What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives data nearly taking or using a medicine. Information technology is possible that the leaflet in your medicine pack may differ from this version because it may take been updated since your medicine was packaged.

Below is a text only representation of the Patient Data Leaflet. The original leaflet can be viewed using the link higher up.

The text just version may be bachelor in large print, Braille or audio CD. For farther information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 41042/0026 .

Humira lxxx mg solution for injection in pre-filled pen

adalimumab

  • Keep this leaflet. You may need to read it once more.
  • Your doctor volition also give yous a Patient Reminder Card, which contains important rubber information that you need to exist aware of before yous begin using Humira and during treatment with Humira. Keep this Patient Reminder Bill of fare with you.
  • If you have any questions, ask your medico or pharmacist.
  • This medicine has been prescribed for y'all simply. Exercise non pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you lot get any side effects, talk to your md or chemist. This includes whatever possible side effects non listed in this leaflet. See department 4.

1. What Humira is and what it is used for
2. What you need to know before you use Humira
iii. How to utilise Humira
4. Possible side effects
v How to store Humira
6. Contents of the pack and other information
seven. Injecting Humira

Humira contains the active substance adalimumab.

Humira is used to care for

  • Rheumatoid arthritis
  • Plaque psoriasis
  • Hidradenitis suppurativa
  • Crohn's affliction
  • Ulcerative colitis
  • Non-infectious uveitis

The active ingredient in Humira, adalimumab, is a human being monoclonal antibody. Monoclonal antibodies are proteins that adhere to a specific target.

The target of adalimumab is a protein chosen tumour necrosis gene (TNFα), which is involved in the allowed (defence) arrangement and is present at increased levels in the inflammatory diseases listed above. By attaching to TNFα, Humira decreases the process of inflammation in these diseases.

Rheumatoid arthritis is an inflammatory disease of the joints.

Humira is used to care for moderate to severe rheumatoid arthritis in adults. You may start exist given other affliction-modifying medicines, such as methotrexate. If you do not respond well enough to these medicines, you will be given Humira.

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

Humira can slow down the damage to the joints caused by the inflammatory affliction and tin can assist them move more freely.

Your md will decide if Humira should be used with methotrexate or lonely.

Plaque psoriasis is a pare condition that causes reddish, flaky, crusty patches of peel covered with silvery scales. Plaque psoriasis can likewise touch on the nails, causing them to crumble, become thickened and elevator abroad from the nail bed which can exist painful.

Humira is used to care for moderate to severe chronic plaque psoriasis in adults.

Hidradenitis suppurativa (sometimes chosen acne inversa) is a chronic and oft painful inflammatory pare disease. Symptoms may include tender nodules (lumps) and abscesses (boils) that may leak pus. It most commonly affects specific areas of the skin, such as nether the breasts, the armpits, inner thighs, groin and buttocks. Scarring may also occur in affected areas.

Humira is used to treat

  • moderate to severe hidradenitis suppurativa in adults and
  • moderate to severe hidradenitis suppurativa in adolescents aged 12 to 17 years.

Humira can reduce the number of nodules and abscesses caused by the disease and the hurting that is often associated with the disease. You may start be given other medicines. If you do not respond well enough to these medicines, y'all will be given Humira.

Crohn'due south illness is an inflammatory disease of the digestive tract.

Humira is used to treat

  • moderate to severe Crohn'due south disease in adults and
  • moderate to severe Crohn's disease in children and adolescents aged 6 to 17 years.

Yous may starting time be given other medicines. If you lot do not respond well enough to these medicines, you will exist given Humira.

Ulcerative colitis is an inflammatory disease of the large intestine.

Humira is used to treat

  • moderate to severe ulcerative colitis in adults and
  • moderate to severe ulcerative colitis in children and adolescents anile 6 to 17 years.

You may first be given other medicines. If y'all do not respond well plenty to these medicines, you lot volition exist given Humira.

Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.

Humira is used to treat

  • adults with non-infectious uveitis with inflammation affecting the back of the eye
  • children with chronic non-infectious uveitis from 2 years of age with inflammation affecting the front of the eye

This inflammation may lead to a decrease of vision and/or the presence of floaters in the center (black dots or wispy lines that move across the field of vision). Humira works by reducing this inflammation. You may first be given other medicines. If y'all do non respond well enough to these medicines, y'all volition exist given Humira.

  • If you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
  • If yous accept active tuberculosis or other severe infections (run into "Warnings and precautions"). It is important that you tell your doctor if you have symptoms of infections, for example, fever, wounds, feeling tired, dental problems.
  • If y'all accept moderate or astringent heart failure. Information technology is important to tell your doctor if y'all accept had or have a serious heart status (see "Warnings and precautions").

Talk to your dr. or pharmacist before using Humira.

Allergic reactions

  • If yous get allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash practice non inject more than Humira and contact your doctor immediately since, in rare cases, these reactions can be life threatening.

Infections

  • If you have an infection, including long-term infection or an infection in one part of the body (for example, leg ulcer) consult your doc before starting Humira. If you lot are unsure, contact your dr..
  • You lot might get infections more easily while you are receiving Humira handling. This risk may increase if you take problems with your lungs. These infections may be serious and include:
    • tuberculosis
    • infections caused by viruses, fungi, parasites or leaner
    • severe infection in the blood (sepsis)
    In rare cases, these infections can be life-threatening. It is of import to tell your doctor if you get symptoms such every bit fever, wounds, feeling tired or dental problems. Your medico may tell you to finish using Humira for some time.
  • Tell your doctor if yous live or travel in regions where fungal infections (for example, histoplasmosis, coccidioidomycosis or blastomycosis) are very common.
  • Tell your doctor if you lot have had infections which keep coming back or other weather condition that increase the take chances of infections.
  • If you are over 65 years you may exist more likely to get infections while taking Humira. You and your doctor should pay special attention to signs of infection while y'all are beingness treated with Humira. It is important to tell your doc if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems.

Tuberculosis

  • It is very of import that you lot tell your physician if you have always had tuberculosis, or if you take been in close contact with someone who has had tuberculosis. If you lot take active tuberculosis, practice not use Humira.
    • As cases of tuberculosis have been reported in patients treated with Humira, your medico will check y'all for signs and symptoms of tuberculosis before starting Humira. This will include a thorough medical evaluation including your medical history and appropriate screening tests (for example, breast X-ray and a tuberculin test). The conduct and results of these tests should be recorded on your Patient Reminder Card.
    • Tuberculosis can develop during therapy even if you take received treatment for the prevention of tuberculosis.
    • If symptoms of tuberculosis (for example, cough that does not get abroad, weight loss, lack of free energy, mild fever), or any other infection appear during or later therapy tell your doctor immediately.

Hepatitis B

  • Tell your medico if y'all are a carrier of the hepatitis B virus (HBV), if you have agile HBV or if yous remember you might be at take a chance of getting HBV.
    • Your md should test you for HBV. In people who carry HBV, Humira can crusade the virus to become agile again.
    • In some rare cases, specially if yous are taking other medicines that suppress the immune organization, reactivation of HBV tin can be life-threatening.

Surgery or dental process

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

Demyelinating disease

  • If you accept or develop a demyelinating disease (a disease that affects the insulating layer effectually the fretfulness, such as multiple sclerosis), your dr. will decide if y'all should receive or continue to receive Humira. Tell your doc immediately if y'all experience symptoms like changes in your vision, weakness in your artillery or legs or numbness or tingling in any part of your body.

Vaccinations

  • Certain vaccines may cause infections and should non be given while receiving Humira.
    • Check with your doc before you lot receive any vaccines.
    • Information technology is recommended that children, if possible, be given all the scheduled vaccinations for their historic period before they start treatment with Humira.
    • If you received Humira while you lot were pregnant, your baby may exist at higher take a chance for getting such an infection for up to approximately five months after the terminal Humira dose y'all received during pregnancy. It is important that y'all tell your baby's doctors and other health care professionals well-nigh your Humira use during your pregnancy and then they can make up one's mind when your baby should receive whatsoever vaccine.

Middle failure

  • If yous accept balmy heart failure and are being treated with Humira, your heart failure condition must exist closely monitored by your doc. It is important to tell your physician if you have had or have a serious heart condition. If you develop new or worsening symptoms of heart failure (e.g. shortness of jiff, or swelling of your feet), you must contact your doctor immediately. Your doctor will determine if you should receive Humira.

Fever, bruising, haemorrhage or looking pale

  • In some patients the trunk may fail to produce enough of the claret cells that fight off infections or assistance you to stop bleeding. Your md may decide to stop treatment. If y'all develop a fever that does not go away, develop lite bruises or drain very hands or expect very pale, call your physician correct away.

Cancer

  • There take been very rare cases of certain kinds of cancer in children and developed patients taking Humira or other TNF blockers.
    • People with more than serious rheumatoid arthritis that accept had the disease for a long time may have a college than average chance of getting lymphoma (a cancer that affects the lymph system) and leukaemia (a cancer that affects the blood and bone marrow).
    • If you lot take Humira the risk of getting lymphoma, leukaemia, or other cancers may increase. On rare occasions, an uncommon and severe type of lymphoma, has been seen in patients taking Humira. Some of those patients were besides treated with azathioprine or 6- mercaptopurine.
    • Tell your doctor if yous are taking azathioprine or 6-mercaptopurine with Humira.
    • Cases of not-melanoma skin cancer have been observed in patients taking Humira.
    • If new pare lesions announced during or after therapy or if existing lesions alter advent, tell your doc.
  • At that place have been cases of cancers, other than lymphoma in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Affliction (COPD) treated with another TNF blocker. If you have COPD, or are a heavy smoker, you lot should discuss with your md whether treatment with a TNF blocker is appropriate for yous.

Autoimmune illness

  • On rare occasions, treatment with Humira could result in lupus-like syndrome. Contact your doctor if symptoms such equally persistent unexplained rash, fever, joint hurting or tiredness occur.
  • Vaccinations: if possible, children should be upwards to engagement with all vaccinations before using Humira.

Tell your medico or chemist if you are taking, have recently taken or might have any other medicines.

You should not take Humira with medicines containing the following active substances due to increased gamble of serious infection:

  • anakinra
  • abatacept.

Humira can be taken together with:

  • methotrexate
  • certain affliction-modifying anti-rheumatic agents (for example, sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations)
  • steroids or pain medications including not-steroidal anti-inflammatory drugs (NSAIDs).

If you accept questions, please inquire your doctor.

  • You should consider the use of acceptable contraception to prevent pregnancy and go on its employ for at least v months after the concluding Humira treatment.
  • If yous are pregnant, think you may be pregnant or are planning to have a baby, ask your dr. for communication well-nigh taking this medicine.
  • Humira should only exist used during a pregnancy if needed.
  • According to a pregnancy study, there was no higher gamble of birth defects when the mother had received Humira during pregnancy compared with mothers with the same disease who did not receive Humira.
  • Humira can exist used during breast-feeding.
  • If you lot receive Humira during your pregnancy, your baby may take a higher risk for getting an infection.
  • It is important that you tell your babe'southward doctors and other wellness intendance professionals virtually your Humira use during your pregnancy earlier the baby receives any vaccine. For more data on vaccines run into the "Warnings and precautions" department.

Humira may have a small event on your ability to drive, bike or utilise machines. Room spinning sensation and vision disturbances may occur later taking Humira.

Always use this medicine exactly equally your doctor or pharmacist has told y'all. Check with your doc or chemist if you are not sure.

The recommended doses for Humira in each of the approved uses are shown in the following table. Your dr. may prescribe some other strength of Humira if y'all need a dissimilar dose.

Rheumatoid arthritis

Age or body weight

How much and how often to accept?

Notes

Adults

forty mg every other calendar week

Note - In rheumatoid arthritis, methotrexate is continued while using Humira. If your md decides that methotrexate is inappropriate, Humira can be given solitary.

If you have rheumatoid arthritis and you practice not receive methotrexate with your Humira therapy, your physician may decide to give Humira 40 mg every calendar week or 80 mg every other week.

Plaque psoriasis

Age or torso weight

How much and how often to take?

Notes

Adults

Get-go dose of 80 mg (i 80 mg injection), followed past 40 mg every other calendar week starting ane calendar week later the showtime dose.

Note - If you have an inadequate response, your doctor may increment the dosage to xl mg every week or fourscore mg every other calendar week.

Hidradenitis suppurativa

Age or body weight

How much and how frequently to accept?

Notes

Adults

First dose of 160 mg (two lxxx mg injections in i twenty-four hours or ane 80 mg injection per twenty-four hours for two consecutive days), followed by an lxxx mg dose (one 80 mg injection) two weeks later. After two farther weeks, continue with a dose of 40 mg every week or 80 mg every other week, as prescribed by your dr..

Note - Information technology is recommended that you use an clarified wash daily on the afflicted areas.

Adolescents from 12 to 17 years of age weighing thirty Kg or more

First dose of 80 mg (one 80 mg injection), followed by xl mg every other week starting 1 week afterwards.

Notation - If you have an inadequate response to Humira twoscore mg every other week, your doctor may increase the dosage to 40 mg every week or lxxx mg every other week.

It is recommended that y'all use an antiseptic wash daily on the affected areas.

Crohn'south disease

Age or torso weight

How much and how ofttimes to accept?

Notes

Children, adolescents and adults from 6 to 17 years of age weighing xl Kg or more than

Offset dose of 80 mg (i 80 mg injection), followed by twoscore mg 2 weeks later.

If a faster response is required, the doctor may prescribe a get-go dose of 160 mg (two 80 mg injections in one day or one 80 mg injection per day for two consecutive days), followed by eighty mg (one 80 mg injection) two weeks subsequently. Thereafter, the usual dose is forty mg every other week.

Notation - Your doctor may increment the dosage to 40 mg every week or eighty mg every other week.

Children and adolescents from half-dozen to 17 years of age weighing less than 40 Kg

Starting time dose of 40 mg, followed by 20 mg two weeks later.

If a faster response is required, the doctor may prescribe a commencement dose of eighty mg (one 80 mg injection), followed by 40 mg ii weeks afterward.

Thereafter, the usual dose is 20 mg every other week.

Note - Your doctor may increase the dose frequency to 20 mg every week.

Ulcerative colitis

Age or torso weight

How much and how often to take?

Notes

Adults

First dose of 160 mg (2 80 mg injections in one 24-hour interval or one 80 mg injection per day for two consecutive days), followed by 80 mg (one 80 mg injection) two weeks later.

Thereafter, the usual dose is 40 mg every other week.

Note - Your dr. may increment the dosage to 40 mg every week or fourscore mg every other week.

Children and adolescents from 6 years of age weighing less than 40 Kg

First dose of 80 mg (one 80 mg injection), followed by forty mg (one 40 mg injection) two weeks subsequently.

Thereafter, the usual dose is xl mg every other week.

Note - You lot should continue taking Humira at your usual dose, fifty-fifty after turning xviii years of age.

Children and adolescents from half dozen years of historic period weighing 40 Kg or more

Outset dose of 160 mg (two 80 mg injections in one day or one lxxx mg injection per day for two consecutive days), followed by 80 mg (ane lxxx mg injection) 2 weeks later.

Thereafter, the usual dose is 80 mg every other week.

Notation - You should continue taking Humira at your usual dose, fifty-fifty after turning 18 years of age.

Not-infectious uveitis

Age or body weight

How much and how often to accept?

Notes

Adults

First dose of eighty mg (ane fourscore mg injection), followed by 40 mg every other week starting i calendar week after the offset dose.

Annotation - Corticosteroids or other medicines that influence the immune system may be continued while using Humira. Humira can likewise be given alone.

Children and adolescents from 2 years of age weighing less than 30 Kg

20 mg every other week

Annotation -Your doctor may prescribe an initial dose of 40 mg to be administered one week prior to the start of the usual dose of xx mg every other week. Humira is recommended for employ in combination with methotrexate.

Children and adolescents from 2 years of age weighing 30 Kg or more

40 mg every other week

40 mg every other calendar week

Note - Your doctor may prescribe an initial dose of 80 mg to exist administered one week prior to the starting time of the usual dose of 40 mg every other week. Humira is recommended for use in combination with methotrexate.

Humira is administered past injection under the peel (by subcutaneous injection).

Detailed instructions on how to inject Humira are provided in section 7 'Injecting Humira'.

If you accidentally inject Humira more than frequently than told to by your physician or pharmacist, telephone call your doc or pharmacist and tell them that y'all take taken more. Always have the outer carton of the medicine with you, even if information technology is empty.

If you forget to requite yourself an injection, you lot should inject the next dose of Humira as soon as y'all think. Then accept your next dose equally you would take on your originally scheduled 24-hour interval, had you not forgotten a dose.

The conclusion to terminate using Humira should be discussed with your doctor. Your symptoms may return if y'all cease using Humira.

If you accept any further questions on the use of this medicine, ask your md or chemist.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate. Notwithstanding, some may be serious and require treatment. Side effects may occur at least up to 4 months after the last Humira injection.

  • astringent rash, hives or other signs of allergic reaction
  • swollen face, hands, feet
  • trouble breathing, swallowing
  • shortness of breath with concrete activity or upon lying down or swelling of the feet
  • 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 up sore that doesn't heal
  • signs and symptoms suggestive of blood disorders such equally persistent fever, bruising, bleeding, paleness

The symptoms described above tin be signs of the beneath listed side effects, which have been observed with Humira.

Very mutual (may bear on more than one in 10 people)

  • 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 (may impact up to 1 in 10 people)

  • serious infections (including blood poisoning and influenza)
  • intestinal infections (including gastroenteritis)
  • skin infections (including cellulitis and shingles)
  • ear infections
  • oral infections (including tooth infections and cold sores)
  • reproductive tract infections
  • urinary tract infection
  • fungal infections
  • joint infections
  • beneficial tumours
  • peel cancer
  • allergic reactions (including seasonal allergy)
  • aridity
  • mood swings (including depression)
  • feet
  • difficulty sleeping
  • sensation disorders such as tingling, prickling or numbness
  • migraine
  • nerve root compression (including low back hurting and leg pain)
  • vision disturbances
  • eye inflammation
  • inflammation of the center lid and heart swelling
  • vertigo (feeling of dizziness or spinning)
  • sensation of middle beating rapidly
  • loftier blood pressure level
  • flushing
  • haematoma (drove of blood outside of blood vessels)
  • cough
  • asthma
  • shortness of breath
  • gastrointestinal haemorrhage
  • 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
  • hair loss
  • new onset or worsening of psoriasis
  • musculus spasms
  • blood in urine
  • kidney problems
  • breast pain
  • oedema (swelling)
  • fever
  • reduction in blood platelets which increases take chances of haemorrhage or bruising
  • impaired healing

Uncommon (may touch on up to i in 100 people)

  • opportunistic infections (which include tuberculosis and other infections that occur when resistance to disease is lowered)
  • neurological infections (including viral meningitis)
  • eye infections
  • bacterial infections
  • diverticulitis (inflammation and infection of the big intestine)
  • cancer
  • cancer that affects the lymph arrangement
  • melanoma
  • immune disorders that could affect the lungs, skin and lymph nodes (most normally presenting as sarcoidosis)
  • vasculitis (inflammation of blood vessels)
  • tremor (shaking)
  • neuropathy (disorder of the nerves)
  • stroke
  • hearing loss, buzzing
  • sensation of heart beating irregularly such every bit skipped beats
  • heart problems that can cause shortness of breath or ankle swelling
  • center attack
  • a sac in the wall of a major artery, inflammation and clot of a vein, blockage of a blood vessel
  • lung diseases causing shortness of breath (including inflammation)
  • pulmonary embolism (blockage in an artery of the lung)
  • pleural effusion (abnormal drove of fluid in the pleural space)
  • inflammation of the pancreas which causes severe pain in the abdomen and back
  • difficulty in swallowing
  • facial oedema (swelling of the face)
  • gallbladder inflammation, gallbladder stones
  • fatty liver
  • dark sweats
  • scar
  • abnormal muscle breakdown
  • systemic lupus erythematosus (including inflammation of pare, heart, lung, joints and other organ systems)
  • sleep interruptions
  • impotence
  • inflammations

Rare (may touch on up to 1 in 1,000 people)

  • leukaemia (cancer affecting the blood and bone marrow)
  • severe allergic reaction with shock
  • multiple sclerosis
  • nerve disorders (such as eye nerve inflammation and Guillain-BarrĂ© syndrome that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body)
  • heart stops pumping
  • pulmonary fibrosis (scarring of the lung)
  • intestinal perforation (hole in the intestine)
  • hepatitis
  • reactivation of hepatitis B
  • autoimmune hepatitis (inflammation of the liver caused by the body'southward own immune arrangement)
  • cutaneous vasculitis (inflammation of claret vessels in the skin)
  • Stevens-Johnson syndrome (early on symptoms include malaise, fever, headache and rash)
  • facial oedema (swelling of the confront) associated with allergic reactions
  • erythema multiforme (inflammatory skin rash)
  • lupus-like syndrome
  • angioedema (localized swelling of the skin)
  • lichenoid skin reaction (itchy reddish-majestic skin rash)

Not known (frequency cannot be estimated from the available data)

  • hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal)
  • Merkel cell carcinoma (a type of pare cancer)
  • Kaposi's sarcoma, a rare cancer related to infection with human herpes virus viii. Kaposi'due south sarcoma almost commonly appears as majestic lesions on the skin
  • liver failure
  • worsening of a condition called dermatomyositis (seen every bit a skin rash accompanying musculus weakness)
  • weight gain (for most patients, the weight gain was minor)

Some side effects observed with Humira may not have symptoms and may but be discovered through blood tests. These include:

Very common (may bear on more 1 in 10 people)

  • depression blood measurements for white blood cells
  • low blood measurements for red blood cells
  • increased lipids in the blood
  • elevated liver enzymes

Common (may affect upwards to one in 10 people)

  • high blood measurements for white blood cells
  • depression blood measurements for platelets
  • increased uric acrid in the blood
  • abnormal blood measurements for sodium
  • depression blood measurements for calcium
  • low blood measurements for phosphate
  • high blood sugar
  • loftier claret measurements for lactate dehydrogenase
  • autoantibodies present in the blood
  • low claret potassium

Uncommon (may affect up to 1 in 100 people)

  • elevated bilirubin measurement (liver claret examination)

Rare (may touch upward to ane in 1,000 people)

  • low blood measurements for white blood cells, blood-red blood cells and platelet count

If yous get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects non listed in this leaflet. You can as well study side effects direct via the national reporting system (come across details below). By reporting side furnishings, you can help provide more information on the safe of this medicine.

United kingdom of great britain and northern ireland

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Shop.

Go on this medicine out of the sight and attain of children.

Practice not use this medicine afterwards the expiry appointment stated on the characterization/blister/carton after EXP.

Store in a refrigerator (two°C – viii°C). Do not freeze.

Go on the pre-filled pen in the outer carton in order to protect from light.

Culling Storage:

When needed (for instance, when you are travelling), a single Humira pre-filled pen may exist stored at room temperature (up to 25°C) for a maximum menstruation of 14 days – be sure to protect it from light. One time removed from the fridge for room temperature storage, the pen must exist used within 14 days or discarded, fifty-fifty if it is returned to the refrigerator.

Yous should tape the date when the pen is first removed from refrigerator and the date after which it should be discarded.

Do not throw away whatsoever medicines via wastewater or household waste. Ask your medico or pharmacist how to throw abroad medicines you no longer employ. These measures will help protect the environment.

The active substance is adalimumab.

The other ingredients are mannitol, polysorbate 80 and water for injections.

Humira fourscore mg solution for injection in pre-filled pen is supplied as a sterile solution of 80 mg adalimumab dissolved in 0.8 ml solution.

The Humira pre-filled pen is a single-employ grey and plum-coloured pen which contains a glass syringe with Humira. There are two caps – one is grey and labelled 'ane' and the other is plum and labelled 'ii'. There is a window on each side of the pen through which you can see the Humira solution within the syringe.

The Humira pre-filled pen is bachelor in packs containing:

  • i pre-filled pen for patient use with two alcohol pads (one spare)
  • iii pre-filled pens for patient use with 4 alcohol pads (one spare)

Non all pack sizes may be marketed.

Humira may be available as a pre-filled syringe and/or a pre-filled pen.

AbbVie Ltd
Maidenhead
SL6 4UB
Britain

AbbVie Biotechnology GmbH
Knollstrasse
67061 Ludwigshafen
Germany

For whatsoever information about this medicine, delight contact the local representative of the Marketing Authorisation Holder:

U.k.

AbbVie Ltd

Tel: +44 (0)1628 561090

This leaflet was last revised in 04/2021

To listen to or request a copy of this leaflet in Braille, large impress or audio, please contact the local representative of the Marketing Authorisation Holder.

  • The post-obit instructions explicate how to give yourself a subcutaneous injection of Humira using the pre-filled pen. Commencement read all the instructions advisedly and then follow them step by stride.
  • You will exist instructed past your medico, nurse or pharmacist on the technique of self-injection.
  • Do not attempt to cocky-inject until you are sure that yous understand how to prepare and give the injection.
  • After proper training, the injection can be given by yourself or given by another person, for example, a family fellow member or friend.
  • But use each pre-filled pen for one injection.

Grey Cap one

White Needle Sleeve

White Arrow

Plum-coloured Cap 2

Needle

Inspection Window

Plum Activator Button

Do not employ the pre-filled pen and call your doc or pharmacist if the

  • liquid is cloudy, discoloured, or has flakes or particles in it
  • expiry (EXP) date has passed
  • liquid has been frozen or left in direct sunlight
  • pre-filled pen has been dropped or crushed

Do not remove the caps until just earlier injection. Keep Humira out of the sight and reach of children.

Take Humira out of the refrigerator.

Go out Humira at room temperature for xv to 30 minutes before injecting.

  • Do not remove the Grey or Plum-coloured Caps while allowing Humira to reach room temperature
  • Practice non warm Humira in any other style. For example, do not warm it in a microwave or in hot water

Check expiry engagement. Practise not use the pre-filled pen if decease date has passed. Place the post-obit on a clean, flat surface

  • ane single-employ pre-filled pen and
  • i alcohol pad

Wash and dry your easily.

Choose an injection site:

  • On the forepart of your thighs or
  • Your abdomen (belly) at least 5 cm from your belly button (bellybutton)
  • At least 3 cm from your last injection site

Wipe the injection site in a circular move with the alcohol pad.

  • Exercise not inject through wearing apparel
  • Do non inject into skin that is sore, hobbling, ruby, hard, scarred, has stretch marks, or areas with psoriasis plaques

Hold the pre-filled pen with the Grey Cap 1 pointing upwardly.

Check the inspection window.

  • It is normal to see one or more bubbling in the window
  • Make certain the liquid is clear and colourless
  • Do not use the pre-filled pen if the liquid is cloudy or has particles
  • Exercise not utilise the pre-filled pen if it has been dropped or crushed

Pull the Grey Cap 1 straight off. Throw the cap away. Do not epitomize.

  • Check that the pocket-sized black needle cover of the syringe has been removed with the cap
  • It is normal to see a few drops of liquid come up out of the needle

Pull the Plum-coloured Cap two straight off. Throw the cap away. Practise not recap.

The pre-filled pen is now prepare to employ.

Turn the pre-filled pen and then that the raised white arrow points toward the injection site.

Squeeze the skin at your injection site with your other manus to make a raised area and hold it firmly until the injection is consummate.

Point the white arrow toward the injection site (thigh or belly).

Identify the white needle sleeve straight (ninety° angle) confronting the injection site.

Hold the pre-filled pen and so that yous tin can see the inspection window.

Practice not press the plum activator button until you are ready to inject.

Firmly push the pre-filled pen down against the injection site before starting the injection.

Keep pushing down to prevent the pre-filled pen from moving abroad from the skin during the injection.

Press the plum activator button and count slowly for 15 seconds.

  • A loud "click" will indicate the start of the injection
  • Keep pushing the pre-filled pen downwardly firmly against the injection site until the injection is complete.

The injection is complete when the yellow indicator has stopped moving.

When the injection is completed, slowly pull the pre-filled pen from the pare. The white needle sleeve will cover the needle tip.

  • A small corporeality of liquid on the injection site is normal

If at that place are more than a few drops of liquid on the injection site, contact your doc, nurse or pharmacist.

After completing the injection, place a cotton brawl or gauze pad on the pare over the injection site.

  • Do not rub

Slight bleeding at the injection site is normal

Throw away the used pre-filled pen in a special disposal container equally instructed by your doctor, nurse or chemist.

  • Do not recycle or throw the pre-filled pen in the household waste material
  • Always continue the pre-filled pen and the special disposal container out of the sight and reach of children

The caps, alcohol pad, cotton ball or gauze pad, cicatrice and packaging may be put in your household waste product.