RHAPSIDO
Generic: REMIBRUTINIB
Basic Information
Manufacturer
Novartis Pharmaceuticals Corporation
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
e5e89bff-6ced-4165-acc5-fb13136b3a3d
Indications & Usage
1 INDICATIONS AND USAGE RHAPSIDO ® is indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment.
Limitations of Use: RHAPSIDO is not indicated for other forms of urticaria.
RHAPSIDO ® is a kinase inhibitor indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment.
( 1 ) Limitations of Use: Not indicated for other forms of urticaria.
( 1 )
Limitations of Use: RHAPSIDO is not indicated for other forms of urticaria.
RHAPSIDO ® is a kinase inhibitor indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment.
( 1 ) Limitations of Use: Not indicated for other forms of urticaria.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions (incidence ≥3%) were nasopharyngitis, bleeding, headache, nausea and abdominal pain.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 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 drug reaction (ADR) 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 RHAPSIDO was based on a pooled safety population from two identical clinical trials of 52 weeks duration, REMIX-1 and REMIX-2 [see Clinical Studies (14)] .
The pooled safety population consisted of 912 adult patients with CSU who remain symptomatic despite H1 antihistamine treatment and who received RHAPSIDO 25 mg orally twice daily (N=606) or placebo (N=306) for 24 weeks during the double-blind, controlled treatment period of the trial.
Adverse reactions that occurred at an incidence greater than or equal to 3% and more common than the placebo group from the pooled safety population (REMIX-1 and REMIX-2) during the 24-week blinded, placebo-controlled treatment period are shown in Table 1.
Table 1 Adverse Reactions with RHAPSIDO with Incidence ≥3% and More Common than Placebo in Adult Patients with CSU (REMIX-1 and REMIX-2) a includes acute sinusitis, chronic sinusitis, nasopharyngitis, pharyngitis, pharyngitis streptococcal, rhinitis, rhinitis allergic, and upper respiratory tract infection b includes conjunctival bleeding, contusion, ecchymosis, epistaxis, gingival bleeding, hematoma, hematuria, hemorrhagic ovarian cyst, intermenstrual bleeding, petechiae, purpura, and urinary occult blood c includes headache and migraine d includes abdominal discomfort, abdominal distention, abdominal pain and abdominal pain upper Adverse Reaction RHAPSIDO (N = 606) n (%) Placebo (N = 306) n (%) Nasopharyngitis a 67 (11%) 27 (9%) Bleeding b 55 (9%) 6 (2%) Headache c 41 (7%) 19 (6%) Nausea 18 (3%) 5 (2%) Abdominal Pain d 18 (3%) 6 (2%) Specific Adverse Reactions Bleeding In the pooled safety population (REMIX-1 and REMIX-2), bleeding occurred in 9% of patients treated with RHAPSIDO compared to 2% in the placebo group during the 24-week controlled treatment period [see Dosage and Administration (2.2), Warnings and Precautions (5.1), and Drug Interactions (7.2)] .
Petechiae (4%) and contusion (2%) were the most commonly reported reactions in patients treated with RHAPSIDO.
No severe bleeding reactions occurred.
No association between bleeding reactions and low platelet counts was observed.
In patients treated with RHAPSIDO, 0.5% experienced bleeding reactions that led to RHAPSIDO discontinuation, while none of these reactions occurred in the placebo group.
Similar safety findings were observed through Week 52 [see Clinical Studies (14)] .
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 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 drug reaction (ADR) 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 RHAPSIDO was based on a pooled safety population from two identical clinical trials of 52 weeks duration, REMIX-1 and REMIX-2 [see Clinical Studies (14)] .
The pooled safety population consisted of 912 adult patients with CSU who remain symptomatic despite H1 antihistamine treatment and who received RHAPSIDO 25 mg orally twice daily (N=606) or placebo (N=306) for 24 weeks during the double-blind, controlled treatment period of the trial.
Adverse reactions that occurred at an incidence greater than or equal to 3% and more common than the placebo group from the pooled safety population (REMIX-1 and REMIX-2) during the 24-week blinded, placebo-controlled treatment period are shown in Table 1.
Table 1 Adverse Reactions with RHAPSIDO with Incidence ≥3% and More Common than Placebo in Adult Patients with CSU (REMIX-1 and REMIX-2) a includes acute sinusitis, chronic sinusitis, nasopharyngitis, pharyngitis, pharyngitis streptococcal, rhinitis, rhinitis allergic, and upper respiratory tract infection b includes conjunctival bleeding, contusion, ecchymosis, epistaxis, gingival bleeding, hematoma, hematuria, hemorrhagic ovarian cyst, intermenstrual bleeding, petechiae, purpura, and urinary occult blood c includes headache and migraine d includes abdominal discomfort, abdominal distention, abdominal pain and abdominal pain upper Adverse Reaction RHAPSIDO (N = 606) n (%) Placebo (N = 306) n (%) Nasopharyngitis a 67 (11%) 27 (9%) Bleeding b 55 (9%) 6 (2%) Headache c 41 (7%) 19 (6%) Nausea 18 (3%) 5 (2%) Abdominal Pain d 18 (3%) 6 (2%) Specific Adverse Reactions Bleeding In the pooled safety population (REMIX-1 and REMIX-2), bleeding occurred in 9% of patients treated with RHAPSIDO compared to 2% in the placebo group during the 24-week controlled treatment period [see Dosage and Administration (2.2), Warnings and Precautions (5.1), and Drug Interactions (7.2)] .
Petechiae (4%) and contusion (2%) were the most commonly reported reactions in patients treated with RHAPSIDO.
No severe bleeding reactions occurred.
No association between bleeding reactions and low platelet counts was observed.
In patients treated with RHAPSIDO, 0.5% experienced bleeding reactions that led to RHAPSIDO discontinuation, while none of these reactions occurred in the placebo group.
Similar safety findings were observed through Week 52 [see Clinical Studies (14)] .