Generic name: baricitinib [ BAR-i-SYE-ti-nib ]
Drug classes: Antirheumatics , Selective immunosuppressants
What is Olumiant?
Olumiant blocks the activity of certain enzymes involved in activating inflammation in the body.
Olumiant is used to reduce pain, stiffness, and swelling in adults with rheumatoid arthritis after other treatments have failed. Olumiant also helps slow the progression of bone and joint damage.
Olumiant is used in adults who are hospitalized with COVID-19 requiring oxygen or assistance with breathing.
Olumiant is also used to treat adults with severe alopecia areata .
Taking Olumiant may increase your risk of life-threatening medical problems including serious infections, a hole or tear in your digestive tract, a heart attack or stroke, blood clots , or cancer.
Olumiant affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, aches, tiredness, cough, skin sores, diarrhea , weight loss , or burning when you urinate.
Tell your doctor if you have a weak immune system, diabetes, chronic lung disease, or an infection such as hepatitis, tuberculosis , shingles , or HIV . Also tell your doctor if you’ve ever had diverticulitis , an ulcer in your stomach or intestines, cancer, heart problems, or a history of smoking , heart attack, stroke, or blood clots.
Call your doctor right away if you have a fever, night sweats , constant tiredness, weight loss , stomach pain, diarrhea or changes in bowel habits, trouble breathing, wheezing, a severe cough, or lumps in your neck, armpits, or groin.
Seek emergency medical help if you have sudden shortness of breath, chest pain spreading to your neck or arms, nausea , severe dizziness , a cold sweat, weakness on one side of your body, slurred speech, or pain, redness, or swelling in an arm or leg.
You should not start taking Olumiant if you have any kind of infection. Your doctor may perform tests to make sure you do not have tuberculosis or other infections.
Before taking this medicine
Taking Olumiant can increase your risk of life-threatening medical problems including serious infections, a hole or tear in your digestive tract, a heart attack or stroke, blood clots, or cancer. Tell your doctor if you’ve had:
- a weak immune system or chronic infection (such as tuberculosis, shingles, HIV, or hepatitis);
- any type of cancer;
- kidney disease;
- diverticulitis, an ulcer in your stomach or intestines;
- heart problems;
- a heart attack, stroke, or blood clot;
- high cholesterol ; or
- if you’ve ever smoked.
Tell your doctor if you’ve been sick with signs of infection, such as fever, chills, muscle aches, cough, trouble breathing, skin sores, diarrhea, or painful urination.
Tell your doctor if you’ve had or been exposed to tuberculosis, or if you recently traveled. Some infections are more common in certain parts of the world, and you may have been exposed during travel.
To make sure Olumiant is safe for you, tell your doctor if you have:
- liver disease (especially hepatitis B or C);
- chronic lung disease;
- diabetes; or
- if you are scheduled to receive any vaccine.
Using Olumiant may increase your risk of developing certain cancers, such as lymphoma or lung cancer. Ask your doctor about this risk.
Tell your doctor if you are pregnant or plan to become pregnant.
Do not breastfeed while taking Olumiant.
Olumiant is not approved for use by anyone younger than 18 years old.
How should I take Olumiant?
Take Olumiant exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
Talk to your doctor if you cannot swallow whole tablets. You may use this medicine in a different administration route if you are not able to swallow the tablets.
Your doctor may perform tests to make sure you do not have tuberculosis or other infections.
You may take Olumiant with or without food.
You may get infections more easily, even serious or fatal infections. You will need frequent medical tests.
If you’ve ever had shingles ( herpes zoster ), using Olumiant can cause these viruses to become active or get worse.
You must remain under the care of a doctor while you are using Olumiant for COVID-19. Use this medicine for the full prescribed length of time (usually for 14 days or until you leave the hospital, whichever comes first).
Store at room temperature away from moisture and heat.
Usual Adult Dose of Olumiant for Rheumatoid Arthritis:
– 2 mg orally once a day
-This drug may be used as monotherapy or in combination with methotrexate or other DMARDs.
Use: For the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies
Usual Adult Dose of Olumiant for COVID-19:
– 4 mg orally once a day
Duration of therapy: 14 days or until hospital discharge, whichever is first.
Use: For the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO.
Usual Adult Dose of Olumiant for Alopecia Areata:
– 2 mg once daily. Increase to 4 mg once daily, if the response to treatment is not adequate. For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider treating with 4 mg once daily. Reduce the dose to 2 mg once daily when an adequate response has been achieved.
Use: For the treatment of adult patients with severe alopecia areata
Usual Pediatric Dose of Olumiant for COVID-19:
For investigational use only
2 years to less than 9 years: 2 mg orally once a day
9 years and older: 4 mg orally once a day
Duration of therapy: 14 days or until hospital discharge, whichever is first.
-In July 2021, the US FDA expanded the Emergency Use Authorization (EUA) for Olumiant to allow the emergency use of this drug, with or without remdesivir, for treatment of suspected or laboratory confirmed COVID-19 in hospitalized pediatric patients two years of age or older requiring supplemental oxygen, invasive mechanical ventilation, or ECMO;
– The optimal duration of therapy is unknown.
-This drug is not authorized for patients younger than 2 years.
Use: For treatment of COVID-19 in hospitalized pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
Note: The EUA for hospitalized adults for the same indication was revoked following FDA approval for this population on May 10, 2022.
Detailed Olumiant dosage information
What happens if I miss a dose?
Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while taking Olumiant?
Avoid receiving a “live” vaccine. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).
Olumiant side effects
Stop taking this medicine and get emergency medical help if you have signs of an allergic reaction to Olumiant: hives ; difficult breathing; swelling of your face, lips, tongue, or throat.
Some people taking Olumiant have developed heart attacks, strokes, or serious blood clots. Stop taking Olumiant and seek emergency medical attention if you have:
- sudden shortness of breath;
- chest pain or pressure that may spread to your jaw, shoulder, arms, or back;
- nausea, vomiting , cold sweat;
- a light-headed feeling, like you might pass out;
- weakness on one side of your body;
- slurred speech, drooping on one side of your mouth; or
- pain, swelling, or redness in an arm or a leg.
Call your doctor at once if you have:
- fever, chills, night sweats, constant tiredness;
- wheezing, trouble breathing, severe or worsening cough;
- increased urination, pain or burning when you urinate;
- unexplained weight loss ;
- lumps in your neck, armpits, or groin;
- signs of shingles – flu-like symptoms, tingly or painful blistering rash on one side of your body;
- a hole (perforation) in your digestive tract – fever, severe stomach pain, diarrhea or changes in bowel habits; or
- signs of hepatitis – loss of appetite, vomiting, stomach pain (upper right side), dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common Olumiant side effects may include:
- cold sores , shingles;
- nausea; or
- cold symptoms such as stuffy nose, sneezing, sore throat .
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Olumiant side effects (more detail)
What other drugs will affect Olumiant?
Tell your doctor about all your other medicines, especially:
- methotrexate (sometimes given with baricitinib);
- probenecid ;
- steroid medicine such as prednisone or dexamethasone ;
- NSAIDs (nonsteroidal anti-inflammatory drugs) – aspirin , ibuprofen ( Advil , Motrin ), naproxen ( Aleve ), celecoxib , diclofenac , indomethacin , meloxicam , and others; or
- other drugs to treat rheumatoid arthritis – abatacept , adalimumab , anakinra, azathioprine , certolizumab, cyclosporine , etanercept , golimumab, infliximab , rituximab , sarilumab, tocilizumab .
This list is not complete. Other drugs may interact with baricitinib, including prescription and over-the-counter medicines, vitamins , and herbal products . Not all possible drug interactions are listed here.
source :: https://www.drugs.com/olumiant.html