Trastuzumab and hyaluronidase-oysk

What is Trastuzumab and hyaluronidase-oysk?

• Trastuzumab and hyaluronidase-oysk (Herceptin Hylecta) is a combination of trastuzumab, a HER2/neu receptor antagonist, and hyaluronidase, an endoglycosidase used for the treatment of HER2-overexpressing breast cancers.
• Trastuzumab and hyaluronidase-oysk is a form of trastuzumab that is given as a subcutaneous injection.
• This form can be given in less time than trastuzumab, which is given as an infusion.

Trastuzumab-HER2 complex 1N8Z

Hyaluronidase-1OJN

What are the uses of this medicine?

Trastuzumab and hyaluronidase-oysk (Herceptin Hylecta) is used to treat:

• Breast cancer that is HER2 positive (HER2+).

It is used in adults with: Hormone receptor-negative or high-risk cancer It is given As combination chemotherapy with:

• Doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; or
• Docetaxel and carboplatin.
• Alone after combination therapy that included anthracycline chemotherapy.

Metastatic cancer It is given:

• With paclitaxel for first-line treatment; or
• Alone in patients who have already been treated with at least one chemotherapy regimen given for metastatic disease.

How does this medicine work?

• A ready-to-use combination of trastuzumab, a recombinant humanized monoclonal antibody directed against the human epidermal growth factor receptor 2 (HER2; receptor tyrosine-protein kinase erbB-2), and hyaluronidase-oysk, a recombinant human hyaluronidase PH20 (rHuPH20), that may be used for the treatment of HER2-overexpressing breast cancers.
• Upon subcutaneous administration, hyaluronidase-oysk temporarily breaks down the hyaluronan barrier, which decreases viscosity of, and allows trastuzumab to spread rapidly through the interstitial space.
• This improves access to lymphatic and capillary vessels and facilitates the absorption of trastuzumab into the bloodstream. Trastuzumab binds to the extracellular ligand-binding domain of HER2 and mediates the activation of an antibody-dependent cell-mediated cytotoxicity (ADCC) against HER2-expressing tumor cells.
• HER2 is overexpressed in many adenocarcinomas, particularly breast adenocarcinomas.
• Hyaluronidase has been shown to increase the absorption rate of a trastuzumab product into the systemic circulation.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• Tell your doctor and pharmacist if you are being treated with anthracycline medications for cancer such as daunorubicin (Cerubidine), doxorubicin (Doxil), epirubicin (Ellence), and idarubicin (Idamycin).
• Your doctor will need to monitor you closely if you receive these medications during your treatment with trastuzumab and hyaluronidase-oysk injection and for up to 7 months after your final dose.

Is this medicine FDA approved?

• Trastuzumab/hyaluronidase was approved for medical use in the United States in February 2019.

How should this medicine be used?

• Select patients based on HER2 protein overexpression or HER2 gene amplification in tumor specimens.

Recommended dosage:

• The recommended dose of Herceptin Hylecta is 600 mg/10,000 units (600 mg trastuzumab and 10,000 units hyaluronidase) administered subcutaneously over approximately 2-5 minutes once every three weeks.
• Do not substitute Herceptin Hylecta for or with ado-trastuzumab emtansine.

Administration:

• For subcutaneous use only.
• Herceptin Hylecta has different dosage and administration instructions than intravenous trastuzumab products.
• Do not administer intravenously.

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

This medicine is available in fallowing doasage form:

• As Injection: 600 mg trastuzumab and 10,000 units hyaluronidase per 5 mL (120 mg/2,000 units per mL) solution in a single-dose vial.

This medicine is available in fallowing brand namesː

• Herceptin Hylecta

What side effects can this medication cause?

The most common side effects of this medicine include: In Adjuvant Breast Cancer:

• fatigue, arthralgia, diarrhea, injection site reaction, upper respiratory tract infection, rash, myalgia, nausea, headache, edema, flushing, pyrexia, cough, and pain in extremity

In Metastatic Breast Cancer (based on intravenous trastuzumab):

• fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash

What special precautions should I follow?

• Herceptin Hylecta can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue Herceptin Hylecta for cardiomyopathy.
• Herceptin Hylecta can result in serious and fatal pulmonary toxicity. Discontinue Herceptin Hylecta for anaphylaxis, angioedema, interstitial pneumonitis or acute respiratory distress syndrome.
• Herceptin Hylecta may exacerbate chemotherapy-induced neutropenia.
• Severe administration-related reactions (ARRs), including hypersensitivity and anaphylaxis, have been reported with Herceptin Hylecta. Closely monitor patients for systemic hypersensitivity reactions, especially during the first administration. Permanently discontinue Herceptin Hylecta in patients who experience anaphylaxis or severe hypersensitivity reactions.
• Herceptin Hylecta can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to the initiation of Herceptin Hylecta. Advise pregnant women and females of reproductive potential that exposure to Herceptin Hylecta during pregnancy or within 7 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of Herceptin Hylecta.

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?

• Herceptin Hylecta can cause fetal harm when administered to a pregnant woman.

Can this medicine be used in children?

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

What are the active and inactive ingredients in this medicine?

Active ingredients include:

• TRASTUZUMAB
• HYALURONIDASE (HUMAN RECOMBINANT)

Inactive ingredients include:

• HISTIDINE MONOHYDROCHLORIDE MONOHYDRATE
• HISTIDINE
• TREHALOSE DIHYDRATE
• POLYSORBATE 20
• METHIONINE
• WATER

Who manufactures and distributes this medicine?

Manufactured by:

• Genentech, Inc.
• A Member of the Roche Group
• 1 DNA Way
• South San Francisco, CA

• Herceptin Hylecta is a trademark of Genentech, Inc.

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

• Store Herceptin Hylecta vials in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
• Do not freeze.
• Do not shake.
• Once removed from the refrigerator, Herceptin Hylecta must be administered within 4 hours and should not be kept above 30°C (86°F).

• Dailymed label info on Trastuzumab and hyaluronidase-oysk
• FDA Trastuzumab and hyaluronidase-oysk

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