Article Contents ::

Details About Generic Salt ::  Trastuzu

Main Medicine Class::    

(tras-TOO-ze-mab)
Herceptin
Sterile Powder for Injection, Lyophilized
440 mg
Class: Humanized monoclonal anti-HER2 antibody

 Indications Breast cancer.

 Contraindications None well documented.

 Route/Dosage

Breast Cancer

ADULTS: IV The recommended initial loading dose is 4 mg/kg infused over 90 min. The recommended weekly maintenance dose is 2 mg/kg and can be infused over 30 min if the initial loading dose was tolerated. Trastuzumab may be administered in an outpatient setting. Do not administer as an IV push or bolus.

Interactions There have been no formal drug interaction studies performed with trastuzumab in humans. Administration of paclitaxel in combination with trastuzumab resulted in a 2-fold decrease in trastuzumab clearance in a nonhuman primate study and in a 1.5-fold increase in trastuzumab serum levels in clinical studies. The incidence and severity of cardiac dysfunction increases in patients who receive trastuzumab in combination with anthracyclines and cyclophosphamide.

Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: CHF; peripheral edema; tachycardia; ventricular dysfunction. CNS: Headache; depression; dizziness; insomnia; neuropathy; paresthesia; peripheral neuritis; asthenia. DERMATOLOGIC: Acne (rare); herpes simplex; rash. GI: Moderate to low potential for nausea and vomiting; diarrhea (25%); anorexia; abdominal pain. GU: Urinary tract infection. HEMATOLOGIC: Mild anemia; leukopenia. HYPERSENSITIVITY: Allergic reactions rarely, including anaphylactoid reactions, asthma, hives, rash. METABOLIC: Peripheral edema. MUSCULOSKELETAL: Arthralgia; bone pain; back pain. RESPIRATORY: Cough; dyspnea; pharyngitis; rhinitis; sinusitis. OTHER: Chills; pain; fever; flu syndrome (eg, fever, chills, malaise); infection. Chills and fever reported in approximately 40% within 1 to 2 hr of the initial infusion. Rigors, dyspnea, and hypotension also may occur. Reactions are usually mild to moderate in severity and do not require discontinuation of therapy. The incidence decreases approximately 20% with subsequent doses.

 Precautions

Pregnancy: Category B. Lactation: Advise women to discontinue nursing during trastuzumab therapy and for 6 mo after the last dose because human IgG is excreted in breast milk, and the potential for absorption and harm to the infant is unknown. Children: Safety and efficacy have not been established. Elderly: The risk of cardiac dysfunction may be increased. The reported clinical experience is not adequate to determine whether older patients respond differently than younger patients. Cardiotoxicity: Signs and symptoms of cardiac dysfunction, such as dyspnea, increased cough, paroxysmal nocturnal dyspnea, peripheral edema, S3 gallop, or reduced ejection fraction, have been observed. Hypersensitivity reactions, including anaphylaxis: Severe hypersensitivity reactions have been infrequently reported in patients with trastuzumab. Infusion reactions: In the postmarketing setting, rare occurrences of severe infusion reactions leading to fatal outcome have been associated with the use of trastuzumab. Pulmonary events: Patients with either symptomatic intrinsic pulmonary disease (eg, asthma, COPD) or extensive tumor involvement of the lungs (eg, lymphangitic spread of tumor, pleural effusions, parenchymal masses), resulting in dyspnea at rest, may be at increased risk for severe pulmonary adverse events.

PATIENT CARE CONSIDERATIONS


 Administration/Storage

  • Refrigerate.
  • Reconstitute vial aseptically with 20 mL of bacteriostatic water for injection (supplied) or sterile water for injection (not supplied). The final concentration will be 21 mg/mL.
  • Withdraw appropriate dose from vial and dilute in 250 mL 0.9% Sodium Chloride.
  • Do not reconstitute or dilute with 5% Dextrose since aggregation may occur.
  • Trastuzumab is stable for 28 days refrigerated.
  • Trastuzumab solutions reconstituted with sterile water are preservative-free; use within 24 hr. The possibility of microbial contamination must be considered.
  • Refrigerate diluted solutions and use within 24 hr when stored in PVC or polyethylene bags.

 Assessment/Interventions

  • Frequently monitor patients for deteriorating cardiac function. Assess baseline cardiac function including history and physicial exam and at least 1 of the following: ECG, echocardiogram, and MUGA scan. Monitoring may not identify all patients who will develop cardiac dysfunction.
  • Use with caution in patients with known hypersensitivity to trastuzumab, Chinese Hamster ovary cell proteins, or any component of this product.
  • For patients with a known hypersensitivity to benzyl alcohol (the preservative in Bacteriostatic Water for Injection), reconstitute trastuzumab with Sterile Water for Injection, and discard following a single use.

Immunogenicity

  • Human anti-human antibody to trastuzumab was detected in 1 patient.
OVERDOSAGE: SIGNS & SYMPTOMS
  There is no experience with overdosage in human clinical trials. Single doses greater than 500 mg have not been tested.

 Patient/Family Education

  • Explain name, action, and potential side effects of drug.
  • Advise patient, family, or caregiver that medication will be prepared and administered by health care provider in a health care setting.
  • Advise patient, family, or caregiver that medication will be used in combination with other agents to achieve maximum benefit possible.
  • Review dosing schedule with patient, family, or caregiver.
  • Advise patient, family, or caregiver to immediately report any of the following to health care provider: rash; itching; hives; shortness of breath or difficulty breathing; unexplained cough; swelling in arms or legs; fever, chills, or other signs of infection.
  • Advise patient, family, or caregiver to report any of the following to health care provider: persistent nausea, vomiting, diarrhea, or appetite loss; persistent or worsening general body weakness.
  • Instruct patient not to take any prescription or OTC medications or dietary supplements unless advised to do so by health care provider.
  • Instruct women of childbearing potential to notify health care provider if pregnant, planning to become pregnant, or breastfeeding.
  • Advise patient that frequent follow-up visits, ECG, heart function tests, and laboratory tests will be required to monitor therapy and to keep appointments.

Medicscientist Drug Facts

 

Drugs Class ::

(tras-TOO-ze-mab)
Herceptin
Sterile Powder for Injection, Lyophilized
440 mg
Class: Humanized monoclonal anti-HER2 antibody

Indications for Drugs ::

 Indications Breast cancer.

Drug Dose ::

 Route/Dosage

Breast Cancer

ADULTS: IV The recommended initial loading dose is 4 mg/kg infused over 90 min. The recommended weekly maintenance dose is 2 mg/kg and can be infused over 30 min if the initial loading dose was tolerated. Trastuzumab may be administered in an outpatient setting. Do not administer as an IV push or bolus.

Contraindication ::

 Contraindications None well documented.

Drug Precautions ::

 Precautions

Pregnancy: Category B. Lactation: Advise women to discontinue nursing during trastuzumab therapy and for 6 mo after the last dose because human IgG is excreted in breast milk, and the potential for absorption and harm to the infant is unknown. Children: Safety and efficacy have not been established. Elderly: The risk of cardiac dysfunction may be increased. The reported clinical experience is not adequate to determine whether older patients respond differently than younger patients. Cardiotoxicity: Signs and symptoms of cardiac dysfunction, such as dyspnea, increased cough, paroxysmal nocturnal dyspnea, peripheral edema, S3 gallop, or reduced ejection fraction, have been observed. Hypersensitivity reactions, including anaphylaxis: Severe hypersensitivity reactions have been infrequently reported in patients with trastuzumab. Infusion reactions: In the postmarketing setting, rare occurrences of severe infusion reactions leading to fatal outcome have been associated with the use of trastuzumab. Pulmonary events: Patients with either symptomatic intrinsic pulmonary disease (eg, asthma, COPD) or extensive tumor involvement of the lungs (eg, lymphangitic spread of tumor, pleural effusions, parenchymal masses), resulting in dyspnea at rest, may be at increased risk for severe pulmonary adverse events.

PATIENT CARE CONSIDERATIONS


Drug Side Effects ::

 Adverse Reactions

CARDIOVASCULAR: CHF; peripheral edema; tachycardia; ventricular dysfunction. CNS: Headache; depression; dizziness; insomnia; neuropathy; paresthesia; peripheral neuritis; asthenia. DERMATOLOGIC: Acne (rare); herpes simplex; rash. GI: Moderate to low potential for nausea and vomiting; diarrhea (25%); anorexia; abdominal pain. GU: Urinary tract infection. HEMATOLOGIC: Mild anemia; leukopenia. HYPERSENSITIVITY: Allergic reactions rarely, including anaphylactoid reactions, asthma, hives, rash. METABOLIC: Peripheral edema. MUSCULOSKELETAL: Arthralgia; bone pain; back pain. RESPIRATORY: Cough; dyspnea; pharyngitis; rhinitis; sinusitis. OTHER: Chills; pain; fever; flu syndrome (eg, fever, chills, malaise); infection. Chills and fever reported in approximately 40% within 1 to 2 hr of the initial infusion. Rigors, dyspnea, and hypotension also may occur. Reactions are usually mild to moderate in severity and do not require discontinuation of therapy. The incidence decreases approximately 20% with subsequent doses.

Drug Mode of Action ::  

(tras-TOO-ze-mab)
Herceptin
Sterile Powder for Injection, Lyophilized
440 mg
Class: Humanized monoclonal anti-HER2 antibody

Drug Interactions ::

Interactions There have been no formal drug interaction studies performed with trastuzumab in humans. Administration of paclitaxel in combination with trastuzumab resulted in a 2-fold decrease in trastuzumab clearance in a nonhuman primate study and in a 1.5-fold increase in trastuzumab serum levels in clinical studies. The incidence and severity of cardiac dysfunction increases in patients who receive trastuzumab in combination with anthracyclines and cyclophosphamide.

Drug Assesment ::

 Assessment/Interventions

  • Frequently monitor patients for deteriorating cardiac function. Assess baseline cardiac function including history and physicial exam and at least 1 of the following: ECG, echocardiogram, and MUGA scan. Monitoring may not identify all patients who will develop cardiac dysfunction.
  • Use with caution in patients with known hypersensitivity to trastuzumab, Chinese Hamster ovary cell proteins, or any component of this product.
  • For patients with a known hypersensitivity to benzyl alcohol (the preservative in Bacteriostatic Water for Injection), reconstitute trastuzumab with Sterile Water for Injection, and discard following a single use.

Immunogenicity

  • Human anti-human antibody to trastuzumab was detected in 1 patient.
OVERDOSAGE: SIGNS & SYMPTOMS
  There is no experience with overdosage in human clinical trials. Single doses greater than 500 mg have not been tested.

Drug Storage/Management ::

 Administration/Storage

  • Refrigerate.
  • Reconstitute vial aseptically with 20 mL of bacteriostatic water for injection (supplied) or sterile water for injection (not supplied). The final concentration will be 21 mg/mL.
  • Withdraw appropriate dose from vial and dilute in 250 mL 0.9% Sodium Chloride.
  • Do not reconstitute or dilute with 5% Dextrose since aggregation may occur.
  • Trastuzumab is stable for 28 days refrigerated.
  • Trastuzumab solutions reconstituted with sterile water are preservative-free; use within 24 hr. The possibility of microbial contamination must be considered.
  • Refrigerate diluted solutions and use within 24 hr when stored in PVC or polyethylene bags.

Drug Notes ::

 Patient/Family Education

  • Explain name, action, and potential side effects of drug.
  • Advise patient, family, or caregiver that medication will be prepared and administered by health care provider in a health care setting.
  • Advise patient, family, or caregiver that medication will be used in combination with other agents to achieve maximum benefit possible.
  • Review dosing schedule with patient, family, or caregiver.
  • Advise patient, family, or caregiver to immediately report any of the following to health care provider: rash; itching; hives; shortness of breath or difficulty breathing; unexplained cough; swelling in arms or legs; fever, chills, or other signs of infection.
  • Advise patient, family, or caregiver to report any of the following to health care provider: persistent nausea, vomiting, diarrhea, or appetite loss; persistent or worsening general body weakness.
  • Instruct patient not to take any prescription or OTC medications or dietary supplements unless advised to do so by health care provider.
  • Instruct women of childbearing potential to notify health care provider if pregnant, planning to become pregnant, or breastfeeding.
  • Advise patient that frequent follow-up visits, ECG, heart function tests, and laboratory tests will be required to monitor therapy and to keep appointments.

Medicscientist Drug Facts

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