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Descriptions
Tofacitinib is a Janus kinase (JAK) inhibitor. JAKs are intracellular enzymes which transmit signals arising from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of hematopoiesis and immune cell function. Within the signaling pathway, JAKs phosphorylate and activate Signal Transducers and Activators of Transcription (STATs) which modulate intracellular activity including gene expression. Tofacitinib modulates the signaling pathway at the point of JAKs, preventing the phosphorylation and activation of STATs. JAK enzymes transmit cytokine signaling through pairing of JAKs (e.g., JAK1/JAK3, JAK1/JAK2, JAK1/TyK2, JAK2/JAK2).
Tofacitinib inhibited the in vitro activities of JAK1/JAK2, JAK1/JAK3, and JAK2/JAK2 combinations with IC50 of 406, 56, and 1377 nM, respectively. However, the relevance of specific JAK combinations to therapeutic effectiveness is not known. To read more visit: Incepata pharma
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In bellow we have Presentation, Descriptions, Indications, Dosage & Administration, Side Effects, Precautions. Buy tofacitinib 5mg 60 tablets only $35. To know more about the product visit Contact Us page.
Tofacent 5: Each tablet contains Tofacitinib Citrate INN equivalent to Tofacitinib 5 mg
Pharmacodynamics
Tofacitinib targets inflammation present in rheumatoid arthritis by inhibiting the janus kinases involve in the inflammatory response pathway.
The controlled trials of rheumatoid arthritis patients receiving 5mg or 10mg of tofacitinib twice daily, higher ACR20 responses were observed within 2 weeks in some patients (with ACR20 being defined as a minimum 20% reduction in joint pain or tenderness and 20% reduction in arthritis pain, patient disability, inflammatory markers, or global assessments of arthritis by patients or by doctors, according to the American College of Rheumatology (ACR) response criteria list), and improvements in physical functioning greater than placebo were also noted.
Adverse effects of Tofacitinib
Common known adverse effects of tofacitinib include headaches, diarrhea, nausea, nasopharyngitis and upper respiratory tract infection. More serious immunologic and hematological adverse effects have noted resulting in lymphopenia, neutropenia, anemia, and increased risk of cancer and infection.
Before initiations of buy tofacitinib patients should tested for latent infections of tuberculosis, and should closely monitored for signs and symptoms of infection (fungal, viral, bacterial, or mycobacterial) during therapy. Therapy is not to started in the presence of active infection, systemic or localized, and is to interrupted if a serious infection occurs.
Tofacitinib has associated with an increased risk of lymphomas, such as Epstein-Barr virus associated lymphomas, and other malignancies (including lung, breast, gastric, and colorectal cancers). It is recommended to monitor lymphocytes, neutrophils, hemoglobin, liver enzymes, and lipids.
Tofacitinib use associate with a rapid decrease in C-reactive protein (CRP), dose dependent decreases in natural killer cells, and dose dependent increases in B cells. Depression in C-reactive protein levels continue after 2 weeks of tofacitinib discontinuation and suggest that pharmacodynamic activity last longer than pharmacokinetic half life.
Mechanism of action
Rheumatoid arthritis is an autoimmune disease characterized by a dysregulation of pro-inflammatory cytokines including IL7, IL15, IL21, IL6, IFN-alpha, and IFN-beta. (3) Cytokines signaling results in tissue inflammation and joint damage by stimulating the recruitment and activation of immune cells via the Janus kinase signaling pathway.
Tofacitinib is a partial and reversible Janus kinase (JAK) inhibitor that will prevent the body from responding to cytokine signals. By inhibiting JAKs, tofacitinib prevents the phosphorylation and activation of STATs. The JAK-STAT signaling pathway involve in the transcription of cells involved in hematopoiesis, and immune cell function. Tofacitinib works therapeutically by inhibiting the JAK-STAT pathway to decrease the inflammatory response. However, there is evidence to suggest that it may also achieve efficacy via other pathways as well.
Absorption
74% oral absorption (absolute bioavailability), with peak plasma concentrations (T max) achieved in 0.5-1 hour. Administration with fatty meals does not alter AUC but reduces Cmax by 32%.
Volume of distribution
Vd= 87L after intravenous administration. Distribution is equal between red blood cells and plasma. Protein binding40%, mostly bound to albumin.
Metabolism
Metabolized in the liver by CYP3A4 and CYP2C19. Metabolites produced are inactive.
Route of elimination
70% metabolized in the liver by CYP3A4 (major) and CYP2C19 (minor). Metabolites produced are inactive. 30% renally eliminated as unchanged drug.
Limitations of Use
Use of Tofacitinib in combination with biologic DMARDs or potent immunosuppressant such as Azathioprine and cyclosporine not recommend
Dosage & Administration
Rheumatoid Arthritis
Tofacitinib is 5 mg twice daily.
Recommended dose in patients with moderate and severe renal impairment and moderate hepatic impairment is Tofacitinib 5 mg once daily.
Use of Tofacitinib in patients with severe hepatic impairment is not recommended.
Side Effects
The most commonly reported adverse reactions during the first 3 months in controlled clinical trials (occurring in greater than or equal to 2% of patients treated with Tofacitinib monotherapy or in combination with DMARDs) were upper respiratory tract infections, headache, diarrhea and nasopharyngitis.
Precautions
Use of Tofacitinib during an active serious infection, including localized infections should avoided
Gastrointestinal Perforations – Should used with caution in patients that may be at increased risk
Laboratory Monitoring – Recommended due to potential changes in lymphocytes, neutrophils, hemoglobin, liver enzymes and lipids
Immunizations – Live vaccines: Should avoided
Contraindications
None
Use in Pregnancy & Lactation
Pregnancy Category C
There are no adequate and well-controlled studies in pregnant women. Tofacitinib should used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether Tofacitinib excrete in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Tofacitinib, a decision made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug for the mother.
Pediatric Use
The safety and effectiveness of Tofacitinib in pediatric patients have not established.
Geriatric Use
The frequency of serious infection among Tofacitinib-treated subjects 65 years of age and older was higher than among those under the age of 65. As there is a higher incidence of infections in the elderly population in general, caution should used when treating the elderly.
Drug Interaction
Potent inhibitors of Cytochrome P450 3A4 (CYP3A4) (e.g., Ketoconazole):
Tofacitinib 5 mg once daily : One or more concomitant medications that result in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g., fluconazole).
Recommended dose is Tofacitinib 5 mg once daily Potent CYP inducers (e.g.Rifampin): May result in loss of or reduced clinical response.
Commercial Packaging
Tofacent 5: Each bottle contains 60 tablets
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