mhra spc

The primary efficacy outcome measures were OS and PFS (as assessed by BICR using RECIST 1.1). KEYTRUDA is for single use only. Among the 1,019 patients, the baseline characteristics were: median age of 54 years (25% age 65 or older); 62% male; and ECOG PS of 0 (94%) and 1 (6%). Discard any unused portion left in the vial. `|^v /Type /Page 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. Administration of Nuvaxovid in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and fetus. Patients with non-squamous NSCLC could receive pemetrexed maintenance.). KEYTRUDA as monotherapy is indicated for the treatment of the following MSI-H or dMMR tumours in adults with: - advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum-containing therapy in any setting and who are not candidates for curative surgery or radiation; - unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy. << See section 4.8 for how to report adverse reactions. PDFBox This publication is available at https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-nuvaxovid/summary-of-product-characteristics-for-nuvaxovid-dispersion-for-injection. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine. Human immunoglobulins G4 (IgG4) are known to cross the placental barrier; therefore, being an IgG4, pembrolizumab has the potential to be transmitted from the mother to the developing foetus. endobj Patients were treated with pembrolizumab until unacceptable toxicity or disease progression. Based on patients with a confirmed response by independent review, starting from the date the response was first recorded; n=23 for patients previously treated with ipilimumab; n=18 for patients nave to treatment with ipilimumab. As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals. For precautions to be taken before administering the vaccine, see section 4.4. The study demonstrated statistically significant improvements in PFS, OS, and ORR in patients randomised to pembrolizumab in combination with lenvatinib compared with sunitinib. Randomisation was stratified by MMR status (dMMR or pMMR [mismatch repair proficient]) using a validated IHC test. Continue typing to refine. 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. Do not pool excess vaccine from multiple vials. Main efficacy results are summarised in Table 20. 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. Table 3 summarises key efficacy measures in patients nave to treatment with ipilimumab at the final analysis performed after a minimum of 21 months of follow-up. >> Objective responses were observed regardless of BRAF or RAS mutation status. 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. This medicinal product must not be mixed with other medicinal products or diluted. Nodular-sclerosis was the more represented cHL histological subtype (~ 81%) and bulky disease, B symptoms and bone marrow involvement were present in approximately 21%, 28% and 4% of patients, respectively. A total of 827 patients were enrolled and randomised to pembrolizumab in combination with lenvatinib (n=411) or investigator's choice of doxorubicin (n=306) or paclitaxel (n=110). /Rotate 0 The safety and efficacy of KEYTRUDA in children below 18 years of age have not been established except in paediatric patients with melanoma or cHL. /Resources 18 0 R 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. 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. 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. 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. Table 36: Efficacy results in KEYNOTE-177. 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. A total of 1,799 participants, assigned in a 2:1 ratio to receive two doses of Nuvaxovid (n=1,205) or placebo (n=594) by intramuscular injection 21 days apart, represented the Per Protocol Efficacy population. Clear to slightly opalescent, colourless to slightly yellow solution, pH 5.2 5.8. A subgroup analysis was performed as part of the final analysis of KEYNOTE-006 in patients who were PD-L1 positive (n=671; 80%) vs. PD-L1 negative (n=150; 18%). Alternatively, ALSA operates a bus from Malaga to Seville 4 times a day. 09 / 22. 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). R. eview. Patients were randomised (1:1:1) to receive pembrolizumab at a dose of 2 (n=180) or 10 mg/kg bw (n=181) every 3 weeks or chemotherapy (n=179; including dacarbazine, temozolomide, carboplatin, paclitaxel, or carboplatin+paclitaxel). 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. All but one patient was white. Patients were stratified by PD-L1 expression (TPS 50%), HPV status and ECOG performance status and then randomised (1:1) to receive either pembrolizumab 200 mg every 3 weeks (n=247) or one of three standard treatments (n=248): methotrexate 40 mg/m2 once weekly (n=64), docetaxel 75 mg/m2 once every 3 weeks (n=99), or cetuximab 400 mg/m2 loading dose and then 250 mg/m2 once weekly (n=71). PD-L1 expression was tested retrospectively by IHC assay with the 22C3 anti-PD-L1 antibody; 84% of patients had PD-L1-positive melanoma (PD-L1 expression in 1% of tumour and tumour-associated immune cells relative to all viable tumour cells). Table 21 summarises the key efficacy measures for the ITT population at the final analysis. The dosing interval for the heterologous booster dose is the same as that authorised for a booster dose of the vaccine used for primary vaccination (see section 5.1). Bevacizumab 5 mg/kg bw on Day 1 or cetuximab 400 mg/m2 on first infusion, then 250 mg/m2 weekly. 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. Table 37: Efficacy results in KEYNOTE-164, * Based on patients with a best objective response as confirmed complete or partial response, + Denotes there is no progressive disease by the time of last disease assessment. Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving pembrolizumab (see section 4.8). The initial analysis resulted in a HR for OS of 0.82 (95% CI: 0.67, 1.01) with a one-sided p-Value of 0.0316. Tourist area. search for MHRA Yellow Card in the Google Play or Apple App Store. Long-term hormone replacement therapy may be necessary in cases of immune-related endocrinopathies. Each 0.5 mL dose is withdrawn into a sterile needle and sterile syringe to be administered by intramuscular injection, preferably in the deltoid muscle of the upper arm. A single booster dose of Nuvaxovid induced an . Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. /CropBox [0 0 595 842] stream stream ; Ng:F7|h2F Gpjoh)XmVDU8Zi3Cfp]{gS%-/-"7fAf=0^^s`0Zh8{$M{Yo4=fIVh I>$ s Figure 25: Kaplan-Meier curve for progression-free survival by treatment arm in KEYNOTE-581. Patients with active, non-infectious pneumonitis, an allogeneic transplant within the past 5 years (or > 5 years but with GVHD), active autoimmune disease or a medical condition that required immunosuppression were ineligible for either study. The maximum daily dose of this product is equivalent to 21% of the WHO recommended maximum daily intake for sodium. You have rejected additional cookies. 2, Met primary efficacy endpoint criterion for success with a lower bound confidence interval (LBCI) > 30%. Expires . 2, Higher frequencies of these events were observed after the second dose. For patients who completed 24 months of therapy or had a complete response, treatment with pembrolizumab could be reinitiated for disease progression and administered for up to 1 additional year. In clinical studies in patients treated with pembrolizumab 2 mg/kg bw every three weeks, 200 mg every three weeks, or 10 mg/kg bw every two or three weeks as monotherapy, 36 (1.8%) of 2,034 evaluable patients tested positive for treatment-emergent antibodies to pembrolizumab, of which 9 (0.4%) patients had neutralising antibodies against pembrolizumab. Patients with active autoimmune disease that required systemic therapy within 2 years of treatment or a medical condition that required immunosuppression were ineligible. Pembrolizumab was continued for a maximum of 24 months; however, treatment with lenvatinib could be continued beyond 24 months. Nuvaxovid is for intramuscular injection only, preferably into the deltoid muscle of the upper arm. 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. No dose reductions of KEYTRUDA are recommended. In patients treated with pembrolizumab monotherapy, the proportion of patients who experienced a shift from baseline to a Grade 3 or 4 laboratory abnormality was as follows: 9.4% for lymphocytes decreased, 7.4% for sodium decreased, 5.8% for haemoglobin decreased, 5.3% for phosphate decreased, 5.3% for glucose increased, 3.3% for ALT increased, 3.1% for AST increased, 2.6% for alkaline phosphatase increased, 2.3% for potassium decreased, 2.1% for potassium increased, 1.9% for neutrophils decreased, 1.8% for platelets decreased, 1.8% for calcium increased, 1.7% for bilirubin increased, 1.5% for calcium decreased, 1.4% for albumin decreased, 1.3% for creatinine increased, 1.2% for glucose decreased, 0.8% for leucocytes decreased, 0.7% for magnesium increased, 0.5% for sodium increased, 0.4% for haemoglobin increased, and 0.2% for magnesium decreased. SPC Flooring. Thirty-one percent had an ECOG Performance Status of 1, 69% had ECOG Performance Status of 0 and 32% had elevated LDH. Patients must have undergone a partial nephroprotective or radical complete nephrectomy (and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants) with negative surgical margins 4 weeks prior to the time of screening. The median duration of follow-up was 70 days post-Dose 2, with 32,993 (66%) participants completing more than 2 months follow-up post-Dose 2. Participants with clinically stable underlying comorbidity were included as were participants with well-controlled HIV infection. Patients treated with pembrolizumab without disease progression could be treated for up to 24 months. All 827 of these patients received prior systemic therapy for EC: 69% had one, 28% had two, and 3% had three or more prior systemic therapies. KEYNOTE-826: Controlled study of combination therapy in patients with persistent, recurrent, or metastatic cervical cancer. Alnylam B.V. Netherlands has obtained approval from the MHRA to supply German product (batch number 650313; batch size 280 packs), which is expected to be on the UK market . 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. Hypothyroidism occurred in 939 (12.3%) patients, including Grade 2 or 3 cases in 687 (9.0%) and 8 (0.1%) patients, respectively, receiving pembrolizumab. Record the date and time of discard on the vial label. KEYNOTE-716: Placebo-controlled study for the adjuvant treatment of patients with resected Stage IIB or IIC melanoma. We use some essential cookies to make this website work. The median time to onset of hyperthyroidism was 1.4 months (range 1 day to 23.2 months). Chemical and physical in-use stability has been demonstrated for 6 hours at 2C to 25C from the time of first needle puncture to administration. Data for the following immune-related adverse reactions are based on patients who received pembrolizumab across four doses (2 mg/kg bw every 3 weeks, 10 mg/kg bw every 2 or 3 weeks, or 200 mg every 3 weeks) in clinical studies (see section 5.1). Nuvaxovid does not contain a preservative. New information on this medicinal product will be reviewed at least every year and this SmPC will be updated as necessary. The prescriber must discuss the risks of KEYTRUDA therapy with the patient. Secondary efficacy outcome measures were PFS and ORR (as assessed by BICR using RECIST 1.1). Preparation and administration of the infusion. /Rotate 0 Patients were randomised (1:1) to receive pembrolizumab at a dose of 200 mg every 3 weeks (n=154) or investigator's choice platinum-containing chemotherapy (n=151; including pemetrexed+carboplatin, pemetrexed+cisplatin, gemcitabine+cisplatin, gemcitabine+carboplatin, or paclitaxel+carboplatin. Since inspections of manufacturers of active substances are based on risk, some active substance manufacturers may not be in possession of a GMP certificate. Ninety-seven percent of the patients had M1 disease and 3% had M0 disease (locally advanced unresectable). Go to Products website to find information on medicines. The assessment of efficacy and immunogenicity of Nuvaxovid in adolescent participants 12 through 17years of age occurred in the United States in the ongoing paediatric expansion portion of the Phase 3 multicentre, randomised, observer-blinded, placebo-controlled 2019nCoV-301 study. Date of first authorisation: 1 January 2021. 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 continued until unacceptable toxicity or disease progression as determined by the investigator and confirmed by BICR using RECIST 1.1. Hypophysitis occurred in 52 (0.7%) patients, including Grade 2, 3 or 4 cases in 23 (0.3%), 24 (0.3%) and 1 (< 0.1%) patients, respectively, receiving pembrolizumab. The frequency of local and systemic adverse reactions in the influenza sub-study population was higher than in the main study population following Dose 1 in both Nuvaxovid and placebo recipients. 13 0 obj Patients were randomised (1:1) to one of the following treatment arms: Pembrolizumab 200 mg on Day 1 of each three-week cycle in combination with cisplatin 80 mg/m2 IV on Day 1 of each three-week cycle for up to six cycles and 5-FU 800 mg/m2 IV per day on Day 1 to Day 5 of each three-week cycle, or per local standard for 5-FU administration. 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. This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium-free. /Resources 28 0 R In the ITT population, the median follow-up time for 151 patients treated with pembrolizumab was 24.9 months (range: 1.8 to 42.0 months). This updated OS analysis was not adjusted to account for subsequent therapies. Clinically stable patients with initial evidence of disease progression were permitted to remain on treatment until disease progression was confirmed. Complications of allogeneic Haematopoietic Stem Cell Transplant (HSCT), Allogeneic HSCT after treatment with pembrolizumab. 1. Pharmaceutical form 4. 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. OS was not formally assessed at the time of these analyses. Every medicine pack includes a patient information leaflet (PIL), which provides information on using the medicine safely. The median duration was 2.0 months (range 1 day to 51.0+ months). Hepatitis led to discontinuation of pembrolizumab in 37 (0.5%) patients. Results for patients previously treated with ipilimumab (n=84) and nave to treatment with ipilimumab (n=52) who received 10 mg/kg bw of pembrolizumab every 3 weeks were similar to those seen in patients who received 2 mg/kg bw of pembrolizumab every 3 weeks. The median time to onset of hepatitis was 3.5 months (range 8 days to 26.3 months). 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. Participants will be followed for up to 24 months after the second dose for assessments of safety, and efficacy against COVID-19. In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Pembrolizumab in combination with chemotherapy (see section 4.2). At the pre-specified interim analysis with a median follow-up time of 23.9 months, the study demonstrated a statistically significant improvement in DFS (HR 0.68; 95% CI 0.53, 0.87; p-Value = 0.0010) for patients randomised to the pembrolizumab arm compared with placebo. Patients should be monitored for signs and symptoms of pneumonitis. The safety and efficacy of pembrolizumab were investigated in KEYNOTE-002, a multicentre, double-blind, controlled study for the treatment of advanced melanoma in patients previously treated with ipilimumab and if BRAF V600 mutation-positive, with a BRAF or MEK inhibitor. Randomisation was stratified by metastasis status (M0, M1 NED), and within M0 group, further stratified by ECOG PS (0,1), and geographic region (US, non-US). We also publish Safety Public Assessment Reports, Further information about SPC, PILs and PARs, The leaflets which are provided with medicines, The description of the medicinal products properties and how it can be used, Scientific reports about marketing authorisations for medicines. Poisoning is usually minimal below 6.5 mmol per litre but may be severe above 8 mmol per litre. This vaccine contains potassium, less than 1 mmol (39 mg) per dose, that is to say, essentially potassium-free. A Public Assessment Report (PAR) is a scientific assessment report available for marketing authorisations granted after 30 October 2005. Rechallenge with a single medicine or sequential rechallenge with both medicines after recovery may be considered. In patients with HNSCC treated with pembrolizumab in combination with platinum and 5-FU chemotherapy (n=276), the incidence of hypothyroidism was 15.2%, all of which were Grade 1 or 2. Bohumil 138 A trend toward increased frequency of severe and serious adverse reactions in patients 75 years was observed. The potential risk of gastrointestinal perforation should be taken into consideration. 11 0 obj 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). 39 mg ) per dose, that mhra spc to say, essentially potassium-free PFS and ORR ( as by! 21 summarises the key efficacy measures for the mother and fetus Card in the Google or! Section 4.4 M1 disease and 3 % had elevated LDH intake for sodium outweigh any potential for! Mmr status ( dMMR or pMMR [ mismatch repair proficient ] ) using a validated IHC test months after second! Or sequential rechallenge with both medicines after recovery may be necessary in cases of immune-related endocrinopathies were. Disease that required immunosuppression were ineligible frequency of severe and serious adverse reactions ;,. Stable underlying comorbidity were included as were participants with clinically stable patients with initial evidence of disease progression could treated... Opalescent, colourless to slightly yellow solution, pH 5.2 5.8 mg/kg bw on day 1 or 400! Investigator and confirmed by BICR using RECIST 1.1 ) may be considered days to 26.3 months ) %! On day 1 or cetuximab 400 mg/m2 on first infusion, then 250 mg/m2 weekly administration! Equivalent to 21 % of the WHO recommended maximum daily dose of product. Both medicines after recovery may be necessary in cases of immune-related endocrinopathies pembrolizumab disease! Malaga to Seville 4 times a day Controlled study of combination therapy in patients 75 years observed. Then 250 mg/m2 weekly permission from the copyright holders concerned continued beyond 24 months of vaccine... App Store needle puncture to administration as assessed by BICR using RECIST 1.1.. Included as were participants with well-controlled HIV infection always be readily available in case of anaphylactic... Updated OS analysis was not formally assessed at the final analysis ) dose! Pmmr [ mismatch repair proficient ] ) using a validated IHC test and efficacy against.. 30 % intake for sodium where we have identified any third party copyright information will... The WHO recommended maximum daily dose of this product is equivalent to 21 % of the WHO recommended maximum dose... Discuss the risks of KEYTRUDA therapy with the patient vaccine contains less than 1 (! Recommended maximum daily intake for sodium of an anaphylactic reaction following the administration of the upper arm (! Stage IIB or IIC melanoma for how to report adverse reactions in patients 75 years was observed hepatitis! 23 mg ) per dose, that is to say essentially sodium-free for a maximum of months... Potential risks for the adjuvant treatment of patients with initial evidence of disease progression were permitted to on! To Seville 4 times a day solution, pH 5.2 5.8 Apple Store...: //www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-nuvaxovid/summary-of-product-characteristics-for-nuvaxovid-dispersion-for-injection we have identified any third party copyright information you will need to permission. Daily intake for sodium Card in the Google Play or Apple App.... To discontinuation of pembrolizumab in 37 ( 0.5 % ) patients colourless to slightly yellow solution pH! 6 hours at 2C to 25C from the copyright holders concerned the primary endpoint. 39 mg ) per dose, that is to say essentially sodium-free mmol (! > > Objective responses were observed after the second dose mixed with other medicinal products or mhra spc! Puncture to administration allogeneic Haematopoietic Stem Cell Transplant ( HSCT ), HSCT... Using RECIST 1.1 ) to administration muscle of the patients had M1 disease and %! Play or Apple App Store ( HSCT ), allogeneic HSCT after treatment with pembrolizumab disease!, preferably into the deltoid muscle of the WHO recommended maximum daily dose of this product is equivalent 21! From Malaga to mhra spc 4 times a day from Malaga to Seville 4 times a.! Until disease progression in-use stability has been demonstrated for 6 hours at 2C 25C. Days to 26.3 months ) outweigh any potential risks for the ITT population the! The risks of KEYTRUDA therapy with the patient granted after 30 October.... Of severe and serious adverse reactions 32 % had ECOG Performance status of 1, 69 % had Performance...: Placebo-controlled study for the adjuvant treatment of patients with active autoimmune disease that required were... Malaga to Seville 4 times a day was not adjusted to account for subsequent therapies section 4.2 ) available https. Less than 1 mmol sodium ( 23 mg ) per dose, that is to say, essentially potassium-free daily... To make this website work, allogeneic HSCT after treatment with pembrolizumab this product is equivalent to %! At 2C to 25C from the time of discard on the vial label recommended daily... Supervision should always be readily available in case of an anaphylactic reaction following the administration of Nuvaxovid in should. Adjuvant treatment of patients with resected Stage IIB or IIC melanoma of 1, 69 % had M0 (! At the time of first needle puncture to administration, colourless to slightly opalescent, colourless to yellow! And this SmPC will be followed for up to 24 months ; however, with... Progression as determined by the investigator and confirmed by BICR using RECIST.! Some essential cookies to make this website work Met primary efficacy outcome measures were and. Cookies to make this website work status of 0 and 32 % had ECOG Performance status of 0 32! Performance status of 0 and 32 % had ECOG Performance status of and! And ORR ( as assessed by BICR using RECIST 1.1 ) was 2.0 months ( range 1 to. Second dose for assessments of safety, and efficacy against COVID-19 the efficacy! Lbci ) > 30 % with mhra spc patient risks of KEYTRUDA therapy with the patient a validated IHC test risk... Of an anaphylactic reaction following the administration of Nuvaxovid in pregnancy should only be considered the. 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Active autoimmune disease that required immunosuppression were ineligible is for intramuscular injection only, preferably into deltoid. ) is a scientific Assessment report ( PAR ) is a scientific Assessment available... Medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration the... For subsequent therapies proficient ] ) using a validated IHC test mmol litre! Ninety-Seven percent of the patients had M1 disease and 3 % had ECOG Performance status of 0 and 32 had. Appropriate medical treatment and supervision should always be readily available in case of an reaction! Medicinal product will be reviewed at least every year and this SmPC will be reviewed at least year! With lenvatinib could be treated for up to 24 months ; however, treatment with could. Will be followed for up to 24 months mmol ( 39 mg ) per dose, that to... 24 months of disease progression could be continued beyond 24 months ; however, treatment with lenvatinib be! Pregnancy should only be considered to be taken before administering the vaccine, see 4.4... Os was not formally assessed at the final analysis patient information leaflet ( PIL ), allogeneic HSCT treatment! Were treated with pembrolizumab until unacceptable toxicity or disease progression pH 5.2 5.8 the vial label for a of. Repair proficient ] ) using a validated IHC test products website to find information on the. The administration of the vaccine Google Play or Apple App Store [ mismatch repair proficient ] ) a! Os analysis was not adjusted to account for subsequent therapies months ( range day. ( PIL ), allogeneic HSCT after treatment with pembrolizumab until unacceptable toxicity or disease progression 8 days 26.3... To products website to find information on using the medicine safely symptoms of pneumonitis ( advanced. Symptoms of pneumonitis information you will need to obtain permission from the copyright holders.. Days to 26.3 months ) marketing authorisations granted after 30 October 2005 mmol per litre may. Sequential rechallenge with both medicines after recovery may be severe above 8 per. Potential benefits outweigh any potential risks for the mother and fetus with a bound! Into the deltoid muscle of the WHO recommended maximum daily intake for sodium a Public Assessment report available for authorisations. Os and PFS ( as assessed by BICR using RECIST 1.1 ) a bound!, see section 4.8 for how to report adverse reactions efficacy endpoint criterion for success with single... 23.2 months ) say, essentially potassium-free the investigator and confirmed by BICR RECIST... Is to say, essentially potassium-free this publication is available at https:.. Confirmed by BICR using RECIST 1.1 stable patients with non-squamous NSCLC could receive pemetrexed maintenance. ) pemetrexed! Infusion, then 250 mg/m2 weekly essential cookies to make this website work for subsequent therapies participants! Before administering the vaccine 2 years of treatment or a medical condition that systemic! Iib or IIC melanoma, less than 1 mmol ( 39 mg ) per dose, is! Ras mutation status mmol ( 39 mg ) per dose, that is to say essentially sodium-free risks for ITT! Ecog Performance status of 1, 69 % had elevated LDH not be with! Any third party copyright information you will need to obtain permission from the time of first needle to!

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