Pertuzumab

What is Pertuzumab?

• Pertuzumab (Perjeta) is a HER2/neu receptor antagonist used in combination with trastuzumab and docetaxel for the treatment of metastatic HER2-positive breast cancer; it also used in the same combination as a neoadjuvant in early HER2-positive breast cancer.

What are the uses of this medicine?

This medicine is used:

• 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.

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.

How does this medicine work?

• Pertuzumab (per tooz’ ue mab) is humanized monoclonal antibody to HER2 which is a growth factor receptor that is overexpressed in 20% to 25% of breast cancers.
• The interaction of epidermal growth factor (EGF) with HER2 results in rapid cell growth and proliferation via intracellular pathways that include MAP and PI3 kinase.
• Blockage of this pathway results in cell cycle arrest and cell death.
• Pertuzumab binds to the dimerization site on the HER2 receptor and prevents pairing of receptors and blocks their intracellular signaling.
• Because the binding site for pertuzumab is different from that of trastuzumab (another monoclonal antibody to HER2), they can be used together and are believed to have additive antitumor effects.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• with known hypersensitivity to pertuzumab or to any of its excipients.

What drug interactions can this medicine cause?

• No drug-drug interactions were observed between pertuzumab and trastuzumab, or between pertuzumab and docetaxel, paclitaxel, or carboplatin.

Is this medicine FDA approved?

• Initial U.S. Approval: 2012

How should this medicine be used?

• Select patients based on HER2 protein overexpression or HER2 gene amplification in tumor specimens.
• Perform using FDA-approved tests by laboratories with demonstrated proficiency.

Recommended Dosage:

• The initial Perjeta 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.
• When administered with Perjeta, the recommended initial dose of trastuzumab is 8 mg/kg administered as a 90-minute intravenous infusion, followed every 3 weeks by a dose of 6 mg/kg administered as an intravenous infusion over 30 to 90 minutes.
• When administered with Perjeta, the recommended initial dose of trastuzumab hyaluronidase-oysk is 600 mg/10,000 units (600 mg trastuzumab and 10,000 units hyaluronidase) administered subcutaneously over approximately 2 to 5 minutes once every three weeks irrespective of the patient's body weight.

Metastatic Breast Cancer (MBC)

• When administered with Perjeta, the recommended initial dose of docetaxel is 75 mg/m2 administered as an intravenous infusion. The dose may be escalated to 100 mg/m2 administered every 3 weeks if the initial dose is well tolerated.

Neoadjuvant Treatment of Breast Cancer

• Administer Perjeta, trastuzumab or trastuzumab hyaluronidase-oysk, and chemotherapy preoperatively every 3 weeks for 3 to 6 cycles.

Adjuvant Treatment of Breast Cancer

• Administer Perjeta, trastuzumab or trastuzumab hyaluronidase-oysk, and chemotherapy postoperatively every 3 weeks for a total of 1 year (up to 18 cycles).

Administration

• Administer as an intravenous infusion only.
• Do not administer as an intravenous push or bolus.
• Do not mix Perjeta with other drugs.

Preparation Prepare the solution for infusion, using aseptic technique, as follows:

• Parenteral drug products should be inspected visually for particulates and discoloration prior to administration.
• Withdraw the appropriate volume of Perjeta solution from the vial(s) using a sterile needle and syringe.
• Dilute into a 250 mL 0.9% sodium chloride PVC or non-PVC polyolefin infusion bag.
• Mix diluted solution by gentle inversion. Do not shake.
• Administer immediately once prepared.
• If the diluted infusion solution is not used immediately, it can be stored at 2°C to 8°C for up to 24 hours.
• Dilute with 0.9% Sodium Chloride injection only. Do not use dextrose (5%) solution.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 420 mg/14 mL single-dose vial.

This medicine is available in fallowing brand namesː

• Perjeta

What side effects can this medication cause?

The most common side effects of this medicine include:

Metastatic Breast Cancer

• Perjeta in combination with trastuzumab and docetaxel were diarrhea, alopecia, neutropenia, nausea, fatigue, rash, and peripheral neuropathy.

Neoadjuvant Treatment of Breast Cancer

• Perjeta in combination with trastuzumab and docetaxel were alopecia, diarrhea, nausea, and neutropenia.
• Perjeta in combination with trastuzumab and docetaxel when given for 3 cycles following 3 cycles of FEC were fatigue, alopecia, diarrhea, nausea, vomiting, and neutropenia.
• Perjeta in combination with docetaxel, carboplatin, and trastuzumab (TCH) were fatigue, alopecia, diarrhea, nausea, vomiting, neutropenia, thrombocytopenia, and anemia.
• Perjeta in combination with trastuzumab and paclitaxel when given for 4 cycles following 4 cycles of ddAC were nausea, diarrhea, alopecia, fatigue, constipation, peripheral neuropathy, and headache.
• Perjeta 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

• Perjeta in combination with trastuzumab and chemotherapy were diarrhea, nausea, alopecia, fatigue, peripheral neuropathy and vomiting.

What special precautions should I follow?

• Perjeta has been associated with infusion reactions, including fatal events. 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 may occur with Perjeta Monitor for signs and symptoms, including angioedema. If a severe hypersensitivity reaction/anaphylaxis occurs, discontinue the infusion immediately and administer appropriate medical therapies.
• Decreases in LVEF have been reported with drugs that block HER2 activity, including Perjeta. Assess LVEF prior to initiation of Perjeta and at regular intervals during treatment to ensure that LVEF is within normal limits.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on its mechanism of action and findings in animal studies, Perjeta can cause fetal harm when administered to a pregnant woman.
• There are no available data on the use of Perjeta in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness of Perjeta have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• PERTUZUMAB

Inactive ingredients:

• HISTIDINE
• ACETIC ACID
• SUCROSE
• POLYSORBATE 20
• WATER

Who manufactures and distributes this medicine?

• Manufactured by:

Genentech, Inc. A Member of the Roche Group 1 DNA Way South San Francisco Perjeta is a registered trademark of Genentech, Inc.

What should I know about storage and disposal of this medication?

• Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) until time of use.
• Keep vial in the outer carton in order to protect from light.
• DO NOT FREEZE.
• DO NOT SHAKE.

• Dailymed label info on Pertuzumab
• FDA Pertuzumab

Pertuzumab Resources
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