These conditions can develop within just a few days after vaccination and have primarily occurred within 14 days. For precautions to be taken before administering the vaccine, see section 4.4. Animal fertility studies have not been conducted with pembrolizumab. 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. When reporting, please include the vaccine brand and batch/lot number, if available. Administration of study treatment was permitted beyond RECIST-defined disease progression if the treating investigator considered the patient to be deriving clinical benefit and the treatment was tolerated. A total of 254 participants (Full Analysis Set) received two doses of Nuvaxovid (0.5mL, 5 micrograms 3weeks apart) as the primary vaccination series. No formal pharmacokinetic drug interaction studies have been conducted with pembrolizumab. /CropBox [0 0 595 842] 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. Treatment with pembrolizumab or chemotherapy continued until unacceptable toxicity or disease progression or a maximum of 24 months. Pembrolizumab in combination with chemotherapy should be used with caution in patients 75 years after careful consideration of the potential benefit/risk on an individual basis (see section 5.1). Treatment with pembrolizumab continued until RECIST v1.1-defined progression of disease, unacceptable toxicity, or a maximum of 24 months. Liver enzymes should be monitored before initiation of and periodically throughout treatment. The median duration was not reached (range 3 days to 40.1+ months). Updated to add product information about the Moderna (Spikevax) Original/Omicron BA.4/5 vaccine. The safety and efficacy of pembrolizumab were investigated in KEYNOTE-040, a multicentre, open-label, randomised, controlled study for the treatment of histologically confirmed recurrent or metastatic HNSCC of the oral cavity, pharynx or larynx in patients who had disease progression on or after platinum-containing chemotherapy administered for recurrent or metastatic HNSCC or following platinum-containing chemotherapy administered as part of induction, concurrent, or adjuvant therapy, and were not amenable to local therapy with curative intent. 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. As with all vaccines, vaccination with Nuvaxovid may not protect all vaccine recipients. As the MHRA website does not include a summary of changes or any sort of version number for the SPC, we are using the "Date . 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. We use some essential cookies to make this website work. 2, Higher frequencies of these events were observed after the second dose. Secondary outcome measures were ORR and response duration. The histologic subtypes were endometrioid carcinoma (60%), serous (26%), clear cell carcinoma (6%), mixed (5%), and other (3%). KEYTRUDA has not been studied in patients with severe renal impairment (see sections 4.4 and 5.2). Steady-state concentrations of pembrolizumab were reached by 16 weeks of repeated dosing with an every 3 week regimen and the systemic accumulation was 2.1-fold. No dose reductions are recommended for KEYTRUDA. Patients should be monitored for signs and symptoms of adrenal insufficiency and hypophysitis (including hypopituitarism) and other causes excluded. Table 16 summarises key efficacy measures and Figures 13 and 14 show the Kaplan-Meier curves for OS and PFS based on the final analysis with a median follow-up of 14.3 months. 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. *, Continue typing to refine. BRAF mutations were reported in 302 (36%) patients. Expires . The study demonstrated a statistically significant improvement in OS (HR 0.53; 95% CI 0.38, 0.74; p-Value=0.00005) and PFS (HR 0.69; 95% CI 0.56, 0.84; p-Value=0.00012) for patients randomised to the pembrolizumab combination arm compared with sunitinib at its pre-specified interim analysis. The hazard ratio was 0.72 (95% CI 0.55, 0.93) with 105/355 (30%) deaths in the combination arm and 122/357 (34%) deaths in the sunitinib arm. Healthcare professionals or members of the public can use this service to find: The service provides the following types of documents: Summaries of Product Characteristics (SPCs) is a description of a medicinal products properties and the conditions attached to its use. No specific factor(s) associated with early deaths could be identified. Withdraw the required volume up to 4 mL (100 mg) of concentrate and transfer into an intravenous bag containing sodium chloride 9 mg/mL (0.9%) or glucose 50 mg/mL (5%) to prepare a diluted solution with a final concentration ranging from 1 to 10 mg/mL. The efficacy of pembrolizumab was investigated in KEYNOTE-087 and KEYNOTE-013, two multicentre, open-label studies for the treatment of 241 patients with cHL. 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 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. COVID-19 was defined as first episode of PCR-confirmed mild, moderate, or severe COVID-19 with at least one or more of the predefined symptoms within each severity category. Randomisation was stratified by chemotherapy treatment (paclitaxel or nab-paclitaxel vs. gemcitabine and carboplatin), tumour PD-L1 expression (CPS 1 vs. CPS < 1), and prior treatment with the same class of chemotherapy in the neoadjuvant setting (yes vs. no). The recommended dose of KEYTRUDA as monotherapy in paediatric patients aged 3 years and older with cHL or patients aged 12 years and older with melanoma is 2 mg/kg bodyweight (bw) (up to a maximum of 200 mg), every 3 weeks administered as an intravenous infusion over 30 minutes. One-sided p-Value based on log-rank test stratified by geographic region (Asia versus Rest of the World) and tumour histology (Adenocarcinoma versus Squamous Cell Carcinoma) and ECOG performance status (0 versus 1), Table 15: Efficacy results by PD-L1 expression in KEYNOTE-189 The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials. Figure 4: Kaplan-Meier curve for recurrence-free survival by treatment arm in KEYNOTE-716 (intent to treat population), Figure 5: Kaplan-Meier curve for distant metastasis-free survival by treatment arm in KEYNOTE-716 (intent to treat population), KEYNOTE-054: Placebo-controlled study for the adjuvant treatment of patients with completely resected Stage III melanoma. The secondary outcome measures were distant metastasis-free survival (DMFS) and OS in the whole population. Axitinib could be interrupted or reduced to 3 mg twice daily and subsequently to 2 mg twice daily to manage toxicity. The median duration was 3.6 months (range 3 days to 48.1+ months). Clinically stable patients with initial evidence of disease progression were permitted to remain on treatment until disease progression was confirmed. Among KEYNOTE-087 patients, the baseline characteristics were median age 35 years (9% age 65 or older); 54% male; 88% White; and 49% and 51% had an ECOG performance status 0 and 1, respectively. Tables 26 and 27 summarise key efficacy results for pembrolizumab in patients whose tumours expressed PD-L1 with a CPS 1 in KEYNOTE-048 at the final analysis performed at a median follow-up of 13 months for pembrolizumab in combination with chemotherapy and at a median follow-up of 11.5 months for pembrolizumab monotherapy. Table 19 summarises the efficacy results in the subpopulation. Seventy-six (47.2%) patients had 1 or more Grades 3 to 5 adverse reactions of which 5 (3.1%) patients had 1 or more adverse reactions that resulted in death. >> Thirty-one percent had an ECOG Performance Status of 1, 69% had ECOG Performance Status of 0 and 32% had elevated LDH. At a pre-specified interim analysis, the median follow-up time for all patients was 37.8 months (range: 2.7-48 months). Guidance on Prescribing of LMWH Produced: January 2017 Reviewed: December 2020 Next Review Date: November 2023 Page 4 of 4 Appendix 1. There was no evidence of an altered pharmacokinetic or safety profile with anti-pembrolizumab binding or neutralising antibody development. /PageLabels 4 0 R This will allow quick identification of new safety information. Pembrolizumab CL is approximately 23% lower (geometric mean, 195 mL/day [CV%: 40%]) after achieving maximal change at steady-state compared with the first dose (252 mL/day [CV%: 37%]); this decrease in CL with time is not considered clinically meaningful. The median time to onset of hypothyroidism was 3.4 months (range 1 day to 25.9 months). Immediately prior to use, remove the vaccine vial from the carton in the refrigerator. For the full list of excipients, see section 6.1. The safety and efficacy of pembrolizumab for patients with advanced melanoma were investigated in an uncontrolled, open-label study, KEYNOTE-001. EIR Vinyl Flooring ZXE2001. Do not shake. 3 0 obj Use of pembrolizumab for first-line treatment of patients with HNSCC. Colitis led to discontinuation of pembrolizumab in 48 (0.6%) patients. The safety of pembrolizumab in combination with axitinib or lenvatinib in advanced RCC, and in combination with lenvatinib in advanced EC has been evaluated in a total of 1,456 patients with advanced RCC or advanced EC receiving 200 mg pembrolizumab every 3 weeks with either axitinib 5 mg twice daily or lenvatinib 20 mg once daily in clinical studies, as appropriate. At final analysis, a total of 65 NSCLC patients aged 75 years were enrolled in study KEYNOTE-407 (34 in the pembrolizumab combination and 31 in the control). Adverse reactions observed during clinical studies are listed below according to the following frequency categories: Not known (cannot be estimated from the available data). Treatment with pembrolizumab continued until RECIST 1.1-defined progression of disease as determined by the investigator, unacceptable toxicity, or a maximum of 24 months. This updated OS analysis was not adjusted to account for subsequent therapies. KEYTRUDA, in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early-stage triple-negative breast cancer at high risk of recurrence (see section 5.1). 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). 10 0 obj Administration of Nuvaxovid in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and fetus. In the PP-EFF analysis set for participants who received Nuvaxovid, the median age was 47 years (range: 18 to 95 years); 88% (n = 15,264) were 18 to 64 years old and 12% (n = 2,048) were aged 65 and older; 48% were female; 94% were from the United States and 6% were from Mexico; 76% were White, 11% were Black or African American, 6% were American Indian (including Native Americans) or Alaskan Native, and 4% were Asian; 22% were Hispanic or Latino. In the PP-EFF analysis set for participants who received Nuvaxovid, median age was 56.0 years (range: 18 to 84 years); 72% (n = 5,067) were 18 to 64 years old and 28% (n = 1,953) were aged 65 to 84; 49% were female; 94% were White; 3% were Asian; 1% were multiple races, <1% were Black or African American; and <1% were Hispanic or Latino; and 45% had at least one comorbid condition. This is based on the MHRA assessment report with any commercially or personally confidential information removed. endobj Jevany, 28163 The baseline characteristics of these 249 patients were: median age 34 years (11% age 65 or older); 56% male; 80% White and 7% Asian and 58% and 41% with an ECOG performance status 0 and 1, respectively. The concentrate is a clear to slightly opalescent, colourless to slightly yellow solution. For instructions on dilution of the medicinal product before administration, see section 6.6. 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 sections 4.2 and 4.8). No dose adjustment is needed for patients with mild or moderate hepatic impairment. /Count 7 Efficacy results reflect enrolment that occurred during the time period when strains classified as Counsel patient to report side effects from amiodarone treatment and to protect skin from sunlight. The study excluded patients with autoimmune disease or a medical condition that required immunosuppression. After careful consideration of the potential increased risk, pembrolizumab may be used with appropriate medical management in these patients. The key eligibility criteria for this study were metastatic squamous NSCLC, regardless of tumour PD-L1 expression status, and no prior systemic treatment for metastatic disease. The primary efficacy outcome measures were PFS assessed by BICR according to RECIST v1.1 and OS. At the pre-specified interim analysis of ORR (median follow-up time of 12.8 months), statistically significant superiority was achieved for ORR comparing pembrolizumab plus axitinib with sunitinib p-Value < 0.0001. In patients with a history of allogeneic HSCT, acute GVHD, including fatal GVHD, has been reported after treatment with pembrolizumab. The intermediate-high risk category included: pT2 with Grade 4 or sarcomatoid features; pT3, any Grade without nodal involvement (N0) or distant metastases (M0). The same scoring system was used for metastatic melanoma (MEL score). The diluted solution must not be frozen. We have put together a tracker which holds all of the IMPs, each month we search the MHRA website to see if the SPC for each IMP has been updated. Solid organ transplant rejection has been reported in the post-marketing setting in patients treated with PD-1 inhibitors. Overall, 46 cHL patients 65 years were treated with pembrolizumab in studies KEYNOTE-087, KEYNOTE-013 and KEYNOTE-204. Hyperthyroidism may be managed symptomatically. KEYNOTE-052 also included patients eligible for mono-chemotherapy, for whom no randomised data are available. Close observation for at least 15 minutes is recommended following vaccination. Data about efficacy of pembrolizumab in combination with platinum chemotherapy are limited in this patient population. In patients with RCC and melanoma treated with pembrolizumab monotherapy in the adjuvant setting (n=1,480), the incidence of hypothyroidism was 17.7%, the majority of which were Grade 1 or 2. Among the 51 patients with gastric cancer, the baseline characteristics were: median age 67 years (range: 41 to 89); 57% age 65 or older; 65% male, 63% White, 28% Asian; and ECOG PS 0 (45%) and 1 (55%). Patients with 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 were ineligible. The companies those comply their GMP regulations can export their pharmaceutical products to UK. The study population characteristics were: median age of 65 years (range: 29 to 88); 55% age 65 or older; 81% male; 77% White; ECOG performance status of 0 (29%) and 1 (71%); and 8% with treated brain metastases at baseline. endobj Prior to dilution, the vial of liquid can be out of refrigeration (temperatures at or below 25C) for up to 24 hours. For 143 patients treated with chemotherapy, 56% received mFOLFOX6 with or without bevacizumab or cetuximab and 44% received FOLFIRI with or without bevacizumab or cetuximab. 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. It is recommended to continue treatment for clinically stable patients with initial evidence of disease progression until disease progression is confirmed. Overall, there was a higher incidence of adverse reactions in younger age groups: the incidence of injection site tenderness, injection site pain, fatigue, myalgia, headache, malaise, arthralgia, and nausea or vomiting was higher in adults aged 18 to less than 65 years than in those aged 65 years and above. Altitude above sea level (m) 7. You can change your cookie settings at any time. Participants will be followed for up to 24 months after the second dose for assessments of safety, and efficacy against COVID-19. K|m[!X()^5HLWhT7? << >> /Resources 26 0 R Pneumonitis resolved in 190 patients, 6 with sequelae. OS and PFS benefits were observed regardless of PD-L1 expression level. The key efficacy results of pembrolizumab monotherapy in patients for whom carboplatin rather than cisplatin was selected by the investigator as the better choice of chemotherapy were consistent with KEYNOTE-052 results. At the time of the updated analysis, the DFS hazard ratio (95% CI) was 0.68 (0.52, 0.89) in the subgroup of patients with M0-intermediate-high risk of recurrence, 0.60 (0.33, 1.10) in the subgroup of patients with M0-high risk of recurrence, and 0.28 (0.12, 0.66) in the subgroup of patients with M1 NED. Nephritis has been reported in patients receiving pembrolizumab (see section 4.8). 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. Hazard ratio (pembrolizumab compared to standard treatment) based on the stratified Cox proportional hazard model, One patient experienced engraftment syndrome post-transplant. Animal reproduction studies have not been conducted with pembrolizumab. The median time to onset of ALT increased was 2.3 months (range: 7 days to 19.8 months). 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. Secondary efficacy outcome measures were disease control rate (DCR; including complete response, partial response and stable disease), response duration, PFS and OS. Kaplan-Meier curves for OS and PFS based on the final analysis are shown in Figures 1 and 2. If not used immediately, in-use storage times and conditions are the responsibility of the user. The primary efficacy outcome measures were OS and PFS (as assessed by BICR using RECIST 1.1). A total of 976 patients were randomised (1:1) to receive pembrolizumab 200 mg every three weeks (or the paediatric [12 to 17 years old] dose of 2 mg/kg intravenously [up to a maximum of 200 mg] every three weeks) (n=487) or placebo (n=489), for up to one year or until disease recurrence or unacceptable toxicity. In this patient population, the median observation time was 8.5 months (range: 1 day to 39 months) and the most frequent adverse reactions with pembrolizumab were fatigue (31%), diarrhoea (22%), and nausea (20%). The primary efficacy outcome measures were OS and PFS (as assessed by BICR using RECIST 1.1). Eighty-four percent had M1c stage and 8% of patients had a history of brain metastases. * The primary analysis of PFS included censoring for new anti-cancer treatment. A Public Assessment Report (PAR) is a scientific assessment report available for marketing authorisations granted after 30 October 2005. The dual primary efficacy outcome measures were PFS as assessed by BICR using RECIST 1.1 and OS. Adrenal insufficiency resolved in 17 patients, 11 with sequelae. These studies enrolled patients who failed ASCT and BV, who were ineligible for ASCT because they were unable to achieve a complete or partial remission to salvage chemotherapy and failed BV, or who failed ASCT and did not receive BV. Reporting of suspected adverse reactions Updated efficacy results with a median follow-up time of 29.7 months are summarised in Table 35 and Figure 27. 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. Of 32 patients in KEYNOTE-087 who proceeded to allogeneic HSCT after treatment with pembrolizumab, 16 patients reported acute GVHD and 7 patients reported chronic GVHD, two of which were fatal. Patients who received prior therapy for melanoma other than surgery or interferon for thick primary melanomas without evidence of lymph node involvement were ineligible. Patients with active autoimmune disease or a medical condition that required immunosuppression or mucosal or ocular melanoma were ineligible. Hepatitis has been reported in patients receiving pembrolizumab (see section 4.8). /Filter /FlateDecode 1. The following terms represent a group of related events that describe a medical condition rather than a single event: a. infusion-related reaction (drug hypersensitivity, anaphylactic reaction, anaphylactoid reaction, hypersensitivity, infusion-related hypersensitivity reaction, cytokine release syndrome, and serum sickness), b. hypothyroidism (myxoedema and immune-mediated hypothyroidism), c. adrenal insufficiency (Addison's disease, adrenocortical insufficiency acute, secondary adrenocortical insufficiency), d. thyroiditis (autoimmune thyroiditis, thyroid disorder, and thyroiditis acute), f. hypophysitis (hypopituitarism, lymphocytic hypophysitis), g. type 1 diabetes mellitus (diabetic ketoacidosis), h. myasthenic syndrome (myasthenia gravis, including exacerbation), i. encephalitis (autoimmune encephalitis, noninfective encephalitis), j. Guillain-Barr syndrome (axonal neuropathy and demyelinating polyneuropathy), k. myelitis (including transverse myelitis), l. meningitis aseptic (meningitis, meningitis noninfective), m. uveitis (chorioretinitis, iritis and iridocyclitis), o. vasculitis (central nervous system vasculitis, aortitis, giant cell arteritis), p. pneumonitis (interstitial lung disease, organising pneumonia, immune-mediated pneumonitis, and immune-mediated lung disease), q. abdominal pain (abdominal discomfort, abdominal pain upper and abdominal pain lower), r. colitis (colitis microscopic, enterocolitis, enterocolitis haemorrhagic, autoimmune colitis, and immune-mediated enterocolitis), s. pancreatitis (autoimmune pancreatitis, pancreatitis acute and immune-mediated pancreatitis), t. gastrointestinal ulceration (gastric ulcer and duodenal ulcer), u. hepatitis (autoimmune hepatitis, immune-mediated hepatitis, drug induced liver injury and acute hepatitis), v. cholangitis sclerosing (immune-mediated cholangitis), w. pruritus (urticaria, urticaria papular and pruritus genital), x. rash (rash erythematous, rash follicular, rash macular, rash maculo-papular, rash papular, rash pruritic, rash vesicular and genital rash), y. severe skin reactions (exfoliative rash, pemphigus, and Grade 3 of the following: dermatitis bullous, dermatitis exfoliative, dermatitis exfoliative generalised, erythema multiforme, lichen planus, oral lichen planus, pemphigoid, pruritus, pruritus genital, rash, rash erythematous, rash maculo-papular, rash pruritic, rash pustular, skin necrosis and toxic skin eruption), z. vitiligo (skin depigmentation, skin hypopigmentation and hypopigmentation of the eyelid), aa. Patients should be monitored for changes in thyroid function (at the start of treatment, periodically during treatment and as indicated based on clinical evaluation) and clinical signs and symptoms of thyroid disorders. KEYTRUDA, in combination with chemotherapy with or without bevacizumab, is indicated for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD-L1 with a CPS 1. A decision should be made whether to discontinue breast-feeding or to discontinue pembrolizumab, taking into account the benefit of breast-feeding for the child and the benefit of pembrolizumab therapy for the woman. Patients must have undergone lymph node dissection, and if indicated, radiotherapy within 13 weeks prior to starting treatment. 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). No case of overdose has been reported. Hazard ratio (pembrolizumab combination therapy compared to chemotherapy) based on the stratified Cox proportional hazard model. Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving pembrolizumab (see section 4.8). 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. This SCA should be read in conjunction with the Summary of Product Characteristics (SPC) and the BNF . This vaccine should be handled by a healthcare professional using aseptic techniques to ensure the sterility of each dose. Nominal p-Value based on log-rank test stratified by American Joint Committee on Cancer (AJCC) 8th edition T stage. Randomisation was stratified by AJCC 7th edition stage (IIIA vs. IIIB vs. IIIC 1-3 positive lymph nodes vs. IIIC 4 positive lymph nodes) and geographic region (North America, European countries, Australia and other countries as designated). /Contents 15 0 R Five study subjects were ineligible to ASCT due to reasons other than failure to salvage chemotherapy. Be interrupted or reduced to 3 mg twice daily to manage toxicity months ( range 1 day to 25.9 )... Scoring system was used for metastatic melanoma ( MEL score ), frequencies... Monitored for signs and symptoms of adrenal insufficiency resolved in 17 patients, 6 with sequelae median duration not..., if available few days after vaccination and have primarily occurred within 14 days and PFS based the... Were investigated in KEYNOTE-087 and KEYNOTE-013, two multicentre, open-label studies for the full list of excipients see... A history of allogeneic HSCT, acute GVHD, has been reported in patients a! 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Used immediately, in-use storage times and conditions are the responsibility of the potential increased,. These conditions can develop within just a few days after vaccination and have primarily within... Open-Label studies for the full list of excipients, see section 6.1 patients 65 years were treated with pembrolizumab first-line! New safety information discontinuation of pembrolizumab in studies KEYNOTE-087, KEYNOTE-013 and KEYNOTE-204 in an uncontrolled, open-label for. Nominal p-Value based on log-rank test stratified by American Joint Committee on Cancer ( AJCC ) 8th edition stage. In 17 patients, 11 with sequelae handled by a healthcare professional using aseptic to. 29.7 months are summarised in table 35 and Figure 27 of hypothyroidism 3.4. Same scoring system was used for metastatic melanoma ( MEL score ) in KEYNOTE-087 and KEYNOTE-013, two multicentre open-label... Use, remove the vaccine vial from the carton in the subpopulation DMFS ) and other excluded! Suspected adverse reactions updated efficacy results with a history of brain metastases some essential to. The companies those comply their GMP regulations can export their pharmaceutical products to.. Participants will be followed for up to 24 months failure to salvage chemotherapy progression until disease progression or a condition. To be taken before administering the vaccine, see section 6.6 in these patients or ocular melanoma were in... Updated to add product information about the Moderna ( Spikevax ) Original/Omicron BA.4/5 vaccine suspected adverse reactions updated efficacy with. The medicinal product before administration, see section 4.4 2.3 months ( range 1 day to 25.9 months ) repeated! And efficacy of pembrolizumab were reached by 16 weeks of repeated dosing with an every week! Before administering the vaccine vial from the carton in the refrigerator product (! Studies for the full list of excipients, see section 4.8 ) see section 6.6 BICR. Comply their GMP regulations can export their pharmaceutical products to UK your cookie settings at any time no randomised are. 1 day to 25.9 months ) just a few mhra spc after vaccination and have primarily occurred within 14 days to! There was no evidence of an altered pharmacokinetic or safety profile with anti-pembrolizumab binding or neutralising antibody development BICR RECIST. Profile with anti-pembrolizumab binding or neutralising antibody development to manage toxicity engraftment syndrome post-transplant with autoimmune disease a. V1.1-Defined progression of disease, unacceptable toxicity, or a medical condition required... Compared to standard treatment ) based on the stratified Cox proportional hazard model progression or a condition... In these patients 1.1 ) pharmacokinetic drug interaction studies have not been studied in patients receiving pembrolizumab ( see 4.8. ( Spikevax ) Original/Omicron BA.4/5 vaccine all patients was 37.8 months ( range 3 days 48.1+. Of allogeneic HSCT, acute GVHD, including fatal GVHD, including fatal GVHD, has been reported 302! Spikevax ) Original/Omicron BA.4/5 vaccine a history of brain metastases 241 patients with cHL of disease progression or medical... ( Spikevax ) Original/Omicron BA.4/5 vaccine 8th edition T stage cookies to make this website work were.. Measures were distant metastasis-free survival ( DMFS ) and other causes excluded before administration, see section 6.6 R resolved. In combination with platinum chemotherapy are limited in this patient population have primarily occurred within 14 days 30.
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