PERTUZUMAB/ TRASTUZUMAB/ HYALURONIDASE-ZZXF INJ,SOLN
Clinical Criteria Summary
Indications
- Neoadjuvant therapy for HER2+, locally advanced, inflammatory or early stage breast cancer (EBC) as part of a treatment regimen for early breast cancer
- Adjuvant therapy in HER2+ EBC at high risk of recurrence
- With docetaxel for HER2+ metastatic breast cancer (MBC) who have not received prior HER2-directed therapy or chemotherapy for metastatic disease
Patient Selection & Inclusion Criteria
- Age > 18 years
- ECOG PS 0-1
- HER2+ status (IHC 3+ and/or ISH+)
- Locally advanced, inflammatory, or early stage breast cancer (operable) stage II-IIIC
- LVEF > 55%
Dosage & Administration
- Subcutaneous injection formulation containing pertuzumab, trastuzumab, and hyaluronidase for subcutaneous dispersion
- Loading dose: 1200 mg pertuzumab, 600 mg trastuzumab, 30,000 units hyaluronidase/15ml SDV
- Maintenance dose: 600 mg pertuzumab, 600 mg trastuzumab, 20,000 units hyaluronidase/10ml SDV
Safety Monitoring & Precautions
- Perform cardiac assessment with LVEF at baseline and throughout therapy
- Following completion of therapy in EBC, monitor for cardiomyopathy every 6 months for at least 2 years
- Verify pregnancy status prior to start of therapy; advise effective contraception during treatment and for 7 months after last dose
- Monitor patients during and for 30 minutes following the initial injection, then during and for 15 minutes following subsequent maintenance injections
- Consider pre-medications (analgesic, anti-pyretic, or antihistamine) for reversible Grade 1 or 2 hypersensitivity reactions
Contraindications & Exclusions
- Known hypersensitivity to pertuzumab, trastuzumab, hyaluronidase, or any excipients
- Not studied in patients with baseline LVEF < 55% (EBC) or < 50% (MBC)
- Exclude patients with prior history of CHF, uncontrolled HTN, recent MI, cumulative anthracycline exposure > 360 mg/m2 doxorubicin equivalent, or serious cardiac arrhythmia requiring treatment
Transition & Place in Therapy
- Patients currently receiving IV pertuzumab and trastuzumab can transition to the subcutaneous formulation
- Depending on time since last dose, patient may require a loading vs. maintenance dose
- Fixed-dose combination minimizes medication error potential from miscalculations and minimizes drug waste
- Shortened drug infusion time reduces clinic time and chair space; less drug preparation time and ancillary equipment required