Rx Item- Cablivi 11mg (11 Mg) Kit 1X1 Each By Sanofi

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 fragment indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy. (1)

DOSAGE AND ADMINISTRATION
CABLIVI should be administered upon the initiation of plasma exchange therapy. The recommended dose of CABLIVI is as follows: (2.1)
First day of treatment: 11 mg bolus intravenous injection at least 15 minutes prior to plasma exchange followed by an 11 mg subcutaneous injection after completion of plasma exchange on day 1.
Subsequent treatment during daily plasma exchange: 11 mg subcutaneous injection once daily following plasma exchange.
Treatment after the plasma exchange period: 11 mg subcutaneous injection once daily for 30 days beyond the last plasma exchange.
If after initial treatment course, 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 on CABLIVI.
The first dose should be administered by a healthcare provider as a bolus 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 the excipients. (4)

WARNINGS AND PRECAUTIONS
Bleeding: Severe bleeding can occur; risk is increased in patients with underlying coagulopathies. If clinically significant bleeding occurs, interrupt treatment. Withhold CABLIVI 7 days prior to elective surgery, dental procedures, 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 at 1-800-745-4447 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 2/2019

CABLIVI 11MG (11 MG) KIT 1X1 E
NDC No.58468-0225-01 58468-225-01 UPC/GTIN No..3-58468-22501-6 MPN 22501Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, Np, Optometrist, Pharma

CABLIVI 11MG (11 MG) KIT 1X1 E
CABLIVI 11MG (11 MG) KIT 1X1 EA by SANOFI "Generic Name: CAPLACIZUMAB-YHDP Description: CABLIVI 11MG (11 MG) KIT 1X1 EA NDC: 58468-0225-01 58468-225-01 5846822501 58468022501 UPC: 358468-0

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CABLIVI 11MG (11 MG) KIT 1X1 E
CABLIVI 11MG (11 MG) KIT 1X1 EA by SANOFI Generic Name: