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Upadacitinib (Oral)

ue-pad-a-SYE-ti-nib

Oral route(Tablet, Extended Release)

Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred. If a serious infection develops, interrupt upadacitinib until the infection is controlled. Prior to starting upadacitinib, perform a test for latent TB; if it is positive, start treatment for TB prior to starting upadacitinib. Monitor all patients for active TB during treatment, even if the initial latent tuberculosis test is negative. Lymphoma and other malignancies have been observed in patients treated with upadacitinib. Thrombosis, including deep vein thrombosis, pulmonary embolism, and arterial thrombosis, have occurred in patients treated with Janus kinase inhibitors used to treat inflammatory conditions

Medically reviewed by Drugs.com. Last updated on Feb 3, 2019.

Commonly used brand name(s)

In the U.S.

  • Rinvoq

Available Dosage Forms:

  • Tablet, Extended Release

Therapeutic Class: Antirheumatic

Pharmacologic Class: Tyrosine Kinase Inhibitor

Uses for upadacitinib

Upadacitinib is used to treat moderate to severely active rheumatoid arthritis in patients who have taken other medicines (eg, methotrexate) that did not work well.

Upadacitinib is available only with your doctor's prescription.

Before using upadacitinib

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 upadacitinib, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to upadacitinib 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 upadacitinib 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 upadacitinib in the elderly. However, elderly patients are more likely to have serious infections and unwanted side effects, which may require caution in patients receiving upadacitinib.

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 upadacitinib, 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 upadacitinib 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.

  • Adenovirus Vaccine
  • Apalutamide
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Carbamazepine
  • Cholera Vaccine, Live
  • Dengue Tetravalent Vaccine, Live
  • Enzalutamide
  • Fosphenytoin
  • Influenza Virus Vaccine, Live
  • Lumacaftor
  • Measles Virus Vaccine, Live
  • Mitotane
  • Mumps Virus Vaccine, Live
  • Phenytoin
  • Poliovirus Vaccine, Live
  • Rifampin
  • Rotavirus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Smallpox Vaccine
  • St John's Wort
  • 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 upadacitinib. Make sure you tell your doctor if you have any other medical problems, especially:

  • Anemia (blood condition) or
  • Cancer or
  • Diabetes or
  • Hyperlipidemia (high cholesterol in the blood) or
  • Infection, history of or
  • Lung disease or
  • Neutropenia (blood disease) or
  • Stomach or bowel problems (eg, 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
  • Liver disease, severe—Use is not recommended in patients with these conditions.

Proper use of upadacitinib

Use upadacitinib 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.

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

Take upadacitinib with or without food.

Swallow the extended-release tablet whole with water. Do not cut, crush, break, or chew it.

A part of the extended-release tablet may pass into your stools. This is normal and is nothing to worry about.

Dosing

The dose of upadacitinib 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 upadacitinib. 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—15 milligrams (mg) once a day.
      • Children—Use and dose must be determined by your doctor.

Missed dose

If you miss a dose of upadacitinib, 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 upadacitinib

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

Using upadacitinib while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using upadacitinib to make sure you are not pregnant. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 4 weeks after the last dose. If you think you have become pregnant while using upadacitinib, tell your doctor right away.

Using upadacitinib together with azathioprine or cyclosporine is not recommended.

You will need to have a skin test for tuberculosis before you start using upadacitinib. 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 upadacitinib. 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 upadacitinib may increase your risk of getting cancer, including skin cancer (eg, non-melanoma skin cancer). Talk to your doctor if you have concerns about this risk.

Upadacitinib may increase your risk of developing blood clots (including 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.

Upadacitinib 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 upadacitinib, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Upadacitinib 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.

Upadacitinib 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
  • ear congestion
  • fever
  • headache
  • itching, pain, redness, swelling, tenderness, warmth on the skin
  • loss of voice
  • runny or stuffy nose
  • sneezing
  • sore throat
  • unusual tiredness or weakness

Less common

  • Black, tarry stools
  • burning or stinging of the skin
  • lower back or side pain
  • painful blisters on the trunk of the body
  • painful cold sores or blisters on the lips, nose, eyes, or genitals
  • painful or difficult urination
  • pale skin
  • ulcers, sores, or white spots in the mouth or tongue
  • unusual bleeding or bruising

Rare

  • Coughing or spitting up blood
  • difficulty with breathing
  • heartburn
  • indigestion
  • muscle aches
  • nausea
  • night sweats
  • pale skin
  • persistent non-healing sore
  • pink growth
  • reddish patch or irritated area
  • severe abdominal or stomach pain, cramping, or burning
  • shiny bump
  • sudden high fever or low-grade fever for months
  • troubled breathing with exertion
  • vomiting of material that looks like coffee grounds, severe and continuing
  • white, yellow or waxy scar-like area

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.

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