mhra spc

To help us improve GOV.UK, wed like to know more about your visit today. The potential risk of gastrointestinal perforation should be taken into consideration. Store the opened vial between 2C to 25C for up to 6 hours after first puncture, see section 6.3. Secondary efficacy outcome measures included response duration, PFS, and OS. The diluted solution must not be frozen. More frequent monitoring of liver enzymes as compared to when the medicines are used in monotherapy may be considered. It will take only 2 minutes to fill in. Nephritis resolved in 20 patients, 5 with sequelae. Alpha Release This is a new service - your feedback will help improve it. When used in combination with lenvatinib, one or both medicines should be interrupted as appropriate. Corticosteroids can also be used as premedication, when pembrolizumab is used in combination with chemotherapy, as antiemetic prophylaxis and/or to alleviate chemotherapy-related adverse reactions. Secondary efficacy outcome measures were ORR and duration of response, according to RECIST v1.1, as assessed by investigator. Frequencies are defined as: very common ( 1/10); common ( 1/100 to < 1/10); uncommon ( 1/1,000 to < 1/100); rare ( 1/10,000 to < 1/1,000); very rare (< 1/10,000); and not known (cannot be estimated from the available data). /Resources 26 0 R 234, Based on log-linear model of PCR-confirmed COVID-19 infection incidence rate using Poisson regression with treatment group and age strata as fixed effects and robust error variance, where VE = 100 (1 relative risk) (Zou 2004). The primary efficacy outcome measures were OS and PFS as assessed by BICR using RECIST 1.1. Concomitant administration of Nuvaxovid with other vaccines has not been studied. Starting from randomisation, patients underwent imaging every 12 weeks for the first 2 years, then every 16 weeks from year 3 to 5, and then every 24 weeks annually. The KEYNOTE-426 study was not powered to evaluate efficacy of individual subgroups. A subset of 105 participants (Safety Analysis Set) were randomiszed to receive a booster dose of Nuvaxovid approximately 6months after receiving Dose2 of the primary series and received at least 1 dose of study vaccine; 104 of the 105 participants received Nuvaxovid (Full Analysis Set). Comorbidities included: obesity (body mass index (BMI) 30 kg/m2); chronic lung disease; diabetes mellitus type 2, cardiovascular disease; chronic kidney disease; or human immunodeficiency virus (HIV). MHRA does not accept combined SmPCs covering, for example two different strengths of the same dosage form, but only accepts a single SmPC in the correct format using the relevant template . This SCA should be read in conjunction with the Summary of Product Characteristics (SPC) and the current edition of the British National Formulary . The Public Assessment Report is a scientific report, written by the MHRA. Demographic characteristics were similar among participants who received Nuvaxovid and those who received placebo. << Patients received pembrolizumab 200 mg every 3 weeks until unacceptable toxicity or disease progression. Table 21: Response to pembrolizumab 200 mg every 3 weeks in patients with urothelial carcinoma previously treated with chemotherapy in KEYNOTE-045, Number (%#) of patients with duration 6 months, Number (%#) of patients with duration 12 months, Figure 23: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-426 (intent to treat population), Figure 24: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-426 (intent to treat population). The median duration was 1.9 months (range 1 day to 47.1+ months). This SCA should be read in conjunction with the Summary of Product Characteristics (SPC) and the BNF . 9 0 obj Overall, 46 cHL patients 65 years were treated with pembrolizumab in studies KEYNOTE-087, KEYNOTE-013 and KEYNOTE-204. /Parent 3 0 R The geometric mean value (CV%) for the terminal half-life is 22 days (32%) at steady-state. Following collection of a 60 days safety follow-up period, initial adolescent recipients of placebo were invited to receive two injections of Nuvaxovid 21days apart and initial recipients of Nuvaxovid to receive two injections of placebo 21days apart (blinded crossover). No new immune-related adverse reactions were identified in the adjuvant setting. Storage at 25C is not the recommended storage or shipping condition but may guide decisions for use in case of temporary temperature excursions during the 9-month storage at 2C to 8C. Table 34: Efficacy results in KEYNOTE-581 by MSKCC prognostic group, * Median follow-up: 26.5 months (data cutoff 28 August 2020), Assessed by BICR according to the IWG 2007 criteria by PET CT scans, Based on patients (n=150) with a response by independent review, Based on patients (n=18) with a response by independent review, # Based on Kaplan-Meier estimation; includes 62 patients with responses of 12 months or longer, Based on Kaplan-Meier estimation; includes 7 patients with responses of 12 months or longer, Based on Kaplan-Meier estimation; includes 37 patients with responses of 24 months or longer, Based on Kaplan-Meier estimation; includes 4 patients with responses of 60 months or longer. 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. Uncommon but serious: (see MHRA alerts below for more information) DKA Fournier's Gangrene Lower limb amputation -encourage regular preventative footcare Please see individual drug monographs in BNF/SPC for a complete side-effect profile -see hyperlink in table overleaf. - Update the SmPC and PIL to include urticaria as an adverse event Table 30: Efficacy of pembrolizumab 200 mg every 3 weeks in HNSCC patients with TPS 50% who were previously treated with platinum chemotherapy in KEYNOTE-040, Number (%) of patients with duration 6 months, Description of selected adverse reactions. In general, the frequency of adverse reactions for pembrolizumab combination therapy is observed to be higher than for pembrolizumab monotherapy or chemotherapy alone, reflecting the contributions of each of these components (see section 4.8). The clinical efficacy, safety, and immunogenicity of Nuvaxovid is being evaluated in two pivotal, placebo-controlled, Phase 3 studies, Study 1 (2019nCoV-301) conducted in North America and Study 2 (2019nCoV-302) conducted in the United Kingdom, and a Phase 2a/b study, Study 3, conducted in South Africa. The MHRA-GMDP database contains the following information issued by the MHRA relating to manufacturing and wholesale authorisations and certificates. /ModDate (D:20190624094123+01'00') Both pembrolizumab arms were superior to chemotherapy for PFS, and there was no difference between pembrolizumab doses. Represents (n1, n2) populations defined as: n1 = number of participants in adult main study (18 through 25 years) with non-missing neutralizing antibodies result 37% of patients received only prior neoadjuvant or adjuvant therapy. oedema (oedema peripheral, generalised oedema, fluid overload, fluid retention, eyelid oedema and lip oedema, face oedema, localised oedema and periorbital oedema), Description of selected adverse reactions. Among patients with BRAF mutant tumours, 10 (50%) were previously treated with a BRAF inhibitor. All participants were offered the opportunity to continue to be followed in the study. Scientific guidelines with SmPC recommendations. 6.5 Nature and contents of container PVC/Aluminium thermoformed blister of 10 soft capsules. 2. The efficacy of pembrolizumab was investigated in KEYNOTE-204, a randomised, open-label, active-controlled study conducted in 304 patients with relapsed or refractory cHL. stream Secondary efficacy outcome measures were objective response rate (ORR) and response duration. There is no information on overdose with pembrolizumab. The recommended dose of KEYTRUDA in adults is either 200 mg every 3 weeks or 400 mg every 6 weeks administered as an intravenous infusion over 30 minutes. MHRA July 2018 Pressurised metered dose inhalers (pMDI): risk of airway obstruction from aspiration of loose objects. Great Britain. It will take only 2 minutes to fill in. There was no statistically significant difference between pembrolizumab and chemotherapy in the final OS analysis that was not adjusted for the potentially confounding effects of crossover. KEYNOTE-826: Controlled study of combination therapy in patients with persistent, recurrent, or metastatic cervical cancer. Table 19 summarises the efficacy results in the subpopulation. 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 primary efficacy outcome measures were PFS assessed by BICR according to RECIST v1.1 and OS. If not used immediately, chemical and physical in-use stability of KEYTRUDA has been demonstrated for 96 hours at 2C to 8C. For patients with Grade 3 or Grade 4 endocrinopathies that improved to Grade 2 or lower and are controlled with hormone replacement, if indicated, continuation of pembrolizumab may be considered after corticosteroid taper, if needed. This does not replace the SPC, which should be read in conjunction with it Date Prepared: October 2011 Reviewed: August 2019 Review Date: July 2022 (Extended to January 2023) References 1. The benefit of treatment with pembrolizumab versus the risk of possible organ rejection should be considered in these patients. News stories, speeches, letters and notices, Reports, analysis and official statistics, Data, Freedom of Information releases and corporate reports, Information for healthcare professionals and the public on Moderna's bivalent vaccines. See section 4.8 for how to report adverse reactions. Co-administration of Nuvaxovid with inactivated influenza vaccines has been evaluated in a limited number of participants in an exploratory clinical trial sub-study, see section 4.8 and section 5.1. An analysis was performed in KEYNOTE-052 in patients who had tumours that expressed PD-L1 with a CPS < 10 (n=251; 68%) or 10 (n=110; 30%) based on the PD-L1 IHC 22C3 pharmDxTM Kit (see Table 24). /Parent 3 0 R << KEYNOTE-052: Open-label study in urothelial carcinoma patients ineligible for cisplatin-containing chemotherapy. Colitis led to discontinuation of pembrolizumab in 48 (0.6%) patients. 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. 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. Randomisation was stratified by nodal status (positive vs. negative), tumour size (T1/T2 vs. T3/T4), and choice of carboplatin (dosed every 3 weeks vs. weekly). The study excluded patients with nasopharyngeal carcinoma, active autoimmune disease that required systemic therapy within 2 years of treatment, a medical condition that required immunosuppression, or who were previously treated with 3 or more systemic regimens for recurrent and/or metastatic HNSCC. 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. Date of first authorisation/renewal of the authorisation 10. Some information may have been excluded from public view. Demographic and baseline characteristics were balanced amongst participants who received Nuvaxovid and participants who received placebo. >> If ALT or AST 10 times ULN or > 3 times ULN with concurrent total bilirubin 2 times ULN, both KEYTRUDA and axitinib should be permanently discontinued and corticosteroid therapy may be considered. All patients received pembrolizumab for a median of 4 doses (range 1-35 doses), with 138 patients (85.7%) receiving pembrolizumab for 2 doses or more. The primary efficacy outcome measure was investigator-assessed disease-free survival (DFS). When used in combination with pembrolizumab, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of six weeks or longer (see section 5.1). Pharmacological properties 6. Pembrolizumab may be restarted within 12 weeks after last dose of KEYTRUDA if the adverse reaction recovers to Grade 1 and corticosteroid dose has been reduced to 10 mg prednisone or equivalent per day. Demographic and baseline characteristics were balanced amongst participants who received Nuvaxovid and participants who received placebo. Do not pool excess vaccine from multiple vials. /MediaBox [0 0 595 842] Based on limited safety data from patients 75 years of age, when administrated in combination with chemotherapy, pembrolizumab showed less tolerability in patients 75 years of age compared to younger patients. Key secondary efficacy outcome measures included OS and ORR. /PageLabels 4 0 R endobj When suggestions are available use up and down arrows to review and ENTER to select. Hazard ratio (pembrolizumab compared to chemotherapy) based on the stratified Cox proportional hazard model. At least one pre-existing comorbidity or lifestyle characteristic associated with an increased risk of severe COVID-19 was present in 16,493 (95%) participants. The median duration was not reached (range 2 days to 63.0+ months). referring specialist and the MHRA yellow card scheme 1. Of the 540 patients, 61% were male, 43% were 65 years (median age was 62 years [range 15-89]) and 98% were white. Patients with active autoimmune disease or a medical condition that required immunosuppression or mucosal or ocular melanoma were ineligible. Based on the stratified Cox proportional hazard model, Based on available safety data in cHL and other tumour types, these differences are not clinically meaningful. Allogeneic HSCT prior to treatment with pembrolizumab. Table 15: Efficacy results by PD-L1 expression in KEYNOTE-189 The two vaccine components elicit B- and T-cell immune responses to the S protein, including neutralising antibodies, which may contribute to protection against COVID-19. Patients had PD-L1 expression with a 50% TPS based on the PD-L1 IHC 22C3 pharmDxTM Kit. When pembrolizumab is administered in combination, refer to the SmPC for the respective combination therapy components prior to initiation of treatment. OS and PFS benefits were observed regardless of PD-L1 expression level. KEYNOTE-361 is a Phase III, randomised, controlled, open-label clinical study of pembrolizumab with or without platinum-based combination chemotherapy (i.e. Severe skin reactions resolved in 93 patients, 2 with sequelae. /Resources 16 0 R These SPC applications are geographically-limited to Northern Ireland, unless/until a separate authorisation is also issued by the MHRA to cover the remainder of the UK, i.e. /MediaBox [0 0 595 842] 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). This service replaces the previously separate MHRA websites, one of which hosted SPC and PILs, the other PARs. 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. 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). Patients were randomised (1:1:1) to one of the following treatment arms: pembrolizumab 200 mg intravenously every 3 weeks up to 24 months in combination with lenvatinib 20 mg orally once daily. Hepatitis has been reported in patients receiving pembrolizumab (see section 4.8). Eighty-six percent had two or more prior lines of therapy and 64% had Stage 3 or higher. In KEYNOTE-361, a higher number of deaths within 6 months of treatment initiation followed by a long-term survival benefit was observed with pembrolizumab monotherapy compared to chemotherapy (see section 5.1). Manufacturers, importers and distributors of active substances are required to register their activities with the MHRA. There is limited experience with use of Nuvaxovid in pregnant women. Dont include personal or financial information like your National Insurance number or credit card details. HWK[%'HNR*3'9!0\BZ_~ @HR`_w?|Qw2jw3&R^E Patients underwent imaging every six months from randomisation through the 4th year, and then once in year 5 from randomisation or until recurrence, whichever came first. Do not shake. KEYTRUDA as monotherapy is indicated for the treatment of recurrent or metastatic head and neck squamous cell carcinoma in adults whose tumours express PD-L1 with a 50% TPS and progressing on or after platinum-containing chemotherapy (see section 5.1). Hypothyroidism resolved in 200 (21.3%) patients, 16 with sequelae. 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. Considered in these patients in urothelial carcinoma patients ineligible for cisplatin-containing chemotherapy metastatic cancer! 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