Herceptin Hylecta, illustration of injection vial form (not a photo of the actual pack)

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Herceptin Hylecta

Trastuzumab

Prescription required

$2100.00

600mg/5ml · 600

BrandBranded medicine· By Roche

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440mg

600mg/5ml

FDA boxed warningCardiomyopathy, embryo-fetal toxicity, and pulmonary toxicity

Cardiomyopathy: 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.

Pulmonary Toxicity: Discontinue HERCEPTIN HYLECTA for anaphylaxis, angioedema, interstitial pneumonitis or acute respiratory distress syndrome.

Embryo-Fetal Toxicity: Exposure to HERCEPTIN HYLECTA during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death. Advise patients of these risks and the need for effective contraception.

Read this with the rest of the clinical information

About Herceptin Hylecta

Overview

Herceptin Hylecta is an injection under the skin that contains trastuzumab and hyaluronidase. It is used to treat adults with breast cancer that has high levels of the HER2 protein, confirmed using an FDA-authorized test. Trastuzumab targets HER2 on cancer cells, while hyaluronidase helps the medicine spread and be absorbed under the skin.

What it treats

HER2-positive breast cancer in adults, confirmed using an FDA-authorized companion diagnostic test for trastuzumab.

Safety information

Side effects

Common side effects include tiredness, joint or muscle pain, diarrhoea, reactions at the injection site, upper respiratory tract infections, rash, nausea, headache, swelling, flushing, fever, cough, and pain in the arms or legs. Serious risks include damage to the heart muscle, lung toxicity, and worsening of chemotherapy-related neutropenia (low levels of certain white blood cells). Contact a doctor promptly if you experience a serious reaction. Severe allergic reactions, including anaphylaxis, and severe reactions related to administration can occur. Seek immediate medical help for a severe allergic reaction. Herceptin Hylecta must be permanently stopped if anaphylaxis or a severe allergic reaction occurs. The label also warns of harm to an unborn baby.

FDA boxed warning

Cardiomyopathy, embryo-fetal toxicity, and pulmonary toxicity

Cardiomyopathy: 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.

Pulmonary Toxicity: Discontinue HERCEPTIN HYLECTA for anaphylaxis, angioedema, interstitial pneumonitis or acute respiratory distress syndrome.

Embryo-Fetal Toxicity: Exposure to HERCEPTIN HYLECTA during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death. Advise patients of these risks and the need for effective contraception.

A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.

When to call your doctor

- Seek medical attention immediately for trouble breathing or sudden swelling of the face, lips, tongue or throat. - Seek medical attention immediately for fever or chills, especially during chemotherapy.

If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.

Using Herceptin Hylecta

Dosing

Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.

Storage

Store in the original carton below 25°C, protected from light, unless the pack states refrigeration. Do not freeze. Keep all medicines out of the sight and reach of children.

Clinical information on this page is summarised from the US FDA label HERCEPTIN HYLECTA (TRASTUZUMAB AND HYALURONIDASE-OYSK) INJECTION, SOLUTION [GENENTECH, INC.] (DailyMed, retrieved 19 September 2026).

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