NULOJIX 250 mg powder for concentrate for solution for infusion

belatacept

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.

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 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:

• Bladder or kidney infection, upper respiratory infection, CMV infection (can cause serious blood and tissue infections), fever, cough, bronchitis
• Shortness of breath
• Constipation, diarrhoea, nausea, vomiting, abdominal pain
• High blood pressure, low blood pressure
• Headache, difficulty sleeping, feeling nervous or anxious, swelling of the hands and feet
• Joint pain, back pain, pain in the extremities
• Pain when passing urine, blood in the urine

Tests may show:

• Low blood count or anaemia, low white blood cell count
• Increased amounts of creatinine in your blood (blood test used to measure kidney function), increased amounts of protein in your urine
• Changes in blood levels of different salts or electrolytes
• Increased amounts of cholesterol and triglyceride (blood fats)
• High levels of sugar in your blood

Common side effects (may affect up to 1 in 10 people) are:

• Cancer and non-cancerous growths of the skin
• Dangerous decrease of blood pressure which, if untreated, may lead to collapse, coma and death
• Stroke
• Dead tissue because of stopped blood supply
• Liver inflammation (cytolytic hepatitis)
• Damage to the kidney
• Fluid in the lungs, wheezing, chest pain or angina, enlarged heart muscle (bottom of the heart)
• Infection of the blood or tissues, respiratory infections, pneumonia, flu, sinus inflammation, runny nose, sore throat, pain in the mouth/throat region, herpes virus infections, shingles and other viral infections, mouth sores, thrush, kidney infection, fungal skin infections,fungal infections of the nails and other fungal infections, skin infection, infection of soft tissues, wound infection, infection limited to one area, slow healing, bloody bruise, build up of lymph fluid around the transplanted kidney
• Fast heart rate, slow heart rate, abnormal and irregular heart beat, weak heart
• Diabetes
• Dehydration
• Inflammation of the stomach and intestines, usually caused by a virus
• Upset stomach
• Unusual sensation of pins and needles, numbness or weakness of the arms and legs
• Rash, itching
• Muscle pain, muscle weakness, bone pain, joint swelling, abnormal cartilage between bones of the spine, sudden inability to bend joint, muscle spasms, arthritis
• Blockage of kidney blood vessels, enlarged kidney due to blockage of urine flow out of the kidney, backflow of urine from the bladder into the kidney tubes, inability to hold urine, incomplete emptying of the bladder, urinating at night, sugar in the urine
• Increase in body weight, decrease in body weight
• Cataract, increased blood congestion in the eye, blurred vision
• Shaking or tremors, dizziness, fainting or passing out, ear pain, buzzing, ringing or other persistent noise in the ears
• Acne, hair loss, abnormal change to the skin, excessive sweating, night sweats
• Weakness/gap in abdominal muscles and out pouching of skin over healed incision, hernia on the stomach wall
• Depression, fatigue, feeling of tiredness, drowsiness, or lack of energy, general feeling of being unwell, difficulty breathing when laying down, nose bleeding
• Typical appearance of a person with high levels of steroids, such as moon face, hump back, upper body obesity
• Abnormal collection of fluid

Tests may show:

• Low platelet counts in your blood, too many white blood cells, too many red blood cells
• Changes in blood levels of carbon dioxide, fluid retention, low protein in the blood
• Abnormal liver function tests, blood parathyroid hormone increased
• Increased protein (c-reactive protein) in blood indicating inflammation
• A decrease of antibodies (proteins that fight infection) in your blood

Uncommon side effects (may affect up to 1 in 100 people) are:

• Lung cancer, rectal cancer, breast cancer, a form of cancer in the bones, musles, or fat tissue, tumor of the skin and intestinal tract caused by a herpes virus and seen in patients with a weakened immune system, prostate cancer, cancer of the cervix, throat cancer, cancer of the lymph nodes, cancer of the bone marrow, cancer of the kidney, kidney tubes, or bladder
• Fungal infection of brain, inflammation of the brain, serious brain infection called PML (progressive multifocal leukoencephalopathy)
• Abnormal swelling of the brain, increased pressure inside the skull and brain, seizure, weakness causing loss of movement on one side of the body, loss of the covering around nerves, inability of muscles to move in the face
• Any disease of the brain causing headache, fever, hallucinations, confusion, abnormal speech and body movement
• Poor blood flow to the heart, blocked heart beats, abnormal aorta heart valve, abnormal rapid heart rate
• Sudden problems with breathing leading to lung damage, increased blood pressure in the lungs, inflammation of the lungs, coughing up blood, abnormality of lungs and air tubes delivering air in and out of lungs, fluid in the sac around the lungs, breathing that stops temporarily during sleep, abnormal speaking sound
• Genital herpes
• Inflammation of the colon (large bowel) caused by the cytomegalovirus, inflammation of the pancreas, ulcer in the stomach, small intestines, or large intestine, blockage of the small intestine, black, tar-like stools, rectal bleeding, abnormal colour of the stool
• Bacterial infections, inflammation or infection of the inner layer of the heart, tuberculosis, bone infection, inflammation of the lymph nodes, chronic dilation of the airways in the lungs with frequent lung infections
• Infection with the strongyloides worm, diarrheal infection with Giardia parasite
• Kidney disease that is caused by a virus (polyomavirus-associated nephropathy), inflammation of the kidneys, scarring of the kidneys, shrinkage of the small tubes in the kidney, inflammation of the bladder with bleeding
• Blood clotting in kidney artery
• Guillian-Barré syndrome (a condition that causes muscle weakness or paralysis)
• EBV (Epstein-Barr virus) lymphoproliferative disease
• Blood clotting in veins, inflamed veins, periodic leg cramps
• Abnormal arteries, scarring of the arteries, clotting in the arteries, narrowing of the arteries, temporary redness of the face/skin, swelling of the face
• Stones in the gallbladder, fluid filled pocket in the liver, fatty liver
• Skin disease with thickened patches of red skin, often with silvery scales, abnormal hair growth, excessive hair breakage, nails breaking, ulcer on the penis
• Abnormal balance of minerals in the body causing bone problems, bone inflammation, abnormal weakening of the bone leading to bone problems, inflammation of the lining of the joints, rare bone condition
• Inflammation of the testicles, an abnormally prolonged penile erection, abnormal cervical cells, breast mass, pain in the testes, ulcer in the female genital area, thinned vaginal walls, infertility or inability to become pregnant, swelling of the scrotum
• Seasonal allergy
• Poor appetite, loss of taste, decreased hearing
• Abnormal dreams, mood swings, abnormal lack of ability to focus and sit still, difficulty understanding or thinking, poor memory, migraine, irritability
• Numbness or weakness from poorly controlled diabetes, changes in the foot from diabetes, inability to keep legs still
• Swelling of back of the eye causing changes in sight, eye inflamed, uncomfortable/increased sensitivity to light, swelling of the eyelid
• Cracking of the corner of the mouth, swollen gums, salivary gland pain
• Increased sexual desire
• Burning sensation
• Reaction to an infusion, scare tissue, inflammation, return of disease, feeling hot, ulcer
• Not making enough urine
• Failure of transplanted organ to work, problems during or after a transfusion, separation of the wound edges before it heals, broken bone, complete tear or separation of tendon, low blood pressure during or after a procedure, high blood pressure during or after a procedure, bruise/collection of blood within the soft tissues after a procedure, pain related to a procedure, headache related to a procedure, bruise of the soft tissue

Tests may show:

• Dangerously low red blood cells, dangerously lowered white cell counts, destruction of red blood cells, blood clotting problems, acid in the blood from diabetes, lack of acid in the blood
• Improper production of hormones by the adrenal glands
• Low vitamin D levels
• Pancreatic enzymes in the blood increased, troponin levels in the blood increased, prostate-specific antigen (PSA) increased, high uric acid levels in the blood, CD-4 lymphocyte cell counts decreased, low blood sugar

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.