- Approval Id
- 2cb4075177f13f97
- Drug Name
- AKYNZEO CAPSULES 300MG/0.5MG
- Product Name
- AKYNZEO CAPSULES 300MG/0.5MG
- Approval Number
- SIN15031P
- Approval Date
- 2016-06-08
- Registrant
- JUNIPER HEALTHCARE PTE LTD
- Licence Holder
- JUNIPER HEALTHCARE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- CAPSULE, GELATIN COATED
- Dosage
- <p><strong>2 DOSAGE AND ADMINISTRATION</strong></p>
<p><u>Administration</u><br>
One AKYNZEO capsule administered approximately 1 hour prior to the start of chemotherapy.</p>
<p><u>Highly Emetogenic Chemotherapy, including Cisplatin Based Chemotherapy</u><br>
The recommended dosage in adults is one capsule of AKYNZEO administered approximately 1 hour prior to the start of chemotherapy with dexamethasone 12 mg administered orally 30 minutes prior to chemotherapy on day 1 and 8 mg orally once daily on days 2 to 4 <em>[see Clinical Studies (14), Table 5)]</em>.</p>
<p>[From <strong>14 CLINICAL STUDIES</strong>]</p>
<img src="/TGIF/Akynzeo-Table5.png" alt="Akynzeo Dosage Table 5" /><br><br>
<p><u>Moderately Emetogenic Chemotherapy / Anthracyclines and Cyclophosphamide-based Chemotherapy</u><br>
The recommended dosage in adults is one capsule of AKYNZEO approximately 1 hour prior to the start of chemotherapy with dexamethasone 12 mg administered orally 30 minutes prior to chemotherapy on day 1. Administration of dexamethasone on days 2 to 4 is not necessary <em>[see Clinical Studies (14), Table 7]</em>.</p>
<p>[From <strong>14 CLINICAL STUDIES</strong>]</p>
<img src="/TGIF/Akynzeo-Table7.png" alt="Akynzeo Dosage Table 7" /><br><br>
<p>AKYNZEO can be taken with or without food.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>1 INDICATIONS AND USAGE</strong></p>
<p>AKYNZEO is indicated in adults for the:</p>
<ul class="dash">
<li>Prevention of acute and delayed nausea and vomiting associated with highly emetogenic chemotherapy, including cisplatin.</li>
<li>Prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy.</li>
</ul>
- Contraindications
- <p><strong>4 CONTRAINDICATIONS</strong></p>
<p>Pregnancy</p>
- Atc Code
- A04AA55
- Atc Item Name
- palonosetron, combinations
- Pharma Manufacturer Name
- juniper healthcare pte ltd
