Rinvoq

Jul 29, 2022

Generic name:  upadacitinib  [ ue-PAD-a-SYE-ti-nib ]
Drug class:  Antirheumatics

What is Rinvoq?

Rinvoq is a prescription medicine that is a Janus kinase (JAK) inhibitor.

Rinvoq is used to treat:

  • adults with moderate to severe  rheumatoid arthritis  when one or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated.
  • adults with active  psoriatic arthritis  when one or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated.
  • adults and children 12 years of age and older with moderate to severe  eczema  (atopic dermatitis) that did not respond to previous treatment and their eczema is not well controlled with other pills or injections, including biologic medicines, or the use of other pills or injections is not recommended.
  • adults with moderate to severe  ulcerative colitis  when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated.
  • adults with active  ankylosing spondylitis  when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated.

It is not known if Rinvoq is safe and effective in children under 18 years of age with juvenile idiopathic arthritis or with psoriatic arthritis.

It is not known if Rinvoq is safe and effective in children under 12 years of age with atopic dermatitis.

It is not known if Rinvoq is safe and effective in children with ulcerative colitis. 

Rinvoq is available as:

  • a 15 mg extended-release tablet. The tablets are purple, biconvex oblong and imprinted with ‘a15’ on one side.
  • a 30 mg extended-release tablet. The tablets are red, biconvex oblong and imprinted with ‘a30’ on one side.

Warnings

Rinvoq 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.

Taking Rinvoq 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.

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.

Before taking this medicine

Taking Rinvoq 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, a kidney transplant, or if you are on dialysis;
  • 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 Rinvoq is safe for you, tell your doctor if you have:

  • liver disease  (especially hepatitis B or C);
  • chronic lung disease;
  • diabetes;
  • low red or white blood cells; or
  • if you are scheduled to receive any vaccine.

Using Rinvoq may increase your risk of developing certain cancers, such as lymphoma or skin cancer. Ask your doctor about this risk.

You may need to have a negative pregnancy test before starting this treatment.

Upadacitinib may harm an unborn baby. Use effective  birth control  while using Rinvoq and for at least 4 weeks after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while using Rinvoq and for at least 6 days after your last dose.

Rinvoq is not approved for use by anyone younger than 18 years old.

How should I take Rinvoq?

Take Rinvoq exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Take Rinvoq tablets with a full glass of water.

Take the medicine at the same time each day, with or without food.

Swallow the Rinvoq extended release tablet whole and do not crush, chew, or break a tablet.

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 ) or hepatitis B or C, using Rinvoq can cause these viruses to become active or get worse.

Store Rinvoq in the original container at room temperature, away from moisture and heat.

Dosing information

Usual Adult Dose for Rheumatoid Arthritis

15 mg orally once a day

Comments:
-This drug may be used as monotherapy or in combination with methotrexate or other nonbiologic DMARDs.
-This drug is not recommended in patients with an absolute lymphocyte count (ALC) less than 500 cells/mm3, absolute neutrophil count (ANC) less than 1000 cells/mm3, or hemoglobin level less than 8 g/dL.

Use: Treatment of patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more TNF blockers.

Usual Adult Dose for Psoriatic Arthritis

15 mg orally once a day

Comments:
-This drug may be used as monotherapy or in combination with methotrexate or other nonbiologic DMARDs.
-This drug is not recommended in patients with an absolute lymphocyte count (ALC) less than 500 cells/mm3, absolute neutrophil count (ANC) less than 1000 cells/mm3, or hemoglobin level less than 8 g/dL.

Use: Treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers.

Usual Adult and Pediatric Dose for Atopic Dermatitis

15 mg orally once a day

Comments:
– for pediatric patients 12 years of age and older weighing at least 40 kg and adults less than 65 years of age: Initiate treatment with 15 mg orally once daily. If an adequate response is not achieved, consider increasing the dosage to 30 mg orally once daily.
– for adults 65 years of age and older: Recommended dosage is 15 mg once daily
– This drug is not recommended in patients with an absolute lymphocyte count (ALC) less than 500 cells/mm3, absolute neutrophil count (ANC) less than 1000 cells/mm3, or hemoglobin level less than 8 g/dL.

Use: Treatment of adult and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable.

Usual Adult Dose for Ulcerative Colitis

Induction dosage: 45 mg orally once a day for 8 weeks. Maintenance dosage: 15 mg orally once a day (30 mg once daily may be considered for patients with refractory, severe, or extensive disease.)

Comments:
– discontinue treatment if adequate therapeutic response is not achieved with the 30 mg dosage. Use the lowest effective dosage needed to maintain response.
–This drug is not recommended in patients with an absolute lymphocyte count (ALC) less than 500 cells/mm3, absolute neutrophil count (ANC) less than 1000 cells/mm3, or hemoglobin level less than 8 g/dL.

Use: Treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers.

Usual Adult Dose for Ankylosing Spondylitis

15 mg orally once a day

Use: Treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers.

Detailed Rinvoq 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 Rinvoq?

Avoid receiving a “live” vaccine. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

Rinvoq side effects

Get emergency medical help if you have signs of an allergic reaction to Rinvoq:  hives ; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people taking Rinvoq have developed heart attacks, strokes, or serious blood clots. Stop taking Rinvoq 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 Rinvoq side effects may include:

  • fever;
  • cough;
  • 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.

Rinvoq side effects  (more detail)

What other drugs will affect Rinvoq?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can interact with upadacitinib, especially:

  • phenytoin ;
  • an antibiotic –  clarithromycin ,  rifampin ;
  • antifungal medicine –  fluconazole ,  itraconazole ,  ketoconazole ,  posaconazole ,  voriconazole ;
  • drugs that weaken the immune system –  azathioprine ,  cyclosporine , and others;
  • NSAIDs (nonsteroidal anti-inflammatory drugs) –  aspirin ,  ibuprofen  ( Advil ,  Motrin ),  naproxen  ( Aleve ),  celecoxib ,  diclofenac ,  indomethacin ,  meloxicam , and others; or
  • steroid medicine –  dexamethasone ,  prednisone , and others.

This list is not complete and many other drugs may interact with upadacitinib. This includes prescription and over-the-counter medicines,  vitamins , and  herbal products . Not all possible drug interactions are listed here.

Rinvoq drug interactions  (more detail)

Popular FAQ

Is Rinvoq a biologic?

Yes, Rinvoq is an oral biologic drug classified as a Janus kinase (JAK) inhibitor. It is approved to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, ankylosing spondylitis and atopic dermatitis (eczema) when other treatments are not effective. Biologics are strong, specialized medicines derived from natural sources that help to slow or stop destructive inflammation.

Does Rinvoq cause hair loss?

No, Rinvoq did not cause hair loss in studies conducted by the manufacturer. Methotrexate, a medicine your doctor may prescribe with Rinvoq, can cause hair loss and hair thinning. Speak with your doctor if you have concerns about hair loss with Rinvoq.

How long does it take for Rinvoq to work?

Some people may feel the effects of Rinvoq after one week, but most people who respond will have significant improvement by 12 weeks. The improvements in pain, swelling and stiffness of rheumatoid arthritis have lasted over one year in many people.

Is Rinvoq the same as methotrexate?

No, Rinvoq (upadacitinib) is classified as a Janus kinase (JAK) inhibitor and methotrexate is a disease-modifying antirheumatic drug (DMARD). Both prescription products are approved to treat rheumatoid arthritis in adults. Rinvoq is also approved to treat adults with psoriatic arthritis, ulcerative colitis, or ankylosing spondylitis, and atopic dermatitis (eczema) in adults and children 12 years of age and older.

Is Rinvoq an anti-inflammatory?

Rinvoq is classified as a Janus kinase (JAK) inhibitor biologic that helps to slow or stop destructive inflammation. It is approved to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis and atopic dermatitis (eczema) when other treatments have not been successful. It works inside the cell to block signals that lead to inflammation.

Does Rinvoq make you sleepy?

Rinvoq may cause you to feel sleepy or tired. In studies of people being treated for eczema (atopic dermatitis) tiredness was reported as a common side effect. Rinvoq may also increase your risk for an infection or low red blood cell counts which could cause you to feel drowsy.

Does Rinvoq cause weight gain?

Weight gain was reported as a possible side effect in people with atopic dermatitis being treated with Rinvoq. In these studies, Rinvoq led to weight gain in 2% of people compared to 1% of those taking an inactive placebo. Weight gain was not reported in rheumatoid arthritis or psoriatic arthritis studies.

source :: https://www.drugs.com/rinvoq.html