Patient Leaflet Updated 30-Jul-2024 | Eli Lilly and Company Limited
Olumiant 1mg, 2 mg and 4 mg Film-Coated Tablets
Olumiant® 1 mg film-coated tablets
Olumiant® 2 mg film-coated tablets
Olumiant® 4 mg film-coated tablets
baricitinib
1. What Olumiant is and what it is used for
2. What you need to know before you take Olumiant
3. How to take Olumiant
4. Possible side effects
5. How to store Olumiant
6. Contents of the pack and other information
Olumiant contains the active substance baricitinib. It belongs to a group of medicines called Janus kinase inhibitors, which help to reduce inflammation.
Olumiant is used to treat adults with moderate to severe rheumatoid arthritis, an inflammatory disease of the joints, if previous therapy did not work well enough or was not tolerated. Olumiant can be used alone or together with some other medicines, such as methotrexate.
Olumiant works by reducing the activity of an enzyme in the body called ‘Janus kinase’, which is involved in inflammation. By reducing the activity of this enzyme, Olumiant helps to reduce pain, stiffness and swelling in your joints, tiredness, and helps to slow damage to the bone and cartilage in the joints. These effects can help you to do normal daily activities and so improve the health-related quality of life for patients with rheumatoid arthritis.
Olumiant is used to treat children from the age of 2 years, adolescents and adults with moderate to severe atopic dermatitis, also known as atopic eczema. Olumiant may be used with eczema medicines that you apply to the skin or it may be used on its own.
Olumiant works by reducing the activity of an enzyme in the body called ‘Janus kinase’, which is involved in inflammation. By reducing the activity of this enzyme, Olumiant helps to improve the condition of your skin and reduce itching. In addition, Olumiant helps improve your sleep disturbance (due to itch) and overall quality of life. Olumiant has also been shown to improve symptoms of skin pain, anxiety, and depression associated with atopic dermatitis.
Olumiant is used to treat adults with severe alopecia areata, an autoimmune disease characterized by inflammatory, nonscarring hair loss on the scalp, face and sometimes on other areas of the body that can be recurrent and progressive.
Olumiant works by reducing the activity of an enzyme in the body called ‘Janus kinase’, which is involved in inflammation. By reducing the activity of this enzyme, Olumiant helps hair to regrow on scalp, face and other areas of the body impacted by the disease.
Olumiant is used for the treatment of active polyarticular juvenile idiopathic arthritis, an inflammatory disease of the joints, in children 2 years of age and older.
Olumiant is also used for the treatment of active enthesitis-related arthritis, an inflammatory disease of the joints and the places where tendons join the bone, in children 2 years of age and older.
Olumiant is also used for the treatment of active juvenile psoriatic arthritis, a condition that is an inflammatory disease of the joints often accompanied by psoriasis, in children 2 years of age and older.
Olumiant can be used alone or together with methotrexate.
Talk to your doctor or pharmacist before and during treatment with Olumiant if you:
If you notice any of the following serious side effects, you need to tell a doctor straight away:
You may need blood tests before you start Olumiant, or while you are taking it, to check if you have a low red blood cell count (anaemia), low white blood cell count (neutropaenia or lymphopaenia), high blood fat (cholesterol) or high levels of liver enzymes, to ensure that treatment with Olumiant is not causing problems.
If possible, children and adolescents should be up to date with all vaccinations before using Olumiant.
Do not give this medicine to children younger than 2 years of age.
Do not give this medicine to children and adolescents with alopecia areata under 18 years old, because there is no information on use in this disease.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take, any other medicines.
In particular, tell your doctor or pharmacist before taking Olumiant if you are taking any other medicine such as:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
You should use an effective method of contraception to avoid becoming pregnant during treatment with Olumiant and for at least one week after the last Olumiant treatment. You must tell your doctor if you become pregnant as Olumiant should not be used during pregnancy.
You should not use Olumiant while breast-feeding as it is not known if this medicine passes into milk. You and your doctor should decide if you will breast-feed or use Olumiant. You should not do both.
Olumiant has no effect on the ability to drive and use machines.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”.
Treatment should be started by a doctor experienced in the diagnosis and treatment of your condition. Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is 4 mg once a day. Your doctor may give you a lower dose of 2 mg once a day, particularly if you are over 65 years old or if you have an increased risk of infections, of blood clots, major cardiovascular events or cancer.
If the medicine is working well, your doctor may decide the dose can be reduced.
If you have reduced kidney function, the recommended dose of Olumiant is 2 mg once a day.
The recommended dose is 4 mg once a day for patients ≥ 30 kg. For patients 10 kg to < 30 kg the recommended dose is 2 mg once a day.
If you have reduced kidney function, the recommended dose of Olumiant should be reduced by half.
For paediatric patients who are unable to swallow whole tablets, the tablets may be dispersed in water:
Only water should be used to disperse the tablet.
After the tablet is dispersed in water it can be used for up to 4 hours if kept at room temperature.
If a tablet is dispersed in water and only part of the dispersed dose is taken, wait until the next day to take the next scheduled dose.
Olumiant is for oral use. You should swallow your tablet with a drink of water.
You can take the tablets either with or without food. To help you remember to take Olumiant, you may find it easier to take it at the same time every day.
If you take more Olumiant than you should, contact your doctor. You may get some of the side effects described in section 4.
Do not stop taking Olumiant unless your doctor tells you to stop taking it.
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.
Infection such as shingles and pneumonia, which may affect up to 1 in 10 people:
Tell your doctor or seek medical help immediately if you get the following symptoms, which may be signs of:
Serious pneumonia and serious herpes zoster were uncommon.
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)
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 Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date which is stated on the blister and carton after ‘EXP’. The expiry date refers to the last day of that month.
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.
Olumiant 1 mg film-coated tablets are very light pink, 6.75 mm round tablets, with “Lilly” on one side and “1” on the other.
Olumiant 2 mg film-coated tablets are light pink, 9 x 7.5 mm oblong tablets, with “Lilly” on one side and “2” on the other.
Olumiant 4 mg film-coated tablets are medium pink, 8.5 mm round tablets, with “Lilly” on one side and “4” on the other.
The tablets are rounded and have hollow sides to help you pick them up.
Olumiant 1 mg is available in blister packs of 14 and 28 tablets in calendar blisters and 28 x 1 tablets in perforated unit dose blisters. Olumiant 2 mg and 4 mg are available in blister packs of 14, 28, 35, 56, 84 and 98 tablets in calendar blisters and 28 x 1 and 84 x 1 tablets in perforated unit dose blisters. Not all the pack sizes may be marketed.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in July 2024.
Other sources of information
www.olumiant.eu
OL050
Please remove this portion of the package leaflet and keep it with you.
This document contains important information you should be aware of before and during treatment with Olumiant.
Keep this information with you and share it with other healthcare professionals involved in your medical care or treatment.
Your name:
_______________________________________
Doctor’s name (who prescribed Olumiant):
_______________________________________
Doctor’s phone number:
_______________________________________
Olumiant may make an existing infection worse or increase the chance of you getting a new infection or increase the chance of viral reactivation. If you have diabetes or are older than 65 you may have an increased chance of getting infections. The infection can become serious if not treated. Inform your doctor immediately if you get symptoms of infection, such as:
Non-melanoma skin cancer has been observed in patients taking Olumiant. If new skin lesions appear during or after therapy or if existing lesions change appearance, tell your doctor.
Olumiant may cause a condition in which a blood clot forms in your leg that may travel to your lungs. Inform your doctor immediately if you experience any of the following symptoms:
Inform your doctor immediately if you experience any of the following:
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