Belatacept

Name: Belatacept

Side Effects of Belatacept

Belatacept increases your risk of serious side effects that can cause death. See "Drug Precautions".

Common side effects of belatacept 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

Tell your doctor about any side effect that bothers you or that does not go away. These are not all the possible side effects of belatacept. For more information, ask your doctor or pharmacist.

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

You may also report side effects to BMS at 1-800-321-1335.

Inform MD

Before receiving belatacept, tell your doctor if you:

  • plan to receive any vaccines. Talk to your doctor about which vaccines are safe for you to receive during your treatment with belatacept. 
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if belatacept will harm your unborn baby. If you become pregnant while taking belatacept:
    • Tell your doctor right away. You and your doctor should decide if you will keep receiving belatacept 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 belatacept or if their partner has received belatacept, and had a transplant. You can also enroll by calling 1-877-955-6877.
  • are breastfeeding or plan to breastfeed. It is not known if belatacept passes into your breast milk. You and your doctor should decide if you will receive belatacept or breastfeed. You should not do both.

Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Belatacept Usage

  • To help prevent rejection of your new kidney, you will receive belatacept regularly as prescribed by your doctor. It is important for you to keep all your appointments for belatacept treatment and follow up.
  • You will receive belatacept as an intravenous (IV) infusion in your arm. Each IV infusion takes about 30 minutes.
  • During treatment with belatacept, 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.
  • 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 belatacept, 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.
  • Avoid receiving live vaccines during treatment with belatacept. Talk to your doctor to find out which vaccines are safe for you during this time. Some vaccines may not work as well while you are receiving belatacept.

Belatacept Dosage

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following your weight.

The recommended dose of belatacept is 10 mg per kg. After 16 weeks, the dose may be reduced to 5 mg per kg.

How is belatacept given?

Belatacept is injected into a vein through an IV. A healthcare provider will give you this injection.

Belatacept must be given slowly, and the IV infusion can take up at least 30 minutes to complete.

Belatacept is usually given just before your kidney transplant, and again 5 days later, followed by once every 2 to 4 weeks. Follow your doctor's dosing instructions very carefully.

Belatacept can increase your risk of infection by changing the way your immune system works. You will need frequent medical tests.

What should I avoid while receiving belatacept?

Avoid exposure to sunlight or tanning beds. Belatacept can increase your risk of skin cancer. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Do not receive a "live" vaccine while using belatacept. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Stability

Storage

Parenteral

Powder for Injection

2–8°C in the original package; protect from light.1

Store fully diluted solution at 2–8°C; protect from light.1 Infusion of diluted solution must be completed within 24 hours of reconstitution; a maximum of 4 hours of the total 24 hours may be at 20–25°C and room light.1

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility

Compatible

Dextrose 5% in water1

Sodium chloride 0.9%1

Actions

  • Consists of the modified extracellular domain of cytotoxic T-lymphocyte-associated antigen (CTLA)-4 fused to a portion of the Fc domain of human IgG1.1

  • Structurally and pharmacologically related to abatacept, but binds CD80 and CD86 more avidly than does abatacept.1 12

  • Binds to CD80 and CD86 on antigen-presenting cells thereby blocking CD28-mediated costimulation of T lymphocytes.1 6

  • In vitro, inhibits T-lymphocyte proliferation and production of interleukin-2, interferon-γ, interleukin-4, and tumor necrosis factor-α (TNF-α).1 6 Activated T lymphocytes are the principal mediators of immunologic rejection.1

  • In nonhuman primate models of renal transplantation, belatacept monotherapy prolonged graft survival and decreased production of antidonor antibodies.1

How is this medicine (Belatacept) best taken?

Use belatacept as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

  • Call your doctor to find out what to do.

How do I store and/or throw out Belatacept?

  • If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Pronunciation

(bel AT a sept)

Special Populations Note

Body weight: Higher clearance of belatacept may be seen with increasing body weight.

Dosing Adult

Note: Dosing is based on actual body weight at the time of transplantation; do not modify weight-based dosing during course of therapy unless the change in body weight is >10%. The prescribed dose must be evenly divisible by 12.5 mg to allow accurate preparation of the reconstituted solution using the provided required disposable syringe for preparation. For example, the calculated dose for a 64 kg patient: 64 kg x 10 mg per kg = 640 mg. The nearest doses to 640 mg that are evenly divisible by 12.5 mg would be 637.5 mg or 650 mg; the closest dose to the calculated dose is 637.5 mg, therefore, 637.5 should be the actual prescribed dose for the patient.

Kidney transplant, prophylaxis of organ rejection: IV: Note: Use in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids.

Initial phase: 10 mg/kg on day 1 (day of transplant, prior to implantation) and on day 5 (~96 hours after day 1 dose), followed by 10 mg/kg at the end of week 2, week 4, week 8, and week 12 following transplantation

Maintenance phase: 5 mg/kg every 4 weeks (plus or minus 3 days) beginning at the end of week 16 following transplantation

Conversion from calcineurin inhibitor (off-label dosing) (Grinyo 2012; Grinyo 2016; Rostaing 2011): IV:

Initial phase: 5 mg/kg on transition days 1, 15, 29, 43, and 57

Maintenance phase: 5 mg/kg every 4 weeks beginning 4 weeks after completion of the initial phase. Note: Taper calcineurin inhibitor dose slowly over 1 month (no reduction on day 1, 40% to 60% reduction on day 15, 70% to 80% reduction on day 23; discontinue on day 29 and beyond).

Lung transplant, prophylaxis of organ rejection (off-label use): IV:

Initial phase: 10 mg/kg on days 0 and 4, and again at weeks 2 and 4 (Timofte 2016)

Maintenance phase (for chronic treatment patients only): 10 mg/kg every month beginning 4 weeks after completion of the initial phase (Timofte 2016)

Pregnancy Risk Factor C Pregnancy Considerations

Adverse events have been observed in animal reproduction studies.

The National Transplantation Pregnancy Registry (NTPR) is a registry which follows pregnancies which occur in maternal transplant recipients or those fathered by male transplant recipients. The NTPR encourages reporting of pregnancies following solid organ transplant by contacting them at 877-955-6877 or NTPR@giftoflifeinstitute.org.

For the Consumer

Applies to belatacept: intravenous powder for solution

Along with its needed effects, belatacept 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 while taking belatacept:

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 of belatacept 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

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