Breast cancer:

Indications for KADCYLA:

Treatment in patients with HER2-positive (+), metastatic breast cancer (MBC) 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 6 months of completing adjuvant therapy. Adjuvant treatment in patients with HER2 (+) early breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment.

Adult:

Give by IV infusion only over 90mins. 3.6mg/kg max every 3 weeks (21-day cycle). MBC: treat until disease progression or unacceptable toxicity. EBC: treat for a total of 14 cycles unless disease recurrence or unacceptable toxicity. Subsequent infusions may be given over 30mins if previously tolerated. Monitor closely for possible SC infiltration during infusion. Dose modifications: see full labeling.

Children:

Not established.

Warnings/Precautions:

Do not substitute for or with trastuzumab. Hepatotoxicity; monitor serum transaminases and bilirubin prior to starting and to each dose; reduce dose or discontinue if occurs. Permanently discontinue if serum transaminases >3XULN and with total bilirubin >2XULN, or if nodular regenerative hyperplasia develops. Risk of left ventricular dysfunction. Assess LVEF prior to initiation and every 3 months during treatment; interrupt and discontinue as appropriate. Permanently discontinue if interstitial lung disease or pneumonitis occurs. Adjuvant therapy: permanently discontinue if Grade ≥3 or unresponsive Grade 2 radiation pneumonitis occurs. Monitor for signs/symptoms of extravasation, infusion-related or hypersensitivity reactions; if significant, slow or interrupt infusion; discontinue if life-threatening. Patients who permanently discontinued trastuzumab due to infusion-related reactions and/or hypersensitivity: not recommended. Monitor platelets at baseline and prior to each dose; if platelets <50,000/mm3, delay dose until recovery to ≥75,000/mm3; if platelets <25,000/mm3, delay until recovery to ≥75,000/mm3 and reduce dose. If thrombocytopenia occurs <100,000/mm3 and concomitant anticoagulants, monitor closely. Monitor for neurotoxicity; withhold temporarily if Grade 3 or 4 peripheral neuropathy occurs. Test for HER2 protein overexpression or gene amplification using FDA-approved tests by labs with demonstrated proficiency. Hepatic impairment: monitor closely. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Use effective contraception during therapy and for 7 months (females) or 4 months (males w. female partners) after last dose. Nursing mothers: not recommended (during and for 7 months after last dose).

Pharmacologic Class:

HER2-targeted antibody-drug conjugate.

Interactions:

Avoid concomitant strong CYP3A4 inhibitors (eg, azole antifungals, clarithromycin, atazanavir, indinavir, ritonavir, nefazodone, nelfinavir, saquinavir, telithromycin); if unavoidable, consider delaying therapy. Caution with concomitant anticoagulation or antiplatelet therapy; monitor closely.

Adverse Reactions:

Fatigue, nausea, musculoskeletal pain, hemorrhage, thrombocytopenia, headache, increased transaminases, constipation, epistaxis, peripheral neuropathy, arthralgia, oligohydramnios (do fetal testing if occurs), possible infertility.

Note:

Enroll pregnant women who were exposed to Kadcyla in the MotHER Pregnancy Registry (800) 690-6720.

Generic Availability:

NO

How Supplied:

Single-use vial—1