Janus Kinase Inhibitors

Janus Kinase Inhibitor

Arthritis, Rheumatoid

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>XELJANZ/XELJANZ XR (tofacitinib) tablets and XELJANZ (tofacitinib) Oral Solution are formulated with the citrate salt of tofacitinib, a JAK inhibitor.Tofacitinib citrate is a white to off-white powder with the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]pyrimidin-4-ylamino)-ß-oxo-1-piperidinepropanenitrile, 2-hydroxy-1,2,3-propanetricarboxylate (1:1).The solubility of tofacitinib citrate in water is 2.9 mg/mL.Tofacitinib citrate has a molecular weight of 504.5 Daltons (or 312.4 Daltons as the tofacitinib free base) and a molecular formula of C16H20N6O∙C6H8O7. The chemical structure of tofacitinib citrate is:<div class="Figure"><a name="id3299"></a><img alt="Chemical Structure" src="xeljanz-01.jpg"/></div>XELJANZ is supplied for oral administration as a 5 mg white round, immediate-release film-coated tablet. Each tablet of XELJANZ contains 5 mg tofacitinib (equivalent to 8.08 mg tofacitinib citrate) and the following inactive ingredients: croscarmellose sodium, HPMC 2910/Hypromellose 6cP, lactose monohydrate, macrogol/PEG3350, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.XELJANZ is supplied for oral administration as a 10 mg blue round, immediate-release film-coated tablet. Each 10 mg tablet of XELJANZ contains 10 mg tofacitinib (equivalent to 16.16 mg of tofacitinib citrate) and the following inactive ingredients: croscarmellose sodium, FD&amp;C Blue #1/Brilliant Blue FCF Aluminum Lake, FD&amp;C Blue #2/Indigo Carmine Aluminum Lake, HPMC 2910/Hypromellose 6cP, lactose monohydrate, macrogol/PEG3350, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin.XELJANZ XR is supplied for oral administration as a 11 mg pink, oval, extended-release film-coated tablet with a drilled hole at one end of the tablet band. Each 11 mg tablet of XELJANZ XR contains 11 mg tofacitinib (equivalent to 17.77 mg tofacitinib citrate) and the following inactive ingredients: cellulose acetate, copovidone, hydroxyethyl cellulose, hydroxypropyl cellulose, HPMC 2910/Hypromellose, magnesium stearate, red iron oxide, sorbitol, titanium dioxide and triacetin. Printing ink contains, ammonium hydroxide, ferrosoferric oxide/black iron oxide, propylene glycol, and shellac glaze.XELJANZ XR is supplied for oral administration as a 22 mg beige, oval, extended-release film-coated tablet with a drilled hole at one end of the tablet band. Each 22 mg tablet of XELJANZ XR contains 22 mg tofacitinib (equivalent to 35.54 mg tofacitinib citrate) and the following inactive ingredients: cellulose acetate, copovidone, FD&amp;C Blue #2 Aluminum Lake, hydroxyethyl cellulose, hydroxypropyl cellulose, HPMC 2910/Hypromellose, magnesium stearate, red iron oxide, sorbitol, titanium dioxide, triacetin, and yellow iron oxide. Printing ink contains ammonium hydroxide, ferrosoferric oxide/black iron oxide, propylene glycol, and shellac glaze.XELJANZ Oral Solution is supplied for oral administration as a 1 mg/mL clear, colorless solution. Each 1 mL of XELJANZ Oral Solution contains 1 mg of tofacitinib (equivalent to 1.62 mg tofacitinib citrate) and the following inactive ingredients: grape flavor (natural), hydrochloric acid, lactic acid, purified water, sodium benzoate, sucralose, and xylitol.</section>

XELJANZ

tofacitinib

tofacitinib 5 MG Oral Tablet

Xeljanz

tofacitinib 5 MG Oral Tablet [Xeljanz]

24 HR tofacitinib 11 MG Extended Release Oral Tablet

24 HR tofacitinib 11 MG Extended Release Oral Tablet [Xeljanz]

tofacitinib 10 MG Oral Tablet

tofacitinib 10 MG Oral Tablet [Xeljanz]

24 HR tofacitinib 22 MG Extended Release Oral Tablet

24 HR tofacitinib 22 MG Extended Release Oral Tablet [Xeljanz]

tofacitinib 1 MG/ML Oral Solution

tofacitinib 1 MG/ML Oral Solution [Xeljanz]

Psoriasis (PsO)

Psoriatic Arthritis (PsA)

Ankylosing Spondylitis (AS)

Nonradiographic Axial Spondyloarthritis

Taltz

Juvenile Idiopathic Arthritis

Hidradenitis Suppurativa (HS)

Cosentyx

Siliq

Tremfya

Crohn's Disease (CD)

Ulcerative Colitis (UC)

Stelara

Skyrizi

Ilumya

Migraine

Cluster Headache

Migraine Prevention

Emgality

Qulipta

Acute Migraine

Ubrelvy

Nurtec ODT

Vyepti

Aimovig

Ajovy

Breast Cancer: HR+ (HER2-)

Verzenio

Ibrance

Kisqali

Atopic Dermatitis (Eczema)

Cibinqo

Eucrisa

Asthma (injectable)

Asthma OCS Dependent

Nasal Polyposis

Eosinophilic Esophagitis (EoE)

Prurigo Nodularis

Dupixent

Opzelura

Adbry

NSCLC ALK+ OR ROS1+ Disease

Lorbrena

Alecensa

Alunbrig

NSCLC cMET Mutation

Xalkori

Rheumatoid Arthritis (RA)

Uveitis

Graft Versus Host Disease (GVHD)

Orencia

COVID-19 Treatment

Alopecia Areata

Olumiant

Multiple Sclerosis (MS)

Secondary Progressive Multiple Sclerosis

Zeposia

Rinvoq

Entyvio

Xeljanz is a medication that blocks a type of enzyme called Janus kinase (JAK) which helps to reduce inflammation in various conditions such as rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, or polyarticular juvenile idiopathic arthritis. The common side effects of this medication are infections, cold-like symptoms, diarrhea, and headache. People with liver or kidney disease or those taking certain medications may need a lower dose of Xeljanz.

Xeljanz is FDA-approved for the following indications: Rheumatoid Arthritis, Psoriatic Arthritis, Ulcerative Colitis, Polyarticular Juvenile Idiopathic Arthritis, and Ankylosing Spondylitis. 

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About Xeljanz: Rheumatoid Arthritis 

Patient Stories: Rheumatoid Arthritis, Psoriatic Arthritis & Ulcerative Colitis 

Instructions For Use: Rheumatoid Arthritis 

Doctor Discussion Guide: Rheumatoid Arthritis 

Side Effects: Rheumatoid Arthritis 

About Xeljanz: Psoriatic Arthritis 

Instructions For Use: Psoriatic Arthritis 

Doctor Discussion Guide: Psoriatic Arthritis 

Side Effects: Psoriatic Arthritis 

About Xeljanz: Ulcerative Colitis 

 Instructions For Use: Ulcerative Colitis 

Doctor Discussion Guide: Ulcerative Colitis 

Side Effects: Ulcerative Colitis 

About Xeljanz: Ankylosing Spondylitis 

Instructions For Use: Ankylosing Spondylitis 

About Xeljanz: Juvenile Idiopathic Arthritis

Instructions For Use: Juvenile Idiopathic Arthritis

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