Nulojix 250 mg intravenous solution

Generic name:
Belatacept - injection

Pronunciation
(bel-AT-a-sept)

Brand name(s)
Nulojix

This medication may increase the risk for developing serious (even fatal) infections or certain cancers after receiving a kidney transplant. Belatacept may also increase the risk for developing a certain medical condition, post-transplant lymphoproliferative disorder (PTLD), which can become a type of cancer. The risk is greater in people who have not previously been exposed to a certain virus (Epstein-Barr virus) that causes a common mild infection, usually before adulthood. Before starting treatment with this medication, your doctor should test you to check if you have had previous exposure to Epstein-Barr virus. (See also the Medication Guide.)

This medication is not recommended for use to help prevent organ rejection after a liver transplant.

Belatacept is used to help prevent organ rejection in people who have received a kidney transplant. It is used along with other medications (such as mycophenolate, corticosteroids) to allow your new organ to function normally. Belatacept belongs to a class of drugs known as immunosuppressants. It works by weakening your body's natural defense (immune system) to prevent your body from rejecting the new kidney.

Read the Medication Guide provided by your pharmacist before you start using belatacept and each time you get a refill. Your doctor may direct you to enroll in a special program from the manufacturer (ENLIST Registry) before using this medication. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a vein as directed by your doctor, usually over 30 minutes. After the first dose, this medication is given on a regular schedule as directed by your doctor. The dosage is based on your weight.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and the risk of serious side effects may increase.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

This medication can increase your risk for serious (even fatal) infections, such as cytomegalovirus or pneumocystis. To help prevent these serious infections, your doctor may direct you to also take other medications along with belatacept. Ask your doctor for details. (See also Precautions section.)

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

See also Warning section.

Headache, nausea, or diarrhea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• signs of kidney problems (such as change in the amount of urine)

Because belatacept works by weakening the immune system, it may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor promptly if you develop any signs of an infection such as cough, sore throat, fever, or chills.

This drug increases the risk of a rare and possibly fatal brain infection (progressive multifocal leukoencephalopathy-PML). Tell your doctor right away if you develop symptoms such as:

• clumsiness
• difficulty speaking
• problems with balance
• sudden change in your thinking (such as confusion, difficulty concentrating, memory loss)
• vision changes
• weakness of the arms and legs that gets worse

The immune system is also important in preventing and controlling cancer. Very rarely, patients using belatacept have developed cancers (such as lymphoma, skin cancer). Tell your doctor right away if you develop symptoms such as:

• new skin lesion or bump, or change in size or color of a mole
• night sweats
• swollen glands
• unexplained weight loss
• unusual tiredness

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using belatacept, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• current/recent/returning infection (such as tuberculosis, hepatitis, cytomegalovirus-CMV infection)
• cancer
• immune system disorder (such as HIV infection, bone marrow disorder)

Belatacept can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using belatacept before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Since this medication may increase your risk of developing skin cancer, limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab)

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as kidney function, complete blood count) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Consult the product instructions and your pharmacist for storage details. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.