Blog Mayotte: Humira 40mg solution for injection in pre-filled pen

Humira

40 mg solution for injection in pre-filled pen

Adalimumab

Read all of this leaflet carefully before you start using this medicine.

Keep this leaflet. You may need to read it again.

Your doctor must also give you a Patient Alert Card, which contains important safety information that you need to be aware of before you are given Humira and during treatment with Humira. Keep this Patient Alert Card with you.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

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.

In this leaflet:

1. What Humira is and what it is used for

2. Before you use Humira

3. How to use Humira

4. Possible side effects

5 How to store Humira

6. Further information

What Humira Is And What It Is Used For

Humira is intended for treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, and psoriasis. 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 TNFα), which is present at increased levels in inflammatory diseases such as rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease and psoriasis.

Rheumatoid arthritis

Rheumatoid arthritis is an inflammatory disease of the joints. If you have moderate to severe active rheumatoid arthritis, you may first be given other disease-modifying medicines, such as methotrexate. If you do not respond well enough to these medicines, you will be given Humira to treat your rheumatoid arthritis.

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

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

Polyarticular juvenile idiopathic arthritis

Polyarticular juvenile idiopathic arthritis is an inflammatory disease, affecting one or more joints, with diagnosis typically occurring in children under the age of 16 years. You may first be given other disease-modifying medicines, such as methotrexate. If you do not respond well enough to these medicines, you will be given Humira to treat your polyarticular juvenile idiopathic arthritis.

Psoriatic arthritis

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

Humira 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.

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 medicines, you will be given Humira 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 Humira to reduce the signs and symptoms of your disease.

Psoriasis

Psoriasis is an inflammatory disease of the skin. If you have moderate to severe plaque psoriasis, you will first be given other medicines or e.g. phototherapy. If you do not respond well enough to these treatments, you will be given Humira to reduce the signs and symptoms of your psoriasis.

Before You Use Humira

Do not use Humira

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

If you have a severe infection, including active tuberculosis (see “Take special care with Humira”). 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 Humira”).

Take special care with Humira

If you experience allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more Humira 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 Humira. If you are unsure, please contact your doctor.

You might get infections more easily while you are receiving Humira treatment. This risk may increase if your lung function is impaired. These infections may be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other 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. Your doctor may recommend temporary discontinuation of Humira.

As cases of tuberculosis have been reported in patients treated with Humira, your doctor will check you for signs and symptoms of tuberculosis before starting Humira. 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 reside or travel in regions where fungal infections such as histoplasmosis coccidioidomycosis or blastomycosis are endemic.

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. Humira 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 over 65 years you may be more susceptible for infections while taking HUMIRA. You and your doctor should pay special attention to signs of infection while you are being treated with HUMIRA. It is important to tell your doctor if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems.

If you are about to undergo surgery or dental procedures please inform your doctor that you are taking Humira. Your doctor may recommend temporary discontinuation of Humira.

If you have demyelinating disease such as multiple sclerosis, your doctor will decide if you should receive Humira.

Some vaccines should not be given while receiving Humira. Please check with your doctor before you receive any vaccines. It is recommended that polyarticular juvenile idiopathic arthritis patients, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating Humira therapy.

If you have mild heart failure and you are being treated with Humira, 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. Your doctor will decide if you should receive Humira.

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 children and adult patients taking Humira 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 lymphoma (a kind of cancer that affects the lymph system), and leukemia (a kind of cancer that affects the blood and bone marrow). If you take Humira the risk of getting lymphoma, leukemia, or other cancers may increase. On rare occasions, a specific and severe type of lymphoma, has been observed in patients taking Humira. Some of those patients were also treated with azathioprine or 6- mercaptopurine. In addition very rare cases of non-melanoma skin cancer have been observed in patients taking Humira. If new skin lesions appear during or after therapy or if existing lesions change appearance, tell your doctor.

There have been cases of cancers, other than lymphoma 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

Humira 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 (NSAIDs).

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 Humira with medicines containing the active substance, anakinra or abatacept. If you have questions, please ask your doctor.

Using Humira with food and drink

Since Humira is injected under the skin (subcutaneously), food and drink should not affect Humira.

Pregnancy and breast-feeding

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

It is not known whether adalimumab passes into breast milk.

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

Driving and using machines

Humira may have a minor influence on your ability to drive and use machines.

Dizziness (including room spinning sensation, blurred vision and tiredness) may occur after you take Humira.

How To Use Humira

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

Humira 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.

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

If you have rheumatoid arthritis and you do not receive methotrexate with your Humira therapy, your doctor may decide to give 40 mg adalimumab every week. The recommended dose of Humira for patients with polyarticular juvenile idiopathic arthritis, aged 13 years and above, is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.

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. The usual dose for adults with psoriasis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. You should continue to inject Humira for as long as your doctor has told you.

Injecting Humira yourself

The following instructions explain how to give yourself an injection of Humira using the pre-filled pen. 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.

What should I do before I give myself a subcutaneous injection of Humira?

1. Wash your hands thoroughly.

2. Take one dose tray containing a pre-filled pen of Humira from the refrigerator.

3. Do not shake or drop the pre-filled pen.

4. Set up the following items on a clean surface.

One pre-filled pen of Humira

One alcohol pad

5. Check the expiry date on the pre-filled pen label (EXP:). Do not use the product if the date has passed the month and year shown.

6. Hold the pre-filled pen with the grey cap (labelled ‘1’) pointing up. Check the appearance of the Humira solution through the windows on the sides of the pre-filled pen. It must be clear and colourless. If it is cloudy or discoloured or has flakes or particles in it, you must not use it. Do not use a pre-filled pen that is frozen or if it has been left in direct sunlight. Only remove both the grey cap and the plum cap immediately before injection.

Where should I give my injection?

1. Choose a site on the top of your thigh or stomach (except the area around the navel).

2. Change the place that you inject each time so that you do not become sore in one area. Each new injection should be given at least 3 cm from the last injection site.

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

How do I give my injection?

1. Wipe your skin by using the enclosed alcohol pad, using a circular motion. Do not touch the area again before injecting.

2. Only remove both the grey cap and the plum cap immediately before injection. Hold the grey body of the pre-filled pen with one hand. Place hand on the middle of the pen so that neither the grey cap (1) nor the plum cap (2) is covered. Hold the pre-filled pen with the grey cap (1) pointing up. With your other hand, pull the grey cap (1) straight off and discard cap. Check that the small grey needle cover of the syringe has been removed with the cap. If a few small drops of liquid come out of the needle, that is okay. The white needle sleeve will now be exposed. Do not try to touch the needle housed in the barrel. DO NOT RECAP as you may damage the needle inside.

3. Pull the plum safety cap (labelled ‘2’) straight off to expose the plum coloured activation button. The pre-filled pen is now ready to use. Do not press the plum activation button until properly positioned as this will result in discharge of medication. DO NOT RECAP as this could cause the unit to discharge.

Giving the injection

1. With your free hand, gently grasp a sizable area of the cleaned skin at the injection site and hold firmly (see below).

2. Place the white end of the pre-filled pen at a right angle (90 degrees) to the skin, so that you can see the window. The presence of one or more bubbles in the window is normal.

3. Holding the barrel of the pre-filled pen, press down slightly onto the injection site (holding in place without moving).

4. With your index finger or your thumb, press the plum coloured button on top once you are ready to begin the injection (see below). You will then hear a loud ‘click’ as the needle is released, and you will feel a small prick as the needle advances.

5. Keep pressing and continue to hold the pre-filled pen with steady pressure in place for about 10 seconds to ensure a complete injection. Do not remove the pre-filled pen while the injection is being given.

6. You will see a yellow indicator move into the windows during the injection. The injection is complete when the yellow indicator stops moving.

7. Lift the pre-filled pen straight up from the injection site. The white needle sleeve will move down over the needle and lock into place over the needle tip. Do not try to touch the needle. The white needle sleeve is there to protect you from touching the needle.

8. You may notice a spot of blood at the injection site. You can press a cotton ball or a piece of gauze over the injection site for 10 seconds. Do not rub the injection site. Use a plaster if you want to.

Throwing away supplies

Only use each pre-filled pen for one injection. Do not put either of the caps back on the pre-filled pen.

After injecting Humira, immediately throw away the used pre-filled pen 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 Humira than you should:

If you accidentally inject Humira 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 pre-filled pen of medicine with you, even if it is empty.

If you forget to take Humira:

If you forget to give yourself an injection, you should inject the next dose of Humira 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.

Possible Side Effects

Like all medicines, Humira 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 Humira injection.

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 persistent fever, bruising, bleeding, paleness.

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

Signs of infection such as fever, feeling sick, wounds, dental problems, burning on urination;

Feeling weak or tired;

Coughing;

Tingling;

Numbness;

Double vision;

Arm or leg weakness

A bump or open sore that doesn’t heal

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

Very common (in more than 1 in 10 patients):

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

respiratory tract infections (including cold, runny nose, sinus infection, pneumonia);

headache;

abdominal pain;

nausea and vomiting;

rash;

musculoskeletal pain.

Common (in more than 1 in 100 patients but less than 1 in 10 patients):

serious infections (including blood poisoning and influenza);

skin infections (including cellulitis and shingles);

ear infections;

oral infections (including tooth infections and cold sores);

reproductive tract infections;

urinary tract infection);

fungal infections;

benign tumors;

skin cancer;

allergic reactions (including seasonal allergy);

mood swings (including depression);

anxiety;

feeling sleepy and difficulty sleeping;

sensation disorders such as tingling, prickling or numbness;

migraine;

sciatica (including low back pain and leg pain);

vision disturbances;

eye inflammation;

vertigo;

sensation of heart beating rapidly;

high blood pressure;

flushing;

haematoma;

cough;

asthma;

shortness of breath;

gastrointestinal bleeding;

dyspepsia (indigestion, bloating, heart burn);

acid reflux disease;

sicca syndrome (including dry eyes and dry mouth);

itching;

itchy rash;

bruising;

inflammation of the skin (such as eczema);

breaking of finger nails and toe nails;

increased sweating;

muscle spasms;

blood in urine;

kidney problems;

chest pain;

oedema;

reduction in blood platelets which increases risk of bleeding or bruising;

impaired healing.

Uncommon (in more than 1 in 1000 patients but less than 1 in 100 patients):

opportunistic infections (which include tuberculosis and other infections that occur when resistance to disease is lowered);

neurological infections (including viral meningitis);

joint infections;

eye infections;

bacterial infections;

cancer;

cancer that affects the lymph system;

melanoma;

dehydration;

tremor;

inflammation of the eye lid and eye swelling;

double vision;

hearing loss, buzzing;

sensation of heart beating irregularly such as skipped beats;

heart problems that can cause shortness of breath or ankle swelling;

lung diseases causing shortness of breath (including inflammation);

inflammation of the pancreas which causes severe pain in the abdomen and back;

difficulty in swallowing;

facial oedema;

gallbladder inflammation, gallbladder stones;

fatty liver;

night sweats;

scar;

abnormal muscle breakdown;

sleep interruptions;

impotence;

inflammations.

Rare ( in more than 1 in 10,000 patients but less than 1 in 1000 patients )

multiple sclerosis;

heart stops pumping;

a sac in the wall of a major artery, inflammation and clot of a vein, blockage of a blood vessel;

systemic lupus erythematosus (including inflammation of skin, heart, lung, joints and other organ systems).

Some adverse experiences seen in clinical trials do not have symptoms and may only be discovered through blood tests.

These include:

Very common (in more than 1 in 10 patients):

low blood measurements for white blood cells;

low blood measurements for red blood cells;

increased lipids in the blood;

elevated liver enzymes.

Common (in more than 1 in 100 patients but less than 1 in 10 patients):

high blood measurements for white blood cells;

low blood measurements for platelets;

abnormal blood measurements for potassium;

increased uric acid in the blood;

abnormal blood measurements for sodium;

low blood measurements for calcium;

low blood measurements for phosphate;

high blood sugar;

high blood measurements for lactate dehydrogenase;

autoantibodies present in the blood.

Rare (in more than 1 in 10,000 patients but less than 1 in 1,000 patients):

low blood measurements for white blood cells, red blood cells and platelet count.

The following side effects have been observed in patients taking Humira with not known frequency:

severe allergic reaction with shock;

nerve disorders (such as eye nerve inflammation and Guillain-Barré syndrome that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body);

intestinal perforation;

reactivation of hepatitis B;

cutaneous vasculitis (inflammation of blood vessels in the skin);

Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash);

erythema multiforme (inflammatory skin rash);

hair loss;

facial oedema associated with allergic reactions;

lupus-like syndrome;

hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal);

leukemia (cancer affecting the blood and bone marrow);

new onset or worsening of psoriasis;

heart attack;

stroke;

diverticulitis (inflammation and infection of the large intestine);

pulmonary embolism (blockage in an artery of the lung).

If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How To Store Humira

Keep out of the reach and sight of children.

Do not use the Humira pre-filled pen 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). Do not freeze. Keep the pre-filled pen in the outer carton.

Further Information

HUMIRA 40 mg solution for injection does not contain preservatives. Any unused product or waste material should be disposed of in accordance with local requirements

What Humira contains

The active substance is adalimumab.

The other ingredients are mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium hydroxide and water for injections.

This medicinal product contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, i.e. essentially ‘sodium-free’.

What the Humira pre-filled pen looks like and contents of the pack

Humira 40 mg solution for injection in pre-filled syringe is supplied as a sterile solution of 40 mg adalimumab dissolved in 0.8 ml solution.

The Humira pre-filled pen is a single-use grey- and plum-coloured pen which contains a glass syringe with Humira. There are two caps – one is grey and labelled ‘1’ and the other is plum and labelled ‘2’. There is a window on each side of the pen through which you can see the Humira solution inside the syringe.

The Humira pre-filled pen is available in packs containing 1, 2, 4, and 6 pre-filled pens. Each pre-filled pen comes with 1 alcohol pad. Not all pack sizes may be marketed. Humira is also available as a vial or pre-filled syringe.

Marketing Authorisation Holder

Abbott Laboratories Ltd

Abbott House

Vanwall Business Park

Vanwall Road

Maidenhead

Berkshire

SL6 4XE

United Kingdom

Manufacturer

Abbott Biotechnology Deutschland GmbH

Max-Planck-Ring 2

D – 65205 Wiesbaden

Germany

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

United Kingdom