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Pertuza

Pertuza420 mg/14 ml

IV Infusion

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Medicine overview

Indications of Pertuza 420 mg/14 ml

locally advancedinflammatory

Theropeutic Class

Targeted Cancer Therapy

Pharmacology

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.

Absorption

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.

Dosage & Administration of Pertuza 420 mg/14 ml

Notes:For intravenous infusion only. Do not administer as an intravenous push or bolus
HER2 testing
Dosage:Perform using FDA-approved tests by laboratories with demonstrated proficiency
Notes: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
Dosage:Administer Pertuza 420 mg/14 ml, trastuzumab, and docetaxel by intravenous infusion every 3 weeks
Neoadjuvant
Dosage:Administer Pertuza 420 mg/14 ml, trastuzumab, and chemotherapy by intravenous infusion preoperatively every 3 weeks for 3 to 6 cycles
Adjuvant
Dosage: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)

Dosage of Pertuza 420 mg/14 ml

Notes:For intravenous infusion only. Do not administer as an intravenous push or bolus
HER2 testing
Dosage:Perform using FDA-approved tests by laboratories with demonstrated proficiency
Notes: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
Dosage:Administer Pertuza 420 mg/14 ml, trastuzumab, and docetaxel by intravenous infusion every 3 weeks
Neoadjuvant
Dosage:Administer Pertuza 420 mg/14 ml, trastuzumab, and chemotherapy by intravenous infusion preoperatively every 3 weeks for 3 to 6 cycles
Adjuvant
Dosage: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)

Interaction of Pertuza 420 mg/14 ml

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.

Contraindications

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

Side Effects of Pertuza 420 mg/14 ml

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.

Pregnancy & Lactation

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.

Precautions & Warnings

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

Storage Conditions

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.

Drug Classes

Targeted Cancer Therapy

Mode Of Action

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.

Pregnancy

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.

Frequently Asked Questions

What is Pertuza 420 mg/14 ml used for?

Pertuzumab 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 morePertuzumab is a HER2/neu receptor antagonist indicated for:Use in combination with trastuzumab and docetaxel f…

What is the dosage of Pertuza 420 mg/14 ml?

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 Pertuzumab 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 Pertuzumab, trastuzumab…

What are the side effects of Pertuza 420 mg/14 ml?

Metastatic Breast Cancer: The most common adverse reactions (> 30%) with Pertuzumab 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 Pertuzumab in combination with trastuzumab and docetaxel were alopecia, diarrhea, nausea, and ne…

Who should not take Pertuza 420 mg/14 ml?

Pertuzumab is contraindicated in patients with known hypersensitivity to pertuzumab or to any of its excipients

What precautions should be taken with Pertuza 420 mg/14 ml?

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 therapie…

Is Pertuza 420 mg/14 ml safe during pregnancy and breastfeeding?

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

Disclaimer

The information provided is accurate to our best practices, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy. The absence of specific information about a drug should not be seen as an endorsement. We are not responsible for any consequences resulting from this information, so consult a healthcare professional for any concerns or questions.

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