Free Charlotte: Humira 40 mg solution for injection in pre-filled syringe

Humira

40 mg solution for injection in pre-filled syringe

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, please 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, psoriatic arthritis, polyarticular juvenile idiopathic 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 rhuematoid 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 epidemic.

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, reactiviation 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 got 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 take 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.

Instructions for preparing and giving an injection of Humira:

The following instructions explain how to inject Humira. 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.

1) Setting up

Wash your hands thoroughly

Set up the following items on a clean surface
- One pre-filled syringe of Humira for injection
- One alcohol pad

Look at the expiry date on the syringe. Do not use the product after the month and year shown.

2) Choosing and preparing an injection site

Choose a site on your thigh or stomach

Each new injection should be given at least 3 cm from the last injection site.
- Do not inject in an area where the skin is reddened, bruised, or hard. This may mean there is an infection.
- Wipe the injection site with the enclosed alcohol pad, using a circular motion.
- Do not touch the area again before injecting.

3) Injecting Humira

Do NOT shake the syringe.

Remove cap from needle syringe, being careful not to 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 Humira syringe should NEVER be reused. NEVER recap a needle.

After injecting Humira, 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 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 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 1,000 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 1,000 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 gets serious, if you have any unusual effects, 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 syringe 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 syringe 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 syringe 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 syringe is a glass syringe containing a solution of adalimumab.

Each pack contains 1, 2, 4 or 6 pre-filled syringes for patient use with 1, 2, 4 or 6 alcohol pads, respectively. Not all pack sizes may be marketed.

Humira is also available as a vial or a pre-filled pen.

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 medicinal product, please contact the local representative of the Marketing Authorisation Holder.

United Kingdom