Olumiant 2 mg film-coated tablets

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Olumiant 1 mg film-coated tablets

Olumiant 2 mg film-coated tablets

Olumiant 4 mg film-coated tablets

baricitinib

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any questions, ask your doctor, pharmacist, or nurse.

• This medicine has been prescribed for you only. Do not pass it on to other people, even if they have the same symptoms as you, because it may harm them.

• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Olumiant is and what it is used for
2. What you need to know before taking Olumiant
3. How to take Olumiant
4. Possible side effects
5. How to store Olumiant
6. Contents of the pack and other information

1. What Olumiant is and what it is used for

Olumiant contains the active substance baricitinib. It belongs to a group of medicines called Janus kinase inhibitors, which help reduce inflammation.

Rheumatoid arthritis

Olumiant is used to treat adults with moderate to severe rheumatoid arthritis, an inflammatory disease of the joints, when previous treatments have not worked well or were not tolerated. Olumiant may be used alone or in combination with other medicines such as methotrexate.

Olumiant works by reducing the activity of an enzyme in the body called 'Janus kinase', which is involved in the inflammatory process. By reducing the activity of this enzyme, Olumiant helps reduce pain, stiffness, and inflammation in your joints, as well as fatigue, and helps slow the progression of bone and cartilage damage in the joints. These effects may help you carry out your daily activities and thus improve health-related quality of life in patients with rheumatoid arthritis.

Atopic dermatitis

Olumiant is used to treat children from 2 years of age, adolescents, and adults with moderate to severe atopic dermatitis, also known as atopic eczema. Olumiant may be used together with other eczema treatments applied to the skin or may be used alone.

Olumiant works by reducing the activity of an enzyme in the body called 'Janus kinase', which is involved in the inflammatory process. By reducing the activity of this enzyme, Olumiant helps improve skin condition and reduce itching. In addition, Olumiant helps improve sleep disturbances (caused by itching) and overall quality of life. Olumiant has also been shown to improve symptoms such as skin pain, anxiety, and depression associated with atopic dermatitis.

Alopecia areata

Olumiant is used to treat adults with severe alopecia areata, an autoimmune disease characterized by inflammatory, non-scarring hair loss on the scalp, face, and sometimes other areas of the body, which may be recurrent and progressive.

Olumiant works by reducing the activity of an enzyme in the body called "Janus kinase", which is involved in the inflammatory process. By reducing the activity of this enzyme, Olumiant helps promote hair regrowth on the scalp, face, and other body areas affected by the disease.

Polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, and juvenile psoriatic arthritis

Olumiant is used for the treatment of active polyarticular juvenile idiopathic arthritis, an inflammatory joint disease, in children from 2 years of age.

Olumiant is also used for the treatment of active enthesitis-related arthritis, an inflammatory disease affecting joints and the sites where tendons attach to bone, in children from 2 years of age.

Olumiant is also used for the treatment of active juvenile psoriatic arthritis, an inflammatory joint disease often associated with psoriasis, in children from 2 years of age.

Olumiant may be used alone or in combination with methotrexate.

2. What you need to know before starting Olumiant

Do not take Olumiant

• if you are allergic to baricitinib or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant or think you might be pregnant.

Warnings and precautions

Talk to your doctor or pharmacist before and during treatment with Olumiant if you:

• are over 65 years of age. Patients aged 65 years or older may have an increased risk of infections, heart problems, including myocardial infarction, and certain types of cancer. Your doctor will discuss with you whether Olumiant is appropriate for you

• have an infection, or you get infections frequently. Inform your doctor if you experience symptoms such as fever, wounds, feel more tired than usual, or have dental problems, as these may be signs of infection. Olumiant may reduce your body's ability to fight infections and may worsen an existing infection or increase the likelihood of acquiring a new infection. If you have diabetes or are over 65 years of age, you may have a higher chance of getting an infection

• have or have previously had tuberculosis. You may need tests to detect tuberculosis before starting Olumiant. Inform your doctor if you develop persistent cough, fever, night sweats, or weight loss during treatment with Olumiant, as these may be signs of tuberculosis

• have previously had herpes infection (herpes zoster), as Olumiant may cause it to reappear. Inform your doctor if you develop a painful skin rash with blisters during treatment with Olumiant, as these may be signs of herpes zoster

• have or have previously had hepatitis B or C

• need to be vaccinated. Certain types of vaccines (live vaccines) should not be given while you are taking Olumiant

• have or have previously had cancer, smoke or have smoked in the past, because your doctor will discuss with you whether Olumiant is appropriate for you

• have reduced liver function

• have or have had heart problems, because your doctor will discuss with you whether Olumiant is appropriate for you

• have previously had blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism), or are at increased risk of developing them (for example: if you recently had major surgery, if you use hormonal contraceptives/hormone replacement therapy, or if you or your close relatives have been identified with a blood clotting disorder). Your doctor will discuss with you whether Olumiant is appropriate for you. Inform your doctor immediately if you suddenly experience shortness of breath or difficulty breathing, chest pain or upper back pain, swelling of an arm or leg, pain or tenderness in the leg, or redness or discoloration in the arm or leg, as these may be signs of blood clots in the veins

• have previously had diverticulitis (a type of inflammation of the large intestine) or ulcers in the stomach or intestine (see section 4)

• Non-melanoma skin cancer has been observed in patients taking Olumiant. Your doctor may recommend regular skin examinations while you are taking Olumiant. If new skin lesions appear during or after treatment, or if existing lesions change in appearance, inform your doctor.

If you experience any of the following serious side effects, contact your doctor immediately:

• wheezing

• severe dizziness or vertigo

• swelling of the lips, tongue, or throat

• hives (itching or welts)

• severe abdominal pain, especially accompanied by fever, nausea, and vomiting

• severe pain or tightness in the chest (which may spread to the arms, jaw, neck, or back)

• difficulty breathing

• cold sweats

• weakness on one side of the arm and/or leg

• slurred speech

You may need blood tests before starting Olumiant or while taking it to check for low red blood cell count (anemia), low white blood cell count (neutropenia or lymphopenia), high levels of blood fats (cholesterol), or elevated liver enzymes, to ensure that treatment with Olumiant is not causing problems.

Children and adolescents

If possible, children and adolescents should be up to date with all vaccinations before using Olumiant.

Do not give this medicine to children under 2 years of age.

Do not give this medicine to children and adolescents with alopecia areata under 18 years of age, as there is no information on use in this condition.

Other medicines and Olumiant

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Specifically, inform your doctor or pharmacist before starting Olumiant if you are taking any of the following medicines:

• probenecid (for gout), as this medicine may increase the levels of Olumiant in your blood. If you are taking probenecid, the recommended dose of Olumiant in adults is 2 mg once daily, and in children and adolescents the dose should be halved

• injectable antirheumatic medicine

• injectable medicines that suppress the immune system, including so-called targeted biological therapies (antibodies)

• medicines used to control the body's immune response, such as azathioprine, tacrolimus, or cyclosporine

• other medicines belonging to the group of Janus kinase inhibitors

• medicines that may increase the risk of diverticulitis, such as non-steroidal anti-inflammatory drugs (commonly used to treat painful or inflammatory conditions of muscles or joints), opioids (used to treat severe pain), or corticosteroids (commonly used to treat inflammatory disorders) (see section 4).

• medicines for treating diabetes or if you have diabetes. Your doctor may decide that you need less antidiabetic medication while taking Olumiant.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You must use an effective method of contraception to avoid becoming pregnant during treatment with Olumiant and for at least one week after stopping treatment with Olumiant. You must inform your doctor if you become pregnant, as Olumiant should not be used during pregnancy.

You should not use Olumiant while breastfeeding, as it is unknown whether this medicine passes into breast milk. You and your doctor must decide whether to breastfeed or take Olumiant. You should not do both.

Driving and using machines

The effect of Olumiant on the ability to drive and use machines is negligible or none.

Olumiant contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Olumiant

Treatment should be initiated by a physician experienced in the diagnosis and treatment of your disease. Follow exactly the administration instructions for this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Adults with rheumatoid arthritis, atopic dermatitis, and alopecia areata

The recommended dose is 4 mg once daily. Your doctor may prescribe a lower dose of 2 mg once daily, especially if you are over 65 years of age or if you have an increased risk of infections, blood clots, serious cardiovascular events, or cancer.

If the medicine is working well, your doctor may decide to reduce the dose.

If you have reduced kidney function, the recommended dose of Olumiant is 2 mg once daily.

Use in children and adolescents

The recommended dose is 4 mg once daily for patients ≥ 30 kg. For patients weighing 10 kg to < 30 kg, the recommended dose is 2 mg once daily.

If you have reduced kidney function, the recommended dose of Olumiant should be reduced by half.

For pediatric patients who cannot swallow whole tablets, the tablets may be dispersed in water:

• Place the whole tablet in a container with 5–10 ml of room temperature water and gently shake to disperse (dissolve) the tablet. The tablet may take up to 10 minutes to disperse into a cloudy, pale pink suspension. Some sediment may appear.
• After dispersing the tablet, gently shake again and then swallow the mixture immediately.
• Rinse the container with 5–10 ml of room temperature water by swirling, and swallow the mixture immediately to ensure the full dose is administered.

Water should be used only to disperse the tablet.

After dispersing the tablet in water, the suspension may 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.

Administration method

Olumiant is for oral administration. Swallow the tablet with some water.

You may take the tablets 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

If you take more Olumiant than you should, consult your doctor. You may experience some of the adverse effects described in section 4.

If you forget to take Olumiant

• If you forget to take a dose, take it as soon as you remember.
• If you forget to take your dose for an entire day, simply skip the missed dose and take a single dose the next day as usual.
• Do not take a double dose to make up for a forgotten tablet.

If you stop taking Olumiant

Do not stop taking Olumiant unless your doctor tells you to stop.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Serious adverse effects

Infections such as shingles and pneumonia, which may affect more than 1 in 10 people: Inform your doctor or seek medical help immediately if you experience any of the following symptoms, which could be signs of:

• shingles: painful rash with blisters and fever (was very rare in atopic dermatitis and uncommon in alopecia areata)

• pneumonia: persistent cough, fever, difficulty breathing, and fatigue (was uncommon in atopic dermatitis and alopecia areata)

Severe pneumonia and severe shingles were uncommon.

Other adverse effects

Very common (may affect more than 1 in 10 people):

• throat and nose infections
• high levels of fat in the blood (cholesterol), observed in blood tests

Common (may affect up to 1 in 10 people):

• hot flushes (herpes simplex)

• infection causing nausea or diarrhea (gastroenteritis)

• urinary tract infection

• high number of platelets (cells involved in blood clotting), observed in blood tests (was uncommon in atopic dermatitis and alopecia areata)

• headache

• stomach discomfort (nausea; was uncommon in atopic dermatitis)

• stomach pain (was uncommon in alopecia areata)

• high levels of liver enzymes, observed in blood tests (was uncommon in atopic dermatitis)

• skin rash

• acne (was uncommon in rheumatoid arthritis)

• increase in an enzyme called creatine kinase, observed in blood tests (was uncommon in rheumatoid arthritis)

• inflammation (swelling) of hair follicles, especially in the scalp area, associated with hair growth (observed in alopecia areata)

Uncommon (may affect up to 1 in 100 people):

• low number of white blood cells (neutrophils), observed in blood tests
• elevated levels of fat in the blood (triglycerides), observed in blood tests
• high levels of liver enzymes, observed in blood tests (was common in alopecia areata)
• weight gain
• facial swelling
• urticaria
• blood clots in the blood vessels of the lungs
• blood clot in the veins of the legs or pelvis, called deep vein thrombosis (DVT)
• diverticulitis (painful inflammation of small pouches in the intestinal lining)

Children and adolescents

• Polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, and juvenile psoriatic arthritis: In a study in children aged 2 years and older with polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, and juvenile psoriatic arthritis, headache was very common, low white blood cell count was common, and blood clots in the lungs were common (1 in every 82 children).
• Pediatric atopic dermatitis: In a study in children aged 2 years and older with atopic dermatitis, adverse effects were consistent with those observed in adult patients, except for low white blood cell count (neutrophils), which was more common compared to adults.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olumiant

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 stated on the blister and carton after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging when they are no longer needed. This helps protect the environment.

6. Contents of the pack and other information

Composition of Olumiant

• The active substance is baricitinib. Each tablet contains 2 or 4 milligrams of baricitinib.

• The other components are: microcrystalline cellulose, sodium croscarmellose (see section 2, “Olumiant contains sodium”), magnesium stearate, mannitol, red iron oxide (E172), lecithin (from soy) (E322), macrogol, polyvinyl alcohol, talc and titanium dioxide (E171).

Appearance of the product and contents of the pack

Olumiant 1 mg film-coated tablets are very light pink, round tablets, 6.75 mm in diameter, marked “Lilly” on one side and “1” on the other.

Olumiant 2 mg film-coated tablets are light pink, oval-shaped tablets, 9 x 7.5 mm, marked “Lilly” on one side and “2” on the other.

Olumiant 4 mg film-coated tablets are medium-intensity pink, round tablets, 8.5 mm in diameter, marked “Lilly” on one side and “4” on the other.

The tablets are rounded and have an indented area to assist handling.

Olumiant 1 mg is available in calendar blister packs containing 14 and 28 tablets, and in single-dose perforated blister packs containing 28 x 1 tablet. Olumiant 2 mg and 4 mg are available in calendar blister packs containing 14, 28, 35, 56, 84 and 98 tablets, and in single-dose perforated blister packs containing 28 x 1 and 84 x 1 tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder

Marketing Authorization Holder: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528BJ, Utrecht, The Netherlands.

Manufacturer

Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain.

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet: Month YYYY.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.euopa.eu.

Include QR code+ www.olumiant.eu

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