For U.S. Healthcare Professionals Only

Help your patients transition from hospital to home with CABLIVI

Financial and educational assistance with CABLIVI Patient Solutions

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SPECIALTY PHARMACY SERVICES

For patients who obtain their medication through Biologics by McKesson:

  • The specialty pharmacy coordinates direct-to-home shipment of CABLIVI for a seamless transition upon discharge
  • Nurses are available to provide ongoing support and answer questions about CABLIVI
  • Pharmacists are available 24 hours a day, 7 days a week
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FINANCIAL ASSISTANCE

  • Support is available to cover the cost of CABLIVI co-pay or co-insurance for qualified, commercially insured patients up to the program maximum*
  • CABLIVI will be provided at no cost to eligible underinsured or uninsured patients
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SUPPLEMENTAL TRAINING

Clinical educators are available to provide:

  • Supplemental education on how to self-administer CABLIVI
  • Support in setting up a plan for administering therapy
  • Additional in-home support after hospital discharge
  • Answers to questions about CABLIVI

CABLIVI Patient Solutions help is available Monday through Friday, 8:00 AM to 8:00 PM ET, at 1-855-724-7222.

CABLIVI Patient Enrollment Form

CABLIVI Patient Enrollment Form

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

CABLIVI Patient Solutions

CABLIVI Patient Solutions

Learn more about the support offered through CABLIVI Patient Solutions.

Hospital and Home

CABLIVI in the hospital and at home

CABLIVI dots

CABLIVI can help make a difference

*This offer is not valid for prescriptions paid, in whole or in part, by Medicaid, Medicare, Veterans Affairs, Departments of Defense, TRICARE, or similar federal or state programs.

Approval is not guaranteed. Sanofi Genzyme reserves the right to modify or discontinue the programs at any time.

CABLIVI clinical educators are paid to provide educational services. They don’t provide medical advice. Patients should always consult their physicians with any health care needs.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

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:

Bleeding Risk:

  • 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. The risk of bleeding is increased, in patients with underlying coagulopathies and concomitant use of CABLIVI with drugs affecting hemostasis.
  • 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:

Concomitant use of CABLIVI with any anticoagulant may increase the risk of bleeding. 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.

References:
  1. 1. CABLIVI [package insert]. Cambridge, MA: Genzyme Corporation; 2019.
  2. 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.
References:
  1. 1. 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.
  2. 2. 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.
  3. 3. 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.
  4. 4. 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.
  5. 5. Joly BS, Coppo P, Veyradier A. Thrombotic thrombocytopenic purpura. Blood. 2017;129(21):2836-2846.
References:
  1. 1. CABLIVI [package insert]. Cambridge, MA: Genzyme Corporation; 2019.
  2. 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. 3. 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
  4. 4. 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.
References:
  1. 1. CABLIVI [package insert]. Cambridge, MA: Genzyme Corporation; 2019.
  2. 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. 3. 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.
  4. 4. 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.
References:
  1. 1. CABLIVI [package insert]. Cambridge, MA: Genzyme Corporation; 2019.
  2. 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.
Reference:
  1. 1. 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.
Reference:
  1. 1. CABLIVI [package insert]. Cambridge, MA: Genzyme Corporation; 2019.
References:
  1. 1. CABLIVI [package insert]. Cambridge, MA: Genzyme Corporation; 2019.
  2. 2. CABLIVI [instructions for use]. Cambridge, MA: Genzyme Corporation; 2019.
References:
  1. 1. Centers for Medicare & Medicaid Services. Draft ICD-10-CM/PCS MS-DRGv28 Definitions Manual: MDC 8 Diseases & Disorders of the Musculoskeletal System & Connective Tissue Disorders. https://www.cms.gov/icd10manual/fullcode_cms/P0209.html. Accessed July 25, 2019.
  2. 2. Centers for Medicare & Medicaid Services. Department of Health and Human Services. 42 CFR §412, 413, 495. Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2020 Rates; Proposed Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Promoting Interoperability Programs Proposed Requirements for Eligible Hospitals and Critical Access Hospitals. Fed Regist. 2019;84:19158-19677.
  3. 3. Data on file. Conshohocken, PA: Sanofi; 2018.
  4. 4. Centers for Medicare & Medicaid Services. 2019 ICD-10-CM. https://www.cms.gov/Medicare/Coding/ICD10/2019-ICD-10-CM.html. Updated June 20, 2019. Accessed July 23, 2019.
  5. 5. Centers for Medicare & Medicaid Services. 2020 ICD-10-PCS. https://www.cms.gov/Medicare/Coding/ICD10/2020-ICD-10-PCS.html. Accessed July 25, 2019.