Hyaluronidase

What it is used for

PHESGO is a combination of pertuzumab and trastuzumab, HER2/neu receptor antagonists, and hyaluronidase, an endoglycosidase, indicated for: Use in combination with chemotherapy as: neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer.

adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence Use in combination with docetaxel for treatment of patients with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. 1.1 Early Breast Cancer (EBC) PHESGO is indicated for use in combination with chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer.

the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence. Select patients for therapy based on an FDA-authorized companion diagnostic test. 1.2 Metastatic Breast Cancer (MBC) PHESGO is indicated for use in combination with docetaxel for the treatment of adult patients with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.

Select patients for therapy based on an FDA-authorized companion diagnostic test.

The most important thing to know

RITUXAN HYCELA can cause serious side effects that can lead to death, including: Severe skin and mouth reactions. Tell your healthcare provider or get medical help right away if you get any of these symptoms at any time during your treatment with RITUXAN HYCELA: painful sores or ulcers on your skin, lips or in your mouth blisters peeling skin rash pustules Hepatitis B virus (HBV) reactivation.

Before you receive RITUXAN HYCELA, your doctor will do blood tests to check for HBV infection. If you have had hepatitis B or are a carrier of hepatitis B virus, receiving RITUXAN HYCELA could cause the virus to become an active infection again. Hepatitis B reactivation may cause serious liver problems including liver failure, and death.

Your healthcare provider will monitor you for hepatitis B infection during and for several months after you stop receiving RITUXAN HYCELA. Tell your healthcare provider right away if you get worsening tiredness, or yellowing of your skin or white part of your eyes during treatment with RITUXAN HYCELA. Progressive Multifocal Leukoencephalopathy (PML).

PML is a rare, serious brain infection caused by a virus that can happen in people who receive RITUXAN HYCELA. People with weakened immune systems can get PML. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML. Tell your healthcare provider right away if you have any new or worsening symptoms or if anyone close to you notices these symptoms: confusion dizziness or loss of balance difficulty walking or talking decreased strength or weakness on one side of your body vision problems, such as blurred vision or loss of vision Serious allergic reactions and other severe reactions.

Serious allergic reactions, and reactions due to release of certain substances by your body that can lead to death, can happen with rituximab products, including RITUXAN HYCELA. Skin reactions at or near the injection site (local), including injection site reactions, can happen with RITUXAN HYCELA. Symptoms at or near the injection site may include: pain, swelling, hardness, redness, bleeding, itching, and rash.

These reactions sometimes happen more than 24 hours after an injection of RITUXAN HYCELA. Tell your healthcare provider or get medical help right away if you get any of these symptoms during or after an injection of RITUXAN HYCELA: hives (red itchy welts) or rash itching swelling of your lips, tongue, throat or face sudden cough shortness of breath, difficulty breathing, or wheezing weakness dizziness or feel faint palpitations (feel like your heart is racing or fluttering) chest pain fever chills or shaking chills See "

Side effects, and when to stop

" for more information about side effects. What is RITUXAN HYCELA? RITUXAN HYCELA is a prescription medicine used to treat adults with: Follicular Lymphoma (FL): alone or with certain chemotherapy medicines. Diffuse Large B-Cell Lymphoma (DLBCL): with certain other chemotherapy medicines in people who have not had previous treatment for their DLBCL.

Chronic Lymphocytic Leukemia (CLL): with the chemotherapy medicines fludarabine and cyclophosphamide. You can only receive RITUXAN HYCELA after you receive at least 1 full dose of a rituximab product by IV infusion. Read the rituximab by IV infusion Medication Guide for more information about severe infusion reactions, which usually happen during the first dose with a rituximab product given by IV infusion.

RITUXAN HYCELA is not for use to treat medical conditions other than cancers. It is not known if RITUXAN HYCELA is safe and effective in children. Before you receive RITUXAN HYCELA, tell your healthcare provider about all of your medical conditions, including if you: have had a severe reaction to a rituximab product or RITUXAN HYCELA have a history of heart problems, irregular heart beat or chest pain have lung or kidney problems have an infection or weakened immune system have or have had any severe infections including: Hepatitis B virus (HBV) Hepatitis C virus (HCV) Cytomegalovirus (CMV) Herpes simplex virus (HSV) Parvovirus B19 Varicella zoster virus (chickenpox or shingles) West Nile Virus have had a recent vaccination or are scheduled to receive vaccinations.

You should not receive certain vaccines before or during treatment with RITUXAN HYCELA. are pregnant or plan to become pregnant. RITUXAN HYCELA may harm your unborn baby. Females who are able to become pregnant: Your healthcare provider should check to see if you are pregnant before you receive RITUXAN HYCELA. You should use effective birth control (contraception) during treatment with RITUXAN HYCELA and for 12 months after the last dose of RITUXAN HYCELA.

Talk to your healthcare provider about effective birth control. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with RITUXAN HYCELA. are breastfeeding or plan to breastfeed. RITUXAN HYCELA may pass into your breast milk. Do not breastfeed during treatment and for 6 months after your last dose of RITUXAN HYCELA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How will I receive RITUXAN HYCELA? RITUXAN HYCELA is given as an injection under the skin, in the stomach-area (abdomen). RITUXAN HYCELA is injected over 5 or 7 minutes.

Your healthcare provider will prescribe medicines before the injection of RITUXAN HYCELA to help reduce side effects such as fever and chills. Your healthcare provider should monitor you for side effects for at least 15 minutes after you receive an injection of RITUXAN HYCELA. If you have CLL, your healthcare provider should prescribe medicines to help prevent certain infections during treatment and for up to 12 months following treatment with RITUXAN HYCELA.

Before each injection of RITUXAN HYCELA treatment, your healthcare provider or nurse will ask you questions about your general health. Tell your healthcare provider or nurse about any new symptoms. What are possible side effects of RITUXAN HYCELA? RITUXAN HYCELA can cause serious side effects, including: Tumor Lysis Syndrome (TLS).

TLS is caused by the fast breakdown of cancer cells. TLS can cause you to have: kidney failure and the need for dialysis treatment abnormal heart rhythm TLS can happen within 12 to 24 hours after an injection of RITUXAN HYCELA. Your healthcare provider may do blood tests to check you for TLS. Your healthcare provider may give you medicine to help prevent TLS.

Tell your healthcare provider right away if you have any of the follow