HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use

CABLIVI® safely and effectively. See full prescribing information for

CABLIVI.

CABLIVI (caplacizumab-yhdp) for injection, for intravenous or

subcutaneous use

Initial U.S. Approval: 2019

INDICATIONS AND USAGE

CABLIVI is a von Willebrand factor (vWF)-directed antibody fragmentindicated for the treatment of adult patients with acquired thromboticthrombocytopenic purpura (aTTP), in combination with plasma exchange and

immunosuppressive therapy. (1)

DOSAGE AND ADMINISTRATION

CABLIVI should be administered upon the initiation of plasma exchangetherapy. The recommended dose of CABLIVI is as follows: (2.1)

o First day of treatment: 11 mg bolus intravenous injection at least 15minutes prior to plasma exchange followed by an 11 mg subcutaneousinjection after completion of plasma exchange on day 1.

o Subsequent treatment during daily plasma exchange: 11 mgsubcutaneous injection once daily following plasma exchange.

o Treatment after the plasma exchange period: 11 mg subcutaneousinjection once daily for 30 days beyond the last plasma exchange.

o If after initial treatment course, sign(s) of persistent underlying diseasesuch as suppressed ADAMTS13 activity levels remain present,treatment may be extended for a maximum of 28 days.

o Discontinue CABLIVI if the patient experiences more than 2recurrences of aTTP, while on CABLIVI. intravenous injection. Administer subsequent doses subcutaneously in the

abdomen. (2.3)

DOSAGE FORMS AND STRENGTHS

For injection: 11 mg as a lyophilized powder in a single-dose vial. (3)

CONTRAINDICATIONS

Previous severe hypersensitivity reaction to caplacizumab-yhdp or any of theexcipients. (4)

WARNINGS AND PRECAUTIONS

Bleeding: Severe bleeding can occur; risk is increased in patients withunderlying coagulopathies. If clinically significant bleeding occurs, interrupttreatment. Withhold CABLIVI 7 days prior to elective surgery, dentalprocedures, or other invasive interventions. (5.1)

ADVERSE REACTIONS

Most common adverse reactions (incidence >15%) are epistaxis, headache,and gingival bleeding. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Ablynx US at1-800-745-4447 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Concomitant use of anticoagulants with CABLIVI may increase the risk ofbleeding. Monitor closely for bleeding with concomitant use. (7)

See 17 for PATIENT COUNSELING INFORMATION and FDAapproved

patient labeling.

Revised: 02/2019 

The first dose should be administered by a healthcare provider as a bolus 

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dose and Schedules

2.2 Discontinuation for Surgery and Other Interventions

2.3 Reconstitution and Administration Instructions

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Bleeding

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Immunogenicity

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Hepatic Impairment