The most common adverse reactions (>10%) during the use of Reblozyl were fatigue, headache, musculoskeletal pain, arthralgia, dizziness/vertigo, nausea, diarrhea, cough, abdominal pain, dyspnea, and allergies.
Adverse reactions reported in Reblozyl clinical trials
Patients with β-thalassemia
Trial results showed that 3.6% of patients treated with Reblozyl experienced serious adverse reactions. Serious adverse reactions reported by 1% of patients were cerebrovascular accidents and deep vein thrombosis. One patient treated with Reblozyl had a fatal adverse reaction, and the patient died of unconfirmed acute myeloid leukemia (AML) (M6).
5.4% of patients treated with Reblozyl permanently discontinued the drug due to adverse reactions (grades 1-4). The most common adverse reactions that required permanent discontinuation in patients treated with Reblozyl included joint pain (1%), back pain (1%), bone pain (<1%), and headache (<1%).
2.7% of patients treated with Reblozyl had their dose reduced due to adverse reactions. The most common adverse reactions requiring dose reductions in patients treated with Reblozyl included hypertension and headache.
Dose interruptions due to adverse reactions occurred in 15.2% of patients treated with Reblozyl. The most common adverse reactions requiring dose interruptions in patients treated with Reblozyl included upper respiratory tract infection, elevated alanine aminotransferase (ALT), and cough.
Patients with anemia associated with myelodysplastic syndrome with ring sideroblasts or myelodysplastic/myeloproliferative neoplasms with ring sideroblasts and thrombocytosis
Among the 242 patients treated with Reblozyl, 5 (2.1%) experienced fatal adverse reactions, 11 (4.5%) discontinued the drug due to adverse reactions, and 7 (2.9%) had dose reductions due to adverse reactions.
The most common (>10%) adverse reactions of all grades included fatigue, musculoskeletal pain, dizziness, diarrhea, nausea, allergic reactions, hypertension, headache, upper respiratory tract infection, bronchitis, and urinary tract infection.
The most common (>2%) grade ≥3 adverse reactions included fatigue, hypertension, syncope, and musculoskeletal pain. Laboratory abnormalities that changed from grade 0-1 at baseline to grade >2 at any time during the study in at least 10% of patients included decreased creatinine clearance, increased total bilirubin, and increased alanine aminotransferase.
Immunogenicity
Of the 284 patients with beta-thalassemia who were treated with Reblozyl and could be evaluated for the presence of anti-Reblozyl antibodies, four patients (1.4%) tested positive for treatment-emergent anti-Reblozyl antibodies, of whom two patients (0.7%) had neutralizing antibodies.
Other Side Effects
Thrombosis
Patients with beta-thalassemia may develop blood clots in the arteries, veins, brain, and lungs during treatment with Reblozyl. Patients who have had a splenectomy or are on hormone replacement therapy or birth control (oral contraceptives) may be at higher risk for blood clots.
See a doctor immediately if you have any of the following symptoms: chest pain, difficulty breathing or shortness of breath, leg pain with or without swelling, cold or pale arms or legs, sudden numbness or weakness that lasts for a short or long time, especially on one side of the body, severe headache or confusion, sudden problems with vision, speech, or balance (such as trouble speaking, walking, or dizziness).
High Blood Pressure
Reblozyl may cause your blood pressure to increase. Patients should have their blood pressure checked before being treated with Reblozyl. If you develop high blood pressure during treatment with Reblozyl, your doctor may prescribe medication to treat your high blood pressure or increase the dose of medication you are already taking to treat your high blood pressure.
