Methoxsalen G.L. Pharma

Package leaflet: Information for the patient

Metoxsalene G.L. Pharma

20 micrograms/ml solution for modification of blood fraction
Metoxsalene

Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Metoxsalene G.L. Pharma is and what it is used for
2. What you need to know before being administered Metoxsalene G.L. Pharma
3. How to use Metoxsalene G.L. Pharma
4. Possible side effects
5. How to store Metoxsalene G.L. Pharma
6. Contents of the pack and other information

1. What Metoxsalene G.L. Pharma is and what it is used for

The active substance of Metoxsalene G.L. Pharma is methoxsalen, a medicine that becomes active through UV radiation.
Methoxsalen is added to your white blood cells outside your body and activated by ultraviolet light (long-wave UV rays). The white blood cells are then reintroduced into your body.
This process is called photoapheresis. As a result of this process, diseased white blood cells can be destroyed.
Metoxsalene G.L. Pharma is used to relieve skin symptoms of advanced cutaneous T-cell lymphoma (a tumor occurring in the skin caused by specific white blood cells called T-lymphocytes) when other treatments have not been effective.

2. What you need to know before you are given Metoxsalene G.L. Pharma

Do not use Metoxsalene G.L. Pharma

• if you are allergic to methoxsalen, to related substances (psoralens), or to any of the other ingredients of this medicine (listed in section 6);
• if you have a skin tumour (e.g. melanoma or basal cell carcinoma);
• if you have a disease associated with increased sensitivity to light, such as porphyria, systemic lupus erythematosus, or albinism;
• if you are sexually active and of childbearing age and have not yet taken contraceptive measures;
• if you have had your lens removed;
• if you are pregnant or breastfeeding.

The photopheresis procedure must not be used:

• if your body cannot tolerate the temporary blood loss caused by the treatment, for example due to heart disease or severe anaemia;
• if you have had your spleen removed;
• if you have a blood coagulation disorder;
• if you have a high number of white blood cells (more than 25,000/mm³).

Warnings and precautions
Talk to your doctor before being treated with Metoxsalene G.L. Pharma:

• If you normally take medicines to reduce high blood pressure, you should wait until the end of the photopheresis treatment before taking them.
• To ensure that the photopheresis procedure can be performed effectively, the level of triglycerides (a specific component of fat) in your blood should be as low as possible. Therefore, your doctor will instruct you to fast before each treatment.
• During treatment with Metoxsalene G.L. Pharma, sexually active men and women of childbearing age must use an appropriate method of contraception.
• If you have liver problems, your doctor may monitor your liver function values.

Important information for preventing damage to skin and eyes
Metoxsalene G.L. Pharma makes your skin more sensitive to sunlight and to artificial light of solar type. Since the amount of medicine used in photopheresis treatment is very low, it is rather unlikely that this adverse effect will occur. Nevertheless, to minimize the risk of adverse effects, particularly to the eyes and skin, you must not expose yourself to sunlight during the first 24 hours after photopheresis treatment.
During treatment with Metoxsalene G.L. Pharma and for 24 hours afterwards, you must wear special wrap-around sunglasses that block UVA rays to protect your eyes from potential damage.
Inform your doctor if you have problems with liver function, as you may need to continue these light-exposure precautions for a longer period.

Children and adolescents (under 18 years)
Metoxsalene G.L. Pharma must not be used in children and adolescents, as there is insufficient experience with this medicine in this age group.

Other medicines and Metoxsalene G.L. Pharma
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Phenytoin (a medicine used to treat epileptic seizures) may lead to a faster elimination of Metoxsalene G.L. Pharma from the body and thus reduce the effectiveness of photopheresis treatment.
The effect of Metoxsalene G.L. Pharma is influenced by substances that may also destroy cells or increase light sensitivity. These include:

• other medicines used to treat skin diseases (e.g. anthralin, coal tar, griseofulvin, retinoids);
• various antibiotics (e.g. tetracyclines, fluoroquinolones) and chemotherapeutic agents (e.g. nalidixic acid, sulfonamides);
• medicines used to treat diabetes (sulfonylureas, particularly tolbutamide);
• diuretics (e.g. thiazides, furosemide);
• medicines with a calming and/or sedative effect (phenothiazines);
• some medicines affecting blood coagulation (oral anticoagulants derived from coumarin, halogenated salicylanilide derivatives);
• dyes (e.g. methylene blue/toluidine blue, rose bengal, methyl orange);
• medicines containing caffeine.

Metoxsalene G.L. Pharma with beverages and alcohol
You should avoid drinking coffee or tea during treatment with Metoxsalene G.L. Pharma. The substances contained in them (caffeine, theophylline) may prolong the duration of light sensitivity.
You should avoid alcohol during treatment with Metoxsalene G.L. Pharma because the effects of ethanol (alcohol) contained in Metoxsalene G.L. Pharma may be increased by other medicines taken simultaneously.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Metoxsalene G.L. Pharma must not be used during pregnancy or breastfeeding.
If you are sexually active and of childbearing age, you must use appropriate contraceptive methods during treatment with Metoxsalene G.L. Pharma, because the active substance methoxsalen may cause harm to a child conceived during treatment with Metoxsalene G.L. Pharma.

Driving and using machines
Warning: this medicine may affect your reaction time and ability to drive vehicles.
You must not drive or operate machinery immediately after treatment.

Metoxsalene G.L. Pharma contains small amounts of ethanol (alcohol), less than 100 mg per ml.
In extracorporeal therapy, systemic effects on your body are expected to be limited. However, your prescribing doctor will monitor you for possible interactions with other medicines. Particular caution is required in patients with liver disorders, alcoholism, epilepsy, or brain injury or disorders.

Metoxsalene G.L. Pharma contains less than 1 mmol (23 mg) of sodium per ml, i.e. essentially ‘sodium-free’.

3. How to use Metoxsalene G.L. Pharma

This medicine is always administered by a specialist doctor who is fully experienced in handling Metoxsalene G.L. Pharma. Your doctor will decide how many treatment sessions you need.
Method of administration
Extracorporeal use (meaning: outside the patient's body).
The contents of the vial are never injected directly into the patient.
A healthcare professional trained in photoapheresis administration will use a needle to draw a small amount of blood from one of your veins. This blood is then separated into red blood cells, white blood cells, and plasma. The red blood cells and most of the plasma will be returned to your bloodstream during the procedure. The white blood cells and the remaining plasma will be mixed with an individually calculated dose of Metoxsalene G.L. Pharma, exposed to UV radiation, and then returned to your body.
During administration of your treatment and for the following 24 hours, you must wear special wraparound sunglasses that block UVA rays at all times to prevent eye damage, which could lead to cataract formation.
Duration of treatment
During the first 3 months, patients are recommended to be treated on two consecutive days every 2–4 weeks.
After that, the two-day treatment cycles usually occur every 3–4 weeks.
At the time of optimal response to treatment, intervals will gradually be extended to 4–8 weeks, and treatment will then continue every 8 weeks.
Photoapheresis should be performed for at least 6 months.
If you respond well to treatment or if your disease does not worsen, photoapheresis should be continued for 2 years or longer.
If you do not respond to photoapheresis alone, your doctor may recommend adding another medicine (e.g., interferon and/or bexarotene).
This is a general guideline. Your doctor may adjust treatment cycles based on individual symptoms and response.
The procedure lasts approximately 3–4 hours in total, from the time the doctor inserts the needle until all components of your blood are returned to your circulation.
Patients with impaired liver or kidney function
If you have liver or kidney problems, your doctor will likely monitor your blood counts regularly; Metoxsalene G.L. Pharma has not been clinically tested in patients with impaired liver or kidney function.
After treatment
After receiving treatment, you must avoid direct sunlight for at least 24 hours, as skin damage due to sunburn or, over time, premature skin aging may occur. If you need to go outdoors, cover your skin, use a high-protection sunscreen, and wear special sunglasses (see above).
If you are given more Metoxsalene G.L. Pharma than you should
Overdose is unlikely. However, if an overdose has been administered, you will need to remain in a darkened room for 24 hours or longer.
If you have any doubts about using this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following side effects have been reported:
Common (may affect up to 1 in 10 people)

• Infections
• Low blood pressure, dizziness
• Nausea, vomiting
• Complications at the venous access site following repeated venous access (venipuncture)

Not known (frequency cannot be estimated from the available data)

• Eye disorders due to exposure to light (phototoxic reactions), such as clouding of the lens (cataract formation) and inflammation of the middle layer of the eye (choroid), leading to inflammation of the retina (chorioretinitis)
• Skin disorders due to exposure to light (phototoxic reactions), such as itching or redness of the skin
• Fever (mild fever may occur from 2 to 12 hours after treatment)

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Metoxsalene G.L. Pharma

Keep in the original packaging to protect the medicine from light.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.

6. Package contents and other information

What Metoxsalene G.L. Pharma contains

• The active substance is: methoxsalen. One 5 ml vial contains 100 micrograms (µg) of methoxsalen. One ml of solution contains 20 µg of methoxsalen.
• The other components are: sodium chloride, ethanol 96%, water for injections.

Description of the appearance of Metoxsalene G.L. Pharma and contents of the pack
Clear, colourless solution.
The solution has a pH of 5.0–7.0.
Amber glass vials of 5 ml.
Pack sizes: packs of 5, 25, 50 and 5 x 25 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
G.L. Pharma GmbH, Schloßplatz 1, 8502 Lannach, Austria

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Oxsoralen 20 microgram/ml solution for modification of a blood fraction
Germany Methoxsalen G.L. Pharma 20 microgram/ml solution for modification of a blood fraction
Spain Metoxaleno G.L. Pharma 20 microgramos/ml solución para modificación de fracciones sanguíneas
Italy Metoxsalene G.L. Pharma 20 μg/ml solution for blood fraction modification
United Kingdom Methoxsalen G.L. Pharma 20 microgram/ml solution for blood fraction modification