Rolvedon Side Effects

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: • Splenic rupture [see Warnings and Precautions ( 5.1 )] • Acute respiratory distress syndrome [see Warnings and Precautions ( 5.2 )] • Serious allergic reactions [see Warnings and Precautions ( 5.3 )] • Sickle cell crisis in patients with sickle cell disorders [see Warnings and Precautions ( 5.4 )] • Glomerulonephritis [see Warnings and Precautions ( 5.5 )] • Leukocytosis [see Warnings and Precautions ( 5.6 )] • Thrombocytopenia [see Warnings and Precautions ( 5.7 )] • Capillary leak syndrome [see Warnings and Precautions ( 5.8 )] • Potential for tumor growth stimulatory effects on malignant cells [see Warnings and Precautions ( 5.9 )] • Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer [see Warnings and Precautions ( 5.10 )] • Aortitis [see Warnings and Precautions ( 5.11 )] • Nuclear Imaging [see Warnings and Precautions ( 5.12 )] The most common adverse reactions (≥20%) are fatigue, nausea, diarrhea, bone pain, headache, pyrexia, anemia, rash, myalgia, arthralgia, and back pain.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact 1-800-518-1084 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 clinical practice.

The safety of Rolvedon was evaluated in Study 1 and Study 2 [see Clinical Studies ( 14 )].

Patients with early-stage breast cancer received Rolvedon 13.2 mg by subcutaneous injection (n=314) or pegfilgrastim 6 mg by subcutaneous injection (n=326) on Day 2 of each cycle after docetaxel 75 mg/m 2 and cyclophosphamide 600 mg/m 2 (TC) chemotherapy.

Among patients receiving Rolvedon, a total of 272 patients received four 21-day treatment cycles.

The most common adverse reactions (≥20%) were fatigue, nausea, diarrhea, bone pain, headache, pyrexia, anemia, rash, myalgia, arthralgia, and back pain.

Table 1 summarizes the adverse reactions that occurred in Studies 1 and

Common Adverse Reactions with a Frequency of ≥10% Through Week 14 in Patients with Early-Stage Breast Cancer in Study 1 and Study 2 Adverse Reaction Rolvedon (N = 314) % Pegfilgrastim** (N=326) % *Grouped Terms **Study 1 and Study 2 were not designed to evaluate meaningful comparisons of the incidence of adverse reactions in the Rolvedon and the pegfilgrastim treatment groups.

Fatigue * 181 (58%) 192 (59%) Nausea 162 (52%) 166 (51%) Diarrhea 125 (40%) 126 (39%) Bone pain 119 (38%) 121 (37%) Headache * 92 (29%) 90 (28%) Pyrexia * 87 (28%) 84 (26%) Anemia * 77 (25%) 52 (16%) Rash * 77 (25%) 99 (30%) Myalgia 69 (22%) 49 (15%) Arthralgia 66 (21%) 48 (15%) Back pain * 63 (20%) 55 (17%) Decreased appetite 61 (19%) 50 (15%) Peripheral edema * 57 (18%) 53 (16%) Abdominal pain * 53 (17%) 67 (21%) Dizziness * 50 (16%) 38 (12%) Dyspnea * 49 (16%) 44 (13%) Cough * 48 (15%) 51 (16%) Thrombocytopenia * 44 (14%) 17 (5%) Pain 37 (12%) 42 (13%) Pain in extremity 36 (11%) 42 (13%) Local administration reactions * 34 (11%) 27 (8%) Flushing 32 (10%) 27 (8%) Permanent discontinuation due to an adverse reaction occurred in 4% of patients who received Rolvedon.

The adverse reaction requiring permanent discontinuation in 3 patients who received Rolvedon was rash.