Deferasirox500 Dispersible Tab

<p style=\"text-align: left;\"><strong>  </strong>Store below 30 ^oC.    </p> <p style=\"text-align: left;\">  Protect from light and moisture. </p> <p style=\"text-align: left;\">  Keep out of rich of children.</p>

<p style=\"text-align: left;\">Contact a poison control center.</p>

<p style=\"text-align: left;\">     <a href=\"http://www.rxlist.com/script/main/art.asp?articlekey=6139\">Abdominal pain</a>, <a href=\"http://www.rxlist.com/script/main/art.asp?articlekey=4510\">nausea</a>, vomiting, <a href=\"http://www.rxlist.com/script/main/art.asp?articlekey=2985\">diarrhea</a>, skin rashes, and increases in serum creatinine were the most frequent adverse reactions reported.</p> <p style=\"text-align: left;\"><strong>                                            </strong></p>

<ul> <li style=\"text-align: left;\">The concomitant administration of deferasirox and aluminum-containing antacid preparations has not been formally studied. Although deferasirox has a lower <a href=\"http://www.rxlist.com/script/main/art.asp?articlekey=23369\">affinity</a> for aluminum than for iron, do not administer with aluminum-containing antacid preparations.</li> <li style=\"text-align: left;\">Deferasirox inhibits human CYP3A4, CYP2C8, CYP1A2, CYP2A6, CYP2D6, and CYP2C19 <em>in vitro. </em>The clinical significance of deferasirox inhibition of CYP2A6, CYP2D6, and CYP2C19 is unknown.Interaction with Midazolam and Other Agents Metabolized by CYP3A4. Interaction with Repaglinide and Other Agents Metabolized by CYP2C8. Interaction with Theophylline and Other Agents Metabolized by CYP1A2. Use caution when deferasirox is administered with other drugs metabolized by CYP1A2 such as cyclobenzaprine, imipramine, haloperidol, fluvoxamine, mexiletine, olanzapine, tizanidine, zileuton, and zolmitriptan.</li> </ul> <h4 style=\"text-align: left;\">·      Interaction with Agents Inducing UDP-glucuronosyltransferase (UGT) Metabolism</h4> <h4 style=\"text-align: left;\">·      Interaction with Cholestyramine</h4>

<p style=\"text-align: left;\">It is not known is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.</p>

<p style=\"text-align: left;\">    FDA pregnancy category C</p>

<h4 style=\"text-align: left;\">·         Renal: <a href=\"http://www.rxlist.com/script/main/art.asp?articlekey=30776\">Acute renal failure</a>, fatal in some patients and requiring <a href=\"http://www.rxlist.com/script/main/art.asp?articlekey=2980\">dialysis</a> in others, has been reported following the post marketing use of (deferasirox). Assess serum creatinine and/or creatinine clearance in duplicate before initiating <a href=\"http://www.rxlist.com/script/main/art.asp?articlekey=10897\">therapy</a> to establish a reliable pretreatment <a href=\"http://www.rxlist.com/script/main/art.asp?articlekey=26233\">baseline</a>, due to variations in measurements. Monitor serum creatinine and/or creatinine clearance monthly thereafter. In patients with additional renal risk factors (see above), monitor serum creatinine and/or creatinine clearance weekly during the first month after initiation or modification of therapy and monthly thereafter.</h4> <ul style=\"text-align: left;\"> <li>Hepatic Dysfunction and Failure: Avoid the use in patients with severe (Child-Pugh C) hepatic impairment. For patients with moderate (Child-Pugh B) hepatic impairment, a 50% reduction in the starting dose is recommended.</li> </ul> <h4 style=\"text-align: left;\">·         Gastrointestinal: Fatal GI hemorrhages, especially in elderly patients who had advanced hematologic malignancies and/or low platelet counts, have been reported. Non-fatal upper GI irritation, <a href=\"http://www.rxlist.com/script/main/art.asp?articlekey=11848\">ulceration</a> and <a href=\"http://www.rxlist.com/script/main/art.asp?articlekey=14263\">hemorrhage</a> have been reported in patients.</h4> <h4 style=\"text-align: left;\">·         Cytopenias: There have been post marketing reports (both spontaneous and from clinical trials) of cytopenias, including <a href=\"http://www.rxlist.com/script/main/art.asp?articlekey=8816\">agranulocytosis</a>, <a href=\"http://www.rxlist.com/script/main/art.asp?articlekey=4560\">neutropenia</a> and <a href=\"http://www.rxlist.com/script/main/art.asp?articlekey=97574\">thrombocytopenia</a>, in patients treated.</h4> <h4 style=\"text-align: left;\">·         Hypersensitivity: Serious hypersensitivity reactions (such as <a href=\"http://www.rxlist.com/script/main/art.asp?articlekey=10935\">anaphylaxis</a> and <a href=\"http://www.rxlist.com/script/main/art.asp?articlekey=2253\">angioedema</a>) have been reported, with the onset of the reaction occurring in the majority of cases within the first month of treatment]. If reactions are severe, discontinue this drug and institute appropriate medical intervention.</h4> <h4 style=\"text-align: left;\">·         Rash: Rashes may occur during (deferasirox) treatment.</h4>

<ul> <li style=\"text-align: left;\">Creatinine clearance &lt; 40 mL/min</li> <li style=\"text-align: left;\">Poor performance status and high-risk myelodysplastic syndromes or advanced malignancies.</li> <li style=\"text-align: left;\"><a href=\"http://www.rxlist.com/script/main/art.asp?articlekey=4941\">Platelet</a> counts &lt; 50 x 10⁹/L;</li> <li style=\"text-align: left;\">Known hypersensitivity to Deferasirox or any component</li> <li style=\"text-align: left;\">Children less than 2 years old</li> </ul>

<ul> <li style=\"text-align: left;\">The recommended initial daily dose is 20 mg/kg body weight.Take once daily on an empty <a href=\"http://www.rxlist.com/script/main/art.asp?articlekey=5560\">stomach</a> at least 30 minutes before food, preferably at the same time each day.</li> <li style=\"text-align: left;\">Calculate doses (mg/kg per day) to the nearest whole tablet.</li> <li style=\"text-align: left;\">Completely disperse tablets by stirring in water, orange juice, or apple juice until a fine suspension is obtained. After swallowing the suspension, re-suspend any residue in a small volume of liquid and swallow.</li> <li style=\"text-align: left;\">Dissolve tablets in water or juice at a temperature of 15-25 ° C.</li> </ul>

<p style=\"text-align: left;\">(deferasirox) is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 6 years of age and older. In these patients, has been shown to reduce liver iron concentration and serum ferritin levels. <a href=\"http://www.rxlist.com/script/main/art.asp?articlekey=2752\">Clinical trials</a> to demonstrate increased survival or to confirm clinical benefit have not been completed.</p>

<p style=\"text-align: left;\">(Deferasirox) is an orally active chelator that is selective for iron (as Fe3+). It is a tridentate <a href=\"http://www.rxlist.com/script/main/art.asp?articlekey=22761\">ligand</a> that binds iron with high affinity in a 2:1 ratio</p>