Trudexa - patient leaflet, side effects, dosage

1. WHAT TRUDEXA IS AND WHAT IT IS USED FOR

Trudexa is intended for treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. It is a medicine that decreases the inflammation process of these diseases. The active ingredient, adalimumab, is a human monoclonal antibody produced by cultured cells. Monoclonal antibodies are proteins that recognise and bind to other unique proteins. Adalimumab binds to a specific protein (tumour necrosis factor or TNFa), which is present at increased levels in inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.

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ammatory disease of the joints. If you have moderate to severe active first be given other disease-modifying medicines, such as methotrexate. ugh to these medicines, you will be given Trudexa to treat your

Trudexa can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.

Trudexa has been shown to slow down the damage to the cartilage and bone of the joints caused by the disease and to improve physical function.

Usually, Trudexa is used with methotrexate. If your doctor determines that methotrexate is inappropriate, Trudexa can be given alone.

irthritis

Psoriatic arthritis is an inflammation of the joints associated with psoriasis.

Ankylosing spondylitis

Ankylosing spondylitis is an inflammatory disease of the spine. If you have ankylosing spondylitis you will first be given other medicines. If you do not respond well enough to these medicine will be given Trudexa to reduce the signs and symptoms of your disease.

Crohn’s disease

Crohn’s disease is an inflammatory disease of the digestive tract. If you have Crohn’s disease you will first be given other medicines. If you do not respond well enough to these medicines, you will be given Trudexa to reduce the signs and symptoms of your disease.

2. BEFORE YOU USE TRUDEXA

Do not use Trudexa:

If you are allergic (hypersensitive) to adalimumab or any of the other ingredients of Trudexa.

If you have a severe infection, including active tuberculosis (see “Take special care with Trudexa”). It is important that you tell your doctor if you have symptoms of infections, e.g. fever, wounds, feeling tired, dental problems.

If you have moderate or severe heart failure. It is important to tell your doctor if you have had or have a serious heart condition (see “Take special care with Trudexa”).

Take special care with Trudexa:

If you experience allergic reactions such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Trudexa and contact your doctor immediately.

The needle cover of the syringe contains natural rubber (latex). This may cause severe allergic reactions in patients sensitive to latex. Patients who have a known sensitivity to latex should be advised to avoid touching the inner shield.

If you have an infection, including long-term or localized infection (for example, leg ulcer) consult your doctor before starting Trudexa. If you are unsure, please contact your doctor.

You might get infections more easily while you are receiving Trudexa treatment including serious infections, tuberculosis, opportunistic infections and sepsis that may, in rare cases, be life-threatening. It is important to tell your doctor if you get symptoms such as fever, wounds, feeling tired or dental problems.

As cases of tuberculosis have been reported in patients treated with Trudexa, your doctor will check you for signs and symptoms of tuberculosis before starting Trudexa. This will include a thorough medical history, a chest X-ray and a tuberculin test. The conduct of these tests should be recorded on your Patient Alert Card. It is very important that you tell your doctor if you have ever had tuberculosis, or if you have been in close contact with someone who has had tuberculosis. If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy tell your doctor immediately.

Advise your doctor if you have a history of recurrent infections or other conditions that increase the risk of infections.

Advise your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV or if you think you might be at risk of contracting HBV. Trudexa can cause reactivation of

HBV in people who carry this virus. In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV can be life-threatening.

If you are about to undergo surgery or dental procedures please inform your doctor that you are taking Trudexa.

If you have multiple sclerosis, your doctor will decide if you should receive Trudexa.

Some vaccines should not be given while receiving Trudexa. Please check with your doctor before you receive any vaccines.

If you have mild heart failure and you are being treated with Trudexa, your heart failure status must be closely monitored by your doctor. It is important to tell your doctor if you have had or have a serious heart condition. If you develop new or worsening symptoms of heart failure (e.g. shortness of breath, or swelling of your feet), you must contact your doctor immediately.

In some patients the body may fail to produce enough of the blood cells that help your body fight infections or help you to stop bleeding. If you develop a fever that does not go away, bruise or bleed very easily or look very pale, call your doctor right away. Your doctor may decide to stop treatment.

There have been very rare cases of certain kinds of cancer in patients taking Trudexa or other TNF blockers. People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting a kind of cancer that affects the lymph system, called lymphoma. If you take Trudexa your risk may increase. In addition very rare cases of non-melanoma skin cancer have been observed in patients taking Trudexa.

Cancers, other than lymphoma, have been reported in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another TNF blocker. If you have COPD, or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you.

Using other medicines

Trudexa can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), steroids or pain medications including non-steroidal anti-inflammatory drugs.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

You should not take Trudexa with medicines containing the active substance, anakinra. If you have questions, please ask your doctor.

Using Trudexa with food and drink

Since Trudexa is given subcutaneously, food and drink should not affect Trudexa.

Pregnancy and breast-feeding

The effects of Trudexa in pregnant women are not known and so the use of Trudexa in pregnant women is not recommended. You are advised to avoid becoming pregnant and must use adequate contraception while using Trudexa and for at least 5 months after the last Trudexa treatment.

It is not known whether adalimumab passes into breast milk.

If you are a breast-feeding mother, you should stop breast-feeding during Trudexa treatment and for at least 5 months after the last Trudexa treatment.

Driving and using machines

Trudexa should not affect your ability to drive or use machinery.

Important information about some of the ingredients of Trudexa

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

3. HOW TO USE TRUDEXA

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

Trudexa is injected under the skin (subcutaneous use). The usual dose for adults with rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis is 40 mg adalimumab given every other week as a single dose. The usual dose regimen for Crohn’s disease is 80 mg at week 0 and followed by 40 mg every other week starting at week 2. In cases where a more rapid response is required your doctor may prescribe a dose of 160 mg at week 0 (as 4 injections in one day or 2 injections per day for two consecutive days), 80 mg (2 injections) at week 2, and thereafter as 40 mg (1 injection) every other week. Depending on your response, your doctor may increase the dose to 40 mg every week. You should continue to inject Trudexa for as long as your doctor has told you.

In rheumatoid arthritis, methotrexate is continued while using Trudexa. If your doctor determines that methotrexate is inappropriate, Trudexa can be given alone.

If you have rheumatoid arthritis and you do not receive methotrexate with your Trudexa therapy, your doctor may decide to give 40 mg adalimumab every week.

Instructions for preparing and giving an injection of Trudexa:

The following instructions explain how to inject Trudexa. Please read the instructions carefully and follow them step by step. You will be instructed by your doctor or his/her assistant on the technique of self-injection. Do not attempt to self-inject until you are sure that you understand how to prepare and give the injection. After proper training, the injection can be self-administered or given by another person, for example a family member or friend.

This injection should not be mixed in the same syringe or vial with any other medicine.

Wash your hands thoroughly

Set up the following items on a clean surface

o One vial of Trudexa for injection o One syringe with fixed needle

o Two alcohol pads

• Each new injection should be given at least 3 cm from the last injection site.

o Do not inject in an area where the skin is reddened, bruised, or hard. This may mean there is an infection.

o Wipe the injection site with the enclosed alcohol pad, using a circular motion.

o Do not touch the area again before injecting.

• 3) Injecting Trudexa
  
  Preparing the Trudexa dose for injection

• Do NOT shake the vial.
• Remove the plastic cap from the Trudexa vial. Do NOT remove the grey stopper or aluminium ring around the top of the vial.
• Use a new alcohol pad to clean the grey stopper on the vial. After cleaning, do not touch the stopper with your hands.
• Remove cap from needle syringe, being careful not to touch needle or let it touch any surface.
• Make sure that the plunger is fully inserted into the syringe. With the vial upright on a flat

surface, such as a table, insert the needle straight through the centre ring of the grey stopper. If the needle is correctly lined up, you should feel a slight resistance and then a “pop” as the needle goes through the centre of the stopper. Look for the needle tip inside the stopper window. If the needle is not correctly lined up with the centre of the stopper, you will feel constant resistance as it goes through the stopper and no “pop.” The needle may then enter at an angle and bend, break or prevent proper removal of the vial contents. If this happens, do not use the syringe or vial.

With the needle still in the vial, turn the vial upside down at eye level. Check that the needle is below the surface of the solution. Slowly pull the plunger back to draw solution into the

syringe.

• With the needle still inserted in the vial, check the syringe for air bubbles. Gently tap the syringe to make any bubbles rise to the top of the syringe near the needle. Slowly press the plunger to push the bubbles out of the syringe and into the vial. When you do this, if you accidentally push some solution back into the vial, pull slowly back in the plunger to draw the entire contents of the vial back into the syringe.
• Pull the needle completely out of the vial. Again, do NOT touch the needle or let it touch any surface.
• With one hand, gently grasp the cleaned areas of skin and hold firmly
• With the other hand, hold syringe at 45-degree angle to skin, with the grooved side up.

With one quick, short motion, push needle all the way into skin

Release the skin with the first hand

Push plunger to inject solution – it can take from 2 to 5 seconds to empty the syringe

When the syringe is empty, remove the needle from skin, being careful to keep it at the same angle as when it was inserted

• Using your thumb or a piece of gauze, apply pressure over the injection site for 10 seconds. A little bleeding may occur. Do not rub the injection site. Use a plaster if you want to.

• 4) Throwing away supplies

• The Trudexa syringe should NEVER be reused. NEVER recap a needle
• After injecting Trudexa, immediately throw away the used syringe in a special container as instructed by your doctor, nurse or pharmacist.
• Keep this container out of the reach and sight of children

If you use more Trudexa than you should:

If you accidentally inject Trudexa more frequently than told to by your doctor, you should call your doctor and tell him/her that you have taken more. Always take the outer carton or the vial of medicine with you, even if it is empty.

If you forget to take Trudexa:

If you forget to give yourself an injection, you should inject the next dose of Trudexa as soon as you remember. Then take your next dose as you would have on your originally scheduled day, had you not forgotten a dose.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Trudexa can have side effects, although not everybody gets them. Most side effects are mild to moderate. However, some may be serious and require treatment. Side effects may occur at least up to 5 months after the last treatment.

Tell your doctor immediately if you notice any of the following:

• Severe rash, hives or other signs of allergic reaction;
• Swollen face, hands, feet;
• Trouble breathing, swallowing;
• Shortness of breath with exertion or upon lying down or swelling of the feet; Signs and symptoms suggestive of blood disorders such as persisten paleness.

Tell your doctor as soon as possible if you notice any of the fol

• Signs of infection such as fever, malaise, wounds, dental
• Feeling weak or tired;
• Coughing;
• Tingling;
• Numbness;
• Double vision;
• Arm or leg weakness.

The symptoms described above can be signs of the below listed side effects, which have been observed with Trudexa:

Very common (> 1/10 patients):

injection site reactions (including pain, swelling, redness or itching).

Common (> 1/100 and < 1/10 patients):

• lower respiratory tract infections (such as bronchitis, pneumonia);
• upper respiratory tract infections (including cold, runny nose, sinus infection);
• urinary tract infection, cold blisters, shingles;
• dizziness, including vertigo, headache;
• eye inflammation;
• cough, sore throat;
• nausea, diarrhoea, abdominal pain, mouth ulcers;
• elevated liver enzymes;
• rash, itching, hair loss;
• fatigue;
• fever.

Uncommon (> 1/1000 and< 1/100 patients):

• serious infections (such as sepsis [blood poisoning]), joint infection, fungal infections;
• skin wart;
• anaemia, low white blood cell counts;
• allergic reactions;
• increased lipid values, appetite disorders;
• anxiety, depression, feeling sleepy and difficulty sleeping;
• nerve disorders (such as multiple sclerosis and eye nerve inflammation), taste disturbances;
• vision disturbances;
• ear discomfort;
• sensation of heart beating rapidly, high blood pressure;

asthma, shortness of breath;

abdominal symptoms (such as vomiting, indigestion, constipation) rectal bleeding;

skin disorders (such as psoriasis, eczema or infections), itchy rash, slow wound healing;

muscle weakness;

urinary disturbances (such as blood in urine, increased urinary frequency);

increased menstrual bleeding;

flu like symptoms, chest pain, swelling of the feet.

Rare (< 1/1000)

• glaucoma;
• skin cancer;
• thyroid disorders;
• protein in urine.

5. HOW TO STORE TRUDEXA

Keep out of the reach and sight of children.

Do not use the Trudexa vial after the expiry date stated on the label/blister/car­ton after EXP:. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C). Keep the vial in the outer carton. Do not freeze.

Trudexa 40 mg solution for inject dissolved in 0.8 ml solution.

The active substance is adalimumab.

nitol, citric acid monohydrate, sodium citrate, sodium dihydrogen

phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium hydroxide and water for injections.

What the Trudexa vial looks like and contents of the pack

The Trudexa vial is a glass vial containing a solution of adalimumab. Each pack contains 1 vial with an empty sterile syringe and 2 alcohol pads.

Trudexa is also available as a pre-filled syringe or a pre-filled pen.

Marketing Authorisation Holder

Abbott Laboratories Ltd Queenborough Kent ME11 5EL United Kingdom

Manufacturer

Abbott Biotechnology Deutschland GmbH

Max-Planck-Ring 2

D – 65205 Wiesbaden

Germany

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

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