RHAPSIDO

RHAPSIDO is not indicated for other forms of urticaria.

Tablets: 25 mg, light yellow, round, curved, unscored, film-coated tablet, debossed with “LV” on one side and Novartis logo on the other side. The tablet diameter is 7 mm.

None.

Consider contacting the poison help line (1-800-222-1222) or a medical toxicologist for overdose management recommendations.

RHAPSIDO (remibrutinib) is a kinase inhibitor.

Its empirical formula (remibrutinib) is C

Remibrutinib is white to pale yellow powder, and it is practically insoluble in water.

RHAPSIDO is supplied as film-coated tablets for oral administration, with each film-coated tablet containing 25 mg of remibrutinib. The tablet core inactive ingredients are copovidone, croscarmellose sodium, mannitol, microcrystalline cellulose, sodium lauryl sulfate, and sodium stearyl fumarate. The tablet coating inactive ingredients are polyethylene glycol 4000, polyvinyl alcohol, red iron oxide (E172), talc, titanium dioxide (E171), and yellow iron oxide (E172).

The efficacy of RHAPSIDO for chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment was evaluated in two identical, 52-week, multi-center, randomized, double-blind, placebo-controlled clinical trials (REMIX-1 [NCT05030311] and REMIX-2 [NCT05032157]).

REMIX-1 and REMIX-2 enrolled a total of 925 adult patients, diagnosed with CSU inadequately controlled despite treatment with H1 antihistamines, as defined by the presence of itch and hives for ≥6 consecutive weeks. All patients were required to have a weekly urticaria activity score (UAS7) ≥16 (range 0-42), a weekly itch severity score (ISS7) ≥6 (range 0-21) and a weekly hives severity score (HSS7) ≥6 (range 0-21) for 7 days prior to randomization. Patients were randomized in a 2:1 ratio to receive either RHAPSIDO 25 mg or placebo, respectively, orally twice daily for 24 weeks during the double-blind treatment period and subsequently continued in a 28-week open-label treatment period, during which all patients received RHAPSIDO 25 mg twice daily. While REMIX-1 and REMIX-2 clinical trials included an open-label period, efficacy is based on results from 912 patients treated during the controlled period of 24 weeks.

Demographics and baseline characteristics in REMIX-1 and REMIX-2 are provided in Table 2.

The reported mean duration of CSU at enrollment across treatment groups was 6.6 and 5.2 years in REMIX-1 and REMIX-2, respectively, with 39% and 29% of the patients having a duration of CSU > 5 years.

The co-primary endpoints were absolute change from baseline in ISS7 and HSS7 at Week 12. The ISS7 (range 0 to 21) was defined as the sum of the daily itch severity scores (range 0 to 3) recorded over a 7-day period. The HSS7 (range 0 to 21) was defined as the sum of the daily hive severity scores (range 0 to 3) recorded over a 7-day period. The key secondary endpoint was absolute change from baseline in UAS7 at Week 12. The UAS7 (range 0 to 42) was a composite of the ISS7 and HSS7.

Secondary endpoints included proportion of patients who achieved UAS7 ≤6 at Weeks 2 and 12, and the proportion of patients who achieved complete absence of itch and hives (UAS7 = 0) at Week 12. In both REMIX-1 and REMIX-2 studies, the co-primary and all secondary endpoints showed statistically significant improvement in itch and hives symptoms in patients treated with RHAPSIDO compared to patients treated with placebo. Results are presented in Table 3.

Figure 1 shows the effect of RHAPSIDO over time up to Week 24 in REMIX-2 patients treated with RHAPSIDO. The results were similar in REMIX-1.

Improvements in ISS7 and HSS7 at Week 12 were consistent regardless of patients’ baseline total IgE level.

RHAPSIDO tablets are supplied as described in Table 4:

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense and store in the original container in order to protect from moisture.

Advise patients to read the FDA-approved patient labeling (Patient Information).

Inform patients to take RHAPSIDO with or without food. Advise patients not to split, crush, or chew the tablet and to swallow the tablet whole with water

Inform patients that bleeding can occur with the use of RHAPSIDO, and to report any signs and symptoms to their healthcare practitioner. Inform patients that RHAPSIDO should be interrupted for 3 to 7 days for any surgical procedures. Instruct patients to inform their healthcare practitioner if they use RHAPSIDO with antithrombotic agents due to the potential increased risk of bleeding

Instruct patients to inform the healthcare practitioner that they are taking RHAPSIDO prior to any potential vaccinations. Advise patients that the vaccines containing live virus (live and live-attenuated) should not be given during treatment with RHAPSIDO

Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to RHAPSIDO during pregnancy

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© Novartis

T2025-55

NDC 0078-1483-20

Rhapsido

(remibrutinib) tablets

25 mg per tablet

Swallow tablets whole with water.

Do not split, crush, or chew tablets.

Rx only

60 tablets

NOVARTIS