Olumiant - Baricitinib uses, dose and side effects

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 joint disease if previous treatment has not worked well enough or has not been tolerated. Olumiant can be used alone or with some other medicines, e.g. methotrexate.

Olumiant works by lowering the activity of an enzyme in the body called “Janus kinase”, which contributes to inflammation. By lowering the activity of the enzyme, Olumiant can help reduce pain, stiffness, and swelling in your joints, reduce fatigue, and slow down damage to bones and cartilage in the joints. These effects may make it easier for you to perform normal daily activities and thus improve the health-related quality of life for patients with rheumatoid arthritis.

Atopic dermatitis

Olumiant is used to treat adults with moderate to severe atopic dermatitis, also called atopic eczema. Olumiant can be used alone or with eczema medicine applied to the skin.

Olumiant works by lowering the activity of an enzyme in the body called “Janus kinase”, which contributes to inflammation. By lowering the activity of the enzyme, Olumiant can help improve the skin and reduce itching. In addition, Olumiant contributes to improved sleep (through less itching ) and increased quality of life. Olumiant has also been shown to reduce symptoms such as skin pain, anxiety, and depression associated with atopic dermatitis.

What you need to know before using Olumiant

Do not take Olumiant:

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

Warnings and cautions

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

have an infection , or if you get infection often . Tell your doctor if you get symptoms such as fever, sores, feel more tired than usual or have problems with your teeth, as this may be a sign of an infection . Olumiant can reduce the body’s ability to fight infection and can make an ongoing infection worse or increase the risk of getting a new infection .
have or have previously had tuberculosis . You may need to be tested for tuberculosis before receiving Olumiant. Tell your doctor if you get persistent cough, fever, night sweats and lose weight while taking Olumiant. This may be a sign of tuberculosis .
have had shingles (a type of herpes infection ), as Olumiant may cause it to return. Tell your doctor if you get painful skin rashes with blisters when you are treated with Olumiant. This may be a sign of shingles .
have or have previously had hepatitis B or C
to be vaccinated. You should not receive certain (live) vaccines while taking Olumiant.
have cancer. Your doctor will need to assess if you can then be treated with Olumiant.
has poor liver function.
previously had blood clots in the veins of the legs (venous thrombosis ) or the lungs ( pulmonary embolism ). Tell your doctor if your leg hurts and it swells, if you have chest pain or shortness of breath as this may be a sign of blood clots in the veins.
have had diverticulitis (a type of inflammation of the colon) or ulcers in the stomach or intestines (see section 4).

If you notice any of the following serious side effects, tell your doctor straight away:

pressure over the chest
hissing breathing
severe dizziness
swelling of the lips, tongue or throat
hives ( itching or rash)
severe abdominal pain, especially if accompanied by fever, nausea and vomiting.

You may need to take blood samples before or while you take Olumiant to make sure that treatment with Olumiant does not cause any problems. The blood tests check if you have a low red blood cell count ( anemia ), low white blood cell count ( neutropenia or lymphopenia), high blood fats ( cholesterol ), or high levels of liver enzymes.

Children and young people

Do not give this medicine to children and adolescents under 18 years of age as there is no information on use in this age group.

Other medicines and Olumiant

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

You must tell your doctor or pharmacist before taking Olumiant if you are taking any other medicines such as:

probenecid (for gout ), as this medicine may increase the levels of Olumiant in the blood. If you are taking probenecid, the recommended dose is one Olumiant 2 mg once a day.
drugs for rheumatism given as an injection
drugs given as injections to inhibit the immune system, including so-called targeted biological (antibody) treatments
drugs used to control the body’s immune system, e.g. azathioprine, tacrolimus or cyclosporine
other medicines belonging to the group Januskinas inhibitors
drugs that may increase the risk of diverticulitis , such as non-steroidal anti-inflammatory drugs (often used as painkillers and / or to treat inflammation in muscles or joints) and / or opioids (used for severe pain), and / or corticosteroids (often used to treat inflammation ) (see section 4).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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 pregnancy while you are being treated with Olumiant and for at least one week after the last dose of Olumiant. You must tell your doctor if you become pregnant as Olumiant should not be used during pregnancy.

You should not use Olumiant while breastfeeding as you do not know if the medicine passes into breast milk. You and your doctor should decide whether to breastfeed or use Olumiant. Dua should not do both.

Driving and using machines

Olumiant does not affect the ability to drive or use machines.

Olumiant contains sodium

Olumiant contains less than 1 mmol (23 mg) sodium per tablet, ie essentially ‘sodium-free’. is next to “sodium-free”.

How to use Olumiant

Treatment should be initiated by a doctor who has experience in diagnosing and treating your disease. Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Rheumatoid arthritis and atopic dermatitis

The recommended dose is 4 mg once daily. Your doctor may give you a lower dose of 2 mg once a day, especially if you are over 75 years old or have an increased risk of infection. If the medicine works well, your doctor may decide to reduce your dose.

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

Olumiant should be taken by mouth. You should swallow the tablet whole with a glass of water.

You can take the tablets either with or without food. It may be easier to remember when to take Olumiant if you take it at the same time each day.

If you take more Olumiant than you should

Contact your doctor if you have taken too much Olumiant. You may experience some of the side effects described in section 4.

If you forget to take Olumiant

If you miss a dose , take it as soon as you remember.
If you have missed your dose for an entire day, just skip the missed dose one and take your regular dose the next day.
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.

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

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Serious side effects are

Infection such as shingles and pneumonia, which can affect up to 1 in 10 users:

Tell your doctor or seek medical attention immediately if you get the following symptoms, which may be signs of:

Shingles ( herpes zoster): painful skin rash with blisters and fever (very rare side effect in atopic dermatitis ).
Pneumonia: persistent cough, fever, shortness of breath and fatigue (this was less common in atopic dermatitis )

Severe pneumonia and severe herpes zoster were less common.

Other side effects are

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

infection you in the throat and nose
high levels of blood fats ( cholesterol ) that show up in blood tests.

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

cold sores ( herpes simplex)
infection that causes vomiting and diarrhea ( gastroenteritis )
urinary tract infection
high platelet count (cells involved in blood coagulation), found by blood tests (uncommon side effect of atopic dermatitis )
headache
nausea (uncommon side effect of atopic dermatitis )
abdominal pain
high levels of liver enzymes, detected by blood tests (uncommon side effect of atopic dermatitis )
rash
acne (less common side effect of rheumatoid arthritis )
increased amount of enzyme et creatine kinase, found by blood tests (less common side effect in rheumatoid arthritis ).

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

low white blood cell count ( neutrophils ), found by blood tests
high levels of blood fats ( triglycerides ), found with blood tests
high levels of liver enzymes, detected by blood tests
weight gain
facial swelling
hives ( urticaria )
blood clots in the blood vessels of the lungs
blood clots in the veins of the legs or pelvis, so-called deep vein thrombosis (DVT)
diverticulitis (painful inflammation in small pockets in the intestinal mucosa).

How to store Olumiant

Keep this medicine out of the sight and reach of children.

No special storage instructions.

Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

The active substance is baricitinib. One tablet contains 2 or 4 milligrams of baricitinib.
The other ingredients are: microcrystalline cellulose, croscarmellose sodium (see section 2, “Olumiant contains sodium”), magnesium stearate, mannitol, red iron oxide (E172), lecithin (soy) (E322), macrogol, poly (vinyl alcohol), talc and titanium dioxide (E171 ).

What the medicine looks like and contents of the pack

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

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

The tablets are rounded and have a recess on each side to make them easier to pick up.

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 tablet in perforated unit dose blisters. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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

Manufacturer: Lilly SA, Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain

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Olumiant – Baricitinib uses, dose and side effects

What Olumiant is and what it is used for