13.12.2013

General guidelines for coding breast cancer and treatment

Hepatotoxicity, predominantly in the form of asymptomatic increases in the concentrations of serum transaminases, has been observed in clinical trials with KADCYLA.
Serious hepatobiliary disorders, including at least 2 fatal cases of severe drug-induced liver injury and associated hepatic encephalopathy, have been reported in clinical trials with KADCYLA.
Monitor serum transaminases and bilirubin prior to initiation of KADCYLA treatment and prior to each KADCYLA dose. In clinical trials of KADCYLA, cases of nodular regenerative hyperplasia (NRH) of the liver have been identified from liver biopsies (3 cases out of 884 treated patients, 1 of which was fatal). Patients treated with KADCYLA are at increased risk of developing left ventricular dysfunction (LVD).
Assess LVEF prior to initiation of KADCYLA and at regular intervals (eg, every 3 months) during treatment. Verify the pregnancy status of women of reproductive potential prior to the initiation of KADCYLA. If KADCYLA is administered during pregnancy or if a patient becomes pregnant while receiving KADCYLA or within 7 months following the last dose of KADCYLA, immediately report exposure to the Genentech Adverse Event Line at 1-888-835-25551-888-835-2555. Cases of interstitial lung disease (ILD), including pneumonitis, some leading to acute respiratory distress syndrome or fatal outcome, have been reported in clinical trials with KADCYLA. Treatment with KADCYLA should be permanently discontinued in patients diagnosed with ILD or pneumonitis. Patients with dyspnea at rest due to complications of advanced malignancy and comorbidities may be at increased risk of pulmonary events. KADCYLA treatment should be interrupted in patients with severe IRRs and permanently discontinued in the event of a life-threatening IRR. Cases of hemorrhagic events, including central nervous system, respiratory, and gastrointestinal hemorrhage, have been reported in clinical trials with KADCYLA. Although in some of the observed cases the patients were also receiving anticoagulation therapy or antiplatelet therapy, or had thrombocytopenia, in others there were no known additional risk factors.
Peripheral neuropathy, mainly as Grade 1 and predominantly sensory, was reported in clinical trials of KADCYLA.


KADCYLA should be temporarily discontinued in patients experiencing Grade 3 or 4 peripheral neuropathy until resolution to ?Grade 2. Detection of HER2 protein overexpression or gene amplification is necessary for selection of patients appropriate for KADCYLA therapy, because these are the only patients studied for whom benefit has been shown.
There is no information regarding the presence of ado-trastuzumab emtansine in human milk, the effects on the breastfed infant, or the effects on milk production. Please see accompanying full Prescribing Information for additional Important Safety Information, including Boxed WARNINGS. Within this section, healthcare providers can find important supplemental information to help in the treatment of patients with HER2-positive (HER2+) metastatic breast cancer (MBC).
KADCYLA® (ado-trastuzumab emtansine), as a single agent, is indicated for the treatment of patients with HER2-positive (HER2+), metastatic breast cancer (MBC) who previously received trastuzumab and a taxane, separately or in combination.
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Some of the observed cases may have been confounded by comorbidities and concomitant medications with known hepatotoxic potential. Patients with known active hepatitis B virus or hepatitis C virus were excluded from EMILIA. A decrease of left ventricular ejection fraction (LVEF) to <40% has been observed in patients treated with KADCYLA.
Treatment with KADCYLA has not been studied in patients with LVEF <50% prior to treatment. Treatment with trastuzumab, the antibody component of KADCYLA, during pregnancy in the postmarketing setting has resulted in cases of oligohydramnios; oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death were observed in the postmarketing setting in patients treated with trastuzumab. Advise pregnant women and females of reproductive potential that exposure to KADCYLA during pregnancy or within 7 months prior to conception can result in fetal harm. In the randomized trial, the overall frequency of IRRs in patients treated with KADCYLA was 1.4%. Medications to treat such reactions, as well as emergency equipment, should be available for immediate use.


Assessment of HER2 status should be done using an FDA-approved test performed by laboratories with demonstrated proficiency.
These reactions, observed more frequently within 24 hours of infusion, were usually mild and comprised erythema, tenderness, skin irritation, pain, or swelling at the infusion site. DM1, the cytotoxic component of KADCYLA, may cause serious adverse reactions in breastfed infants, based on its mechanism of action. If, at routine monitoring, LVEF is <40%, or is 40% to 45% with a 10% or greater absolute decrease below the pretreatment value, withhold KADCYLA and repeat LVEF assessment within approximately 3 weeks. DM1, the cytotoxic component of KADCYLA, can cause embryo-fetal toxicity, based on its mechanism of action. Advise women of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of KADCYLA. In most patients, these reactions resolved over the course of several hours to a day after the infusion was terminated.
Use caution with these agents and consider additional monitoring when concomitant use is medically necessary. In clinical trials of KADCYLA, the incidence and severity of thrombocytopenia were higher in Asian patients.
The infusion site should be closely monitored for possible subcutaneous infiltration during drug administration. Advise women not to breastfeed during treatment and for 7 months following the last dose of KADCYLA.
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