An eight-ounce cup for measuring fluids for hydration is also supplied. In the long-term safety population, the pattern and incidence of confirmed decreases in ANC remained consistent with what was seen in the controlled clinical trials [see WARNINGS AND PRECAUTIONS]. How should I store XELJANZ/XELJANZ XR/XELJANZ Oral Solution? Dose 2 – In the evening before your colonoscopy (sometime between 10:00 PM to 12:00 AM): Stop drinking clear liquids 2 hours before your colonoscopy, or as advised to you by your healthcare provider. In a single study of patients 9 to 16 years of age, approximately 20% of patients in another oral product of sodium picosulfate, magnesium oxide, and anhydrous citric acid arms had orthostatic changes (changes in blood pressure and/or heart rate) compared with approximately 7% of those who received the comparator (PEG) [see Clinical Studies]. Reproduction studies with sodium picosulfate, magnesium oxide, and anhydrous citric acid have been performed in pregnant rats following oral administration of up to 2000 mg/kg twice daily (about 1.2 times the recommended human dose based on body surface area) during the period of organogenesis. XELJANZ/XELJANZ Oral Solution is indicated for the treatment of active polyarticular course juvenile idiopathic arthritis (pcJIA) in patients 2 years of age and older. However, the relevance of specific JAK combinations to therapeutic effectiveness is not known. The safety and effectiveness of XELJANZ XR in pediatric patients have not been established. CLENPIQ (sodium picosulfate, magnesium oxide, and anhydrous citric acid) oral solution is a stimulant and osmotic laxative that is provided as a cranberry-flavored, colorless to slightly yellow, clear oral solution, and is supplied as two bottles in each carton. Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Instruct patients to take two separate doses in conjunction with fluids, as follows: The Day-Before regimen is the alternative dosing method for patients for whom the Split-Dosing is inappropriate. The derived half-life using these model estimates would be 7 hours. Remove the plunger from the barrel by pulling the plunger and the barrel away from each other. CLENPIQ comes in a carton containing 2 bottles, along with an 8-ounce cup for measuring fluids for hydration. Proportion of Patients 9 to 16 Years of Age with Successful Colon Cleansing1, CLENPIQ™ Analyses of erosion and joint space narrowing scores were consistent with the overall results. See additional information. Read and understand these Medication Guide instructions at least 2 days before your colonoscopy and again before you start taking CLENPIQ. Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Avoid use of XELJANZ/XELJANZ XR/XELJANZ Oral Solution in patients with an active, serious infection, including localized infections. Consume only clear fluids (no solid food) from the start of CLENPIQ treatment until after the colonoscopy. In a human radiolabeled study, more than 65% of the total circulating radioactivity was accounted for by unchanged tofacitinib, with the remaining 35% attributed to 8 metabolites, each accounting for less than 8% of total radioactivity. Your healthcare provider should monitor you closely for signs and symptoms of TB infection during treatment with XELJANZ/XELJANZ XR/XELJANZ Oral Solution. Store in the original bottle and carton to protect from light. There are 2 different methods for taking CLENPIQ. In the long-term extension study, malignancies (including solid cancers and lymphomas) were observed more often in patients treated with XELJANZ 10 mg twice daily. Oral corticosteroids were received as concomitant treatment for UC by 47% of patients (45% in Study UC-I and 48% in Study UC-II) and 71% were receiving concomitant aminosalicylates as treatment for UC (71% in Study UC-I, and 72% in Study UC-II). Disease-Associated Maternal And/Or Embryo/Fetal Risk. All people taking CLENPIQ should follow these general instructions starting 1 day. The patient was varicella virus naïve, as evidenced by no previous history of varicella infection and no anti-varicella antibodies at baseline. Take CLENPIQ exactly as your healthcare provider tells you to take it. As there is a higher incidence of infection in diabetic population in general, caution should be used when treating patients with diabetes. The primary endpoints were the proportion of patients who achieved an ACR20 response at Month 6, changes in HAQ-DI at Month 3, and rates of DAS28-4(ESR) less than 2.6 at Month 6. Avoid initiation of XELJANZ/XELJANZ XR/XELJANZ Oral Solution treatment in patients with a low lymphocyte count (i.e., less than 500 cells/mm³). Advise patients to stop taking XELJANZ/XELJANZ XR/XELJANZ Oral Solution and to call their healthcare provider right away if they experience any symptoms of thrombosis (sudden shortness of breath, chest pain worsened with breathing, swelling of leg or arm, leg pain or tenderness, red or discolored skin in the affected leg or arm) [see WARNINGS AND PRECAUTIONS]. This Instructions for Use has been approved by the U.S. Food and Drug Administration. Patients receiving XELJANZ 5 mg twice daily demonstrated significantly greater improvement (p ≤0.05) from baseline in physical functioning compared to placebo at Month 3 (Table 16). Table 16: Change from Baseline in HAQ-DI in Studies PsA-I and PsA-II. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined. Fully push in the plunger so that the oral solution flows back into the bottle. have kidney problems or take medicines for kidney problems. CLENPIQ may affect how other medicines work. In the seven controlled trials, during the 0 to 3 months exposure, the overall frequency of infections was 20% and 22% in the 5 mg twice daily and 10 mg twice daily groups, respectively, and 18% in the placebo group. Note: Reference group is administration of concomitant medication alone; OCT = Organic Cationic Transporter; MATE = Multidrug and Toxic Compound Extrusion. Table 6: Clinical Relevant Interactions Affecting XELJANZ/XELJANZ XR/XELJANZ Oral Solution When Coadministered with Other Drugs. It may harm them. Figure 7: Occurrence of Disease Flare by Visit in the Double-Blind Phase in Study pcJIA-I, XELJANZ XR(ZEL’ JANS’ EKS-AHR)(tofacitinib) extended-release tablets, for oral use, XELJANZ(ZEL’ JANS’)(tofacitinib) Oral Solution. Therefore, coadministration with XELJANZ/XELJANZ XR is not expected to result in clinically relevant increases in the metabolism of CYP substrates in rheumatoid arthritis patients. Cleaning your colon helps your healthcare provider see the inside of your colon more clearly during your colonoscopy. In trials RA-I through V, patients treated with 5 mg twice daily XELJANZ had higher ACR20, ACR50, and ACR70 response rates versus placebo, with or without background DMARD treatment, at Month 3 and Month 6. Inactive ingredients: croscarmellose sodium, HPMC 2910/Hypromellose 6cP, lactose monohydrate, macrogol/PEG3350, magnesium stearate, microcrystalline cellulose, titanium dioxide, and triacetin. Maintenance of clinical response was observed in 52% in the XELJANZ 5 mg twice daily group and 62% in the XELJANZ 10 mg twice daily group compared to 20% of placebo patients. For current full prescribing information, please visit www.pfizer.com. There is no specific antidote for overdose with XELJANZ/XELJANZ XR/XELJANZ Oral Solution. No lymphomas were reported. have recently received or are scheduled to receive a vaccine. Study RA-III (NCT00853385) was a 12-month trial in 717 patients with moderate to severe active rheumatoid arthritis who had an inadequate response to MTX. Patients receiving XELJANZ 5 mg twice daily demonstrated greater improvement from baseline in physical functioning compared to placebo at Month 3. Approximately 20% of patients in both arms (sodium picosulfate, magnesium oxide, and anhydrous citric acid, 2 L of PEG + E plus two x 5-mg bisacodyl tablets) of clinical trials of another oral product of sodium picosulfate, magnesium oxide, and anhydrous citric acid had orthostatic changes in blood pressure and/or heart rate on the day of colonoscopy and up to seven days post colonoscopy. The mean (95% CI) difference from placebo in HAQ-DI improvement from baseline at Month 3 in Study RA-III was -0.22 (-0.35, -0.10) in patients receiving 5 mg XELJANZ twice daily. Table 5: Common Adverse Reactions* in -UC Patients during the Maintenance Trial (Study UC-III). Normalization Of The Endoscopic Appearance Of The Mucosa At Week 8. Your healthcare provider should do blood tests to check your cholesterol levels 4 to 8 weeks after you start receiving XELJANZ/XELJANZ XR/XELJANZ Oral Solution, and as needed after that.
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