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Fuzeon (Enfuvirtide)

What Fuzeon is and what it is used for

What Fuzeon is

Fuzeon inhibits the entry of the human immunodeficiency virus (HIV) into the cells that HIV attacks (called CD4 or T-cells) in your blood. It works by preventing the HIV from making contact with the affected cell membrane. This means that the HIV cannot enter the cell and then it cannot multiply. This is because HIV needs the DNA in the host cell so it can multiply.

When Fuzeon should be used

Fuzeon is used in combination with other antiretroviral medicinal products by persons who are infected with HIV, the virus which causes AIDS. Your doctor has prescribed Fuzeon to help control your HIV infection. Fuzeon is not a cure for HIV infection. Never use or share used needles.

Before you use Fuzeon

Do not use Fuzeon

if you are allergic (hypersensitive) to enfuvirtide or any of the other ingredients of Fuzeon. (see section 6).

Take special care with Fuzeon:

Tell your doctor

  1. if you have any other medical conditions,
  2. if you have had any lung disease in the past; are currently, or have been, an intravenous drug user; are a smoker,
  3. if you have a history of any kidney problems.

Fuzeon does not reduce the risk of passing HIV to others through sexual contact or blood contamination. It is important to continue to take appropriate precautions to prevent passing HIV to others. Fuzeon is not a cure for HIV infection.

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. Patients with chronic hepatitis B and C and treated with antiretroviral therapy are at an increased risk for serious liver problems. If you notice any symptoms of infection, please inform your doctor immediately.

Bone problems

Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor.

Taking other medicines

Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed. Fuzeon has been shown not to interact with your other anti-HIV medicines or rifampicin (an antibiotic).

Using Fuzeon with food and drink

You can take Fuzeon with or without food but you still need to follow the instructions given in the package leaflets for your other medicines.

Pregnancy and breast-feeding

Pregnant women and breast-feeding mothers should not take Fuzeon unless specifically directed to by their doctor. Be sure to tell your doctor immediately if you are or may be pregnant or if you are breastfeeding a baby. HIV-infected women should not breast-feed their infants because of the risk that your baby can be infected with HIV through your breast milk. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Fuzeon has not been specifically tested for its possible effects on your ability to drive a car or operate machines. However, if you feel dizzy while taking Fuzeon then please do not drive nor operate machines.

How to use Fuzeon

Always use Fuzeon exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The usual dose is 90 mg twice a day, given as a 1 ml subcutaneous (just below the skin) injection.

See further instructions on how to use Fuzeon at the end of this leaflet. There you will find instructions on how to prepare Fuzeon and how to give yourself an injection.

If you take more Fuzeon than you should

There is no specific antidote for overdose with Fuzeon. If you take more than the recommended dose please consult your doctor.

If you forget to take Fuzeon

Take the dose as soon as you remember and then take your next dose at its regular time. Do not take the forgotten dose if it is less than 6 hours before you are going to take your next regular dose and never take a double dose to make up for a forgotten dose.

Possible side effects

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

The side effect that you may experience most commonly when taking Fuzeon, are reactions at the place on your body where you have given yourself the injection. You will probably experience one or more of the following mild to moderate reactions at the place where you inject your medicine:

  • itchiness
  • swelling
  • redness
  • pain or tenderness
  • hardened skin or bumps.

These reactions can appear within the first week of treatment and generally do not get worse with continued use of Fuzeon. Reactions at an individual injection site usually last for equal to or less than 7 days. If you experience reactions at an injection site, it is important not to stop taking Fuzeon until you have talked with your doctor about any concerns you may have.

Injection site reactions may be worse when injections are repeated in the same place on the body, or when the injection is given deeper than intended (for example, into a muscle). In rare instances, patients experienced an infection at an individual injection site. To reduce the risk of infection, it is important that you follow the Fuzeon Injection Instructions provided below.

Apart from reactions at the injection site, the side effects most frequently reported in patients receiving antiretroviral treatment with or without Fuzeon are diarrhoea and feeling sick.

Very common side effects (affects more than 1 in 10 persons) are pain and numbness in hands, feet or legs, and loss of weight.

Common side effects (affects 1 to 10 users in 100) are

  • inflammation of the sinuses (cavities in the forehead),
  • local swelling on the skin,
  • reactions at injection sites,
  • pneumonia,
  • ear infection,
  • swollen glands,
  • decreased appetite,
  • anorexia,
  • increased blood fat values,
  • diabetes,
  • feeling anxious or irritated,
  • nightmares,
  • feeling dizzy,
  • lack of concentration,
  • tremor (shaking),
  • inflamed eye lids,
  • nasal congestion,
  • inflammation of the pancreas,
  • heart burn,
  • dry skin,
  • eczema,
  • redness of the skin,
  • acne,
  • muscle pain,
  • kidney stones,
  • ‘flu-like’ symptoms,
  • feeling weak
  • blood in the urine.
  • Hypersensitivity (allergy) to Fuzeon is rare (affects 1 to 10 users in 10,000).

However if you develop symptoms that may suggest that you are allergic to this medicine then you must stop taking it straight away and tell your doctor as soon as possible. Symptoms that you should look out for are rash, a high temperature or chill, feeling sick or being sick and sweating and shaking. These symptoms do not definitely mean you are allergic to this medicine but you must discuss them with your doctor.

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 to store Fuzeon

Keep out of the reach and sight of children.

Do not use Fuzeon 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 immediately it must be stored in a refrigerator (2°C – 8°C) and used within 24 hours. Do not use Fuzeon 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.

Further information

What Fuzeon contains

The active substance is enfuvirtide. Each vial contains 108 mg enfuvirtide. After reconstitution with the solvent provided 1 ml of reconstituted solution contains 90 mg enfuvirtide. The other ingredients are:

Powder

Sodium Carbonate, anhydrous

Mannitol

Sodium Hydroxide

Hydrochloric Acid

Solvent

Water for Injections

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.

What Fuzeon looks like and contents of the pack

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.

Fuzeon is also available in a carton containing 60 vials of Fuzeon and 60 vials of Water for Injections.

How to use Fuzeon

Always take Fuzeon exactly as your doctor has instructed you. Check with your doctor or pharmacist if you are unsure.

The usual dose is 90 mg twice a day, given as a 1 ml subcutaneous (just below the skin) injection into the upper arm, anterior thigh or abdomen. Each injection should be given at a site different from the last place you injected and never where there is still an injection site reaction from an earlier dose. You should not inject your medicine into moles, scar tissue, bruises or your navel.

When to take Fuzeon

It is best to take Fuzeon at the same time each day if you can. Try and space the doses evenly apart whenever it is convenient for you. First thing in the morning and again in the evening are good times.

The following is a basic, step-by-step guide to injecting your medicine. Please contact your doctor or pharmacist if you have any questions about Fuzeon administration.

How long should you take Fuzeon for?

You should keep taking your medicine until your doctor tells you to stop. If you stop and interrupt your treatment with Fuzeon this may lead to the HIV in your blood becoming resistant to it quicker than if you take it regularly and without treatment interruptions. The HIV virus in your blood may eventually become resistant to Fuzeon and your blood levels of virus begin to rise. This is when your doctor may decide to no longer keep treating you with Fuzeon. Your doctor should discuss this with you at that time.

What to do if you are left-handed

The illustrations in this leaflet show individuals who are right-handed. If you are left-handed, do what comes naturally to you. You will probably find it most comfortable to hold the syringe in your left hand and hold the vial between thumb and forefinger of your right hand.

When to have a carer help you

Certain injection sites, such as the upper arms, can be difficult to use at first. Have your partner, a friend, or a family member with you if you need help. To reduce the risk of needlestick injury, you should have a carer attend an injection training session with your healthcare provider.

Your syringes

The syringes supplied with this medicine have a coloured needle protection device that is attached to the needle. This safety device covers the needle after use and reduces the risk of needle-stick injuries.

Although these syringes offer this safety feature, it is important that you dispose of used syringes properly and according to the instructions given to you by your healthcare provider.

Safety Tips

Wash your hands well to reduce the risk of bacterial infections. Do not touch anything except the medicine and supplies.

When handling the syringe, do not touch the needle. Do not touch the tops of the vials once they have been cleaned with alcohol swabs.

Make sure none of the items in your kit have been opened. Do not use opened materials.

Never use a syringe with a bent or damaged needle.

Never mix your medicine with tap water.

Never inject your medicine with other injectable medicines.

The only recommended route of injection is subcutaneous (under the skin). Fuzeon should not be given intravenously (directly into your veins) or intramuscularly (directly into your muscle).

Throw away used syringes into your dedicated waste container with a lid for the safe disposal of waste materials. Consult your doctor if you have any questions about safe disposal of these items.

Step 1: getting started Gather Supplies

Gather all of the following supplies:

One vial of Fuzeon (glass container with white powder inside)

One vial of water for injections (glass container with clear and colourless liquid inside)

One 3 ml syringe (larger syringe) with a 25 mm needle

One 1 ml syringe (smaller syringe) with a 13 mm needle

3 Alcohol swabs

Dedicated waste container with a lid for the safe disposal of the waste materials. Open Syringe Packages and Remove Vial Caps

Throw away packages and vial caps into the rubbish.

Place syringes and vials onto a clean surface. Wash Hands Thoroughly

After washing hands, do not touch anything except the injection supplies and the injection site. Clean the Tops of Vials

Wipe each vial top with a fresh alcohol pad. Let the tops air-dry.

Be sure not to touch the rubber tops after cleaning them. If you touch them, be sure to clean them again.

Step 2: mixing Fuzeon

Draw Up Water for Injections

Pick up the 3 ml large syringe. Using your index finger, push back the coloured needle protection device towards the syringe.

To ensure that the needle is secure, hold the clear plastic cap and tighten the needle/cap assembly with a gentle clockwise twist. Do not use too much force as the needle may loosen.

To remove the clear plastic cap push towards the syringe and then pull the cap off.

Draw back 1.1 ml of air.

Insert the syringe needle into the rubber top of the vial of water for injections and press the plunger, injecting the air.

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.

Slowly pull back the plunger until the water reaches the 1.1 ml mark. Please be aware that the vial contains an excess of water for injections (2 ml); you only have to withdraw 1.1 ml of it to prepare your medication properly.

Tap the syringe gently to make any air bubbles rise to the top.

If excess air enters the syringe, gently press the plunger to force any air back into the vial and withdraw the water again, making sure you have 1.1 ml of water for injections in the syringe.

Remove the needle from the vial, making sure you never touch the needle with your fingers or any other object.

Throw away the vial into the rubbish. The solvent vial is intended for single use only and the remaining water for injections in the vial after withdrawal of the volume required for reconstitution has to be discarded.

Injecting Water For Injections Into Fuzeon Powder

Gently tap the vial of Fuzeon to loosen the powder.

Hold the water-filled syringe by the barrel and push the needle through the rubber top of the vial at a slight angle.

Press the syringe plunger in slowly. Allow the water to flow slowly down the inside of the vial. Be careful not to forcefully shoot water into the powder, since this can cause foaming. If foaming occurs, it may take longer for the powder to dissolve completely.

After all of the sterile water for injections has been added to the vial of Fuzeon, remove the syringe from the vial.

Hold the barrel of the syringe with one hand and gently press the coloured needle protection device down on a flat surface until it covers the needle. You will hear a click. Do not use your free hand to press the device over the needle.

Throw away the syringe into a dedicated waste container. Mixing the Water with the Fuzeon Powder

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 excessive foaming. After the powder begins to dissolve you can set the vial aside to allow it to completely dissolve. The powder may take up to 45 minutes to dissolve in to solution. The vial can also be gently rolled between your hands after adding the water for injections until it is fully dissolved and this may reduce the time it takes for the powder to dissolve.

If you accidentally touch the rubber stopper, be sure to clean it again with a new alcohol swab.

Make sure the powder has dissolved completely, allowing any bubbles that may have formed to settle. If bubbles still exist, gently tap the side of the vial to help settle them.

As with all injectable medicines, it is important to inspect the solution for particles. If you notice any particles in the solution, do not use it. You should throw away the vial into the dedicated waste container with a lid or return it to the pharmacy. Start again with a new vial of Fuzeon powder.

Once a dose is mixed with water for injections, it must be used immediately or stored in a refrigerator and used within 24 hours. Allow the solution to return to room temperature before using.

If you are preparing both of your daily doses at one time, be sure to use new syringes, water for injections, and Fuzeon for each dose.

Step 3: preparing for the injection

Where to Inject

Injection sites include the abdomen, upper thighs, and upper arms. Each injection should be given at a site different from the last place you injected and never where there is still an injection site reaction from an earlier dose. You should not inject your medicine into moles, scar tissue, bruises or your navel.

Choose a different area from where you last injected yourself, and then check for any places where you may have a reaction (press the skin to see if there are any hard bumps). It is much better to avoid these areas. Also avoid areas that could become irritated by your belt or the waistline of your clothing.

Cleansing the Injection Site

Cleanse the area for injection thoroughly with an alcohol swab in a circular motion, working outward. Allow to air-dry completely.

Drawing Up Fuzeon into the 1 ml Syringe

Wipe the top of the Fuzeon vial again with a new alcohol swab.

Pick up the 1 ml small syringe. Using your index finger, push back the coloured needle protection device towards the syringe

To ensure that the needle is secure, hold the plastic cap and tighten the needle/cap assembly by slightly turning and pushing it towards the syringe.

To remove the clear plastic cap push towards the syringe and then pull the cap off.

Draw back 1 ml of air. Be careful not to pull the plunger too fast past the 1 ml marker and/or out of the barrel.

Insert the syringe needle into the rubber top of the Fuzeon vial and press the plunger, injecting the air. 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. Slowly pull back the plunger until the solution reaches the 1.0 ml mark. Be careful not to pull the plunger too fast past the 1 ml marker and/or out of the barrel.

Tap the syringe gently to make any air bubbles rise to the top.

If excess air enters the syringe, gently press the plunger to inject the air back into the vial and withdraw the solution again, making sure you have 1.0 ml of solution in the syringe (whatever volume your doctor prescribed, if different). This step may be repeated until the correct amount of solution is in the syringe.

Remove the syringe from the vial.

Step 4: injecting fuzeon

Tip:   Your healthcare provider may suggest different injection techniques that will work best for you. Pinch as much of a skin fold as possible without making yourself uncomfortable.

Pierce the skin at a 45-degree angle.

When the needle is in, release the skin, and using the same hand, hold on to the syringe barrel to help steady it and prevent shifting.

Using the thumb, depress the plunger in to inject the solution. After the dose is fully delivered, remove the needle from the skin.

Hold the barrel of the syringe with one hand and gently press the coloured needle protection device down on a flat surface until it covers the needle. You will hear a click. Do not use your free hand to press the device over the needle.

Throw away the syringe into a dedicated waste container with a lid.

Cover the injection site with a sticking plaster if any blood is present.

Step 5: disposing of used supplies

Throw away all used syringes directly into the dedicated waste container with a lid. Keep the cover of this container tight and keep the dedicated waste container with a lid out of the reach of children. Check with your doctor or pharmacist about proper disposal of the container.

In addition, you should safely dispose of all used alcohol swabs and vials, even if the vials contain unused amounts of medicine or water for injections. The vials of Fuzeon and water for injections should only be used once. Used supplies other than syringes (alcohol swabs and empty vials) may be disposed of into the rubbish as long as no blood is visible. If blood is visible, dispose of the items into the dedicated waste container with a lid.

If you have any questions or concerns about the safe disposal of these materials, please call your doctor or pharmacist.

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