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adverse reactions
6. ADVERSE REACTIONS The following clinically significant adverse reactions are discussed elsewhere in the labeling: Hepatotoxicity, Including Hepatic VOD (also known as Sinusoidal Obstruction Syndrome) [see Warnings and Precautions ( 5.1 )] Infusion-Related Reactions [see Warnings and Precautions ( 5.2 )] Edema [see Warnings and Precautions ( 5.3 )] The most common adverse reactions (≥20%) were edema, fatigue, musculoskeletal pain, hemorrhage, infusion-related reactions, nausea, and diarrhea. ( 6.1 ) The most common Grade 3 or 4 laboratory abnormalities (≥10%) were neutrophils decreased, platelets decreased, lymphocyte count decreased, white blood cells decreased, hemoglobin decreased, and glucose increased. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical T rials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of DECNUPAZ was evaluated in CADENZA, a single-arm, open-label study that included 116 adults with newly diagnosed or relapsed/refractory myeloid malignancies, including 84 with BPDCN, treated with DECNUPAZ 0.045 mg/kg once every three weeks. The median number of cycles administered was 3 (range: 1 to 34) in the overall population, and 3.5 (range: 1 to 34) in patients with BPDCN. Serious adverse reactions occurred in 55% of patients treated with DECNUPAZ. The most common (≥2%) serious adverse reactions were febrile neutropenia, pneumonia, edema, sepsis, hemorrhage, thrombosis, infusion-related reactions, viral infection, pneumonitis, infections without specified pathogens, pyrexia, and musculoskeletal pain. Fatal adverse reactions occurred in 4.3% of patients who received DECNUPAZ, including cardiac arrest (0.9%), clostridium difficile infection (0.9%), failure to thrive (0.9%), depressed level of consciousness (0.9%), and respiratory failure (0.9%). Permanent discontinuation due to adverse reactions occurred in 10% of patients who received DECNUPAZ. Adverse reactions which resulted in permanent discontinuation of DECNUPAZ in ≥1% of patients included veno-occlusive disease and pneumonitis. Dosage interruptions of DECNUPAZ due to adverse reactions occurred in 37% of patients. Adverse reactions which resulted in dosage interruptions in ≥2% of patients included edema, pneumonia, infusion-related reaction, bacterial infections, fatigue, hemorrhage, neutropenia, pneumonitis, and pyrexia. Dose reductions of DECNUPAZ due to an adverse reaction occurred in 6% of patients. Adverse reactions which required dose reductions in ≥2% of patients included edema. The most common adverse reactions (≥20%) were edema, fatigue, musculoskeletal pain, hemorrhage, infusion-related reactions, nausea, and diarrhea. The most common Grade 3 to 4 laboratory abnormalities (≥10%) were neutrophils decreased, platelets decreased, lymphocyte count decreased, white blood cells decreased, hemoglobin decreased, and glucose increased. Table 3 summarizes the common adverse reactions (≥10%) in patients treated with DECNUPAZ in CADENZA. Table 3. Adverse Reactions (≥10%) in Patients Who Received DECNUPAZ in CADENZA DECNUPAZ (N=116) Adverse Reaction § All Grades (%) Grade 3 or 4 (%) General disorders and administration site conditions Edema a 52 16 Fatigue b 34 5 Pyrexia b 16 0.9 Chills 11 0 Musculoskeletal and connective tissue disorders Musculoskeletal pain b 34 8 Vascular disorders Hemorrhage b 28 6 Thrombosis b 13 5 Injury, poisoning and procedural complications Infusion-related reactions 26 5 Fall 13 1.7 Gastrointestinal disorders Nausea b 24 0.9 Diarrhea b 21 0.9 Constipation 19 0 Abdominal pain b 14 0.9 Respiratory , thoracic and mediastinal disorders Dyspnea b 19 1.7 Cough b 15 0 Skin and subcutaneous tissue disorders Rash c 19 0 Nervous system disorder s Neuropathy peripheral d 18 1.7 Headache b 16 2.6 Dizziness b 10 0.9 Metabolism and nutrition disorders Decreased appetite b 16 0.9 Infections and i nfestations Infections without specified pathogens b 16 6 Viral infections e 13 6 Bacterial infections f 12 5 Pneumonia g 11 9 Psychiatric disorders Insomnia 15 0 Blood and lymphatic system disorders Febrile neutropenia 11 11 § Adverse reactions were graded based on CTCAE Version 4.03 a. Edema includes acute pulmonary edema, face edema, generalized edema, hypervolemia, edema, edema genital, edema peripheral, pericardial effusion, peripheral swelling, pleural effusion, pulmonary edema, swelling face, weight increased, ascites. b. Consists of multiple related terms. c. Rash includes erythema, erythema nodosum, guttate psoriasis, photosensitivity reaction, psoriasis, rash, rash erythematous, rash macular, rash maculo-papular, rash pruritic, skin lesion, skin lesion inflammation, stasis dermatitis. d. Neuropathy peripheral includes burning sensation, dysesthesia, facial nerve disorder, hypoesthesia, IIIrd nerve disorder, neuralgia, neuropathy peripheral, paresthesia, sciatica. e. Viral infections includes COVID-19, cytomegalovirus infection, HCoV-229E infection, herpes simplex, herpes zoster, herpes zoster disseminated, influenza, ophthalmic herpes simplex, oral herpes. f. Bacterial infections includes cellulitis, clostridium difficile infection, erysipelas, folliculitis, vulval abscess. g. Pneumonia includes pneumocystis jirovecii pneumonia, pneumonia, pneumonia viral. Clinically relevant adverse reactions occurring in <10% of patients who received DECNUPAZ in CADENZA included: Vascular disorders : capillary leak syndrome (9%) a , hypotension b (7%) Gastrointestinal disorders: stomatitis b (6%) Infections and infestations: sepsis c (7%), fungal infections d (5%) Respiratory, thoracic and mediastinal disorders: pneumonitis (5%) Cardiac disorders : arrhythmia e (6%) Renal and urinary disorders : acute kidney injury b (6%) Hepatobiliary disorders: veno-occlusive disease (1.7%) a. At least 2 of the following new onset signs and symptoms within 7 days of each other: hypoalbuminemia (including albumin <3.0 g/dL), edema (including weight increase >5 kg), hypotension (including systolic blood pressure <90 mmHg). b. Consists of multiple related terms. c. Includes bacteremia, klebsiella bacteremia, pulmonary sepsis, sepsis, and streptococcal bacteremia. d. Includes candida infection, fungal balanitis, fungal foot infection, fungal skin infection. e. Includes arrhythmia, atrial fibrillation, atrioventricular block, bradycardia, cardiac arrest, tachyarrhythmia. Table 4 summarizes laboratory abnormalities in CADENZA. Table 4. Select Laboratory Abnormalities (≥10%) That Worsened from Baseline in Patients Who Received DECNUPAZ in CADENZA Laboratory Abnormality* DECNUPAZ a All Grades (%) Grade 3 or 4 (%) Chemistry Creatinine increased 76 0 Glucose increased 53 10 Albumin decreased 50 1.8 Phosphate decreased 39 8 Calcium decreased 34 1.8 Alanine aminotransferase increased 32 4.4 Aspartate aminotransferase increased 29 0.9 Sodium decreased 28 1.8 Potassium decreased 26 3.5 Alkaline phosphatase increased 20 0.9 Magnesium decreased 18 0 Bilirubin increased 16 0.9 Hematology Platelets decreased 64 40 Neutrophils decreased 63 45 Lymphocyte count decreased 62 39 White blood cells decreased 55 34 Hemoglobin decreased 40 20 * Laboratory abnormalities were graded based on CTCAE Version 4.03. a The denominator used to calculate the rate varied from 78 to 114 based on the number of patients with at least one post-baseline value.