0 mg / mL concentrate for infusion solution for
anti-human T lymphocyte immunoglobulin from rabbit
1. What Grafalon is and what it is used for
Grafalon belongs to a group of medicines called immunosuppressants. These drugs are used to prevent the body from organ rejection after transplantation or during cell transplantation.
You can get Grafalon if you have had or will have a kidney transplant . This is to prevent your immune system from rejecting the new organ. Grafalon helps prevent or stop this rejection reaction by blocking the appearance of certain cells that would normally attack the transplanted organ.
You can also get Grafalon before a stem cell transplant (such as a bone marrow transplant) to prevent a condition called “graft-versus-host-disease”. This is a common but serious complication that can develop after a stem cell transplant if the donated cells react to the patient’s own tissue .
Grafalon is used with other immunosuppressive drugs as part of the immunosuppressive treatment you are receiving.
2. What you need to know before you take Grafalon
Do not use Grafalon and tell your doctor
- if you are allergic (hypersensitive) to the active substance in Grafalon (anti-human T lymphocyte immunoglobulin from rabbit) or to any of the other ingredients of Grafalon
- if you have an infection where the treatment is currently not effective
- if you have difficulty stopping bleeding
- if you have a tumor , unless you are having a stem cell transplant
Take special care with Grafalon
It is important that you tell your doctor if any of the following statements apply to you. You may be able to use Grafalon, but you must first talk to your doctor.
- if you have previously had allergic reactions to immunosuppressive drugs or to egg whites derived from rabbits
- if you have liver disease
- if you have heart problems
Infection is with Grafalon
Grafalon weakens the body’s own immune system. This means that your body will not be able to fight the infection you as efficiently as it normally does. Your doctor will treat these infections for you appropriately.
Use of other medicines
Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. These drugs can affect the effect of Grafalon.
- Grafalon is used with other immunosuppressive drugs, including corticosteroid is . Taking Grafalon at the same time as other immunosuppressive drugs may increase the risk of infection , abnormal bleeding and anemia ( anemia ).
- You should not take live vaccines if you are receiving immunosuppressive therapy. If you are receiving non-live vaccines , tell your doctor. These vaccines may not work as well if taken at the same time as Grafalon.
Tell your doctor if you are pregnant or think you may be pregnant. If it is necessary for you to use Grafalon, your doctor will discuss the risks and benefits of taking it during pregnancy.
Tell your doctor if you are breast-feeding. Grafalon can pass into breast milk.
If it is necessary for you to use Grafalon, your doctor will discuss the risks and benefits of taking it while you are breast-feeding.
Important information about how Grafalon is manufactured
Human material (eg red blood cells ) is used in the manufacture of Grafalon and therefore certain measures are applied to prevent infection from being transmitted to the patient. These measures include careful selection of blood donors in order to ensure that people who are at risk of carrying an infection are excluded and that all donated blood is tested to see if there are viruses / infections. The manufacturing process also includes steps that can inactivate or remove viruses . Nevertheless, the risk of transmission of infectious agents when administering medicinal products using human material cannot be completely ruled out . This also applies to new, hitherto unknown virusesor other types of infection .
The measures taken for Grafalon are considered effective for enveloped viruses such as human immunodeficiency virus ( HIV ), hepatitis B virus and hepatitis C virus and for non-enveloped viruses such as hepatitis A virus and parvovirus B19.
3. How to use Grafalon
Your Grafalon treatment has been prescribed by a doctor who has experience in the use of immunosuppressive drugs.
You will receive Grafalon in hospital. The drug is given in the form of a drip into a vein. Before the drip is given, the drug will be diluted with sodium chloride solution.
Adults and children may receive one of the following doses , depending on their weight and condition:
If you have already received a kidney transplant
The usual daily dose is 3-5 mg / kg body weight. The treatment lasts for 5 to 14 days.
Adults who are to undergo a stem cell transplant
The usual dose is 20 mg / kg body weight and it is usually started one to three days before the stem cell transplant .
Use in children and adolescents
Available information indicates that children do not require dosing other than adults.
If you take more Grafalon than you should
Administration of Grafalon is discontinued and other concomitant immunosuppressive therapy is adjusted. Your immune system may be weakened due to excessive Grafalon, and therefore you may be given medicines to prevent infection .
4. Possible side effects
Like all medicines, Grafalon can cause side effects, although not everybody gets them.
Tell your doctor immediately if you notice any symptoms of allergic reactions or anaphylactic shock as described below:
Allergic reactions are a common side effect after treatment with Grafalon that occurs in 1 to 10 in 100 people and may have the following symptoms:
- chest pain
- hissing and wheezing
- muscle pain
- reddening of the skin
In 3 of more than 240 patients, allergic reactions have developed into anaphylactic shock . This is a serious and potentially life-threatening condition in which the patient may have the following symptoms:
- high fever
- breathing difficulties
- low blood pressure
Tell your doctor if you notice any of the side effects listed below:
Very common side effects are (seen in more than 1 in 10 people):
- abdominal pain
- breathing difficulties
- hot flashes
- increased incidence of infection (eg urinary tract infection)
- low red blood cell count ( anemia )
Common side effects are (seen in 1 to 10 in 100):
- thrombocytopenia (decreased number of platelets ), leukopenia (decreased number of white blood cells ), pancytopenia (disorders of the blood picture)
- chest pain
- joint and muscle pain
- back pain
- muscle stiffness
- low or high blood pressure
- tingling, tingling or numbness in the skin
- fast heartbeat
- increase in laboratory values
- increased bilirubin in the blood
- blood in the urine
- reddening of the skin
- tubular necrosis of the kidneys ( renal failure )
- lymphoproliferative disease (type of cancer that originates in certain white blood cells )
- veno-occlusive liver disease (blockage of small veins in the liver)
Less common side effects are (seen in 1 to 10 out of 1000 persons):
- mucositis due to reflux of gastric juice into the esophagus
- increase in liver laboratory values
- increase in cholesterol levels
- increased number of red blood cells
- abnormal accumulation of lymph (tissue fluid)
- accumulation of water
Rare but medically important adverse reactions are (seen in 1 to 10 out of 10 000 people):
- Hemolysis (abnormal breakdown of red blood cells )
In rare cases, especially if the medicine is given for a long period of time, serum sickness may occur. This is a type of allergic reaction to foreign protein and causes symptoms such as fever, muscle aches, joint pain and itchy skin rash.
Additional side effects are in children and adolescents
Available information suggests that the side effects of Grafalon in children and adolescents are not fundamentally different from the side effects seen in adults.
Reporting of side effects ar
If you get any side effects , talk to your doctor. This also applies to side effects that are not mentioned in this
information. You can also report side effects directly via the Medical Products Agency, Box 26, 751 03
Uppsala, Website: www.lakemedelsverket.se
By reporting side effects , you can help increase drug safety information.
5. How to store Grafalon
- Keep out of sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the label after “EXP.” The expiration date is the last day of the specified month.
- Grafalon should be stored in a refrigerator (2 –C – 8 ºC). Keep the unopened vial in the outer carton. Sensitive to light.
- Grafalon must not be used if the solution is cloudy.
- Your doctor will take care of any unused medicine.
6. Contents of the packaging and other information
The active substance is 20 mg / ml rabbit anti-human T lymphocyte immunoglobulin. The other ingredients are sodium dihydrogen phosphate dihydrate, phosphoric acid (85%) and water for injections.
What the medicine looks like and contents of the pack
Grafalon is a clear to slightly opalescent, colorless to pale yellow solution in glass vials. The smaller 5 ml vial contains 100 mg of Grafalon, while the larger 10 ml vial contains 200 mg of Grafalon.
Grafalon is supplied in cartons containing either 1 vial or 10 vials
Marketing Authorization Holder and Manufacturer
Neovii Biotech GmbH
Am Haag 6 + 7