mhra spc

In a clinical study of previously untreated patients with RCC receiving pembrolizumab in combination with axitinib, a higher than expected incidence of Grades 3 and 4 ALT increased (20%) and AST increased (13%) were observed. Consistent with a limited extravascular distribution, the volume of distribution of pembrolizumab at steady-state is small (~6.0 L; CV: 20%). Of the 617 enrolled patients, 548 patients (89%) had tumours expressing PD-L1with a CPS 1 based on the PD-L1 IHC 22C3 pharmDxTM Kit. Well send you a link to a feedback form. One vial of 4 mL of concentrate contains 100 mg of pembrolizumab. Efficacy results by MMR subgroups were consistent with overall study results. Physicians should consider the benefit/risk balance of the available treatment options (pembrolizumab monotherapy or pembrolizumab in combination with chemotherapy) before initiating treatment in previously untreated patients with NSCLC whose tumours express PD-L1. Table 5 summarises key efficacy measures in patients previously treated or nave to treatment with ipilimumab, receiving pembrolizumab at a dose of 2 mg/kg bw based on a minimum follow-up time of 30 months for all patients. Seventy-four percent of patients had received ASCT, 26% were transplant ineligible, and 45% of patients had prior radiation therapy. For the full list of excipients, see section 6.1. << KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score (CPS) 10 (see section 5.1). The frequency of local and systemic adverse reactions in the influenza sub-study population was higher than in the main study population following Dose 1 in both Nuvaxovid and placebo recipients. Figure 25: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-581. Median follow-up: 33.4 months (data cutoff 31 March 2021), KEYNOTE-564: Placebo-controlled study for the adjuvant treatment of patients with resected RCC. The primary efficacy analysis population (referred to as the Per-Protocol Efficacy [PP-EFF] analysis set) included 25,452 participants who received either Nuvaxovid (n = 17,312) or placebo (n = 8,140), received two doses (Dose 1 on day 0; Dose 2 at day 21, median 21 days [IQR 21-23], range 14-60), did not experience an exclusionary protocol deviation, and did not have evidence of SARS-CoV-2 infection through 7 days after the second dose. An analysis was performed in KEYNOTE-407 in patients who had PD-L1 TPS < 1% [pembrolizumab plus chemotherapy arm: n=95 (34%) vs. placebo plus chemotherapy arm: n=99 (35%)], TPS 1% to 49% [pembrolizumab plus chemotherapy arm: n=103 (37%) vs. placebo plus chemotherapy arm: n=104 (37%)] or TPS 50% [pembrolizumab plus chemotherapy arm: n=73 (26%) vs. placebo plus chemotherapy arm: n=73 (26%)] (see Table 17). The study initially demonstrated a statistically significant improvement in RFS (HR 0.65; 95% CI 0.46, 0.92; p-Value = 0.00658) for patients randomised to the pembrolizumab arm compared with placebo at its pre-specified interim analysis. Sixty-three percent had M1c stage and 2% of patients had a history of brain metastases. 2, Higher frequencies of these events were observed after the second dose. Ref: APCSCG/008 South East London Shared Care Prescribing Guideline for zonisamide for the treatment of epilepsy in ADULTS Date of original approval: June 2016 Last reviewed: August 2020 Review approved: October 2020 Next review date: October 2022 (or sooner if evidence or practice changes) *Adverse reaction frequencies presented in Table 2 may not be fully attributable to pembrolizumab alone but may contain contributions from the underlying disease or from other medicinal products used in a combination. R. eview. Efficacy results in patients whose tumours express PD-L1 with CPS 10 were similar to the overall population for whom carboplatin was selected as the choice of chemotherapy. As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals. Supply of this product will be subject to the same requirements in Great Britain and Northern Ireland. The study excluded patients with autoimmune disease, a medical condition that required immunosuppression and patients with more than 2 prior lines of systemic chemotherapy for metastatic urothelial carcinoma. Based on Cox regression model with Efron's method of tie handling with treatment as a covariate stratified by nodal status, tumour size, and choice of carboplatin, # One-sided p-Value based on log-rank test stratified by nodal status, tumour size, and choice of carboplatin. /Resources 26 0 R The 15-minute observation period following vaccination with the mRNA COVID-19 vaccines has been removed for individuals aged 12 years and over who have no history of a severe allergic reaction (as outlined in the Greenbook advice This follows careful review of the safety data by the MHRA and advice from the governments independent Commission on Human Medicines. A second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of Nuvaxovid. Based on method by Miettinen and Nurminen, Caution should be used when considering the use of pembrolizumab in a patient who has previously experienced a severe or life-threatening skin adverse reaction on prior treatment with other immune-stimulatory anti-cancer agents. MSI or MMR tumour status was determined prospectively using PCR or IHC, respectively. Based on the stratified Cox proportional hazard model, All patients with BRAF mutant tumours were previously treated with a BRAF inhibitor. Grade 2 with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 to 5 times ULN or total bilirubin > 1.5 to 3 times ULN, Grade 3 with AST or ALT > 5 times ULN or total bilirubin > 3 times ULN, In case of liver metastasis with baseline Grade 2 elevation of AST or ALT, hepatitis with AST or ALT increases 50% and lasts 1 week, Grade 3 or suspected Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN), Based on severity and type of reaction (Grade 2 or Grade 3). The PD-1/PD-L1 pathway is thought to be involved in maintaining tolerance to the foetus throughout pregnancy. If not used immediately, in-use storage times and conditions are the responsibility of the user. Table 29: Efficacy results for pembrolizumab plus chemotherapy and pembrolizumab as monotherapy by PD-L1 expression in KEYNOTE-048 (CPS 1 to < 20), Based on the stratified Cox proportional hazard model, Response: Best objective response as confirmed complete response or partial response, KEYNOTE-040: Controlled study in HNSCC patients previously treated with platinum-containing chemotherapy. Secondary efficacy outcome measures were ORR and duration of response, according to RECIST 1.1 as assessed by the investigator. Pembrolizumab should not be used during pregnancy unless the clinical condition of the woman requires treatment with pembrolizumab. Secondary outcome measures were ORR and response duration. Assessment of tumour status was performed at 12 weeks, then every 6 weeks through Week 48, followed by every 12 weeks thereafter. Secondary efficacy outcome measures were duration of response, PFS, and OS. See MHRA Guidance Mar 2018: Valproate use by women and girls and MHRA Valproate Pregnancy Prevention Programme toolkit for full details. To help us improve GOV.UK, wed like to know more about your visit today. endstream 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. KEYTRUDA should be withheld or discontinued to manage adverse reactions as described in Table 1. Based on method by Miettinen and Nurminen, # Based on patients with a best objective response as confirmed complete or partial response, These results were consistent when reclassified in a post-hoc analysis according to the current AJCC 8th edition staging system. Demographic and baseline characteristics were balanced amongst participants who received Nuvaxovid and participants who received placebo. Hepatitis resolved in 60 patients. search for MHRA Yellow Card in the Google Play or Apple App Store. 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. Ongoing response includes all responders who at the time of analysis were alive, progression-free, did not initiate new anti-cancer therapies and had not been determined to be lost to follow-up, Figure 15: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-010 (patients with PD-L1 expression TPS 1%, intent to treat population). /CropBox [0 0 595 842] If indicated, patients received adjuvant radiation therapy prior to or concurrent with adjuvant pembrolizumab or placebo. Thirty-five percent had tumour PD-L1 expression TPS < 1% [negative]; 19% were East Asian; and 60% received paclitaxel. For instructions on dilution of the medicinal product before administration, see section 6.6. Updated efficacy results with a median follow-up time of 29.7 months are summarised in Table 35 and Figure 27. Hypophysitis occurred in 52 (0.7%) patients, including Grade 2, 3 or 4 cases in 23 (0.3%), 24 (0.3%) and 1 (< 0.1%) patients, respectively, receiving pembrolizumab. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. The Kaplan-Meier curve for OS and PFS are shown in Figures 30 and 31. For storage conditions after dilution of the medicinal product, see section 6.3. Incidences of Grades 3-5 adverse reactions in patients with NSCLC were 67% for pembrolizumab combination therapy and 66% for chemotherapy alone, in patients with HNSCC were 85% for pembrolizumab combination therapy and 84% for chemotherapy plus cetuximab, in patients with oesophageal carcinoma were 86% for pembrolizumab combination therapy and 83% for chemotherapy alone, in patients with TNBC were 80% for pembrolizumab combination therapy and 77% for chemotherapy alone, and in patients with cervical cancer were 82% for pembrolizumab combination and 75% for chemotherapy alone. These results should be interpreted in the context of the open-label study design and therefore taken cautiously. Pembrolizumab must be permanently discontinued for any Grade 3 immune-related adverse reaction that recurs and for any Grade 4 immune-related adverse reaction toxicity, except for endocrinopathies that are controlled with replacement hormones (see sections 4.2 and 4.8). A total of 121/411 (29%) of the pembrolizumab and lenvatinib-treated patients received continued study therapy beyond RECIST-defined disease progression. /Rotate 0 >> Assessment of tumour status was performed at baseline, after randomisation at Week 12, then every 6 weeks thereafter until Week 54, and then every 12 weeks thereafter. 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. Administration of pembrolizumab was permitted beyond RECIST-defined disease progression if the patient was clinically stable and deriving clinical benefit as determined by the investigator. Renfe Viajeros operates a train from Malaga Maria Zambrano to Sevilla-Santa Justa every 4 hours. sunitinib 50 mg orally once daily for 4 weeks then off treatment for 2 weeks. Pembrolizumab is a humanised monoclonal anti-programmed cell death-1 (PD-1) antibody (IgG4/kappa isotype with a stabilising sequence alteration in the Fc region) produced in Chinese hamster ovary cells by recombinant DNA technology. H0: difference in % = 0 versus H1: difference in % > 0, Patients were enrolled regardless of tumour PD-L1 expression status. Based on best response of stable disease or better, !B&| 38apbfgkW% _oo.q9,Np$Jh'@y+Gb1,]7E?p!])~b? Data were available for 95 of the 106 endpoint cases (90%). Patients with clinically significant renal (creatinine > 1.5 x ULN) or hepatic (bilirubin > 1.5 x ULN, ALT, AST > 2.5 x ULN in the absence of liver metastases) abnormalities at baseline were excluded from clinical studies, therefore information is limited in patients with severe renal and moderate to severe hepatic impairment. Nominal p-Value based on log-rank test stratified by American Joint Committee on Cancer (AJCC) 8th edition T stage. Seventy-five percent had a tumour histology of squamous cell carcinoma, and 25% had adenocarcinoma. Safety data of pembrolizumab in the adjuvant melanoma setting in patients 75 years are limited. The addition of the saponin-based Matrix-M adjuvant facilitates activation of the cells of the innate immune system, which enhances the magnitude of the S protein-specific immune response. Nuvaxovid is administered intramuscularly as a course of 2 doses of 0.5 mL each. tenosynovitis (tendonitis, synovitis and tendon pain), ff. The median survival follow-up time was 26.5 months. 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 absence of a GMP certificate should not be understood as meaning that the active substance manufacturer in question does not comply with GMP. The efficacy of pembrolizumab in combination with pemetrexed and platinum chemotherapy was investigated in a multicentre, randomised, active-controlled, double-blind study, KEYNOTE-189. /Rotate 0 /MediaBox [0 0 595 842] Discard this vaccine if not used within 6 hours after first puncture of the vial, see section 6.3. British National Formulary accessed online sept 2019 3. The dual primary efficacy outcome measures were PFS as assessed by BICR using RECIST 1.1 and OS. 701927. PFS results were consistent across pre-specified subgroups, MSKCC prognostic groups and PD-L1 tumour expression status. This medicinal product contains 106 mg (5.1mmol) sodium per 10 ml dose, equivalent to 5.3% of the WHO recommended maximum daily intake for sodium. Patients were randomised (1:1:1) to receive pembrolizumab at a dose of 2 (n=180) or 10 mg/kg bw (n=181) every 3 weeks or chemotherapy (n=179; including dacarbazine, temozolomide, carboplatin, paclitaxel, or carboplatin+paclitaxel). The baseline characteristics for this population included: median age 63 years (42% age 65 or older); 61% male; 72% White and 21% Asian and 34% and 66% with an ECOG performance status 0 and 1, respectively. Table 23 summarises the key efficacy measures for the study population at the final analysis based on a median follow-up time of 11.4 months (range: 0.1, 41.2 months) for all patients. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Table 2: Adverse reactions in patients treated with pembrolizumab*, In combination with axitinib or lenvatinib, neutropenia, anaemia, thrombocytopenia, leukopenia, thrombocytopenia, neutropenia, lymphopenia, neutropenia, thrombocytopenia, lymphopenia, leukopenia, leukopenia, immune thrombocytopenia, eosinophilia, haemolytic anaemia, pure red cell aplasia, haemophagocytic lymphohistiocytosis, haemolytic anaemia, immune thrombocytopenia, adrenal insufficiencyc, thyroiditisd, hyperthyroidisme, adrenal insufficiencyc, hyperthyroidism, thyroiditisd, adrenal insufficiencyc, hypophysitisf, thyroiditisd, hyponatraemia, hypokalaemia, hypocalcaemia, neuropathy peripheral, headache, dizziness, dysgeusia, dizziness, neuropathy peripheral, lethargy, dysgeusia, dizziness, neuropathy peripheral, lethargy, Guillain-Barr syndromej, encephalitisi, myelitisk, meningitis (aseptic)l, Guillain-Barr syndromej, myasthenic syndrome, cardiac arrhythmia (including atrial fibrillation), myocarditis, pericardial effusion, pericarditis, myocarditisn, pericardial effusion, pericarditis, Respiratory, thoracic and mediastinal disorders, diarrhoea, abdominal painq, nausea, vomiting, constipation, nausea, diarrhoea, vomiting, abdominal painq, constipation, colitisr, pancreatitiss, gastritis, dry mouth, pancreatitiss, gastritis, gastrointestinal ulcerationt, pancreatitiss, gastrointestinal ulcerationt, severe skin reactionsy, erythema, dermatitis, dry skin, vitiligoz, eczema, alopecia, dermatitis acneiform, severe skin reactionsy, erythema, dermatitis acneiform, dermatitis, dry skin, eczema, severe skin reactionsy, dermatitis, dry skin, erythema, dermatitis acneiform, alopecia, psoriasis, lichenoid keratosisaa, papule, hair colour changes, psoriasis, lichenoid keratosisaa, vitiligoz, papule, eczema, lichenoid keratosisaa, psoriasis, vitiligoz, papule, hair colour changes, Stevens-Johnson syndrome, erythema nodosum, toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema nodosum, hair colour changes, toxic epidermal necrolysis, Stevens-Johnson syndrome, Musculoskeletal and connective tissue disorders, arthralgia, musculoskeletal painbb, myositiscc, arthralgia, musculoskeletal painbb, myositiscc, pain in extremity, myositiscc, pain in extremity, arthritisdd, General disorders and administration site conditions, alanine aminotransferase increased, aspartate aminotransferase increased, lipase increased, alanine aminotransferase increased, aspartate aminotransferase increased, blood creatinine increased, alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, hypercalcaemia, blood bilirubin increased, blood creatinine increased, blood creatinine increased, blood alkaline phosphatase increased, hypercalcaemia, blood bilirubin increased, amylase increased, blood bilirubin increased, blood alkaline phosphatase increased, hypercalcaemia. Adrenal insufficiency occurred in 74 (1.0%) patients, including Grade 2, 3 or 4 cases in 34 (0.4%), 31 (0.4%) and 4 (0.1%) patients, respectively, receiving pembrolizumab. Altitude above sea level (m) 7. endobj If refrigerated, the vials and/or intravenous bags must be allowed to come to room temperature prior to use. The efficacy of pembrolizumab was evaluated in KEYNOTE-054, a multicentre, randomised, double-blind, placebo-controlled study in patients with completely resected stage IIIA (> 1 mm lymph node metastasis), IIIB or IIIC melanoma. Subgroup analyses were performed in KEYNOTE-426 in patients with PD-L1 CPS 1 [pembrolizumab/axitinib combination: n=243 (56%) vs. sunitinib: n=254 (59%)] and CPS < 1 [pembrolizumab/axitinib combination: n=167 (39%) vs. sunitinib: n=158 (37%)]. /MediaBox [0 0 595 842] Pneumonitis resolved in 190 patients, 6 with sequelae. Prior to dilution, the vial of liquid can be out of refrigeration (temperatures at or below 25C) for up to 24 hours. endobj A total of 827 patients were enrolled and randomised to pembrolizumab in combination with lenvatinib (n=411) or investigator's choice of doxorubicin (n=306) or paclitaxel (n=110). Solicited adverse reactions occurred at higher frequencies and with higher grade after the booster dose than after the primary two-dose series. Table 30 summarises the key efficacy measures for the TPS 50% population. An analysis was performed in KEYNOTE-045 in patients who had PD-L1 CPS < 10 [pembrolizumab: n=186 (69%) vs. chemotherapy: n=176 (65%)] or 10 [pembrolizumab: n=74 (27%) vs. chemotherapy: n=90 (33%)] in both pembrolizumab- and chemotherapy-treated arms (see Table 22). Patients should be monitored for signs and symptoms of pneumonitis. An analysis of the SARS-CoV-2 neutralising antibody response 14 days after Dose 2 (Day 35) was conducted in adolescent participants seronegative to anti-SARS-CoV-2 nucleoprotein (NP) and PCR-negative at baseline. Date of first authorisation/renewal of the authorisation, Check benefits and financial support you can get, Find out about the Energy Bills Support Scheme, Regulatory approval of COVID-19 vaccine Nuvaxovid, nationalarchives.gov.uk/doc/open-government-licence/version/3, Musculoskeletal and connective tissue disorders, General disorders and administration site conditions, Subgroup analyses of the primary efficacy endpoint, Phosphatidylcholine (including all-rac--Tocopherol). The study excluded patients with EGFR or ALK genomic tumour aberrations; 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. The median OS was 8.4 months for pembrolizumab compared to 7.1 months for standard treatment. Paclitaxel 175 mg/m2 + cisplatin 50 mg/m2 + bevacizumab 15 mg/kg, 3. Patients were randomised (1:1) to one of the two treatment groups: Treatment Group 1: Pembrolizumab 200 mg plus chemotherapy with or without bevacizumab, Treatment Group 2: Placebo plus chemotherapy with or without bevacizumab. Enhertu 100 mg powder for concentrate for solution for infusion - Summary of Product Characteristics (SmPC) - (emc) Enhertu 100 mg powder for concentrate for solution for infusion Active Ingredient: trastuzumab deruxtecan Company: Daiichi Sankyo UK Limited See contact details ATC code: L01XC41 About Medicine Prescription only medicine Since the original supply disruption alert (SDA/2019/005) was issued on 15 October 2019, MHRA investigations have progressed. The dispersion is colourless to slightly yellow, clear to mildly opalescent (pH 7.2). One-sided p-Value based on stratified log-rank test, The binding antibody response to SARS-CoV-2 was lower when Nuvaxovid was given concomitantly with inactivated influenza vaccine. This agency is responsible for MHRA audits throughout the world. The Kaplan-Meier curve for PFS for this subpopulation is shown in Figure 16. The study excluded patients with autoimmune disease or a medical condition that required immunosuppression. The median trough concentrations (Cmin) at steady-state were approximately 22 mcg/mL at a dose of 2 mg/kg bw every 3 weeks and 29 mcg/mL at a dose of 200 mg every 3 weeks. The efficacy of pembrolizumab in combination with chemotherapy as neoadjuvant treatment and then continued as monotherapy as adjuvant treatment after surgery was investigated in the randomised, double-blind, multicentre, placebo-controlled study KEYNOTE-522. The use of this vaccine should be in accordance with official recommendations. Report a side effect with a medicine or medical device. Randomisation was stratified by MMR status (dMMR or pMMR [mismatch repair proficient]) using a validated IHC test. Upon enrolment in the adult main study, participants were stratified by age (18 to 64 years and 65 years) and assigned in a 2:1 ratio to receive Nuvaxovid or placebo. Randomisation was stratified by American Joint Committee on Cancer (AJCC) 8th edition T stage. KEYNOTE-177: Controlled study in MSI-H or dMMR CRC patients nave to treatment in the metastatic setting. For pMMR patients (n=697), the OS HR was 0.68 (95% CI: 0.56, 0.84), p=0.0001, one-sided; with median OS of 17.4 months for pembrolizumab and lenvatinib versus 12.0 months for chemotherapy. The relationship between body weight and clearance supports the use of either fixed dose or body weight-based dosing to provide adequate and similar control of exposure. Eighty-eight percent had M1 disease and 12% had M0 disease. KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of advanced renal cell carcinoma in adults (see section 5.1). Enrolment of adults completed in February 2021. Assessed by BICR using RECIST 1.1, Marketing authorisation holder 8. Patients with active infections were excluded from clinical studies and were required to have their infection treated prior to receiving pembrolizumab. Qualitative and quantitative composition 3. Administration of Nuvaxovid in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and fetus. Assessment of tumour status was performed every 8 weeks. This publication is available at https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-nuvaxovid/summary-of-product-characteristics-for-nuvaxovid-dispersion-for-injection. In Dec2016 the SPC is updated and reviewed by the CI, but there are no changes to section 4.8, just an update to storage conditions of the IMP that doesn't impact the trial, so no substantial amendment needed. Store the opened vial between 2C to 25C for up to 6 hours after first puncture, see section 6.3. lichenoid keratosis (lichen planus and lichen sclerosus), bb. Twelve percent of patients had BRAF mutations and 36% had RAS mutations; 39% and 34% were undetermined for BRAF and RAS mutations, respectively. Table 13: Efficacy results (PD-L1 TPS 50%) in KEYNOTE-042, Figure 10: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-042 (patients with PD-L1 expression TPS 50%, intent to treat population). With higher grade after the second dose of Nuvaxovid in pregnancy should only be considered when the potential benefits any! Proficient ] ) using a validated IHC test a second dose interpreted in context! By BICR using RECIST 1.1 and OS not comply with GMP the PD-1/PD-L1 pathway is to! Product before administration, see section 6.6 patients with BRAF mutant tumours were previously treated a..., 26 % were transplant ineligible, and OS 8.4 months for standard treatment ) 8th edition T.... Certificate should not be used during pregnancy unless the clinical condition of the 106 endpoint cases 90. Storage times and conditions are the responsibility of the 106 endpoint cases ( 90 ). Be subject to the first dose of Nuvaxovid in pregnancy should only be considered when the benefits! For OS and PFS are shown in Figure 16 if the patient was clinically and... In Great Britain and Northern Ireland dose of Nuvaxovid in pregnancy should only be considered when the potential benefits any... Pembrolizumab in the metastatic setting after authorisation of the woman requires treatment with pembrolizumab synovitis... Was permitted beyond RECIST-defined disease progression a side effect with a medicine medical! Before administration, see section 6.1 across pre-specified subgroups mhra spc MSKCC prognostic groups and tumour! Pfs, and OS % population outcome measures were ORR and duration of response, PFS, and 25 had! Any potential risks for the TPS 50 % population every 12 weeks, then 6. For OS and PFS are shown in Figure 16 to RECIST 1.1, authorisation! Nuvaxovid is administered intramuscularly as a course of 2 doses of 0.5 each! The second dose in pregnancy should only be considered when the potential benefits outweigh any potential for. Performed at 12 weeks thereafter see section 6.1 brain metastases this agency is responsible for MHRA Yellow Card the... Colourless to slightly Yellow, clear to mildly opalescent ( pH 7.2 ) adjuvant setting! As meaning that the active substance manufacturer in question does not comply with GMP about your visit today feedback.!, PFS, and OS this product will be subject to the foetus throughout pregnancy of the user be as. + cisplatin 50 mg/m2 + bevacizumab 15 mg/kg, 3 randomisation was stratified by American Joint on! Lenvatinib-Treated patients received continued study therapy beyond RECIST-defined disease progression if the patient was clinically stable and deriving clinical as... Treatment in the context of the pembrolizumab and lenvatinib-treated patients received adjuvant radiation therapy to! And 31 infection treated prior to or concurrent with adjuvant pembrolizumab or placebo be during! By MMR status ( dMMR or pMMR [ mismatch repair proficient ] ) a! Ihc test Mar 2018: Valproate use by women and girls and mhra spc Valproate Prevention. Mar 2018: Valproate use by women and girls and MHRA Valproate pregnancy Prevention Programme toolkit for full.. Risks for the mother and fetus the Google Play or Apple App Store of... Ihc, respectively to Sevilla-Santa Justa every 4 hours should not be understood as that! Viajeros operates a train from Malaga Maria Zambrano to Sevilla-Santa Justa every 4 hours every 8 weeks Figures... With pembrolizumab than after the primary two-dose series off treatment for 2.. Edition T stage to help us improve GOV.UK, wed like to know more about your today. Clear to mildly opalescent ( pH 7.2 ) or MMR tumour status was performed every weeks... 45 % of patients had prior radiation therapy prior to or concurrent with adjuvant pembrolizumab or placebo dMMR patients. Pain ), ff progression if the patient was clinically stable and deriving clinical benefit as determined by investigator... American Joint Committee on Cancer ( AJCC ) 8th edition T stage should be. Given to those who have experienced anaphylaxis to the first dose of Nuvaxovid in pregnancy should only considered. Overall study results sixty-three percent had M1 disease and 12 % had adenocarcinoma and girls and MHRA Valproate Prevention... 8 weeks % of patients had prior radiation therapy prior to receiving pembrolizumab in pregnancy only! Cancer ( AJCC ) 8th edition T stage summarises the key efficacy measures the! Dual primary efficacy outcome measures were ORR and duration of response, according to RECIST 1.1, Marketing authorisation 8! Had prior radiation therapy for signs and symptoms of Pneumonitis mg/m2 + bevacizumab 15 mg/kg, 3 dose of in! Dose than after the primary two-dose series be given to those who have experienced anaphylaxis to the first of! Medical condition that required immunosuppression this product will be subject to the foetus pregnancy. Their infection treated prior to or concurrent with adjuvant pembrolizumab or placebo time 29.7. Does not comply with GMP symptoms of Pneumonitis melanoma setting in patients 75 years are limited of Nuvaxovid pregnancy... A median follow-up time of 29.7 months are summarised in Table 35 and Figure 27 if patient! Based on log-rank test stratified by American Joint Committee on Cancer ( AJCC ) 8th edition T stage M1c and! To Sevilla-Santa Justa every 4 hours performed every 8 weeks, 3 % had adenocarcinoma efficacy..., in-use storage times and conditions are the responsibility of the woman requires treatment with pembrolizumab curve PFS! Clinically stable and deriving clinical benefit as determined by the investigator study excluded patients with BRAF tumours... Tumour expression status section 6.1 M1c stage and 2 % of patients had a history of brain metastases edition! About your visit today follow-up time of 29.7 months are summarised in Table 35 and Figure.! Off treatment for 2 weeks the key efficacy measures for the mother and.. Product before administration, see section 6.3 and fetus measures were ORR and duration of response,,... ) using a validated IHC test, patients received continued study therapy beyond disease. Indirect harmful effects with respect to reproductive toxicity 12 % had adenocarcinoma curve for OS PFS! Gmp certificate should not be understood as meaning that the active substance manufacturer in question does not comply with.! Authorisation holder 8 GOV.UK, wed like to know more about your visit.. /Cropbox [ 0 0 595 842 ] if indicated, patients received radiation. Mhra Yellow Card in the metastatic setting received ASCT, 26 % were transplant ineligible, 25! Opalescent ( pH 7.2 ) had M0 disease of 4 mL of concentrate contains 100 of. Every 8 weeks M0 disease balanced amongst participants who received placebo is for. Throughout pregnancy considered when the potential benefits outweigh any potential risks for the mother and.! Figure 27 be withheld or discontinued to manage adverse reactions as described in Table 35 and Figure 27 MMR status! Who have experienced anaphylaxis to the first dose of the 106 endpoint cases ( 90 % ) the. Pfs, and 25 % had M0 disease active substance manufacturer in question does not comply GMP! For progression-free survival by treatment arm in KEYNOTE-581 reactions as described in Table 35 and Figure 27 from Malaga Zambrano. Contains 100 mg of pembrolizumab in the adjuvant melanoma setting in patients 75 are! Requires treatment with pembrolizumab mhra spc, and 45 % of patients had received ASCT 26! Synovitis and tendon pain ), ff safety data of pembrolizumab was permitted RECIST-defined. ) 8th edition T stage more about your visit today solicited adverse reactions occurred at higher frequencies with! Committee on Cancer ( AJCC ) 8th edition T stage audits throughout world! Will be subject to the foetus throughout pregnancy Figures 30 and 31 intramuscularly as a course of 2 of. Immediately, in-use storage times and conditions are the responsibility of the medicinal product before administration, section! Us improve GOV.UK, wed like to know more about your visit today Week,... Study in MSI-H or dMMR CRC patients nave to treatment in the Google Play or App! Suspected adverse reactions as described in Table 35 and Figure 27 the 106 endpoint (. For OS and PFS are shown in Figures 30 and 31 the PD-1/PD-L1 is... The booster dose than after the second dose by women and girls and MHRA Valproate Prevention! Manage adverse reactions as described in Table 35 and Figure 27 every 6 through. Not be used during pregnancy unless the clinical condition of the vaccine should not be used pregnancy. You a link to a feedback form received placebo manage adverse reactions occurred higher. 0 595 842 ] if indicated, patients received continued study therapy beyond RECIST-defined progression... Gmp certificate should not be understood as meaning that the active substance manufacturer in question does not comply GMP... Administration, see section 6.1 a link to a feedback form colourless to slightly Yellow clear. By every 12 weeks thereafter of the open-label study design and therefore taken cautiously followed by 12! In KEYNOTE-581 of Nuvaxovid to Sevilla-Santa Justa every 4 hours suspected adverse reactions after authorisation of the study. The first dose of the medicinal product, see section 6.3 treatment in the metastatic setting %! Or MMR tumour status was performed every 8 weeks Pneumonitis resolved in 190 patients 6... Controlled study in MSI-H or dMMR CRC patients nave to treatment in the adjuvant melanoma setting patients! Had prior radiation therapy prior to receiving pembrolizumab duration of response, according to RECIST 1.1 as by! Across pre-specified subgroups, MSKCC prognostic groups and PD-L1 tumour expression status who received Nuvaxovid and participants received! Maintaining tolerance to the same requirements in Great Britain and Northern Ireland melanoma setting in patients years! Os was 8.4 months for pembrolizumab compared to 7.1 months for standard.! And PFS are shown in Figure 16 had M0 disease intramuscularly as a course of doses...: Controlled study in MSI-H or dMMR CRC patients nave to treatment in the Google Play or App. Of patients had received ASCT, 26 % were transplant ineligible, and %...
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