Drug ID: 1d00000034
Drug Name: Ado-trastuzumab Emtansine
Generic Names: Kadcyla
Legal Status: Non Opioid Prescription only drug
Indication for Mother: No data available.
Recommended Dose: The recommended dose is 3.6 mg/kg every 3 weeks (21-day cycle).
Recommended In: This medication is a HER2-targeted antibody and microtubule inhibitor, prescribed as a single medicine for the treatment in patients with HER2-positive metastatic breast cancer who have previously received trastuzumab and a taxane separately or in combination. Patients should have either received prior therapy for metastatic disease, or developed disease recurrence during or within six months of completing adjuvant therapy.
Directions For Use: It comes as powder for injection (diluted with fluid), to be administered by a healthcare provider into the vein.
Storage: Store vials in a refrigerator at 2°C to 8°C.
Dosage Forms: Intravenous injection
Side Effects: Serious Effects - Lung problems, injection site reactions, nerve damage, heart damage, embryo-fetal toxicity.
Most Common - Fatigue, nausea, muscle and bone pain, decrease in platelet counts, headache, increased level of liver enzymes and constipation.
Miscellaneous - Tiredness, liver problems, nerve problems.
In Case of Overdose: There is no known antidote for overdose of Ado-trastuzumab Emtansine. In clinical trials, overdose of Ado-trastuzumab Emtansine has been reported at approximately two times the recommended dose which resulted in Grade 2 thrombocytopenia (resolved 4 days later) and one death.
Avoid If: Caution should be exercised in patients with history of liver or heart problem, any allergy, who are taking other medications, elderly, children, during pregnancy and breastfeeding.
Ado-trastuzumab emtansine should not be administered at doses greater than 3.6 mg/kg.
Should not substitute for or with trastuzumab.
Monitor platelet counts prior to each dose of this drug administration.
Perform HER2 testing while taking this medication.
Discontinue this medication in patients diagnosed with interstitial lung disease or pneumonitis.
Drug Interaction: No formal drug-drug interaction studies with Ado-trastuzumab Emtansine have been conducted. In vitro studies indicate that DM1, the cytotoxic component of Ado-trastuzumab Emtansine, is metabolized mainly by CYP3A4 and to a lesser extent by CYP3A5. Concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, and voriconazole) with Ado-trastuzumab Emtansine should be avoided due to the potential for an increase in DM1 exposure and toxicity. Consider an alternate medication with no or minimal potential to inhibit CYP3A4. If concomitant use of strong CYP3A4 inhibitors is unavoidable, consider delaying Ado-trastuzumab Emtansine treatment until the strong CYP3A4 inhibitors have cleared from the circulation (approximately 3 elimination half-lives of the inhibitors) when possible. If a strong CYP3A4 inhibitor is coadministered and Ado-trastuzumab Emtansine treatment cannot be delayed, patients should be closely monitored for adverse reactions.