trastuzumab


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trastuzumab

 [tras-tuz´u-mab]
a monoclonal antibody that binds to a protein overexpressed in some breast cancers; used as an antineoplastic agent in treatment of metastatic breast cancer with such overexpression.

trastuzumab

Herceptin

Pharmacologic class: Recombinant DNA-derived monoclonal antibody

Therapeutic class: Antineoplastic

Pregnancy risk category B

FDA Box Warning

Drug can result in subclinical and clinical cardiac failure manifesting as congestive heart failure and decreased left ventricular ejection fraction.

Incidence and severity of left ventricular dysfunction were highest in patients who received trastuzumab concurrently with anthracycline-containing chemotherapy regimens.

Discontinue trastuzumab in patients receiving adjuvant therapy and strongly consider discontinuing in patients with metastatic breast cancer who develop clinically significant decrease in left ventricular function.

Monitor patients for decreased left ventricular function before starting trastuzumab and frequently during and after treatment. Monitor more frequently if drug is withheld in patients who develop significant left ventricular dysfunction.

Serious infusion reactions, some fatal, and pulmonary toxicity have occurred. In most cases, signs and symptoms occurred during or within 24 hours of administration. Interrupt infusion for patients experiencing dyspnea or clinically significant hypotension.

Discontinue drug for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.

Exacerbation of chemotherapy-induced neutropenia has also occurred.

Action

Selectively binds to human epidermal growth factor receptor 2 (HER2), inhibiting proliferation of human tumor cells that overexpress HER2

Availability

Lyophilized powder: 440-mg vial (each vial contains 20 ml bacteriostatic water for injection, 1.1% benzyl alcohol)

Indications and dosages

Metastatic breast cancer in patients whose tumors overexpress HER2

Adults: As monotherapy, loading dose of 4 mg/kg I.V. infusion over 90 minutes, followed by weekly maintenance dose of 2 mg/kg I.V. infusion given over 30 minutes if loading dose was tolerated. Don't give by I.V. push.

Contraindications

None

Precautions

Use cautiously in:

• hypersensitivity to Chinese hamster ovary cell protein or to benzyl alcohol

• cardiac disease, anemia, leukopenia

• elderly patients

• pregnant or breastfeeding patients

• children younger than age 18 (safety and efficacy not established).

Administration

• Be aware that baseline left ventricular ejection fraction (LVEF) measurement should be performed immediately before starting drug.

• Follow facility policy for handling, administering, and disposal of carcinogenic, mutagenic, and teratogenic agents.

• Give antiemetic, as prescribed, before administering trastuzumab.

Administer by I.V. infusion only. Don't give by I.V. push or bolus.

• To reconstitute, add 20 ml of bacteriostatic water for injection to vial, pointing diluent stream at lyophilized cake. Swirl vial gently; don't shake. Withdraw prescribed dose and add it to 250 ml of normal saline solution. (Don't use dextrose 5% in water.)

• Infuse loading dose I.V. over 90 minutes. Infuse weekly doses I.V. over 30 minutes.

• Immediately after reconstituting, write a date that is 28 days from reconstitution date in the space after "Do not use after" on vial label.

• If patient has benzyl alcohol hypersensitivity, reconstitute with sterile water for injection. Use immediately after reconstitution; discard unused portion.

Never administer intrathecally; doing so causes death.

• Know that for patient who hasn't previously received chemotherapy for metastatic disease, drug is given at same dosage but in combination with paclitaxel.

Adverse reactions

CNS: dizziness, headache, depression, paresthesia, insomnia, ataxia, confusion, manic reaction, seizures

CV: peripheral edema, hypotension, tachycardia, syncope, arrhythmias, shock, pericardial effusion, vascular thrombosis, heart failure, cardiotoxicity, cardiac arrest, cardiomyopathy

EENT: amblyopia, hearing loss

GI: nausea, vomiting, diarrhea, gastroenteritis, hematemesis, colitis, esophageal ulcer, stomatitis, ileus, anorexia, intestinal obstruction, pancreatitis

GU: urinary tract infection, hematuria, hemorrhagic cystitis, hydronephrosis, pyelonephritis, renal failure

Hematologic: coagulation disorder, pancytopenia, leukemia, exacerbation of chemotherapy-induced neutropenia

Hepatic: ascites, hepatitis, hepatic failure

Metabolic: hypothyroidism, hypercalcemia, hyponatremia

Musculoskeletal: back, bone, or joint pain; myopathy; fractures; bone necrosis

Respiratory: upper respiratory infection, dyspnea, pulmonary toxicity (dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, noncardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, pulmonary fibrosis)

Skin: cellulitis, rash, acne, herpes simplex, herpes zoster, skin ulcers

Other: weight loss, edema, infection, fever, chills, flulike syndrome, lymphangitis, hypersensitivity reactions including anaphylaxis, infusion reaction

Interactions

Drug-drug. Anthracyclines, cyclophosphamide: cardiotoxicity

Patient monitoring

Monitor closely for signs and symptoms of infusion reaction (including respiratory distress). Halt infusion if these occur.

• Monitor vital signs, especially for hypotension and bradycardia.

Use with extreme caution in patients with cardiac dysfunction. Assess cardiovascular status carefully; stay alert for heart failure, cardiomyopathy, and peripheral edema.

• Assess neurologic status for depression and paresthesia.

• Monitor respiratory status. Report increased dyspnea or flulike symptoms.

• Watch closely for signs and symptoms of infection, including herpes simplex.

• Monitor electrolyte levels and CBC with white cell differential.

• Monitor LVEF measurement every 3 months during and at completion of therapy; measure LVEF at 4-week intervals if drug is withheld for significant left ventricular cardiac dysfunction. Continue LVEF measurement every 6 months for at least 2 years after completion of therapy.

Patient teaching

Instruct patient to immediately report difficulty breathing, flulike symptoms, and fever, chills, and other signs and symptoms of infection.

Advise patient to monitor weight. Tell him to report sudden weight gain as well as swelling and other signs and symptoms of heart failure.

Instruct patient to immediately report abdominal pain, change in bowel habits, yellowing of skin or eyes, and easy bruising or bleeding.

• Tell patient drug may cause depression. Advise him (or significant other as appropriate) to contact prescriber if this occurs.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs mentioned above.

trastuzumab

(trăs-to͞o′zə-măb′)
n.
A humanized monoclonal antibody used intravenously to treat certain types of breast cancer and gastric cancer.

trastuzumab

Herceptin® Oncology A bioengineered monoclonal antibody used to manage Pts with breast CA who overexpress HER2, which transmits growth signals to breast CA cells. See HER2.

trastuzumab

A monoclonal antibody drug used to treat breast cancers that over-express the HER2 growth factor receptor. Trastuzumab blocks the receptors on cancer cells thus preventing the growth factor from promoting reproduction and growth of the cancer cells. In May 2005 it was announced that an international trial called Hera involving 5000 women in 39 countries had shown a 46 percent reduction in the risk of recurrence of the early stages of this kind of cancer by the use of trastuzumab. The drug is being tested on a range of other cancers. A brand name is Herceptin.
References in periodicals archive ?
And although there have been advances in the treatment of early stage HER2-positive breast cancer, around a quarter of people treated with trastuzumab following surgery will have a recurrence of their cancer.
Women (n=2,840) with early stage HER2-positive breast cancer and within two years of completing adjuvant trastuzumab therapy were randomized to receive either neratinib (n=1420) or placebo (n=1420) for one year.
According to the company, the results of the ExteNET trial demonstrated that after two years of follow-up, for patients with hormone receptor positive, HER2-positive early stage breast cancer patients who were treated within one year after the completion of trastuzumab based adjuvant therapy, invasive disease-free survival (iDFS) was 95.3% in the patients treated with neratinib compared with 90.8% in those receiving placebo.
At the time of approval, KANJINTI is the only trastuzumab biosimilar to incorporate the evaluation of a single transition in the clinical study, demonstrating similar safety and immunogenicity in patients who were previously on Herceptin.
HERITAGE is a double-blind, randomized clinical trial designed to evaluate comparative efficacy and safety of the trastuzumab biosimilar trastuzumab-dkst (formerly known as MYL-14010) versus branded trastuzumab.
The safety and tolerability profile of trastuzumab deruxtecan was also consistent with previous experience.
Purchase of a pharmaceutical preparation for intravenous use containing a trastuzumab active ingredient under itemized billing for 12 active months under an open procedure for the conclusion of a framework agreement total trastuzumab (oeno: 06010): 1,260,000 mg (exercise obligation: 1,260,000 mg) + 200% option the contracting authority draws attention to the fact that the name, potency, presentation and presentation of the medicinal product (product, preparation) offered by the offeror is a professional offer, so it cannot be filled or modified!
- Companies to share equally development and commercialization costs as well as profits worldwide from [fam-] trastuzumab deruxtecan with Daiichi Sankyo maintaining exclusive rights in Japan
Subcutaneous administration of Herceptin Hylecta resulted in non- inferior levels of trastuzumab in the blood (pharmacokinetics) and non-inferior clinical efficacy (pathological complete response rate; pCR) compared to intravenous Herceptin.
In the study, patients were given Pertuzumab along with their standard care of one-year adjuvant Trastuzumab treatment.
A separate research collaboration to conduct preclinical studies evaluating [fam-] trastuzumab deruxtecan in combination with avelumab, the DDR inhibitor and other investigational compounds in Merck KGaA, Darmstadt, Germany's and Pfizer's pipelines is also underway.
20, 2018 (HealthDay News) -- Risk of cardiotoxicity is higher for patients receiving trastuzumab and/or anthracyclines for the treatment of breast cancer, according to a study published in the Aug.