11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

16.2 Storage

17 PATIENT COUNSELING INFORMATION

*Sections or subsections omitted from the full prescribing information are notlisted. 

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

CABLIVI is indicated for the treatment of adult patients with acquired thromboticthrombocytopenic purpura (aTTP), in combination with plasma exchange andimmunosuppressive therapy.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dose and Schedules

CABLIVI should be administered upon initiation of plasma exchange therapy. Therecommended dose of CABLIVI is as follows:

First day of treatment: 11 mg bolus intravenous injection at least 15 minutes prior toplasma exchange followed by an 11 mg subcutaneous injection after completion of

plasma exchange on day 1.

Subsequent days of treatment during daily plasma exchange: 11 mg subcutaneousinjection once daily following plasma exchange.

Treatment after plasma exchange period: 11 mg subcutaneous injection once dailycontinuing for 30 days following the last daily plasma exchange. If after initial treatmentcourse, sign(s) of persistent underlying disease such as suppressed ADAMTS13 activity

levels remain present, treatment may be extended for a maximum of 28 days.

Discontinue CABLIVI if the patient experiences more than 2 recurrences of aTTP, while onCABLIVI.

Missed Dose

If a dose of CABLIVI is missed during the plasma exchange period, it should be given as soon aspossible. If a dose of CABLIVI is missed after the plasma exchange period, it can be

administered within 12 hours of the scheduled time of administration. Beyond 12 hours, themissed dose should be skipped and the next daily dose administered according to the usual

dosing schedule.

2.2 Discontinuation for Surgery and Other Interventions

Withhold CABLIVI treatment 7 days prior to elective surgery, dental procedures, or otherinvasive interventions [see Warnings and Precautions (5.1)].

2.3 Reconstitution and Administration Instructions

The first dose of CABLIVI should be administered by a healthcare provider as a bolusintravenous injection. Administer subsequent doses subcutaneously in the abdomen. Avoidinjections around the navel. Do not administer consecutive injections in the same abdominal

quadrant.

Patients or caregivers may inject CABLIVI subcutaneously after proper training on thepreparation and administration of CABLIVI, including aseptic technique [see Instructions for Use].

Ensure the CABLIVI vial and diluent syringe are at room temperature.

Reconstitute CABLIVI before administration using the provided syringe containing 1 mLSterile Water for Injection, USP, to yield an 11 mg/mL single-dose solution.

Using aseptic technique throughout the preparation of the solution, attach the vial adapterto the vial containing CABLIVI.

 Remove the plastic cap from the syringe and attach it to the vial adapter by twisting it

clockwise until it cannot twist any further.