Prescription Drug Information: Jevtana (Page 2 of 6)

5.2 Increased Toxicities in Elderly Patients

In a randomized trial (TROPIC), 2% of patients (3/131) <65 years of age and 6% (15/240) ≥65 years of age died of causes other than disease progression within 30 days of the last JEVTANA dose. Patients ≥65 years of age are more likely to experience certain adverse reactions, including neutropenia and febrile neutropenia. The incidence of the following grade 3–4 adverse reactions was higher in patients ≥65 years of age compared to younger patients; neutropenia (87% vs 74%), and febrile neutropenia (8% vs 6%).

In a randomized clinical trial (PROSELICA) comparing two doses of JEVTANA, deaths due to infection within 30 days of starting JEVTANA occurred in 0.7% (4/580) patients on the 20 mg/m2 arm and 1.3% (8/595) patients on the 25 mg/m2 arm; all of these patients were >60 years of age.

In PROSELICA, on the 20 mg/m2 arm, 3% (5/178) of patients <65 years of age and 2% (9/402) ≥65 years of age died of causes other than disease progression within 30 days of the last JEVTANA dose. On the 25 mg/m2 arm, 2% (3/175) patients <65 years of age and 5% (20/420) ≥65 years of age died of causes other than disease progression within 30 days of the last JEVTANA dose [see Adverse Reactions (6) and Use in Specific Populations (8.5)].

In CARD, a death due to infection within 30 days of starting JEVTANA occurred in 0.8% (1/126) patient who was >75 years of age. There were 2.4% (3/126) of patients who died of causes other than disease progression within 30 days of the last JEVTANA dose; all of these patients were >75 years of age.

5.3 Hypersensitivity Reactions

Hypersensitivity reactions may occur within a few minutes following the initiation of the infusion of JEVTANA, thus facilities and equipment for the treatment of hypotension and bronchospasm should be available. Severe hypersensitivity reactions can occur and may include generalized rash/erythema, hypotension and bronchospasm.

Premedicate all patients prior to the initiation of the infusion of JEVTANA [see Dosage and Administration (2.1)]. Observe patients closely for hypersensitivity reactions, especially during the first and second infusions. Severe hypersensitivity reactions require immediate discontinuation of the JEVTANA infusion and appropriate therapy. JEVTANA is contraindicated in patients with a history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80 [see Contraindications (4)].

5.4 Gastrointestinal Adverse Reactions

Nausea, vomiting and severe diarrhea, at times, may occur. Deaths related to diarrhea and electrolyte imbalance occurred in the randomized clinical trials. Intensive measures may be required for severe diarrhea and electrolyte imbalance. Antiemetic prophylaxis is recommended. Treat patients with rehydration, antidiarrheal or antiemetic medications as needed. Treatment delay or dosage reduction may be necessary if patients experience Grade ≥3 diarrhea [see Dosage and Administration (2.2)].

Gastrointestinal (GI) hemorrhage and perforation, ileus, enterocolitis, neutropenic enterocolitis, including fatal outcome, have been reported in patients treated with JEVTANA [see Adverse Reactions (6.2)]. Risk may be increased with neutropenia, age, steroid use, concomitant use of NSAIDs, antiplatelet therapy or anticoagulants, and patients with a prior history of pelvic radiotherapy, adhesions, ulceration and GI bleeding.

Abdominal pain and tenderness, fever, persistent constipation, diarrhea, with or without neutropenia, may be early manifestations of serious gastrointestinal toxicity and should be evaluated and treated promptly. JEVTANA treatment delay or discontinuation may be necessary.

The incidence of gastrointestinal adverse reactions is greater in the patients who have received prior radiation. In PROSELICA, diarrhea was reported in 41% (297/732) of patients who had received prior radiation and in 27% (118/443) of patients without prior radiation. Of the patients who had previously received radiation, more patients on the 25 mg/m2 arm reported diarrhea, compared to patients on the 20 mg/m2 arm.

5.5 Renal Failure

In the randomized clinical trial (TROPIC), renal failure of any grade occurred in 4% of the patients being treated with JEVTANA, including four cases with fatal outcome. Most cases occurred in association with sepsis, dehydration, or obstructive uropathy [see Adverse Reactions (6.1)]. Some deaths due to renal failure did not have a clear etiology. Appropriate measures should be taken to identify causes of renal failure and treat aggressively.

5.6 Urinary Disorders Including Cystitis

Cystitis, radiation cystitis, and hematuria, including that requiring hospitalization, has been reported with JEVTANA in patients who previously received pelvic radiation [see Adverse Reactions (6.2)]. In PROSELICA, cystitis and radiation cystitis were reported in 1.2% and 1.5% of patients who received prior radiation, respectively. Hematuria was reported in 19.4% of patients who received prior radiation and in 14.4% of patients who did not receive prior radiation. Cystitis from radiation recall may occur late in treatment with JEVTANA. Monitor patients who previously received pelvic radiation for signs and symptoms of cystitis while on JEVTANA. Interrupt or discontinue JEVTANA in patients experiencing severe hemorrhagic cystitis. Medical and/or surgical supportive treatment may be required to treat severe hemorrhagic cystitis.

5.7 Respiratory Disorders

Interstitial pneumonia/pneumonitis, interstitial lung disease and acute respiratory distress syndrome have been reported and may be associated with fatal outcome [see Adverse Reactions (6.2)]. Patients with underlying lung disease may be at higher risk for these events. Acute respiratory distress syndrome may occur in the setting of infection.

Interrupt JEVTANA if new or worsening pulmonary symptoms develop. Closely monitor, promptly investigate, and appropriately treat patients receiving JEVTANA. Consider discontinuation. The benefit of resuming JEVTANA treatment must be carefully evaluated.

5.8 Use in Patients with Hepatic Impairment

Cabazitaxel is extensively metabolized in the liver.

JEVTANA is contraindicated in patients with severe hepatic impairment (total bilirubin >3 × ULN) [see Contraindications (4)]. Dose should be reduced for patients with mild (total bilirubin >1 to ≤1.5 × ULN or AST >1.5 × ULN) and moderate (total bilirubin >1.5 to ≤3.0 × ULN and any AST) hepatic impairment, based on tolerability data in these patients [see Dosage and Administration (2.3) and Use in Specific Populations (8.7)]. Administration of JEVTANA to patients with mild and moderate hepatic impairment should be undertaken with caution and close monitoring of safety.

5.9 Embryo-Fetal Toxicity

Based on findings in animal reproduction studies and its mechanism of action, JEVTANA can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)]. There are no available data in pregnant women to inform the drug-associated risk. In animal reproduction studies, intravenous administration of cabazitaxel in pregnant rats during organogenesis caused embryonic and fetal death at doses lower than the maximum recommended human dose (approximately 0.06 times the Cmax in patients at the recommended human dose). Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of JEVTANA [see Use in Specific Populations (8.1, 8.3)].

6 ADVERSE REACTIONS

The following serious adverse reactions are discussed in greater detail in another section of the label:

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other trials and may not reflect the rates observed in clinical practice.

TROPIC Trial (JEVTANA 25 mg/m2 compared to mitoxantrone)

The safety of JEVTANA in combination with prednisone was evaluated in 371 patients with metastatic castration-resistant prostate cancer treated in the randomized TROPIC trial, compared to mitoxantrone plus prednisone.

Deaths due to causes other than disease progression within 30 days of last study drug dose were reported in 18 (5%) JEVTANA-treated patients and 3 (<1%) mitoxantrone-treated patients. The most common fatal adverse reactions in JEVTANA-treated patients were infections (n=5) and renal failure (n=4). The majority (4 of 5 patients) of fatal infection-related adverse reactions occurred after a single dose of JEVTANA. Other fatal adverse reactions in JEVTANA-treated patients included ventricular fibrillation, cerebral hemorrhage, and dyspnea.

The most common (≥10%) grade 1–4 adverse reactions were anemia, leukopenia, neutropenia, thrombocytopenia, diarrhea, fatigue, nausea, vomiting, constipation, asthenia, abdominal pain, hematuria, back pain, anorexia, peripheral neuropathy, pyrexia, dyspnea, dysgeusia, cough, arthralgia, and alopecia.

The most common (≥5%) grade 3–4 adverse reactions in patients who received JEVTANA were neutropenia, leukopenia, anemia, febrile neutropenia, diarrhea, fatigue, and asthenia.

Treatment discontinuations due to adverse reactions occurred in 18% of patients who received JEVTANA and 8% of patients who received mitoxantrone. The most common adverse reactions leading to treatment discontinuation in the JEVTANA group were neutropenia and renal failure. Dose reductions were reported in 12% of JEVTANA-treated patients and 4% of mitoxantrone-treated patients. Dose delays were reported in 28% of JEVTANA-treated patients and 15% of mitoxantrone-treated patients.

Table 2: Adverse Reactions * and Hematologic Abnormalities in ≥5% of Patients in TROPIC
Adverse Reactions JEVTANA 25 mg/m2 every 3 weeks with prednisone 10 mg dailyn=371 Mitoxantrone 12 mg/m2 every 3 weeks with prednisone 10 mg dailyn=371
Grade 1–4 % Grade 3–4 % Grade 1–4 % Grade 3–4 %
*
Graded using NCI CTCAE version 3.
Based on laboratory values, JEVTANA: n=369, mitoxantrone: n=370.
Includes abdominal discomfort, abdominal pain lower, abdominal pain upper, abdominal tenderness, and GI pain.
§
Includes gastroesophageal reflux disease and reflux gastritis.
Includes peripheral motor neuropathy and peripheral sensory neuropathy.
#
Includes urinary tract infection enterococcal and urinary tract infection fungal.
Þ
Includes atrial fibrillation, atrial flutter, atrial tachycardia, atrioventricular block complete, bradycardia, palpitations, supraventricular tachycardia, tachyarrhythmia, and tachycardia.
Blood and Lymphatic System Disorders
Anemia 98 11 82 5
Leukopenia 96 69 93 42
Neutropenia 94 82 87 58
Thrombocytopenia 48 4 43 2
Febrile Neutropenia 7 7 1 1
Gastrointestinal Disorders
Diarrhea 47 6 11 <1
Nausea 34 2 23 <1
Vomiting 22 2 10 0
Constipation 20 1 15 <1
Abdominal Pain 17 2 6 0
Dyspepsia § 10 0 2 0
General Disorders and Administration Site Conditions
Fatigue 37 5 27 3
Asthenia 20 5 12 2
Pyrexia 12 1 6 <1
Peripheral Edema 9 <1 9 <1
Mucosal Inflammation 6 <1 3 <1
Pain 5 1 5 2
Renal and Urinary Tract Disorders
Hematuria 17 2 4 <1
Dysuria 7 0 1 0
Musculoskeletal and Connective Tissue Disorders
Back Pain 16 4 12 3
Arthralgia 11 1 8 1
Muscle Spasms 7 0 3 0
Metabolism and Nutrition Disorders
Anorexia 16 <1 11 <1
Dehydration 5 2 3 <1
Nervous System Disorders
Peripheral Neuropathy 13 <1 3 <1
Dysgeusia 11 0 4 0
Dizziness 8 0 6 <1
Headache 8 0 5 0
Respiratory, Thoracic and Mediastinal Disorders
Dyspnea 12 1 4 <1
Cough 11 0 6 0
Skin and Subcutaneous Tissue Disorders
Alopecia 10 0 5 0
Investigations
Weight Decreased 9 0 8 <1
Infections and Infestations
Urinary Tract Infection # 8 2 3 1
Cardiac Disorders
Arrhythmia Þ 5 1 2 <1
Vascular Disorders
Hypotension 5 <1 2 <1

PROSELICA Trial (comparison of two doses of JEVTANA)

In a noninferiority, multicenter, randomized, open-label study (PROSELICA), 1175 patients with metastatic castration-resistant prostate cancer, previously treated with a docetaxel-containing regimen, were treated with either JEVTANA 25 mg/m2 (n=595) or the 20 mg/m2 (n=580) dose.

Deaths within 30 days of last study drug dose were reported in 22 (3.8%) patients in the 20 mg/m2 and 32 (5.4%) patients in the 25 mg/m2 arm. The most common fatal adverse reactions in JEVTANA-treated patients were related to infections, and these occurred more commonly on the 25 mg/m2 arm (n=15) than on the 20 mg/m2 arm (n=8). Other fatal adverse reactions in JEVTANA-treated patients included cerebral hemorrhage, respiratory failure, paralytic ileus, diarrhea, acute pulmonary edema, disseminated intravascular coagulation, renal failure, sudden death, cardiac arrest, ischemic stroke, diverticular perforation, and cardiorenal syndrome.

Grade 1–4 adverse reactions occurring ≥5% more commonly in patients on the 25 mg/m2 versus 20 mg/m2 arms were leukopenia, neutropenia, thrombocytopenia, febrile neutropenia, decreased appetite, nausea, diarrhea, asthenia, and hematuria.

Grade 3–4 adverse reactions occurring ≥5% more commonly in patients on the 25 mg/m2 versus 20 mg/m2 arms were leukopenia, neutropenia, and febrile neutropenia.

Treatment discontinuations due to adverse reactions occurred in 17% of patients in the 20 mg/m2 group and 20% of patients in the 25 mg/m2 group. The most common adverse reactions leading to treatment discontinuation were fatigue and hematuria. The patients in the 20 mg/m2 group received a median of 6 cycles (median duration of 18 weeks), while patients in the 25 mg/m2 group received a median of 7 cycles (median duration of 21 weeks). In the 25 mg/m2 group, 128 patients (22%) had a dose reduced from 25 to 20 mg/m2 , 19 patients (3%) had a dose reduced from 20 to 15 mg/m2 and 1 patient (0.2%) had a dose reduced from 15 to 12 mg/m2. In the 20 mg/m2 group, 58 patients (10%) had a dose reduced from 20 to 15 mg/m2 , and 9 patients (2%) had a dose reduced from 15 to 12 mg/m2.

Table 3: Adverse Reactions * and Hematologic Abnormalities in ≥5% of Patients in PROSELICA
Adverse Reactions JEVTANA 20 mg/m2 every 3 weeks with prednisone 10 mg dailyn=580 JEVTANA 25 mg/m2 every 3 weeks with prednisone 10 mg dailyn=595
Grade 1–4 % Grade 3–4 % Grade 1–4 % Grade 3–4 %
*
Grade from NCI CTCAE version 4.03.
Based on laboratory values, JEVTANA 20 mg/m2: n=577, JEVTANA 25 mg/m2: n=590.
Includes urinary tract infection staphylococcal, urinary tract infection bacterial, urinary tract infection fungal, and urosepsis.
§
Includes neutropenic sepsis.
Blood and Lymphatic System Disorders
Anemia 99.8 10 99.7 14
Leukopenia 80 29 95 60
Neutropenia 67 42 89 73
Thrombocytopenia 35 3 43 4
Febrile Neutropenia 2 2 9 9
Gastrointestinal Disorders
Diarrhea 31 1 40 4
Nausea 25 0.7 32 1
Constipation 18 0.3 18 0.7
Vomiting 15 1.2 18 1
Abdominal pain 6 0.5 9 1
Stomatitis 5 0 5 0.3
General Disorders and Administration Site Conditions
Fatigue 25 3 27 4
Asthenia 15 2 20 2
Edema peripheral 7 0.2 9 0.2
Pyrexia 5 0.2 6 0.2
Renal and Urinary Disorders
Hematuria 14 2 21 4
Dysuria 5 0.3 4 0
Metabolism and Nutrition Disorders
Decreased appetite 13 0.7 19 1
Musculoskeletal and Connective Tissue Disorders
Back pain 11 0.9 14 1
Bone pain 8 2 8 2
Arthralgia 8 0.5 7 0.8
Pain in extremity 5 0.2 7 0.5
Nervous System Disorders
Dysgeusia 7 0 11 0
Peripheral sensory neuropathy 7 0 11 0.7
Dizziness 4 0 5 0
Headache 5 0.2 4 0.2
Infections and Infestations
Urinary tract infection 7 2 11 2
Neutropenic infection § 3 2 7 6
Respiratory, Thoracic and Mediastinal Disorders
Dyspnea 5 0.9 8 0.7
Cough 6 0 6 0
Investigations
Weight decreased 4 0.2 7 0
Skin and Subcutaneous Tissue Disorders
Alopecia 3 0 6.1 0
Injury, Poisoning and Procedural Complications
Wrong technique in drug usage process 0.3 0 5 0

CARD Trial (JEVTANA 25 mg/m2 + primary prophylaxis with G-CSF)

The safety of JEVTANA 25 mg/m2 in combination with prednisone/prednisolone and primary prophylaxis G-CSF was evaluated in a randomized, open-label study (CARD) in patients with metastatic castration-resistant prostate cancer who progressed after receiving prior docetaxel-containing regimens and abiraterone acetate or enzalutamide [see Clinical Studies 14.3]. This study compared JEVTANA 25 mg/m2 in combination with prednisone/prednisolone and primary prophylaxis with G-CSF to either abiraterone acetate 1000 mg once daily plus prednisone/prednisolone 5 mg twice daily or enzalutamide 160 mg once daily. Among patients receiving JEVTANA, 35% remained on treatment at 6 months and 4.7% remained on treatment at 12 months.

Serious adverse reactions occurred in 39% of patients receiving JEVTANA. Serious adverse reactions in ≥3% of patients included neutropenia (6%), infections (4.8%), and diarrhea, fatigue, pneumonia, and spinal cord compression (3.2% each). Deaths due to causes other than disease progression were reported in 2.4% of JEVTANA treated patients. Fatal adverse reactions in JEVTANA-treated patients were septic shock, urinary tract infection (UTI), and aspiration (0.8% each).

Treatment discontinuations due to adverse drug reactions occurred in 20% of patients who received JEVTANA and 8% of patients who received abiraterone acetate plus prednisone/prednisolone or enzalutamide. The adverse reactions leading to treatment discontinuation in >1% of patients in JEVTANA arm were nervous system disorders, infections/infestations, and gastrointestinal disorders.

Dose interruptions (alone or in combination with dose reduction) due to an adverse reaction occurred in 31% of patients receiving JEVTANA. Dose reductions were reported in 18% of JEVTANA-treated patients. The most frequent adverse reactions leading to dose interruption of JEVTANA were fatigue (7%) and hypersensitivity reaction (3.2%); the most frequent adverse reaction leading to reduction of JEVTANA were neutropenia and peripheral neuropathy (3.9% each).

Table 4 summarizes the adverse reactions and laboratory hematologic abnormalities in patients in CARD.

The most common (≥10%) adverse reactions were fatigue, diarrhea, musculoskeletal pain, nausea, infections, peripheral neuropathy, hematuria, constipation, abdominal pain, decreased appetite, vomiting, dysgeusia, edema peripheral and lower urinary tract symptoms.

The most common (≥10%) hematologic abnormalities were anemia, lymphopenia, neutropenia and thrombocytopenia.

Table 4: Adverse Reactions * and Hematologic Abnormalities in ≥5% of Patients in CARD Trial
Adverse Reactions JEVTANA 25 mg/m2 + prednisone/prednisolone + G-CSF Abiraterone + prednisone/prednisolone or Enzalutamide
(N=126) (N=124)
Grade 1–4 % Grade 3–4 % Grade 1–4 % Grade 3–4 %
*
Grade from NCI CTC version 4.0.
Based on laboratory values — % calculated using the number of patients with at least one event(n) over the number of patients assessed for each parameter during the on-treatment period.
includes asthenia, fatigue, lethargy, malaise.
§
includes lymphoedema, edema peripheral, peripheral swelling.
includes colitis, diarrhea, diarrhea hemorrhagic, gastroenteritis.
#
includes abdominal pain, abdominal pain lower, abdominal pain upper, flank pain, gastrointestinal pain.
Þ
includes arthralgia, back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, myalgia, neck pain, noncardiac chest pain.
ß
incudes femoral neck fracture, pathological fracture, rib fracture, spinal compression fracture, sternal fracture, thoracic vertebral fracture.
à
includes bacteremia, bacteriuria, cellulitis, device related sepsis, Enterobacter sepsis, erysipelas, furuncle, influenza, influenza like illness, localized infection, oral fungal infection, perineal cellulitis, pulmonary sepsis, pyelocaliectasis, pyelonephritis, pyelonephritis acute, respiratory tract infection, respiratory tract infection viral, sepsis, septic shock, subcutaneous abscess, upper respiratory tract infection, ureteritis, urinary tract infection, urinary tract infection bacterial, urosepsis, viral infection.
è
includes neuropathy peripheral, paresthesia, peripheral motor neuropathy, peripheral sensorimotor neuropathy, peripheral sensory neuropathy.
ð
includes hematuria, cystitis hemorrhagic.
ø
include lower urinary tract symptoms, micturition urgency, nocturia, pollakiuria, urinary incontinence, urinary retention, dysuria.
ý
includes acute kidney injury, blood creatinine increased, renal failure, renal impairment.
£
includes aortic valve incompetence, aortic valve stenosis, atrial fibrillation, atrial flutter, atrioventricular block complete, atrioventricular block second degree, bradycardia, sinus bradycardia, tachycardia, cardiac failure, acute coronary syndrome, angina pectoris.
¥
includes lower respiratory tract infection, lung infection, lung infiltration, pneumonia.
Œ
includes hypertension, hypertensive crisis.
Blood and Lymphatic System Disorders
Anemia 99 8 95 4.8
Lymphopenia 72 27 55 17
Neutropenia 66 45 7 3.2
Thrombocytopenia 41 3.2 16 1.6
General Disorders and Administration Site Conditions
Fatigue 53 4 36 2.4
Edema peripheral § 11 0.8 10 1.6
Pyrexia 6 0 7 0
Pain 6 0 6 0.8
Gastrointestinal Disorders
Diarrhea 40 4.8 6 0
Nausea 23 0 23 0.8
Constipation 15 0 11 0
Abdominal pain # 14 1.6 6 0.8
Vomiting 13 0 12 1.6
Stomatitis 8 0 1.6 0
Dyspepsia 4.8 0 2.4 0
Musculoskeletal and Connective Tissue Disorders
Musculoskeletal pain Þ 27 1.6 40 6
Pain in extremity 4.8 0 11 2.4
Bone fracture ß 3.2 1.6 8 2.4
Infections and Infestations
Infections à 19 4 14 6
Nervous System Disorders
Peripheral neuropathy è 18 1.6 4.8 0
Dysgeusia 11 0 4 0
Polyneuropathy 6 1.6 0 0
Dizziness 0.8 0 4.8 0
Renal and Urinary Disorders
Hematuria ð 16 0.8 6 1.6
Lower urinary tract symptoms ø 10 0 9 0
Acute kidney injury ý 5 2.4 10 4
Metabolism and Nutrition Disorders
Decreased appetite 14 0.8 15 2.4
Hypokalemia 3.2 0 6 0
Neoplasms Benign, Malignant and Unspecified (incl cysts and polyps)
Cancer pain 8 1.6 9 2.4
Cardiac disorders £ 6 0.8 6 3.2
Respiratory, Thoracic and Mediastinal Disorders
Pneumonia ¥ 6 1.6 3.2 0.8
Dyspnea 6 0 2.4 0
Skin and Subcutaneous Tissue Disorders
Alopecia 6 0 0 0
Injury, Poisoning and Procedural Complications
Fall 4.8 0 0 0
Vascular Disorders
Hypertension Π4 2.4 8 2.4
Investigations
Weight decreased 4 0 6 0
Psychiatric Disorders
Insomnia 3.2 0 4.8 0

Clinically relevant ≥ Grade 3 adverse reactions in <5% of patients who received JEVTANA in combination with prednisone and primary prophylaxis G-CSF: febrile neutropenia (3.2%), pulmonary embolism (1.6%), and neutropenic infection (0.8%).

Hematuria

In study TROPIC, adverse reactions of hematuria, including those requiring medical intervention, were more common in JEVTANA-treated patients. The incidence of grade ≥2 hematuria was 6% in JEVTANA-treated patients and 2% in mitoxantrone-treated patients. Other factors associated with hematuria were well-balanced between arms and do not account for the increased rate of hematuria on the JEVTANA arm.

In study PROSELICA, hematuria of all grades was observed in 18% of patients overall.

In CARD, hematuria of all grades was observed in 16% of patients receiving JEVTANA.

Hepatic Laboratory Abnormalities

The incidences of grade 3–4 increased AST, increased ALT, and increased bilirubin were each ≤1%.

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