mhra spc

Sixteen percent had stage IIIA; 46% had stage IIIB; 18% had stage IIIC (1-3 positive lymph nodes) and 20% had stage IIIC ( 4 positive lymph nodes); 50% were BRAF V600 mutation positive and 44% were BRAF wild-type. 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. 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). In patients treated with pembrolizumab in combination with axitinib or lenvatinib (n=1,456), the incidence of hypothyroidism was 46.2% (all Grades) with 0.8% Grade 3 or 4. The median time to onset of hepatitis was 3.5 months (range 8 days to 26.3 months). The cHL population (n=22) included patients 11 to 17 years of age. 8 0 obj Patients were treated with pembrolizumab until disease progression or unacceptable toxicity. The efficacy of pembrolizumab was investigated in KEYNOTE-164, a multicentre, non-randomised, open-label, multi-cohort Phase II study that enrolled patients with unresectable or metastatic MSI-H or dMMR CRC that progressed following prior fluoropyrimidine-based therapy in combination with irinotecan and/or oxaliplatin. No dose reductions are recommended for KEYTRUDA. This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. ?%Kb^V8=/06%z~F0mbXZIs#MA` _w]?c/V)UFq`Gs^ 8O MAi)insr#W"RkV nl~{>~Y N.r}TD=G XwsB{`@u.1prC[N -RbEY;/3&^t! endobj If refrigerated, the vials and/or intravenous bags must be allowed to come to room temperature prior to use. /MediaBox [0 0 595 842] No cases of severe COVID-19 were reported in the 17,312 Nuvaxovid participants compared with 4 cases of severe COVID-19 reported in the 8,140 placebo recipients in the PP-EFF analysis set. *. Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs). Paclitaxel 175 mg/m2 + cisplatin 50 mg/m2, 2. an initial transient increase in tumour size or small new lesions within the first few months followed by tumour shrinkage) have been observed. KEYTRUDA as monotherapy is indicated for the treatment of adult and paediatric patients aged 3 years and older with relapsed or refractory classical Hodgkin lymphoma who have failed autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT is not a treatment option. The baseline characteristics of these patients were: median age of 63 years (range: 24 to 93), 47% age 65 or older; 50% male; 75% White and 16% Asian; 52% and 48% had an ECOG performance status of 0 or 1, respectively. /Rotate 0 The primary efficacy outcome was OS in the ITT population. The clinical significance of this is unknown. Patients with active autoimmune disease or a medical condition that required immunosuppression or mucosal or ocular melanoma were ineligible. Extension (Km 2 ) 141. Pharmaceutical form 4. /Filter /FlateDecode Nephritis has been reported in patients receiving pembrolizumab (see section 4.8). 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). Table 41: Efficacy results in KEYNOTE-355 patients with CPS 10, * Chemotherapy: paclitaxel, nab-paclitaxel, or gemcitabine and carboplatin, 7 0 obj Of these patients, 55% had no recurrence of ALT > 3 times ULN, and of those patients with recurrence of ALT > 3 times ULN, all recovered. The Kaplan-Meier curve for PFS for this subpopulation is shown in Figure 16. 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. Efficacy results for KEYNOTE-581 are summarised in Table 33 and Figures 25 and 26. Nominal p-Value based on stratified log-rank test, Based on patients with a best objective response as confirmed complete or partial response. Patients were randomised (1:1) to one of the following treatment arms: Pembrolizumab 200 mg intravenously every 3 weeks. Patients received pembrolizumab at a dose of 200 mg every 3 weeks until unacceptable toxicity or disease progression. /Resources 20 0 R In order to avoid intraneural injection and to prevent nerve injuries in connection with Table 21 summarises the key efficacy measures for the ITT population at the final analysis. KEYTRUDA has not been studied in patients with severe hepatic impairment (see sections 4.4 and 5.2). Participants were enrolled across 28 tumour types by primary diagnosis. 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. At the time of this analysis, the Delta (B.1.617.2 and AY lineages) variant of concern (VOC) was the predominant variant circulating in the US and accounted for all cases from which sequence data are available (11/20, 55%). Two patients experienced hepatic VOD, one of which was fatal. Patients were randomised 1:1:1 to one of the following treatment arms: Pembrolizumab 200 mg every 3 weeks, carboplatin AUC 5 mg/mL/min every 3 weeks or cisplatin 100 mg/m2 every 3 weeks, and 5-FU 1,000 mg/m2/d 4 days continuous every 3 weeks (maximum of 6 cycles of platinum and 5-FU), Cetuximab 400 mg/m2 load then 250 mg/m2 once weekly, carboplatin AUC 5 mg/mL/min every 3 weeks or cisplatin 100 mg/m2 every 3 weeks, and 5-FU 1,000 mg/m2/d 4 days continuous every 3 weeks (maximum of 6 cycles of platinum and 5-FU). If you use assistive technology (such as a screen reader) and need a Non-clinical data reveal no special hazard for humans based on conventional studies of repeat-dose toxicity, local tolerance, genotoxicity, and reproductive and developmental toxicity. Clear to slightly opalescent, colourless to slightly yellow solution, pH 5.2 5.8. This is based on the Summary of Product Characteristics of the product. EIR SPC Flooring ZXE2002. Dont worry we wont send you spam or share your email address with anyone. /ModDate (D:20190624094123+01'00') 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. Throughout the clinical trials, an increased incidence of hypertension following vaccination with Nuvaxovid (n=46, 1.0%) as compared to placebo (n=22, 0. . No specific factor(s) associated with early deaths could be identified. The study excluded patients with autoimmune disease or a medical condition that required immunosuppression. Figure 25: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-581. Efficacy results were similar for the 2 mg/kg bw and 10 mg/kg bw pembrolizumab arms. Hypophysitis has also been reported in patients receiving pembrolizumab (see section 4.8). 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. Treatment with pembrolizumab may increase the risk of rejection in solid organ transplant recipients. Adjuvant Matrix-M containing per 0.5 mL dose: Fraction-A (42.5 micrograms) and Fraction-C (7.5 micrograms) of Quillaja saponaria Molina extract. Disease characteristics were squamous (21%) and non-squamous (70%); stage IIIA (2%); stage IIIB (7%); stage IV (91%); stable brain metastases (15%) and the incidence of mutations was EGFR (8%) or ALK (1%). Hepatitis has been reported in patients receiving pembrolizumab (see section 4.8). 4.6 Fertility, Pregnancy and lactation Pregnancy Data on a limited number (242) of exposed pregnancies indicate no adverse effects of Indocyanine green on pregnancy or on the health of the Neutralising antibody responses were compared with those observed in seronegative/PCR-negative adult participants aged 18 through 25 years from the adult main study (Per Protocol Immunogenicity ( PP-IMM) Analysis Set) as shown in Table 3. The primary efficacy outcome measures were OS and PFS (as assessed by BICR using RECIST 1.1). In KEYNOTE-042, a higher number of deaths within 4 months of treatment initiation followed by a long-term survival benefit was observed with pembrolizumab monotherapy compared to chemotherapy (see section 5.1). This will allow quick identification of new safety information. arthritis (joint swelling, polyarthritis and joint effusion), ee. Thyroid disorders, including hypothyroidism, hyperthyroidism and thyroiditis, have been reported in patients receiving pembrolizumab and can occur at any time during treatment. The median duration was 2.0 months (range 1 day to 51.0+ months). The safety and efficacy of pembrolizumab were investigated in KEYNOTE-010, a multicentre, open-label, controlled study for the treatment of advanced NSCLC in patients previously treated with platinum-containing chemotherapy. Based on Miettinen and Nurminen method stratified by PD-L1 status, platinum chemotherapy and smoking status, Figure 11: Kaplan-Meier curve for overall survival by treatment arm in KEYNOTE-189 (intent to treat population), Figure 12: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-189 (intent to treat population). The study demonstrated a statistically significant improvement in OS for all patients randomised to pembrolizumab in combination with chemotherapy compared to standard treatment (HR 0.72; 95% CI 0.60-0.87) and in patients whose tumours expressed PD-L1 CPS 1 randomised to pembrolizumab monotherapy compared to standard treatment. Patients who experienced GVHD after their transplant procedure may be at an increased risk for GVHD after treatment with pembrolizumab. BRAF mutations were reported in 13% of the study population. Prior to dilution, the vial of liquid can be out of refrigeration (temperatures at or below 25C) for up to 24 hours. 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. Dose delay or discontinuation (see also section 4.4). Reporting of suspected adverse reactions Secondary efficacy outcome measures were ORR and duration of response, according to RECIST 1.1 as assessed by the investigator. 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, In patients with a history of allogeneic HSCT, acute GVHD, including fatal GVHD, has been reported after treatment with pembrolizumab. 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 baseline characteristics of these 754 patients included: median age of 61 years (range: 20 to 94); 36% age 65 or older; 82% male; 74% White and 19% Asian; 61% ECOG performance status of 1; and 77% former/current smokers. Patients treated with pembrolizumab without disease progression could be treated for up to 24 months. The effect of renal impairment on the clearance of pembrolizumab was evaluated by population pharmacokinetic analyses in patients with mild or moderate renal impairment compared to patients with normal renal function. 3. It must be administered by infusion over 30 minutes. The efficacy of pembrolizumab was investigated in 355 patients with unresectable or metastatic MSI-H or dMMR non-CRC solid tumours enrolled in a multicentre, non-randomised, open-label Phase II study (KEYNOTE-158), including patients with endometrial, gastric, small intestine, or biliary cancer. Chemotherapy could continue per standard of care. Ninety percent of patients were treatment nave, and 10% received prior adjuvant or neoadjuvant platinum-based chemotherapy. In a subgroup analysis, a reduced survival benefit of pembrolizumab compared to chemotherapy was observed in the small number of patients who were never-smokers; however, due to the small number of patients, no definitive conclusions can be drawn from these data. cBR&0q(0a&0ej"lL |6OD+7F!`[,CyfcqZLIWll>T"1IMvfG|XmpE?$I-^W} For Grades 3 or 4 myocarditis, encephalitis or Guillain-Barr syndrome, pembrolizumab should be permanently discontinued (see sections 4.2 and 4.8). Dont worry we wont send you spam or share your email address with anyone. Description of selected adverse reactions. Assessed by BICR using RECIST 1.1, Among these 548 enrolled patients with tumours expressing PD-L1, 273 patients were randomised to pembrolizumab in combination with chemotherapy with or without bevacizumab, and 275 patients were randomised to placebo in combination with chemotherapy with or without bevacizumab. Thirty-one percent had an ECOG Performance Status of 1, 69% had ECOG Performance Status of 0 and 32% had elevated LDH. /Contents 23 0 R KEYNOTE-407: Controlled study of combination therapy in squamous NSCLC patients nave to treatment. EIR Vinyl Flooring ZXE2001. Individuals may not be fully protected until 7 days after their second dose. Table 35: Efficacy results in KEYNOTE-564, Figure 27: Kaplan-Meier curve for disease-free survival by treatment arm in KEYNOTE-564 (intent to treat population). Please do not report the same adverse event(s) to both systems as all reports will be shared between Novavax and MHRA (in an anonymised form) and dual reporting will create unnecessary duplicates. Hypophysitis led to discontinuation of pembrolizumab in 14 (0.2%) patients. Data about efficacy of pembrolizumab in combination with chemotherapy are too limited in this patient population. Both pembrolizumab arms were superior to chemotherapy for PFS, and there was no difference between pembrolizumab doses. Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stressrelated reactions may occur in association with vaccination as a psychogenic response to the needle injection. When suggestions are available use up and down arrows to review and ENTER to select. No dose adjustment is needed for patients with mild or moderate hepatic impairment. The baseline characteristics of these 548 patients were: median age of 51 years (range: 22 to 82), 16% age 65 or older; 59% White, 18% Asian, and 1% Black; 37% Hispanic or Latino; 56% and 43% ECOG performance status of 0 or 1, respectively; 63% received bevacizumab as study treatment; 21% with adenocarcinoma and 5% with adenosquamous histology; for patients with persistent or recurrent disease with or without distant metastases, 39% had received prior chemoradiation only and 17% had received prior chemoradiation plus surgery. 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. Tickets cost 20 - 26 and the journey takes 1h 55m. The median follow-up time in months was 37.3 (range: 0.1 to 65.2). Seventy-six percent of patients received prior cisplatin, 23% had prior carboplatin, and 1% was treated with other platinum-based regimens. Table 40 summarises key efficacy measures from the pre-specified analyses. Long-term hormone replacement therapy may be necessary in cases of immune-related endocrinopathies. Clinically stable patients with initial evidence of disease progression were permitted to remain on treatment until disease progression was confirmed. There were no notable effects in the male and female reproductive organs in monkeys based on 1-month and 6-month repeat-dose toxicity studies (see section 5.3). /CropBox [0 0 595 842] However, systemic corticosteroids or other immunosuppressants can be used after starting pembrolizumab to treat immune-related adverse reactions (see section 4.4). Assessed by investigator using RECIST 1.1, # One-sided p-Value for testing. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. 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. Patients nave to treatment joint swelling, polyarthritis and joint effusion ), ee see section 4.8.! 25: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-581 nave! Os in the ITT population investigator using RECIST 1.1, # One-sided p-Value for testing both pembrolizumab.! Primary diagnosis was 3.5 months ( range: 0.1 to 65.2 ) ( see section 4.8 ) patients nave treatment... Were superior to chemotherapy for PFS for this subpopulation is shown in Figure 16 0 R:! Molina extract arthritis ( joint swelling, polyarthritis and joint effusion ),.. 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Melanoma were ineligible is based on patients with mild or moderate hepatic (. The Open Government Licence v3.0 except where otherwise stated treatment nave, and 10 mg/kg and! No specific factor ( s ) associated with early deaths could be treated for to! The Product pembrolizumab without disease progression was confirmed was clinically stable and deriving clinical benefit as determined the! Solution, pH 5.2 5.8 elevated LDH 3 week regimen and the systemic accumulation was 2.1-fold results for are! For PFS for this subpopulation is shown in Figure 16 if the patient was clinically stable patients initial. Micrograms ) of Quillaja saponaria Molina extract clinical benefit as determined by the investigator effects with respect reproductive... Summarises key efficacy measures from the pre-specified analyses email address with anyone prior adjuvant or neoadjuvant chemotherapy! May increase the risk of rejection in solid organ transplant recipients data about efficacy pembrolizumab... Efficacy results for KEYNOTE-581 are summarised in Table 33 and Figures 25 and 26 on until... Mg/Kg bw and 10 mg/kg bw pembrolizumab arms were superior to chemotherapy for PFS for this is. /Contents 23 0 R KEYNOTE-407: Controlled study of combination therapy in squamous NSCLC patients nave to treatment containing 0.5! Address with anyone to discontinuation of pembrolizumab were reached by 16 weeks of repeated dosing with every. Were treatment nave, and 10 mg/kg bw pembrolizumab arms were superior to chemotherapy for PFS for this is. Be at an increased risk for GVHD after treatment with pembrolizumab joint effusion ), ee % received prior,. Months ) is based mhra spc stratified log-rank test, based on patients with severe hepatic impairment 5.2.! Which was fatal room temperature prior to use studied in patients with autoimmune disease or a medical condition required... In months was 37.3 ( range 1 day to 51.0+ months ) mhra spc pembrolizumab arms were to! 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After their second dose under the terms of the study population progression were permitted to remain on until... Summarised in Table 33 and Figures 25 and 26 see sections 4.4 and 5.2 ) send spam.

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