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Tofacitinib - Xr (Xeljanz)

Trade Name : XELJANZ

Pfizer Laboratories Div Pfizer Inc

TABLET, FILM COATED, EXTENDED RELEASE

Strength 11 mg/1

TOFACITINIB CITRATE Janus Kinase Inhibitor [EPC],Janus Kinase Inhibitors [MoA]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Tofacitinib - Xr (Xeljanz) which is also known as XELJANZ and Manufactured by Pfizer Laboratories Div Pfizer Inc. It is available in strength of 11 mg/1 per ml. Read more

Tofacitinib - Xr (Xeljanz) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY AND THROMBOSIS
  • See full prescribing information for complete boxed warning.
  • Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred. ()
  • If a serious infection develops, interrupt XELJANZ/XELJANZ XR until the infection is controlled. ()
  • Prior to starting XELJANZ/XELJANZ XR, perform a test for latent tuberculosis; if it is positive, start treatment for tuberculosis prior to starting XELJANZ/XELJANZ XR. ()
  • Monitor all patients for active tuberculosis during treatment, even if the initial latent tuberculosis test is negative. ()
  • Thrombosis, including pulmonary embolism, deep venous thrombosis and arterial thrombosis have occurred in patients treated with XELJANZ and other Janus kinase inhibitors. Rheumatoid arthritis patients with at least one cardiovascular (CV) risk factor had a higher rate of all-cause mortality and thrombosis with XELJANZ 10 mg twice daily vs. 5 mg twice daily or TNF blockers. (, )
  • Lymphoma and other malignancies have been observed in patients treated with XELJANZ, including an increased rate of Epstein Barr Virus-associated post-transplant lymphoproliferative disorder. ()
  • No data
  • XELJANZ/XELJANZ XR is a Janus kinase (JAK) inhibitor.
  • Rheumatoid Arthritis
  • Psoriatic Arthritis
  • Ulcerative Colitis
  • Administration Instructions
  • Recommended Dosage
  • Rheumatoid Arthritis
  • Psoriatic Arthritis (in combination with nonbiologic DMARDs)
  • Ulcerative Colitis
  • Dosage Adjustment
  • XELJANZ Tablets: 5 mg, 10 mg tofacitinib ()
  • XELJANZ XR Tablets: 11 mg, 22 mg tofacitinib ()
  • None.
  • None ()
  • No data
  • Serious Infections
  • Thrombosis, including pulmonary, deep venous and arterial, some fatal:
  • Gastrointestinal Perforations
  • Laboratory Monitoring
  • Immunizations
  • The following clinically significant adverse reactions are described elsewhere in the labeling:
  • Most common adverse reactions are:
  • Rheumatoid and Psoriatic Arthritis
  • Ulcerative Colitis
  • Table 5 includes drugs with clinically important drug interactions when administered concomitantly with XELJANZ/XELJANZ XR and instructions for preventing or managing them.
  • See full prescribing information for clinically relevant drug interactions. (, )
  • All information provided in this section is applicable to XELJANZ and XELJANZ XR as they contain the same active ingredient (tofacitinib).
  • Lactation
  • 8.2
  • There is no specific antidote for overdose with XELJANZ/XELJANZ XR. In case of an overdose, it is recommended that the patient be monitored for signs and symptoms of adverse reactions.
  • In a study in subjects with end stage renal disease (ESRD) undergoing hemodialysis, plasma tofacitinib concentrations declined more rapidly during the period of hemodialysis and dialyzer efficiency, calculated as dialyzer clearance/blood flow entering the dialyzer, was high [mean (SD) = 0.73 (0.15)]. However, due to the significant non-renal clearance of tofacitinib, the fraction of total elimination occurring by hemodialysis was small, and thus limits the value of hemodialysis for treatment of overdose with XELJANZ/XELJANZ XR.
  • XELJANZ/XELJANZ XR (tofacitinib) tablets 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)-u00df-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 CHNOu2219CHO. The chemical structure of tofacitinib citrate is:
  • 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&C Blue #1/Brilliant Blue FCF Aluminum Lake, FD&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&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.
  • No data
  • In a 39-week toxicology study in monkeys, tofacitinib at exposure levels approximately 6 times the recommended dose of 5 mg twice daily, and approximately 3 times the 10 mg twice daily dose (on an AUC basis at oral doses of 5 mg/kg twice daily) produced lymphomas. No lymphomas were observed in this study at exposure levels 1 times the recommended dose of 5 mg twice daily, and approximately 0.5 times the 10 mg twice daily dose (on an AUC basis at oral doses of 1 mg/kg twice daily).
  • The carcinogenic potential of tofacitinib was assessed in 6-month rasH2 transgenic mouse carcinogenicity and 2-year rat carcinogenicity studies. Tofacitinib, at exposure levels approximately 34 times the recommended dose of 5 mg twice daily, and approximately 17 times the 10 mg twice daily dose (on an AUC basis at oral doses of 200 mg/kg/day) was not carcinogenic in mice.
  • In the 24-month oral carcinogenicity study in Sprague-Dawley rats, tofacitinib caused benign Leydig cell tumors, hibernomas (malignancy of brown adipose tissue), and benign thymomas at doses greater than or equal to 30 mg/kg/day (approximately 42 times the exposure levels at the recommended dose of 5 mg twice daily, and approximately 21 times the 10 mg twice daily dose on an AUC basis). The relevance of benign Leydig cell tumors to human risk is not known.
  • Tofacitinib was not mutagenic in the bacterial reverse mutation assay. It was positive for clastogenicity in the chromosome aberration assay with human lymphocytes in the presence of metabolic enzymes, but negative in the absence of metabolic enzymes. Tofacitinib was negative in the rat micronucleus assay and in the CHO-HGPRT assay and the rat hepatocyte unscheduled DNA synthesis assay.
  • In rats, tofacitinib at exposure levels approximately 17 times the recommended dose of 5 mg twice daily, and approximately 8.3 times the 10 mg twice daily dose (on an AUC basis at oral doses of 10 mg/kg/day) reduced female fertility due to increased post-implantation loss. There was no impairment of female rat fertility at exposure levels of tofacitinib equal to the recommended dose of 5 mg twice daily, and approximately 0.5 times the 10 mg twice daily dose (on an AUC basis at oral doses of 1 mg/kg/day). Tofacitinib exposure levels at approximately 133 times the recommended dose of 5 mg twice daily, and approximately 67 times the 10 mg twice daily dose (on an AUC basis at oral doses of 100 mg/kg/day) had no effect on male fertility, sperm motility, or sperm concentration.
  • No data
  • Store XELJANZ/XELJANZ XR at 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F). [See USP Controlled Room Temperature].
  • XELJANZ/XELJANZ XR
  • Do not repackage.
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.
  • LAB-0445-19.0
  • No data
  • ALWAYS DISPENSE WITHMEDICATION GUIDE
  • Pfizer
  • NDC 0069-1001-01
  • Xeljanz
  • 5 mg*
  • 60 Tabletsn n
  • ALWAYS DISPENSE WITHMEDICATION GUIDE
  • Pfizer
  • NDC 0069-0501-30
  • Xeljanzn- XR
  • Extended Release Tablets
  • 11 mg*
  • 30 Tabletsn n
  • ALWAYS DISPENSE WITH MEDICATION GUIDE
  • Pfizer
  • NDC 0069-1002-01
  • Xeljanz
  • 10 mg*
  • 10mg Is Recommended Only InUlcerative Colitis
  • 60 Tabletsn n
  • ALWAYS DISPENSE WITH MEDICATION GUIDE
  • Pfizer
  • NDC 0069-0502-30
  • Xeljanzn- XR
  • 22 mg*
  • 22mg Is Recommended Only InUlcerative Colitis
  • 30 Tabletsn n

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