Belatacept

Belatacept is a prescription medication used in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids to prevent kidney transplant rejection.

• Belatacept is available under the following different brand names: Nulojix

Common side effects of Belatacept include:

• High or low potassium,
• Increased blood pressure,
• Nausea,
• Vomiting,
• Diarrhoea,
• Constipation,
• Kidney or bladder infection,
• Headache,
• Fever,
• Cough, and
• Swelling in the legs or feet

Serious side effects of Belatacept include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Fever,
• Swollen glands,
• Flu symptoms,
• Night sweats,
• Stomach pain,
• Vomiting,
• Diarrhoea,
• Weight loss,
• Weakness on one side of the body,
• Decreased vision,
• Problems with speech or walking,
• Memory problems,
• Changes in your mental state,
• Blood in your urine,
• Burning when you urinate,
• Little or no urination,
• Tenderness around the transplanted kidney,
• New skin lesion,
• Mole that has changed in size or color,
• Pale skin,
• Unusual tiredness,
• Lightheaded,
• Cold hands and feet,
• Nausea,
• Weakness,
• Tingly feeling,
• Chest pain,
• Irregular heartbeats,
• Loss of movement,
• Leg cramps,
• Constipation,
• Fluttering in the chest,
• Increased thirst or urination,
• Muscle weakness, and
• Limp feeling

Rare side effects of Belatacept include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, lyophilized powder for reconstitution

• 250 mg/vial

Kidney Transplant Rejection Prophylaxis

Adult dosage

• Dose calculation and schedule
  • Total infusion dose based on actual body weight of patient at the time of transplantation; modify dose if weight changes by above 10%
  • The prescribed dose must be divisible by 12.5 mg to accurately prepare the dose from the reconstituted solution
  • Initial phase: 10 mg/kg Intravenous on the day of transplant (before implantation); repeat this dose on Day 5 and at end of Weeks 2, 4, 8, and 12 after transplantation  
  • Maintenance phase: 5 mg/kg Intravenous at end of Week 16 after transplantation and then every 4 weeks (within +/- 3 days) thereafter

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Belatacept has severe interactions with the following drug
  • upadacitinib
• Belatacept has serious interactions with the following drugs
  • axicabtagene ciloleucel
  • brexucabtagene autoleucel
  • ciltacabtagene autoleucel
  • idecabtagene vicleucel
  • influenza virus vaccine quadrivalent, adjuvanted
  • influenza virus vaccine trivalent, adjuvanted
  • lisocabtagene maraleucel
  • sipuleucel-T
  • tisagenlecleucel
  • tofacitinib
• Belatacept has moderate interactions with at least 119 other drugs.
• Belatacept has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity
• Patients who are EBV seronegative or with unknown EBV serostatus (see Black Box Warnings)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Belatacept?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Belatacept?”

Cautions

• See Black Box Warnings
• In postmarketing experience, use in conjunction with basiliximab induction, MMF, and corticosteroid minimization to 5 mg/day between Day 3 and Week 6 post-transplant was associated with an increased rate and grade of acute rejection, particularly Grade III rejection; these Grade III rejections occurred in patients with 4 to 6 HLA mismatches; graft loss was a consequence of Grade III rejection in some patients.
• Serious infections may occur including bacterial, viral (cytomegalovirus [CMV], herpes, polyomavirus nephropathy), fungal, and protozoal infections, including opportunistic infections (.g, tuberculosis); these infections may lead to serious, including fatal, outcomes
• Tuberculosis was more frequently observed
• Cases of polyoma virus-associated nephropathy (PVAN), mostly due to BK virus infection, reported
• Patients receiving immunosuppressants, including belatacept, are at increased risk for developing malignancies; advised added precautions including limiting UV exposure and wearing sunscreen
• Risk of rejection with the conversion from a calcineurin inhibitor (CNI) based maintenance regimen reported; conversion of stable kidney transplant recipients from CNI-based maintenance therapy to a belatacept-based maintenance therapy not recommended unless the patient is CNI intolerant
• Post-transplant lymphoproliferative disorder
  • Increased risk for developing post-transplant lymphoproliferative disorder (PTLD), predominantly involving the CNS, compared to patients on a cyclosporine-based regimen
  • As the total burden of immunosuppression is a risk factor for PTLD, higher than the recommended doses or more frequent dosing of belatacept and higher than recommended doses of concomitant immunosuppressive agents are not recommended
  • Consider PTLD in patients reporting new or worsening neurological, cognitive, or behavioral signs or symptoms
  • Risk of PTLD was higher in EBV seronegative patients compared to EBV seropositive patients
  • EBV seropositive patients are defined as having evidence of acquired immunity shown by the presence of IgG antibodies to viral capsid antigen (VCA) and EBV nuclear antigen (EBNA)
  • Epstein-Barr virus serology should be ascertained before starting administration of belatacept, and only patients who are EBV seropositive should receive belatacept
  • Transplant recipients who are EBV seronegative, or with unknown serostatus, should not receive belatacept (see Black Box Warnings and Contraindications)
  • Other known risk factors for PTLD include cytomegalovirus (CMV) infection and T-cell depleting therapy
• Progressive multifocal leukoencephalopathy (PML)
  • PML is a rare occurrence but is a rapidly progressive and fatal opportunistic infection of the CNS that is caused by the JC virus, a human polyomavirus
  • In clinical trials, 2 cases of PML were reported in patients receiving belatacept at higher cumulative doses and administered more frequently than the recommended regimen
• Drug interaction overview
  • Avoid the use of live vaccines during treatment with belatacept, including but not limited to the following: intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, and TY21a typhoid vaccines
  • In the postmarketing experience in de novo kidney transplant recipients, venous thrombosis of the renal allograft was reported when the initial dose of antithymocyte globulin (ATG), as immunosuppressive induction, was coadministered (at the same or nearly the same time) with the first dose of belatacept; coadministration of ATG and belatacept may pose a risk for venous thrombosis of the renal allograft; if ATG (or any other cell-depleting induction treatment) and belatacept will be administered concomitantly, consider a 12-hr interval between the 2 administrations
  • Monitor mycophenolate mofetil (MMF) dosage when a patient’s therapy is switched between cyclosporine and belatacept; cyclosporine decreases mycophenolic acid (MPA) exposure by preventing enterohepatic recirculation of MPA while belatacept does not

Pregnancy and Lactation

• To monitor maternal-fetal outcomes of pregnant women who have received immunosuppressants, healthcare providers are strongly encouraged to register pregnant patients in the Transplant Pregnancy Registry International (TPR) by calling 1-877-955-687
• There is insufficient data on belatacept use in pregnant women to inform on drug-associated risk
• Lactation
  • There are no data on the presence of belatacept in human milk or the effects of belatacept on breastfed infants or human milk production to inform risk of belatacept to an infant during lactation
  • Belatacept is excreted in rat milk after IV administration, and the drug may be present in human milk