- Approval Id
- 1ae00e38e27f392e
- Drug Name
- NIBINASE HARD GELATIN CAPSULE 12.5MG
- Product Name
- NIBINASE HARD GELATIN CAPSULE 12.5MG
- Approval Number
- SIN16741P
- Approval Date
- 2023-03-24
- Registrant
- RANBAXY (MALAYSIA) SDN. BHD.
- Licence Holder
- RANBAXY (MALAYSIA) SDN. BHD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- CAPSULE
- Dosage
- <p><strong>DOSE AND METHOD OF ADMINISTRATION</strong></p>
<p>Therapy should be initiated by a physician experienced in the administration of anti-cancer agents.</p>
<p>For GIST and MRCC, the recommended dose of sunitinib is 50 mg taken orally once daily for 4 consecutive weeks, followed by a 2-week off period (Schedule 4/2) to comprise a complete cycle of 6 weeks.</p>
<p>For pNET, the recommended dose of sunitinib is 37.5 mg taken orally once daily without a scheduled rest period.</p>
<p>Sunitinib may be taken with or without food.</p>
<p>If a dose is missed, the patient should not be given an additional dose. The patient should take the usual prescribed dose on the following day.</p>
<p><u>Dose Modifications</u></p>
<p><em>Safety and Tolerability</em></p>
<p>For GIST and MRCC, dose modifications in 12.5 mg increments or decrements may be applied based on individual safety and tolerability up to 75 mg or down to 25 mg.</p>
<p>For pNET, dose modification in 12.5 mg increments or decrements may be applied based on individual safety and tolerability. The maximum dose administered in the Phase 3 pNET study was 50 mg daily.</p>
<p>Dose interruptions may be required based on individual safety and tolerability.</p>
<p><em>CYP3A4 Inhibition/Induction</em></p>
<p>Co-administration of sunitinib with strong CYP3A4 inducers such as rifampin, should be avoided (see <strong>DRUG INTERACTIONS</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). If this is not possible, the dose of sunitinib may need to be increased in 12.5 mg increments to a maximum of 87.5 mg (GIST and RCC) or 62.5 mg (pNET) daily, based on careful monitoring of tolerability.</p>
<p>Co-administration of sunitinib with strong CYP3A4 inhibitors, such as ketoconazole, should be avoided (see <strong>DRUG INTERACTIONS</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). If this is not possible, the dose of sunitinib may need to be reduced in 12.5 mg decrements to a minimum of 37.5 mg (GIST and RCC) or 25 mg (pNET) daily, based on careful monitoring of the tolerability.</p>
<p>Selection of an alternate concomitant medication with no or minimal potential to induce or inhibit CYP3A4 should be considered.</p>
<p><em>Pediatric Use</em><br>
The safety and efficacy of sunitinib in pediatric patients have not been established.</p>
<p>Sunitinib should not be used in pediatric population until further data become available.</p>
<p><em>Elderly Patients Use</em><br>
Approximately 34% of the subjects in clinical studies of sunitinib were 65 years of age or over. No significant differences in safety or efficacy were observed between younger and older patients.</p>
<p><em>Hepatic Insufficiency</em><br>
No dose adjustment is recommended when administering sunitinib to patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. Sunitinib has not been studied in subjects with severe (Child-Pugh Class C) hepatic impairment (see <strong>PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES, pharmacokinetic properties</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em>Renal Insufficiency</em><br>
No starting dose adjustment is required when administering sunitinib to patients with renal impairment (mild-severe) or with end-stage renal disease (ESRD) on hemodialysis. Subsequent dose adjustments should be based on individual safety and tolerability.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>INDICATIONS</strong></p>
<p><strong>Gastrointestinal Stromal Tumor</strong><br>
Sunitinib is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumor (GIST) after failure of imatinib mesylate treatment due to resistance or intolerance (see <strong>PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES, Pharmacodynamic properties</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</p>
<p><strong>Metastatic Renal Cell Carcinoma</strong><br>
Sunitinib is indicated for the treatment of advanced and/or metastatic renal cell carcinoma (MRCC) (see <strong>PHARMACODYNAMIC AND PHARMACOKINETIC PROPERTIES, Pharmacodynamic properties</strong> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Pancreatic Neuroendocrine Tumors</strong><br>
Sunitinib is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET) with disease progression.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS</strong></p>
<p>Use of sunitinib is contraindicated in patients with hypersensitivity to sunitinib malate or to any of the excipients.</p>
- Atc Code
- L01EX01
- Atc Item Name
- sunitinib
- Pharma Manufacturer Name
- RANBAXY (MALAYSIA) SDN. BHD.
