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SAFETY PROFILE
The safety evaluation of Reblozyl® in β-thalassemia is based on the double-blind, randomized, placebo-controlled Phase 3 BELIEVE trial (with 224 patients treated with Reblozyl® and 112 patients receiving placebo).1
The most commonly reported Grade 3 or higher adverse drug reaction was hyperuricemia. The most serious adverse reactions reported included thromboembolic events of deep vein thrombosis, ischemic stroke, portal vein thrombosis, and pulmonary embolism.1
Most frequently reported adverse drug reactions
in at least 15% of patients receiving Reblozyl®1
HEADACHE
BONE PAIN
ARTHRALGIA
For full details on adverse drug reactions in patients treated with Reblozyl® for MDS, please refer to the Summary of Product Characteristics (SmPC): SmPC in French, SmPC in Dutch.
SELECTED ADVERSE REACTIONS
Selected adverse reactions in BELIEVE trial1
- Bone pain: Bone pain was reported in 19.7% of patients with β-thalassemia treated with Reblozyl® (placebo 8.3%). In patients with β-thalassemia treated with Reblozyl, bone pain was most common in the first 3 months (16.6%) compared to months 4-6 (3.7%). Most events (41/44 events) were Grade 1-2, with 3 events Grade 3. One of the 44 events was serious, and 1 event led to treatment discontinuation.1
- Arthralgia: Arthralgia was reported in 19.3% of patients with β-thalassemia treated with Reblozyl® (placebo 11.9%). In the patients with β-thalassemia treated with Reblozyl, arthralgia led to treatment discontinuation in 2 patients (0.9%).
- Hypertension: Patients treated with Reblozyl® had an average increase in systolic and diastolic blood pressure of 5 mmHg from baseline not observed in patients receiving placebo. Hypertension was reported in 8.1% of patients with β-thalassemia (placebo 2.8%)1.
- In patients with β-thalassemia, Grade 3 events were reported in 4 patients (1.8%) treated with Reblozyl® (0.0% placebo). No patient discontinued due to hypertension
- Hypersensitivity: Hypersensitivity-type reactions (including eyelid edema, drug hypersensitivity, swelling face, periorbital edema, face edema, angioedema, lip swelling, drug eruption) were reported 4.5% of patients with β-thalassemia treated with Reblozyl® (1.8% placebo). In clinical studies, all events were Grade 1/2. In patients with β-thalassemia treated with Reblozyl®, hypersensitivity led to treatment discontinuation in 1 patient (0.4%).
- Thromboembolic events (TEEs): Thromboembolic events (including deep vein thrombosis, portal vein thrombosis, ischemic stroke, and pulmonary embolism) occurred in 3.6% of patients with β-thalassemia receiving Reblozyl® (placebo 0.9%). All events were reported in patients who had undergone splenectomy and had at least 1 other risk factor.
- Injection site reactions: Injection site reactions (including injection site erythema, injection site pruritus, injection site swelling, and injection site rash) were reported in 2.2% of patients with β-thalassemia receiving Reblozyl® (placebo 1.8%). In clinical studies, all events were Grade 1 and none led to discontinuation.1
- Immunogenicity: In clinical studies of β-thalassemia, an analysis of 284 patients who were treated with Reblozyl® and who were evaluable for the presence of anti-luspatercept antibodies, 4 (1.4%) of patients tested positive for treatment-emergent anti-luspatercept antibodies, including 2 (0.7%) of patients who had neutralizing antibodies against Reblozyl®.
- Luspatercept serum concentration tended to decrease in the presence of neutralizing antibodies. There were no severe systemic hypersensitivity reactions reported for patients with anti-luspatercept antibodies. There was no association between hypersensitivity type reactions or injection site reactions and presence of anti-luspatercept antibodies.
Selected adverse reactions in β-thalassemia1
BONE PAIN
19.7% Reblozyl®
8.3% Placebo
ARTHRALGIA
19.3% Reblozyl®
11.9% Placebo
HYPERTENSION
8.1% Reblozyl®
2.8% Placebo
HYPERSENSITIVITY
4.5% Reblozyl®
1.8% Placebo
THROMBOEMBOLIC EVENTS
3.6% Reblozyl®
0.9% Placebo
INJECTION SITE REACTIONS
2.2% Reblozyl®
1.8% Placebo
IMMUNOGENICITY
1.4% of Reblozyl® patients tested positive for
treatment-emergent anti-Reblozyl® antibodies
DISCONTINUATIONS
Treatment discontinuation due to an adverse event occurred in 2.6% of β-thalassemia patients treated with Reblozyl®. Adverse reactions leading to study drug discontinuation in the Reblozyl® treatment arm were arthralgia, back pain, bone pain, and headache.1
The safety evaluation of Reblozyl® in β-thalassemia is based on the double-blind, randomized, placebo-controlled Phase 3 BELIEVE trial (with 224 patients treated with Reblozyl® and 112 patients receiving placebo).1
Most frequently reported adverse drug reactions in at least 15% of patients receiving Reblozyl®1
HEADACHE
BONE PAIN
ARTHRALGIA
The most commonly reported Grade 3 or higher adverse drug reaction was hyperuricemia. The most serious adverse reactions reported included thromboembolic events of deep vein thrombosis, ischemic stroke, portal vein thrombosis, and pulmonary embolism.1
For full details on adverse drug reactions in patients treated with Reblozyl® for MDS, please refer to the Summary of Product Characteristics (SmPC): SmPC in French, SmPC in Dutch.
Selected adverse reactions in BELIEVE trial1
BONE PAIN
19.7% Reblozyl®
8.3% Placebo
Bone pain: Bone pain was reported in 19.7% of patients with β-thalassemia treated with Reblozyl® (placebo 8.3%). In patients with β-thalassemia treated with Reblozyl, bone pain was most common in the first 3 months (16.6%) compared to months 4-6 (3.7%). Most events (41/44 events) were Grade 1-2, with 3 events Grade 3. One of the 44 events was serious, and 1 event led to treatment discontinuation.1
ARTHRALGIA
19.3% Reblozyl®
11.9% Placebo
Arthralgia: Arthralgia was reported in 19.3% of patients with β-thalassemia treated with Reblozyl® (placebo 11.9%). In the patients with β-thalassemia treated with Reblozyl, arthralgia led to treatment discontinuation in 2 patients (0.9%).
HYPERTENSION
8.1% Reblozyl®
2.8% Placebo
Hypertension: Patients treated with Reblozyl® had an average increase in systolic and diastolic blood pressure of 5 mmHg from baseline not observed in patients receiving placebo. Hypertension was reported in 8.1% of patients with β-thalassemia (placebo 2.8%).1
- In patients with β-thalassemia, Grade 3 events were reported in 4 patients (1.8%) treated with Reblozyl® (0.0% placebo). No patient discontinued due to hypertension
HYPERSENSITIVITY
4.5% Reblozyl®
1.8% Placebo
Hypersensitivity: Hypersensitivity-type reactions (including eyelid edema, drug hypersensitivity, swelling face, periorbital edema, face edema, angioedema, lip swelling, drug eruption) were reported 4.5% of patients with β-thalassemia treated with Reblozyl® (1.8% placebo). In clinical studies, all events were Grade 1/2. In patients with β-thalassemia treated with Reblozyl®, hypersensitivity led to treatment discontinuation in 1 patient (0.4%).
THROMBOEMBOLIC EVENTS
3.6% Reblozyl®
0.9% Placebo
Thromboembolic events (TEEs): Thromboembolic events (including deep vein thrombosis, portal vein thrombosis, ischemic stroke, and pulmonary embolism) occurred in 3.6% of patients with β-thalassemia receiving Reblozyl® (placebo 0.9%). All events were reported in patients who had undergone splenectomy and had at least 1 other risk factor.
INJECTION SITE REACTIONS
2.2% Reblozyl®
1.8% Placebo
Injection site reactions: Injection site reactions (including injection site erythema, injection site pruritus, injection site swelling, and injection site rash) were reported in 2.2% of patients with β-thalassemia receiving Reblozyl® (placebo 1.8%). In clinical studies, all events were Grade 1 and none led to discontinuation.1
IMMUNOGENICITY
1.4% of Reblozyl® patients tested positive for treatment-emergent anti-Reblozyl® antibodies
Immunogenicity: In clinical studies of β-thalassemia, an analysis of 284 patients who were treated with Reblozyl® and who were evaluable for the presence of anti-luspatercept antibodies, 4 (1.4%) of patients tested positive for treatment-emergent anti-luspatercept antibodies, including 2 (0.7%) of patients who had neutralizing antibodies against Reblozyl®.
Luspatercept serum concentration tended to decrease in the presence of neutralizing antibodies. There were no severe systemic hypersensitivity reactions reported for patients with anti-luspatercept antibodies. There was no association between hypersensitivity type reactions or injection site reactions and presence of anti-luspatercept antibodies.
Only 2.6%
of β-thalassemia patients treated with Reblozyl® discontinued treatment due to an adverse reaction1
Treatment discontinuation due to an adverse event occurred in 2.6% of β-thalassemia patients treated with Reblozyl®. Adverse reactions leading to study drug discontinuation in the Reblozyl® treatment arm were arthralgia, back pain, bone pain, and headache.1