mhra spc

/Filter /FlateDecode Clinically stable patients with initial evidence of disease progression were permitted to remain on treatment until disease progression was confirmed. Eighty-eight percent had M1 disease and 12% had M0 disease. This vaccine should be handled by a healthcare professional using aseptic techniques to ensure the sterility of each dose. Manufacturers of all affected formulations of ranitidine have been instructed One vial of 4 mL of concentrate contains 100 mg of pembrolizumab. We also use cookies set by other sites to help us deliver content from their services. From a microbiological point of view, after first opening (first needle puncture), the vaccine should be used immediately. EVUSHELD is indicated for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19 (see sections 4.2, 5.1 and 5.2).. Physicians should consider the benefit/risk balance of the available treatment options (pembrolizumab monotherapy or pembrolizumab in combination with chemotherapy) before initiating treatment in patients with HNSCC whose tumours express PD-L1 (see section 5.1). /Parent 3 0 R /CropBox [0 0 595 842] 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). 0086 136 9073 4191. domogres@spcfloorings.net. Patients were treated with pembrolizumab until disease progression or unacceptable toxicity. Assessment of tumour status was performed every 9 weeks for the first 45 weeks, and every 12 weeks thereafter. Based on Kaplan-Meier estimates; includes 16 patients with responses of 6 months or longer, Figure 9: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-024 (intent to treat population). This will allow quick identification of new safety information. In the absence of these data, pembrolizumab should be used with caution in this population after careful consideration of the potential risk-benefit on an individual basis. Information on the original Spikevax COVID-19 vaccine can found on a separate page (link below). Hazard ratio (pembrolizumab compared to chemotherapy) based on the stratified Cox proportional hazard model. Among the 5 adolescent participants with advanced melanoma treated on KEYNOTE-051, no patient had a complete or a partial response, and 1 patient had stable disease. Patients with EGFR or ALK positive tumour mutations should also have received targeted therapy before receiving KEYTRUDA. The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials. The KEYNOTE-426 study was not powered to evaluate efficacy of individual subgroups. Nominal p-Value based on Miettinen and Nurminen method stratified by IMDC risk group and geographic region. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Assessment of tumour status was performed at 9 weeks after the first dose, then every 6 weeks through the first year, followed by every 12 weeks thereafter. This is based on the Summary of Product Characteristics of the product. The clinical significance of this is unknown. QRjj$HUwg Table 25: Response to pembrolizumab 200 mg every 3 weeks or chemotherapy in patients with previously untreated urothelial carcinoma for whom carboplatin rather than cisplatin was selected by the investigator as the better choice of chemotherapy in KEYNOTE-361, Table 19: Efficacy results in cHL patients who failed a transplant before enrolling or who failed 2 or more prior therapies and were ineligible for ASCT in KEYNOTE-204, Number (%) of patients with duration 6 months, Number (%) of patients with duration 12 months, * Based on the stratified Cox proportional hazard model, No cases of severe COVID-19 were reported in the 7,020 Nuvaxovid participants compared with 4 cases of severe COVID-19 reported in the 7,019 placebo recipients in the PP-EFF analysis set. Study1 is an ongoing Phase3, multicentre, randomised, observer-blinded, placebo-controlled study with an adult main study conducted in participants 18years of age and older in United States and Mexico, and a paediatric expansion occurring in participants 12 through 17 years of age in the United States. 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). One patient experienced engraftment syndrome post-transplant. The efficacy of Nuvaxovid may be lower in immunosuppressed individuals. Based on stratified log-rank test, 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. /CropBox [0 0 595 842] Note: toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v.4). Kaplan-Meier curves for OS based on the final analysis are shown in Figures 20 and 21. Report a suspected side effect or falsified product to the MHRA Yellow Card scheme. PILs are based on the Summaries of Product Characteristics (SPCs) which are a description of a medicinal products properties and the conditions attached to its use. . Adverse reactions were usually mild to moderate in severity with a median duration of less than or equal to 2 days for local events and less than or equal to 1 day for systemic events following vaccination. Based on Kaplan-Meier estimation, Figure 16: Kaplan-Meier curve for progression-free survival by treatment arm in cHL patients who failed a transplant before enrolling or who failed 2 or more prior therapies and were ineligible for ASCT in KEYNOTE-204, KEYNOTE-087 and KEYNOTE-013: Open-label studies in patients with relapsed or refractory cHL. After careful consideration of the potential increased risk, pembrolizumab may be used with appropriate medical management in these patients. Table 4 summarises key efficacy measures at the final analysis in patients previously treated with ipilimumab, and the Kaplan-Meier curve for PFS is shown in Figure 3. Assessment of tumour status was performed at 12 weeks, then every 6 weeks through Week 48, followed by every 12 weeks thereafter. 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. NEW Colors. Rare cases of SJS and TEN, some of them with fatal outcome, have been observed (see sections 4.2 and 4.4). The primary efficacy outcome measure was investigator-assessed disease-free survival (DFS). Each multidose vial contains a colourless to slightly yellow, clear to mildly opalescent dispersion free from visible particles. 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). 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 Sixty-one percent of patients had received ASCT, 38% were transplant ineligible; 17% had no prior brentuximab vedotin use; and 37% of patients had prior radiation therapy. We also use cookies set by other sites to help us deliver content from their services. The efficacy of pembrolizumab was evaluated in KEYNOTE-716, a multicentre, randomised, double-blind, placebo-controlled study in patients with resected Stage IIB or IIC melanoma. # From product-limit (Kaplan-Meier) method for censored data, Figure 34: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-355 patients with PD-L1 expression (CPS 10), Figure 35: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-355 patients with PD-L1 expression (CPS 10), KEYNOTE-775: Controlled study of combination therapy in advanced EC patients previously treated with systemic chemotherapy. Scientific guidelines with SmPC recommendations. Immunogenicity in Adolescents 12 through 17 years of age. Altitude above sea level (m) 7. Not statistically significant after adjustment for multiplicity, Figure 28: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-177 (intent to treat population), Figure 29: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-177 (intent to treat population), * Not statistically significant after adjustment for multiplicity, KEYNOTE-164: Open-label study in patients with unresectable or metastatic MSI-H or dMMR CRC who have received prior therapy. 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. Participants were enrolled across 28 tumour types by primary diagnosis. 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. For security reasons, new Registrations will not be activated until registration details have been checked and verified by the MHRA. Table 40 summarises key efficacy measures from the pre-specified analyses. Well send you a link to a feedback form. Based on best response of stable disease or better, Sevilla. No dose adjustment is necessary in patients 65 years (see sections 4.4 and 5.1). << 11 0 obj We use some essential cookies to make this website work. Qualitative and quantitative composition 3. 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). Eighty-four percent had M1c stage and 8% of patients had a history of brain metastases. KEYNOTE-024: Controlled study of NSCLC patients nave to treatment. The median time to onset of ALT increased was 2.3 months (range: 7 days to 19.8 months). An analysis was performed in KEYNOTE-189 in patients who had PD-L1 TPS < 1% [pembrolizumab combination: n=127 (31%) vs. chemotherapy: n=63 (31%)], TPS 1-49% [pembrolizumab combination: n=128 (31%) vs. chemotherapy: n=58 (28%)] or 50% [pembrolizumab combination: n=132 (32%) vs. chemotherapy: n=70 (34%)] (see Table 15). Approval date: September 2019, updated December 2019 Review date: December 2021 (or earlier if indicated) South East London Area Prescribing Committee. The median duration was 2.0 months (range 1 day to 51.0+ months). Individuals may not be fully protected until 7 days after their second dose. /Parent 3 0 R Type 1 diabetes mellitus, including diabetic ketoacidosis, has been reported in patients receiving pembrolizumab (see section 4.8). Administration of pembrolizumab was permitted beyond RECIST-defined disease progression by BICR or beyond discontinuation of pemetrexed if the patient was clinically stable and deriving clinical benefit as determined by the investigator. Their services with initial evidence of disease progression were permitted to remain on until... Not be activated until registration details have been observed ( see sections 4.4 5.1... Dose adjustment is necessary in patients 65 years ( see sections 4.2 4.4., have been checked and verified by the vaccine should be handled by a healthcare professional aseptic! Compared to chemotherapy ) based on Miettinen and Nurminen method stratified by IMDC risk group and geographic.! Verified by the MHRA TEN, some of them with fatal outcome, have been observed ( see sections and! Treated with pembrolizumab until disease progression were permitted to remain on treatment until disease progression or unacceptable toxicity to. Security reasons, new Registrations will not be activated until registration details have been and! Progression were permitted to remain on treatment until disease progression was confirmed sections 4.4 and 5.1 ) well you... Patients had a history of brain metastases the original Spikevax COVID-19 vaccine can on... Potential increased risk, pembrolizumab may be used with appropriate medical management in these patients months ) for first. 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mhra spc