- Approval Id
- 0fd3781b73f1ff2e
- Drug Name
- TUKYSA (TUCATINIB) FILM-COATED TABLETS 50 mg
- Product Name
- TUKYSA (TUCATINIB) FILM-COATED TABLETS 50 mg
- Approval Number
- SIN15943P
- Approval Date
- 2020-05-19
- Registrant
- PFIZER PRIVATE LIMITED
- Licence Holder
- PFIZER PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>2 DOSAGE AND ADMINISTRATION</strong></p>
<p><strong>2.1 Recommended Dosage</strong></p>
<p>The recommended dose of TUKYSA is 300 mg (two 150 mg tablets) taken orally twice daily until disease progression or unacceptable toxicity.</p>
<p>TUKYSA tablets should be swallowed whole. Tablets should not be chewed, crushed, or split prior to swallowing.</p>
<p>TUKYSA should be taken approximately 12 hours apart, at the same time every day, with or without a meal. In the case of a missed dose, the next dose should be taken at the regularly scheduled time.</p>
<p>Refer to the Prescribing Information for trastuzumab administered in combination with TUKYSA for recommended dosing.</p>
<p>When given with TUKYSA, the recommended dose of capecitabine is 1000 mg/m<sup>2</sup> orally twice daily on Days 1 to 14 every 21 days, taken within 30 minutes after a meal. TUKYSA may be taken at the same time with capecitabine.</p>
<p><strong>2.2 Dose Modifications</strong></p>
<p><u>Dose Modifications for Adverse Reactions</u></p>
<p>The recommended TUKYSA dose modifications for patients with adverse reactions are provided in Tables 1 to 4. Refer to the Full Prescribing Information for co-administered trastuzumab and capecitabine for dose modifications for toxicities suspected to be caused by those therapies.</p>
<img src="/TGIF/Tukysa-Table1_291124.png" alt="Tukysa Dosage Table 1" /><br><br>
<img src="/TGIF/Tukysa-Table2_291124.png" alt="Tukysa Dosage Table 2" /><br><br>
<img src="/TGIF/Tukysa-Table3_291124.png" alt="Tukysa Dosage Table 3" /><br><br>
<img src="/TGIF/Tukysa-Table4_291124.png" alt="Tukysa Dosage Table 4" /><br><br>
<p><u>Dosage Modifications for Severe Hepatic Impairment</u></p>
<p>For patients with severe hepatic impairment (Child-Pugh C), reduce the recommended dosage to 200 mg orally twice daily [<em>see Use in Specific Populations (8.7), Clinical Pharmacology (11.3)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</p>
<p><u>Dosage Modifications for Concomitant Use with Strong CYP2C8 Inhibitors</u></p>
<p>Avoid concomitant use of strong CYP2C8 inhibitors with TUKYSA. If concomitant use with a strong CYP2C8 inhibitor cannot be avoided, reduce the recommended dosage to 100 mg orally twice daily. After discontinuation of the strong CYP2C8 inhibitor for 3 elimination half-lives, resume the TUKYSA dose that was taken prior to initiating the inhibitor [<em>see Drug Interactions (7.1), Clinical Pharmacology (11.3)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>].</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>1 INDICATIONS AND USAGE</strong></p>
<p>TUKYSA is indicated in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting.</p>
<p>TUKYSA is indicated in combination with trastuzumab for the treatment of patients with RAS wild-type, HER2- positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.</p>
- Contraindications
- <p><strong>4 CONTRAINDICATIONS</strong></p>
<p>Hypersensitivity to the active substance or to any of the excipients contained in TUKYSA.</p>
- Atc Code
- Pending
- Atc Item Name
- xpending
- Pharma Manufacturer Name
- MSD PHARMA (SINGAPORE) PTE. LTD.
