Pertuza420 mg/14 ml

Pertuza 420 mg/14 ml is a HER2/neu receptor antagonist indicated for:Use in combination with trastuzumab and docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.Use in ... Read morePertuza 420 mg/14 ml is a HER2/neu receptor antagonist indicated for:Use in combination with trastuzumab and docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.Use in combination with trastuzumab and chemotherapy as: Neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. Adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence

Targeted Cancer Therapy

Pertuza 420 mg/14 ml is a humanized monoclonal antibody designed to bind to the HER2 receptor and inhibit the ability of HER2 to interact with other HER family members (HER1, HER2, HER3, and HER4) on the surface of cancer cells. The HER signaling pathway plays a role in the formation and growth of numerous cancers, and previous clinical trials of Pertuza 420 mg/14 ml in a single agent setting had suggested clinical activity-including stable disease-in heavily pretreated patients with advanced ovarian and breast cancers.

For intravenous infusion only. Do not administer as an intravenous push or bolus.HER2 testing: Perform using FDA-approved tests by laboratories with demonstrated proficiency.The initial Pertuza 420 mg/14 ml dose is 840 mg administered as a 60-minute intravenous infusion, followed every 3 weeks thereafter by 420 mg administered as a 30 to 60 minute intravenous infusion.MBC: Administer Pertuza 420 mg/14 ml, trastuzumab, and docetaxel by intravenous infusion every 3 weeks. Neoadjuvant: Administer Pertuza 420 mg/14 ml, trastuzumab, and chemotherapy by intravenous infusion preoperatively every 3 weeks for 3 to 6 cycles.Adjuvant: Administer Pertuza 420 mg/14 ml, trastuzumab, and chemotherapy by intravenous infusion postoperatively every 3 weeks for a total of 1 year (up to 18 cycles).

For intravenous infusion only. Do not administer as an intravenous push or bolus.HER2 testing: Perform using FDA-approved tests by laboratories with demonstrated proficiency.The initial Pertuza 420 mg/14 ml dose is 840 mg administered as a 60-minute intravenous infusion, followed every 3 weeks thereafter by 420 mg administered as a 30 to 60 minute intravenous infusion.MBC: Administer Pertuza 420 mg/14 ml, trastuzumab, and docetaxel by intravenous infusion every 3 weeks. Neoadjuvant: Administer Pertuza 420 mg/14 ml, trastuzumab, and chemotherapy by intravenous infusion preoperatively every 3 weeks for 3 to 6 cycles.Adjuvant: Administer Pertuza 420 mg/14 ml, trastuzumab, and chemotherapy by intravenous infusion postoperatively every 3 weeks for a total of 1 year (up to 18 cycles).

No drug-drug interactions were observed between Pertuza 420 mg/14 ml and trastuzumab, or between Pertuza 420 mg/14 ml and docetaxel, paclitaxel, or carboplatin.

Pertuza 420 mg/14 ml is contraindicated in patients with known hypersensitivity to Pertuza 420 mg/14 ml or to any of its excipients

Metastatic Breast Cancer: The most common adverse reactions (> 30%) with Pertuza 420 mg/14 ml in combination with trastuzumab and docetaxel were diarrhea, alopecia,neutropenia, nausea, fatigue, rash, and peripheral neuropathy. Neoadjuvant Treatment of Breast Cancer: The most common adverse reactions (> 30%) with Pertuza 420 mg/14 ml in combination with trastuzumab and docetaxel were alopecia, diarrhea, nausea, and neutropenia. The most common adverse reactions (>30%) with Pertuza 420 mg/14 ml in combination with trastuzumab and docetaxel when given for 3 cycles following 3 cycles of FEC were fatigue, alopecia, diarrhea, nausea, vomiting, and neutropenia.  The most common adverse reactions (>30%) with Pertuza 420 mg/14 ml in combination with docetaxel, carboplatin, and trastuzumab (TCH) were fatigue, alopecia, diarrhea, nausea, vomiting, neutropenia, thrombocytopenia, and anemia. The most common adverse reactions (>30%) with Pertuza 420 mg/14 ml in combination with trastuzumab and paclitaxel when given for 4 cycles following 4 cycles of ddAC were nausea, diarrhea, alopecia, fatigue, constipation and headache. The most common adverse reactions (>30%) with Pertuza 420 mg/14 ml in combination with trastuzumab and docetaxel when given for 4 cycles following 4 cycles of FEC were diarrhea, nausea, alopecia, asthenia, constipation, fatigue, mucosal inflammation, vomiting, myalgia, and anemia. Adjuvant Treatment of Breast Cancer: The most common adverse reactions (>30%) with Pertuza 420 mg/14 ml in combination with trastuzumab and chemotherapy were diarrhea, nausea, alopecia, fatigue, peripheral neuropathy and vomiting.

Females and Males of Reproductive Potential: Verify the pregnancy status of females prior to initiation of Pertuza 420 mg/14 ml. There is no information regarding the presence of Pertuza 420 mg/14 ml in human milk, the effects on the breastfed infant or the effects on milk production.

Infusion-Related Reactions: Monitor for signs and symptoms. If a significant infusion-associated reaction occurs, slow or interrupt the infusion and administer appropriate medical therapies.Hypersensitivity Reactions/Anaphylaxis: Monitor for signs and symptoms. If a severe hypersensitivity reaction/anaphylaxis occurs, discontinue the infusion immediately and administer appropriate medical therapies

Store vials in a refrigerator at 2°C to 8°C until time of use. Keep vial in the outer carton in order to protect from light.

Targeted Cancer Therapy

Pertuza 420 mg/14 ml is a humanized monoclonal antibody designed to bind to the HER2 receptor and inhibit the ability of HER2 to interact with other HER family members (HER1, HER2, HER3, and HER4) on the surface of cancer cells. The HER signaling pathway plays a role in the formation and growth of numerous cancers, and previous clinical trials of Pertuza 420 mg/14 ml in a single agent setting had suggested clinical activity-including stable disease-in heavily pretreated patients with advanced ovarian and breast cancers.

Females and Males of Reproductive Potential: Verify the pregnancy status of females prior to initiation of Pertuza 420 mg/14 ml. There is no information regarding the presence of Pertuza 420 mg/14 ml in human milk, the effects on the breastfed infant or the effects on milk production.