• HER2-positive metastatic breast cancer in patients previously treated with trastuzumab and a taxane who have either received prior therapy for metastatic disease or developed disease recurrence during or within 6 mo of completing adjuvant therapy.
• Adjuvant treatment of HER2–positive early breast cancer in patients who have residual invasive disease after neoadjuvant taxane and trastuzumab-based therapy.

Contraindicated in:

• Interstitial lung disease or pneumonitis
• OB: Pregnancy
• Lactation: Lactation.

Use Cautiously in:

• Underlying cardiovascular or pulmonary disease, including dyspnea at rest
• Women of reproductive potential and men with female partners of reproductive potential should use effective contraception
• Pedi: Safety and effectiveness not established in children.

CV: HF, hypertension, peripheral edema.

Derm: pruritus, rash.

EENT: ↑ lacrimation, blurred vision, conjunctivitis, dry eyes.

F and E: hypokalemia.

GI: ↑ liver enzymes, constipation, nausea, altered taste, diarrhea, dry mouth, dyspepsia, HEPATOTOXICITY, stomatitis, vomiting.

GU: ↓ fertility.

Hemat: anemia, HEMORRHAGE, neutropenia, THROMBOCYTOPENIA.

MS: musculoskeletal pain, arthralgia, myalgia.

Neuro: fatigue, headache, peripheral neuropathy, dizziness, insomnia, weakness.

Resp: cough, INTERSTITIAL LUNG DISEASE.
Misc: chills, fever, HYPERSENSITIVITY REACTIONS, infusion-related reactions.

Drug-Drug:

• Strong CYP3A4 inhibitors, including atazanavir, clarithromycin, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, and voriconazole may ↑ levels and risk of toxicity; avoid concurrent use.
• Concurrent use of anticoagulants, or antiplatelet agents, especially during the first cycle, may ↑ risk of bleeding.

• Lyophilized powder for injection: 100 mg/vial; 160 mg/vial;

Metastatic Breast Cancer

• IV (Adults): 3.6 mg/kg every 3 wk until disease progression or unacceptable toxicity.

Early Breast Cancer

• IV (Adults): 3.6 mg/kg every 3 wk (21–day cycle) for a total of 14 cycles unless there is disease progression or unacceptable toxicity.

Kadcyla

• A HER2-targeted antibody and microtubule inhibitor conjugate. Trastuzumab, the antibody, attaches to receptors and is taken into the cell, where the microtubule inhibitor, DM1, causes cell cycle arrest and death.

• Decreased spread of metastatic breast cancer, with improved progression-free survival.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: drug-antibody conjugates

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism/Excretion: DM1 is metabolized by CYP3A4/5.

Half-life: 4 days.

(comparative improvement in progression-free survival)

• Explain purpose of medication to patient. If a dose is missed administer as soon as possible; do not wait until next scheduled dose. Adjust schedule to maintain 3 wk interval between doses.
• Inform patient of potential liver injury and HF. Advise patient to notify health care professional immediately if signs and symptoms of liver injury (nausea, vomiting, abdominal pain, jaundice, dark urine, pruritus, anorexia) or HF (new onset or worsening shortness of breath, cough, swelling of ankles/legs, palpitations, weight gain of >5 lbs in 24 hr, dizziness, loss of consciousness) occur.
• Advise patient to notify health care professional if signs of peripheral neuropathy (burning, numbness, pain in hands and feet/legs) occur.
• May cause fetal harm. Advise females of reproductive potential to use a highly effective method (IUD, hormonal contraceptive, tubal ligation, partner's vasectomy) of contraception during and for at least 7 mo after last dose. Advise males with a female partner of reproductive potential to use highly effective contraception during and for at least 4 mo after last dose. Instruct patient to notify health care professional promptly if pregnancy is suspected and to avoid breastfeeding for at least 7 mo after last dose. Encourage women who have been exposed to ado-trastuzumab either directly or through seminal fluid, to immediately report exposure to Genentech Adverse Event Line at 1-888-835-2555. May impair fertility in male and female patients.

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