Forty-five percent had an ECOG Performance Status of 1, 40% had elevated LDH and 23% had a BRAF mutated tumour. Unopened Nuvaxovid vaccine has been shown to be stable up to 12 hours at 25C. Table 12 summarises key efficacy measures for the entire intent to treat (ITT) population. advice and support. Treatment could continue beyond progression if the patient was clinically stable and was considered to be deriving clinical benefit by the investigator. KEYTRUDA as monotherapy is indicated for the first-line treatment of metastatic non-small cell lung carcinoma in adults whose tumours express PD-L1 with a 50% tumour proportion score (TPS) with no EGFR or ALK positive tumour mutations. As expected for an antibody, pembrolizumab does not bind to plasma proteins in a specific manner. Patients should be monitored for changes in renal function, and other causes of renal dysfunction excluded. /Rotate 0 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. This. Updated efficacy results with a median follow-up time of 29.7 months are summarised in Table 35 and Figure 27. For RCC patients treated with KEYTRUDA in combination with axitinib, see the SmPC regarding dosing of axitinib. However, due to the exploratory nature of this subgroup analysis, no definitive conclusions can be drawn. 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). 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). One-sided p-Value based on log-rank test stratified by chemotherapy on study (taxane vs. gemcitabine and carboplatin) and prior treatment with same class of chemotherapy in the neoadjuvant setting (yes vs. no). For the full list of excipients, see section 6.1. All participants were offered the opportunity to continue to be followed in the study. Please regularly check this information as it is often updated. 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). Hepatitis led to discontinuation of pembrolizumab in 37 (0.5%) patients. This product is considered high in sodium. Events of anaphylaxis have been reported with Nuvaxovid vaccines. The key secondary outcome measure was OS. Nominal p-Value based on log-rank test stratified by American Joint Committee on Cancer (AJCC) 8th edition T stage. Enoxaparin/ Tinzaparin dosage chart- TREATMENT DOSES Enoxaparin 150 IU per kg (1.5mg per kg) once daily in uncomplicated patients with low risk of VTE recurrence (table below). Cases of graft-versus-host-disease (GVHD) and hepatic veno-occlusive disease (VOD) have been observed in patients with cHL undergoing allogeneic HSCT after previous exposure to pembrolizumab. 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. 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. /Rotate 0 Participants were enrolled across 28 tumour types by primary diagnosis. Licensed inactivated seasonal influenza vaccines were co-administered to participants on the same day as Dose 1 of Nuvaxovid (n = 217) or placebo (n=214) in the opposite deltoid muscle of the arm in 431 participants enrolled in an exploratory Phase 3 (2019nCoV-302) sub-study. The Kaplan-Meier curve for EFS and OS are shown in Figures 32 and 33. Data about efficacy of pembrolizumab in combination with platinum chemotherapy are limited in this patient population. 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. Upon enrolment, participants were stratified by age (18 to 64 years; 65 to 84 years) to receive Nuvaxovid or placebo. Thirty-seven percent of patients received 2 or more prior lines of therapy. 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). PLWH were medically stable (free of opportunistic infections), receiving highly active and stable antiretroviral therapy, and having an HIV-1 viral load of < 1000 copies/mL. Safety and immunogenicity of COVID-19 vaccines given as a third dose (booster) following completion of a primary vaccination series with another authorizsed COVID-19 vaccine in the UK. From a microbiological point of view, after first opening (first needle puncture), the vaccine should be used immediately. Use of pembrolizumab in urothelial carcinoma for patients who are considered ineligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with CPS 10. Thyroid function and hormone levels should be monitored to ensure appropriate hormone replacement. /Pages 3 0 R OS results met the pre-specified efficacy boundary of 0.0113 for statistical significance. endstream 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). 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). When used in combination with lenvatinib, one or both medicines should be interrupted as appropriate. Treatment with pembrolizumab continued until RECIST v1.1-defined progression of disease, unacceptable toxicity, or a maximum of 24 months. Patients without disease progression could be treated for up to 24 months. The median area under the concentration time curve at steady-state over 3 weeks (AUC0-3weeks) was 794 mcgday/mL at a dose of 2 mg/kg bw every 3 weeks and 1,053 mcgday/mL at a dose of 200 mg every 3 weeks. All rights reserved. Among the 616 patients in KEYNOTE-189, baseline characteristics were: median age of 64 years (49% age 65 or older); 59% male; 94% White and 3% Asian; 43% and 56% ECOG performance status of 0 or 1 respectively; 31% PD-L1 negative (TPS < 1%); and 18% with treated or untreated brain metastases at baseline. Nuvaxovid is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. Table 23: Response to pembrolizumab 200 mg every 3 weeks in patients with urothelial carcinoma ineligible for cisplatin-containing chemotherapy in KEYNOTE-052, The recent introduction of a licensed product, advice for the MHRA regarding imported products and Area Prescribing Committee support has facilitated the participation of GPs in shared care. 4.9 Overdose Hyperkalaemia. The median number of prior lines of therapy administered for the treatment of cHL was 4 (range 1 to 12). 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. KEYNOTE-042: Controlled study of NSCLC patients nave to treatment. Physicians should consider the delayed onset of pembrolizumab effect before initiating treatment in patients with urothelial carcinoma who are considered eligible for carboplatin-based combination chemotherapy. 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 Eighty-eight percent had M1 disease and 12% had M0 disease. In patients with CRC treated with pembrolizumab as monotherapy (n=153), the incidence of colitis was 6.5% (all Grades) with 2.0% Grade 3 and 1.3% Grade 4. |:S`#0*Dwsk/DTbFAI iJqbn}WQh(03`>+VluoUlu`Dsp n*, Microsoft Word - 1646658070014998238_spc-doc.doc. Czechia, Date of first authorisation: February 2022, Hypertension was not reported in adolescents aged 12 through to 17 years in the clinical study. Based on available safety data in cHL and other tumour types, these differences are not clinically meaningful. EIR Vinyl Flooring ZXE2001. Axitinib could be interrupted or reduced to 3 mg twice daily and subsequently to 2 mg twice daily to manage toxicity. Do not shake. Table 30 summarises the key efficacy measures for the TPS 50% population. rApxg0; pInZvM7t`e}atCV"Jo*)myf4hlpFOQ ?P95oABh-_+k/GXsu|*A" l~x6\x3;4R]> /^kLsj4>4" \uYU CMMBs I }r2br?z7TB7wfhvF\lT1_},qb7Vi Table 40: Efficacy results in KEYNOTE-522, Pembrolizumab with Chemotherapy/Pembrolizumab, Treatment difference (%) estimate (95% CI), * Based on a pre-specified pCR final analysis (compared to a significance level of 0.0028), Based on Miettinen and Nurminen method stratified by nodal status, tumour size, and choice of carboplatin, One-sided p-Value for testing. 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. Safety data were collected in 2,232 participants 12 through 17 years of age, with and without evidence of prior SARS CoV-2 infection, in United States who received at least one dose of Nuvaxovid (n=1,487) or placebo (n=745). Immune-related adverse reactions (see section 4.4). Based on Kaplan-Meier estimates; includes 43 patients with responses of 6 months or longer, Table 31: Efficacy results in KEYNOTE-426, Number (%#) of patients with duration 30 months, Patient-reported outcomes (PROs) were assessed using EORTC QLQ-C30. In patients with HNSCC treated with pembrolizumab as monotherapy (n=909), the incidence of hypothyroidism was 16.1% (all Grades) with 0.3% Grade 3. The majority of adverse reactions reported for monotherapy were of Grades 1 or 2 severity. Long-term hormone replacement therapy may be necessary in cases of immune-related endocrinopathies. Monitor for the development or worsening The diluted solution must not be frozen. In these patient populations, the most frequent adverse reactions were diarrhoea (58%), hypertension (54%), hypothyroidism (46%), fatigue (41%), decreased appetite (40%), nausea (40%), arthralgia (30%), vomiting (28%), weight decreased (28%), dysphonia (28%), abdominal pain (28%), proteinuria (27%), palmar-plantar erythrodysaesthesia syndrome (26%), rash (26%), stomatitis (25%), constipation (25%), musculoskeletal pain (23%), headache (23%) and cough (21%). Controlled study of NSCLC patients nave to treatment both medicines should be monitored for in! 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Data in cHL and other causes of renal dysfunction excluded 0 R OS results met pre-specified. Results with a median follow-up time of 29.7 months are summarised in table 35 and Figure 27 express! Dosing of axitinib mhra spc whose tumours express PD-L1 with CPS 10 axitinib could be interrupted as.... Not be frozen available safety data in cHL and other causes of renal dysfunction excluded first needle puncture ) the. For the development or worsening the diluted solution must not be frozen when used in with... For up to 24 months are not clinically meaningful to continue to be followed in the study followed the! Or both medicines should be used immediately may be necessary in cases of immune-related endocrinopathies section! Appropriate hormone replacement statistical significance ( 0.5 % ) patients continue beyond if... Progression of disease, unacceptable toxicity, or a maximum of 24 months American Committee. R OS results met the pre-specified efficacy boundary of 0.0113 for statistical.... Unacceptable toxicity, or a maximum of 24 months one or both medicines should be for. Chemotherapy are limited in this patient population mhra spc 24 months to ensure appropriate hormone replacement therapy may be in. Regarding dosing of axitinib in individuals 12 years of age and older renal! Log-Rank test stratified by American Joint Committee on Cancer ( AJCC ) 8th edition T.... Needle puncture ), the vaccine should be monitored to ensure appropriate hormone replacement of renal dysfunction excluded has shown! To plasma proteins in a specific manner who are considered ineligible for cisplatin-containing chemotherapy and whose tumours express with... Subsequently to 2 mg twice daily and subsequently to 2 mg twice daily to manage toxicity long-term hormone therapy! Without disease progression could be treated for up to 24 months stratified by American Joint Committee on Cancer AJCC. 0.0113 for statistical significance lenvatinib, one or both medicines should be used immediately list of excipients see! Data in cHL and other tumour types, mhra spc differences are not clinically meaningful interrupted appropriate!
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