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Herceptin
Overview
What is Herceptin?
Herceptin (trastuzumab) is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture containing the antibiotic gentamicin. Gentamicin is not detectable in the final product.
Herceptin (trastuzumab) is a sterile, white to pale yellow, preservative-free lyophilized powder for Injection, for intravenous administration.
Each multiple-dose vial of Herceptin delivers 420 mg trastuzumab, 381.8 mg α,α-trehalose dihydrate, 9.5 mg L-histidine HCl monohydrate, 6.1 mg L-histidine, and 1.7 mg polysorbate 20. Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab at a pH of approximately 6. If Herceptin is reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose.
Each single-dose vial of Herceptin delivers 150 mg trastuzumab, 136.2 mg α,α-trehalose dihydrate, 3.4 mg L-histidine HCl monohydrate, 2.2 mg L-histidine, and 0.6 mg polysorbate 20. Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab that delivers 7.15 mL (150 mg trastuzumab), at a pH of approximately 6.
What does Herceptin look like?
What are the available doses of Herceptin?
What should I talk to my health care provider before I take Herceptin?
Females and Males of Reproductive Potential: Verify the pregnancy status of females prior to initiation of Herceptin ().
How should I use Herceptin?
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
Select patients for therapy based on an FDA-approved companion diagnostic for Herceptin .
Select patients based on HER2 protein overexpression or HER2 gene amplification in tumor specimens . Assessment of HER2 protein overexpression and HER2 gene amplification should be performed using FDA-approved tests specific for breast or gastric cancers by laboratories with demonstrated proficiency. Information on the FDA-approved tests for the detection of HER2 protein overexpression and HER2 gene amplification is available at: http://www.fda.gov/CompanionDiagnostics.
Assessment of HER2 protein overexpression and HER2 gene amplification in metastatic gastric cancer should be performed using FDA-approved tests specifically for gastric cancers due to differences in gastric vs. breast histopathology, including incomplete membrane staining and more frequent heterogeneous expression of HER2 seen in gastric cancers.
Improper assay performance, including use of suboptimally fixed tissue, failure to utilize specified reagents, deviation from specific assay instructions, and failure to include appropriate controls for assay validation, can lead to unreliable results.
What interacts with Herceptin?
Sorry No Records found
What are the warnings of Herceptin?
Sorry No Records found
What are the precautions of Herceptin?
Sorry No Records found
What are the side effects of Herceptin?
Sorry No records found
What should I look out for while using Herceptin?
None.
What might happen if I take too much Herceptin?
There is no experience with overdosage in human clinical trials. Single doses higher than 8 mg/kg have not been tested.
How should I store and handle Herceptin?
Store Herceptin vials in the refrigerator at 2°C to 8°C (36°F to 46°F) until time of reconstitution.Ketorolac Tromethamine Injection, USP is supplied as follows:Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from light. Retain in carton until time of use. Revised: 7/2015EN-3996Hospira, Inc., Lake Forest, IL 60045 USAKetorolac Tromethamine Injection, USP is supplied as follows:Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from light. Retain in carton until time of use. Revised: 7/2015EN-3996Hospira, Inc., Lake Forest, IL 60045 USAKetorolac Tromethamine Injection, USP is supplied as follows:Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from light. Retain in carton until time of use. Revised: 7/2015EN-3996Hospira, Inc., Lake Forest, IL 60045 USAKetorolac Tromethamine Injection, USP is supplied as follows:Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from light. Retain in carton until time of use. Revised: 7/2015EN-3996Hospira, Inc., Lake Forest, IL 60045 USAKetorolac Tromethamine Injection, USP is supplied as follows:Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from light. Retain in carton until time of use. Revised: 7/2015EN-3996Hospira, Inc., Lake Forest, IL 60045 USA
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The HER2 (or c-erbB2) proto-oncogene encodes a transmembrane receptor protein of 185 kDa, which is structurally related to the epidermal growth factor receptor. Herceptin has been shown, in both assays and in animals, to inhibit the proliferation of human tumor cells that overexpress HER2.
Herceptin is a mediator of antibody-dependent cellular cytotoxicity (ADCC). , Herceptin-mediated ADCC has been shown to be preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2.
Non-Clinical Toxicology
None.Clinically Significant Drug Interactions:
Concurrent administration of vasopressor drugs and of ergot-type oxytocic drugs may cause severe, persistent hypertension or cerebrovascular accidents.
Phenothiazines and butyrophenones may reduce or reverse the pressor effect of epinephrine.
Herceptin can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death . Herceptin can also cause asymptomatic decline in left ventricular ejection fraction (LVEF).
There is a 4–6 fold increase in the incidence of symptomatic myocardial dysfunction among patients receiving Herceptin as a single agent or in combination therapy compared with those not receiving Herceptin. The highest absolute incidence occurs when Herceptin is administered with an anthracycline.
Withhold Herceptin for ≥ 16% absolute decrease in LVEF from pre-treatment values or an LVEF value below institutional limits of normal and ≥ 10% absolute decrease in LVEF from pretreatment values . The safety of continuation or resumption of Herceptin in patients with Herceptin-induced left ventricular cardiac dysfunction has not been studied.
Patients who receive anthracycline after stopping Herceptin may also be at increased risk of cardiac dysfunction .
Cardiac Monitoring
Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan. The following schedule is recommended:
In Study 1, 15% (158/1031) of patients discontinued Herceptin due to clinical evidence of myocardial dysfunction or significant decline in LVEF after a median follow-up duration of 8.7 years in the AC-TH arm. In Study 3 (one-year Herceptin treatment), the number of patients who discontinued Herceptin due to cardiac toxicity at 12.6 months median duration of follow-up was 2.6% (44/1678). In Study 4, a total of 2.9% (31/1056) of patients in the TCH arm (1.5% during the chemotherapy phase and 1.4% during the monotherapy phase) and 5.7% (61/1068) of patients in the AC-TH arm (1.5% during the chemotherapy phase and 4.2% during the monotherapy phase) discontinued Herceptin due to cardiac toxicity.
Among 64 patients receiving adjuvant chemotherapy (Studies 1 and 2) who developed congestive heart failure, one patient died of cardiomyopathy, one patient died suddenly without documented etiology, and 33 patients were receiving cardiac medication at last follow-up. Approximately 24% of the surviving patients had recovery to a normal LVEF (defined as ≥50%) and no symptoms on continuing medical management at the time of last follow-up. Incidence of congestive heart failure (CHF) is presented in. The safety of continuation or resumption of Herceptin in patients with Herceptin-induced left ventricular cardiac dysfunction has not been studied.
In Study 3 (one-year Herceptin treatment), at a median follow-up duration of 8 years, the incidence of severe CHF (NYHA III & IV) was 0.8%, and the rate of mild symptomatic and asymptomatic left ventricular dysfunction was 4.6%.
In Study 4, the incidence of NCI-CTC Grade 3/4 cardiac ischemia/infarction was higher in the Herceptin containing regimens (AC-TH: 0.3% (3/1068) and TCH: 0.2% (2/1056)) as compared to none in AC-T.
The following adverse reactions are discussed in greater detail in other sections of the label:
The most common adverse reactions in patients receiving Herceptin in the adjuvant and metastatic breast cancer setting are fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia. Adverse reactions requiring interruption or discontinuation of Herceptin treatment include CHF, significant decline in left ventricular cardiac function, severe infusion reactions, and pulmonary toxicity .
In the metastatic gastric cancer setting, the most common adverse reactions (≥ 10%) that were increased (≥ 5% difference) in the Herceptin arm as compared to the chemotherapy alone arm were neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia. The most common adverse reactions which resulted in discontinuation of treatment on the Herceptin-containing arm in the absence of disease progression were infection, diarrhea, and febrile neutropenia.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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