Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Nulojix

Descriptions


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.

This product is available in the following dosage forms:

  • Powder for Solution

Before Using

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.

Pediatric

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.

Geriatric

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

Pregnancy

Information about this belatacept-intravenous-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

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.

Drug Interactions

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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

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

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

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

  1. Abdominal or stomach pain
  2. agitation
  3. black, tarry stools
  4. bladder pain
  5. bloating or swelling of the face, arms, hands, lower legs, or feet
  6. bloody or cloudy urine
  7. blurred vision
  8. bone pain
  9. burning while urinating
  10. chest pain
  11. chills
  12. coma
  13. confusion
  14. convulsions
  15. cough or hoarseness
  16. decreased frequency or amount of urine
  17. decreased urine output
  18. depression
  19. difficult or labored breathing
  20. difficult, burning, or painful urination
  21. dizziness
  22. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  23. drowsiness
  24. dry mouth
  25. fainting
  26. fast or irregular heartbeat
  27. fever
  28. frequent urge to urinate
  29. headache
  30. hostility
  31. inability to move the arms and legs
  32. increased blood pressure
  33. increased thirst
  34. irritability
  35. itching in other skin areas
  36. lethargy
  37. loss of appetite
  38. loss of bladder control
  39. lower back or side pain
  40. mood or mental changes
  41. muscle pain or cramps
  42. muscle spasms (tetany) or twitching
  43. nausea or vomiting
  44. nervousness
  45. numbness or tingling in the hands, feet, or lips
  46. pale skin
  47. pounding in the ears
  48. rapid weight gain
  49. scaling
  50. shortness of breath
  51. slow or fast heartbeat
  52. sore throat
  53. sores, ulcers, or white spots on the lips or in the mouth
  54. stupor
  55. sudden decrease in the amount of urine
  56. sudden numbness and weakness in the arms and legs
  57. sweating
  58. swelling of the face, ankles, or hands
  59. swollen glands
  60. tightness in the chest
  61. trembling
  62. troubled breathing
  63. troubled breathing with exertion
  64. unusual bleeding or bruising
  65. unusual tiredness or weakness
  66. unusual weight gain or loss
  67. weakness or heaviness of the legs
  68. weight gain
  69. wheezing

Less common

  1. Back pain
  2. coughing or spitting up blood
  3. drowsiness
  4. joint pain, stiffness, or swelling
  5. loss of appetite
  6. night sweats
  7. persistent non-healing sore
  8. pink growth reddish patch or irritated area
  9. shiny bump
  10. sudden high fever or low-grade fever for months
  11. swelling of the feet or lower legs
  12. weight gain
  13. 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

  1. Abdominal or stomach cramps
  2. blemishes on the skin
  3. body aches or pain
  4. collection of blood under the skin
  5. cough producing mucus
  6. deep, dark purple bruise
  7. diarrhea
  8. difficulty having a bowel movement (stool)
  9. difficulty with moving
  10. dry mouth
  11. ear congestion
  12. flushed, dry skin
  13. fruit-like breath odor
  14. hair loss or thinning of the hair
  15. increased hunger
  16. increased sweating
  17. increased urination
  18. itching, pain, redness, or swelling
  19. loss of consciousness
  20. loss of voice
  21. muscle cramps in the hands, arms, feet, legs, or face
  22. muscle or bone pain
  23. muscle pain or stiffness
  24. numbness and tingling around the mouth, fingertips, or feet
  25. pain in the joints
  26. pimples
  27. shakiness in the legs, arms, hands, or feet
  28. shortness of breath
  29. sleeplessness
  30. sneezing
  31. swelling or inflammation of the mouth
  32. tightness in the chest
  33. tremor
  34. trouble sleeping
  35. unable to sleep
  36. 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.