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CABLIVI helped to normalize platelet counts and reduce serious aTTP-related events1,2

Patients achieved normal platelet count faster with CABLIVI1,2*

The CABLIVI group (72) reached platelet count normalization* significantly faster than the PEX and immunosuppressive therapy group (73).

Clock

SIGNIFICANTLY FASTER

time to platelet normalization* with CABLIVI

The CABLIVI group (72) reached platelet count normalization significantly faster than the PEX and imunsuppressive therapy group (73). HR (95% CI): 1.55 (1.10-2.20); P=0.01 The CABLIVI group (72) reached platelet count normalization significantly faster than the PEX and imunsuppressive therapy group (73). HR (95% CI): 1.55 (1.10-2.20); P=0.01

CABLIVI significantly reduced potentially fatal or serious aTTP-related events1,2

Compared with PEX and immunosuppressive therapy alone (73), the CABLIVI group (72) demonstrated a significant reduction in a composite endpoint of aTTP-related events (36 [49.3%] vs 9 [12.7%], respectively):

75 % Reduction

74% REDUCTION IN aTTP-RELATED EVENTS

P<0.0001

Total composite endpoint of aTTP-related events during the study-drug period

CABLIVI + PEX + Immunosuppressive Therapy N=72, n (%) PEX +
Immunosuppressive Therapy N=73, n (%)
aTTP-related death 0 3 (4.1%)
Recurrence during treatment 3 (4.2%) 28 (38.4%)
≥1 major thromboembolic event 6 (8.5%) 6 (8.2%)
Total 9 (12.7%) 36 (49.3%)

Four aTTP-related deaths occurred during the trial, including 1 non–treatment-related death in the CABLIVI group during the treatment-free follow-up period and 3 deaths in the placebo group during the treatment period.2

CABLIVI resulted in significantly fewer recurrences requiring reinitiation of PEX1,2‡

67% Reduction

67% REDUCTION IN RECURRENCE

during treatment and through 28 days post-treatment vs PEX and immunosuppressive therapy alone

9 (13%) vs 28 (38%); P<0.001

67% reduction in recurrence during treatment and through 28 days post-treatment. 9 (13%) vs. 28 (38%) compared with PEX and immunosuppressive therapy alone (P<0.001) 67% reduction in recurrence during treatment and through 28 days post-treatment. 9 (13%) vs. 28 (38%) compared with PEX and immunosuppressive therapy alone (P<0.001)
CABLIVI dots

CABLIVI is a once-daily treatment for added strength against aTTP

Patients

Established safety in more than 100 patients

aTTP=acquired thrombotic thrombocytopenic purpura; HR=hazard ratio; PEX=plasma exchange.

*Platelet count normalization was defined as platelet count ≥150,000/µL with discontinuation of daily PEX 5 days thereafter.2

71 patients received at least 1 dose of study drug.

Thrombocytopenia after initial recovery of platelet count (platelet count ≥150,000/µL) that required reinitiation of daily PEX was considered a recurrence. Recurrences were termed exacerbations if they occurred within 30 days of the last PEX and relapses if they occurred more than 30 days after the last PEX.2

IMPORTANT SAFETY INFORMATION AND INDICATIONS

CONTRAINDICATIONS:

CABLIVI is contraindicated in patients with a previous severe hypersensitivity reaction to caplacizumab-yhdp or to any of its excipients. Hypersensitivity reactions have included urticaria.

WARNINGS AND PRECAUTIONS:

Bleeding Risk:

  • CABLIVI increases the risk of bleeding. In clinical studies, severe bleeding adverse reactions of epistaxis, gingival bleeding, upper gastrointestinal hemorrhage, and metrorrhagia were each reported in 1% of subjects. Overall, bleeding events occurred in approximately 58% of patients on CABLIVI versus 43% of patients on placebo. The risk of bleeding is increased, in patients with underlying coagulopathies and concomitant use of CABLIVI with drugs affecting hemostasis.
  • If clinically significant bleeding occurs, interrupt use of CABLIVI. Von Willebrand factor concentrate may be administered to rapidly correct hemostasis. If CABLIVI is restarted, monitor closely for signs of bleeding.
  • Withhold CABLIVI for 7 days prior to elective surgery, dental procedures or other invasive interventions. If emergency surgery is needed, the use of von Willebrand factor concentrate may be considered to correct hemostasis. After the risk of surgical bleeding has resolved, and CABLIVI is resumed, monitor closely for signs of bleeding.

ADVERSE REACTIONS:

The most common adverse reactions (>15% of patients) were epistaxis (29%), headache (21%) and gingival bleeding (16%).

CONCOMITANT USE OF ANTICOAGULANTS:

Concomitant use of CABLIVI with any anticoagulant may increase the risk of bleeding. Assess and monitor closely for bleeding with concomitant use.

PREGNANCY:

There are no available data on CABLIVI use in pregnant women to inform a drug associated risk of major birth defects and miscarriage.

  • Fetal/neonatal adverse reactions: CABLIVI may increase the risk of bleeding in the fetus and neonate. Monitor neonates for bleeding.
  • Maternal adverse reactions: All patients receiving CABLIVI, including pregnant women, are at risk for bleeding. Pregnant women receiving CABLIVI should be carefully monitored for evidence of excessive bleeding.

INDICATIONS:

CABLIVI (caplacizumab-yhdp) is indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.