Foscan （替莫泊芬注射液）4 mg/ml solution for injection Temoporfin - United Kingdom[英国药品]

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Foscan （替莫泊芬注射液）4 mg/ml solution for injection Temoporfin

2014-12-09 22:22:16 来源: 作者: 【大中小】浏览:1431次评论:0条

Foscan （替莫泊芬注射液）4 mg/ml solution for injection Temoporfin

主成分：Temoporfin

劑型：4mg/ml

劑量：5ml/vial

特性：本品為第二代光動力治療藥物，具有器官及功能保留特色，可以治療早期的淺層癌症，為頭頸癌治療的新選擇。

適應症：頭頸部癌症治療

包裝：1vial/Box

What is it and how is it used?

Foscan is a porphyrin photosensitising medicine.

Foscan is used for the treatment of head and neck cancer in patients who cannot be treated with other therapies.

What do you have to consider before using it?

Do not use Foscan

Take special care with Foscan
Foscan will make you sensitive to light for about 15 days after your injection. This means that normal daylight or bright indoor lighting could give you skin burns. To stop this, you MUST follow carefully the instructions for gradual exposure to increasing light levels indoors over the first week and outdoor, shaded light during the second week after treatment. Please speak to your doctor about this before you go home after being injected with Foscan. Sunscreen creams will not prevent this sensitivity. You will gradually become less sensitive to light. Normally, people are able to begin to return to normal outdoor lighting after 15 days.
You must not let an optician or ophthalmologist examine your eyes with bright lights for 30 days after Foscan injection.
You must not use UV sunbeds or sunbathe for 3 months after Foscan injection.
For 6 months following Foscan treatment, avoid prolonged direct sunlight exposure of the injection site arm. As a precautionary measure, if prolonged outdoor activity is planned, protect your injection arm by wearing a long sleeved, coloured shirt.

The table of instructions tells you what to do to prevent skin burns. You must follow these instructions carefully.

Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Using Foscan with food and drink:
Your normal food and drink will not affect your treatment with Foscan

Pregnancy
You must avoid becoming pregnant for 3 months after Foscan treatment.
Ask you doctor or pharmacist for advice before taking any medicine if you are pregnant

Breast-feeding
Do not breastfeed for at least 1 month after Foscan injection.

Driving and using machines
In the light conditions recommended for the first 15 days after Foscan injection, driving is not recommended, and it may not be practical to operate machines.

Important information about some of the ingredients of Foscan
WARNING: This product contains 48 vol % ethanol (alcohol), i.e up to 1 g per dose, equivalent to 21 ml of beer, 9 ml wine per dose. Harmful for those suffering from alcoholism. To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease or epilepsy.

How is it used?

Your doctor or nurse will give you Foscan by injection into a vein.

If necessary, your doctor or nurse may give you another injection at least 4 weeks later.

Four days after your injection, your doctor will treat your cancer with laser light.

If you are given more Foscan than you should
You may not be given the laser treatment. You may be sensitive to light for more than 15 days. You must follow carefully the instructions on preventing skin burns.

What are possible side effects?

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

Everyone who takes Foscan will become sensitive to light for about 15 days after injection. You must follow the instructions given to you to avoid sunlight and bright indoor light. These instructions are written in this leaflet. Your doctor will also tell you what to do. If you do not follow these instructions, you may get severe sunburn that leads to permanent scarring.

Very common side effects (likely to occur in more than 1 in 10 patients)
You may feel some pain when Foscan is injected. After the laser treatment, you may feel pain in your face and pain around the treatment area. There may also be bleeding, ulcers, swelling, and scarring. These effects may make it difficult to eat and drink. You may get constipation.

Common side effects (likely to occur in more than 1 in 100 patients)
There may be some irritation, a burning sensation or skin damage where Foscan is injected, but this will not last long. You may also get ulcers, blisters, skin redness, or skin darkening. Other effects may be vomiting, fever, nausea, anaemia, light sensitivity, sunburn, burns, difficulty with swallowing or giddiness. There may be swelling or may have a stiff jaw. Some people may get an infection in the treated area.

If you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.

How should it be stored?

Keep out of the reach and sight of children.
Do not use after the expiry date stated on the label and the carton.
Foscan will be stored at the hospital pharmacy.
Do not store above 25 ^oC.
Store in the original package in order to protect from light.

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For doctors

What is it?

Foscan is a solution for injection containing the active substance temoporfin (1 or 4 mg/ml).

What is it used for?

Foscan is used to relieve the symptoms of advanced head and neck squamous cell carcinoma (a type of cancer that starts in the cells lining the mouth, nose, throat or ear). It is used in patients in whom other treatments have stopped working, and who are not suitable for radiotherapy (treatment with radiation), surgery or systemic chemotherapy (medicines used to treat cancer; ‘systemic’ means that they are given as treatments throughout the body).
The medicine can only be obtained with a prescription.

How is it used?

Foscan must only be given in a specialist cancer centre where a team can assess the patient’s treatment under the supervision of a doctor who has experience in photodynamic therapy (treatment that uses light). Treatment with Foscan is a two-step process: the medicine is given first, before it is activated using a laser. The medicine is given by an indwelling intravenous cannula (a thin tube permanently inserted into a vein) as a single slow injection over at least six minutes. The dose is 0.15 mg per kilogram body weight. Four days later, the entire surface of the tumour and the surrounding 0.5-cm margin is illuminated with light from a laser at a specific wavelength, using a fibre-optic cable, for around three minutes and 20 seconds. Each area of the tumour should be illuminated only once during each treatment. During treatment, other areas of the body should be shielded from the light so that the activation of the medicine is limited to the tumour. If a second treatment is necessary, this should take place at least four weeks later.

How does it work?

The active substance in Foscan, temoporfin, is a photosensitising agent (a substance that changes when exposed to light). When Foscan is injected, temoporfin is distributed within the body, including within the tumour. When it is illuminated with laser light of a specific wavelength, temoporfin is activated and reacts with oxygen in the cells to create a highly reactive and toxic type of oxygen. This kills the cells by reacting with and destroying their components, such as their proteins and DNA. By restricting the illumination to the tumour, cell damage is limited to the tumour cells, leaving other areas of the body unaffected.

How has it been studied?

Foscan has been studied in four main studies involving a total of 409 patients with head or neck cancer. The first three studies looked at whether the tumour was eradicated after up to three treatments with Foscan in a total of 189 patients. The fourth study looked at the reduction of symptoms in 220 patients with advanced head or neck cancer who could not receive surgery or radiotherapy. In all studies, the response was assessed between 12 and 16 weeks after the final treatment with Foscan, but Foscan was not compared with any other treatment.

What benefits has it shown during the studies?

The results of the first three studies were insufficient to support the use of Foscan in the eradication of head and neck cancer tumours. However, in the study looking at improving symptoms of advanced head and neck cancer, 28 (22%) of the 128 patients assessed had a significant improvement in their most troubling symptom. Around a quarter of the patients in this study also had a reduction in tumour size.

What is the risk associated?

The most common side effects with Foscan (seen in more than 1 patient in 10) are pain at the injection site, at the site of the tumour or in the face, haemorrhage (bleeding), scarring, mouth necrosis (death of cells or tissue in the mouth), dysphagia (difficulty swallowing), face oedema (swelling) and constipation. For the full list of all side effects reported with Foscan, see the Package Leaflet. Foscan should not be used in people who may be hypersensitive (allergic) to temoporfin or any of the other ingredients. Foscan must not be used in patients with porphyria (an inability to break down porphyrins), other diseases made worse by light, allergy to porphyrins, or tumours that are spreading into a blood vessel or that are next to where the laser is to be shone. Foscan must also not be used in patients who have an operation planned in the next 30 days, who have an eye disease that is likely to need examination using a ‘slit lamp’ (an instrument used by eye specialists to look into the eye) in the next 30 days, or who are already being treated with another medicine that increases sensitivity to light. Patients receiving Foscan should take care to avoid exposure to bright light for up to six months after injection to avoid skin burns. See the Package Leaflet for full details.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that Foscan’s effects on relieving the symptoms associated with advanced head and neck cancer were of interest. Therefore, the Committee decided that Foscan’s benefits are greater than its risks for the palliative treatment of patients with advanced head and neck squamous cell carcinoma who have failed other treatments and are not suitable for radiotherapy, surgery or systemic chemotherapy. The Committee recommended that Foscan be given marketing authorisation.
Foscan was originally authorised under ‘Exceptional Circumstances’, because, as the disease is rare and for scientific reasons, limited information was available at the time of approval. As the company had supplied the additional information requested, the ‘Exceptional Circumstances’ ended on 21 May 2008.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Foscan on 24 October 2001. The marketing authorisation was renewed on 24 October 2006. The marketing authorisation holder is Biolitec Pharma Ltd.

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