How does this medication work? What will it do for me?
This medication belongs to the class of medications called disease-modifying antirheumatic agents. Baricitinib is used alone or in combination with methotrexate to reduce the signs and symptoms of moderate to severely active rheumatoid arthritis (RA). It is used when treatment with one or more disease-modifying antirheumatic medications has not provided enough relief.
Rheumatoid arthritis (RA) is an autoimmune disease. This means that the body's immune system fails to recognize its own tissue, and views it as a foreign invader. In the case of RA, the immune system attacks the joints and tissue, causing long-term damage.
Baricitinib is believed to work by interfering with the activity of an enzyme that sends inflammatory signals in the body called Janus Kinase. Baricitinib attaches to this enzyme which helps to reduce swelling and joint tenderness in people with RA.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each light pink, film-coated, oblong tablet with a recessed area on each face of the tablet surface, debossed with "Lilly" on one side and "2" on the other, contains 2 mg of baricitinib. Nonmedicinal ingredients: croscarmellose sodium, magnesium stearate, mannitol, and microcrystalline cellulose; colour coating ferric oxide, lecithin (soya), polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
How should I use this medication?
The recommended dose of this medication is one 2 mg tablet taken by mouth once daily. It may be taken with food or on an empty stomach.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor.
If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take this medication if you are allergic to baricitinib or any ingredients of the medication.
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- back pain
- cold sores
- cold symptoms (e.g., runny nose, sinus congestion)
- joint pain
- mouth and throat pain
- muscle spasms
- sinus infection
- stomach pain
- trouble sleeping
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- increased blood pressure
- signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
- signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
- skin infection (e.g., red, swollen or painful skin)
- new skin lesions or change in appearance of existing skin lesions
- symptoms of bronchitis (e.g., cough, tiredness, shortness of breath)
- symptoms of pneumonia (e.g., coughing, fever, fatigue)
- symptoms of shingles (e.g., skin rash or blisters with itching, burning or tingling pain, usually on one side of the body)
- symptoms of stomach or bowel infection (e.g., vomiting, stomach pain, watery or bloody diarrhea, loss of appetite)
- symptoms of a urinary tract infection (e.g. pain when urinating, urinating more often than usual, low back or flank pain)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- signs of a blood clot in the arm or leg (tenderness, pain, swelling, warmth, or redness in the arm or leg) or lungs (difficulty breathing, sharp chest pain that is worst when breathing in, coughing, coughing up blood, sweating, or passing out)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
November 1, 2022
Health Canada has issued a new advisory concerning the use of baricitinib. To read the full Health Canada Advisory, visit Health Canada's web site at recalls-rappels.canada.ca.
Blood cholesterol: Baricitinib has been associated with increased blood cholesterol levels. If you have elevated blood cholesterol levels, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Blood clots: This medication may increase the chance of blood clot formation, causing reduction of blood flow to organs or the extremities.
If you have a history of clotting you may be at increased risk of experiencing blood clot-related problems such as heart attack, stroke, or clots in the lungs or deep veins of your leg. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision or difficulty speaking, contact your doctor immediately.
Cancer: Rarely, people taking baricitinib and similar medications have developed cancer, including lymphoma and non-melanoma skin cancer. In general, people with rheumatoid arthritis who take medications that suppress the immune system over long periods of time may also have a higher risk of developing lymphoma, even if they don't take baricitinib. Discuss any concerns you have with your doctor.
Gastrointestinal perforation: People who take anti-inflammatory medications such as NSAIDs or corticosteroids while they are also taking baricitinib may be more at risk of experiencing a tear in the lining of the stomach, which can cause serious bleeding. This can occur without abdominal pain.
If you notice bloody or black and tarry stools, or vomit blood or material that looks like coffee grounds, seek medical help immediately.
Infection: This medication reduces your body's response to infection. People taking baricitinib are at an increased risk of developing serious infections that can be difficult to treat and may cause hospitalization or death. These infections include tuberculosis and fungal infections as well as infections caused by bacteria and viruses. These infections are more likely to occur if you are taking another medication that reduces the activity of the immune system.
If you have been exposed to tuberculosis, have a history of serious or recurrent infections or have medical conditions that may increase the likelihood of developing infections, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness.
Kidney function: Decreased kidney function may cause baricitinib to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Liver function: People taking baricitinib may have changes in liver function that produce abnormal liver test results. Your doctor will recommend regular liver tests while you are taking this medication.
If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.
People with severely reduced liver function should not use this medication.
Lung inflammation: Lung inflammation (interstitial lung disease), causing difficulty breathing has occurred in some people taking this medication. This complication can be serious and sometimes fatal.
If you experience new or worsening shortness of breath or cough (with or without fever) at any time while you are taking baricitinib contact your doctor immediately.
Vaccinations: People taking this medication should not receive certain vaccines. Talk to your doctor about whether any vaccines you are scheduled to take may be used with this medication.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately. Women who are of childbearing age should use appropriate birth control while taking baricitinib and for at least 1 week after taking the last dose of medication.
Breast-feeding: It is not known if baricitinib passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children.
Seniors: People over the age of 65 years may be more at risk of side effects from this medication.
What other drugs could interact with this medication?
There may be an interaction between baricitinib and any of the following:
- cancer medications (e.g., carboplatin, cyclophosphamide, doxorubicin, ifosfamide, vincristine)
- corticosteroids (e.g., budesonide, dexamethasone, hydrocortisone, fluticasone, prednisone)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
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