Rituximab and Hyaluronidase Human Injection

IMPORTANT WARNING:

Rituximab and hyaluronidase human injection has caused severe, life-threatening skin and mouth reactions. If you experience any of the following symptoms, tell your doctor immediately: painful sores or ulcers on the skin, lips, or mouth; blisters; rash; or peeling skin.

You may already be infected with hepatitis B (a virus that infects the liver and may cause severe liver damage) but not have any symptoms of the disease. In this case, receiving rituximab and hyaluronidase human injection may increase the risk that your infection will become more serious or life-threatening and you will develop symptoms. Tell your doctor if you have or ever had a severe infection, including hepatitis B virus infection. Your doctor will order a blood test to see if you have an inactive hepatitis B infection. If necessary, your doctor may give you medication to treat this infection before and during your treatment with rituximab and hyaluronidase human injection. Your doctor will also monitor you for signs of hepatitis B infection during and for several months after your treatment. If you experience any of the following symptoms during or after your treatment, call your doctor immediately: excessive tiredness, yellowing of the skin or eyes, loss of appetite, nausea or vomiting, muscle aches, stomach pain, or dark urine.

Some people who received rituximab and hyaluronidase human injection developed progressive multifocal leukoencephalopathy (PML; a rare infection of the brain that cannot be treated, prevented, or cured and that usually causes death or severe disability) during or after their treatment. If you experience any of the following symptoms, call your doctor immediately: new or sudden changes in thinking or confusion; difficulty talking or walking; loss of balance; loss of strength; new or sudden changes in vision; or any other unusual symptoms that develop suddenly.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to rituximab and hyaluronidase human injection.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with rituximab injection and each time you receive the medication. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of using rituximab and hyaluronidase human injection.

WHY is this medicine prescribed?

Rituximab and hyaluronidase human injection is used alone or with other medications to treat various types of non-Hodgkin's lymphoma (NHL; a type of cancer that begins in a type of white blood cells that normally fights infection). Rituximab and hyaluronidase human injection is also used with other medications to treat chronic lymphocytic leukemia (CLL; a type of cancer of the white blood cells). Rituximab and hyaluronidase human injection is in a class of medications called monoclonal antibodies. It treats the various types of NHL and CLL by killing cancer cells.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Rituximab and hyaluronidase human injection comes as a solution (liquid) to be injected subcutaneously (under the skin, in the stomach area) over approximately 5 to 7 minutes. Your dosing schedule will depend on the condition that you have, the other medications you are using, and how well your body responds to treatment.

Rituximab and hyaluronidase human injection may cause serious reactions while you receive the medication or within 24 hours after receiving a dose. You will receive each dose of rituximab and hyaluronidase human injection in a medical facility, and a doctor or nurse will monitor you carefully while you are receiving the medication and for at least 15 minutes after you receive the medication. You will receive certain medications to help prevent an allergic reaction before you receive each dose of rituximab and hyaluronidase human injection.

You must receive your first dose as a rituximab injection product injected slowly intravenously (into a vein). After the first dose, you may receive rituximab and hyaluronidase human injection under the skin, depending on how you respond to intravenous treatment with a rituximab injection product.

What SPECIAL PRECAUTIONS should I follow?

Before receiving rituximab and hyaluronidase human injection,

• tell your doctor and pharmacist if you are allergic to rituximab, hyaluronidase, any other medications, or any of the ingredients in rituximab and hyaluronidase human injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

• tell your doctor if you have any of the conditions mentioned in the IMPORTANT WARNING section and if you have or have ever had hepatitis C or other viruses such as chicken pox, herpes (a virus that may cause cold sores or outbreaks of blisters in the genital area), shingles, West Nile virus (a virus that is spread through mosquito bites and may cause serious symptoms), parvovirus B19 (fifth disease; a common virus in children that usually only causes serious problems in some adults), or cytomegalovirus (a common virus that usually only causes serious symptoms in people who have weakened immune systems or who are infected at birth), an irregular heartbeat, chest pain, other heart problems, or lung or kidney problems. Also tell your doctor if you have any type of infection now or if you have or have ever had an infection that would not go away or an infection that comes and goes.

• tell your doctor if you are pregnant or if you plan to become pregnant. You should use birth control to prevent pregnancy during your treatment with rituximab and hyaluronidase human injection and for 12 months after your final dose. Talk to your doctor about types of birth control that will work for you. If you become pregnant while using rituximab and hyaluronidase human injection, call your doctor. Rituximab may harm the fetus.

• tell your doctor if you are breastfeeding. You should not breastfeed during your treatment with rituximab and hyaluronidase human injection and for 6 months after your final dose.

• ask your doctor whether you should receive any vaccinations before you begin your treatment with rituximab and hyaluronidase human injection. Do not have any vaccinations during your treatment without talking to your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss an appointment to receive rituximab and hyaluronidase human injection, call your doctor right away.

What SIDE EFFECTS can this medicine cause?

Rituximab and hyaluronidase human injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• constipation
• flushing
• hair loss
• pain, irritation, swelling, redness or itching in the place where the injection was given
• muscle, joint, or back pain

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• hives, rash, itching, swelling of the lips, tongue, or throat, shortness of breath, difficulty breathing or swallowing
• wheezing
• dizziness or fainting
• weakness
• diarrhea
• lack of energy
• chest pain
• pounding or irregular heartbeat
• sore throat, fever, chills, cough, earache, headache, or other signs of infection
• white patches in the throat or mouth
• difficult, painful, or frequent urination
• redness, tenderness, swelling or warmth of area of skin

Rituximab and hyaluronidase human injection may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.