- Neutropenia (<2,000 neutrophils/mm3) occurs in virtually all patients
given 60-100 mg/m2 of Taxotere® and grade 4 neutropenia
(<500 cells/mm3) occurs in 85% of patients given 100 mg/m2
and 75% of patients given
60 mg/m2
- Patients should be premedicated with oral corticosteroids prior to each Taxotere® administration to reduce the incidence and severity of fluid retention. Patients with pre-existing effusions should be closely monitored from the first dose for possible exacerbation of the effusions
- Treatment-related acute myeloid leukemia (AML) or myelodysplasia has occurred in
patients given anthracyclines and/or cyclophosphamide, including use with Taxotere®
in adjuvant therapy of breast cancer
- Localized erythema of the extremities with edema followed by desquamation has been
observed
- In case of severe skin toxicity, an adjustment in dosage is recommended
- Severe neurosensory symptoms (paresthesia, dysesthesia, pain) were observed in 5.5%
(53/965) of metastatic breast cancer patients, and resulted in
treatment discontinuation in 6.1%
- When these symptoms occur, dosage must be adjusted; if symptoms persist, treatment
should be discontinued
- Severe asthenia was reported in 14.9% (144/965) of metastatic breast cancer
patients, but led to treatment discontinuation in only 1.8%
- Symptoms of fatigue and weakness may last a few days up to several weeks and may
be associated with deterioration of performance status in patients with progressive
disease
- Taxotere® can cause fetal harm when administered to pregnant women. Women of childbearing potential should be advised to avoid becoming pregnant during therapy with Taxotere®
- The most common adverse reactions across all Taxotere® indications are infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions and myalgia
- In patients treated with TCF for gastric cancer, the incidence of serious adverse
events was higher in patients ≥65 years than in younger patients. Adverse events
(all grades) occurring at rates ≥10% higher in elderly patients included lethargy,
stomatitis, diarrhea, dizziness, edema, and febrile neutropenia/neutropenic infection.
- Taxotere® should be administered in a facility equipped to manage possible complications (e.g. anaphylaxis)
Please click here for Taxotere full prescribing information, including boxed WARNING.
Taxotere® (docetaxel) Injection Concentrate Indications
Breast Cancer
TAXOTERE® is indicated for the treatment of patients with locally
advanced or metastatic breast cancer after failure of prior chemotherapy
TAXOTERE® in combination with doxorubicin and cyclophosphamide is
indicated for the adjuvant treatment of patients with operable node-positive breast
cancer
Advanced Non-Small Cell Lung Cancer
TAXOTERE®, as a single agent, is indicated for the treatment of patients
with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure
of prior platinum-based chemotherapy
TAXOTERE® in combination with cisplatin is indicated for the treatment
of patients with unresectable, locally advanced or metastatic NSCLC who have not
previously received chemotherapy for this condition.
Metastatic Androgen-Independent Prostate Cancer
TAXOTERE® in combination with prednisone is indicated for the treatment
of patients with androgen-independent (hormone-refractory) metastatic prostate cancer.
Advanced Gastric/GE Junction Cancer
TAXOTERE® in combination with cisplatin and fluorouracil is indicated
for the treatment of patients with advanced gastric adenocarcinoma, including adenocarcinoma
of the gastroesophageal junction, who have not received prior chemotherapy for advanced
disease.
Locally Advanced Head and Neck Cancer
TAXOTERE® in combination with cisplatin and fluorouracil is indicated
for the induction treatment of patients with locally advanced squamous cell carcinoma
of the head and neck (SCCHN).
Important safety information for Herceptin® (trastuzumab)
Boxed WARNINGS and Additional Important Safety Information
Cardiomyopathy
- Herceptin administration can result in sub-clinical and clinical cardiac
failure. The incidence and severity was highest in patients receiving Herceptin
with anthracycline-containing chemotherapy regimens. In a pivotal adjuvant trial,
one patient who developed CHF died of cardiomyopathy.
- Herceptin can cause left ventricular cardiac dysfunction, arrhythmias, hypertension,
disabling cardiac failure, cardiomyopathy, and cardiac death.
- Herceptin can also cause asymptomatic decline in LVEF.
- Discontinue Herceptin treatment in patients receiving adjuvant therapy and
withhold Herceptin in patients with metastatic disease for clinically significant
decrease in left ventricular function.
Cardiac Monitoring
- Evaluate cardiac function prior to and during treatment. For adjuvant therapy,
also evaluate cardiac function after completion of Herceptin.
- Conduct thorough cardiac assessment, including history, physical examination, and
determination of LVEF by echocardiogram or MUGA scan.
- Monitor frequently for decreased left ventricular function during and after Herceptin
treatment.
- Monitor more frequently if Herceptin is withheld for significant left ventricular
cardiac dysfunction.
Infusion Reactions
- Herceptin administration can result in serious and fatal infusion reactions.
- Symptoms usually occur during or within 24 hours of Herceptin administration.
- Interrupt Herceptin infusion for dyspnea or clinically significant hypotension.
- Monitor patients until symptoms completely resolve.
- Discontinue Herceptin for infusion reactions manifesting as anaphylaxis,
angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. Strongly
consider permanent discontinuation in all patients with severe infusion reactions.
- Infusion reactions consist of a symptom complex characterized by fever and chills,
and on occasion include nausea, vomiting, pain (in some cases at tumor sites), headache,
dizziness, dyspnea, hypotension, rash, and asthenia.
Embryo-Fetal Toxicity
- Exposure to Herceptin during pregnancy can result in oligohydramnios and
oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities,
and neonatal death.
- Advise women of the potential hazard to the fetus resulting from Herceptin exposure
during pregnancy and provide counseling to women of childbearing potential to use
effective contraceptive methods during treatment and for a minimum of six months
following Herceptin.
- Advise nursing mothers treated with Herceptin to discontinue nursing or discontinue
Herceptin, taking into account the importance of the drug to the mother.
- Encourage women who are exposed to Herceptin during pregnancy to enroll in MotHER-
the Herceptin Pregnancy Registry.
Pulmonary Toxicity
- Herceptin administration can result in serious and fatal pulmonary toxicity,
which includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural
effusions, non-cardiogenic pulmonary edema, pulmonary insufficiency and hypoxia,
acute respiratory distress syndrome, and pulmonary fibrosis. Such events can occur
as sequelae of infusion reactions.
- Patients with symptomatic intrinsic lung disease or with extensive tumor involvement
of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity.
- Discontinue Herceptin in patients experiencing pulmonary toxicity.
Exacerbation of Chemotherapy-Induced Neutropenia
- In randomized, controlled clinical trials, the per-patient incidences of NCI CTC
Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving
Herceptin in combination with myelosuppressive chemotherapy as compared to those
who received chemotherapy alone. The incidence of septic death was similar among
patients who received Herceptin and those who did not.
HER2 Testing
- Detection of HER2 protein overexpression is necessary for selection of patients
appropriate for Herceptin therapy because these are the only patients studied and
for whom benefit has been shown. Tests should be performed by laboratories with
demonstrated proficiency in the specific technology being utilized.
Most Common Adverse Reactions
- The most common adverse reactions associated with Herceptin® use
were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased
cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia.
Please see the
Herceptin full prescribing information including Boxed WARNINGS
and additional important safety information.
Herceptin® (trastuzumab) Indication
Herceptin® is indicated for adjuvant treatment of HER2-overexpressing,
node-positive or node-negative
(ER/PR negative or with one high-risk feature*) breast cancer as part of a treatment
regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel,
or a treatment regimen with docetaxel and carboplatin
* High risk is defined as ER/PR positive with one of the following features: tumor
size >2 cm, age <35 years, or histological or tumor grade 2 or 3.