【Drug Name】

Name:Upadacitinib Tablets

Product Name:UPADX

【Specification】15mg

【Indications】

UPADX is a prescription medicine that is a Janus kinase (JAK) inhibitor. UPADX is used:

• to treat adults with moderate to severe rheumatoid arthritis when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated.

• to treat adults with active psoriatic arthritis when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated.

• to treat 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.

• to treat 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.

• to treat 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.

UPADX is safe and effective in children 12 years of age and older weighing at least 88 pounds (40 kg) with atopic dermatitis.

It is not known if UPADX is safe and effective in children with juvenile idiopathic arthritis, with psoriatic arthritis, or with ankylosing spondylitis.

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

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

【Recommended Dosage】

•Take UPADX exactly as your healthcare provider tells you to use it.

• Take UPADX 1 time a day with or without food.

• Swallow UPADX tablets whole. Do not split, crush, or chew the tablets.

• If you take too much UPADX, call your healthcare provider or poison control center.

【Side Effects】

The most common side effects of UPADX in people treated for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis include:

• upper respiratory tract infections (common cold, sinus infections)

• shingles (herpes zoster)

• herpes simplex virus infections, including cold sores

• bronchitis

• nausea

• cough

• fever

• acne

• headache

The most common side effects of UPADX in people treated for atopic dermatitis include:

•upper respiratory tract infections (common cold, sinus infections)

• acne

• herpes simplex virus infections, including cold sores

• headache

• increased blood levels of creatine phosphokinase

• cough

• allergic reactions

• inflammation of hair follicles

• nausea

• stomach-area (abdominal) pain

• fever

• increased weight

• shingles (herpes zoster)

• flu

• tiredness

• low white blood cell count (neutropenia)

• muscle pain

• flu-like illness

The most common side effects of UPADX in people treated for ulcerative colitis include:

• upper respiratory tract infections (common cold, sinus infections)

• acne

• herpes simplex virus infections, including cold sores

• inflammation of the hair follicles

• rash

• flu

• shingles (herpes zoster)

• increased blood cholesterol levels

• increased blood levels of creatine phosphokinase

• increased liver enzyme levels

• low number of certain types of white blood cells (neutropenia, lymphopenia)

Separation or tear to the lining of the back part of the eye (retinal detachment) has happened in people with atopic dermatitis treated with UPADX. Call your healthcare provider right away if you have any sudden changes in your vision

during treatment with UPADX.

These are not all the possible side effects of UPADX. Call your doctor for medical advice about side effects.

【Storage】

• Store UPADX at 36°F to 86°F (2°C to 30°C).

• Store UPADX in the original bottle to protect it from moisture.

• Keep UPADX and all medicines out of the reach of children.