Belatacept

What is Belatacept?

• Belatacept (Nulojix) is a selective T cell costimulation blocker used in adults to prevent transplant rejection in people who have received a kidney transplant.

What are the uses of this medicine?

• Belatacept (Nulojix) is a prescription medicine used in adults to prevent transplant rejection in people who have received a kidney transplant.
• Transplant rejection happens when the body’s immune system senses that the new transplanted kidney is different or foreign, and attacks it.
• Nulojix is used with corticosteroids and certain other medicines to help prevent rejection of your new kidney.

Limitations of Use:

• Nulojix is only used in people who have been exposed to the EBV virus.
• It is not known if Nulojix is safe and effective in people who receive an organ transplant other than a kidney transplant.

How does this medicine work?

• Belatacept, a selective T cell (lymphocyte) costimulation blocker, binds to CD80 and CD86 on antigen-presenting cells thereby blocking CD28 mediated costimulation of T lymphocytes.
• In vitro, belatacept inhibits T lymphocyte proliferation and the production of the cytokines interleukin-2, interferon-γ, interleukin-4, and TNF-α.
• Activated T lymphocytes are the predominant mediators of immunologic rejection.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are EBV negative.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Is this medicine FDA approved?

• Belatacept was developed by Bristol-Myers-Squibb and approved by the U.S. Food and Drug Administration (FDA) on June 15, 2011.

How should this medicine be used?

Recommended dosage:

Dosing of NULOJIX for Kidney Transplant Recipients

Dosing for Initial Phase	Dose
Day 1 (day of transplantation, prior to implantation) and Day 5 (approximately 96 hours after Day 1 dose)	10 mg per kg
End of Week 2 and Week 4 after transplantation	10 mg per kg
End of Week 8 and Week 12 after transplantation	10 mg per kg

Dosing for Maintenance Phase:

• End of Week 16 after transplantation and every 4 weeks (plus or minus 3 days) thereafter: 5 mg per kg

Administration:

• Belatacept injection comes as a solution (liquid) to be injected over 30 minutes into a vein, usually by a doctor or nurse in a hospital or medical facility.
• During treatment with Nulojix, your doctor will test your blood and urine to check how your kidney is working.
• Take all the medicines prescribed by your doctor to prevent infection or transplant rejection.
• Take them exactly as your doctor tells you.
• Talk to your doctor or pharmacist if you have any questions about how to take your medicines.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Lyophilized powder for injection: 250 mg per vial

This medicine is available in fallowing brand namesː

• Nulojix

What side effects can this medication cause?

The most common side effects of this medicine include:

• low red blood count (anemia)
• diarrhea
• kidney or bladder infection
• swollen legs, feet, or ankles
• constipation
• high blood pressure
• fever
• new kidney not working well
• cough
• nausea or vomiting
• headache
• low potassium or high potassium in your blood
• low white blood cell count

Nulojix increases your risk of serious side effects, including:

• Post-transplant lymphoproliferative disorder (PTLD)
• Increased risk of getting cancers other than PTLD
• Progressive multifocal leukoencephalopathy (PML)
• Increased risk of getting other serious infections, including tuberculosis (TB) and other infections caused by bacteria, viruses, or fungi

What special precautions should I follow?

• Nulojix-treated patients have an increased risk for developing post-transplant lymphoproliferative disorder (PTLD), predominantly involving the CNS. Monitor for new or worsening neurological, cognitive, or behavioral signs and symptoms.
• Epstein-Barr virus serology should be ascertained before starting administration of Nulojix, and only patients who are EBV seropositive should receive Nulojix. Transplant recipients who are EBV seronegative, or with unknown serostatus, should not receive Nulojix.
• Only physicians experienced in management of systemic immunosuppressant therapy in transplantation should prescribe Nulojix. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources.
• Limit the amount of time you spend in sunlight. Avoid using tanning beds or sunlamps. People who take medicines that weaken the immune system, including Nulojix, have a higher risk of getting cancer, including skin cancer. Wear protective clothing and use sunscreen with a high protection factor (SPF) when you have to be in the sun.
• Progressive multifocal leukoencephalopathy (PML) is an often rapidly progressive and fatal opportunistic infection of the CNS that is caused by the JC virus, a human polyoma virus. If PML is diagnosed, consideration should be given to reduction or withdrawal of immunosuppression taking into account the risk to the allograft.
• Patients receiving immunosuppressants, including Nulojix, are at increased risk of developing bacterial, viral (cytomegalovirus [CMV] and herpes), fungal, and protozoal infections, including opportunistic infections. These infections may lead to serious, including fatal, outcomes. Prophylaxis for cytomegalovirus is recommended for at least 3 months after transplantation. Prophylaxis for Pneumocystis jiroveci is recommended after transplantation.
• Tuberculosis was more frequently observed in patients receiving Nulojix. Treatment of latent tuberculosis infection should be initiated prior to Nulojix use.
• Use of Nulojix in liver transplant patients is not recommended.
• corticosteroid utilization should be consistent with the Nulojix clinical trial experience.
• The use of live vaccines should be avoided during treatment with Nulojix.
• In de novo kidney transplant recipients, especially those with other predisposing risk factors for venous thrombosis of the renal allograft, coadministration (at the same or nearly the same time) with anti-thymocyte globulin may pose a risk for venous thrombosis of the renal allograft.
• Conversion of maintenance kidney transplant recipients from a CNI based to Nulojix based maintenance regimen increases the risk of acute rejection. Conversion of stable kidney transplant recipients from a CNI based maintenance therapy to a belatacept based maintenance therapy is not recommended unless the patient is CNI intolerant.
• There are no data on the presence of Nulojix in human milk or the effects of Nulojix on breastfed infants or human milk production to inform risk of Nulojix to an infant during lactation.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• CNS-related adverse reactions

Management of overdosage:

• In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment instituted.

Can this medicine be used in pregnancy?

• It is not known if Nulojix will harm your unborn baby. If you become pregnant while taking Nulojix:
• Tell your doctor right away. You and your doctor should decide if you will keep receiving Nulojix while you are pregnant.
• Talk with your doctor about enrolling in the National Transplant Pregnancy Registry (NTPR). This Registry collects information about pregnancies in women who have received Nulojix or if their partner has received Nulojix, and had a transplant. You can also enroll by calling 1-877-955-6877.

Can this medicine be used in children?

• It is not known if Nulojix is safe and effective in children under 18 years of age.

What are the active and inactive ingredients in this medicine?

• Active ingredient: belatacept
• Inactive ingredients: monobasic sodium phosphate, sodium chloride, and sucrose

Who manufactures and distributes this medicine?

Manufactured by:

• Bristol-Myers Squibb Company
• Princeton, New Jersey

What should I know about storage and disposal of this medication?

• Nulojix lyophilized powder is stored refrigerated at 2°C to 8°C (36°F to 46°F).
• Protect Nulojix from light by storing in the original package until time of use.
• The reconstituted solution should be transferred from the vial to the infusion bag or bottle immediately.
• The Nulojix infusion must be completed within 24 hours of constitution of the Nulojix lyophilized powder.
• If not used immediately, the infusion solution may be stored under refrigeration conditions: 2°C to 8°C (36°F to 46°F) and protected from light for up to 24 hours (a maximum of 4 hours of the total 24 hours can be at room temperature: 20°C to 25°C [68°F to 77°F] and room light).

• Dailymed label info on Belatacept
• FDA Belatacept

Belatacept Resources
Need Help Finding a Doctor? Need help finding a doctor or specialist anywhere in the world? Explore our world directory. WikiMD's DocFinder can assist you in locating millions of physicians.	Medical Knowledge Access the latest research - Most recent articles Ongoing trials.

Translate to: East Asian 中文, 日本, 한국어, South Asian हिन्दी, Urdu, বাংলা, తెలుగు, தமிழ், ಕನ್ನಡ,
Southeast Asian Indonesian, Vietnamese, Thai, မြန်မာဘာသာ, European español, Deutsch, français, русский, português do Brasil, Italian, polski

Belatacept Resources
Need Help Finding a Doctor? Need help finding a doctor or specialist anywhere in the world? Explore our world directory. WikiMD's DocFinder can assist you in locating millions of physicians.	Medical Knowledge Access the latest research - Most recent articles Ongoing trials.

Translate to: East Asian 中文, 日本, 한국어, South Asian हिन्दी, Urdu, বাংলা, తెలుగు, தமிழ், ಕನ್ನಡ,
Southeast Asian Indonesian, Vietnamese, Thai, မြန်မာဘာသာ, European español, Deutsch, français, русский, português do Brasil, Italian, polski