Medicine guide

Libmyris

Prescription status not stated
Cancer treatments and immune-system medicines

Active substance: Adalimumab
Used in: Cancer treatments and immune-system medicines
Made by: Stada Arzneimittel AG
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

What it is for

Libmyris is used to treat:

Libmyris contains the active substance adalimumab.
• Rheumatoid arthritis
• Polyarticular juvenile idiopathic arthritis
• Enthesitis-related arthritis
• Ankylosing spondylitis
• Axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
• Psoriatic arthritis
• Plaque psoriasis
• Hidradenitis suppurativa
• Crohn’s disease
• Ulcerative colitis
• Non-infectious uveitis The active substance in Libmyris, 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, Libmyris decreases the process of inflammation in these diseases.
Rheumatoid arthritis Rheumatoid arthritis is an inflammatory disease of the joints.
Libmyris 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 Libmyris.
Libmyris can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.
Libmyris 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 Libmyris should be used with methotrexate or alone.
Polyarticular juvenile idiopathic arthritis Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the joints.
Libmyris is used to treat polyarticular juvenile idiopathic arthritis in patients from 2 years of age. 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 Libmyris.
Your doctor will decide if Libmyris should be used with methotrexate or alone.
Enthesitis-related arthritis Enthesitis-related arthritis is an inflammatory disease of the joints and the places where tendons join the bone.
Libmyris is used to treat enthesitis-related arthritis in patients from 6 years of age. 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 Libmyris.
Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis are inflammatory diseases of the spine.
Libmyris is used to treat severe ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults. You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Libmyris.
Psoriatic arthritis Psoriatic arthritis is an inflammatory disease of the joints that is usually associated with psoriasis.
Libmyris is used to treat psoriatic arthritis in adults. Libmyris can slow down the damage to the joints caused by the disease and can help them move more freely. You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Libmyris.
Plaque psoriasis 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.
Libmyris is used to treat
• moderate to severe chronic plaque psoriasis in adults and
• severe chronic plaque psoriasis in children and adolescents aged 4 to 17 years for whom topical therapy and phototherapies have either not worked very well or are not suitable.
Hidradenitis suppurativa 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.
Libmyris is used to treat
• moderate to severe hidradenitis suppurativa in adults and
• moderate to severe hidradenitis suppurativa in adolescents aged 12 to 17 years.
Libmyris 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 Libmyris.
Crohn’s disease Crohn’s disease is an inflammatory disease of the digestive tract.
Libmyris is used to treat
• moderate to severe Crohn’s disease in adults and
• moderate to severe Crohn’s disease in children and adolescents aged 6 to 17 years.
You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Libmyris.
Ulcerative colitis Ulcerative colitis is an inflammatory disease of the large intestine.
Libmyris is used to treat
• moderate to severe ulcerative colitis in adults and
• moderate to severe ulcerative colitis in children and adolescents aged 6 to 17 years.
You may first be given other medicines. If you do not respond well enough to these medicines, you will be given Libmyris.
Non-infectious uveitis Non-infectious uveitis is an inflammatory disease affecting certain parts of the eye.
Libmyris 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 eye (black dots or wispy lines that move across the field of vision). Libmyris 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 Libmyris.

From the package leaflet in EMA’s product information, p. 119–121 · 2026-07-13

Do not take it if

If you are allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
If you have active tuberculosis or other severe infections (see “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 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 “Warnings and precautions”).

From the package leaflet in EMA’s product information, p. 122.

How to take it

These directions are for this exact strength and form. Another one is different.

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 Libmyris in each of the approved uses are shown in the following table.
Your doctor may prescribe another strength of Libmyris if you need a different dose.
Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis or axial spondyloarthritis without radiographic evidence of ankylosing spondylitis Age or body weight How much and how often to Notes take?
Adults 40 mg every other week In rheumatoid arthritis, methotrexate is continued while using Libmyris. If your doctor decides that methotrexate is inappropriate, Libmyris can be given alone.
If you have rheumatoid arthritis and you do not receive methotrexate with your Libmyris therapy, your doctor may decide to give Libmyris 40 mg every week or 80 mg every other week.
Polyarticular juvenile idiopathic arthritis Age or body weight How much and how often to Notes take?
Children, adolescents and 40 mg every other week Not applicable adults from 2 years of age weighing 30 kg or more Enthesitis-related arthritis Age or body weight How much and how often to Notes take?
Children, adolescents and 40 mg every other week Not applicable adults from 6 years of age weighing 30 kg or more Plaque psoriasis Age or body weight How much and how often to Notes take?
Adults First dose of 80 mg (two 40 mg If you have an inadequate injections in one day), followed response, your doctor may by 40 mg every other week increase the dose to 40 mg starting one week after the first every week or 80 mg every dose. other week.
Children and adolescents First dose of 40 mg, followed by Not applicable from 4 to 17 years of age 40 mg one week later.
weighing 30 kg or more Thereafter, the usual dose is 40 mg every other week.
Hidradenitis suppurativa Age or body weight How much and how often to Notes take?
Adults First dose of 160 mg (four 40 mg It is recommended that you use injections in one day or two an antiseptic wash daily on the 40 mg injections per day for two affected areas.
consecutive days), followed by an 80 mg dose (two 40 mg injections in one day) 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.
Adolescents from 12 to First dose of 80 mg (two 40 mg If you have an inadequate 17 years of age weighing injections in one day), followed response to Libmyris 40 mg 30 kg or more by 40 mg every other week every other week, your doctor starting one week later. may increase the dose 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 Notes take?
Children, adolescents and First dose of 80 mg (two 40 mg Your doctor may increase the adults from 6 years of age injections in one day), followed dose to 40 mg every week or weighing 40 kg or more by 40 mg two weeks later. 80 mg every other week.
If a faster response is required, the doctor may prescribe a first dose of 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg (two 40 mg injections in one day) two weeks later.
Thereafter, the usual dose is 40 mg every other week.
Children and adolescents First dose of 40 mg, followed by Your doctor may increase the from 6 to 17 years of age 20 mg two weeks later. dose frequency to 20 mg every weighing less than 40 kg week. * If a faster response is required, the doctor may prescribe a first dose of 80 mg (two 40 mg injections in one day), followed by 40 mg two weeks later.
Thereafter, the usual dose is 20 mg every other week.*
* Libmyris is only available as 40 mg pre-filled syringe, 40 mg pre-filled pen, 80 mg pre-filled syringe and 80 mg pre-filled pen. Thus, it is not possible to administer Libmyris to patients that require less than a full 40 mg dose.
Ulcerative colitis Age or body weight How much and how often to Notes take?
Adults First dose of 160 mg (four 40 mg Your doctor may increase the injections in one day or two dose to 40 mg every week or 40 mg injections per day for two 80 mg every other week.
consecutive days), followed by 80 mg (two 40 mg injections in one day) two weeks later.
Thereafter, the usual dose is 40 mg every other week.
Children and adolescents First dose of 80 mg (two 40 mg You should continue taking from 6 years of age weighing injections in one day), followed adalimumab at your usual dose, less than 40 kg by 40 mg (one 40 mg injection) even after turning 18 years of two weeks later. age.
Thereafter, the usual dose is 40 mg every other week.
Children and adolescents First dose of 160 mg (four 40 mg You should continue taking from 6 years of age weighing injections in one day or two adalimumab at your usual dose, 40 kg or more 40 mg injections per day for two even after turning 18 years of consecutive days), followed by age.
80 mg (two 40 mg injections in one day) two weeks later.
Thereafter, the usual dose is 80 mg every other week.
Non-infectious uveitis Age or body weight How much and how often to Notes take?
Adults First dose of 80 mg (two 40 mg Corticosteroids or other injections in one day), followed medicines that influence the by 40 mg every other week immune system may be starting one week after the first continued while using dose. Libmyris. Libmyris can also be given alone.
Children and adolescents 40 mg every other week Your doctor may prescribe an from 2 years of age weighing initial dose of 80 mg to be at least 30 kg administered one week prior to the start of the usual dose of 40 mg every other week.
Libmyris is recommended for use in combination with methotrexate.
Method and route of administration Libmyris is administered by injection under the skin (by subcutaneous injection).
Detailed instructions on how to inject Libmyris are provided in section 7, “Instructions for use”.
If you use more Libmyris than you should If you accidentally inject Libmyris 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 use Libmyris If you forget to give yourself an injection, you should inject the next dose of Libmyris 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 stop using Libmyris The decision to stop using Libmyris should be discussed with your doctor. Your symptoms may return if you stop using Libmyris.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

From the package leaflet in EMA’s product information, p. 125–128.

Warnings and precautions

Talk to your doctor or pharmacist before using Libmyris.
Allergic reactions
If you get allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash, do not inject more Libmyris 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 doctor before starting Libmyris. If you are unsure, contact your doctor.
You might get infections more easily while you are receiving Libmyris treatment. This risk may increase if you have problems with your lungs. These infections may be serious and include:
o tuberculosis o infections caused by viruses, fungi, parasites or bacteria o severe infection in the blood (sepsis)
In rare cases, these infections can 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 tell you to stop using Libmyris for some time.
Tell your doctor if you live or travel in regions where fungal infections (for example, histoplasmosis, coccidioidomycosis or blastomycosis) are very common.
Tell your doctor if you have had infections which keep coming back or other conditions that increase the risk of infections.
If you are over 65 years you may be more likely to get infections while taking Libmyris. You and your doctor should pay special attention to signs of infection while you are being treated with Libmyris. It is important to tell your doctor if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems.
Tuberculosis
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 you have active tuberculosis, do not use Libmyris.
o As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check you for signs and symptoms of tuberculosis before starting Libmyris.
This will include a thorough medical evaluation including your medical history and appropriate screening tests (for example chest X-ray and a tuberculin test). The conduct and results of these tests should be recorded on your Patient Reminder Card.
o Tuberculosis can develop during therapy even if you have received treatment for the prevention of tuberculosis.
o If symptoms of tuberculosis (for example, cough that does not go away, weight loss, lack of energy, mild fever), or any other infection appear during or after therapy, tell your doctor immediately.
Hepatitis B
Tell 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 getting HBV.
o Your doctor should test you for HBV. In people who carry HBV, adalimumab can cause the virus to become active again.
o In some rare cases, especially if you are taking other medicines that suppress the immune system, reactivation of HBV can be life-threatening.
Surgery or dental procedures
If you are about to have surgery or dental procedures tell your doctor that you are taking Libmyris. Your doctor may recommend temporary discontinuation of Libmyris.
Demyelinating disease
If you have or develop a demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if you should receive or continue to receive Libmyris. Tell your doctor immediately if you experience symptoms like changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body.
Vaccinations
Certain vaccines may cause infections and should not be given while receiving Libmyris.
o Check with your doctor before you receive any vaccines.
o It is recommended that children, if possible, be given all the scheduled vaccinations for their age before they start treatment with Libmyris.
o If you received Libmyris while you were pregnant, your baby may be at higher risk for getting such an infection for up to approximately five months after the last Libmyris dose you received during pregnancy. It is important that you tell your baby's doctors and other health care professionals about your Libmyris use during your pregnancy so they can decide when your baby should receive any vaccine.
Heart failure
If you have mild heart failure and are being treated with Libmyris, 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 Libmyris.
Fever, bruising, bleeding or looking pale
In some patients the body may fail to produce enough of the blood cells that fight off infections or help you to stop bleeding. Your doctor may decide to stop treatment. If you develop a fever that does not go away, develop light bruises or bleed very easily or look very pale, call your doctor right away.
Cancer
There have been very rare cases of certain kinds of cancer in children and adult patients taking adalimumab or other TNF blockers.
o People with more serious rheumatoid arthritis who have had the disease for a long time may have a higher than average risk of getting lymphoma (a cancer that affects the lymph system) and leukaemia (a cancer that affects the blood and bone marrow).
o If you take Libmyris 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 adalimumab. Some of those patients were also treated with azathioprine or 6-mercaptopurine.
o Tell your doctor if you are taking azathioprine or 6-mercaptopurine with Libmyris.
o Cases of non-melanoma skin cancer have been observed in patients taking adalimumab.
o 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.
Autoimmune disease
On rare occasions, treatment with Libmyris could result in lupus-like syndrome. Contact your doctor, if symptoms such as persistent unexplained rash, fever, joint pain or tiredness occur.
Children and adolescents
Vaccinations: if possible, children should be up to date with all vaccinations before using Libmyris.

From the package leaflet in EMA’s product information, p. 122–124.

Pregnancy and breastfeeding

You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Libmyris treatment.
If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice about taking this medicine.
Libmyris should only be used during a pregnancy if needed.
According to a pregnancy study, there was no higher risk of birth defects when the mother had received adalimumab during pregnancy compared with mothers with the same disease who did not receive adalimumab.
Libmyris can be used during breast-feeding.
If you receive Libmyris during your pregnancy, your baby may have a higher risk for getting an infection.
It is important that you tell your baby’s doctors and other health care professionals about your Libmyris use during your pregnancy before the baby receives any vaccine. For more information on vaccines see the “Warnings and precautions” section.

From the package leaflet in EMA’s product information, p. 124–125.

Other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
You should not take Libmyris with medicines containing the following active substances due to increased risk of serious infection:
anakinra
abatacept.
Libmyris can be taken together with:
methotrexate
certain disease-modifying anti-rheumatic agents (for example, sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations)
steroids or pain medicine including non-steroidal anti-inflammatory drugs (NSAIDs).
If you have questions, please ask your doctor.

From the package leaflet in EMA’s product information, p. 124.

Driving and using machines

Libmyris may have a small effect on your ability to drive, cycle or use machines. Room spinning sensation and vision disturbances may occur after taking Libmyris.
Libmyris contains sodium and polysorbate 80 This medicine contains less than 1 mmol sodium (23 mg) per 0.4 ml, that is to say essentially ‘sodium- free’.
This medicine contains 1 mg of polysorbate 80 in each ml. Polysorbates may cause allergic reactions.
Tell your doctor if you have any known allergies.

From the package leaflet in EMA’s product information, p. 125.

Side effects

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 Libmyris 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 physical activity or upon lying down or swelling of the feet 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
signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding, paleness The symptoms described above can be signs of the below listed side effects, which have been observed with adalimumab:
Very common (may affect more than 1 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 affect 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
benign tumours
skin cancer
allergic reactions (including seasonal allergy)
dehydration
mood swings (including depression)
anxiety
difficulty sleeping
sensation disorders such as tingling, prickling or numbness
migraine
nerve root compression (including low back pain and leg pain)
vision disturbances
eye inflammation
inflammation of the eye lid and eye swelling
vertigo (feeling of dizziness or spinning)
sensation of heart beating rapidly
high blood pressure
flushing
haematoma (collection of blood outside of blood vessels)
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
hair loss
new onset or worsening of psoriasis
muscle spasms
blood in urine
kidney problems
chest pain
oedema (swelling)
fever
reduction in blood platelets which increases risk of bleeding or bruising
impaired healing Uncommon (may affect up to 1 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 large intestine)
cancer
cancer that affects the lymph system
melanoma
immune disorders that could affect the lungs, skin and lymph nodes (most commonly 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 as skipped beats
heart problems that can cause shortness of breath or ankle swelling
heart 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 collection 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
night sweats
scar
abnormal muscle breakdown
systemic lupus erythematosus (including inflammation of skin, heart, lung, joints and other organ systems)
sleep interruptions
impotence
inflammations Rare (may affect 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-Barré 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's own immune system)
cutaneous vasculitis (inflammation of blood vessels in the skin)
Stevens-Johnson syndrome (early symptoms include malaise, fever, headache and rash)
facial oedema (swelling of the face) associated with allergic reactions
erythema multiforme (inflammatory skin rash)
lupus-like syndrome
angioedema (localised swelling of the skin)
lichenoid skin reaction (itchy reddish-purple 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 skin cancer)
Kaposi’s sarcoma, a rare cancer related to infection with human herpes virus 8. Kaposi’s sarcoma most commonly appears as purple lesions on the skin
liver failure
worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness)
weight gain (for most patients, the weight gain was small)
Some side effects observed with adalimumab may not have symptoms and may only be discovered through blood tests. These include:
Very common (may affect more than 1 in 10 people)
low blood measurements for white blood cells
low blood measurements for red blood cells
increased lipids in the blood
elevated liver enzymes Common (may affect up to 1 in 10 people)
high blood measurements for white blood cells
low blood measurements for platelets
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
low blood potassium Uncommon (may affect up to 1 in 100 people)
elevated bilirubin measurement (liver blood test)
Rare (may affect up to 1 in 1,000 people)
low blood measurements for white blood cells, red blood cells and platelet count Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

From the package leaflet in EMA’s product information, p. 128–132.

How to store it

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is 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 in order to protect from light.
Alternative Storage:
When needed (for example when you are travelling), a single Libmyris pre-filled syringe may be stored at 20 °C to 25 °C for a maximum period of up to 30 days – be sure to protect it from light. Once removed from the refrigerator for storage at 20 °C to 25 °C, the syringe must be used within the 30 days or discarded, even if it is returned to the refrigerator.
You should record the date when the syringe is first removed from refrigerator and the date after which it should be discarded.
Do not use this medicine if the liquid is cloudy, discoloured, or has flakes or particles in it.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

From the package leaflet in EMA’s product information, p. 132.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

United StatesNo exact match for this strength and form

Every strength and form (4)

SpainNo exact match for this strength and form

Every strength and form (41)

FranceNo exact match for this strength and form

Every strength and form (46)

CanadaNo exact match for this strength and form

Every strength and form (45)

NetherlandsNo exact match for this strength and form

Every strength and form (51)

SwitzerlandNo exact match for this strength and form

Every strength and form (44)

Details

Made by	Stada Arzneimittel AG
Active substance	Adalimumab
Used in	Cancer treatments and immune-system medicines
Classification	L04AB04 · Cancer treatments and immune-system medicines
Biosimilar	Yes — a biosimilar medicine, according to the register
Authorised on	2021-11-12
Last updated by the regulator	2026-07-13
EMA product number	EMEA/H/C/005947

Source: European Medicines Agency — medicine data · 2026-09-30 · not reviewed by a clinician

Source: European Medicines Agency (EMA). Product information as published by EMA. Reuse terms: EMA legal notice (reproduction authorised).

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