Herceptin Hylecta

Generic name: Trastuzumab And Hyaluronidase-oysk
Dosage form: subcutaneous injection
Drug class: HER2 inhibitors

Usage of Herceptin Hylecta

Herceptin Hylecta (trastuzumab and Hyaluronidase-oysk) is a type of targeted immunotherapy used in the treatment of HER2 (human epidermal growth factor receptor 2)-positive breast cancers. HER2-positive breast cancer cells overexpress - have excessive amounts of - the HER2 receptor protein on their surface. HER2 (previously called HER2/Neu) helps cancer cells to grow and divide quickly.

Herceptin Hylecta contains a monoclonal antibody known as trastuzumab. Trastuzumab is a HER2 inhibitor. It works by targeting and binding to HER2, which stops the cancer cells from growing and dividing. Trastuzumab initiates antibody-Dependent cell-mediated cytotoxicity (ADCC), which means it gets your own immune system cells to target and kill the cancer cells that are coated with antibodies.

Herceptin Hylecta is administered over 2-5 minutes via a quick suBC UTAneous injection under the skin, unlike Herceptin which is an intravenous (IV) trastuzumab product that is administered via infusion into a vein or port over 30-90 minutes. The quick administration of Herceptin Hylecta is made possible by the addition of hyaluronidase, which is an enzyme that works temporarily at the injection site to facilitate the absorption of trastuzumab into the blood stream.

Herceptin Hylecta was approved by the US Food and Drug Administration (FDA) in 2019.

Herceptin Hylecta side effects

Herceptin Hylecta can cause serious side effects:

See 'Important information' above

The most common side effects of Herceptin Hylecta seen in patients with adjuvant breast cancer are:

tiredness

joint pain

diarrhea

injection site reaction

upper respiratory tract infection

rash

muscle pain

nausea

headache

swelling

flushing

fever

cough

pain in an extremity

The most common side effects of Herceptin Hylecta seen in patients with metastatic breast cancer (based on intravenous trastuzumab) are:

fever

chills

headache

infection

congestive heart failure

insomnia

cough

rash

These are not all the possible side effects of this medication.

You should contact your doctor immediately if you have any of the side effects listed above. You may report side effects to the FDA at 1‑800‑FDA‑1088 or http://www.fda.gov/medwatch. You may also report side effects to Genentech at 1‑888‑835‑2555.

Before taking Herceptin Hylecta

Tell your healthcare provider if you are pregnant or plan to become pregnant. Herceptin Hylecta may result in the death of an unborn baby or birth defects. Contraception should be used while receiving treatment and for 7 months after your last dose of this medication. If you are or become pregnant while receiving this medication or within 7 months after your last dose, healthcare providers and patients should report Herceptin Hylecta exposure to Genentech at 1‑888‑835‑2555 straight away.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Herceptin Hylecta is present in human breast and what effects it may have on breastfeed infants or milk production. Talk to your doctor about the best way to feed your baby while on this medication and for 7 months afterwards.

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How to use Herceptin Hylecta

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.

See full prescribing information for further details about dosing.

Warnings

Herceptin Hylecta may cause serious side effects including:

Heart Problems. This include heart problems - such as congestive heart failure or reduced heart function - with or without symptoms. The risk for and seriousness of these heart problems were highest in people who received both Herceptin Hylecta and a certain type of chemotherapy (anthracycline). In a study of adjuvant (early) breast cancer, one patient died of significantly weakened heart muscle. Your doctor will check for signs of heart problems before, during, and after treatment with this medication. Contact a health care professional immediately for any of the following: new onset or worsening shortness of breath, cough, swelling of the ankles/legs, swelling of the face, palpitations, weight gain of more than 5 pounds in 24 hours, dizziness or loss of consciousness.

Severe lung problems including:

Severe shortness of breath

Scarring of the lungs

Fluid in or around the lungs

Weakening of the valve between the heart and the lungs

Not enough oxygen in the body

Swelling of the lungs Your doctor may check for signs of severe lung problems when he or she examines you. These signs usually happen within 24 hours after receiving Herceptin Hylecta.

Embryo-Fetal Toxicity. Herceptin Hylecta may result in the death of an unborn baby or birth defects. Contraception should be used while receiving treatment and for 7 months after your last dose of this medication. If you are or become pregnant while receiving this medication or within 7 months after your last dose, you are encouraged to report Herceptin Hylecta exposure to Genentech at 1‑888‑835‑2555.

Exacerbation of Chemotherapy-Induced Neutropenia. Neutropenia (low white blood cell counts) can be life threatening. Low white blood cell counts were seen more often in patients receiving intravenous trastuzumab plus chemotherapy than in patients receiving chemotherapy alone in clinical trials. Your doctor may check for signs of low white blood cell counts when they examine you.

Hypersensitivity and Administration-Related Reactions. Hypersensitivity and administration-related reactions have been reported with this medication. Serious and fatal reactions have been reported after treatment with intravenous trastuzumab products. Your doctor will monitor you for signs of these reactions. Contact your healthcare provider immediately if you experience any symptoms of hypersensitivity and administration-related reactions, including dizziness, nausea, chills, fever, vomiting, diarrhea, hives, swelling under the skin, breathing problems, or chest pain.

What other drugs will affect Herceptin Hylecta

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your doctor if you are prescribed an anthracycline drug after stopping Herceptin Hylecta. It is recommended to avoid anthracycline-based therapy for up to 7 months after stopping Herceptin Hylecta.

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