Belatacept (Intravenous)

Belatacept is administered periodically via an injection into the arm to prevent organ rejection in patients who have had a kidney transplant.

Overview

Having a healthy and active immune system is essential to fighting diseases and infections. However, sometimes the immune system can cause unwanted effects, such as when a patient has a major organ transplant. The white blood cells in a patient's body will often try to get rid of or fight the implanted organ, treating it as an invader. This is particularly common in patients that have had a kidney transplant.

There are various drugs that can help the body to accept implanted organs such as kidneys. Belatacept is a prescription only drug that is given to those that have had a kidney transplant, to prevent organ rejection. The drug may be used in conjunction with other medications.

Belatacept is part of a family of drugs called immunosuppressive agents, as they can suppress the immune system, preventing it from taking certain action. It is administered as an injection and is only given to a patient under close and direct supervision of a doctor. It is supplied as a powder, which is then used to make the injectable solution.

Belatacept is also marketed and sold under the brand name Nulogix in the United States.

Conditions treated

  • Organ rejection after a transplant - specifically kidney transplant

Type of medicine

  • Intravenous route, supplied as a powder to make into an injectable solution

Side effects

As with any drug, there are possible side effects that patients may experience as a result of taking this medication. Most patients will not experience severe side effects. However, patients should be carefully monitored by a doctor throughout the course of belatacept as some side effects can become severe or persistent.

Some of the common side effects that you may experience while taking this medication include:

  • Tiredness or drowsiness
  • Nausea
  • Diarrhea or constipation
  • Fever or cough
  • Swelling of the hands and feet
  • Lower levels of iron in the blood
  • Stomach pain or cramps
  • Agitation
  • Swelling in the face, arms, legs
  • Pain in the bladder
  • Feeling of bloatedness in the stomach
  • Pain in the bones
  • Cloudy urine

There are some serious side effects that can be experienced in rare cases of taking belatacept. Occasionally, the drug may result in the body producing too much of one type of white blood cell. Over-production of this cell can lead to a number of severe conditions, including brain infection, cancer, and viral infections that can cause failure of the kidney transplant. If you have any of the following symptoms, you should consult your doctor immediately, as it may be a sign that you are developing one of these conditions.

  • Blood in the urine
  • Vomiting
  • Diarrhea
  • Urination that is painful or difficult
  • Sweating - particularly at night
  • Swollen glands
  • Fever or flu type symptoms
  • New skin lesions
  • Poor or blurry vision
  • Change in mental health, e.g. depression, severe mood swings, confusion
  • Weakness down one side of the body
  • Difficulty speaking, or slurred speech
  • Convulsions
  • Faintness when standing up from a sitting or lying position
  • Dry mouth
  • Faster heartbeat than normal
  • Hostility towards others
  • Frequent need to urinate
  • Loss of appetite
  • Twitching
  • Pounding or ringing sensation in the ears
  • Pale skin
  • Weight gain
  • Thirstiness
  • Difficulty breathing or becoming exerted easily

Rarer side effects of the above serious conditions can also include:

  • Spitting up blood
  • Joint pain
  • Back pain
  • Sores
  • Constant fever lasting several weeks

Always consult your doctor if you notice any other changes in your physical or mental well-being since starting a course of belatacept.

Dosage

For adults, the normal dosage is 250 mg/vial. This dose is intended to be administered with other medications - corticosteroids, mycophenolate mofetil and basiliximab induction. Due to the significant risk of developing serious conditions as a result of the immune system being made less effective, it is not usually recommended that the dosage of belatacept is increased.

The dose is calculated on the body weight of the patient at the time of the kidney transplant. The dose will be modified if the patient's weight changes by 10 percent either way. The prescribed dose needs to be divided by 12.5 in order to accurately prepare the solution. Patients are usually given 10 mg/kg IV on the day of the kidney transplant. They are then given the same dose on the fifth day after the transplant, and again after two weeks, four weeks, eight weeks and 12 weeks after the kidney transplant.

After this, the maintenance dose is 5 mg/kg IV. This is given to the patient after the 16th week. Then it is given every four weeks afterwards, until the end of the treatment.

Each treatment is delivered as an injection into a vein in one of the arms. Each treatment session will last for around 30 minutes. During each of the treatments, the doctor will take blood and urine samples from the patients, which will then be tested to check the progress of the drug and how the body is reacting to the new kidney.

There is no variation in the recommended dosage according to age. Children and the elderly can also use the medication and their dose will again be prescribed according to their body weight.

Major drug interactions

There are various drugs that can cause "interactions"with others. This means that the drugs react when taken together, causing unique side effects and impacting on their original purpose. If you are taking any other medication - particularly prescribed drugs - you should always tell your doctor. This may mean that belatacept will not be suitable for you. Or it could mean that your doctor alters the dose given to you. Here is a list of the 30 drugs that have been reported to have caused a major reaction when mixed with belatacept. These are the ones that it is most important to tell your doctor about:

  • adalimumab
  • bcg
  • certolizumab
  • clozapine
  • deferiprone
  • etanercept
  • fingolimod
  • golimumab
  • infliximab
  • influenza virus vaccine, h1n1, live
  • influenza virus vaccine, live, trivalent
  • leflunomide
  • measles virus vaccine
  • measles virus vaccine, mumps virus vaccine, rubella virus vaccine
  • measles virus vaccine, mumps virus vaccine, rubella virus vaccine, varicella virus vaccine
  • measles virus vaccine, rubella virus vaccine
  • mumps virus vaccine
  • mumps virus vaccine, rubella virus vaccine
  • natalizumab
  • poliovirus vaccine, live, trivalent
  • rotavirus vaccine
  • rubella virus vaccine
  • smallpox vaccine
  • talimogene laherparepvec
  • teriflunomide
  • tofacitinib
  • typhoid vaccine, live
  • varicella virus vaccine
  • yellow fever vaccine
  • zoster vaccine live

Aside from those with major reactions, there are some drugs that can cause a less significant interaction. These drugs may not have a significant impact on the belatacept you are prescribed, but may alter the impact of the drug in some way. It is always best to be on the safe side and tell your doctor about anything else you are taking. There are 65 that cause a moderate interaction, and 15 that cause a minor reaction. [ref 1]

Warnings

General care

You should always take all of the medications prescribed to you by your doctor while taking belatacept. These other medicines can play just as crucial a role in helping your body to accept its new kidney and in helping your body to protect against infections and side effects.

You should also take care to limit the time you spend outdoors in sunlight. The same applies to sunbeds and tanning - avoid these while you are undergoing treatment. This is because, while taking belatacept, you are at an increased risk of developing cancer, including skin cancer. When outdoors, you should always protect your skin with clothing and a high factor of sun cream (SFP).

Alcohol interaction

To improve the chances of your belatacept working, and to reduce the chances of unwanted side effects, you should avoid alcohol when you are taking the drug. Alcohol can seriously impair your judgement when mixed with belatacept. You will also be more likely to become inebriated quicker, and more vulnerable to fainting, dizziness, vomiting, nausea, confusion and severe headaches.

There are no foods that have been found to cause an interaction with belatacept. However, as your immune system will be weakened, you can help yourself by adopting a wholesome and healthy diet that is rich in essential vitamins such as C and E. Your doctor may advise you on dietary habits to help you avoid unpleasant side effects and infections.

Allergies

Always tell your doctor about any allergies that you may have - this includes allergies to foods, preservatives, animals, other medications or ingredients. This may have an impact on the aftercare following your kidney transplant.

Pregnancy and breastfeeding

Belatacept is not normally used in patients that are pregnant. Animal studies have shown that the drug results in fetal toxicity and infections, and can increase mortality by up to 100 percent. It is therefore only recommended that belatacept is used on pregnant mothers if there is no other alternative available. A doctor will judge whether the benefits to the patient outweigh the risk to the unborn child. In most cases, the risk is likely to be deemed too high.

There is no data to suggest that belatacept should not be taken by breastfeeding mothers. However, there is a chance that it can get into breast milk. Remnants may also remain in the breast milk for at least a month after taking the treatment, as its life is between 8-10 days.

Missed doses

As the medication is administered by a doctor, you will not likely miss a dose. Always stick to your appointments when you are due to visit your doctor for your follow-up doses of belatacept. Missing a dose may mean that your immune system may increase in effectiveness and start to reject your transplanted kidney.

Other diseases

There are also conditions and diseases that interact with belatacept. Always tell your doctor if you are suffering from any other conditions, particularly infections. As belatacept causes a reduction in the effectiveness of the body's immune system, it can make the body vulnerable to contracting other infections and not having adequate white blood cells to fight them. Therefore, if you have any serious infections already, your doctor may decide to prescribe you with a different medication.

These are the diseases that cause an interaction with belatacept:

Storage

Belatacept is supplied in a powder form that must be kept at a certain temperature to remain at its most effective.

You should refrigerate the powder at between 2 and 8 degrees centigrade (36 - 46 degrees Fahrenheit). It should be kept away from light sources, and stored in its original packaging until it is due to be used. To make the solution, the belatacept powder should be taken out of its vial to a bottle or infusion bag immediately. The infusion of the powder needs to take place within 24 hours of it being taken out of the original packaging. For that 24-hour period, it must remain refrigerated.

Belatacept must be disposed of after its expiration date has been reached.

Summary

Belatacept is an effective treatment that has led to many successful kidney transplants when used in conjunction with other medications, and when administered at the correct times. [ref 2] It is a medication that is only to be administered to patients by a trained doctor or healthcare professional, and the patient's progress must be closely monitored to check that the drug is preventing rejection of the kidney.

There have been various studies into the effectiveness and the dangers of belatacept. [ref 3] As the drug lowers the immune system, it has been found to make the patient particularly vulnerable to contracting infections. Studies in animals have also shown there to be considerable risks to pregnant mothers and their unborn babies - the risk to the fetus has been concluded to be usually greater than the benefit to the mother. The medication is therefore to be prescribed with caution and an alternative may be sought in some cases.

Patients can help to protect themselves against the side effects of belatacept by being upfront and accurate with their doctors about their medical history, other prescriptions and other conditions. This will be vital in determining if belatacept will be the most effective treatment and will not have a detrimental impact on health.

Patients receiving belatacept may have their names added to a research register in order to help scientists gather data on the safety and effectiveness of the medication.

Resources
Last Reviewed:
December 23, 2017
Last Updated:
April 04, 2018
Content Source: