Revatio 0.8mg/ml solution for injection Sildenafil - United Kingdom[英国药品]

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Revatio 0.8mg/ml solution for injection Sildenafil

2014-05-10 23:21:45 来源: 作者: 【大中小】浏览:311次评论:0条

For doctors

What is it and how is it used?

Revatio belongs to a group of medicines called phosphodiesterase type 5 inhibitors. Revatio brings down pulmonary blood pressure by widening the blood vessels in the lungs. Revatio is used to treat pulmonary arterial hypertension (high blood pressure in the blood vessels in the lungs).

Revatio solution for injection is an alternative formulation of Revatio for patients who temporarily cannot take their Revatio tablets.

What do you have to consider before using it?

You should not be given Revatio

Take special care with Revatio

Tell your doctor

Special considerations for children and adolescents
Revatio should not be given to children and adolescents under the age of 18.

Special considerations for patients with kidney or liver problems
You should tell your doctor if you have kidney or liver problems, as your dose may need to be adjusted.

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.

If you are taking other therapies for pulmonary hypertension (e.g. bosentan, iloprost) ask your doctor or pharmacist for advice before taking Revatio.

If you are taking medicines containing St. John’s Wort (herbal medicinal product), rifampicin (used to treat bacterial infections), carbamazepine, phenytoin and phenobarbital (used, among others, to treat epilepsy) please inform your doctor or pharmacist before taking Revatio

If you are taking medicines that inhibit blood clotting (for example warfarin) please inform your doctor or pharmacist before taking Revatio.

If you are taking medicines containing erythromycin, clarithromycin, telithromycin (these are antibiotics used to treat certain bacterial infections), saquinavir (for HIV) or nefazodone (for mental depression), ask your doctor or pharmacist for advice before taking Revatio, as your dose may need to be adjusted.

If you are taking alpha-blocker therapy for the treatment of high blood pressure or prostate problems, ask your doctor or pharmacist for advice before taking Revatio.

Pregnancy and breast feeding
If you are pregnant, or think you might be pregnant, ask your doctor or pharmacist for advice before you are given Revatio. Revatio should not be used during pregnancy unless strictly necessary.Stop breast feeding when you start Revatio treatment. Revatio should not be given to women who are breast feeding since it is not known if the medicine passes into the breast milk.

Driving and using machines
Revatio can cause dizziness and can affect vision. You should be aware of how you react to the medicinal product before you drive or use machinery.

How is it used?

Revatio is given as an intravenous injection and will always be given to you by a doctor or a healthcare professional. Your doctor will determine the duration of your treatment and how much Revatio intravenous injection you will receive each day and will monitor your response and condition. The usual dose is 10mg (corresponding to 12.5ml) three times a day.

A Revatio intravenous injection will be given to you instead of your Revatio tablets.

If you receive more Revatio than you should
If you are concerned that you may have been given too much Revatio, tell your doctor or anotherhealthcare professional immediately.

If you miss a dose of Revatio
As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed. However tell your doctor or pharmacist if you think that a dose has been forgotten. A double dose should not be given to make up for a forgotten dose.

If you stop use of Revatio
Suddenly stopping your treatment with Revatio may lead to your symptoms getting worse. Your doctor may reduce the dose over a few days before stopping completely.

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, Revatio can cause side effects, although not everybody gets them.

Side effects reported in a clinical trial with intravenous Revatio were similar to those reported in clinical trials with Revatio tablets. In clinical trials the side effects reported commonly (seen in less than 1 in 10 but more than 1 in 100 patients) were facial flushing, headache, low blood pressure and nausea. In clinical trials side effects reported commonly (seen in less than 1 in 10 but more than 1in100 patients) by patients with pulmonary arterial hypertension were facial flushing and nausea.

In clinical trials with Revatio tablets side effects reported very commonly (seen in more than 1 in 10 patients) were headache, facial flushing, indigestion, diarrhoea and limb pain.

Other side effects with Revatio tablets reported commonly (seen in less than 1 in 10 but more than 1 in 100 patients) included: infection under the skin, flu-like symptoms, sinusitis, anaemia, fluid retention, difficulty sleeping, anxiety, migraine, tremor, pins and needles, burning sensation, reduced skin sensation, bleeding at the back of the eye, effects on vision, blurred vision and light sensitivity, effects on colour vision, eye irritation, bloodshot eyes /red eyes, vertigo, bronchitis, nosebleed, runny nose, cough, stuffy nose, stomach inflammation, gastroenteritis, heartburn, piles, abdominal distension, dry mouth, hair loss, redness of the skin, night sweats, muscle aches, back pain and increased body temperature.

Other side effects with Revatio tablets reported less commonly (seen in less than 1 in 100 but more than 1 in 1000 patients) included: reduced sharpness of vision, double vision, abnormal sensation in the eye and breast enlargement in men.
Skin rash has also been reported.
Sudden decrease or loss of hearing has been reported.
Decreased blood pressure has been reported.

Revatio contains the same active substance, sildenafil, that is used to treat men with male erectile dysfunction (MED). Sildenafil belongs to a class of medicine called phosphodiesterase type 5 (PDE5)

inhibitors. When used to treat MED, the following visual side effects have been reported with PDE5 inhibitors, including sildenafil: partial, sudden, temporary, or permanent decrease or loss of vision in one or both eyes.

Prolonged and sometimes painful erections have been reported after taking sildenafil. If you have such an erection, which lasts continuously for more than 4 hours, you should contact a doctor immediately.

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 Revatio after the expiry date which is stated on the vial label and carton. The expiry date refers to the last day of that month.

Revatio does not require any special storage conditions.

Medicines should not be disposed of via wastewater 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?

Revatio is a medicine that contains the active substance sildenafil. It is available as round, white tablets (20 mg) and as a solution for injection (0.8 mg/ml).

What is it used for?

Revatio tablets are used to treat adults with pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity). PAH is abnormally high blood pressure in the arteries of the lungs. Revatio is used in patients with class II or III disease. The ‘class’ reflects the seriousness of the disease: ‘class II’ involves slight limitation of physical activity and ‘class III’ involves marked limitation of physical activity. Revatio has been shown to be effective in PAH with no identified cause and in PAH caused by connective tissue disease.

Revatio solution for injection is for patients who cannot take their Revatio tablets for a short period, but whose condition is stable.

Because the number of patients with PAH is low, the disease is considered ‘rare’, and Revatio was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 12 December 2003.

The medicine can only be obtained with a prescription.

How is it used?

Revatio treatment should only be started and monitored by a doctor who has experience in the treatment of PAH.

Revatio is taken as one tablet three times a day, about six to eight hours apart. The solution for injection is injected into a vein by a doctor or nurse at a dose of 10 mg (12.5 ml) three times a day. The same doses are used in patients with kidney or liver problems, and should only be lowered if the patient does not tolerate the normal dose. Different doses of Revatio may be needed in patients taking some medicines that affect the way that Revatio is broken down in the body.

How does it work?

PAH is a debilitating disease where there is severe constriction (narrowing) of the blood vessels of the lungs. It causes high blood pressure in the vessels taking blood from the heart to the lungs. This pressure reduces the amount of oxygen that can get into the blood in the lungs, making physical activity more difficult. The active substance in Revatio, sildenafil, belongs to a group of medicines called ‘phosphodiesterase type 5 (PDE5) inhibitors’, which means that it blocks the PDE5 enzyme. This enzyme is found in the blood vessels of the lungs. When it is blocked, a substance called ‘cyclic guanine monophosphate’ (cGMP) cannot be broken down, so that it remains in the vessels where it causes relaxation and widening of the blood vessels. In patients with PAH, sildenafil widens the blood vessels of the lungs, which lowers the blood pressure and improves symptoms.

How has it been studied?

Three doses of Revatio tablets (20, 40 and 80 mg three times a day) have been compared with placebo (a dummy treatment) in one main study involving 277 patients with PAH, most of whom had class II or class III disease. The main measure of effectiveness was the change in the distance patients could walk in six minutes after 12 weeks of treatment. This is a way of measuring the change in exercise capacity.

The company also presented the results of studies to show that the 10 mg injections produce similar levels of sildenafil in the blood as the 20 mg tablets.

What benefits has it shown during the studies?

Revatio was more effective than placebo at improving exercise capacity. Before treatment, the patients with class II disease could walk an average of 379 m in six minutes. After 12 weeks, this distance had increased by 49 m more in the patients taking 20 mg Revatio than in the patients taking placebo. The patients with class III disease could walk an average of 325 m at the start of the study. This distance had increased by 45 m more in the patients taking 20 mg Revatio than in those taking placebo after 12 weeks. As the three doses of Revatio had similar effects, the lowest dose (20 mg three times a day) was chosen for use in patients.

What is the risk associated?

The most common side effects with Revatio tablets (seen in more than 1 patient in 10) are headache, flushing (reddening of the skin), dyspepsia (heartburn), diarrhoea and limb (arm or leg) pain. Side effects are similar with the solution for injection. For the full list of all side effects reported with Revatio, see the package leaflet.

Revatio should not be used in people who may be hypersensitive (allergic) to sildenafil or any of the other ingredients. It must not be taken by patients who have ever had loss of vision because of a problem with blood flow to the nerve in the eye called non-arteritic anterior ischaemic optic neuropathy (NAION). Revatio must not be taken with nitrates (a group of medicines used to treat angina), or with medicines that could affect the way that Revatio is broken down in the body, such as ketoconazole or itraconazole (antifungal medicines) and ritonavir (used to treat HIV infection). It must not be used in patients with severe liver disease or severe hypotension (very low blood pressure), or who have recently had a stroke or myocardial infarction (heart attack), because Revatio has not been studied in these groups of patients.

Why has it been approved?

The CHMP concluded that Revatio provides an alternative treatment option for PAH. The Committee decided that Revatio’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Revatio was originally authorised under ‘exceptional circumstances’, because, as the disease is rare, limited information was available at the time of approval. As the company had supplied the additional information requested, the ‘exceptional circumstances’ ended on 25 August 2008.

How has it been studied?

The company that makes Revatio will agree on how the solution for injection will be distributed in each European Union Member State. It will also ensure that doctors and pharmacists who will prescribe or dispense the solution for injection in each Member State receive information about how it should be used and how to report side effects such as low blood pressure.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Revatio to Pfizer Limited on 28 October 2005. The marketing authorisation is valid for an unlimited period.

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

The summary of opinion of the Committee for Orphan Medicinal Products for Revatio is available here.

This summary was last updated in 08-2010.

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