Rituxan Hycela - Rituximab; Hyaluronidase Injection

What is this medication?

RITUXIMAB; HYALURONIDASE (ri TUX i mab; hye al ur ON i dase) treats leukemia and lymphoma. Rituximab works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread of cancer cells. Hyaluronidase works by increasing the absorption of the other medications in the body to help them work better. It is a combination medication that contains a monoclonal antibody.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Rituxan Hycela

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Heart disease
• Immune system problems
• Infection, such as hepatitis B, chickenpox, cold sores, herpes
• Irregular heartbeat
• Kidney disease
• Lung or breathing disease, such as asthma
• Recently received or scheduled to receive a vaccine
• An unusual or allergic reaction to rituximab, rituximab;hyaluronidase, mouse proteins, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is for injection under the skin. It is given by a care team in a hospital or clinic setting.

A special MedGuide will be given to you before each treatment. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

What may interact with this medication?

Do not take this medication with any of the following:

• Live virus vaccines

This medication may also interact with the following:

• Cisplatin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication. You may need blood work while taking this medication.

This medication can cause serious allergic reactions. To reduce the risk, your care team may give you other medications to take before receiving this one. Be sure to follow the directions from your care team.

In some patients, this medication may cause a serious brain infection that may cause death. If you have any problems seeing, thinking, speaking, walking, or standing, tell your care team right away. If you cannot reach your care team, urgently seek other source of medical care.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Talk to your care team if you may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 12 months after the last dose. Your will need a negative pregnancy test before starting this medication. Contraception is recommended while taking this medication and for 12 months after the last dose. Your care team can help you find the option that works for you.

Do not breastfeed while taking this medication and for at least 6 months after the last dose.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions or angioedema—skin rash, itching or hives, swelling of the face, eyes, lips, tongue, arms, or legs, trouble swallowing or breathing
• Bowel blockage—stomach cramping, unable to have a bowel movement or pass gas, loss of appetite, vomiting
• Dizziness, loss of balance or coordination, confusion or trouble speaking
• Fever, chills, unusual weakness or fatigue, loss of appetite, nausea, headache, dizziness, feeling faint or lightheaded, shortness of breath, fast or irregular heartbeat, which may be signs of cytokine release syndrome
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Stomach pain that is severe, does not go away, or gets worse
• Tumor lysis syndrome (TLS)—nausea, vomiting, diarrhea, decrease in the amount of urine, dark urine, unusual weakness or fatigue, confusion, muscle pain or cramps, fast or irregular heartbeat, joint pain

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Constipation
• Fatigue
• Hair loss
• Nausea
• Pain, redness, or irritation at injection site

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.