PREZISTA 150 mg film-coated tabletsPatient’s LeafletSummary - United Kingdom[英国药品]

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PREZISTA 150 mg film-coated tabletsPatient’s LeafletSummary

2015-02-11 18:50:45 来源: 作者: 【大中小】浏览:387次评论:0条

For doctors

What is it and how is it used?

What is PREZISTA?
PREZISTA is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of medicines called protease inhibitors. PREZISTA works by reducing the amount of HIV in your body. This will improve your immune system and reduces the risk of developing illnesses linked to HIV infection.

What it is used for?
PREZISTA is used to treat adults and children of 6 years of age and above, and at least 20 kilogram body weight who are infected by HIV and who have already used other antiretroviral medicines.

PREZISTA must be taken in combination with a low dose of ritonavir and other anti-HIV medicines. Your doctor will discuss with you which combination of medicines is best for you.

What do you have to consider before using it?

PREZISTA must be taken in combination with a low dose of ritonavir and other antiretroviral medicines. It is therefore important that you read the package leaflet that is provided with these medicines. If you have any questions about your medicines, please ask your doctor or pharmacist.

Do not take PREZISTA

Do not combine PREZISTA with any of the following medicines
If you are taking any of these, ask your doctor about switching to another medicine.

Medicine Purpose of the medicine astemizole or terfenadine to treat allergy symptoms triazolam and oral taken by mouth midazolam to help you sleep andor relieve anxiety cisapride to treat some stomach conditions pimozide or sertindole to treat psychiatric conditions

Take special care with PREZISTA
PREZISTA is not a cure for HIV infection. PREZISTA does not reduce the risk of passing HIV to others through sexual contact or blood contamination. Therefore, you must continue to use appropriate precautions.

People taking PREZISTA may still develop infections or other illnesses associated with HIV infection. You must keep in regular contact with your doctor.

People taking PREZISTA may develop a skin rash. Infrequently a rash may become severe or potentially life-threatening. Please contact your doctor whenever you develop a rash.

In patients taking PREZISTA and raltegravir, rashes (generally mild or moderate) may occur more frequently than in patients taking either drug separately.

PREZISTA is not for use in children younger than 6 years of age or weighing less than 20 kilograms, as it has not been studied in this group.

PREZISTA has only been used in limited numbers of patients 65 years or older. If you belong to this age group, please discuss with your doctor if you can use PREZISTA.

Tell your doctor about your situation BEFORE and DURING your treatment Make sure that you check the following seven points and tell your doctor if any of these apply to you.

knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor.

Taking other medicines
PREZISTA might interact with other medicines. Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

There are some medicines that you must not combine with PREZISTA. These are mentioned above under the heading ‘Do not combine PREZISTA with any of the following medicines:’

In most cases, PREZISTA can be combined with anti-HIV medicines belonging to another class [e.g. NRTIs (nucleoside reverse transcriptase inhibitors), NNRTIs (non-nucleoside reverse transcriptase inhibitors), CCR5 antagonists and FIs (fusion inhibitors)]. PREZISTA with ritonavir has not been tested with all PIs (protease inhibitors) and must not be used with some PIs. Therefore always tell your doctor if you take other anti-HIV medicines and follow your doctor’s instruction carefully on which medicines can be combined.

The effects of PREZISTA might be reduced if you take any of the following products. Tell your doctor if you take:

The effects of other medicines might be influenced if you take PREZISTA. Tell your doctor if you take:

The dosage of other medicines might need to be changed since either their own or PREZISTA’s therapeutic effect or unwanted side effects may be influenced when combined.
Tell your doctor if you take:

Taking PREZISTA with food and drink
See section 3 ‘How to take PREZISTA.’

Pregnancy and breast-feeding
Tell your doctor immediately if you are pregnant or if you are breast-feeding. Pregnant or breast-feeding mothers must not take PREZISTA unless specifically directed by the doctor. It is recommended that HIV infected women must not breast-feed their infants because of both the possibility of your baby becoming infected with HIV through your breast milk and because of the unknown effects of the medicine on your baby.

Driving and using machines
Do not operate machines or drive if you feel dizzy after taking PREZISTA.

How is it used?

Always use PREZISTA exactly as your doctor has told you. You must check with your doctor if you are not sure.
Even if you feel better, do not stop taking PREZISTA without talking to your doctor.

After therapy has been initiated, the dose must not be changed or therapy must not be stopped without instruction of the doctor.

Dose for children of 6 years of age and above, weighing at least 20 kilograms
The doctor will work out the right dose based on the weight of the child (see table below). This dose must not exceed the recommended adult dose, which is 600 milligram PREZISTA together with 100 milligram ritonavir two times per day.
The doctor will inform you on how many PREZISTA tablets and how much ritonavir (capsules or solution) the child must take. Tablets of other strengths are available and your doctor may have prescribed a certain combination of tablets to construct the appropriate dosing regimen.

Weight One dose is between 20 and 30 kilograms 375 milligram PREZISTA 50 milligram ritonavir between 30 and 40 kilograms 450 milligram PREZISTA 60 milligram ritonavir more than 40 kilograms 600 milligram PREZISTA 100 milligram ritonavir

Instructions for children of 6 years of age and above, weighing at least 20 kilograms

Dose for adults who have not taken antiretroviral medicines before (your doctor will determine this)
You will require a different dose of PREZISTA which cannot be administered with these 150 milligram tablets. Other strengths of PREZISTA are available.

Dose for adults who have taken antiretroviral medicines before (your doctor will determine this) The dose is either:

Please discuss with your doctor which dose is right for you.
Instructions for adults

Removing the child resistant cap

The plastic bottle comes with a child resistant cap and must be opened as follows Push the plastic screw cap down while turning it counter clockwise. Remove the unscrewed cap.

If you take more PREZISTA than you should
Contact your doctor or pharmacist immediately.

If you forget to take PREZISTA
If you notice within 6 hours, you must take the tablets immediately. Always take with ritonavir and food. If you notice after 6 hours, then skip the intake and take the next doses as usual. Do not take a double dose to make up for a forgotten dose.

Do not stop using PREZISTA without talking to your doctor first
HIV therapy may increase your sense of well-being. Even when you feel better, do not stop taking PREZISTA. Talk to your doctor first.

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

What are possible side effects?

Like all medicines, PREZISTA can cause side effects, although not everybody gets them. When treating HIV infection, it is not always easy to identify what side effects are caused by PREZISTA, which are caused by other medicines you are taking, or which are caused by the HIV infection itself.

The frequency of possible side effects listed below is defined using the following convention:

Tell your doctor if you develop any of the following side effects.

Very common side effects

Common side effects

Uncommon side effects

Some side effects are typical for anti-HIV medicines in the same family as PREZISTA. These are:

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

How should it be stored?

Keep out of the reach and sight of children.

Do not use PREZISTA after the expiry date which is stated on the box and on the bottle after the letters EXP. The expiry date refers to the last day of that month.

PREZISTA does not require any special storage conditions.

Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

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For doctors

What is it?

Prezista is a medicine that contains the active substance darunavir. It is available as tablets (white and caplet-shaped: 75 mg; white and oval: 150 mg; orange and oval: 300 and 600 mg; light orange and oval: 400 mg).

What is it used for?

Prezista is used together with low-dose ritonavir and other antiviral medicines to treat patients aged six years or over who are infected with human immunodeficiency virus (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS). Prezista can be used in adults (over the age of 18 years), whether they have been treated before or not. In children and adolescents aged between six and 18 years, it can only be used if they have been treated before and weigh at least 20 kg.

Doctors should prescribe Prezista to patients who have been treated before only once they have looked at the antiviral medicines that the patient has taken before and checked that the virus causing the infection is likely to respond to the medicine.

The medicine can only be obtained with a prescription.

How is it used?

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

For adults who have not been treated before, the recommended dose is 800 mg once a day. For adults who have been treated before, the dose is 600 mg twice a day. A dose of 800 mg once a day can also be taken, provided that the patients are healthy enough and that the HIV virus causing their infection has been shown to be likely to respond to Prezista. Children and adolescents receive doses that depend on their body weight, and vary between 375 and 600 mg twice a day. Each dose of Prezista must be taken with ritonavir, within 30 minutes of finishing a meal.

How does it work?

The active substance in Prezista, darunavir, is a protease inhibitor. It 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 rate of replication. Ritonavir is another protease inhibitor that is used as a ‘booster’. It slows down the rate at which darunavir is broken down, increasing the levels of darunavir in the blood. This allows a lower dose of darunavir to be used for the same antiviral effect.

Prezista, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level. Prezista does not cure HIV infection or AIDS, but it may delay or reverse the damage to the immune system and the development of infections and diseases associated with AIDS.

How has it been studied?

In adults, Prezista has been studied in five main studies. One study compared ritonavir-boosted Prezista 800 mg once a day with ritonavir-boosted lopinavir (another protease inhibitor) in 691 adults who had not been treated for HIV before.

Three studies involved adults who had been treated before who received 600 mg Prezista twice a day. One study compared ritonavir-boosted Prezista with ritonavir-boosted lopinavir in 604 patients who had taken some anti-HIV medicines in the past. The other two studies compared ritonavir-boosted Prezista with other protease inhibitors chosen on the basis of the patient’s previous treatments and predicted response, in a total of 628 patients who had taken many anti-HIV medicines in the past.

The fifth study involved 590 adults who had been treated before and compared Prezista 800 mg once a day with Prezista 600 mg twice a day.

Ritonavir-boosted Prezista has also been studied in 80 children and adolescents aged between six and 18 years. All of these patients had been treated before and weighed at least 20 kg.

In all of the studies, the patients also took other anti-HIV medicines. The main measures of effectiveness were based on the change in HIV levels in the blood (viral load).

What benefits has it shown during the studies?

In adults who had not been treated before, Prezista was as effective as lopinavir. After 48 weeks, 84% of the patients taking ritonavir-boosted Prezista had viral loads below 50 copies/ml (287 out of 343) compared with 78% of those taking ritonavir-boosted lopinavir (271 out of 346).

In adults who had been treated before, those taking Prezista achieved lower viral loads than those taking the comparator protease inhibitors. In patients who had taken some anti-HIV medicines in the past, 77% of those taking ritonavir-boosted Prezista had viral loads below 400 copies/ml after 48 weeks, compared with 68% of those taking ritonavir-boosted lopinavir. In adults who had received many anti-HIV medicines in the past, 70% of those taking the approved dose of ritonavir-boosted

Prezista (92 out of 131) had at least a 90% reduction in viral load after 24 weeks, compared with 21% of those taking the comparator protease inhibitors (26 out of 124).

Prezista 800 mg once a day was as effective as Prezista 600 mg twice a day in patients who had been treated before: after 48 weeks, 72% of the patients taking Prezista 800 mg once day had viral loads below 50 copies/ml (212 out of 294) compared with 71% of those taking Prezista 600 mg twice a day (210 out of 296).

Similar results were seen in children and adolescents: 74% (59 out of 80) had at least a 90% reduction in viral loads after 24 weeks of treatment.

What is the risk associated?

In adults, the most common side effects with Prezista are diarrhoea, ‘immune reconstitution syndrome’, nausea (feeling sick), pyrexia (fever) and rash. Immune reconstitution syndrome happens when the patient’s immune system starts working again and fights existing infections, causing inflammation at the site of the infection. Side effects are similar in children and adolescents. For the full list of all side effects reported with Prezista, see the package leaflet.

Prezista should not be taken by patients who may be hypersensitive (allergic) to darunavir or any of the other ingredients. It must not be taken by patients who have severe problems with their liver, or who are taking the following medicines:

rifampicin used to treat tuberculosis

ritonavir-boosted lopinavir

St Johns wort a herbal preparation used to treat depression

medicines that are broken down in the same way as Prezista and are harmful at high levels in the blood. See the package leaflet for the full list of these medicines.

The 300- and 600-mg tablets contain a colouring agent called sunset yellow (E110), which can cause allergies. Patients who are allergic to this agent may need to take the lower strength tablets, which do not contain sunset yellow.

Why has it been approved?

The CHMP decided that Prezista’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Prezista was originally given ‘conditional approval’. This means that there was more evidence to come about the medicine, in particular its safety. As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.

Further information

The European Commission granted a conditional marketing authorisation valid throughout the European Union for Prezista to Janssen-Cilag International NV on 12 February 2007. This was switched to a full marketing authorisation on 16 December 2008. The marketing authorisation is valid for five years, after which it can be renewed. europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Prezista, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 02-2011.

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