Herceptin Hylecta

Herceptin Hylecta is a prescription medication used to treat certain types of breast cancers.

Herceptin Hylecta is a single product containing 2 medications: trastuzumab and hyaluronidase-OYSK. Trastuzumab belongs to a group of drugs called monoclonal antibodies, which help stop the growth of cancer cells. Hyaluronidase helps the drug to enter the site of the cancer and be most effective. 

This medication is available in an injectable form to be given into the skin (subcutaneously) by a healthcare professional.

Common side effects of Herceptin Hylecta include fatigue, joint pain and diarrhea.

Herceptin Hylecta is a prescription medicine used to treat HER2 overexpressing breast cancers. Herceptin Hylecta may be used alone or in combination therapies.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Herceptin Hylecta. See the "Herceptin Hylecta Precautions" section for more information.

Common side effects of Herceptin Hylecta include the following:

• Hair loss
• Nausea
• Abnormal heart rhythm
• Low blood count
• Diarrhea
• Weakness or lack of energy
• Vomiting

This is not a complete list of Herceptin Hylecta side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medications you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Tell your doctor about your medications before, during, and after treatment with Herceptin Hylecta. Especially tell your doctor if you take:

• anthracyclines (Taxane, Cytarabine, Doxorubicin)

This is not a complete list of Herceptin Hylecta drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Herceptin Hylecta including the following:

• Cardiomyopathy is disease of the heart muscle. Tell your healthcare provider right away if you have some or all of the following symptoms of cardiomyopathy:
  • chest pain
  • shortness of breath
  • lightheaded or dizziness
  • general weakness or fatigue
  • palpitations (feel like your heart is racing or fluttering)
  • fainting
  • high blood pressure
• Infusion Reactions. Infusion reactions can occur with this medication. Tell your healthcare provider or get medical help right away if you get any of these symptoms during or after an infusion with this medication:
  • hives (red itchy welt) or rash
  • itching
  • swelling of lips, tongue, throat or face
  • sudden cough
  • weakness
  • dizziness or feeling faint
  • palpitations (feel like your heart is racing or fluttering)
  • chest pain
• Embryo-Fetal Toxicity. Tell your healthcare provider right away if you are pregnant, trying to become pregnant, or become pregnant during or within 7 months of treatment with Herceptin Hylecta.
• Pulmonary Toxicity is when damage occurs to your lungs. Tell your healthcare provider right away if you have some or all of the following symptoms of pulmonary toxicity.
  • difficulty breathing or catching your breath
  • fatigue
  • dry cough
  • discomfort or worsening of other symptoms when lying flat
• Worsening of chemotherapy-induced neutropenia. A low white blood cell count can cause you to get infections, which may become serious. Tell your doctor right away if you have any of the following signs or symptoms of an infection:
  • fever
  • shortness of breath
  • pain or burning on urination
  • chills
  • cough

Do not take Herceptin Hylecta if you are allergic to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Herceptin Hylecta, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Herceptin Hylecta, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Herceptin Hylecta or to any of its ingredients
• have a history of heart failure
• have ongoing lung problems
• have an active infection
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if are pregnant or plan to become pregnant.

It has been shown that use of Herceptin Hylecta in pregnant women caused some babies to be born with problems and some women to miscarry. However, in some situations, the benefit of using this medication may be greater than the risk of harm to the baby.

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.

If you are woman and of reproductive age, it is advised that you use effective contraception during treatment and for 7 months following the last dose of Herceptin Hylecta.

Tell your doctor if you are breastfeeding or planning to breastfeed.

It is not known if Herceptin Hylecta crosses into human milk or not. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with the use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Herceptin Hylecta.

Take Herceptin Hylecta exactly as prescribed.

This medication is available in an injectable form to be given directly into the skin (subcutaneous) by a healthcare professional.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Herceptin Hylecta at the same time.

This medication should be administered into the skin (subcutaneous) by a healthcare professional. The usual dose is 600mg/ 10,000U over 2-5 minutes once every three weeks, for one year (52 weeks). Follow your doctor's instructions about your individual dosing schedule.

If you miss a dose, give the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and administer the next dose at the regular time. There should not be less than 3 weeks between 2 doses of Herceptin Hylecta.

If side effects become intolerable, you may need to wait longer between doses, receive a lower dose, or permanently stop the medicine if potentially serious side effects occur.

Herceptin Hylecta is administered by a healthcare provider in a medical setting, therefore it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.

FDA Warning

HERCEPTIN HYLECTA administration can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving HERCEPTIN HYLECTA with anthracycline-containing chemotherapy regimens.

Evaluate left ventricular function in all patients prior to and during treatment with HERCEPTIN HYLECTA. Discontinue HERCEPTIN HYLECTA treatment in patients receiving adjuvant therapy and withhold HERCEPTIN HYLECTA in patients with metastatic disease for clinically significant decrease in left ventricular function

Pulmonary Toxicity

HERCEPTIN HYLECTA administration can result in serious and fatal pulmonary toxicity. Symptoms usually occur during or within 24 hours of HERCEPTIN HYLECTA administration. Discontinue HERCEPTIN HYLECTA for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. Monitor patients until symptoms completely resolve

Embryo-Fetal Toxicity

Exposure to HERCEPTIN HYLECTA during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception

Exacerbation of chemotherapy-induced neutropenia has also occurred

Hypersensitivity and severe Administration-Related Reactions (ARRs) including anaphylaxis, have been reported with HERCEPTIN HYLECTA. Serious and fatal reactions have been reported after treatment with intravenous trastuzumab products