Clinical Pharmacology Details


Ado-Trastuzumab Emtansine


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Indications & Dose:

As a single agent, for the treatment of patients with HER2-positive, metastatic breast cancer who 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.


DOSAGE AND ADMINISTRATION · For intravenous infusion only. Do not administer as an intravenous push or bolus. Do not use Dextrose (5%) solution · The recommended dose is 3.6 mg/kg given as an intravenous infusion every 3 weeks (21-day cycle) until disease progression or unacceptable toxicity. Do not administer at doses greater than 3.6 mg/kg. Do not substitute for or with trastuzumab· Management of adverse events (infusion-related reactions, hepatotoxicity, left ventricular cardiac dysfunction, thrombocytopenia, pulmonary toxicity or peripheral neuropathy) may require temporary

Contraindications:

None

Side Effects:

Cautions:

Precautions:

Interaction:

Warnings:

Pulmonary Toxicity: Permanently discontinue in patients diagnosed with interstitial lung disease or pneumonitis· Infusion-Related Reactions,


Hypersensitivity Reactions: Monitor for signs and symptoms during and after infusion. If significant infusionrelated reactions or hypersensitivity reactions occur, slow or interrupt the infusion and administer appropriate medical therapies. Permanently discontinue for life threatening infusion-related reaction. ·


Thrombocytopenia: Monitor platelet counts prior to each dose. Institute dose modifications as appropriate · Neurotoxicity: Monitor for signs or symptoms. Withhold dosing temporarily for patients experiencing Grade 3 or 4 peripheral neuropathy ·HER2
Testing: Perform using FDA-approved tests by laboratories with demonstrated proficiency. 

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

The most common adverse drug reactions (frequency > 25%) were fatigue, nausea, musculoskeletal pain, thrombocytopenia, headache, increased transaminases, and constipation

Patient And Carer Advice: