Grafalon

PATIENT INFORMATION LEAFLET: USER INFORMATION

Grafalon 20 mg/ml concentrate for solution for infusion

rabbit immunoglobulin against human T lymphocytes

Read the leaflet carefully before using the medicine

• Keep this leaflet, you may need to read it again.
• Ask your doctor if you have any further questions.
• This medicine has been prescribed for you only. Do not pass it on to others.
• The medicine may harm them, even if their symptoms are the same
• If any of the side effects get worse, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Table of contents of the leaflet:

• 1. What is Grafalon and what is it used for
• 2. Important information before using Grafalon
• 3. How to use Grafalon
• 4. Possible side effects
• 5. How to store Grafalon
• 6. Contents of the pack and other information

1. WHAT IS GRAFALON AND WHAT IS IT USED FOR

Grafalon belongs to a group of medicines called immunosuppressants. Immunosuppressants are
used to prevent the body from rejecting a transplanted organ or transplanted cells.
Grafalon may be given to a patient who has had or will have an organ transplant. This is to prevent the new organ from being rejected by the patient's immune system.
Grafalon helps prevent or stop such a rejection reaction by blocking the development of special cells that normally attack the transplanted organ.
Grafalon is used as part of immunosuppressive treatment, together with other immunosuppressive medicines.
Grafalon may also be given to a patient before a stem cell transplant (e.g. bone marrow transplant) to prevent a disease called "graft versus host disease". This is a common but serious complication that can develop after a stem cell transplant if the donor cells react against the patient's tissues.

2. IMPORTANT INFORMATION BEFORE USING GRAFALON

When not to use Grafalon

Warnings and precautions

It is important to inform your doctor if you have any of the following conditions. You will probably still be able to receive Grafalon, but you must consult your doctor first.

Infections and Grafalon

Grafalon weakens the body's defense system. As a result, the body will not be able to fight infections as well as it normally does. Your doctor will treat any infections that occur.

Other medicines and Grafalon

Tell your doctor about all the medicines you have taken recently, including those that are available without a prescription. These medicines may affect the way Grafalon works.

• Grafalon is used together with other immunosuppressive medicines, such as corticosteroids. Taking Grafalon at the same time as other immunosuppressive medicines may increase the risk of infection, prolonged bleeding, and anemia (a blood disease).
• Because of immunosuppressive treatment, live vaccines should not be given to the patient. Tell your doctor if the patient is going to receive an inactivated vaccine. These vaccines may not work if they are taken at the same time as Grafalon.

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or think you may be pregnant. If Grafalon needs to be used, your doctor will discuss the risks and benefits of taking the medicine during pregnancy.
Tell your doctor if you are breastfeeding. Grafalon may pass into breast milk.

Important information about the manufacture of Grafalon

Human-derived components (e.g. red blood cells) are used in the manufacture of Grafalon.
Therefore, certain measures are taken to prevent the transmission of infectious agents to patients. These include careful selection of donors to ensure that donors who may be carriers of infections are excluded, as well as testing all donated samples for the presence of viruses/infections. The manufacturing process also includes steps to inactivate or remove viruses from human-derived components. Despite these measures, it cannot be completely excluded that the transmission of infections may occur when medicines manufactured using human-derived components are administered. This may also apply to unknown or newly emerging viruses or other types of infections.
The measures taken are considered effective against enveloped viruses, such as human immunodeficiency virus (HIV), hepatitis B virus, and hepatitis C virus, as well as non-enveloped viruses such as hepatitis A virus and parvovirus B19.

3. HOW TO USE GRAFALON

Treatment with Grafalon has been prescribed by a qualified doctor with experience in immunosuppressive treatment.
Grafalon will be given to the patient in a hospital. Grafalon will be given as an infusion into a vein.
Before the infusion is given, it will be diluted in a sodium chloride solution.
Adults and children may be given one of the following doses, based on weight and patient condition:
If the patient is going to have an organ transplant
The daily dose is 2-5 mg/kg body weight. Treatment lasts from 5 to 14 days.
If the patient has had an organ transplant
The usual daily dose is 3-5 mg/kg body weight. The treatment cycle will last from 5 to 14 days.
Adults with a planned stem cell transplant
The usual daily dose is 20 mg/kg body weight, given from -3 to -1 days before the stem cell transplant.

Use in children and adolescents

Available information suggests that children and adolescents do not require different dosing than adult patients.

Using a higher dose of Grafalon than recommended

Grafalon administration will be stopped, and treatment with another immunosuppressive medicine will be changed. The patient's immune system may be weakened after receiving too much Grafalon, so medicines to prevent infection may be given.
If you have any doubts about the use of the medicine, consult your doctor.

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 of the following side effects, related to allergic reactions and anaphylactic shock.
Allergic reactions are common side effects of Grafalon treatment.
In less than 1 in 10 patients, the following may occur:

• chest pain
• wheezing
• muscle pain
• redness of the skin

In 3 out of 240 patients, allergic reactions developed into anaphylactic shock. This is a serious and potentially life-threatening condition, during which the patient may experience the following symptoms:

• high fever
• skin rash
• swelling
• difficulty breathing
• low blood pressure

Tell your doctor if you notice any of the following side effects:
Very common side effects, occurring in more than 1 in 10 patients:

• fever
• chills
• headache
• shivering
• vomiting
• nausea
• diarrhea
• abdominal pain
• difficulty breathing
• sudden redness of the face
• increased frequency of infections
• low red blood cell count (anemia)

Common side effects, occurring in less than 1 in 10 patients:

• thrombocytopenia, leukopenia, pancytopenia (blood diseases)
• mucositis
• swelling
• fatigue
• chest pain
• joint and muscle pain
• back pain
• muscle stiffness
• low or high blood pressure
• tingling, pricking, or numbness of the skin
• rapid heartbeat
• sensitivity to light
• elevated laboratory parameters
• increased bilirubin levels in the blood
• blood in the urine
• cough
• nasal bleeding
• redness of the skin
• itching
• rash
• renal tubular necrosis (kidney impairment)
• lymphoproliferative disease (a type of cancer derived from a certain type of white blood cell)
• hepatic veno-occlusive disease (small veins in the liver blocked)

Uncommon side effects, occurring in less than 1 in 100 patients:

• indigestion
• esophageal reflux
• elevated liver laboratory parameters
• elevated cholesterol levels
• shock
• increased red blood cell count
• abnormal lymph accumulation
• fluid retention

Rare but medically important side effects, occurring in less than 1 in 1,000 patients:

• hemolysis (abnormal breakdown of red blood cells)

In rare cases, especially if the medicine is given for a long time, a serum sickness-like disease may develop, which is a type of allergic reaction to foreign protein, with symptoms such as fever, muscle and joint pain, and itchy skin rash.
If any of the side effects get worse, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Additional side effects in children and adolescents

Available data indicate that the side effects of Grafalon in children and adolescents are essentially the same as those observed in adult patients.

Reporting side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE GRAFALON

• Keep out of the sight and reach of children.
• Do not use Grafalon after the expiry date stated on the label after EXP. The expiry date refers to the last day of that month.

Explanations of abbreviations:

• Expiry date (EXP)
• Batch number (Lot)
• Grafalon should be stored in a refrigerator (2°C - 8°C) in an unopened vial placed in the outer packaging to protect from light.
• Do not use Grafalon if the solution is cloudy.
• Any unused medicine should be disposed of in accordance with local requirements.
• Siliconized syringes must not be used to draw up Grafalon from vials or to prepare the infusion solution.
• The medicine is not intended for multiple use

6. CONTENTS OF THE PACK AND OTHER INFORMATION

WHAT GRAFALON CONTAINS

The active substance is 20 mg/ml rabbit immunoglobulin against human T lymphocytes

• Other ingredients of the medicine are sodium dihydrogen phosphate dihydrate, phosphoric acid (85%), and water for injections.

WHAT GRAFALON LOOKS LIKE AND CONTENTS OF THE PACK

Grafalon is a clear to slightly opalescent and 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 a carton containing 1 vial or 10 vials.

MARKETING AUTHORIZATION HOLDER AND MANUFACTURER

Neovii Biotech GmbH Am Haag 6+7 82166 Gräfelfing Germany For more detailed information, please contact the representative of the marketing authorization holder. Fresenius Medical Care Polska S.A. ul. Krzywa 13 60-118 Poznań 0-61 83 92 600

DATE OF REVISION OF THE LEAFLET:

09/2024