Gently swirl the vial until the cake or powder is completely dissolved. Do not shake.

Visually inspect that the reconstituted solution is clear and colorless.

Withdraw all of the clear, colorless reconstituted solution from the vial into the syringe.

Label the CABLIVI syringe.

Administer the full amount of reconstituted solution.

For the initial intravenous injection, if using an intravenous line, the glass syringe shouldbe connected to a standard Luer lock (and not a needleless connector) and flushed with

either 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP.

Use the CABLIVI solution immediately. If not, use CABLIVI within 4 hours afterreconstitution when stored in the refrigerator at 2°C to 8°C (36°F to 46°F).

3 DOSAGE FORMS AND STRENGTHS

For injection: 11 mg as a white lyophilized powder in a single-dose vial.

4 CONTRAINDICATIONS

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

[see Adverse Reactions (6.1)].

5 WARNINGS AND PRECAUTIONS

5.1 Bleeding

CABLIVI increases the risk of bleeding [see Adverse Reactions (6.1)]. In clinical studies, severebleeding adverse reactions of epistaxis, gingival bleeding, upper gastrointestinal hemorrhage,

and metrorrhagia were each reported in 1% of subjects. Overall, bleeding events occurred inapproximately 58% of patients on CABLIVI versus 43% of patients on placebo.

The risk of bleeding is increased in patients with underlying coagulopathies (e.g. hemophilia,other coagulation factor deficiencies). It is also increased with concomitant use of CABLIVI

with drugs affecting hemostasis and coagulation [see Drug Interactions (7) and ClinicalPharmacology (12.3)]. 

Interrupt use of CABLIVI if clinically significant bleeding occurs. If needed, 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 invasiveinterventions. 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, andCABLIVI is resumed, monitor closely for signs of bleeding.

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are also discussed in other sections of thelabeling:

Bleeding [see Warnings and Precautions (5.1)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction ratesobserved 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 CABLIVI was eva luated in two placebo-controlled clinical studies (HERCULES,in which 71 patients received CABLIVI; and TITAN, in which 35 patients received CABLIVI).

The data described below and in the Warnings and Precautions reflect exposure to CABLIVIduring the blinded periods of both studies, which include 106 patients with aTTP who received at