Tukanic 150 mg (Tablet)
Unit Price: ৳ 1,200.00 (1 x 30: ৳ 36,000.00)
Medicine Details
| Category | Details |
|---|---|
| Generic | Tucatinib |
| Company | Ziska pharmaceuticals ltd |
Indications
- Treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer
- Treatment of patients with brain metastases
- Combination therapy with trastuzumab and capecitabine
- Patients who have received one or more prior anti-HER2-based regimens in the metastatic setting
Pharmacology
- Tucatinib is a tyrosine kinase inhibitor of HER2
- Inhibition of downstream MAPK and AKT signaling
- Cell proliferation inhibition
- Anti-tumor activity in HER2 expressing tumor cells
- Inhibition of the growth of HER2 expressing tumors
- Tucatinib and trastuzumab combination showed increased anti-tumor activity
Exposure Response Relationship
Not fully characterized
Cardiac Electrophysiology
No large mean increase in QTc detected
Pharmacokinetics
- Tucatinib AUC0-INF and Cmax increases proportionally over a dosage range
- 1.7-fold accumulation for AUC and 1.5-fold accumulation for Cmax following administration of Tucatinib 300 mg twice daily for 14 days
- Time to steady state approximately 4 days
Absorption
Median time to peak plasma concentration of Tucatinib was approximately 2 hours
Distribution
- Geometric mean apparent volume of distribution of tucatinib was approximately 1670 L
- Plasma protein binding was 97.1% at clinically relevant concentrations
Elimination
- Geometric mean half-life of tucatinib was approximately 8.5 hours
- Apparent clearance was 148 L/h
Metabolism
Tucatinib is metabolized primarily by CYP2C8 and to a lesser extent via CYP3A
Excretion
Approximately 86% of the total radiolabeled dose was recovered in feces and 4.1% in urine
Dosage & Administration
- Recommended dosage of Tucatinib is 300 mg taken orally twice daily
- Dosage modifications for severe hepatic impairment
- Dosage modifications for concomitant use with strong CYP2C8 inhibitors
Side Effects
- Diarrhea
- Hepatotoxicity
- Palmar-plantar erythrodysesthesia
- Nausea
- Fatigue
- Vomiting
- Stomatitis
- Decreased appetite
- Abdominal pain
- Headache
- Anemia
- Rash
Pregnancy & Lactation
- Tucatinib can cause fetal harm when administered to a pregnant woman
- No available human data on Tucatinib use in pregnant women
- Advise pregnant women of the potential risk to the fetus
- No data on the presence of Tucatinib or its metabolites in human or animal milk
- Adverse reactions in a breastfed child
Precautions & Warnings
- Severe diarrhea including dehydration, hypotension, acute kidney injury, and death
- Median time to onset of the first episode of diarrhea was 12 days
- Severe hepatotoxicity
- Advice on embryo-fetal toxicity
- Pediatric use not established
- Renal and hepatic impairment considerations
Use in Special Populations
- Pediatric use not established
- Not recommended in patients with severe renal impairment
- Tucatinib exposure increased in severe hepatic impairment
Overdose Effects
No specific antidote
Therapeutic Class
Cytotoxic Chemotherapy
Storage Conditions
- Store below 25°C
- Cool and dry place
- Keep away from light
- Keep out of the reach of children