General Information
Manufacturer: Abbvie
Medical Name: Upadacitinib
Purpose: Rinovq is a Janus kinase (JAK) inhibitor that works inside your cells to block certain signals that are thought to cause inflammation.
Rinovq is a prescription medicine used to treat adults with:
- Moderate to severe rheumatoid arthritis
- Active psoriatic arthritis (PsA)
- Active ankylosing spondylitis (AS)
- Active non-radiographic axial spondyloarthritis (nr-axSpA)
- Giant cell arteritis (GCA)
- Moderate to severe ulcerative colitis (UC)
- Moderate to severe Crohn’s disease (CD)
Side Effects
| Side-Effect | Percentage |
|---|---|
| Upper respiratory tract infections (common cold, sinus infections) | Up to 25% (very common) |
| Acne | 10% to 16% (very common) |
| Nausea | 4% (common, 1-10%) |
| Headache | Common (1-10%) |
| Cough | Common (1-10%), often associated with bronchitis |
| Fever (pyrexia) | Common (1-10%) |
| Elevated liver enzymes | Common (1-10%) |
| Increased blood creatine phosphokinase (CPK) | Common (1-10%) |
| Low white blood cell counts (neutropenia, lymphopenia) | Common (1-10%) |
| Rash | Common (1-10%) |
| Herpes zoster (shingles) or herpes simplex (cold sores) | Common (1-10%) |
| Anemia (low red blood cell counts) | Common (1-10%) |
Serious but Less Common Side Effects
| Side Effect | Description |
|---|---|
| Serious infections (e.g., pneumonia, tuberculosis, cellulitis, opportunistic infections) | The rate of serious infections was 3.7 events per 100 patient-years in one study. Generally considered rare. |
| Major Adverse Cardiovascular Events (MACE) (heart attack, stroke, cardiovascular death) | Higher rate observed in patients 50+ with at least one CV risk factor when compared to TNF blockers. The exact percentage varies by patient risk profile. |
| Cancer and immune system problems (including lymphoma and non-melanoma skin cancer) | Higher rate observed with JAK inhibitors versus TNF blockers in specific patient populations (current/past smokers). Generally rare in absolute terms. |
| Blood clots (deep venous thrombosis [DVT], pulmonary embolism [PE], arterial thrombosis) | Rare, but can be life-threatening. Higher risk in patients 50+ with CV risk factors. |
| Gastrointestinal (GI) perforations (tears in the stomach or intestines) | Rare; occurs most often in patients taking NSAIDs or corticosteroids. |
| Hypersensitivity/Allergic Reactions (anaphylaxis, angioedema, trouble breathing, swelling) | Rare, but potentially serious; requires immediate medical attention. |
Contraindications - Do Not Use This Medication
| Precondition | Description |
|---|---|
| Hypersensitivity to upadacitinib or any of its ingredients | |
| Rinvoq is not recommended for use in combination with the following |
|
| Active Serious Infections | Avoid use in patients with active, serious infections, including localized infections. This includes active tuberculosis (TB), invasive fungal, bacterial, viral (such as herpes zoster), and other opportunistic infections. Patients should be tested for latent TB before and during therapy, with treatment considered prior to Rinvoq use if positive. |
| Severe Laboratory Abnormalities |
Initiation of Rinvoq is not recommended in patients with:
|
| Severe Hepatic Impairment | Rinvoq is not recommended for use in patients with severe liver impairment (Child-Pugh C). |
| Pregnancy and Breastfeeding | Based on animal studies, Rinvoq may cause fetal harm. Pregnant women should be advised of the potential risk, and females of reproductive potential must use effective contraception during treatment and for 4 weeks after the final dose. Breastfeeding is not recommended during treatment and for 6 days after the last dose. |
| Vaccinations | Avoid the use of live vaccines during, or immediately prior to, Rinvoq therapy. |
| History of Certain Conditions |
|
| Cardiovascular Risks | Special consideration of risks vs. benefits is required for patients 50 years and older with at least one cardiovascular risk factor (e.g., current or past long-time smokers) due to a higher rate of MACE observed in studies with another JAK inhibitor. |
| Gastrointestinal Perforations | Monitor patients at risk for GI perforations. |