Belatacept — Membership Pricing

Other medications in Transplant

• Antithymocyte Globulin
• Basiliximab

What Belatacept is approved for (FDA label)

• NULOJIX is a selective T cell costimulation blocker indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant. (1.1) • Use in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids. (1.1) Limitations of Use : • Use only in patients who are EBV seropositive. (1.2 , 4 , 5.1) • Use has not been established for the prophylaxis of organ rejection in transplanted organs other than the kidney. (1.2 , 5.6) 1.1 Adult Kidney Transplant Recipients NULOJIX ® (belatacept) is indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant.

Source: Read the full FDA label on DailyMed. Label effective date: July 28, 2021.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Boxed warning for Belatacept (FDA label)

WARNING: POST-TRANSPLANT LYMPHOPROLIFERATIVE DISORDER, OTHER MALIGNANCIES, AND SERIOUS INFECTIONS Increased risk for developing post-transplant lymphoproliferative disorder (PTLD), predominantly involving the central nervous system (CNS). Recipients without immunity to Epstein-Barr virus (EBV) are at a particularly increased risk; therefore, use in EBV seropositive patients only. Do not use NULOJIX in transplant recipients who are EBV seronegative or with unknown EBV serostatus [see Contraindications (4) and Warnings and Precautions (5.1) ] . Only physicians experienced in immunosuppressive therapy and management of kidney transplant patients should prescribe NULOJIX. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient [see Warnings and Precautions (5.2) ] . Increased susceptibility to infection and the possible development of malignancies may result from immunosuppression [see Warnings and Precautions (5.1 , 5.3 , 5.4 , 5.5) ] . Use in liver transplant patients is not recommended due to an increased risk of graft loss and death [see Warnings and Precautions (5.6) ] . WARNING: POST-TRANSPLANT LYMPHOPROLIFERATIVE DISORDER, OTHER MALIGNANCIES, AND SERIOUS INFECTIONS See full prescribing information for complete boxed warning. • Increased risk for developing post-transplant lymphoproliferative disorder (PTLD), predominantly involving the central nervous system (CNS). Recipients without immunity to Epstein-Barr virus (EBV) are at a particularly increased risk; therefore, use in EBV seropositive patients only.

Source: FDA prescribing information (DailyMed). Set ID: c16ac648-d5d2-9f7d-8637-e2328572754e. SPL document ID: 9057087d-7e59-4e5a-8e4a-96a532efb0ab. Label effective date: July 28, 2021. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Belatacept (FDA label)

Lyophilized powder for injection: 250 mg per vial. Lyophilized powder for injection: 250 mg per vial (3)

Source: FDA prescribing information (DailyMed). Set ID: c16ac648-d5d2-9f7d-8637-e2328572754e. SPL document ID: 9057087d-7e59-4e5a-8e4a-96a532efb0ab. Label effective date: July 28, 2021. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Belatacept (FDA label)

The most serious adverse reactions reported with NULOJIX are: • PTLD, predominantly CNS PTLD, and other malignancies [see Boxed Warning and Warnings and Precautions (5.1 , 5.3) ] • Serious infections, including JC virus-associated PML and polyoma virus nephropathy [see Warnings and Precautions (5.4 , 5.5 , 5.6) ] Most common adverse reactions (≥20% on NULOJIX treatment) are anemia, diarrhea, urinary tract infection, peripheral edema, constipation, hypertension, pyrexia, graft dysfunction, cough, nausea, vomiting, headache, hypokalemia, hyperkalemia, and leukopenia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other trials and may not reflect the rates observed in clinical practice.

Source: FDA prescribing information (DailyMed). Set ID: c16ac648-d5d2-9f7d-8637-e2328572754e. SPL document ID: 9057087d-7e59-4e5a-8e4a-96a532efb0ab. Label effective date: July 28, 2021. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Belatacept (FDA label)

NULOJIX is contraindicated in transplant recipients who are Epstein-Barr virus (EBV) seronegative or with unknown EBV serostatus due to the risk of post-transplant lymphoproliferative disorder (PTLD), predominantly involving the central nervous system (CNS) [see Boxed Warning and Warnings and Precautions (5.1) ] . Patients who are EBV seronegative or with unknown EBV serostatus. (4)

Source: FDA prescribing information (DailyMed). Set ID: c16ac648-d5d2-9f7d-8637-e2328572754e. SPL document ID: 9057087d-7e59-4e5a-8e4a-96a532efb0ab. Label effective date: July 28, 2021. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Belatacept (FDA label)

• Post-Transplant Lymphoproliferative Disorder (PTLD) : increased risk, predominantly involving the CNS; monitor for new or worsening neurological, cognitive, or behavioral signs and symptoms. (Boxed Warning , 4 , 5.1 , 5.6) • Other malignancies : increased risk with all immunosuppressants; appears related to intensity and duration of use. Avoid prolonged exposure to UV light and sunlight. (5.3) • Progressive Multifocal Leukoencephalopathy (PML) : increased risk; consider in the diagnosis of patients reporting new or worsening neurological, cognitive, or behavioral signs and symptoms. Recommended doses of immunosuppressants should not be exceeded. (5.4) • Other serious infections : increased risk of bacterial, viral, fungal, and protozoal infections, including opportunistic infections and tuberculosis. Some infections were fatal. Polyoma virus-associated nephropathy can lead to kidney graft loss; consider reduction in immunosuppression. Evaluate for tuberculosis and initiate treatment for latent infection prior to NULOJIX use.

Source: FDA prescribing information (DailyMed). Set ID: c16ac648-d5d2-9f7d-8637-e2328572754e. SPL document ID: 9057087d-7e59-4e5a-8e4a-96a532efb0ab. Label effective date: July 28, 2021. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Belatacept (FDA label)

7.1 Mycophenolate Mofetil (MMF) Monitor for a need to adjust concomitant mycophenolate mofetil (MMF) dosage when a patient’s therapy is switched between cyclosporine and NULOJIX, as cyclosporine decreases mycophenolic acid (MPA) exposure by preventing enterohepatic recirculation of MPA while NULOJIX does not [see Clinical Pharmacology (12.3) ] : • A higher MMF dosage may be needed after switching from NULOJIX to cyclosporine, since this may result in lower MPA concentrations and increase the risk of graft rejection.

Source: FDA prescribing information (DailyMed). Set ID: c16ac648-d5d2-9f7d-8637-e2328572754e. SPL document ID: 9057087d-7e59-4e5a-8e4a-96a532efb0ab. Label effective date: July 28, 2021. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.