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Telzir 700 mg film-coated tablets Amprenavir
2014-08-30 23:33:15 来源: 作者: 【 】 浏览:323次 评论:0

For doctors

 

What is it and how is it used?

Telzir is used to treat HIV (human immunodeficiency virus) infection.

Telzir is a type of medicine known as an anti-retroviral. It is taken with low doses of another medicine, ritonavir, which boosts the level of Telzir in the blood. Telzir belongs to a group of anti-retroviral medicines called protease inhibitors. Protease is an enzyme produced by HIV which enables the virus to multiply in white blood cells (CD4 cells) in your blood. By stopping protease from working, Telzir stops HIV multiplying and infecting more CD4 cells.

Telzir with low doses of ritonavir is used in combination with other anti-retroviral medicines (‘combination therapy’) to treat adults, adolescents and children aged over 6 years infected with HIV.

HIV can become resistant to anti-HIV medicines. To avoid this happening, and to stop your illness getting worse, it is very important that you keep taking all your medicines exactly as prescribed.

Telzir will not stop you passing on HIV. HIV infection is spread by sexual contact with someone who’s got the infection, or by transfer of infected blood (for example by sharing needles).

What do you have to consider before using it?

Telzir is to be taken in combination with low doses of ritonavir and other antiretroviral medicines. It is therefore important that you carefully read the package leaflet provided with these medicines. If you have any further questions about ritonavir or the other medicines prescribed, please ask your doctor or pharmacist.

Don’t take Telzir:

Tell your doctor if any of these applies to you.

Take special care with Telzir
Before you take Telzir
your doctor needs to know:

Tell your doctor if any of these applies to you. You will need extra check-ups, including blood tests, while you’re taking your medication.

Your doctor will monitor your blood glucose levels before and during treatment with Telzir.

Look out for important symptoms
Some people taking medicines for HIV infection develop other conditions, which can be serious. These include:

You may get a skin rash. However you can still continue to take Telzir.It can be treated with antihistamines. Rarely, the skin rash can be severe and serious ( Stevens Johnson syndrome). If this happens, Telzir must be stopped immediately and you must never take it again.

Protect other people. Telzir will not stop you passing HIV infection on to other people, by having sex or by blood transfer. To protect other people from becoming infected with HIV:→ Use a condom when you have oral or penetrative sex.
Don’t risk blood transfer – for example, don’t share needles.

Other medicines and Telzir

Tell your doctor or pharmacist if you’re taking any other medicines, if you’ve taken any recently, or if you start taking new ones – these include herbal medicines or other medicines you bought without a prescription. Your doctor will decide if these medicines are suitable for you to take with Telzir and ritonavir. This is very important, as Telzir or ritonavir can strengthen or weaken the effects of other medicines. This can sometimes lead to serious medical conditions.

There are some medicines that must not be taken with Telzir. You must check the list of medicines under 'Don't take Telzir' at the beginning of section 2 of this leaflet.

These medicines are not recommended with Telzir/ritonavir:

You will be closely monitored if you are taking these medicines with Telzir/ritonavir:

Your dose of Telzir may need to be changed if you are taking

Hormonal contraception
Taking Telzir and ritonavir while taking the contraceptive pill may harm your liver and may stop the contraceptive from working properly.
Use an alternative non-hormonal type of contraception such as a condom.
No studies have been done on the use of Telzir/ritonavir with other hormonal therapies, such as hormone replacement therapy (HRT).

Pregnancy and breast feeding
If you are pregnant, if you become pregnant, or if you are planning to become pregnant: → Talk to your doctor about the risks and benefits of taking Telzir.

Women who are HIV-positive must not breast feed because HIV infection can be passed on to the baby in breast milk. If you’re breast feeding, or thinking about breast feeding:
Talk to your doctor.

Driving and using machines
Telzir can make you feel dizzy and have other side effects that make you less alert. → Don’t drive or operate machinery unless you’re feeling well.

Stay in regular contact with your doctor

Telzir helps to control your condition, but it is not a cure for HIV infection. You need to keep taking it every day to stop your illness getting worse. You may still develop other infections and illnesses linked to HIV infection.
Keep in touch with your doctor, and don’t stop taking Telzir without your doctor’s advice.

How is it used?

Always take Telzir exactly as your doctor has told you. It is very important that you take the full daily dose of Telzir and ritonavir as prescribed by your doctor. Do not take more than the recommended dose. Check with your doctor or pharmacist if you are not sure.

Swallow the tablets whole, with some water or another drink. Telzir tablets can be taken with or without food.Telzir is also available as a liquid (oral suspension) for people who are unable to swallow tablets. (Read the package leaflet of Telzir oral suspension for guidance on whether to take it with or without food.)

How much to take
Adults

The recommended dose is one 700 mg Telzir tablet twice daily with 100 mg ritonavir twice daily.

Children from 6 years of age and weighing at least 39 kg
Children can take the adult tablet dose of one 700 mg Telzir tablet twice daily with ritonavir 100 mg twice daily if they can swallow the tablets whole.

Children from 6 years of age and weighing less than 39 kg
Use Telzir oral suspension.

Adults with liver disease
If you have mild liver disease, the dose is one Telzir tablet (700 mg) twice daily with 100 mg ritonavir only once daily. If you have moderate or severe liver disease the dose of Telzir has to be lowered. This dose adjustment can not be made with Telzir tablets. You must take Telzir oral suspension.

If you take too much Telzir
If you have taken more than the prescribed dose of Telzir:
Contact your doctor or pharmacist immediately for advice.

If you forget to take Telzir
If you forget to take a dose of Telzir, take it as soon as you remember and then continue your treatment as before. Don’t take a double dose to make up for a missed dose.

Don’t stop Telzir without advice
Take Telzir for as long as your doctor recommends. Don’t stop unless your doctor advises you to.

What are possible side effects?

Like all medicines, Telzir can cause side effects, but not everyone gets them. When treating HIV, it can be hard to tell whether side effects are caused by Telzir, by other medicines taken at the same time or by the HIV disease itself. For this reason, it is very important to talk to your doctor about any changes in your health.

Very common side effects
These may affect more than 1 in 10 people:

Common side effects
These may affect up to 1 in 10 people:

Uncommon side effects
These may affect up to 1 in 100 people:

Rare side effects
These may affect up to 1 in 1000 people:

You may experience muscle problems
There have been reports of muscle pain, tenderness or weakness, particularly with antiretroviral therapy including protease inhibitors and nucleoside analogues. On rare occasions, these muscle disorders have been serious ( rhabdomyolysis). If you notice any muscle problems:→ Tell your doctor.

Haemophiliacs may bleed more
In patients with haemophilia type A and B, there have been reports of increased bleeding while taking protease inhibitors.
If this happens to you:
Talk to your doctor immediately.

If you get side effects
Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you notice any side effects not listed in this leaflet.

Other side effects of combination therapy for HIV

Old infections may flare up

People with advanced HIV infection (AIDS) have weak immune systems and are more likely to develop serious infections (opportunistic infections). When these people start treatment, they may find that old, hidden infections flare up, causing signs and symptoms of inflammation. These symptoms are probably caused by the body’s immune system becoming stronger, so that the body starts to fight these infections.
If you get any symptoms of infection or signs of inflammation while you’re taking Telzir:Tell your doctor immediately. Don’t take other medicines for the infection without your doctor’s advice.

Your body shape may change
People taking combination therapy may find that their body shape changes, because of changes in fat distribution:

You may have problems with your bones
Some people taking combination therapy for HIV develop a condition called osteonecrosis. With this condition, parts of the bone tissue die because of reduced blood supply to the bone.

People may be more likely to get this condition:

Other effects may show up in tests
Combination therapy for HIV can also cause:

How should it be stored?

Keep out of the reach and sight of children.

Do not use Telzir after the expiry date shown on the bottle and the carton.

Telzir does not require any special storage conditions.

If you have any unwanted Telzir tablets, don’t dispose of them in your waste water or your household waste. Take them back to your pharmacist who will dispose of them in a way that won’t harm the environment.

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For doctors

What is it?

Telzir is a medicine that contains the active substance fosamprenavir. It is available as pink, capsule-shaped tablets (700 mg) and as an oral suspension (50 mg/ml).

What is it used for?

Telzir is used in combination with ritonavir and other antiviral medicines to treat patients aged six years or above who are infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). Doctors should prescribe Telzir to patients who have already taken medicines belonging to the same class as Telzir (protease inhibitors) only after they have looked at the antiviral medicines the patient has taken before and considered the likelihood that the virus will respond to the medicine.

The medicine can only be obtained with a prescription.

How is it used?

Treatment with Telzir should be started by a doctor who has experience in the management of HIV infection.

The recommended dose of Telzir for adults (aged 18 years or over) and for patients aged between six and 18 years who weigh more than 39 kg is 700 mg twice a day. In patients aged between six and 18 years who weigh between 25 and 39 kg, the dose depends on body weight. There is no recommended dose for patients below 18 years who weigh less than 25 kg.

Telzir tablets can be taken with or without food. The oral suspension should be taken without food on an empty stomach in adults, but in younger patients it should be taken with food in order to hide the taste and help them stick to treatment. In adults, each dose of Telzir must be given with 100 mg ritonavir, twice a day. In younger patients, the dose of ritonavir depends on body weight.

Adults with liver problems should take a reduced dose of Telzir and be closely monitored for safety and their response to treatment. For more information, see the package leaflet.

How does it work?

The active substance in Telzir, fosamprenavir, is a ‘prodrug’ of the protease inhibitor amprenavir, which means that it is converted into amprenavir in the body. Amprenavir has been authorised in the European Union (EU) since October 2000 as Agenerase. Amprenavir blocks an enzyme called protease, which is involved in the reproduction of HIV. When the enzyme is blocked, the virus does not reproduce normally, slowing down the spread of infection.

Ritonavir is another protease inhibitor that is used as a ‘booster’. It slows down the rate at which amprenavir is broken down, increasing the levels of amprenavir in the blood. This allows a lower dose of Telzir to be used for the same antiviral effect. Telzir, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level. Telzir does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.

How has it been studied?

Telzir has been studied in three main studies involving 1,862 adults infected with HIV. The first compared ritonavir-boosted Telzir with nelfinavir (another protease inhibitor) in treatment-naïve adults (who had previously taken treatment for HIV infection for no longer than four weeks). The other two studies compared Telzir with lopinavir (another protease inhibitor), both of which were boosted with ritonavir. In one of these studies, the patients were treatment-naïve, but in the other study, they had taken HIV treatment including protease inhibitors before. In all three studies, the patients also took two reverse transcriptase inhibitors (another type of antiviral medicine). The main measure of effectiveness was the level of HIV in the blood (viral load) in the first 48 weeks of treatment.

Telzir, taken in combination with other antiviral medicines, has also been assessed in one main study including 57 HIV-infected patients aged between two and 18 years.

What benefits has it shown during the studies?

In the studies of treatment-naïve adults, ritonavir-boosted Telzir was as effective as the comparator medicines, but it was less effective in adults who had been treated before. After 48 weeks, 69% of the treatment-naïve adults taking ritonavir-boosted Telzir (221 out of 322) and 68% of those taking nelfinavir (221 out of 327) had viral loads below 400 copies/ml. Similar results were seen in the study comparing Telzir with lopinavir, with around three-quarters of both groups of patients having viral loads below 400 copies/ml. In the study of patients who had been treated before, the patients taking lopinavir had larger reductions in viral loads over the first 48 weeks.

A similar benefit has also been seen in younger patients receiving Telzir. However, there were too few patients aged below six years to support the use of Telzir in this age group.

What is the risk associated?

The most common side effects in adults taking Telzir (seen in more than 1 patient in 10) are diarrhoea and increases in the levels of triglycerides (a type of fat) in the blood. Similar side effects are seen in younger patients. For the full list of all side effects reported with Telzir, see the package leaflet.

Telzir should not be used in people who may be hypersensitive (allergic) to fosamprenavir, amprenavir, any of the other ingredients, or ritonavir. Telzir must not be used in patients who are taking rifampicin (used to treat tuberculosis), St John’s wort (a herbal preparation used to treat depression), or medicines that are broken down in the same way as Telzir or ritonavir and are harmful at high levels in the blood. See the package leaflet for the full list of these medicines. As Telzir is converted into amprenavir in the body, it must not be given at the same time as other medicines containing amprenavir.

As with other anti-HIV medicines, patients taking Telzir may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system). Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking Telzir.

Why has it been approved?

The CHMP concluded that Telzir, which contains a prodrug of amprenavir, provides an advantage for patients, as the number of tablets they need to take is reduced when compared to the number of Agenerase capsules that they would need to take for the same dose of amprenavir. Although the Committee noted that the use of ritonavir-boosted Telzir had not been studied sufficiently in heavily pretreated patients and that no comparative studies had been carried out in children, it decided that Telzir’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the EU for Telzir on 12 July 2004. The marketing authorisation holder is ViiV Healthcare UK Limited. The marketing authorisation is valid for an unlimited period.

For more information about treatment with Telzir, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 06-2010.

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Name

 

Telzir 700 mg film-coated tablets

 

Composition

 

Each film-coated tablet contains 700 mg of fosamprenavir as fosamprenavir calcium (equivalent to approximately 600 mg of amprenavir).

For a full list of excipients, see section 6.1.

 

Pharmaceutical Form

 

Film-coated tablet

Pink film coated, capsule shaped, biconvex tablets, marked with GXLL7 on one side.

 

Are you an Healthcare Professional? Access professional drug leaflets on Diagnosia.com!

 

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