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Gliolan - Patient leaflet, side effects, dosage

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Sources: Original PDF (ema.europa.eu)

Patient leaflet - Gliolan

1. What Gliolan is and what it is used for

Gliolan is used for the visualisation of certain brain tumours (called malignant glioma) during tumour surgery.

Gliolan contains a substance called aminolevulinic acid (5-ALA). 5-ALA accumulates preferably in tumour cells where it is transformed into another similar substance. If the tumour is then exposed to blue light, this new substance emits a red-violet light which helps to better see what is normal tissue and what is tumour tissue. This helps the surgeon to remove the tumour while sparing healthy tissue.

2. What you need to know before you take Gliolan

Do not take Gliolan

  • if you are allergic to 5-ALA or porphyrins.
  • in case of known or suspected acute or chronic types of porphyria (i.e. inherited or acquired disorders of certain enzymes in the synthesis pathway of red blood pigment).
  • in case of known or suspected pregnancy.

Warnings and precautions

Talk to your doctor or pharmacist before taking Gliolan.

  • For 24 hours after administration of this medicine, protect your eyes and skin from strong light (for example direct sunlight or brightly focused indoor light).
  • If you have a heart disease or had heart disease in the past, you should tell your doctor. In this case, this medicine should be used with caution because your blood pressure may be decreased.

Renal or hepatic impairment

No trials have been performed in patients with poor liver or kidney function. Therefore, this medicine should be used with caution in such patients.

Elderly

There are no special instructions for use in elderly patients with normal organ function.

Children and adolescents (< 18 years)

There is no experience with Gliolan in children and adolescents. Therefore this medicine is not recommended in this age group.

Other medicines and Gliolan

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, particularly medicines that may cause skin problems when the skin comes under strong light (for example some types of medicines called antibiotics), but also medicines obtained without prescription (for example hypericin or Saint John’s wort extracts).

One case of severe sunburn lasting for 5 days has been reported in a patient after having taken this medicine and a hypericin extract. You should not take any such products up to 2 weeks after you have taken Gliolan.

Within 24 hours after having taken Gliolan, avoid any other medicines that may harm the liver.

Gliolan with food and drink

This medicine is generally used once only, namely 2–4 hours before anaesthesia for surgery for certain brain tumours called glioma. You should not drink or eat for at least 6 hours before anaesthesia.

Pregnancy and breast-feeding

Pregnancy

It is not known whether Gliolan will harm an unborn baby. Do not use this medicine if you are pregnant.

Breast-feeding

It is not known whether this medicine enters breast milk. Breast-feeding mothers should not breast-feed for 24 hours after treatment with this medicine.

Driving and using machines

This medicine itself has no influence on the ability to drive and use machines.

3. How to take Gliolan

This medicine is a powder that must be first mixed with drinking water before use. This is always done by a pharmacist or a nurse and not by yourself. The usual dose is 20 mg 5-ALA HCl per kilogram body weight. The pharmacist or nurse will calculate the exact dose you need and the amount of the solution (in ml) you have to drink. You have to drink the prepared solution 2–4 hours before anaesthesia.

If the surgery is postponed by more than 12 hours, surgery should be re-scheduled for the next day or later. Another dose of this medicine can be taken 2 – 4 hours before anaesthesia.

If you take more Gliolan than you should

If you have taken more Gliolan than you should, your doctor will decide on any necessary measures to avoid any problems, including sufficient protection from strong light (for example direct sunlight).

If you forget to take Gliolan

This medicine is given once only at the day of surgery, 2 – 4 hours before start of anaesthesia. If you have forgotten to take this medicine during this time period, it is not advisable to take it just before start of anaesthesia. In this case, anaesthesia and surgery must be postponed for at least 2 hours, if possible.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Most serious side effects include mild alterations of blood cell counts (red and white cells, platelets), disorders that affect the nervous system (neurological disorders) like partial paralysis of one side of the body (hemiparesis) and blood clots that may obstruct blood vessels (thromboembolism). Further frequently observed side effects are being sick (vomiting), feeling sick (nausea) and slight increase of some enzymes (transaminases, y-GT, amylase) or bilirubin (a bile pigment produced in the liver by breakdown of red blood pigment) in the blood.

Tell your doctor immediately if you experience any complaints.

Side effects are divided into the following two categories:

  • immediate side effects after having taken Gliolan and before anaesthesia
  • combined side effects of Gliolan, anaesthesia, and tumour resection.

5. How to store Gliolan

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 carton after EXP. The expiry date refers to the last day of that month.

Keep the bottle in the outer carton in order to protect from light.

The reconstituted solution is physically-chemically stable for 24 hours at 25 °C.

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.

6. Contents of the pack and other information

What Gliolan contains

The active substance is 5-aminolevulinic acid hydrochloride (5-ALA HCl). One bottle contains 1.17 g of 5-aminolevulinic acid (5-ALA), corresponding to 1.5 g 5-ALA HCl.

One ml of reconstituted solution contains 23.4 mg of 5-ALA, corresponding to 30 mg 5-ALA HCl.

What Gliolan looks like and contents of the pack

This medicine is a powder for oral solution. The powder is a white to off-white cake. The reconstituted solution is a clear and colourless to slightly yellowish fluid.

Gliolan is provided in a glass bottle and presented in packs of 1, 2 and 10 bottles. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

medac

Gesellschaft für klinische

Spezialpräparate mbH

Theaterstr. 6

22880 Wedel

Germany

Tel. +49 4103 8006–0

Fax: +49 4103 8006–100

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

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Sources: Original PDF (ema.europa.eu)

The drug is classified in the ATC tree:

L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS

L01 ANTINEOPLASTIC AGENTS

L01X OTHER ANTINEOPLASTIC AGENTS in ATC

L01XD Sensitizers used in photodynamic/radiation therapy

L01XD04 aminolevulinic acid

Frequently Asked Questions

What is Gliolan and how does it work?

Gliolan, containing aminolevulinic acid, is a medication used during surgery to help identify cancerous tissue. It works by enhancing the visibility of tumors under specific blue light.

Who can benefit from Gliolan treatment?

Gliolan is typically used for patients with certain types of brain tumors. Your doctor will assess if it's suitable for your specific condition.

Is Gliolan safe for everyone?

While Gliolan is generally safe, it's important to inform your doctor about any allergies or medical conditions you have to ensure it's appropriate for you.

Can Gliolan cause allergic reactions?

Yes, some individuals may experience allergic reactions to Gliolan. Notify your healthcare provider immediately if you notice any unusual symptoms.

How is Gliolan administered before surgery?

Gliolan is usually taken orally in a specific dosage, typically 3 hours before the surgical procedure to optimize its effectiveness in highlighting tumor tissues.

What should I do if I miss a dose of Gliolan?

If you miss a dose, contact your healthcare provider for advice. Do not take extra medication to make up for the missed dose.

Are there any dietary restrictions while using Gliolan?

Your doctor might advise avoiding certain foods or drinks before taking Gliolan, but generally, there are no strict dietary restrictions.

Can I take other medications while using Gliolan?

Always inform your doctor about any other medications you are taking, as some may interact with Gliolan and affect its effectiveness.

What side effects should I expect from Gliolan?

Common side effects may include nausea, headache, or sensitivity to light. Always discuss potential side effects with your healthcare provider.

How long does the effect of Gliolan last during surgery?

The effect of Gliolan typically lasts throughout the surgical procedure, helping surgeons visualize tumors more effectively during their operation.

Will I be able to see normally after taking Gliolan?

After administration of Gliolan, your vision might be temporarily affected by light sensitivity; however, this usually resolves shortly after the surgery.

Can Gliolan affect my recovery time after surgery?

Gliolan itself does not typically affect recovery time; however, as with any surgical procedure, recovery will depend on individual health factors and the extent of surgery performed.

Is there a specific age limit for using Gliolan?

While there are no strict age limits for using Gliolan, its safety and efficacy in children and elderly patients should be evaluated by a healthcare professional.

Should I inform my doctor about my pregnancy or breastfeeding status before taking Gliolan?

Yes, it’s essential to inform your doctor if you are pregnant or breastfeeding before using Gliolan due to potential risks involved.

How can I prepare for surgery after being prescribed Gliolan?

Follow your doctor's instructions carefully regarding pre-surgery preparations and discuss any concerns you have about the procedure or use of Gliolan.

Will my insurance cover the use of Gliolan during my surgery?

Insurance coverage for Gliolan can vary. It's best to check with your insurance provider regarding coverage details related to this medication.

What happens if my doctor decides not to use Gliolan during my surgery?

If your doctor decides against using Gliolan during surgery, they will have alternative methods for identifying tumor tissue and ensuring effective treatment.

How often can I useGliolan if needed in subsequent surgeries?

Your healthcare provider will determine how often you can use Gliolan based on individual circumstances and the type of surgeries planned.

Where can I find more information about clinical studies involving Gliolan?

You can find information about clinical studies involving Gliolan on medical research websites or ask your healthcare provider for published studies related to its use.