Trastuzumab Emtansine

Cytostatic · Monoclonal antibody

Indications

Used as a single agent for the treatment of 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 6 months of completing adjuvant therapy.

Dosage

Adults: 3.6 mg/kg via IV inf every 3 wks (21-day cycle) until disease progression or unacceptable toxicity. Do not adm more than recommended dose. Do not substitute trastuzumab emtansine with trastuzumab. Do not increase the dose again after a dose reduction is done. Children: Not recommended.

Administration

Administer as an IV infusion only with a 0.22 micron in-line non-protein adsorptive polyethersulfone (PES) filter. Do not administer as an IV push or bolus. First infusion: Adm inf over 90 mins. Patient should be observed during the inf and for at least 90 mins following the initial dose for fever, chills, or other infusion-related reactions. Subsequent infusions: Adm over 30 mins if prior infusions were well tolerated. Patients should be observed during the infusion and for at least 30 mins after infusion. Reconstitution: Using a sterile syringe, slowly inject 5 mL of SWFI into the 100 mg Trastuzumab emtansine (TE) vial, or 8 mL of SWFI into the 160 mg TE vial to yield a soln containing 20 mg/mL. Swirl the vial gently until completely dissolved. Do not shake. Inspect the soln for particulates and discolouration. The colour of the soln should be colourless to pale brown. Dilution:…

Adverse Effects

Infusion-related reactions, hepatotoxicity, left ventricular cardiac dysfunction, thrombocytopaenia, pulmonary toxicity, peripheral neuropathy (May require temporary interruption, dose reduction, or treatment discontinuation). Other: Fatigue, nausea, musculoskeletal pain, headache, constipation, increased transaminases.

Risk Factor (Pregnancy/Lactation)

Pregnancy: Positive evidence of risk: Use only when no safer alternative exists for a serious problem. Lactation: Caution advised or effect undetermined. Precautions: Discontinue in patients diagnosed with interstitial lung disease or pneumonitis. Monitor for signs and symptoms during and after infusion, reactions may require medical intervention. Monitor platelet counts prior to each dose, adjust dose as required. Monitor for signs and symptoms of neurotoxicity during infusion, stop dosing temporarily for patients experiencing Grade 3 or 4 peripheral neuropathy. Perform HER2 testing using FDA-approved tests by labs with demonstrated proficiency.

Interactions

Avoid CYP3A4 inhibitors: Ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole.

Advice to Patient

Seek medical attention if you experience symptoms of acute hepatitis such as nausea, vomiting, abdominal pain, jaundice, dark urine, generalized pruritus, anorexia. Report immediately if you experience new onset or worsening shortness of breath, cough, swelling of the ankles/legs, palpitations, wt gain >5 pounds in 24 hrs, dizziness or loss of consciousness. Females of reproductive potential must use effective contraception during treatment and for 6 months after the last dose of this medication.

Pharmacokinetics

Metabolism: Hepatic. Half-life elimination: 4 days.

Compiled by Healify Pharmacy from published drug references. How we compile it →

Always consult a pharmacist or doctor.