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Herceptin Hylecta is the brand name for trastuzumab and hyaluronidase-oysk subcutaneous injection.

Herceptin Hylecta is available as a single-dose vial that contains 600 mg trastuzumab and 10,000 units hyaluronidase per 5 mL.

Herceptin Hylecta is a monoclonal antibody that is used to treat:

• HER2-positive, breast cancers – IV and SQ injections
• HER2-positive, metastatic stomach cancer – IV injection only

Herceptin Hylecta is a monoclonal antibody that acts as a human epidermal growth factor receptor 2 (HER2) inhibitor. It blocks a specific protein in the body that’s important for cell growth called HER2. HER2 is found on both normal and cancer cells. Cancer cells usually have more HER2 proteins than normal cells. This can cause cancer cells to grow more quickly than normal cells. When HER2 is blocked by Herceptin Hylecta, cancer cells can’t grow and spread as well.

Herceptin Hylecta is given by a healthcare provider as an injection into a vein (IV) or as an injection under the skin (subcutaneous, SQ). When given IV, the dose depends on your body weight. Your healthcare provider will determine the appropriate dose for you each time you receive the medication.

HER2-positive, breast cancers

• IV injection: The typical dose is 4 mg/kg of bodyweight IV for the first injection, and then 2 mg/kg given once a week. It can also be given as 8 mg/kg for the first injection, and then 6 mg/kg every 3 weeks thereafter
• SQ injection (Herceptin Hylecta brand only): Herceptin Hylecta for injection under the skin contains trastuzumab and hyaluronidase. The typical dose is 600 mg/10,000 units (trastuzumab/hyaluronidase) given under the skin every 3 weeks. The SQ injection is a flat dose and isn’t dependent on weight
• HER2-positive, metastatic stomach cancer: The typical dose is 8 mg/kg IV for the first injection, and then 6 mg/kg every 3 weeks thereafter

Herceptin Hylecta is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of Herceptin Hylecta:

• Body and joint pain
• Weakness
• Fever
• Nausea
• Chills
• Headache
• Cough
• Diarrhea
• Vomiting
• Infection

Serious side effects are rare with Herceptin Hylecta. Contact your healthcare provider immediately if you experience any of the following.

• Heart problems: chest pain, racing heartbeat, shortness of breath that usually worsens with activity or while lying flat, swelling of your legs or feet, sudden weight gain, fatigue
• Serious infusion reactions: trouble breathing, itching or hives, flushing, swelling, chest pain, fast heartbeat, dizziness, fainting
• Lung problems: shortness of breath, trouble breathing
• Serious infections (when receiving in combination with chemotherapy): repeated fevers, chills, sweating, cough, trouble breathing, severe diarrhea, vomiting, painful or frequent urination

• There are no major drug interactions listed for Herceptin Hylecta. However, always let your physician and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking

Genentech, Inc.

Herceptin Hylecta can cause embryo-fetal harm when administered during pregnancy. Females of reproductive potential to use effective contraception during treatment with Herceptin Hylecta and for 7 months following the last dose of Herceptin Hylecta. There is a pregnancy pharmacovigilance program for Herceptin Hylecta. If Herceptin Hylecta is administered during pregnancy, or if a patient becomes pregnant while receiving Herceptin Hylecta or within 7 months following the last dose of Herceptin Hylecta, health care providers and patients should immediately report Herceptin Hylecta exposure to Genentech at 1-888-835-2555.

• Trastuzumab And Hyaluronidase-OYSK