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Fuzeon 90 mg/ml Powder and Solvent for Solution for Injection
Fuzeon 90 mg/ml powder and solvent for solution for injection
1. What Fuzeon is and what it is used for
2. What you need to know before you use Fuzeon
3. How to use Fuzeon
4. Possible side effects
5. How to store Fuzeon
6. Contents of the pack and other information
7. Step-by-step guide to injecting Fuzeon
Fuzeon contains the active substance enfuvirtide and belongs to a group of medicines called ‘antiretrovirals’.
Fuzeon is used for the treatment of Human Immune deficiency Virus (HIV) - in combination with other antiretroviral medicines in patients infected with HIV.
HIV attacks cells in your blood called CD4 or T-cells. The virus needs to make contact with, and get inside these cells in order for the virus to multiply. Fuzeon helps by preventing this.
If you are not sure, talk to your doctor, pharmacist or nurse before using Fuzeon.
Talk to your doctor, pharmacist or nurse before using Fuzeon if:
In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed that these symptoms are due to a recovery of the body’s immune system. This improvement enables the body to fight infections that may have been present with no obvious symptoms. If you notice any symptoms of infection, please inform your doctor immediately.
In addition to the opportunistic infections, autoimmune disorders (a condition that occurs when the immune system attacks healthy body tissue) may also occur after you start taking medicines for the treatment of your HIV infection. Autoimmune disorders may occur many months after the start of treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor immediately to seek necessary treatment.
Patients with chronic hepatitis B or C and treated with anti-HIV therapy are at an increased risk for serious liver problems. Speak with your doctor if you have a history of liver disease.
Some patients taking combination anti-HIV medicines may develop a bone disease called osteonecrosis. This is where the bone tissue dies because the blood supply has been lost (death of bone tissue caused by loss of blood supply to the bone).
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. Fuzeon has been shown not to interact with your other anti-HIV medicines or rifampicin (an antibiotic).
You can use Fuzeon with or without food. However, you still need to follow the instructions given in the package leaflets for the other medicines you are taking.
Fuzeon has not been tested for its effect on your ability to drive a car or use tools or machines. If you feel dizzy while using Fuzeon do not drive or use any tools or machines.
Fuzeon contains less than 1 mmol sodium (23 mg) per dose, that is to say it is essentially ‘sodium-free’.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Fuzeon must be given as an injection just below the skin – called a ‘subcutaneous’ injection. Section 7 tells you how to prepare Fuzeon and how to give yourself an injection.
See further instructions on how to use Fuzeon at the end of this leaflet (see Section 7). There you will find instructions on how to prepare Fuzeon and how to give yourself an injection.
If you use more Fuzeon than you should, talk to a doctor or go to a hospital straight away. Take the medicine pack with you.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
This side effect is rare (affects less than 1 in 1,000 people). These signs do not definitely mean you are allergic to this medicine.
The most common side effects (affect more than 1 in 10 people), are problems at the place on your body where you have the injection. You will probably have one or more of the following mild to moderate reactions:
These reactions can appear in the first week of treatment and usually only last for up to 7 days. They generally do not get worse after this time. If you have any of these reactions do not stop using Fuzeon, but talk to your doctor about any concerns you have.
Reactions may be worse when injections are repeated in the same place on the body. They may also be worse when the injection is given deeper than intended (for example, into a muscle). Rarely, you may get an infection at a place where an individual injection was given. To reduce the risk of infection, it is important that you follow the instructions provided in Section 7.
Fuzeon can cause a build-up of a type of protein, called amyloid, under the skin at the injection site. This may feel like lumps under the skin. Please contact your doctor if this occurs.
Very common (affects more than 1 in 10 people)
Common (affects less than 1 in 10 people)
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
or search for MHRA Yellow Card in the Google Play or Apple App Store
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 label of either the Fuzeon or the Water for Injections Vials after EXP. The expiry date refers to the last day of that month.
Keep the vial in the outer carton in order to protect from light.
Once the solution has been prepared for your injection it should be used immediately. If it is not used straight away it must be stored in a refrigerator (2°C – 8°C) and used within 24 hours.
Do not use this medicine if you notice any particles in the powder or the solution once the water for injection has been added. Also do not use the Water for Injections if you see any particles in the vial or if the water is cloudy.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Sodium Carbonate, anhydrous
Water for Injections
See section 2 “Fuzeon contains sodium”.
Fuzeon powder and solvent for solution for injection comes in a carton containing:
60 vials of Fuzeon
60 vials of Water for Injections that is used to reconstitute the Fuzeon powder
60 3 ml syringes
60 1 ml syringes
180 alcohol swabs.
This pack provides you with everything you need to prepare and take your Fuzeon for 30 days of injections.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in December 2022
Always use this medicine exactly as your doctor or pharmacist has told you. You should check with your doctor, pharmacist or nurse if you are not sure.
The pictures in this leaflet show people who are right-handed. If you are left-handed, do what comes naturally to you. You will probably find it most comfortable to:
It may be difficult at first to inject in some places, such as the upper arms. If you need help, ask your partner, a friend, or a family member. You may like to ask someone to come with you to an injection training session with your doctor or nurse.
The syringes supplied with this medicine have a coloured needle protector. This is attached to the needle and covers it after use to lower the risk of the needle accidently pricking another person. Although these syringes have this safety feature, it is still important that you dispose of used syringes properly. Follow the instructions given to you by your doctor, pharmacist or nurse.
The following is a basic, step-by-step guide to injecting your medicine.
1. Get the following things together:
2. Open syringe packs and take off vial caps.
3. Wash hands thoroughly.
4. Clean the tops of the vials.
Draw Up Water for Injections
1. Pick up the 3 ml large syringe. Using your index finger, move the coloured needle protector away from the needle.
2. To make sure that the needle is firmly on the syringe:
3. To remove the clear plastic cap:
4. Draw back 1.1 ml of air.
5. Push the syringe needle into the rubber top of the vial of Water for Injections and press the plunger. This injects the air.
6. Gently turn the vial upside down. Make sure the tip of the needle is always below the surface of the Water for Injections to help keep any air bubbles from entering the syringe.
7. Slowly pull back the plunger until the water reaches the 1.1 ml mark. Please be aware that the vial contains more liquid than you need (2 ml); you only have to pull out 1.1 ml to prepare your injection properly.
8. Tap the syringe gently to make any air bubbles rise to the top.
9. Take out the needle from the vial. Make sure you never touch the needle with your fingers or anything else.
10. Dispose of the vial and the Water for Injections into your special waste container with a lid - this vial is for single use only.
Injecting Water For Injections Into Fuzeon Powder
1. Gently tap the vial of Fuzeon to loosen the powder.
2. Hold the main part of the water-filled syringe and push the needle through the rubber top of the vial at a slight angle.
3. Press the syringe plunger in slowly.
4. After all of the Water for Injections has been added to the vial of Fuzeon, take out the syringe from the vial.
5. Hold the main part of the syringe with one hand and gently press the coloured needle protector down on a flat surface until it covers the needle.
6. Throw away the syringe into the special waste container with a lid.
Mixing the Water for Injections with the Fuzeon Powder
1. Gently tap the vial with your fingertip until the powder begins to dissolve. Never shake the vial or turn it upside down to mix—this will cause too much foaming.
2. When the powder begins to dissolve you can put the vial aside to allow it to completely dissolve.
3. After the powder has dissolved completely
4 It is important to check the liquid for bits (particles).
Then start again with a new vial of Fuzeon powder.
5. If you accidentally touch the rubber stopper, make sure to clean it again with a new alcohol swab.
6. Once a dose is mixed with Water for Injections, it must be used straight away. If not, store in a refrigerator and use within 24 hours.
7. If you are preparing both of your daily doses at one time, make sure to use new syringes, Water for Injections, and Fuzeon for each dose.
Drawing up Fuzeon into the 1 ml syringe
1. Wipe the top of the Fuzeon vial again with a new alcohol swab.
2. Pick up the 1 ml small syringe. Using your index finger, move back the coloured needle protector away from the needle.
3. To make sure that the needle is firmly on the syringe:
4. To remove the clear plastic cap:
5. Draw back 1 ml of air.
6. Push the syringe needle into the rubber top of the Fuzeon vial and press the plunger. This injects the air.
7. Gently turn the vial upside down.
Make sure the tip of the needle is always below the surface of the solution to help keep air bubbles from entering the syringe.
8. Slowly pull back the plunger until the solution reaches the 1.0 ml mark.
9. Tap the syringe gently to make any air bubbles rise to the top.
10. Take out the syringe from the vial.
Tip: Your doctor or nurse may suggest different injection techniques that will work best for you.
Where to Inject
Cleansing the injection site
Clean the area for injection well with an alcohol swab. Do this in a circular motion, starting in the middle and working outward. Allow it to dry in the air completely.
Putting in the needle and injecting
1. Pinch as much of a skin fold as possible - without making yourself uncomfortable.
2. Push the needle into the skin at a 45-degree angle.
3. When the needle is in:
4. Using the thumb of your other hand, press the plunger to inject the liquid.
After pulling out the needle
1. Hold the main part of the syringe with one hand
Do not use your free hand to press the protector over the needle.
2. Dispose of the syringe into a special waste container with a lid.
3. If there is any blood where you have given the injection, cover the skin with a sticking plaster.
. If you have any questions or concerns about the safe disposal of these materials, please talk to your doctor, pharmacist or nurse.