Rinvoq

Approved Uses

Rinvoq is used to treat the following conditions in specific patient groups:

• Rheumatoid Arthritis: For adults with moderate to severe rheumatoid arthritis when one or more tumor necrosis factor (TNF) blockers have been tried and did not work well or could not be tolerated.
• Psoriatic Arthritis: For adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers.
• Atopic Dermatitis: For adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis) that is not well controlled with other pills or injections, or when those treatments are not recommended.
• Ulcerative Colitis: For adults with moderate to severe ulcerative colitis when one or more TNF blockers have been tried and did not work well or could not be tolerated.
• Crohn's Disease: For adults with moderate to severe Crohn's disease when one or more TNF blockers have been tried and did not work well or could not be tolerated.
• Ankylosing Spondylitis: For adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers.
• Non-radiographic Axial Spondyloarthritis: For adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy.

Mechanism of Action

Rinvoq belongs to a class of medications known as Janus kinase (JAK) inhibitors. It works by interfering with the signaling pathways inside certain immune cells that contribute to inflammation.

Blocking Inflammatory Signals

In many autoimmune and inflammatory conditions, the body produces proteins called cytokines. These proteins attach to receptors on cell surfaces, which then use JAK enzymes to send a signal to the cell's nucleus to create more inflammation. Rinvoq specifically targets and blocks an enzyme called JAK1.

Reducing Immune Response

By blocking these signals, the medication helps to:

• Decrease inflammation: It lowers the production of inflammatory substances that cause swelling and pain.
• Regulate the immune system: It helps prevent the immune system from attacking the body's own healthy tissues, such as the joints, skin, or the lining of the digestive tract.

Because it targets a specific pathway within the immune system, it is considered a targeted therapy. This helps manage symptoms and prevent further damage caused by chronic inflammation in conditions like rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, and Crohn's disease.

Common Side Effects

• Upper respiratory tract infections (such as the common cold or sinus infections)
• Nausea
• Cough
• Fever
• Acne
• Headache
• Weight gain
• Cold sores or shingles
• Folliculitis (inflammation of hair follicles)

Serious Side Effects

Some side effects can be severe and require immediate medical attention. Contact a healthcare provider right away if you experience any of the following:

• Serious Infections: Rinvoq can lower the immune system's ability to fight infections. Symptoms may include fever, chills, persistent cough, or extreme tiredness.
• Allergic Reactions: Signs include skin rash, hives, swelling of the face, lips, or throat, and difficulty breathing.
• Blood Clots: This medication may increase the risk of clots in the legs, lungs, or arteries. Symptoms include sudden shortness of breath, chest pain, or pain and swelling in an arm or leg.
• Gastrointestinal Perforation: Some patients may develop tears in the stomach or intestines, often marked by severe abdominal pain and fever.
• Changes in Laboratory Tests: Your doctor may monitor for changes in liver function, increased cholesterol levels, or low blood cell counts.
• Malignancies: There is an increased risk of certain cancers, including lymphoma and skin cancer, while taking this medication.

Boxed Warnings

Rinvoq has several boxed warnings, which are the most serious warnings from the FDA. These include:

• Serious Infections: There is an increased risk of developing serious infections that may lead to hospitalization or death. These include tuberculosis (TB), shingles (herpes zoster), and various bacterial, fungal, or viral infections.
• Increased Risk of Death: In studies of similar medications, there was a higher rate of death in people 50 years and older who had at least one heart disease risk factor.
• Cancer and Immune System Issues: Lymphoma, lung cancer, and other malignancies have occurred in patients taking this medication. Current or past smokers may be at a higher risk.
• Heart-Related Events: There is an increased risk of major cardiovascular events, such as heart attack or stroke, particularly in those who smoke or have existing heart disease risk factors.
• Blood Clots: Serious and sometimes fatal blood clots in the legs (deep vein thrombosis), lungs (pulmonary embolism), or arteries have been reported.

Other Precautions

Healthcare providers typically screen for tuberculosis and other infections before starting Rinvoq. Treatment should not begin if an active, serious infection is present.

Gastrointestinal Perforation: There is a risk of developing tears in the stomach or intestines. This risk may be higher in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate.

Laboratory Monitoring: Regular blood tests are often necessary to monitor for changes in liver enzymes, cholesterol levels, and blood cell counts. Treatment may need to be interrupted if white blood cell or red blood cell counts become too low.

Vaccinations: Live vaccines should be avoided immediately before and during treatment with Rinvoq, as the medication may affect the body's immune response.

Pregnancy and Breastfeeding: Rinvoq may cause harm to an unborn baby. Effective birth control is recommended during treatment and for four weeks after the final dose. Breastfeeding is generally not advised while using this medication and for six days after the last dose.

Pregnancy

Rinvoq may cause harm to a fetus if taken during pregnancy. Healthcare providers typically recommend that individuals who can become pregnant use effective birth control during treatment and for at least 4 weeks after the final dose. If you become pregnant while taking this medication, you should contact your doctor right away.

Breastfeeding

It is not known whether Rinvoq passes into breast milk. Because of the potential for serious side effects in a nursing child, breastfeeding is not recommended during treatment and for at least 6 days after the last dose. Patients should discuss feeding options and the risks and benefits of the medication with their healthcare provider.

Dosage Forms

Rinvoq is supplied as an extended-release tablet. This formulation is designed to release the medication slowly after it is swallowed.

Administration

• Rinvoq is taken by mouth.
• The tablets must be swallowed whole.
• Do not crush, chew, or break the tablets, as this can affect how the medication is released into the body.

FDA Approval and Indications

Rinvoq was first approved by the U.S. Food and Drug Administration (FDA) in 2019. It is currently approved for use in adults with the following conditions:

• Moderately to severely active rheumatoid arthritis
• Active psoriatic arthritis
• Atopic dermatitis (eczema)
• Moderately to severely active ulcerative colitis
• Moderately to severely active Crohn's disease
• Active ankylosing spondylitis
• Active non-radiographic axial spondyloarthritis

For many of these conditions, the FDA specifies that Rinvoq should be used only after one or more tumor necrosis factor (TNF) blockers have been tried and were not effective or could not be tolerated.

Boxed Warning

The FDA requires a Boxed Warning for Rinvoq, which is the agency's most serious type of warning. This warning is based on data showing that JAK inhibitors may increase the risk of:

• Serious heart-related events, such as heart attack or stroke
• Blood clots in the lungs, legs, or arteries
• Certain types of cancer, including lymphoma and lung cancer
• Serious infections that may lead to hospitalization or death
• Increased risk of death, particularly in patients 50 years of age and older who have at least one cardiovascular risk factor

Regulatory Safety Communications

In 2021, the FDA issued a safety communication requiring updates to the Boxed Warning for Rinvoq and other JAK inhibitors. This regulatory action followed the review of a large safety clinical trial involving a similar medication in the same drug class. Although Rinvoq was not the specific drug in that trial, the FDA concluded it carries similar risks because of how it works in the body. Patients are advised to discuss their cardiovascular and cancer history with a healthcare provider before starting treatment.

Estimated Pricing

Rinvoq is classified as a specialty medication. The list price for a 30-day supply of 15 mg, 30 mg, or 45 mg extended-release tablets is approximately $6,600 to $7,000. However, the actual out-of-pocket cost for most patients is typically lower than the list price.

Insurance and Coverage

Most private insurance plans and Medicare provide coverage for Rinvoq, though the specific copayment or coinsurance amount will vary. Because it is a high-cost specialty drug, insurance providers often require prior authorization. This process requires your healthcare provider to submit documentation to the insurance company to confirm that the medication is medically necessary for your condition.

Financial Assistance

There are several options available to help reduce the cost of Rinvoq:

• Manufacturer Savings Cards: Patients with commercial insurance may be eligible for savings cards that significantly reduce monthly copayments.
• Patient Assistance Programs: For individuals who are uninsured or underinsured, programs may be available to provide the medication at a reduced cost or for free, based on income eligibility and other requirements.

It is recommended to check with your insurance provider and specialty pharmacy to determine your specific costs and coverage requirements.