Tucaxen 150 Tablet

Tucatinib
150 mg
Everest Pharmaceuticals Ltd.
Pack size 30's pack
Unite Price 2160.00 BDT

Indications

Tucaxen 150 Tablet is used for: Advanced or Metastatic Breast Cancer, Colorectal Cancer

Adult Dose

Adult Oral Indicated for treatment of advanced unresectable or metastatic human epidermal growth factor (HER2)-positive, breast cancer (including brain metastases), in patients who have received >1 anti-HER2-based regimens in the metastatic setting in combination with trastuzumab and capecitabine. 300 mg BID in combination with trastuzumab and capecitabine Continue until disease progression or unacceptable toxicity Colorectal Cancer Indicated in combination with trastuzumab for RAS wild-type HER 2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy 300 mg BID Continue until disease progression or unacceptable toxicity Hepatic impairment Mild-to-moderate (Child-Pugh A or B): No dosage adjustment necessary Severe (Child-Pugh C): Reduce to 200 mg BID

Child Dose

Renal Dose

Renal impairment Mild-to-moderate (CrCl 30-89 mL/min): No dosage adjustment necessary Severe (CrCl <30 mL/min): Use in combination with trastuzumab and capecitabine is not recommended; capecitabine is contraindicated in patients with severe renal impairment

Administration

Take with or without meals Note: Capecitabine is given PO BID and taken within 30 min after a meal When given in combination, tucatinib and capecitabine can be taken at the same time

Contra Indications

Precautions

Severe hepatotoxicity has been report; monitor ALT, AST, and bilirubin prior to initiation, q3Weeks during treatment, and as clinically indicated May cause fetal harm Severe diarrhea, including dehydration, acute kidney injury, and death, has been reported Administer antidiarrheal treatment as clinically indicated Perform diagnostic tests as clinically indicated to exclude other causes of diarrhea

Pregnancy-Lactation

Pregnancy Based on animal data and its mechanism of action, fetal harm may occur when administer to pregnant females No data available on use in pregnant females to inform a drug-associated risk Verify pregnancy status of females of reproductive potential before treatment Contraception Females of reproductive potential or males with female partners of reproductive potential: Use effective contraception during treatment and at least 1 week after final dose Infertility May impair male and female fertility Animal data Administration to pregnant rats and rabbits during organogenesis resulted in embryofetal mortality, reduced fetal weight, and fetal abnormalities at maternal exposure ?1.3x the AUC at the recommended dose Advise pregnant women and females of reproductive potential of potential risk to fetus Lactation No data available on the presence of tucatinib or its metabolites in human or animal milk or its effects on the breastfed child or on milk production Advise females not to breastfeed during treatment and for at least 1 week after final dose

Interactions

Tucatinib is a substrate of CYP3A4, CYP2C8, P-glycoprotein (P-gp), and BCRP Also, reversible inhibitor of CYP3A4 and CYP2C8; time-dependent inhibitor of CYP3A4; P-gp inhibitor Strong CYP3A or moderate CYP2C8 inducers Avoid coadministration Concomitant use of tucatinib with a strong CYP3A or moderate CYP2C8 inducer decreased tucatinib plasma concentrations, which may reduce the efficacy of tucatinib CYP2C8 inhibitors Avoid coadministration with strong CYP2C8 inhibitors; reduce tucatinib dose if concomitant use cannot be avoided Concomitant use of tucatinib with a strong CYP2C8 inhibitor may increase tucatinib plasma concentrations, which may increase the risk of tucatinib toxicity Coadministration with moderate CYP2C8 inhibitors: Increase monitoring for tucatinib toxicity CYP3A substrates Avoid coadministration with sensitive CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities P-gp substrates Consider reducing dose of P-gp substrates, where minimal concentration changes may lead to serious or life-threatening toxicities

Side Effects

Side effects of Tucatinib : >10% All grades (BC) Diarrhea (81%) Palmoplantar erythrodysesthesia syndrome (63%) Decreased hemoglobin (59%) Nausea (58%) Decreased phosphate (57%) Increased bilirubin (47%) Increased ALT (46%) Increased AST (43%) Hepatotoxicity (42%) Decreased magnesium (40%) Vomiting (36%) Decreased potassium (36%) Increased creatinine (33%) Stomatitis (32%) Decreased sodium (28%) Increased alkaline phosphatase (26%) Decreased appetite (25%) Anemia (21%) Rash (20%) Arthralgia (15%) Increased creatinine (14%) Decreased weight (13%) Peripheral neuropathy (13%) Epistaxis (12%) All grades (mCRC) Diarrhea (64%) Increased creatinine (58%) Increased glucose (56%) Decreased hemoglobin (46%) Increased ALT (46%) Fatigue (44%) Decreased lymphocytes (39%) Rash (37%) Nausea (35%) Increased AST (33%) Increased bilirubin (28%) Increased alkaline phosphatase (25%) Decreased albumin 24%) Decreased leukocytes (22%) Abdominal pain (21%) Infusion-related reaction (21%) Pyrexia (20%) Decreased sodium (20%) Chills (19%) Decreased appetite (19%) Back pain (17%) Vomiting (16%) Arthralgia (16%) Cough (16%) Decreased potassium (16%) Decreased platelets (15%) Constipation (14%) Dyspnea (14%) Myalgia (13%) Grade 3 to 4 (BC) Palmoplantar erythrodysesthesia syndrome (13%) Diarrhea (0.5-12%) Grade 3 or 4 (mCRC) Decreased lymphocytes (12%) 1-10% Grade 3 to 4 (BC) Hepatoxicity (0.2-9%) Increased ALT (8%) Decreased phosphate (8%) Increased AST (6%) Decreased potassium (6%) Anemia (3.7%) Nausea (3.7%) Decreased hemoglobin (3.3%) Vomiting (3%) Stomatitis (2.5%) Decreased sodium (2.5%) Increased bilirubin (1.5%) Decreased weight (1%) Grade 3 or 4 (mCRC) Anemia (10%) Anxiety (10%) Hypertension (7%) Decreased sodium (6%) Diarrhea (3.5%) Decreased hemoglobin (3.5%) Increased AST (2.4-3.5%) Increased bilirubin (2.4-3.5%) Increased glucose (2.4%) Increased ALT (2.4%) Abdominal pain (2.3%) Fatigue (2.3%) Back pain (2.3%) Constipation (1.2%) Chills (1.2%) Arthralgia (1.2%) Increased alkaline phosphatase (1.2%) Decreased bilirubin (1.2%) Decreased potassium (1.2%)

Mode of Action

Tyrosine kinase inhibitor for HER2 Inhibits HER2 and HER3 phosphorylation in vitro, resulting in inhibition of downstream MAPK and AKT signaling and cell proliferation, and showed antitumor activity in HER2 expressing tumor cells In vivo, tucatinib inhibited growth of HER2 expressing tumors

Note

Tucaxen 150 150 mg Tablet generic name is Tucatinib. Tucaxen 150 150 mg Tablet is manufactured by Everest Pharmaceuticals Ltd.Tucaxen 150 is availble in all over Bangladesh. Mes BD drug index information on Tucaxen 150 Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

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