Rinvoq (Upadacitinib)

Rinvoq is not recommended:

• If you are allergic or have had an allergic reaction to Rinvoq or ingredients in Rinvoq
• If you have heart problems
• If you have had cancer
• If you suffer from blood clots
• If you recently received any type of vaccine
• If you are pregnant or breastfeeding
• If you are under 12 years of age

What are the Indications for Rinvoq?

Rinvoq is approved to treat Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Ulcerative Colitis and Atopic Dermatitis.

How is Rinvoq used?

Storage

Rinvoq should be stored in its original bottle in the refrigerator or at room temperature, and away from light and moisture. Do not store in the bathroom.

Keep out of reach of children.

Instruction

Take Rinvoq by mouth, as directed by your doctor, once a day with or without food, or on an empty stomach. Do not split, crush, or chew the tablet.

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, only take one dose. Do not catch up by taking two doses at once.

Do not change your dosage, take more than what is prescribed, or stop using Rinvoq without consulting with your doctor. If you took more than prescribed, contact your doctor immediately or seek emergency medical care.

Dosage

Rinvoq is available in extended-release tablets in the following strengths: 15 mg, 30 mg and 45 mg. The recommended starting dose is 15 mg once a day for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis and Atopic Dermatitis.

For Ulcerative Colitis the recommended starting dose is 30 – 45 mg once day for 8 weeks, and a maintenance dose of 15 mg daily thereafter.

Side Effects

It’s important to understand that although Rinvoq is FDA-approved, it comes with side effects that may or may not affect you.

Before starting Rinvoq, you should discuss possible side effects with your doctor or pharmacist.

Common Side Effects

Not all side effects require medical attention. As your body adjusts to Rinvoq, side effects may go away. Tell your doctor if you experience the following symptoms, and they become severe or do not go away on their own.

Common side effects include:

Rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: upper respiratory tract infections (common cold, sinus infections), shingles (herpes zoster), herpes simplex virus infections, including cold sores, bronchitis, nausea, cough, fever, acne and headache.

Atopic dermatitis: upper respiratory tract infections, acne, herpes simplex virus infections, headache, increased blood levels of creatine phosphokinase, cough, allergic reactions, inflammation of hair follicles, nausea, abdominal pain, fever, increased weight, shingles, flu or flu-like symptoms, tiredness, low white blood cell count (neutropenia) and muscle pain.

Ulcerative colitis: upper respiratory tract infections, acne, herpes simplex virus infections, inflammation of the hair follicles, rash, flu, shingles, increased blood cholesterol levels, increased blood levels of creatine phosphokinase, increased liver enzyme levels and a low number of certain types of white blood cells (neutropenia, lymphopenia).

Serious Side Effects

Severe adverse reactions while taking Rinvoq may occur. Seek emergency medical care or call 911 if you experience any of the following symptoms:

• Heart attack: chest discomfort/heaviness, tightness, pain, shortness of breath, cold sweat, nausea, lightheadedness, weakness on one side of the body, slurred speech.
• Blood clots: swelling, pain/tenderness in one or both legs, sudden chest or upper back pain, shortness of breath, difficulty breathing.
• Stomach or intestines: fever or abdominal pain that does not go away, change in bowel habits.
• Serious allergic reactions: rash/hives, itching/swelling, especially the face, tongue and throat, severe dizziness and trouble breathing.

Cancer

If you take Rinvoq, you may have a higher risk of developing lymphoma, and other malignancies, including non-melanoma skin cancer lymphoma or lung cancer (current or past smokers).

Blood clots

Rinvoq may increase your risk for blood clots. If you have a history of clotting you may be at increased risk of developing blood clot-related problems such as heart attack, stroke, clots in the deep veins of your legs or lungs or arterial thrombosis. Symptoms of blood clots include swelling or pain in your arms, legs, hands or feet, shortness of breath and pain in a new area of your body. This is a serious condition and can even lead to death.

Cardiovascular problems or increased risk of death

Rinvoq may raise your risk for cardiovascular problems, such as a heart attack, stroke, and even death, if you are over 50 years old, have at least one heart disease risk factor, or being treated with another JAK inhibitor medication.

Serious infections

Rinvoq can increase your risk of developing serious infections that may lead to hospitalization or death. Some of these infections include active tuberculosis (TB), invasive fungal infections, bacterial and viral infections.

The information above does not list all possible side effects. Contact your doctor or pharmacist if you experience any side effects not listed. You or your doctor may report side effects to the FDA by calling 1-800-FDA-1088.

Warnings & Precautions

Before using Rinvoq, tell your doctor or pharmacist:

• If you are allergic to Rinvoq or any ingredients in Rinvoq
• If you are being treated for an infection TB or came into close contact with someone who has TB
• If you are a current or past smoker
• If you had a heart attack, heart problems or stroke
• If you have or had any type of cancer, hepatitis B or C, shingles, blood clots, diverticulitis or ulcers in your stomach or intestines.
• If you have recently received any type of vaccine, or are scheduled to get a vaccine.
• If you have other medical conditions, e.g. liver problems, low blood cell counts, diabetes, chronic lung disease, anemia, high cholesterol, HIV or a weak immune system.
• If you are pregnant or plan to become pregnant.
• If you are breastfeeding or plan to breastfeed.

Gastrointestinal perforations

Some patients have reported gastrointestinal perforation while taking Rinvoq. If you have a history of diverticulitis or take anti-inflammatory medications you may be more likely to experience a tear in the lining of your stomach, which can cause serious bleeding. If you have pain, notice bloody or black and tarry stools, or vomit blood or material that looks like coffee grounds, contact your emergency room immediately.

Immune system

Rinvoq can lower your immune system and increase your risk of developing serious infections, such as sepsis, chicken pox, fungal infections and tuberculosis. If you notice signs of an infection such as a fever, chills, aches, tiredness, cough, skin sores, diarrhea, weight loss, or burning when you urinate, contact your doctor as soon as possible.

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.

Do not take Rinvoq if you currently have an infection.

Pregnant or Planning to Become Pregnant

Taking Rinvoq while pregnant can impact the unborn baby and cause harm. If you are a female patient and planning to become pregnant, you should use effective birth control during the treatment, and for another 4 weeks after the final dose. If you become pregnant while using Rinvoq, please contact your doctor immediately.

Breastfeeding or Planning to Breastfeed

It is not known if Rinvoq will pass through to human milk. If you are a breastfeeding mother and are taking this medication, it may affect your baby. Breastfeeding while being treated with Rinvoq is not recommended and for 6 days after stopping treatment.

Interactions & Contraindications

Before using Rinvoq, tell your doctor or pharmacist if you take any medications, herbal supplements, or vitamins.

Rinvoq should not be used if you have:

• A severely decreased liver function
• Recently received a vaccine, or are due to receive one.

Vaccines

Getting live vaccines while using Rinvoq may weaken your immune system and could make you sick. Some of these vaccines include:

• measles, mumps, rubella (MMR)
• intranasal flu (FluMist)
• smallpox
• chickenpox
• rotavirus
• yellow fever
• typhoid

Strong CYP3A4 inhibitors

Taking a CYP3A4 inhibitor with Rinvoq increases the amount of this medication in your body and can lead to an increased risk in side effects and make the medication less effective. CYP3A4 inhibitors should be avoided while taking Rinvoq unless otherwise directed.

CYP3A inhibitors include itraconazole, ketoconazole, clarithromycin, erythromycin, diltiazem, efavirenz, nevirapine, dexamethasone, carbamazepine, oxcarbazepine, phenytoin, rifampin, rifabutin, verapamil, darunavir and ritonavir.

St. John’s wort

St. John’s wort may decrease the amount of Rinvoq in your body and this can make it less effective. You should avoid taking St. John’s wort while using Rinvoq.

Grapefruit

Consuming grapefruit or drinking grapefruit juice while on treatment with Rinvoq may increase the potency of Rinvoq. This can lead to an increased risk of severe side effects. Grapefruit and grapefruit juice should be avoided while being treated with Rinvoq unless directed otherwise.

Frequently Asked Questions