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adverse reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Myelosuppression [see Warnings and Precautions ( 5.1 )] Seizures [see Warnings and Precautions ( 5.2 )] Skin Disorders [see Warnings and Precautions ( 5.3 )] Injection Site Reactions and Tissue Necrosis [see Warnings and Precautions ( 5.4 )] Secondary Malignancies [see Warnings and Precautions ( 5.5 )] The most common adverse reactions (≥20%) are musculoskeletal pain, stomatitis, pyrexia, nausea, edema, infection, and vomiting. ( 6.1 ) Selected Grade 3 or 4 nonhematological laboratory abnormalities are increased GGT, increased bilirubin, increased ALT, increased AST, and increased creatinine. To report SUSPECTED ADVERSE REACTIONS, contact Medexus Pharma, Inc. at 1-855-336 -3322 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials 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. MC‑FludT.14/L Trial II The safety of GRAFAPEX was evaluated in 553 adult patients with AML and MDS in a randomized trial (MC‑FludT.14/L Trial II) comparing GRAFAPEX in combination with fludarabine to busulfan in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation. The patients were randomized to receive GRAFAPEX (n=270) 10 g/m² daily on day -4, -3 and -2 or to busulfan (n=283) 0.8 mg/kg every 6 hours on day -4 and -3 in combination with fludarabine 30 mg/m 2 daily on day -6, -5, -4, -3 and -2, and hematopoietic stem cell transplantation on day 0 [see Clinical Studies ( 14 )] . Fatal regimen-related adverse reactions occurred within 30 days of transplantation in 1.9% of patients on the GRAFAPEX arm. All fatalities were due to pulmonary adverse reactions. The most common adverse reactions (≥20%) in patients treated with GRAFAPEX were musculoskeletal pain, stomatitis, pyrexia, nausea, edema, infection, and vomiting. Selected Grade 3 or 4 nonhematological laboratory abnormalities were increased GGT, increased bilirubin, increased ALT, increased AST, and increased creatinine. Table 3 shows the adverse reactions in Study MC‑FludT.14/L Trial II through transplant Day +30. Table 3: Adverse Reactions in ≥10% of Patients through Transplant Day +30 in Study MC-FludT.14/L Trial II Adverse Reaction* All Grades Grades 3 or 4 GRAFAPEX (N = 270) Busulfan (N = 283) GRAFAPEX (N = 270) Busulfan (N = 283) % % % % Musculoskeletal pain 39 27 5 2 Stomatitis 38 48 6 7 Pyrexia 34 36 1 3 Nausea 33 41 3 6 Edema 29 18 0.7 1 Infection 1 23 18 12 6 Vomiting 22 19 1 1 Rash 17 13 1 1 Diarrhea 17 18 1 1 Headache 16 18 1 1 Febrile neutropenia 15 11 15 11 Abdominal pain 15 13 3 2 Hypertension 14 21 8 10 Hemorrhage 14 14 1 1 Fatigue 13 15 1 0.4 Constipation 12 12 0.4 0 Tachycardia 10 5 1 2 Hepatotoxicity 10 8 4 3 *Includes grouped terms 1 Includes fatalities: n=6 in the GRAFAPEX arm and n=2 in the busulfan arm Grading is based on Common Terminology Criteria for Adverse Events version 4.03 Clinically relevant adverse reactions in <10% of patients who received GRAFAPEX included: Neoplasms benign, malignant and unspecified (including cysts and polyps): second malignancy Metabolism and nutrition disorders: Decreased appetite, impaired glucose tolerance Psychiatric disorders: Insomnia, confusional state, agitation Nervous system disorders: Paresthesia, dizziness Ear and labyrinth disorders: Vertigo Cardiac disorders: Cardiac failure, pericardial effusion Vascular disorders: Flushing, embolism, hypotension Respiratory, thoracic and mediastinal disorders: Pneumonitis, pleural effusion, pharyngeal or laryngeal inflammation, dyspnea, cough, oropharyngeal pain, hiccups, dysphonia Gastrointestinal disorders: Oral pain, gastritis, dyspepsia, dysphagia, abdominal distension, dry mouth Skin and subcutaneous tissue disorders: Palmar plantar erythrodysesthesia syndrome, pruritus, erythema, dermatitis, skin hyperpigmentation, dry skin Renal and urinary disorders: Acute kidney injury, hematuria, urinary tract pain General disorders and administration site conditions: Chills, pain Investigations: Weight decreased or increased, increase of C‑reactive protein All patients treated with GRAFAPEX and fludarabine developed neutropenia, anemia, and thrombocytopenia. One patient on the GRAFAPEX arm had graft failure. Table 4 summarizes the selected nonhematological laboratory abnormalities in Study MC-FludT.14/L Trial II by treatment arm through Day +30 posttransplant. Table 4. Selected Grades 3-4 Laboratory Abnormalities through Transplant Day +30 in Study MC-FludT.14/L Trial II Laboratory Abnormality GRAFAPEX N = 270 % Busulfan N = 283 % Gamma Glutamyl Transferase Increased 16 28 Bilirubin Increased 6 5 Alanine Aminotransferase Increased 6 4 Aspartate Aminotransferase Increased 4 1 Creatinine Increased 3 0.7 Grading is based on Common Terminology Criteria for Adverse Events version 4.03 6.2 Postmarketing Experience The following additional adverse reactions have been identified during post approval use of GRAFAPEX in preparative regimens prior to hematopoietic stem cell transplantation in adult and pediatric patients in other countries. As these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Metabolism and Nutrition Disorders: Acidosis Nervous system disorders: Peripheral sensory neuropathy Renal and urinary disorders: Renal failure Immune system disorders: Hypersensitivity