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<li> <a href="https://medic.co.il/news-index/">All News</a> </li> <li> <a href="https://medic.co.il/jobs/">Bulletin Board</a> </li> </ul> </div> </li> <li class="sign-up"><a href="#">SIGN IN</a></li></menu> </div> </div> <div class="page-wrap"> <div class="page-title-wrap " > <div class="page-title" > <h1 class="title en"> <span>Cresemba 100 mg Capsules</span> <div class="subtitle"> <span class="subtitle-slash">/ </span> <span class="manufacturer-name tooltip-bottom-center" title="Pfizer Pharmaceuticals Israel Ltd"> Pfizer </span> </div> </h1> </div> <div class="page-title-footer"> <div class="icons"> <div class="icon"> <img src="https://medic.co.il/wp-content/themes/rgb/assets/images/icons/Rx 45px.svg" class="tooltip-bottom-left" title="Medical prescription" alt="RX"> </div> <div class="icon"> <img src="https://medic.co.il/wp-content/themes/rgb/assets/images/icons/partial basket 45px.svg" class="tooltip-bottom-center" title="Partially covered by the Health basket" alt="partial basket chart"> </div> </div> </div> </div> <div class="page-breadcrumbs-wrap"> <div class="page-breadcrumbs-inner"> <div class="page-breadcrumbs"> <div class="page-breadcrumb "> <div class="page-breadcrumb-inner"> <div class="breadcrumb-level"> <a href="https://medic.co.il/biological-system/infections/"> Infections </a> </div> <div class="breadcrumb-level"> <a href="https://medic.co.il/therapeutic-system/fungal-infections/"> Fungal Infections </a> </div> </div> </div> </div> <div class="drug-class"> <div class="drug-class-item"><a href="https://medic.co.il/drug-class/antimycotic/">Antimycotic</a></div> <div class="drug-class-item"><a href="https://medic.co.il/drug-class/triazole-derivatives/">Triazole Derivatives</a></div> </div> </div> </div> <div class="page-content"> <aside> <div class="drug-summary"> <div class="title">Drug summary</div> <p><a href="https://medic.co.il/drug-class/antimycotic/"><i>Antimycotic</i></a>, <a href="https://medic.co.il/drug-class/triazole-derivatives/"><i>Triazole Derivatives</i></a>. <a href="https://medic.co.il/active-ingredient/isavuconazole/">Isavuconazole 100 mg</a>. </br>CAPS.: 14. <strong>Loading dose is 2 caps (200mg)脳3/d every 8 hrs. for the first 48 hrs. (6 admin. in total).<br /> </strong><strong>Mainten. dose: 2 caps. (200mg)脳1/d, start. 12-24 hrs. after the last load. dose. </strong><strong>Durat. of ther. should be determin. by the clinic. response.<br /> </strong><strong>For long-term tmt. beyond 6 mnths., the benefit-risk balance should be careful. consid.<br /> </strong><em>Tmt. of invas. aspergillosis; mucormycosis in pt. for whom amphotericin B is inapprop.聽 </em><em>Consider. should be given to offic. guidance on the approp. use of antifung. agents.<br /> </em><strong>C/I</strong>: Hypersens. Co-admin. with ketoconazole. Co-admin. with high-dose ritonavir (>200 mg every 12 hrs). Co-admin. with strong CYP3A4/5 induc. such as rifampicin, rifabutin, carbamazepine, long-act. barbiturates (e.g. phenobarbital), phenytoin and St. John鈥檚 wort or with moder. CYP3A4/5 induc. such as efavirenz, nafcillin & etravirine. Pts. with famil. short QT syndr.</p> </div> <div class="info-line "> <h2 class="title">INFO LINE</h2> <hr> <h2>Related docs</h2> <a target="_blank" href="https://medic.co.il/wp-content/uploads/2019/07/Cresemba-100-mg-capsules-LPD-CC-160924.cleaned.pdf" class="buttons button-blue he">注诇讜谉诇专讜驻讗</a> <hr> <h2>Researches</h2> <div class="posts-lists"> <div class="post-item he"> <div class="from-date">02/03/2025</div> <a href="https://medic.co.il/2025/03/02/%d7%97%d7%a9%d7%99%d7%91%d7%95%d7%aa-%d7%94%d7%a2%d7%a8%d7%9b%d7%aa-%d7%94%d7%a1%d7%99%d7%9b%d7%95%d7%9f-%d7%9c%d7%a0%d7%a4%d7%99%d7%9c%d7%94-%d7%91%d7%91%d7%97%d7%99%d7%a8%d7%94-%d7%91%d7%99%d7%9f-ga/" class="post-title" target="_self">讞砖讬讘讜转讛注专讻转讛住讬讻讜谉诇谞驻讬诇讛讘讘讞讬专讛讘讬谉 Gabapentin 讜-Duloxetine 讘拽砖讬砖讬诐</a> <div class="underline"> <span class="from">From</span> <span class="writer medic">Medic</span> <span class="source">By <span class="he">诪讚讬拽<span></span> </div> </div> <div class="post-item he"> <div class="from-date">26/02/2025</div> <a href="https://medic.co.il/2025/02/26/%d7%a2%d7%93%d7%95%d7%99%d7%95%d7%aa-%d7%97%d7%93%d7%a9%d7%95%d7%aa-%d7%aa%d7%95%d7%9e%d7%9b%d7%95%d7%aa-%d7%91%d7%91%d7%98%d7%99%d7%97%d7%95%d7%aa-%d7%95%d7%99%d7%a2%d7%99%d7%9c%d7%95%d7%aa-tildrakiz/" class="post-title" target="_self">注讚讜讬讜转讞讚砖讜转转讜诪讻讜转讘讘讟讬讞讜转讜讬注讬诇讜转 Tildrakizumab 诇讗讜专讱讝诪谉讻谞讙讚驻住讜专讬讗讝讬住专讜讘讚讬转砖诇讛拽专拽驻转</a> <div class="underline"> <span class="from">From</span> <span class="writer medic">Medic</span> <span class="source">By <span class="he">诪讚讬拽<span></span> </div> </div> <div class="post-item he"> <div class="from-date">25/02/2025</div> <a href="https://medic.co.il/2025/02/25/%d7%90%d7%99%d7%9a-%d7%90%d7%95%d7%a8%d7%95%d7%a7%d7%a1%d7%99%d7%9c%d7%99%d7%9f-a-%d7%9e%d7%a9%d7%a4%d7%99%d7%a2-%d7%a2%d7%9c-%d7%a4%d7%a1%d7%95%d7%a8%d7%99%d7%90%d7%96%d7%99%d7%a1-2/" class="post-title" target="_self">讗讬讱讗讜专讜拽住讬诇讬谉 A 诪砖驻讬注注诇驻住讜专讬讗讝讬住?</a> <div class="underline"> <span class="from">From</span> <span class="writer medic">Medic</span> <span class="source">By <span class="he">诪讚讬拽<span></span> </div> </div> </div> </div> </aside> <main> <div class="active-ingredient"> <div class="ingredient"> <hr class="firts"> <div class="title"> Active Ingredient </div> <div class="content"> <div class="item"> <a href="https://medic.co.il/active-ingredient/isavuconazole/">Isavuconazole</a> 100 mg </div> </div> </div> <div class="status"> <hr class=""> <div class="title"> Status in Israel </div> <div class="content"> <img src="https://medic.co.il/wp-content/themes/rgb/assets/images/icons/Rx 45px.svg" class="tooltip-bottom-left" title="Medical prescription" alt="RX"> </div> </div> </div> <hr> <h2 class="section-title">Presentation and Status in Health Basket</h2> <div class="chart-wrap"> <table class="chart not_kupot"> <thead> <tr> <th>Presentation</th> <th>Basket</th> <th>Yarpa</th> <th>Pharmasoft</th> </tr> </thead> <tbody> <tr> <td> <p> <strong> Capsules </strong> </p> <p> 14 X 100 mg </p> </td> <td> <img src="https://medic.co.il/wp-content/themes/rgb/assets/images/icons/partial basket chart.svg" class="tooltip-bottom-center" title="Partially covered by the Health basket" alt="partial basket chart"> </td> <td>40384</td> <td></td> </tr> </tbody> </table> </div> <hr class=""> <div class="read-more-wrap"> <h2 class="section-title">Dosage</h2> <div class="body-text read-more-block"> <p><strong><em>Loading dose:聽</em></strong>The recommended loading dose is two capsules (equivalent to 200 mg of isavuconazole) every 8 hours for the first 48 hours (6 administrations in total).<br /> <strong><em>Maintenance dose:聽</em></strong>The recommended maintenance dose is two capsules (equivalent to 200 mg of isavuconazole) once daily, starting 12 to 24 hours after the last loading dose.<br /> Duration of therapy should be determined by the clinical response.<br /> For long-term treatment beyond 6 months, the benefit-risk balance should be carefully considered.<br /> This drug聽 is also available as powder for concentrate for solution for infusion containing 200 mg isavuconazole, equivalent to 372 mg isavuconazonium sulfate.<br /> On the basis of the high oral bioavailability (98%), switching between intravenous and oral administration is appropriate when clinically indicated.<br /> <strong><em>Elderly:聽</em></strong>No dose adjustment is necessary for elderly patients; however the clinical experience in elderly patients is limited.<br /> <strong><em>Renal impairment:聽</em></strong>No dose adjustment is necessary in patients with renal impairment, including patients with end-stage renal disease.<br /> <strong><em>Hepatic impairment:聽</em></strong>No dose adjustment is necessary in patients with mild or moderate hepatic impairment (Child-Pugh Classes A and B).<br /> Isavuconazole has not been studied in patients with severe hepatic impairment (Child-Pugh Class C). Use in these patients is not recommended unless the potential benefit is considered to outweigh the risks.<br /> <strong><em>Paediatric population:聽</em></strong>Isavuconazole is not indicated for children aged below 18 years.<br /> <em><strong>Method of administration:</strong></em> Isavuconazole capsules can be taken with or without food. Isavuconazole capsules should be swallowed whole. Do not chew, crush, dissolve or open the capsules.</p> </div> </div> <hr class=""> <div class="read-more-wrap"> <h2 class="section-title">Indications</h2> <div class="body-text read-more-block"> <p>In adults for the treatment聽of:<br /> – invasive aspergillosis.<br /> – mucormycosis in patients for whom amphotericin B is inappropriate.<br /> Consideration should be given to official guidance on the appropriate use of antifungal agents.</p> </div> </div> <hr class=""> <div class="read-more-wrap"> <h2 class="section-title">Contra-Indications</h2> <div class="body-text read-more-block"> <p>Hypersensitivity to the active substance or to any of the excipients.<br /> Co-administration with ketoconazole.<br /> Co-administration with high-dose ritonavir (>200 mg every 12 hours).<br /> Co-administration with strong CYP3A4/5 inducers such as rifampicin, rifabutin, carbamazepine, long-acting barbiturates (e.g. phenobarbital), phenytoin and St. John鈥檚 wort or with moderate CYP3A4/5 inducers such as efavirenz, nafcillin and etravirine.<br /> Patients with familial short QT syndrome.</p> </div> </div> <hr class=""> <div class="read-more-wrap"> <h2 class="section-title">Special Precautions</h2> <div class="body-text read-more-block"> <p><strong><em>Hypersensitivity:</em></strong>Caution should be used in prescribing isavuconazole to patients with hypersensitivity to other azole antifungal agents. Hypersensitivity to isavuconazole may result in adverse reactions that include: hypotension, respiratory failure, dyspnoea, drug eruption, pruritus, and rash.<strong><em><br /> </em></strong><strong><em>Severe cutaneous adverse reactions:聽</em></strong>Severe cutaneous adverse reactions, such as Stevens-Johnson syndrome, have been reported during treatment with azole antifungal agents. If a patient develops a severe cutaneous adverse reaction, isavuconazole should be discontinued.<br /> <strong><em>QT shortening:聽</em></strong>CRESEMBA is contraindicated in patients with familial short QT syndrome. In a QT study in healthy human subjects, isavuconazole shortened the QTc interval in a concentration-related manner.<br /> <strong><em>Elevated liver transaminases or hepatitis:聽</em></strong>Elevated liver transaminases have been reported in clinical studies. The elevations in liver transaminases rarely required discontinuation of Isavuconazole. Monitoring of hepatic enzymes should be considered, as clinically indicated. Hepatitis has been reported with azole antifungal agents including isavuconazole.<br /> <strong><em>Severe hepatic impairment:聽</em></strong>Isavuconazole has not been studied in patients with severe hepatic impairment (Child-Pugh Class C). Use in these patients is not recommended unless the potential benefit is considered to outweigh the risks. These patients should be carefully monitored for potential drug toxicity.<br /> See prescribing information for full details.</p> </div> </div> <hr class=""> <div class="read-more-wrap"> <h2 class="section-title">Side Effects</h2> <div class="body-text read-more-block"> <p>Elevated liver chemistry tests, nausea, vomiting, dyspnea, abdominal pain, diarrhea, injection site reaction, headache, hypokalaemia and rash.<br /> See prescribing information for full details.</p> </div> </div> <hr class=""> <div class="read-more-wrap"> <h2 class="section-title">Drug interactions</h2> <div class="body-text read-more-block"> <p><em><strong>Potential of medicinal products to affect the pharmacokinetics of isavuconazole:聽</strong></em>Isavuconazole is a substrate of CYP3A4 and CYP3A5. Co-administration of medicinal products which are inhibitors of CYP3A4 and/or CYP3A5 may increase the plasma concentrations of isavuconazole. Co-administration of medicinal products which are inducers of CYP3A4 and/or CYP3A5 may decrease the plasma concentrations of isavuconazole.<br /> <strong><em>Medicinal products that inhibit CYP3A4/5:聽</em></strong>Co-administration of Isavuconazole with the strong CYP3A4/5 inhibitor ketoconazole is contraindicated, since this medicinal product can significantly increase plasma concentrations of isavuconazole.<br /> For the strong CYP3A4 inhibitor lopinavir/ritonavir, a two-fold increase in isavuconazole exposure was observed. For other strong CYP3A4 inhibitors, such as clarithromycin, indinavir and saquinavir, a less pronounced effect can be expected, based on their relative potency. No dose adjustment of CRESEMBA is necessary when co-administered with strong CYP3A4/5 inhibitors, however caution is advised as adverse drug reactions may increase.<br /> <strong><em>Medicinal products that induce CYP3A4/5:聽</em></strong>Co-administration of Isavuconazole with potent CYP3A4/5 inducers such as rifampicin, rifabutin, carbamazepine, long-acting barbiturates (e.g., phenobarbital), phenytoin and St. John鈥檚 wort, or with moderate CYP3A4/5 inducers such as efavirenz, nafcillin and etravirine, is contraindicated, since these medicinal products can significantly decrease plasma concentrations of isavuconazole.<br /> Co-administration with mild CYP3A4/5 inducers such as aprepitant, prednisone and pioglitazone, may result in mild to moderate decreases of isavuconazole plasma levels; co-administration with mild CYP3A4/5 inducers should be avoided unless the potential benefit is considered to outweigh the risk.<br /> Co-administration with high-dose ritonavir (>200 mg twice daily) is contraindicated, as at high doses ritonavir may induce CYP3A4/5 and decrease isavuconazole plasma concentrations.<br /> See prescribing information for full details.</p> </div> </div> <hr class=""> <div class="read-more-wrap"> <h2 class="section-title">Pregnancy and Lactation</h2> <div class="body-text read-more-block"> <p><strong><em>Pregnancy:聽</em></strong>There are no data from the use of use isavuconazole聽 in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown.<br /> Isavuconazole must not be used during pregnancy except in patients with severe or potentially life-threatening fungal infections, in whom isavuconazole may be used if the anticipated benefits outweigh the possible risks to the foetus.<br /> <strong><em>Lactation</em><em>:聽</em></strong>Breast-feeding should be discontinued during treatment with Isavuconazole.<em><br /> </em>See prescribing information for full details.</p> </div> </div> <hr class=""> <div class="read-more-wrap"> <h2 class="section-title">Overdose</h2> <div class="body-text read-more-block"> <p><strong><em>Symptoms:聽</em></strong>Symptoms reported more frequently at supratherapeutic doses of Isavuconazole (equivalent to isavuconazole 600 mg/day) evaluated in a QT study than in the therapeutic dose group (equivalent to isavuconazole 200 mg/day dose) included: headache, dizziness, paraesthesia, somnolence, disturbance in attention, dysgeusia, dry mouth, diarrhoea, oral hypoaesthesia, vomiting, hot flush, anxiety, restlessness, palpitations, tachycardia, photophobia and arthralgia.<br /> <em><strong>Management:聽</strong></em>Isavuconazole is not removed by haemodialysis. There is no specific antidote for isavuconazole. In the event of an overdose, supportive treatment should be institute.</p> </div> </div> <hr class=""> <div class="read-more-wrap"> <h2 class="section-title">Important notes</h2> <div class="body-text read-more-block"> <p><strong><em>Storage</em></strong><strong>:</strong> Store below 25掳C. Store in the original package in order to protect from moisture.</p> </div> </div> <hr class=""> <div class="manufacture-block"> <div class="item manufacturer"> <div class="headline">Manufacturer</div> <div class="text"> <span>Almac Pharma Services Limited, UK</span> </div> </div> <div class="item"> <div class="headline">Licence holder</div> <div class="text"> <a href="https://medic.co.il/license-holder/pfizer-pfe-pharmaceuticals-israel-ltd/"> Pfizer Pharmaceuticals Israel Ltd </a> </div> </div> </div> </main> </div> <script type="text/javascript"> var drugObj = {"id":61138,"name":"Cresemba 100 mg Capsules","alternative_user_id":0,"user_email":"","first_name":"","FirstName":"","last_name":"","LastName":"","reg_date":"","profession":"","expertise":"","sub_expertise":"","biological":"Infections","therapeutic":"Fungal Infections","drug_classes":"Antimycotic|Triazole Derivatives","active_ingredients":"Isavuconazole"}; </script> </div> <footer> <div class="footer-inner"> <div 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