Frequently Asked Questions About Olumiant® (baricitinib)
Last Reviewed by C. H. Weaver M.D., Medical Editor 8/1/2018
Class: Biologic Therapy
How is this Olumiant®used? Olumiant is approved for adults with moderate to severe active rheumatoid arthritis (RA) who have not responded well to one or more TNF antagonist therapies. Combination treatment of Olumiant with other JAK inhibitors, DMARDS or potent immunosuppressants is not recommended. Patients treated with Olumiant are at risk for developing serious infections, malignancies and thrombosis.
What is the mechanism of action of Olumiant®? Olumiant is a JAK inhibitor that works by inhibiting certain JAK enzymes that contribute to the processes of immune cell function.
How is Olumiant given (administered)? Olumiant is taken orally in the form of a tablet.
How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Olumiant. Typically, blood will be drawn to check blood counts, lymphocyte counts, and neutrophil counts; and to monitor functions of some organ systems, such as the kidneys or liver. Patients will also be monitored for signs and symptoms of tuberculosis (TB.)
What are the most common side effects of treatment with Olumiant?
- Common cold
- Sinus infection
- Cold sores
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which are serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What are some of the less common but potentially serious side effects of Olumiant?
· Serious infections
· Cancer and immune system problems
· Blood clots
· Tears (perforations) in the stomach or intestines
· Hepatitis B or C infection or reactivation
Are there any special precautions patients should be aware of before starting treatment with Olumiant?
· Serious infections may occur. Patients with an active infection will not start treatment. Patients will be screened for tuberculosis (TB) before starting treatment.
·Patients may have an increased risk of cancer and other immune problems.
·Patients have an increased risk for developing shingles.
·Olumiant is not for people with severe liver problems.
·Let your doctor know if you have been diagnosed with diverticulitis or ulcers or if you are at an increased risk of getting certain fungal infections.
·Patients should not receive live vaccines while taking Olumiant.
What should you tell your healthcare provider before starting treatment with Olumiant?
Tell your healthcare provider if you:
·Have an infection or think you have symptoms of an infection, such as: fever, sweating, chills, cough, burning during urination, muscle aches, diarrhea, stomach pain, fatigue, and weight loss.
·Are being treated for an infection.
·Are susceptible to infections and have a hard time getting rid of them.
·Have diabetes, a weak immune system, hepatitis B, hepatitis C or HIV.
·Have TB or have been in close contact with someone with TB.
·Have lived or traveled to certain parts of the country that have higher rates of certain fungal infections.
·Have liver or kidney problems.
·Have had any stomach area pain or have been diagnosed with diverticulitis or ulcers in your stomach or intestines, or a narrowing of the digestive tract.
·Have had a reaction to Olumiant or any ingredients of Olumiant.
·Have received or are scheduled to receive a vaccine.
· Are pregnant or planning to become pregnant. It is not known if Olumiant will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while receiving Olumiant.
· Have had any type of cancer
· Are breastfeeding or plan to breastfeed
Tell your healthcare provider about all the medicines you take, especially medicines that affect the way your liver enzymes work and any other medicines to treat your RA. Also any other prescriptions, over-the-counter medicines, vitamins, and herbal supplements.
When should patients notify their physician?
Contact your healthcare professional immediately in case of any of the following:
· You have symptoms of an infection. These include: fever; unusual tiredness; cough; flu-like symptoms; and warm, red, or painful skin, etc.
· You have symptoms of an intestinal or stomach perforation. These include: stomach area pain that does not go away, change in bowel habits, and fever.
· You have symptoms of hepatitis B or C infection. These include: feel very tired, little or no appetite, clay-colored bowel movements, chills, muscle aches, skin rash, skin or eyes look yellow, vomiting, fevers, stomach discomfort, or dark urine.
· You become pregnant.
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Last updated on 08/2018.
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