Big Bear TUKADX Tucatinib 150mg

Product Information

• Product name: TUKADX Tucatinib 150mg
• Manufacturer / brand: Laos BigBear Pharma
• Active ingredient: Tucatinib
• Current strength: 150mg
• SKU: BB-ITEM-71
• Site category: HER2 target, other cancer

Product Summary

TUKADX Tucatinib 150mg is an AISTIKA-listed product supplied by Laos BigBear Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Tucatinib is the active ingredient used for this product page. Public prescribing information for Tucatinib was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

Tucatinib is a tyrosine kinase inhibitor of HER2. The combination of tucatinib and trastuzumab showed increased anti-tumor activity in vitro and in vivo compared to either drug alone.

Reference Indications

Tucatinib is a kinase inhibitor indicated: in combination with trastuzumab and capecitabine for treatment of adult patients with 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. This indication is approved under accelerated approval based on tumor response rate and durability of response . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. This indication is approved under accelerated approval based on tumor response rate and durability of response . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Reference Dosage and Administration

Recommended dosage: 300 mg taken orally twice daily with or without food.

With this 150mg product, that corresponds to 2 x 150mg tablets when that reference dose is clinically appropriate.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

Diarrhea : Severe diarrhea, including dehydration, acute kidney injury, and death, has been reported. Administer antidiarrheal treatment as clinically indicated. Interrupt dose, then dose reduce, or permanently discontinue Tucatinib based on severity. ( 2.2 , 5.1 ) Hepatotoxicity : Severe hepatotoxicity has been reported on Tucatinib. Monitor ALT, AST and bilirubin prior to starting Tucatinib, every 3 weeks during treatment and as clinically indicated. Interrupt dose, then dose reduce, or permanently discontinue Tucatinib based on severity. ( 2.2 , 5.2 ) Embryo-Fetal Toxicity : Tucatinib can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. ( 5.3 , 8.1 , 8.3 ) Also, refer to the of trastuzumab and capecitabine for pregnancy and contraception information.

Common Adverse Reactions and Monitoring

HER2-Positive Metastatic Breast Cancer The safety of Tucatinib in combination with trastuzumab and capecitabine was evaluated in HER2CLIMB . Patients received either Tucatinib 300 mg twice daily plus trastuzumab or a non-US approved trastuzumab product, and capecitabine (n=404) or placebo plus trastuzumab or a non-US approved trastuzumab product and capecitabine (n=197). The median duration of treatment was 5.8 months (range: 3 days, 2.9 years) for the Tucatinib arm.

Drug Interactions and Special Populations

Strong CYP3A Inducers or Moderate CYP2C8 Inducers : Avoid concomitant use. Strong CYP2C8 Inhibitors : Avoid concomitant use; reduce Tucatinib dose if concomitant use cannot be avoided. ( 2.4 , 7.1 ) CYP3A Substrates : Avoid concomitant use with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. P-gp Substrates : Consider reducing the dose of P-gp substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. Management Avoid concomitant use of Tucatinib with a strong CYP3A inducer or a moderate CYP2C8 inducer. Strong or Moderate CYP2C8 Inhibitors Clinical Impact Concomitant use of Tucatinib with a strong CYP2C8 inhibitor increased tucatinib plasma concentrations , which may increase the risk of Tucatinib toxicity.

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: TUKYSA public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.