Adjuvant treatment

• Herceptin, Ogivri
• Indicated for adjuvant treatment of HER-2 overexpressing breast cancer
• See also Administration
• During and following paclitaxel, docetaxel, or docetaxel/carboplatin
  • 4 mg/kg IV over 90 min, THEN
  • 2 mg/kg IV over 30 min qWeek during chemotherapy for the first 12 weeks (paclitaxel or docetaxel) or 18 weeks (docetaxel/carboplatin)
  • One week following the last weekly dose, administer at 6 mg/kg as an IV over 30−90 min q3Weeks
  • Administer according to doses and schedules for a total of 52 weeks
• As a single agent within 3 weeks following completion of multi-modality, anthracycline-based chemotherapy regimens
  • 8 mg/kg IV over 90 min, THEN
  • 6 mg/kg as an IV over 30−90 min q3Weeks
  • Administer according to doses and schedules for a total of 52 weeks
  • Extending adjuvant treatment beyond one year not recommended

Metastatic breast cancer

• Treat as a single agent or in combination with paclitaxel
• 4 mg/kg IV over 90 min, THEN
• 2 mg/kg IV over 30 min, qWeek, continue until disease progression

Infusion Reactions

• Decrease infusion rate for mild-moderate infusion reactions
• Interrupt infusion if dyspnea or clinically significant hypotension
• Strongly consider permanent discontinuation if severe and life-threatening infusion reactions

Cardiomyopathy

• Assess LVEF prior to initiation and frequently during treatment
• Withhold for at least 4 weeks
  • 16% absolute decrease in LVEF from pre-treatment values
  • LVEF below institutional limits of normal and ≥10% absolute decrease in LVEF from pretreatment values
  • Resume drug if, within 4-8 weeks, the LVEF returns to normal and absolute decrease from baseline is ≤15%
  • Permanently discontinue for a persistent (>8 weeks) LVEF decline or for suspension of drug on >3 occasions for cardiomyopathy

Orphan indication sponsor

• Genentech, Inc; 1 DNA Way; South San Francisco, CA 94080-4990

  Adverse Effects:

  >10% (Metastatic breast cancer)

  Pain (47%)

  Asthenia (42%)

  Fever (36%)

  Nausea (33%)

  Chills (32%)

  Cough (26%)

  Headache (26%)

  Diarrhea (25%)

  Vomiting (23%)

  Abdominal pain (22%)

  Back pain (22%)

  Dyspnea (22%)

  Infection (20%)

  Rash (18%)

  Anorexia (14%)

  Insomnia (14%)

  Dizziness (13%)

  1-10% (Adjuvant Breast Treatment)

  Headache (10%)

  Nasopharyngitis (8%)

  Diarrhea (7%)

  Nausea (6%)

  Pyrexia (6%)

  Peripheral edema (5%)

  Back pain (5%)

  Chills (5%)

  Asthenia (4.5%)

  Myalgia (4%)

  Hypertension (4%)

  Dizziness (4%)

  Influenza (4%)

  Rash (4%)

  Vomiting (3.5%)

  Bone pain (3%)

  UTI (3%)

  Administration:

  IV Incompatibilities

  Dextrose solutions

  Not to be mixed with other drugs

  IV Preparation

  420 mg multiple-dose vial

  • Reconstitute powder with 20 mL of supplied diluent (bacteriostatic water for injection [BWFI]; contains 1.1% benzyl alcohol as a preservative)
  • If patient has known hypersensitivity to benzyl alcohol, drug may be reconstituted with sterile water for injection (SWI), but use SWI-reconstituted drug immediately
  • Reconstituted vial yields 21 mg/mL
  • Slowly inject 20 mL of diluent into vial; stream of diluent should be directed into the lyophilized cake
  • Do not shake; swirl vial gently to aid reconstitution
  • Slight foaming of the product may be present upon reconstitution; allow vial to stand undisturbed for ~5 minutes
  • Solution should be free of visible particulates; appear clear to slightly opalescent and colorless to pale yellow
  • See also Storage

  150 mg single-dose vial

  • Reconstitute with 7.4 mL of Sterile Water for Injection (SWFI) (not supplied) to yield a solution containing 21 mg/mL trastuzumab
  • Do not shake; swirl vial gently to aid reconstitution
  • Slight foaming of the product may be present upon reconstitution; allow vial to stand undisturbed for ~5 minutes
  • Solution should be free of visible particulates; appear clear to slightly opalescent and colorless to pale yellow

  Further dilution

  • Withdraw calculated dose from reconstituted vial and add to a polyvinylchloride- or polyethylene-bag containing 250 mL 0.9% NaCl
  • Gently invert the bag to mix the solution

  IV Administration

  Not for IV push or bolus administration

  Administer initial IV infusion over 90 min

  Subsequent weekly IV infusions may be administered over 30 min if prior infusions are well tolerated

  Missed dose ≤1 week

  • Usual maintenance dose (weekly schedule: 2 mg/kg; three-weekly schedule: 6 mg/kg) should be administered as soon as possible
  • Do not wait until next planned cycle
  • Subsequent maintenance doses should be administered 7 days or 21 days later according to qWeek or q3Weeks schedule, respectively

  Missed dose >1 week

  • Reload dose (weekly schedule: 4 mg/kg; three-weekly schedule: 8 mg/kg) over ~90 min, as soon as possible
  • Subsequent maintenance doses (weekly schedule: 2 mg/kg; three-weekly schedule 6 mg/kg) should be administered 7 days or 21 days later according to qWeek or q3Weeks schedule, respectively