90 mg/ml powder and solvent for injection, solution
Enfuvirtide

1. What Fuzeon is and what it is used for

What Fuzeon is

Fuzeon contains the active substance ‘enfuvirtide’ and it belongs to a group of medicines called ‘antiretroviral agents’.

What Fuzeon is used for

Fuzeon is used to treat human immunodeficiency virus ( HIV ) – in combination with other antiretroviral medicines in patients infected with HIV .

  • Your doctor has prescribed Fuzeon to help control your HIV – infection .
  • Fuzeon does not cure HIV – infection .

How Fuzeon works

HIV attacks the cells in your blood called CD4s or T cells . The virus needs to get in touch with and enter these cells in order for the virus to multiply. Fuzeon helps prevent this.

2. What you need to know before using Fuzeon

Do not use Fuzeon

  • you are allergic to enfuvirtide or any of the other ingredients of this medicine (listed in section 6).

If you are not sure, talk to your doctor, pharmacist or nurse before using Fuzeon.

Warnings and cautions

Talk to your doctor, pharmacist or nurse before using Fuzeon if:

  • you have ever had a lung disease
  • you have ever had kidney problems
  • you have chronic hepatitis B or C or any other liver disease – because you have a higher risk of getting serious liver problems when you use this medicine

Signs of previous infection

In some patients with advanced HIV infection ( AIDS ) and who have previously had opportunistic infections , signs and symptoms of inflammation from previous infections may occur shortly after starting treatment for HIV . These symptoms are probably due to a recovery of the body’s immune system. This improvement allows the body to fight infections that may have been present without any obvious symptoms. Tell your doctor immediately if you notice any symptoms of infection .

Signs of autoimmune disease

In addition to opportunistic infections , autoimmune disorders (conditions in which the immune system attacks healthy body tissue) can also occur after you start taking medicines to treat your HIV infection . Autoimmune disorders can occur several months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness that starts in the hands or feet and moves to the torso, palpitations, tremors or hyperactivity, inform your doctor immediately for the necessary treatment.

Patients with liver disease

Patients with chronic hepatitis B or C who are being treated with anti- HIV drugs are at increased risk of serious liver problems. Talk to your doctor if you have had liver disease before.

Bone Disease ( Osteonecrosis )

Some patients receiving combinations of anti- HIV drugs may develop a bone disease called osteonecrosis . This means that the bone tissue dies due to the blood supply having disappeared (bone tissue dies due to lost blood supply to the bone).

  • Signs of osteonecrosis are stiffness in the joints, aches and pains (especially in the hip, knee and shoulders) and difficulty moving. Tell your doctor if you experience any of these symptoms.
  • The risk factors for developing this disease include: how long you have been taking HIV , if you are taking corticosteroids , how much alcohol you are drinking, how well your immune system is working and being overweight.

Transmit HIV to others

You can still transmit HIV infection when you take this medicine, even though the risk of effective antiviral therapy is reduced . Discuss with your doctor the necessary steps to avoid infecting others.

Other drugs and Fuzeon

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This also applies to over-the-counter medicines and herbal medicines. Fuzeon has not been shown to interact with your other HIV medicines or with rifampicin (an antibiotic ).

Fuzeon with food and drink

You can use Fuzeon with or without food. However, you must still follow the instructions given in the package leaflets of the other HIV medicines you are taking.

Pregnancy and breastfeeding

  • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You should not use Fuzeon unless your doctor has explicitly told you to do so.
  • Do not breast-feed if you have HIV because of the risk of your baby becoming infected with HIV .

Driving and using machines

Fuzeon has not been studied for its effect on the ability to drive or use machines. If you feel dizzy while using Fuzeon, do not drive or use machines.

Fuzeon contains sodium

Fuzeon contains less than 1 mmol sodium (23 mg) per dose , ie essentially ‘sodium-free’.

3. How to use Fuzeon

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

How to prepare and inject Fuzeon

Fuzeon must be given as an injection just under the skin, a so-called ‘subcutaneous’ injection . Section 7 explains how to prepare Fuzeon and how to give yourself an injection .

How much to use

  • The recommended dose is 90 mg twice daily for adults and adolescents (from 16 years of age).
  • This is given as a 1 ml injection just under the skin.
  • It is best to use Fuzeon at the same time each day.
  • Try to spread the doses at an even time interval that suits you – for example, the first thing you do in the morning and the next early in the evening.

See the end of this leaflet for further instructions on how to use Fuzeon (see section 7). There are instructions on how to prepare Fuzeon and how to give yourself an injection .

If you use more Fuzeon than you should

If you have used more Fuzeon than you should, consult a doctor immediately or go to a hospital. Bring the medicine pack.

If you forget to take Fuzeon

  • If you miss a dose , take dose one as soon as you remember. However, if it is less than 6 hours until the time to take the next dose , skip the missed dose .
  • Do not take a double dose to make up for a forgotten dose .

If you stop using Fuzeon

  • Continue to use your medicine until your doctor tells you to stop. If you stop and there is a break in your treatment, it may accelerate the risk of HIV in your blood becoming resistant to Fuzeon. This is less likely if you use it regularly and without any interruption in treatment.
  • HIV – the virus et in your blood may eventually become resistant to Fuzeon. If this happens, your virus levels in the blood may start to rise. Then your doctor may decide that you should no longer be treated with Fuzeon. Your doctor will then discuss this with you.

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

4. Possible side effects

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

Stop using Fuzeon and see a doctor straight away if you notice any of the following serious side effects as you may need urgent medical attention:

This side effect is rare (affects less than 1 in 1,000 patients). These symptoms do not necessarily mean that you are allergic to the medicine

Tell your doctor if you get side effects is then injecting a given

The most common side effects (affecting more than 1 patient in 10) are problems at the site on the body where you received the injection . You will probably get one or more of the following mild to moderate reactions:

  • redness
  • swelling
  • itching
  • bruises
  • skin hardening or lumps
  • pain or tenderness

These reactions can occur within the first week of treatment and usually last for up to 7 days. They usually do not worsen after this time. If you get any of these reactions, do not stop taking Fuzeon but talk to your doctor about your concerns.

Reactions can be aggravated if the injections are repeated in the same place on the body. They can also be aggravated when the injections are given deeper than intended (for example in a muscle). In rare cases, you can get an infection in a place where a certain injection has been given. To reduce the risk of infection , it is important that you follow the instructions in section 7.

Fuzeon can cause an accumulation of a type of protein called amyloid under the skin at the injection site. It can feel like lumps under the skin. Contact your doctor if this happens.

Other possible side effects are

Very common (affects more than 1 patient in 10)

  • diarrhea
  • nausea
  • weight loss
  • pain and numbness in hands, feet or legs.

Common (affects less than 1 in 100 patients)

5. How to store Fuzeon

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the vial label with Fuzeon or water for injections after “Exp. that ”. The expiration date is the last day of the specified month.

Keep the vial in the outer carton. Sensitive to light.

After the solution has been prepared for your injection , it should be used immediately. If not used immediately, in refrigerator (2 ° C – 8 ° C) and within 24 hours.

Do not use this medicine if you see any particles in the powder or in the solution after the water for injection has been added. Also, do not use water for injections if you see any particles in the vial or if the water is cloudy.

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.

6. Contents of the packaging and other information

Content declaration

  • The active substance is enfuvirtide. Each vial contains 108 mg enfuvirtide. After reconstitution with the diluent provided, 1 ml of solution containing 90 mg enfuvirtide is obtained.
  • Other ingredients are:

Powder

Anhydrous sodium carbonate

Mannitol

Sodium hydroxide

Hydrochloric acid

Diluent

Water for injections

What the medicine looks like and contents of the pack

Fuzeon powder and solvent for solution for injection are supplied in a carton containing:

60 vials of Fuzeon

60 vials of water for injections used to dissolve Fuzeon powder

60 syringes of 3 ml

60 syringes of 1 ml

180 alcohol swabs

This pack contains everything you need to prepare and take your injections with Fuzeon for 30 days.

Marketing Authorisation Holder

Roche Registration GmbH

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

Manufacturer responsible for release of batch

Roche Pharma AG

Emil-Barell-Str. 1,

D-79639 Grenzach-Wyhlen

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorization Holder:Show larger

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Muhammad Nadeem

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