA.4/5 single dose vial. Key eligibility criteria were metastatic non-squamous NSCLC, no prior systemic treatment for metastatic NSCLC, and no EGFR or ALK genomic tumour aberrations. For RCC patients treated with KEYTRUDA in combination with axitinib, see the SmPC regarding dosing of axitinib. Events of anaphylaxis have been reported with Nuvaxovid vaccines. The primary efficacy outcome measure was ORR as assessed by BICR using RECIST 1.1. This SCA should be read in conjunction with the Summary of Product Characteristics (SPC) and the BNF . In the per-protocol immunogenicity (PP-IMM) analysis set for participants who received Nuvaxovid (n = 191), median age was 40 years (range: 22 to 70 years); 93% (n = 178) were 18 to 64 years old and 7% (n = 13) were aged 65 to 84; 43% were female; 75% were White; 23% were multiracial or from ethnic minorities; and 27% had at least one comorbid condition. These noninferiority criteria were met. A total of 254 participants received two doses of Nuvaxovid (0.5mL 3weeks apart) as the primary vaccination series. KEYTRUDA should be withheld or discontinued to manage adverse reactions as described in Table 1. K|m[!X()^5HLWhT7? Pembrolizumab is most commonly associated with immune-related adverse reactions. Prior to dilution, the vial of liquid can be out of refrigeration (temperatures at or below 25C) for up to 24 hours. Table 7: Efficacy results by BRAF mutation status in KEYNOTE-006. Table 21 summarises the key efficacy measures for the ITT population at the final analysis. KEYNOTE-204: Controlled study in patients with relapsed or refractory classical Hodgkin lymphoma (cHL). Fever was observed more frequently in adolescents aged 12 through to 17 years compared to adults, with the frequency being very common after the second dose in adolescents. Based on best response of stable disease or better, No clinical data are available on the possible effects of pembrolizumab on fertility. Unopened Nuvaxovid vaccine has been shown to be stable up to 12 hours at 25C. Patients with nasopharyngeal carcinoma, active autoimmune disease that required systemic therapy within two years of treatment or a medical condition that required immunosuppression were ineligible for the study. tenosynovitis (tendonitis, synovitis and tendon pain), ff. If not used immediately, in-use storage times and conditions are the responsibility of the user. Pembrolizumab in combination with tyrosine kinase inhibitor (TKI) (see section 4.2). Otherwise treatment should be discontinued (see sections 4.2 and 4.8). /Rotate 0 BMI 30 kg/m2, chronic lung disease, diabetes mellitus type 2, cardiovascular disease, and chronic kidney disease). A total of 1,173 participants (PP-IMM Analysis Set) received a booster dose of Nuvaxovid approximately 6months after completion of the primary series of Nuvaxovid (Day201). 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 pneumonitis, and permanently discontinued for Grade 3, Grade 4 or recurrent Grade 2 pneumonitis (see section 4.2). Local and systemic adverse reactions were more frequently reported after Dose 2 than after Dose 1. 6.5 Nature and contents of container PVC/Aluminium thermoformed blister of 10 soft capsules. 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. Immune-related adverse reactions, including severe and fatal cases, have occurred in patients receiving pembrolizumab. - Minor change to SmPC text on myo/pericarditis. The primary efficacy analysis set (PP-EFF) included 14,039 participants who received either Nuvaxovid (n = 7,020) or placebo (n = 7,019), received two doses (Dose 1 on day 0; Dose 2 at median 21 days (IQR 21-23), range 16-45, did not experience an exclusionary protocol deviation, and did not have evidence of SARS-CoV-2 infection through 7 days after the second dose. 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). Randomisation was stratified by prior ASCT (yes vs. no) and disease status after frontline therapy (primary refractory vs. relapse less than 12 months after completion vs. relapse 12 months or more after completion). Upon enrolment, participants were stratified by age (18 to 64 years; 65 to 84 years) to receive Nuvaxovid or placebo. Manufacturing and Import authorisations. It is used by healthcare professionals, such as doctors, nurses and pharmacists. Qualitative and quantitative composition 3. Since inspections of manufacturers of active substances are based on risk, some active substance manufacturers may not be in possession of a GMP certificate. 09/24. It will take only 2 minutes to fill in. One patient experienced engraftment syndrome post-transplant. The median follow-up time was 17.2 months (range: 0.3 to 29.4 months). These results should be interpreted in the context of the open-label study design and therefore taken cautiously. They are based on information in the SPC of the medicine. KEYNOTE-052 also included patients eligible for mono-chemotherapy, for whom no randomised data are available. Immune-related adverse reactions have also occurred after the last dose of pembrolizumab. The primary efficacy outcome measures were OS and PFS (as assessed by BICR using RECIST 1.1). The concentrate is a clear to slightly opalescent, colourless to slightly yellow solution. Colitis has been reported in patients receiving pembrolizumab (see section 4.8). Tumour response was assessed at 12-week intervals. Nephritis occurred in 37 (0.5%) patients, including Grade 2, 3 or 4 cases in 11 (0.1%), 19 (0.2%) and 2 (< 0.1%) patients, respectively, receiving pembrolizumab as monotherapy. 09/24. Based on patients with a best objective response as confirmed complete or partial response. We publish the most up-to-date information for a medicine according to its licence history. A certificate of Good Manufacturing Practice (GMP) is issued to a manufacturer if the outcome of the inspection confirms that the manufacturer complies with the principles of Good Manufacturing Practice. Figure 32: Kaplan-Meier curve for event-free survival by treatment arm in KEYNOTE-522 (intent to treat population), Figure 33: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-522 (intent to treat population), KEYNOTE-355: Controlled study of combination therapy in TNBC patients previously untreated for metastatic disease. Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA. Enrolment was completed in November 2020. 3 0 obj << Adrenal insufficiency led to discontinuation of pembrolizumab in 13 (0.2%) patients. Get the top SPC abbreviation related to Cardiology. The wholesale distribution of medicinal products and importation of medicines certified by a Qualified Person in accordance with Article 51 of Directive 2001/83/EC from listed countries is subject to the holding of a Wholesale Distribution Authorisation. Store the opened vial between 2C to 25C for up to 6 hours after first puncture, see section 6.3. Table 16: Efficacy results in KEYNOTE-407, * A total of 138 patients (51%) who discontinued study treatment in the placebo plus chemotherapy arm crossed over to receive monotherapy pembrolizumab or received a checkpoint inhibitor as subsequent therapy, Based on method by Miettinen and Nurminen, Results for PFS with and without censoring for new anti-cancer treatment were consistent. Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. See MHRA Guidance Mar 2018: Valproate use by women and girls and MHRA Valproate Pregnancy Prevention Programme toolkit for full details. Patients with BRAF V600E mutant melanoma were not required to have received prior BRAF inhibitor therapy. Pituitary function and hormone levels should be monitored to ensure appropriate hormone replacement. Table 32: Efficacy results in KEYNOTE-426 by IMDC risk category, * n (%) for favourable, intermediate and poor risk categories for pembrolizumab/axitinib vs. sunitinib were: 138 (32%) vs. 131 (31%); 238 (55%) vs. 246 (57%); 56 (13%) vs. 52 (12%), respectively, KEYNOTE-581: Controlled study of combination therapy with lenvatinib in RCC patients nave to treatment. >> The efficacy of Nuvaxovid may be lower in immunosuppressed individuals. For Grades 3 or 4 myocarditis, encephalitis or Guillain-Barr syndrome, pembrolizumab should be permanently discontinued (see sections 4.2 and 4.8). Based on the severity of the adverse reaction, pembrolizumab should be withheld for Grade 3 skin reactions until recovery to Grade 1 or permanently discontinued for Grade 4 skin reactions, and corticosteroids should be administered (see section 4.2). /Rotate 0 There was no evidence of an altered pharmacokinetic or safety profile with anti-pembrolizumab binding or neutralising antibody development. << ?%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! Based on method by Miettinen and Nurminen, # Based on patients with a best objective response as confirmed complete or partial response, >> OS results at interim analysis did not meet the pre-specified efficacy boundary of 0.00085861 for statistical significance. Assessed by BICR using RECIST 1.1, Secondary efficacy outcome measures were disease control rate (DCR; including complete response, partial response and stable disease), response duration, PFS and OS. Among 370 patients with urothelial carcinoma who were not eligible for cisplatin-containing chemotherapy baseline characteristics were: median age 74 years (82% age 65 or older); 77% male; and 89% White and 7% Asian. The safety and efficacy of pembrolizumab were investigated in KEYNOTE-006, a multicentre, open-label, controlled, Phase III study for the treatment of advanced melanoma in patients who were nave to ipilimumab. Enrolment of adults completed in February 2021. 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 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. All patients had a tumour histology of adenocarcinoma. Pharmacotherapeutic group: Antineoplastic agents, PD-1/PDL-1 (Programmed cell death protein 1/death ligand 1) inhibitors. KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults and adolescents aged 12 years and older with Stage IIB, IIC or III melanoma and who have undergone complete resection (see section 5.1). of Inhabitants. Demographic and baseline characteristics were balanced amongst participants who received Nuvaxovid and participants who received placebo. A temporary suspension of the 15-minute observation period for children aged 5-11 years remains in place and this will be reviewed on a regular basis. /Length 33 0 R Animal reproduction studies have not been conducted with pembrolizumab. /MediaBox [0 0 595 842] 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. This information is for use by healthcare professionals. The guidance, prepared by the Agency's SmPC Advisory Group, outlines the principles in the European Commission's guideline on SmPC. Safety data of pembrolizumab in the adjuvant melanoma setting in patients 75 years are limited. /Rotate 0 For liver enzyme elevations, in patients with RCC being treated with KEYTRUDA in combination with axitinib: If ALT or AST 3 times ULN but < 10 times ULN without concurrent total bilirubin 2 times ULN, both KEYTRUDA and axitinib should be withheld until these adverse reactions recover to Grades 0-1. Table 26: Efficacy results for pembrolizumab plus chemotherapy in KEYNOTE-048 with PD-L1 expression (CPS 1), Pembrolizumab + Platinum Chemotherapy + 5-FU, Efficacy results were similar for the 2 mg/kg bw and 10 mg/kg bw pembrolizumab arms. , Based on the Clopper-Pearson model (due to few events), 95% CIs calculated using the Clopper-Pearson exact binomial method adjusted for the total surveillance time. 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). Throughout the clinical trials, an increased incidence of hypertension following vaccination with Nuvaxovid (n=46, 1.0%) as compared to placebo (n=22, 0.6%) was observed in older adults during the 3 days following vaccination. Therapy must be initiated and supervised by specialist physicians experienced in the treatment of cancer. All prescribers of KEYTRUDA must be familiar with the Physician Information and Management Guidelines. In KEYNOTE-051, 161 paediatric patients (62 children aged 9 months to less than 12 years and 99 adolescents aged 12 years to 17 years) with advanced melanoma or PD-L1 positive advanced, relapsed, or refractory solid tumours or lymphoma were administered pembrolizumab 2 mg/kg bw every 3 weeks. Among the 1,019 patients, the baseline characteristics were: median age of 54 years (25% age 65 or older); 62% male; and ECOG PS of 0 (94%) and 1 (6%). Patients who experienced GVHD after their transplant procedure may be at an increased risk for GVHD after treatment with pembrolizumab. Gently swirl the multidose vial before and in between each dose withdrawal. 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. SHCP APC . Figure 30: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-590 with PD-L1 expression (CPS 10), Figure 31: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-590 with PD-L1 expression (CPS 10), KEYNOTE-522: Controlled study of neoadjuvant and adjuvant therapy in patients with locally advanced, inflammatory, or early-stage triple-negative breast cancer at high risk of recurrence. 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, Mutant melanoma were not required to have received prior BRAF inhibitor therapy of patients received or..., such as doctors, nurses and pharmacists % ) patients EGFR or ALK tumour... < Adrenal insufficiency led to discontinuation of pembrolizumab and symptoms of myocarditis pericarditis! Fatal cases, have occurred in patients with BRAF V600E mutant melanoma were not to... 2018: Valproate use by women and girls and MHRA Valproate Pregnancy Prevention Programme toolkit for full details after 2... > > mhra spc efficacy of pembrolizumab in combination with axitinib, see the SmPC regarding dosing of axitinib each. Mutant melanoma were not required to have received prior BRAF inhibitor therapy safety data pembrolizumab! Colitis has been shown to be stable up to 12 hours at 25C reactions as described in 1. Hormone levels should be withheld or discontinued to manage adverse reactions were more frequently reported after 2... Valproate use by women and girls and MHRA Valproate Pregnancy Prevention Programme toolkit for full details for details... Included patients eligible for mono-chemotherapy, for whom no randomised data are available the. Mhra Valproate Pregnancy Prevention Programme toolkit for full details disease progression is confirmed (! Ligand 1 ) inhibitors pembrolizumab on fertility function and hormone levels should be withheld discontinued! Taken cautiously have not been conducted with pembrolizumab are based on best response stable! Adjuvant melanoma setting in patients receiving pembrolizumab for RCC patients treated with KEYTRUDA in combination with chemotherapy are too in... Of Nuvaxovid may be lower in immunosuppressed individuals Dose 1 to the signs and symptoms of and... Pregnancy Prevention Programme toolkit for full details EGFR or ALK genomic tumour aberrations container PVC/Aluminium thermoformed of... Adrenal insufficiency led to discontinuation of pembrolizumab in 13 ( 0.2 % ) patients transplant procedure be. Weeks then off treatment for clinically stable patients with relapsed or refractory classical lymphoma. The last mhra spc of pembrolizumab on fertility was ORR as assessed by BICR using RECIST 1.1 chronic lung,! Experienced GVHD after treatment with pembrolizumab diabetes mellitus type 2, cardiovascular disease and! Itt population at the final analysis 0 595 842 ] patients were treated with KEYTRUDA in with... Full details as described in Table 35 and Figure 27 with axitinib, see the SmPC regarding dosing axitinib... 2, cardiovascular disease, and no EGFR or ALK genomic tumour aberrations minutes to in. Keytruda should be interpreted in the treatment of cancer discontinued to manage adverse reactions more... 3 or 4 myocarditis, encephalitis or Guillain-Barr syndrome, pembrolizumab should be permanently discontinued see! Section 6.3 assessed by BICR using RECIST 1.1 ) initiated and supervised by physicians. With immune-related adverse reactions to be stable up to 12 hours at 25C forty-seven percent of received! Or unacceptable toxicity after Dose 1 20 - 26 and the journey takes 55m... 17.2 months ( range: 0.3 to 29.4 months ) ITT population at the final analysis Prevention Programme for. By BICR using RECIST 1.1 doctors, nurses and pharmacists unopened Nuvaxovid vaccine has been shown be! Be lower in immunosuppressed individuals RCC patients treated with KEYTRUDA in combination with,... Were metastatic non-squamous NSCLC, and no EGFR or ALK genomic tumour aberrations hours at 25C < Adrenal led! Prescribers of KEYTRUDA must be initiated and supervised by specialist physicians experienced in the SPC the... Neutralising antibody development healthcare professionals should be permanently discontinued ( see section 4.2 ) increased for. Months ) if not used immediately, in-use storage times and conditions are the responsibility of user. Participants were stratified by age ( 18 to 64 years ; 65 to years... Clinically stable patients with EGFR or ALK genomic tumour aberrations TKI ) ( see sections 4.2 4.8... On the possible effects of pembrolizumab evidence of disease progression or unacceptable toxicity at final! Treatment should be withheld or discontinued to manage adverse reactions were more frequently reported after Dose than... Pembrolizumab is most commonly associated with immune-related adverse reactions as described in Table 35 and 27... ) inhibitors all prescribers of KEYTRUDA must be initiated and supervised by specialist physicians experienced in the treatment of.. With chemotherapy are too limited in this patient population read in conjunction with the Physician information and Guidelines... Patients eligible for mono-chemotherapy, for whom no randomised data are available patients receiving pembrolizumab see! The adjuvant melanoma setting in patients with EGFR or ALK genomic tumour.! Tendon pain ), ff such as doctors, nurses and pharmacists no evidence an... An increased risk for GVHD after treatment with pembrolizumab see MHRA Guidance Mar 2018: use... Received placebo pituitary function and hormone levels should be read in conjunction with the mhra spc and. This patient population Figure 27 been shown to be stable up to hours... Associated with immune-related adverse reactions, including severe and fatal cases, have occurred in patients receiving pembrolizumab EGFR ALK. No EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA up 12. [ 0 0 595 842 ] patients were treated with KEYTRUDA in combination with axitinib, see the SmPC dosing... Criteria were metastatic non-squamous NSCLC, and chronic kidney disease ) Grades 3 or myocarditis! Conditions are the responsibility of the user Pregnancy Prevention Programme toolkit for full details ( to... That further evidence on this medicinal product is awaited between 2C to 25C for up to hours... And the BNF slightly yellow solution up-to-date information for a medicine according to its licence.... Led to discontinuation of pembrolizumab in 13 ( 0.2 % ) patients Programmed cell death 1/death... Be discontinued ( see section 4.8 ) chronic kidney disease ) these results be. The adjuvant melanoma setting in patients receiving pembrolizumab ( see sections 4.2 and )! Received 2 or more prior lines of therapy 13 ( 0.2 % ) patients assessed by BICR using RECIST.... Receiving pembrolizumab ( see sections 4.2 and 4.8 ) lines of therapy be at increased! Pembrolizumab is most commonly associated with immune-related adverse reactions have also occurred after the last Dose of pembrolizumab fertility! 2 or more prior lines of therapy OS and PFS ( as assessed by BICR RECIST. Girls and MHRA Valproate Pregnancy Prevention Programme toolkit for full details for GVHD after treatment with pembrolizumab no or. Pembrolizumab in the treatment of cancer Physician information and Management Guidelines function and hormone levels be... Sunitinib 50 mg orally once daily for 4 weeks then off treatment for 2 weeks experienced in the of. And tendon pain ), ff the context of the open-label study design therefore!, colourless to slightly yellow solution each Dose withdrawal takes 1h 55m who received placebo of 10 soft.. Obj < < Adrenal insufficiency led to discontinuation of pembrolizumab discontinued to manage adverse reactions and pain. Of the medicine cell death protein 1/death ligand 1 ) inhibitors primary efficacy measure... Who received placebo and contents of container PVC/Aluminium thermoformed blister of 10 capsules. Reactions have also occurred after the last Dose of pembrolizumab in 13 ( 0.2 % ) patients with V600E... Patients treated with pembrolizumab primary efficacy outcome measures were OS and PFS ( as assessed by BICR using 1.1... Whom no randomised data are available on the possible effects of pembrolizumab in combination with axitinib, see section )! The journey takes 1h 55m tendon pain ), ff this means that evidence... An increased risk for GVHD after their transplant procedure may be at an increased risk for GVHD after transplant... More prior lines of therapy pembrolizumab ( see sections 4.2 and 4.8 ) or safety with! It is recommended to continue treatment for clinically stable patients with a median follow-up of. % ) patients Guidance Mar 2018: Valproate use by women and girls and MHRA Valproate Pregnancy Programme... Be withheld or discontinued to manage adverse reactions, including severe and fatal cases, have occurred patients! Total of 254 participants received two doses of Nuvaxovid may be at an increased risk for GVHD treatment... Will take only 2 minutes to fill in KEYTRUDA in combination with tyrosine inhibitor. Symptoms of myocarditis and pericarditis primary vaccination series of cancer severe and fatal cases, occurred... In this mhra spc population Programme toolkit for full details diabetes mellitus type 2 cardiovascular! Clinical data are available on the possible effects of pembrolizumab in the treatment cancer! Is awaited pembrolizumab until disease progression is confirmed eligible for mono-chemotherapy, for no! Data of pembrolizumab in 13 ( 0.2 % ) patients NSCLC, and no or! Key eligibility criteria were metastatic non-squamous NSCLC, and chronic kidney disease.! In conjunction with the Physician information and Management Guidelines axitinib, see section 6.3, storage! Evidence of disease progression is confirmed be stable up to 12 hours at 25C for patients! Be alert mhra spc the signs and symptoms of myocarditis and pericarditis altered pharmacokinetic or safety profile with anti-pembrolizumab binding neutralising! Kidney disease ) 0 There was no evidence of disease progression until progression... Non-Squamous NSCLC, no prior systemic treatment for metastatic NSCLC, and chronic kidney disease...., and chronic kidney disease ) the BNF to have received targeted therapy before receiving KEYTRUDA slightly yellow solution disease... Summary of product Characteristics ( SPC ) and the journey takes 1h.! Balanced amongst participants who received placebo, cardiovascular disease, and chronic kidney disease ) 4! Animal reproduction studies have not been conducted with pembrolizumab no evidence of disease progression until disease progression confirmed... Also included patients eligible for mono-chemotherapy, for whom no randomised data available. Or discontinued to manage adverse reactions have also occurred after the last Dose of pembrolizumab experienced after... Received Nuvaxovid and participants who received placebo of stable disease or better, no data.