Olumiante

Package leaflet: Information for the patient

Olumiant 1 mg film-coated tablets, 2 mg film-coated tablets, 4 mg film-coated tablets

baricitinib
Please read this leaflet carefully before you are given 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 give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this 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 and 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 joint
disease, when previous therapy has not worked well enough or was not tolerated. Olumiant may be used
alone or together 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 joint pain,
stiffness, and swelling, as well as fatigue, and helps slow down damage to the bones and joint cartilage.
These effects may help patients carry out their normal daily activities and 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 topical medications
for eczema 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 (due to
itching) and overall quality of life. Olumiant has been shown to improve symptoms of skin pain, anxiety,
and depression associated with atopic dermatitis.
Alopecia areata
Olumiant is used to treat adolescents from 12 years of age and adults with severe alopecia areata, an
autoimmune disease characterized by inflammation, non-scarring hair loss on the scalp, face, and
sometimes other body areas, 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
regrowth of hair on the scalp and hair on the 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 aged 2 years and older.
Olumiant is also used for the treatment of active enthesitis-related arthritis, an inflammatory disease
affecting the joints and the sites where tendons attach to bone, in children aged 2 years and older.
Olumiant is also used for the treatment of active juvenile psoriatic arthritis, a condition characterized by
inflammatory joint disease often accompanied by psoriasis, in children aged 2 years and older.
Olumiant may be used alone or in combination with methotrexate.

2. What you should know before taking 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 suspect you may be pregnant.

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

• you are over 65 years old. Patients aged 65 years or older may be at higher risk of infections, heart problems including heart attack, and certain types of cancer. Your doctor will discuss with you whether Olumiant is appropriate for you.
• you have an infection, or frequently get infections. Inform your doctor if you have 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 developing a new infection. If you have diabetes or are over 65 years old, you may have a higher risk of infections.
• you have or have previously had tuberculosis. Before starting Olumiant, you may need to be tested for tuberculosis. Inform your doctor if, during treatment with Olumiant, you develop a persistent cough, fever, night sweats, or weight loss, as these may be signs of tuberculosis.
• you have had herpes infection (herpes zoster – shingles), as Olumiant may cause it to recur. Inform your doctor if, during treatment with Olumiant, you develop a painful rash with blisters, as these may be signs of herpes zoster.
• you have or have previously had hepatitis B or C.
• you need to receive a vaccination. While taking Olumiant, you should not be given any live vaccines.
• you have or have had cancer, smoke or have previously smoked, as your doctor will discuss with you whether Olumiant is appropriate for you.
• you have liver problems.
• you have or have had heart problems, as your doctor will discuss with you whether Olumiant is appropriate for you.
• you have previously had blood clots in the veins of your legs (deep vein thrombosis) or lungs (pulmonary embolism), or if you are at higher 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 diagnosed with a blood clotting disorder). Your doctor will discuss with you whether Olumiant is appropriate for you. Inform your doctor if you experience sudden shortness of breath or difficulty breathing, chest pain or upper back pain, swelling of the leg or arm, pain or tenderness in the legs, or redness or discoloration of the leg or arm, as these may be signs of blood clots in the veins.
• you have had diverticulitis (a type of inflammation of the large intestine) or stomach or intestinal ulcers (see section 4).
• in patients taking Olumiant, a type of skin cancer other than melanoma has been observed. Your doctor may recommend regular skin examinations during treatment with Olumiant. If new skin lesions appear during or after treatment, or if existing lesions change in appearance, inform your doctor.

You must immediately contact a doctor if you notice any of the following serious adverse events:

• wheezing
• severe dizziness or mild confusion
• swelling of lips, tongue, or throat
• hives (itching, skin rash)
• severe abdominal pain, especially accompanied by fever, nausea, and vomiting
• severe pain or tightness in the chest (which may spread to arms, jaw, neck, back)
• shortness of breath
• cold sweating
• one-sided weakness of the arm and/or leg
• slurred speech

Before starting Olumiant, or during treatment, blood tests may be required to check whether you have a low number of red blood cells (anaemia), a low number of white blood cells (neutropenia or lymphopenia), high levels of fat in the blood (cholesterol), or elevated liver enzymes, to ensure that treatment with Olumiant does not cause problems.

Children and adolescents
Whenever possible, children and adolescents should be up to date with all vaccinations before starting Olumiant.
Do not give this medicine to children under 2 years of age.
Do not give this medicine to children with alopecia areata under 12 years of age or weighing < 30 kg, as there is no information on its use for this condition.

Other medicines and Olumiant
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, before taking Olumiant, inform your doctor or pharmacist if you are taking any other medicines such as:

• probenecid (for gout), as this medicine may increase Olumiant levels in the blood. If you are taking probenecid, the recommended dose of Olumiant for adults is 2 mg once daily, and for children and adolescents the dose should be halved.
• injectable anti-rheumatic medicines.
• injectable medicines that suppress the immune system, including so-called biological targeted 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 (usually used to treat painful and/or inflammatory conditions of muscles or joints) and/or opioids (used to treat severe pain), and/or corticosteroids (usually used to treat inflammatory conditions) (see section 4).
• medicines for the treatment of diabetes or if you have diabetes. Your doctor may decide whether you need to reduce the dose of your antidiabetic medicines while taking Olumiant.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before taking this medicine.
Use an effective method of contraception to avoid pregnancy during treatment with Olumiant and for at least one week after the last dose of Olumiant. You must inform your doctor if you become pregnant, as Olumiant must not be used during pregnancy.
Do not take Olumiant while breastfeeding, as it is unknown whether this medicine passes into breast milk. Together with your doctor, you must decide whether to breastfeed or take Olumiant. You cannot do both.

Driving and using machines
Olumiant has no effect on the ability to drive or use machinery.

Olumiant contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. essentially “sodium-free”.

3. How to take Olumiant

Treatment should be initiated by a physician 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 have any doubts.

Adults with rheumatoid arthritis, atopic dermatitis, and alopecia areata
The recommended dose is 4 mg once daily. Your doctor may prescribe you 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, major 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
Children and adolescents with atopic dermatitis, polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, and juvenile psoriatic arthritis
The recommended dose is 4 mg once daily for patients weighing ≥ 30 kg. For patients weighing between 10 kg and < 30 kg, the recommended dose is 2 mg once daily.
If you have reduced renal function, the recommended dose of Olumiant should be reduced by half.

Adolescents with alopecia areata
The recommended dose is 4 mg once daily for patients weighing ≥ 30 kg.
If you have reduced renal function, the recommended dose of Olumiant should be halved.
For pediatric patients who are unable to swallow whole tablets, the tablets may be dispersed in water:

• Place the whole tablet in a container with 5–10 ml of water at room temperature and gently shake to disperse (break up) the tablet. It may take up to 10 minutes for the tablet to disperse into a cloudy, pale pink suspension. Sediment may form.
• After the tablet has dispersed, gently shake again and immediately swallow the mixture.
• Rinse the container with 5–10 ml of water at room temperature, gently swirl, and immediately swallow the mixture to ensure the full dose is taken.

Only water should be used to disperse the tablet.
After the tablet has been dispersed in water, the mixture may be used within 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.

Method of administration
Olumiant is taken orally. Swallow the tablet with a glass of 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 each day.

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

If you forget to take Olumiant

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

If you stop taking Olumiant
Do not stop taking Olumiant unless your doctor tells you to.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Serious adverse events
Infections such as Herpes Zoster (shingles) and lung infection, which may occur in up to 1 in 10 patients:
Inform your doctor or seek immediate medical help if you experience any of the following symptoms, which may indicate:

• shingles (herpes zoster): painful rash with blisters and fever (very rare in atopic dermatitis and not common in alopecia areata)
• lung infection: persistent cough, fever, shortness of breath and fatigue (not common in atopic dermatitis and alopecia areata). Severe lung infection and severe herpes zoster have been reported as not common

Other side effects
Very common (may occur in more than 1 out of 10 people)

• throat and nose infections
• elevated levels of fats in the blood (cholesterol), detected by blood tests

Common (may occur in up to 1 out of 10 people)

• cold sores (herpes simplex)
• infection causing stomach ache or diarrhoea (gastroenteritis)
• urinary tract infection
• increased platelet count (blood cells involved in blood clotting), detected by blood tests (not common in atopic dermatitis and alopecia areata)
• headache
• feeling of stomach discomfort (nausea, not common in atopic dermatitis)
• stomach pain (not common in alopecia areata)
• increased liver enzymes, detected by blood tests (not common in atopic dermatitis)
• skin rash
• acne (not common in rheumatoid arthritis)
• increased levels of an enzyme called creatine kinase, detected by blood test (not common in rheumatoid arthritis)
• inflammation (swelling) of hair follicles, particularly in the scalp area, associated with hair regrowth (observed in alopecia areata)

Uncommon (may occur in up to 1 out of 100 people)

• low number of white blood cells (neutrophils) in the blood, detected by blood tests
• elevated levels of fats in the blood (triglycerides), detected by blood tests
• high levels of liver enzymes, detected by blood tests (common in alopecia areata)
• weight gain
• facial swelling
• hives (urticaria)
• blood clots in the blood vessels of the lungs
• blood clot in the veins of the legs or pelvis, known as deep vein thrombosis (DVT)
• diverticulitis (painful inflammation of small pouches forming in the intestinal wall)

Children and adolescents

• Juvenile polyarticular idiopathic arthritis, enthesitis-related arthritis, and juvenile psoriatic arthritis: In a study of children aged 2 years and older with juvenile polyarticular idiopathic arthritis, enthesitis-related arthritis, and juvenile psoriatic arthritis, headache was very common, while low white blood cell count and blood clots in the lungs were common (1 in 82 children).
• Pediatric atopic dermatitis: In a study of children aged 2 years and older with atopic dermatitis, side effects were consistent with those seen in adult patients, except for low white blood cell count (neutrophils), which was more common compared to adults.
• Adolescents with alopecia areata: In a study of adolescents aged 12 years and older with alopecia areata, side effects were consistent with those observed in adult patients, except for acne and low white blood cell count (neutrophils), which were more common than in adults.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 pack and the carton after
'EXP'/'Scad.'. The expiry date refers to the last day of that month.
Do not dispose of this medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Olumiant contains

• The active substance is baricitinib. Each tablet contains 1, 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).

Description of the appearance of Olumiant and contents of the pack
Olumiant 1 mg film-coated tablets are very light pink, 6.75 mm in size, round in shape, with "Lilly" engraved on one side and "1" on the other.
Olumiant 2 mg film-coated tablets are light pink, 9 x 7.5 mm in size, oval-shaped, with "Lilly" engraved on one side and "2" on the other.
Olumiant 4 mg film-coated tablets are pink, 8.5 mm in size, round in shape, with "Lilly" engraved on one side and "4" on the other.
The tablets are rounded and have indentations on the sides to facilitate handling.
Olumiant 1 mg is available in packs of 14 and 28 tablets in calendar blister packs and in 28 x 1 tablet unit-dose divisible blister packs. Olumiant 2 mg and 4 mg are available in packs of 14, 28, 35, 56, 84 and 98 tablets in calendar blister packs and in 28 x 1 and 84 x 1 tablet unit-dose divisible blister packs. Not all pack sizes may be marketed.

Marketing Authorization Holder
Eli Lilly Nederland B.V., Orteliuslaan 1000, 3528 BD, Utrecht, The Netherlands

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

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

Belgique/België/Belgien Lietuva
Eli Lilly Benelux S.A./N.V. Eli Lilly Lietuva
Tél/Tel: + 32-(0)2 548 84 84 Tel: +370 (5) 2649600

България Luxembourg/Luxemburg
ТП "Ели Лили Недерланд" Б.В. - България Eli Lilly Benelux S.A./N.V.
тел. + 359 2 491 41 40 Tél/Tel: + 32-(0)2 548 84 84

Česká republika Magyarország
ELI LILLY ČR, s.r.o. Lilly Hungária Kft.
Tel: + 420 234 664 111 Tel: + 36 1 328 5100

Danmark Malta
Eli Lilly Danmark A/S Charles de Giorgio Ltd.
Tlf: +45 45 26 60 00 Tel: + 356 25600 500

Deutschland Nederland
Lilly Deutschland GmbH Eli Lilly Nederland B.V.
Tel. + 49-(0) 6172 273 2222 Tel: + 31-(0) 30 60 25 800

Eesti Norge
Eli Lilly Nederland B.V. Eli Lilly Norge A.S.
Tel: +372 6 817 280 Tlf: + 47 22 88 18 00

Ελλάδα Österreich
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε. Eli Lilly Ges.m.b.H.
Τηλ: +30 210 629 4600 Tel: + 43-(0) 1 711 780

España Polska
Lilly S.A. Eli Lilly Polska Sp. z o.o.
Tel: + 34-91 663 50 00 Tel: +48 22 440 33 00

France Portugal
Lilly France Lilly Portugal Produtos Farmacêuticos, Lda
Tél: +33-(0) 1 55 49 34 34 Tel: + 351-21-4126600

Hrvatska România
Eli Lilly Hrvatska d.o.o. Eli Lilly România S.R.L.
Tel: +385 1 2350 999 Tel: + 40 21 4023000

Ireland Slovenija
Eli Lilly and Company (Ireland) Limited Eli Lilly farmacevtska družba, d.o.o.
Tel: + 353-(0) 1 661 4377 Tel: +386 (0)1 580 00 10

Ísland Slovenská republika
Icepharma hf. Eli Lilly Slovakia s.r.o.
Sími + 354 540 8000 Tel: + 421 220 663 111

Italia Suomi/Finland
Eli Lilly Italia S.p.A. Oy Eli Lilly Finland Ab
Tel: + 39- 055 42571 Puh/Tel: + 358-(0) 9 85 45 250

Κύπρος Sverige
Phadisco Ltd Eli Lilly Sweden AB
Τηλ: +357 22 715000 Tel: + 46-(0) 8 7378800

Latvija
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā
Tel: + 371 67364000

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

Please remove this section of the leaflet and keep it with you.