Upendo 15 Mg Tablet

Description

What Is Upendo 15 Mg Tablet (Upadacitinib)?

Upendo 15 Mg Tablet (also marketed as Upadoz 15 Mg) is a prescription oral medication containing 15 mg of Upadacitinib, a selective and reversible Janus kinase 1 (JAK1) inhibitor. It is a generic equivalent of Rinvoq® (AbbVie Inc, FDA-approved August 2019) — one of the most advanced targeted oral therapies currently available for autoimmune and inflammatory diseases.

Upadacitinib belongs to the targeted synthetic disease-modifying antirheumatic drug (tsDMARD) class. It is approved for multiple immune-mediated conditions including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and inflammatory bowel diseases, and is an important treatment option for patients who have not responded adequately to prior biologic therapies.

⚠ FDA BLACK-BOX WARNING: Upadacitinib carries the highest level of US FDA prescribing warning. Serious risks include: (1) Serious and sometimes fatal infections, including tuberculosis, bacterial, invasive fungal, viral, and opportunistic infections; (2) Malignancy — including lymphoma and lung cancer; (3) Major Adverse Cardiovascular Events (MACE) — heart attack, stroke, and cardiovascular death; (4) Thrombosis — deep vein thrombosis and pulmonary embolism; (5) Increased all-cause mortality. This medication must only be prescribed and monitored by physicians experienced in managing the relevant autoimmune condition.

Composition and Pharmacological Classification

Parameter	Details
Active Ingredient	Upadacitinib 15 mg
Drug Class	Selective JAK1 Inhibitor / Targeted Synthetic DMARD (tsDMARD)
Dosage Form	Extended-release oral tablet — once daily
Brand Equivalent	Rinvoq® (AbbVie; FDA-approved: August 16, 2019)
Administration	Oral, once daily, with or without food
Tablet Instructions	Swallow whole — do not crush, cut, or chew
Rx Status	Prescription Required; specialist initiation recommended

How Upadacitinib Works (Mechanism of Action)

Upadacitinib selectively and reversibly inhibits Janus Kinase 1 (JAK1) — an intracellular non-receptor tyrosine kinase that plays a critical role in cytokine-driven inflammatory signalling. When pro-inflammatory cytokines bind their surface receptors, JAK enzymes phosphorylate and activate STAT (Signal Transducer and Activator of Transcription) proteins, which then enter the cell nucleus and drive expression of genes involved in inflammation, immune cell proliferation, and tissue damage.

Many cytokines central to autoimmune disease — including Interleukins 4, 6, 7, 13, 15, 17, and 21, as well as interferon-gamma — rely on JAK1 for their cellular signalling. By blocking JAK1 with approximately 74-fold selectivity over JAK2 in cellular assays, upadacitinib disrupts these inflammatory cascades while aiming to preserve certain JAK2-dependent haematopoietic pathways. The result in clinical practice is:

• Reduced synovial inflammation, joint swelling, and tenderness in rheumatoid and psoriatic arthritis
• Decreased inflammatory skin activity in atopic dermatitis
• Suppressed intestinal mucosal inflammation in ulcerative colitis and Crohn’s disease
• Reduced axial and peripheral inflammation in ankylosing spondylitis

The extended-release formulation maintains stable plasma drug levels over 24 hours, enabling once-daily dosing and improving long-term adherence.

Approved Indications for Upadacitinib 15 Mg

Upadacitinib 15 mg is the standard dose for the following conditions. All treatments must be initiated and supervised by a physician experienced in the relevant speciality.

Rheumatoid Arthritis (RA)

Indicated for adults with moderately to severely active rheumatoid arthritis with inadequate response or intolerance to one or more TNF inhibitors. May be used as monotherapy or combined with methotrexate or other non-biologic conventional DMARDs. Not for use with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants such as azathioprine or cyclosporine. In the SELECT-COMPARE trial, upadacitinib 15 mg demonstrated superior ACR50 response rates compared to adalimumab at week 26 in patients with inadequate methotrexate response.

Psoriatic Arthritis (PsA)

For adults with active PsA who have had inadequate response or intolerance to conventional synthetic or biologic therapy. Upadacitinib 15 mg improves both joint symptoms and skin psoriasis signs.

Ankylosing Spondylitis (AS) and Non-Radiographic Axial Spondyloarthritis (nr-axSpA)

For adults with active AS or nr-axSpA with objective signs of inflammation who have had inadequate response or intolerance to NSAIDs.

Atopic Dermatitis

For moderate-to-severe atopic dermatitis in adults and adolescents aged ≥12 years who are inadequately controlled with topical therapies or systemic agents. (Note: the 30 mg dose is more commonly used for atopic dermatitis; discuss specific dosing with your dermatologist.)

Ulcerative Colitis and Crohn’s Disease

For moderate-to-severe IBD: 45 mg induction dose, followed by 15 mg or 30 mg maintenance, based on response and tolerability.

Dosage and Administration

• RA, AS, nr-axSpA, PsA: 15 mg once daily orally
• Swallow the tablet whole — do not crush, cut, or chew (extended-release formulation)
• Can be taken at any time of day, with or without food
• If a dose is missed, take it the same day as soon as remembered — do not double up the next day

Laboratory Monitoring Before and During Treatment

Your physician will check and monitor the following:

• Complete blood count: Do not start if lymphocytes <500/mm³, ANC <1,000/mm³, or Hb <8 g/dL
• Liver function tests
• Lipid profile — upadacitinib raises LDL and HDL cholesterol; treat dyslipidaemia as clinically indicated
• TB screening (TST/IGRA) — latent TB must be treated before starting
• Hepatitis B and C serologies
• Vaccination review — update non-live vaccines before starting; live vaccines are contraindicated during treatment

Important Warnings and Precautions

Serious Infections

Upadacitinib suppresses JAK1-dependent immune signalling, increasing the risk of serious and potentially life-threatening infections including TB reactivation, invasive fungal infections (Pneumocystis, histoplasmosis), and herpes zoster reactivation. Do not start during an active serious infection. Contact your doctor immediately for any unexplained fever, persistent cough, or unusual fatigue. Where possible, the non-live recombinant herpes zoster vaccine (Shingrix) should be administered before starting therapy.

Malignancy

Increased rates of lymphoma, lung cancer, and other malignancies have been observed with the JAK inhibitor class, based on long-term post-marketing data. Exercise particular caution in patients with prior malignancy, current or former smokers, and those over 65 years. Individual risk-benefit assessment is essential before prescribing.

Major Adverse Cardiovascular Events (MACE)

Increased risk of non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death has been observed with JAK inhibitors as a class. Risk is higher in patients with established cardiovascular disease, older age, smoking history, or other cardiovascular risk factors. Careful patient selection and monitoring are required.

Thrombosis

Deep vein thrombosis (DVT), pulmonary embolism (PE), and arterial thromboembolism have been reported. Evaluate thromboembolic risk factors prior to prescribing. Use with caution or avoid in patients with a history of VTE.

Pregnancy

Upadacitinib is teratogenic in animal models at sub-clinical doses. It is not recommended during pregnancy. Women of childbearing potential must use effective contraception during treatment and for at least 4 weeks after the final dose.

Contraindications

• Known hypersensitivity to upadacitinib or any excipient
• Active serious infections, including active tuberculosis
• Severe hepatic impairment (Child-Pugh C)
• Pregnancy (without adequate contraception)
• Combination with other JAK inhibitors or biologic DMARDs

Side Effects of Upadacitinib 15 Mg

Very Common (≥1 in 10 patients)

• Upper respiratory tract infections (common cold, sinusitis)
• Nausea
• Raised blood cholesterol (requires monitoring and possible treatment)

Common (1 in 10 to 1 in 100 patients)

• Herpes zoster (shingles)
• Herpes simplex
• Bronchitis
• Cough and fever
• Acne and folliculitis
• Headache and weight gain
• Anaemia, neutropenia, lymphopenia
• Elevated liver enzymes

Serious Side Effects Requiring Immediate Attention

• Signs of serious infection: persistent fever, chills, sweats, unusual fatigue, difficulty breathing
• Signs of DVT: leg pain, swelling, warmth, or redness
• Signs of pulmonary embolism: sudden breathlessness, chest pain, rapid heart rate
• Signs of MACE: chest pain, sudden weakness or numbness, speech difficulties
• Sudden severe abdominal pain (possible GI perforation)

Drug Interactions

• Strong CYP3A4 inhibitors (ketoconazole, ritonavir, clarithromycin): Significantly increase upadacitinib exposure — avoid or reduce dose with close monitoring
• Strong CYP3A4 inducers (rifampicin, carbamazepine, St John’s Wort): Substantially reduce upadacitinib levels — avoid combination
• Other JAK inhibitors: Do not combine
• Biologic DMARDs: Do not combine (additive immunosuppression)
• Potent immunosuppressants (azathioprine, cyclosporine): Not recommended
• Live vaccines: Contraindicated during treatment; update non-live vaccines before starting
• Methotrexate and NSAIDs: Co-administration acceptable in approved indications

Related Rheumatology Products on IndoGenMed

IndoGenMed offers a range of DMARDs and immunomodulatory medicines for rheumatic diseases. For patients on conventional DMARD therapy, Hydroquin 200 Mg (Hydroxychloroquine 200 mg) is a widely used non-biologic DMARD for RA and lupus. For patients requiring immunosuppressive therapy in transplant settings or IBD, Imuran 50 Mg (Azathioprine) and Lefumide 20 Mg (Leflunomide) are established options. Patients with comorbid osteoporosis may require concurrent bone protection such as Osteofos 70 Mg (Alendronate).

Storage

Store at room temperature (15–30°C) in the original packaging, away from moisture, heat, and direct light. Keep out of reach of children. Do not use after the expiry date.

Frequently Asked Questions About Upadacitinib

Can I take Upendo 15 Mg with methotrexate?

Yes. Upadacitinib can be used as monotherapy or in combination with methotrexate and other non-biologic conventional DMARDs (hydroxychloroquine, sulfasalazine) for rheumatoid arthritis. It must not be combined with biologic DMARDs or other JAK inhibitors.

How long does it take to work?

Many patients begin to notice improvement in joint pain, morning stiffness, and fatigue within 2–4 weeks of starting treatment. Formal assessment of disease activity response typically occurs at 12–16 weeks. Maximum therapeutic benefit may take several months to become fully apparent.

What vaccinations should I have before starting?

Your doctor will review vaccination history and may recommend pneumococcal, influenza, hepatitis B, and the non-live recombinant herpes zoster subunit vaccine (Shingrix) before starting. Live or live-attenuated vaccines cannot be given during treatment.

What should I do if I develop a fever or signs of infection?

Contact your doctor immediately. Any fever, persistent cough, unusual fatigue, or skin infection requires prompt evaluation. Your doctor may pause treatment until the infection is investigated and treated.

Can I stop upadacitinib suddenly?

Do not stop without consulting your rheumatologist. Abrupt discontinuation can cause disease flare. Your doctor will advise on a structured tapering plan if dose reduction or discontinuation is planned based on sustained clinical remission.

References

• AbbVie Inc. Rinvoq (upadacitinib) US Prescribing Information. Revised 2024. Available at: rxabbvie.com
• U.S. FDA. Upadacitinib (Rinvoq) Drug Label. Available at: fda.gov
• Arthritis Foundation. Upadacitinib Drug Guide. Available at: arthritis.org
• Fleischmann RM, et al. (2019). Upadacitinib versus placebo or adalimumab in patients with RA (SELECT-COMPARE). Lancet. 393(10179):2503–2512.