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Access CABLIVI quickly and efficiently

CABLIVI pharmacy ordering information

Consider stocking or consigning CABLIVI so that therapy is on hand when it's needed most. CABLIVI is available through a network of authorized specialty distributors (SD) for hospital acquisition. Hospitals and health systems can obtain CABLIVI by placing an order to stock or consign through 1 of the 4 authorized SDs below. It is up to your institution to determine the procurement option that works best for your practice or facility.

SDs for hospital inpatient acquisition

Cardinal SPD

1-855-855-0708

ASD

1-800-746-6273

McKesson SD

1-877-625-2566

BioCare SD

1-800-304-3064

SDs for hospital inpatient acquisition

Cardinal SPD

1-855-855-0708

ASD

1-800-746-6273

McKesson SD

1-877-625-2566

BioCare SD

1-800-304-3064

SDs for hospital inpatient acquisition

Cardinal SPD

1-855-855-0708

ASD

1-800-746-6273

McKesson SD

1-877-625-2566

BioCare SD

1-800-304-3064

If your institution enrolls in CoverMyMeds®, you can use it to complete and process electronic prior authorizations (ePAs) and enroll patients in CABLIVI Patient Solutions.

CABLIVI patient enrollment form

To help your patients transition from hospital to home, complete the CABLIVI Patient Enrollment Form as soon as treatment is initiated. Download, print, and fax the enrollment form to 800-914-0694 to ensure your patients have access to support.

Because prior authorization for outpatient use may take several days, it is recommended that healthcare providers initiate the process simultaneously with the start of inpatient treatment.

CABLIVI Patient Solutions:

  • Provides financial assistance for eligible patients
  • Helps patients with supplemental administration training

Biologics, the specialty pharmacy provider for CABLIVI:

  • Performs a benefit investigation and faxes a summary of benefits to the HCP
  • Coordinates timely home delivery of CABLIVI
  • Provides ongoing support from nurses who can answer questions about CABLIVI
  • Provides access to a pharmacist 24 hours a day, 7 days a week

Contact information for discharge planning and shipping

Biologics

1-855-724-7222, Option 2

CABLIVI Patient Enrollment Form

Enroll patients in CABLIVI Patient Solutions for access to specialty pharmacy services, financial assistance, and supplemental administration training.

Download the patient
enrollment form

CABLIVI Hospital Guide

This guide highlights key information related to the procurement of, and patient access to, CABLIVI.

Download the hospital guide

Help your patients transition from hospital to home

Learn about CABLIVI Patient Solutions

CABLIVI in the hospital and at home

Explore dosing and administration

aTTP=acquired thrombotic thrombocytopenic purpura; HCP=healthcare professional; ISTH=International Society on Thrombosis and Haemostasis; iTTP=immune-mediated thrombotic thrombocytopenic purpura.

IMPORTANT SAFETY
INFORMATION AND INDICATIONS

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS:

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

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IMPORTANT SAFETY
INFORMATION AND INDICATIONS

IMPORTANT SAFETY INFORMATION

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:

Hemorrhage:
  • 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.
  • In the postmarketing setting cases of life-threatening and fatal bleeding were reported in patients receiving CABLIVI.
  • 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.
  • Avoid concomitant use of CABLIVI with antiplatelet agents or anticoagulants. 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 OR ANTIPLATELET AGENTS:

Concomitant use of CABLIVI with any anticoagulant or antiplatelet agent may increase the risk of bleeding. Avoid concomitant use when possible. 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.

Please see Full Prescribing Information

Instructions for Use

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References: 1. CABLIVI Prescribing Information: Genzyme Corporation. 2. Scully M, Cataland SR, Peyvandi F, et al; for the HERCULES Investigators. Caplacizumab treatment for acquired thrombotic thrombocytopenic purpura. N Engl J Med. 2019;380(4):335-346. 3. Zheng XL, Vesely SK, Cataland SR, et al. ISTH guidelines for the diagnosis of thrombotic thrombocytopenic purpura. J Thromb Haemost. 2020;18(10):2486-2495. doi:10.1111/jth.15006. 4. Grall M, Azoulay E, Galicier L, et al. Thrombotic thrombocytopenic purpura misdiagnosed as autoimmune cytopenia: causes of diagnostic errors and consequence on outcome. Experience of the French thrombotic microangiopathies reference centre. Am J Hematol. 2017;92(4):381-387. 5. Scully M, Hunt BJ, Benjamin S, et al. On behalf of British Committee for Standards in Haematology. Guidelines on the diagnosis and management of thrombotic thrombocytopenic purpura and other thrombotic microangiopathies. Br J Haematol. 2012;158(3):323-335. 6. Goel R, King KE, Takemoto CM, Ness PM, Tobian AAR. Prognostic risk-stratified score for predicting mortality in hospitalized patients with thrombotic thrombocytopenic purpura: national representative data from 2007 to 2012. Transfusion. 2016;56(6):1451-1458. 7. Peyvandi F, Scully M, Kremer Hovinga JA, et al. Caplacizumab reduces the frequency of major thromboembolic events, exacerbations and death in patients with acquired thrombotic thrombocytopenic purpura. J Thromb Haemost. 2017;15(7):1448-1452. 8. Joly BS, Coppo P, Veyradier A. Thrombotic thrombocytopenic purpura. Blood. 2017;129(21):2836-2846. 9. Masias C, Wu H, McGookey M, Jay L, Cataland S, Yang S. No major differences in outcomes between the initial and relapse episodes in patients with thrombotic thrombocytopenic purpura: the experience from the Ohio State University Registry. Am J Hematol. 2018;93(3):E73-E75. doi:10.1002/ajh.25002. 10. Schieppati F, Russo L, Marchetti M, et al. Low levels of ADAMTS-13 with high anti-ADAMTS-13 antibodies during remission of immune-mediated thrombotic thrombocytopenic purpura highly predict for disease relapse: a multi-institutional study. Am J Hematol. 2020;95(8):953-959. doi:10.1002/ajh.25845. 11. Knoebl P, Cataland S, Peyvandi F, et al. Efficacy and safety of open-label caplacizumab in patients with exacerbations of acquired thrombotic thrombocytopenic purpura in the HERCULES study. J Thromb Haemost. 2020;18(2):479-484. doi:10.1111/jth.14679. 12. Sayani FA, Abrams CS. How I treat refractory thrombotic thrombocytopenic purpura. Blood. 2017;130(14):1684. doi:10.1182/blood-2017-08-803171. 13. Kremer Hovinga JA, Coppo P, Lämmle B, Moake JL, Miyata T, Vanhoorelbeke K. Thrombotic thrombocytopenic purpura. Nat Rev Dis Primers. 2017;3:17020. doi:10.1038/nrdp.2017.20. 14. Holz J-B. The TITAN trial—assessing the efficacy and safety of an anti-von Willebrand factor Nanobody in patients with acquired thrombotic thrombocytopenic purpura. Transfus Apher Sci. 2012;46(3):343-346. 15. Azoulay E, Bauer PR, Mariotte E, et al; Nine-i Investigators. Expert statement on the ICU management of patients with thrombotic thrombocytopenic purpura. Intensive Care Med. 2019;45(11):1518-1539. doi:10.1007/s00134-019-05736-5. 16. Kremer Hovinga JA, Vesely SK, Terrell DR, Lämmle B, George JN. Survival and relapse in patients with thrombotic thrombocytopenic purpura. Blood. 2010;115(8):1500-1511. doi:10.1182/blood-2009-09-243790. 17. Upreti H, Kasmani J, Dane K, et al. Reduced ADAMTS13 activity during TTP remission is associated with stroke in TTP survivors. Blood. 2019;134(13):1037-1045. doi:10.1182/blood.2019001056. 18. Cuker A, Cataland SR, Coppo P, et al. Redefining outcomes in immune TTP: an international working group consensus report. Blood. 2021;137(14):1855-1861. doi:10.1182/blood.2020009150. 19. Vincent J-L, Castro P, Hunt BJ, et al. Thrombocytopenia in the ICU: disseminated intravascular coagulation and thrombotic microangiopathies—what intensivists need to know. Crit Care. 2018;22(1):158. 20. Chiasakul T, Cuker A. Clinical and laboratory diagnosis of TTP: an integrated approach. Hematology Am Soc Hematol Educ Program. 2018;2018(1):530-538. 21. Canpolat N. Hemolytic uremic syndrome. Turk Pediatri Ars. 2015;50(2):73-82. 22. Venugopal A. Disseminated intravascular coagulation. Indian J Anaesth. 2014;58(5):603-608. 23. Wada H, Matsumoto T, Suzuki K, et al. Differences and similarities between disseminated intravascular coagulation and thrombotic microangiopathy. Thromb J. 2018;16:14. 24. Cataland SR, Wu HM. How I treat: the clinical differentiation and initial treatment of adult patients with atypical hemolytic uremic syndrome. Blood. 2014;123(16):2478-2484. 25. Laurence J, Haller H, Mannucci PM, Nangaku M, Praga M, de Cordoba SR. Atypical hemolytic uremic syndrome (aHUS): essential aspects of an accurate diagnosis. Clin Adv Hematol Oncol. 2016;14 Suppl 11(11):2-15. 26. Supplement to: Scully M, Cataland SR, Peyvandi F, et al; for the HERCULES Investigators. Caplacizumab treatment for acquired thrombotic thrombocytopenic purpura. N Engl J Med. 2019;380(4):335-346. doi:10.1056/NEJMoa1806311. 27. Protocol for: Scully M, Cataland SR, Peyvandi F, et al; for the HERCULES Investigators. Caplacizumab treatment for acquired thrombotic thrombocytopenic purpura. N Engl J Med. 2019;380(4):335-346. doi:10.1056/NEJMoa1806311. 28. CABLIVI [instructions for use]. Cambridge, MA: Genzyme Corporation. 29. Zheng XL, Vesely SK, Cataland SR, et al. ISTH guidelines for treatment of thrombotic thrombocytopenic purpura. J Thromb Haemost. 2020;18(10):2496-2502. doi:10.1111/jth.15010 30. Centers for Medicare & Medicaid Services. ICD-10-CM/PCS MS-DRGv37 Definitions Manual: MDC 8 Diseases & Disorders of the Musculoskeletal System & Connective Tissue Disorders. https://www.cms.gov/icd10m/version37-fullcode-cms/fullcode_cms/P0213.html. Updated September 12, 2019. Accessed January 9, 2023. 31. Centers for Medicare & Medicaid Services. 2023 ICD-10-CM. https://www.cms.gov/files/zip/2023-code-tables-tabular-and-index.zip. Updated July 27, 2022. Accessed January 9, 2023. 32. Centers for Medicare & Medicaid Services. 2023 ICD-10-PCS. https://www.cms.gov/files/zip/2023-icd-10-pcs-code-tables-and-index.zip. Accessed January 9, 2023.