Pronunciation:

bel-AT-a-sept

Brand Names:

• Nulojix

Dosage Forms:

• Powder for Solution

Warnings:

Increased risk for developing posttransplant lymphoproliferative disorder (PTLD), predominantly involving the 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 belatacept in transplant recipients who are EBV seronegative or with unknown EBV serostatus. Only physicians experienced in immunosuppressive therapy and management of kidney transplant patients should prescribe belatacept. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. Increased susceptibility to infection and the possible development of malignancies may result from immunosuppression. Use in liver transplant patients is not recommended due to an increased risk of graft loss and death .

Classifications:

Therapeutic—

Immunological Agent

Uses of This Medicine:

Belatacept injection belongs to a group of medicines known as immunosuppressive agents. It is used together with other medicines to prevent the body from rejecting a transplanted kidney.

When a patient receives a kidney transplant, the body's white blood cells will try to get rid of (reject) the transplanted kidney. Belatacept works by suppressing the immune system and prevents the white blood cells from trying to get rid of the transplanted organ.

This medicine is to be given only by or under the direct supervision of a doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of belatacept injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of belatacept injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine
• Antithymocyte Globulin Equine
• Antithymocyte Globulin Rabbit
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cytomegalovirus (CMV) infection—Use with caution. May increase risk for more serious side effects.

• Infection (e.g., bacteria, fungus, virus, or protozoa)—May decrease your body's ability to fight infection.

• Tuberculosis infection—Should be treated before starting therapy with this medicine.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so the needle will need to stay in place for at least 30 minutes.

This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects. Be sure to keep all appointments.

It is important to tell your doctor if you become pregnant. Your doctor may want you to join a pregnancy registry for patients using this medicine.

Do not receive this medicine if your doctor says you are Epstein-Barr virus (EBV) negative. Your doctor will test you for EBV.

Using this medicine may increase your risk of having serious conditions called post-transplant lymphoproliferative disorder (PTLD) or progressive multifocal leukoencephalopathy. The risk of developing PTLD is higher in patients who are EBV negative, have cytomegalovirus (CMV) infection, or have received treatments for transplant rejections. Check with your doctor right away if you have changes in mood or usual behavior, confusion, problems with thinking, loss of memory, decreased strength on one side of the body, or changes in vision, walking, or talking.

This medicine may increase your risk of getting certain types of cancer, especially of the skin. Talk to your doctor if you have concerns about this risk.

Use sunscreen or sunblock lotions with a sun protection factor (SPF) of at least 15 on a regular basis when you are outdoors. Wear protective clothing and hats, and stay out of direct sunlight between the hours of 10 a.m. and 3 p.m. Avoid sunlamps and tanning beds.

This medicine may increase your risk of developing infections. Avoid being near people who are sick or have infections while you are using this medicine. Wash your hands often. Tell your doctor if you have any kind of infection before you start using this medicine. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.

You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

This medicine may increase your risk for developing a rare and serious virus infection called polyoma virus-associated nephropathy (PVAN). PVAN is caused by BK virus. The BK virus may affect how your kidneys work and cause a transplanted kidney to fail. Check with your doctor right away if you are having more than one of these symptoms: bloody urine; a decreased frequency or amount of urine; increased thirst; loss of appetite; lower back or side pain; nausea; swelling of the face, fingers, or lower legs; trouble with breathing; unusual tiredness or weakness; vomiting; or weight gain.

While you are being treated with belatacept, and after you stop using it, it is important to talk to your doctor about the immunizations (vaccines) you should receive. Do not get any vaccine without your doctor's approval. Belatacept may lower your body's resistance and there is a chance you might get the infection the vaccine is meant to prevent. In addition, other persons living in your household should not receive certain vaccines since there is a chance they could pass the infection on to you. Talk to your doctor if you have questions about this.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Abdominal or stomach pain

agitation

black, tarry stools

bladder pain

bloating or swelling of the face, arms, hands, lower legs, or feet

bloody or cloudy urine

blurred vision

bone pain

burning while urinating

chest pain

chills

coma

confusion

convulsions

cough or hoarseness

decreased frequency or amount of urine

decreased urine output

depression

difficult or labored breathing

difficult, burning, or painful urination

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

drowsiness

dry mouth

fainting

fast or irregular heartbeat

fever

frequent urge to urinate

headache

hostility

inability to move the arms and legs

increased blood pressure

increased thirst

irritability

itching in other skin areas

lethargy

loss of appetite

loss of bladder control

lower back or side pain

mood or mental changes

muscle pain or cramps

muscle spasms (tetany) or twitching

nausea or vomiting

nervousness

numbness or tingling in the hands, feet, or lips

pale skin

pounding in the ears

rapid weight gain

scaling

shortness of breath

slow or fast heartbeat

sore throat

sores, ulcers, or white spots on the lips or in the mouth

stupor

sudden decrease in the amount of urine

sudden numbness and weakness in the arms and legs

sweating

swelling of the face, ankles, or hands

swollen glands

tightness in the chest

trembling

troubled breathing

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

unusual weight gain or loss

weakness or heaviness of the legs

weight gain

wheezing

Less common

Back pain

coughing or spitting up blood

drowsiness

joint pain, stiffness, or swelling

loss of appetite

night sweats

persistent non-healing sore

pink growth reddish patch or irritated area

shiny bump

sudden high fever or low-grade fever for months

swelling of the feet or lower legs

weight gain

white, yellow, or waxy scar-like area

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Abdominal or stomach cramps

blemishes on the skin

body aches or pain

collection of blood under the skin

cough producing mucus

deep, dark purple bruise

diarrhea

difficulty having a bowel movement (stool)

difficulty with moving

dry mouth

ear congestion

flushed, dry skin

fruit-like breath odor

hair loss or thinning of the hair

increased hunger

increased sweating

increased urination

itching, pain, redness, or swelling

loss of consciousness

loss of voice

muscle cramps in the hands, arms, feet, legs, or face

muscle or bone pain

muscle pain or stiffness

numbness and tingling around the mouth, fingertips, or feet

pain in the joints

pimples

shakiness in the legs, arms, hands, or feet

shortness of breath

sleeplessness

sneezing

swelling or inflammation of the mouth

tightness in the chest

tremor

trouble sleeping

unable to sleep

unexplained weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.