Nulojix

Nulojix is a prescription medication used in combination with other medications to prevent kidney transplant rejection. Nulojix belongs to group of drugs called selective T-cell costimulation blockers which work by weakening the immune system to prevent it from attacking the transplanted kidney.

This medication comes in an injectable form to be given directly into a vein (IV) by a healthcare provider.

Common side effects of Nulojix include low red blood cell count (anemia), diarrhea, and kidney or bladder infection.

Nulojix is a prescription medicine used in adults to prevent transplant rejection in people who have received a kidney transplant. Nulojix is used with corticosteroids and certain other medicines to help prevent kidney rejection. Nulojix is only used in people who have been exposed to the Epstein-Barr virus (EBV).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Bristol-Myers Squibb Co.

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

Common side effects of Nulojix 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 Nulojix. 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.

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

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. Do not take any new medicine without talking with your transplant doctor first.

Nulojix increases your risk of serious side effects, including:

• Post-transplant lymphoproliferative disorder (PTLD). PTLD is a condition that can happen if certain white blood cells grow out of control after an organ transplant because your immune system is weak. PTLD can get worse and become a type of cancer. PTLD can lead to death.
  

  People treated with Nulojix have a higher risk of getting PTLD. If you get PTLD with Nulojix you are at especially high risk of getting it in your brain. Your risk for PTLD is also higher if you:

  • have never been exposed to the Epstein-Barr virus (EBV). Your doctor should test you for EBV. Do not receive Nulojix  unless you are EBV positive (you have been exposed to EBV).
  • get an infection with a virus called cytomegalovirus (CMV).
  • receive treatment for transplant rejection that lowers certain white blood cells called T lymphocytes.

• Increased risk of getting cancers other than PTLD. People who take medicines that weaken the immune system, including Nulojix, have a higher risk of getting other cancers, including skin cancer. Talk to your doctor about your risk for cancer. 
• Progressive multifocal leukoencephalopathy (PML). PML is a rare, serious brain infection caused by JC virus. People with weakened immune systems are at risk for getting PML. PML can result in death or severe disability. There is no known prevention, treatment, or cure for PML.
• Increased risk of getting other serious infections, including tuberculosis (TB) and other infections caused by bacteria, viruses, or fungi. These serious infections may lead to death. Also, a virus called BK virus can affect how your kidney works and cause your transplanted kidney to fail.

Tell your doctor right away if you get any of the following symptoms during treatment with Nulojix:

• change in mood or your usual behavior
• confusion or problems thinking or with memory
• change in the way you walk or talk
• decreased strength or weakness on one side of your body
• change in vision
• fever, night sweats, or tiredness that does not go away
• weight loss
• swollen glands
• flu, cold symptoms, or cough
• stomach-area pain
• vomiting or diarrhea
• tenderness over your transplanted kidney
• change in the amount of urine that you make, blood in your urine, pain or burning on urination
• a new skin lesion or bump, or change in size or color of a mole

Liver transplant patients should not receive Nulojix because of an increased risk of losing the transplanted liver (graft loss) and death. Talk to your doctor if you would like more information about this risk.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Nulojix there are no specific foods that you must exclude from your diet when receiving Nulojix.

Before receiving Nulojix, 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 Nulojix. 
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if Nulojix will harm your unborn baby. If you become pregnant while taking Nulojix:
  • Tell your doctor right away. You and your doctor should decide if you will keep receiving Nulojix 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 Nulojix or if their partner has received Nulojix, 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 Nulojix passes into your breast milk. You and your doctor should decide if you will receive Nulojix 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.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C.

• Tell your doctor right away. You and your doctor should decide if you will keep receiving Nulojix 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 Nulojix or if their partner has received Nulojix, and had a transplant. You can also enroll by calling 1-877-955-6877.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Nulojix passes into your breast milk. You and your doctor should decide if you will receive Nulojix or breastfeed. You should not do both.

• To help prevent rejection of your new kidney, you will receive Nulojix regularly as prescribed by your doctor. It is important for you to keep all your appointments for Nulojix treatment and follow up.
• You will receive Nulojix as an intravenous (IV) infusion in your arm. Each IV infusion takes about 30 minutes.
• During treatment with Nulojix, 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 Nulojix, 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 Nulojix. 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 Nulojix.

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 Nulojix is 10 mg per kg. After 16 weeks, the dose may be reduced to 5 mg per kg.

Nulojix is usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if overdose is suspected, seek emergency medical attention.

WARNING: POST-TRANSPLANT LYMPHOPROLIFERATIVE DISORDER, OTHER MALIGNANCIES, AND SERIOUS INFECTIONS

Increased risk for developing post-transplant lymphoproliferative disorder (PTLD), predominantly involving the central nervous system (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 Nulojix 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 Nulojix. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.

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.