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The product code(s) for this leaflet is: PLGB 15105/0132.
NULOJIX 250 mg powder for concentrate for solution for infusion
NULOJIX 250 mg powder for concentrate for solution for infusion
belatacept
1. What NULOJIX is and what it is used for
2. What you need to know before you use NULOJIX
3. How to use NULOJIX
4. Possible side effects
5. How to store NULOJIX
6. Contents of the pack and other information
NULOJIX contains the active substance belatacept which belongs to a group of medicines called immunosuppressants. These are medicines that reduce the activity of the immune system, the body's natural defences.
NULOJIX is used in adults to prevent the immune system from attacking your transplanted kidney and causing transplant rejection. It is used with other immunosuppressive medicines, including mycophenolic acid and corticosteroids.
Post-transplant lymphoproliferative disorder
Treatment with NULOJIX increases the risk of getting a type of cancer called post-transplant lymphoproliferative disorder (PTLD). With NULOJIX treatment, this more often develops in the brain and can lead to death. People are at a higher risk of developing PTLD in the following cases:
Serious infections
Serious infections can happen with NULOJIX treatment and can lead to death.
NULOJIX weakens the body’s ability to fight infections. Serious infections can include
There have been reports of a rare type of brain infection called progressive multifocal leukoencephalopathy (PML) that have occurred in patients who have been given NULOJIX. PML often leads to severe disability or death.
Tell your family or caregiver about your treatment. You might get symptoms that you might not be aware of yourself. Your doctor may need to investigate your symptoms to rule out PML, PTLD or other infections. For a list of symptoms please see section 4, “Possible side effects”.
Skin cancer
Limit your exposure to sunlight and ultraviolet (UV) light whilst using NULOJIX. Wear protective clothing and use a sunscreen with a high protection factor. People who use NULOJIX have a higher risk of getting certain other types of cancer, especially skin cancer.
Blood clotting in your transplanted kidney
Depending on the type of kidney transplant that you received, you may be at higher risk of blood clotting in your transplanted kidney.
Use in conversion from another type of immunosuppressive maintenance treatment
If your healthcare professional changes your maintenance treatment to a NULOJIX based immunosuppressive regimen, he/she may check your kidney function more often for a period of time after the change, to monitor for rejection.
Use in liver transplants
The use of NULOJIX is not recommended if you have had a liver transplant.
Use with other immunosuppressive medicines
Nulojix is normally given with steroids. Too rapid reduction of steroid intake can increase the risk that your body may reject the transplanted kidney. Please take the exact steroid dose as determined by your doctor.
NULOJIX has not been studied in children and adolescents under 18 years of age, therefore it is not recommended in this age group.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Ask your doctor or pharmacist for advice before taking any other medicine while using NULOJIX.
The use of live vaccines should be avoided with the use of NULOJIX. Tell your doctor if you need to have vaccinations. Your doctor will advise you what to do.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
If you become pregnant while using NULOJIX, tell your doctor.
Do not use NULOJIX if you are pregnant unless your doctor specifically recommends it. The effects of NULOJIX in pregnant women are not known. You must not get pregnant while using NULOJIX. If you are of child bearing potential, you should use effective contraception during treatment with NULOJIX and up to 8 weeks after the last dose of treatment since the potential risk to embryonic/foetal development is unknown. Your doctor will advise you about using a reliable contraceptive.
You must stop breast-feeding if you are being treated with NULOJIX. It is not known whether belatacept, the active substance, passes into human milk.
Belatacept has a minor influence on the ability to drive and use machines. However you should not drive or operate any machines if you are feeling tired or unwell after receiving NULOJIX.
Tell your doctor if you are on a low-sodium (low-salt) diet before you are treated with NULOJIX. This medicine contains 0.55 mmol (or 13 mg) sodium per vial. This is equivalent to 0.64% of the recommended maximum daily dietary intake of sodium for an adult.
Treatment with NULOJIX will be prescribed and supervised by a specialist in kidney transplantation.
NULOJIX will be given to you by a healthcare professional.
It will be given to you by infusion (as a "drip") into one of your veins over a period of about 30 minutes.
The recommended dose is based on your body weight (in kg) and will be calculated by a healthcare professional. The dose and treatment frequency is given below.
Initial Phase [Day of transplantation, prior to implantation (Day 1), Day 5, Day 14 and Day 28, End of Week 8 and Week 12 after transplantation] Dose: 10 mg/kg
Maintenance Phase [Every 4 weeks (± 3 days) starting at end of week 16 after transplantation] Dose: 6 mg/kg
At the time of your kidney transplant you may be given NULOJIX in combination with other types of immunosuppressant medication to help prevent your body from rejecting your transplanted kidney.
Your doctor may decide to change your immunosuppressive treatment to a treatment with NULOJIX during the maintenance phase after your kidney transplant.
Information for medical and healthcare professionals on dose calculation, preparation and administration of NULOJIX is provided at the end of the leaflet.
If this happens, your doctor will monitor you for any signs or symptoms of side effects, and treat these symptoms if necessary.
It is very important for you to keep all appointments to receive NULOJIX. If you miss receiving NULOJIX when you are supposed to, ask your doctor when to schedule your next dose.
Your body may reject the transplanted kidney if you stop using NULOJIX. The decision to stop using NULOJIX should be discussed with your doctor and another therapy will generally be started.
If you stop treatment with NULOJIX for a long period of time, without taking any other medicines to prevent rejection, and then restart, it is not known if belatacept will have the same effect as before.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. However, NULOJIX can cause serious side effects that may need treatment.
Tell your family or caregiver about your treatment as you might get symptoms that you might not be aware of yourself.
Tell your doctor immediately if you or your family notice any symptoms listed below:
Nervous system symptoms may include memory lapse; speech and communication difficulties; a change in your mood or behaviour; confusion or inability to control your muscles; weakness on one side of the body; vision changes; or headache.
Infection symptoms may include fever; unexplained weight loss; swollen glands; cold symptoms such as a runny nose or sore throat; cough with sputum; blood in your sputum; earache; cuts or scrapes that are red; warm and oozing pus.
Kidney or bladder symptoms may include tenderness at the site of your transplanted kidney; difficulty passing urine; changes in the amount of urine you produce; blood in the urine; pain or burning on urination.
Gastrointestinal symptoms may include pain on swallowing; painful mouth ulcers; white patches in the mouth or throat; upset stomach; stomach pain; vomiting; or diarrhoea.
Skin changes may include unexpected bruising or bleeding; brown or black skin lesion with uneven borders, or one part of the lesion does not look like the other; a change in the size and colour of a mole; or a new skin lesion or bump.
Allergic reactions may include, but are not limited to, rash; reddened skin; hives; itching; lip swelling; tongue swelling; swelling of the face; swelling over entire body; chest pain; shortness of breath; wheezing; or dizziness..
Very common side effects (may affect more than 1 in 10 people) are:
Tests may show:
Common side effects (may affect up to 1 in 10 people) are:
Tests may show:
Uncommon side effects (may affect up to 1 in 100 people) are:
Tests may show:
If any of the side effects gets serious, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
or search for MHRA Yellow Card in the Google Play or Apple App Store
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the vial label and carton after EXP. The expiry date refers to the last day of that month.
This medicine will be stored in the healthcare facility where it is administered.
Store in a refrigerator (2 °C – 8 °C).
Store in the original package in order to protect from light.
After reconstitution, the reconstituted solution should be transferred from the vial to the infusion bag or bottle immediately.
After dilution, and from a microbiological point of view, the product should be used immediately. If not used immediately, the solution for infusion may be stored in a refrigerator (2 °C – 8 °C) for up to 24 hours. The solution for infusion may be stored for a maximum of 4 hours of the total 24 hours below 25 °C. Do not freeze.
The NULOJIX infusion must be completed within 24 hours of reconstitution of the powder.
Do not use NULOJIX if you notice any particles or discolouration in the reconstituted or diluted solution.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
NULOJIX powder for concentrate for solution for infusion (powder for concentrate) is a white to off-white powder that can appear solid or broken into pieces.
Each vial contains 250 mg belatacept.
Packs of either 1 glass vial and 1 syringe or 2 glass vials and 2 syringes.
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Manufacturer:
This leaflet was last revised in April 2022
Approved v1.0