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Olumiant (Oral)

Generic Name: baricitinib (Oral route)

Oral route(Tablet)

Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred in patients receiving baricitinib. If a serious infection develops, interrupt baricitinib until the infection is controlled. Prior to starting baricitinib, perform a test for latent tuberculosis; if positive, start treatment for tuberculosis prior to starting baricitinib. Monitor all patients for active tuberculosis during treatment, even if the initial latent tuberculosis test is negative .Lymphoma and other malignancies have been observed in patients treated with baricitinib .Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis, some fatal, have occurred in patients treated with baricitinib. Patients with symptoms of thrombosis should be evaluated promptly .

Commonly used brand name(s)

In the U.S.

  • Olumiant

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antirheumatic

Pharmacologic Class: Tyrosine Kinase Inhibitor

Uses for Olumiant

Baricitinib is used alone or together with other medicines (eg, methotrexate, DMARDs) to treat moderately to severely active rheumatoid arthritis in patients who have taken other medicines (eg, tumor necrosis factor or TNF antagonist) that did not work well.

Baricitinib is a Janus kinase (JAK) inhibitor that works on the immune system.

This medicine is available only with your doctor's prescription.

Before using Olumiant

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of baricitinib in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of baricitinib in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and adjustment in the dose for patients receiving baricitinib.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abatacept
  • Adenovirus Vaccine, Live
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Cholera Vaccine, Live
  • Dengue Tetravalent Vaccine, Live
  • Gemfibrozil
  • Influenza Virus Vaccine, Live
  • Leflunomide
  • Measles Virus Vaccine, Live
  • Mumps Virus Vaccine, Live
  • Nitisinone
  • Poliovirus Vaccine, Live
  • Probenecid
  • Rotavirus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Smallpox Vaccine
  • Teriflunomide
  • Tofacitinib
  • Tolvaptan
  • Typhoid Vaccine
  • Varicella Virus Vaccine, Live
  • Yellow Fever Vaccine
  • Zoster Vaccine, Live

Interactions with food/tobacco/alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Anemia (blood disease) or
  • Infection, history of or
  • Neutropenia (blood disease) or
  • Lymphopenia (blood disease) or
  • Stomach or bowel problems (eg, blockage, diverticulitis, perforation, ulcers), history of—Use with caution. May make these conditions worse.
  • Hepatitis B, history of or
  • Hepatitis C, history of or
  • Herpes zoster infection or
  • Tuberculosis, active or history of or
  • Weakened immune system—May cause side effects to become worse.
  • Infection, active or
  • Kidney disease, severe or
  • Liver disease, severe—Use is not recommended in patients with these conditions.
  • Kidney disease, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper use of Olumiant

Use this medicine exactly as directed by your doctor. Do not take more or less of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (extended-release tablets):
    • For rheumatoid arthritis:
      • Adults—2 milligrams (mg) once a day.
      • Children—Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions while using Olumiant

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if this medicine is working properly and to decide whether you should continue to use it. Blood and urine tests are needed to check for unwanted effects.

You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

Your body's ability to fight infections may be reduced while you are using baricitinib. It is very important that you call your doctor at the first sign of an infection. Check with your doctor right away if you have a fever, chills, cough, flu-like symptoms, or unusual tiredness or weakness.

Using this medicine may increase your risk of getting skin cancer (eg, non-melanoma skin cancer) or cancer of the lymph system (lymphoma). Talk to your doctor if you have concerns about this risk.

This medicine may increase your risk of developing blood clots (eg, arterial thrombosis, deep vein thrombosis, pulmonary embolism). Check with your doctor right away if you have chest pain, difficulty breathing, or pain, redness, swelling, or tenderness in your arms or legs.

Baricitinib can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection:

  • If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Check with your doctor right away if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects, such as a safety razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injury could occur.

While you are being treated with baricitinib, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Baricitinib may lower your body's resistance and there is a chance you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Olumiant side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

  • Body aches or pain
  • chills
  • cough
  • difficulty in breathing
  • ear congestion
  • fever
  • headache
  • loss of voice
  • runny or stuffy nose
  • sneezing
  • sore throat
  • unusual tiredness or weakness

Less common

  • Bladder pain
  • bloody or cloudy urine
  • difficult, burning, or painful urination
  • frequent urge to urinate
  • hoarseness
  • lower back or side pain
  • pains in the chest, groin, or legs, especially calves of the legs
  • severe headaches of sudden onset
  • sudden loss of coordination
  • sudden onset of shortness of breath for no apparent reason
  • sudden onset of slurred speech
  • sudden vision changes

Rare

  • Burning or stinging of the skin
  • coughing or spitting up blood
  • muscle aches
  • night sweats
  • painful blisters on the trunk of body
  • painful cold sores or blisters on the lips, nose, eyes, or genitals
  • sudden high fever or low-grade fever for months

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  • Nausea

Rare

  • Blemishes on the skin
  • pimples

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.