Glivec 50 mg hard capsules Imatinib - United Kingdom[英国药品]

TOP

Glivec 50 mg hard capsules Imatinib

2013-11-12 19:31:47 来源: 作者: 【大中小】浏览:456次评论:0条

For doctors

What is it and how is it used?

Glivec is a medicine containing an active substance called imatinib. This medicine works by inhibiting the growth of abnormal cells in the diseases listed below. These include some types of cancer.

Glivec is a treatment for adults and children for:

Glivec is also a treatment for adults for:

If you have any questions about how Glivec works or why this medicine has been prescribed for you, ask your doctor.

What do you have to consider before using it?

Glivec will only be prescribed to you by a doctor with experience in medicines to treat blood cancers or solid tumours.

Follow all your doctor’s instructions carefully, even if they differ from the general information contained in this leaflet.

Do not take Glivec:

If you think you may be allergic but are not sure, ask your doctor for advice.

Take special care with Glivec
Before taking Glivec, tell your doctor:

During treatment with Glivec, tell your doctor straight away if you put on weight very quickly. Glivec may cause your body to retain water (severe fluid retention).

While you are taking Glivec, your doctor will regularly check whether the medicine is working. You will also have blood tests and be weighed regularly.

Glivec is also a treatment for children with CML. There is no experience in children with CML below 2 years of age. There is limited experience in children with Ph-positive ALL. There is no experience in children with GIST.

Some children and adolescents taking Glivec may have slower than normal growth. The doctor will monitor the growth at regular visits.

Taking 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 (such as paracetamol) and including herbal medicines (such as St. John’s Wort). Some medicines can interfere with the effect of Glivec when taken together. They may increase or decrease the effect of Glivec, either leading to increased side effects or making Glivec less effective. Glivec may do the same to some other medicines.

Pregnancy and breast-feeding

Driving and using machines
You may feel dizzy or get blurred vision while taking this medicine. If this happens, do not drive or use any tools or machines until you are feeling well again.

How is it used?

Your doctor has prescribed Glivec because you suffer from a serious condition. Glivec can help you to fight this condition.

However, always take Glivec exactly as your doctor has told you. It is important that you do this as long as your doctor tells you to. You should check with your doctor or pharmacist if you are not sure.

Do not stop taking Glivec unless your doctor tells you to. If you are not able to take the medicine as your doctor prescribed or you feel you do not need it anymore, contact your doctor straight away.

How much to take

Use in adults
Your doctor will tell you exactly how many capsules of Glivec to take.

If you are being treated for CML Depending on your condition the usual starting dose is either 400 mg or 600 mg 400 mg to be taken as 8 capsules once a day. 600 mg to be taken as 12 capsules once a day.

If you are being treated for GIST The starting dose is 400 mg, to be taken as 8 capsules once a day.

For CML and GIST, your doctor may prescribe a higher or lower dose depending on how you respond to treatment. If your daily dose is 800 mg (16 capsules), you should take 8 capsules in the morning and 8 capsules in the evening.

If you are being treated for Ph-positive ALL The starting dose is 600 mg to be taken as 12 capsules once a day.

If you are being treated for MDSMPD The starting dose is 400 mg, to be taken as 8 capsules once a day.

If you are being treated for HESCEL The starting dose is 100 mg, to be taken as 2 capsules once a day. Your doctor may decide to increase the dose to 400 mg, to be taken as 8 capsules once a day, depending on how you respond to treatment.

If you are being treated for DFSP The dose is 800 mg per day 16 capsules, to be taken as 8 capsules in the morning and 8 capsules in the evening.

Use in children
The doctor will tell you how many capsules of Glivec to give to your child. The amount of Glivec given will depend on your child’s condition, body weight and height. The total daily dose in children must not exceed 800 mg. The treatment can either be given to your child as a once-daily dose or alternatively the daily dose can be split into two administrations (half in the morning and half in the evening).

When and how to take Glivec

How long to take Glivec
Keep taking Glivec every day for as long as your doctor tells you.

If you take more Glivec than you should
If you have accidentally taken too many capsules, talk to your doctor straight away. You may require medical attention. Take the medicine pack with you.

If you forget to take Glivec

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

What are possible side effects?

Like all medicines, Glivec can cause side effects, although not everybody gets them. They are usually mild to moderate.

These side effects may occur with certain frequencies, which are defined as follows:

Some side effects may be serious. Tell your doctor straight away if you get any of the following:

Very common or common side effects:
- Rapid weight gain. Glivec may cause your body to retain water (severe fluid retention). - Signs of infection such as fever, severe chills, sore throat or mouth ulcers. Glivec can reduce the number of white blood cells, so you might get infections more easily.
- Unexpected bleeding or bruising (when you have not hurt yourself).

Other side effects may include:

Very common side effects Headache or feeling tired. Feeling sick nausea, being sick vomiting, diarrhoea or indigestion. Rash. Muscle cramps or joint, muscle or bone pain. Swelling such as round your ankles or puffy eyes. Weight gain. If any of these affects you severely, tell your doctor.

Common side effects Anorexia, weight loss or a disturbed sense of taste. Feeling dizzy or weak. Difficulty in sleeping insomnia. Discharge from the eye with itching, redness and swelling conjunctivitis, watery eyes or having blurred vision. Nose bleeds. Pain or swelling in your abdomen, flatulence, heartburn or constipation. Itching.

Unusual hair loss or thinning. Numbness of the hands or feet. Mouth ulcers. Joint pain with swelling. Dry mouth, dry skin or dry eye. Decreased or increased skin sensitivity. Hot flushes, chills or night sweats. If any of these affects you severely, tell your doctor.

Not known:
- Reddening and/or swelling on the palms of the hands and soles of the feet which may be accompanied by tingling sensation and burning pain.
- Slowing of growth in children and adolescents.
If any of these affects you severely, tell your doctor.

If any of the side effects gets serious or if you notice any side effects not listed 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 which is stated on the carton. Do not store above 30C. Store in the original package in order to protect from moisture. Do not use any pack that is damaged or shows signs of tampering.

↑ back to table of contents ↑

For doctors

What is it?

Glivec is a medicine that contains the active substance imatinib. It is available as capsules (orange-yellow: 50 mg; orange: 100 mg) and dark yellow/orange tablets (round: 100 mg; oval: 400 mg).

What is it used for?

Glivec is an anticancer medicine. It is used to treat the following diseases:

removed with surgery, and in adults who are not eligible for surgery when the cancer has returned after treatment or has spread to other parts of the body.
Because the number of patients with these diseases is low, they are considered ‘rare’, and Glivec was designated an ‘orphan medicine’ (a medicine used in rare diseases) on various dates (see below). The medicine can only be obtained with a prescription.

How is it used?

Glivec treatment should be started by a doctor who has experience in the treatment of patients with cancers of the blood or solid tumours. Glivec is given by mouth with a meal and a large glass of water to reduce the risk of irritation of the stomach and gut. The dose depends on the disease being treated, the age and condition of the patient, and the response to treatment, but it should not exceed 800 mg a day. For more information, see the Package Leaflet.

How does it work?

The active substance in Glivec, imatinib, is a protein-tyrosine kinase inhibitor. This means that it blocks some specific enzymes known as tyrosine kinases. These enzymes can be found in some receptors on the surface of cancer cells, including the receptors that are involved in stimulating the cells to divide uncontrollably. By blocking these receptors, Glivec helps to control cell division.

How has it been studied?

For CML, Glivec has been examined in four main studies involving 2,133 adults and one study of 54 children. These included a study involving 1,106 adults that compared Glivec with the combination of interferon alpha plus cytarabine (other anticancer medicines). This study measured how long the patients lived without their cancer getting worse.
For ALL, Glivec has been examined in three studies involving 456 adults, including one study comparing Glivec with standard chemotherapy (medicines used to kill cancer cells) in 55 newly-diagnosed patients.
For GIST, Glivec has been examined in two main studies. One involved 147 patients whose GIST could not be surgically removed or had spread to other parts of the body, and looked at whether the tumours shrank in size. This study did not compare Glivec with any other medicines. The other study compared Glivec with placebo (a dummy treatment) in 713 patients whose cancer had been removed with surgery. This study measured how long the patients lived without their cancer coming back. For MD/MPD (31 patients), HES and CEL (176 patients), and DFSP (18 patients), Glivec was not compared with any other medicines. These studies examined whether blood cell counts returned to normal levels, or whether the number of cancerous blood cells or the size of tumours fell.

What benefits has it shown during the studies?

Glivec was more effective than the comparator medicines. In patients with CML, the cancer had got worse in 16% of the patients taking Glivec after five years, compared with 28% of those taking interferon alpha plus cytarabine. Glivec was also better than standard chemotherapy in patients with ALL. In patients with GIST that had been removed with surgery, patients taking Glivec lived for longer than those taking placebo without their cancer coming back. In the non-comparative studies of CML, ALL and GIST, between 26 and 96% of patients showed a response to Glivec. Due to their rarity, limited data were available for the other diseases, but around two thirds of the patients showed at least a partial response to Glivec.

What is the risk associated?

The most common side effects with Glivec (seen in more than 1 in 10 patients) are weight increase, neutropenia (low levels of the white blood cells that fight infection), thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), headache, nausea (feeling sick), vomiting, diarrhoea, dyspepsia (indigestion), abdominal (tummy) pain, oedema (fluid retention), rash, muscle spasm and cramps, muscle and joint pain, and fatigue (tiredness). For the full list of all side effects reported with Glivec, see the Package Leaflet.
Glivec should not be used in people who may be hypersensitive (allergic) to imatinib or any of the other ingredients.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Glivec’s benefits are greater than its risks for the treatment of CML, ALL, MD/MPD, HES, CEL, GIST and DFSP. The Committee recommended that Glivec be given marketing authorisation.
Glivec was originally authorised under ‘Exceptional Circumstances’, because, as the diseases are rare, limited information was available at the time of the approval. As the company had supplied the additional information requested, the ‘Exceptional Circumstances’ were lifted on 13 April 2007.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Glivec to Novartis Europharm Limited on 7 November 2001. The marketing authorisation was renewed on 7 November 2006.

The summaries of opinion of the Committee for Orphan Medicinal Products for Glivec are available here (CML: 14 February 2001), here (GIST: 20 November 2001), here (ALL: 26 August 2005), here (DFSP: 26 August 2005), here (HES and CEL: 28 October 2005) and here (MD/MPD: 23 December 2005).

↑ back to table of contents ↑