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The product code(s) for this leaflet is: PLGB 41042/0026 .
Humira 80 mg/0.8 ml solution for injection in pre-filled pen (Great Britain)
Humira 80 mg solution for injection in pre-filled pen
adalimumab
1. What Humira is and what it is used for
2. What you need to know before you use Humira
3. How to use Humira
4. Possible side effects
5 How to store Humira
6. Contents of the pack and other information
7. Injecting Humira
Humira contains the active substance adalimumab.
Humira is used to treat
The active ingredient in Humira, adalimumab, is a human monoclonal antibody. Monoclonal antibodies are proteins that attach to a specific target.
The target of adalimumab is a protein called tumour necrosis factor (TNFα), which is involved in the immune (defence) system 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 treat moderate to severe rheumatoid arthritis in adults. 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.
Humira can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.
Humira can slow down the damage to the joints caused by the inflammatory disease and can help them move more freely.
Your doctor will decide if Humira should be used with methotrexate or alone.
Plaque psoriasis is a skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. Plaque psoriasis can also affect the nails, causing them to crumble, become thickened and lift away from the nail bed which can be painful.
Humira is used to treat moderate to severe chronic plaque psoriasis in adults.
Hidradenitis suppurativa (sometimes called acne inversa) is a chronic and often painful inflammatory skin 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 under the breasts, the armpits, inner thighs, groin and buttocks. Scarring may also occur in affected areas.
Humira is used to treat
Humira can reduce the number of nodules and abscesses caused by the disease and the pain that is often associated with the disease. You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Humira.
Crohn’s disease is an inflammatory disease of the digestive tract.
Humira is used to treat
You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Humira.
Ulcerative colitis is an inflammatory disease of the large intestine.
Humira is used to treat
You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Humira.
Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.
Humira is used to treat
This inflammation may lead to a decrease of vision and/or the presence of floaters in the eye (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 you do not respond well enough to these medicines, you will be given Humira.
Talk to your doctor or pharmacist before using Humira.
Allergic reactions
Infections
Tuberculosis
Hepatitis B
Surgery or dental procedure
Demyelinating disease
Vaccinations
Heart failure
Fever, bruising, bleeding or looking pale
Cancer
Autoimmune disease
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
You should not take Humira with medicines containing the following active substances due to increased risk of serious infection:
Humira can be taken together with:
If you have questions, please ask your doctor.
Humira may have a small effect on your ability to drive, cycle or use machines. Room spinning sensation and vision disturbances may occur after taking Humira.
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended doses for Humira in each of the approved uses are shown in the following table. Your doctor may prescribe another strength of Humira if you need a different dose.
Rheumatoid arthritis
Age or body weight
How much and how often to take?
Notes
Adults
40 mg every other week
Note - In rheumatoid arthritis, methotrexate is continued while using Humira. If your doctor decides 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 Humira 40 mg every week or 80 mg every other week.
Plaque psoriasis
Age or body weight
How much and how often to take?
Notes
Adults
First dose of 80 mg (one 80 mg injection), followed by 40 mg every other week starting one week after the first dose.
Note - If you have an inadequate response, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.
Hidradenitis suppurativa
Age or body weight
How much and how often to take?
Notes
Adults
First dose of 160 mg (two 80 mg injections in one day or one 80 mg injection per day for two consecutive days), followed by an 80 mg dose (one 80 mg injection) two weeks later. After two further weeks, continue with a dose of 40 mg every week or 80 mg every other week, as prescribed by your doctor.
Note - It is recommended that you use an antiseptic wash daily on the affected areas.
Adolescents from 12 to 17 years of age weighing 30 Kg or more
First dose of 80 mg (one 80 mg injection), followed by 40 mg every other week starting one week later.
Note - If you have an inadequate response to Humira 40 mg every other week, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.
It is recommended that you use an antiseptic wash daily on the affected areas.
Crohn’s disease
Age or body weight
How much and how often to take?
Notes
Children, adolescents and adults from 6 to 17 years of age weighing 40 Kg or more
First dose of 80 mg (one 80 mg injection), followed by 40 mg two weeks later.
If a faster response is required, the doctor may prescribe a first dose of 160 mg (two 80 mg injections in one day 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 doctor may increase the dosage to 40 mg every week or 80 mg every other week.
Children and adolescents from 6 to 17 years of age weighing less than 40 Kg
First dose of 40 mg, followed by 20 mg two weeks later.
If a faster response is required, the doctor may prescribe a first dose of 80 mg (one 80 mg injection), followed by 40 mg two weeks later.
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 body weight
How much and how often to take?
Notes
Adults
First dose of 160 mg (two 80 mg injections in one day 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 doctor may increase the dosage to 40 mg every week or 80 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 40 mg (one 40 mg injection) two weeks later.
Thereafter, the usual dose is 40 mg every other week.
Note - You should continue taking Humira at your usual dose, even after turning 18 years of age.
Children and adolescents from 6 years of age weighing 40 Kg or more
First dose of 160 mg (two 80 mg injections in one day 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 80 mg every other week.
Note - You should continue taking Humira at your usual dose, even after turning 18 years of age.
Non-infectious uveitis
Age or body weight
How much and how often to take?
Notes
Adults
First dose of 80 mg (one 80 mg injection), followed by 40 mg every other week starting one week after the first dose.
Note - Corticosteroids or other medicines that influence the immune system may be continued while using Humira. Humira can also be given alone.
Children and adolescents from 2 years of age weighing less than 30 Kg
20 mg every other week
Note -Your doctor may prescribe an initial dose of 40 mg to be administered one week prior to the start of the usual dose of 20 mg every other week. Humira is recommended for use 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 week
Note - Your doctor may prescribe an initial dose of 80 mg to be administered one week prior to the start of the usual dose of 40 mg every other week. Humira is recommended for use in combination with methotrexate.
Humira is administered by injection under the skin (by subcutaneous injection).
Detailed instructions on how to inject Humira are provided in section 7 ‘Injecting Humira’.
If you accidentally inject Humira more frequently than told to by your doctor or pharmacist, call your doctor or pharmacist and tell them that you have taken more. Always take the outer carton of the medicine with you, even if it is empty.
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.
The decision to stop using Humira should be discussed with your doctor. Your symptoms may return if you stop using Humira.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause 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 4 months after the last Humira injection.
The symptoms described above can be signs of the below listed side effects, which have been observed with Humira.
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
Not known (frequency cannot be estimated from the available data)
Some side effects observed with Humira may not have symptoms and may only be discovered through blood tests. These include:
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label/blister/carton after EXP.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep the pre-filled pen in the outer carton in order to protect from light.
Alternative Storage:
When needed (for example, when you are travelling), a single Humira pre-filled pen may be stored at room temperature (up to 25°C) for a maximum period of 14 days – be sure to protect it from light. Once removed from the refrigerator for room temperature storage, the pen must be used within 14 days or discarded, even if it is returned to the refrigerator.
You should record the date when the pen is first removed from refrigerator and the date after which it should be discarded.
Do not throw away any medicines via wastewater or household waste. Ask your doctor or pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substance is adalimumab.
The other ingredients are mannitol, polysorbate 80 and water for injections.
Humira 80 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-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:
Not all pack sizes may be marketed.
Humira may be available as a pre-filled syringe and/or a pre-filled pen.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in 04/2021
To listen to or request a copy of this leaflet in Braille, large print or audio, please contact the local representative of the Marketing Authorisation Holder.
Grey Cap 1
White Needle Sleeve
White Arrow
Plum-coloured Cap 2
Needle
Inspection Window
Plum Activator Button
Do not use the pre-filled pen and call your doctor or pharmacist if the
Do not remove the caps until just before injection. Keep Humira out of the sight and reach of children.
Take Humira out of the refrigerator.
Leave Humira at room temperature for 15 to 30 minutes before injecting.
Check expiry date. Do not use the pre-filled pen if expiry date has passed. Place the following on a clean, flat surface
Wash and dry your hands.
Choose an injection site:
Wipe the injection site in a circular motion with the alcohol pad.
Hold the pre-filled pen with the Grey Cap 1 pointing up.
Check the inspection window.
Pull the Grey Cap 1 straight off. Throw the cap away. Do not recap.
Pull the Plum-coloured Cap 2 straight off. Throw the cap away. Do not recap.
The pre-filled pen is now ready to use.
Turn the pre-filled pen so that the raised white arrow points toward the injection site.
Squeeze the skin at your injection site with your other hand to make a raised area and hold it firmly until the injection is complete.
Point the white arrow toward the injection site (thigh or abdomen).
Place the white needle sleeve straight (90° angle) against the injection site.
Hold the pre-filled pen so that you can see the inspection window.
Do 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 away from the skin during the injection.
Press the plum activator button and count slowly for 15 seconds.
The injection is complete when the yellow indicator has stopped moving.
When the injection is completed, slowly pull the pre-filled pen from the skin. The white needle sleeve will cover the needle tip.
If there are more than a few drops of liquid on the injection site, contact your doctor, nurse or pharmacist.
After completing the injection, place a cotton ball or gauze pad on the skin over the injection site.
Slight bleeding at the injection site is normal
Throw away the used pre-filled pen in a special disposal container as instructed by your doctor, nurse or pharmacist.
The caps, alcohol pad, cotton ball or gauze pad, blister and packaging may be put in your household waste.