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Ado-Trastuzumab Emtansine Dosage

Applies to the following strength(s): 160 mg ; 100 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Breast Cancer

Usual dose: 3.6 mg/kg IV every 3 weeks

Maximum dose: 3.6 mg/kg IV every 3 weeks

Duration of therapy: Until disease progression or unacceptable toxicity

Comments: Administer the first infusion over 90 minutes. Subsequent infusions may be administered over 30 minutes as tolerated.

Do not substitute ado-trastuzumab emtansine for or with trastuzumab.

Renal Dose Adjustments

Mild to moderate renal dysfunction (CrCl 30 - 89 mL/min): No adjustment recommended
Severe renal dysfunction (CrCl less than 30 mL/min): Data not available

Liver Dose Adjustments

Dosing information is not available for patients with preexisting liver dysfunction.

A reduction in dose is recommended for increases in serum transaminases and/or hyperbilirubinemia that develop while on ado-trastuzumab emtansine as follows:

Serum Transaminase (AST/ALT) increases:
-Grade 2 increase (greater than 2.5 to less than or equal to 5 times ULN): No dose adjustment
-Grade 3 increase (greater than 5 to less than or equal to 20 times ULN): Hold further doses until AST/ALT recovers to Grade 2 or less and then reduce dose one level.
-Grade 4 increase (greater than 20 times ULN): Permanently discontinue treatment.

Hyperbilirubinemia:
-Grade 2 (greater than 1.5 to less than or equal to 3 times ULN): Hold further doses until total bilirubin is Grade 1 or lower and then resume treatment at same dose level.

-Grade 3 (greater than 3 to less than or equal to 10 times ULN): Hold further doses until total bilirubin is Grade 1 or lower and then reduce one dose level.

-Grade 4 (greater than 10 times ULN): Permanently discontinue ado-trastuzumab emtansine.

Permanently discontinue for concomitant serum transaminases greater than 3 times ULN and total bilirubin greater than two times ULN or for patients diagnosed with nodular regenerative hyperplasia (NRH).

Dose Adjustments

Dose Reductions:
First dose reduction: 3 mg/kg
Second dose reduction: 2.4 mg/kg
Requirement for further dose reduction: Discontinue treatment

Doses should not be re-escalated after a dose reduction is made.

Left Ventricular Dysfunction:
-For symptomatic CHF, discontinue treatment.
-For LVEF less than 40%, hold treatment and repeat LVEF assessment within 3 weeks. If LVEF less than 40% is confirmed, discontinue treatment.
-For LVEF of 40% to less than or equal to 45% with a greater than or equal to 10% decrease from baseline, hold treatment. Repeat LVEF assessment within 3 weeks. If the LVEF has not recovered to within 10% of baseline, discontinue treatment.
-For LVEF of 40% to less than or equal to 45% with a baseline decrease of less than 10%, continue treatment and repeat LVEF assessment within 3 weeks.
-For LVEF greater than 45%, continue treatment at current dose level.

Thrombocytopenia:
Platelet count less than 25,000/mm3: Hold treatment until platelet count recovers to less than or equal to Grade 1 (greater than or equal to 75,000/mm3) and then reduce one dose level.
Platelet count of 25,000/mm3 to less than 50,000/mm3: Hold treatment until platelet count recovers to less than or equal to Grade 1 (greater than or equal to 75,000/mm3) and then resume treatment at the same dose level.

Grade 3 or 4 peripheral neuropathy: Temporarily withhold treatment until resolution to Grade 2 or less.

Precautions

Consult WARNINGS section for dosing related precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-Closely monitor the infusion site for possible subcutaneous infiltration during drug administration.
-Administer the first infusion over 90 minutes. Patients should be observed during the infusion and for at least 90 minutes following the initial dose for fever, chills, or other infusion related reactions.
-Administer subsequent infusions over 30 minutes if prior infusions were well tolerated. Patients should be observed during the infusion and for at least 30 minutes after infusion.
-The infusion rate should be slowed or interrupted if the patient develops an infusion related reaction.
-If a planned dose is delayed or missed, it should be administered as soon as possible; do not wait until the next planned cycle. The schedule of administration should be adjusted to maintain a 3 week interval between doses. The infusion may be administered at the dose and rate the patient tolerated in the most recent infusion.

Storage requirements: Store vials in a refrigerator at 36 to 46 degrees Fahrenheit until time of reconstitution. Do not freeze or shake.

Reconstitution/preparation techniques: Refer to the manufacturer's product information for complete reconstitution instructions.

General:
-In order to prevent medication errors it is important to check the vial labels to ensure that the drug being prepared and administered is ado-trastuzumab emtansine and not trastuzumab.
-Follow procedures for proper handling and disposal of anticancer drugs.

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