Rituxan Hycela

Rituxan Hycela is a prescription medication used to treat certain types of non-Hodgkin's lymphoma, (a type of cancer that begins in a type of white blood cells that normally fights infection) and chronic lymphocytic leukemia (a type of cancer that begins in the white blood cells) in adults.

It is a single product containing 2 medications: rituximab and hyaluronidase. Rituximab belongs to a group of drugs called monoclonal antibodies. These work by killing cancer cells and blocking activation of the immune system. Hyaluronidase is an enzyme that allows connective tissue penetration by hydralizing hyaluronic acid. 

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

Common side effects of Rituxan Hycela include infections, neutropenia (an abnormally low count of a certain type of white blood cells), and nausea.

Rituxan Hycela is used alone or with other medications to treat the following types of non-Hodgkin's lymphoma (NHL, a type of cancer that begins in a type of white blood cells that normally fights infection):

• Follicular Lymphoma (FL)
  • Relapsed or refractory, follicular lymphoma
  • Previously untreated follicular lymphoma
  • Non-progressing (including stable disease), follicular lymphoma
• Diffuse Large B-Cell Lymphoma (DLBCL)

Rituxan Hycela is also used to treat chronic lymphocytic leukemia (CLL, a type of cancer that begins in the white blood cells).

Rituxan Hycela treatment can only be initiated after patients have received at least one full dose of a rituximab product by intravenous infusion.

Rituxan Hycela is not indicated for the treatment of non-malignant (non-cancer) conditions.

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

• Genentech, Inc.

Serious side effects have been reported with Rituxan Hycela. See the “Rituxan Hycela Precautions” section.

Common side effects of Rituxan Hycela in people with Follicular Lymphoma (FL) include the following:

• infections
• low white blood cell count
• nausea
• constipation
• cough
• tiredness

Common side effects of Rituxan Hycela in people with Diffuse Large B-cell Lymphoma (DLBCL) include the following:

• infections
• low white blood cell count 
• loss of hair
• nausea
• low red blood cell count

Common side effects of Rituxan Hycela in people with Chronic Lymphocytic Leukemia (CLL) include the following:

• infections 
• low white blood cell count
• nausea
• low platelet count 
• fever
• vomiting
• injection site redness

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

Tell your doctor if you have any side effects that bother you or that do 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 medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take cisplatin (Platinol).

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

Serious side effects have been reported with Rituxan Hycela including the following:

• Serious allergic reactions. Serious injection reactions including anaphylaxis or serum sickness-like reactions may occur. You must receive at least one full dose of a rituximab product by intravenous infusion before receiving Rituxan Hycela due to the higher risk of hypersensitivity and other acute reactions during the first injection. The injection should be interrupted immediately when observing signs of a severe reaction. 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.You will be given an allergy medication and acetaminophen (Tylenol) before each administration of Rituxan Hycela. Tell your doctor or get medical help right away if you get any of these symptoms during or after an Rituxan Hycela injection:
  • 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
• Severe reactions of the skin or mucous membranes. Tell your doctor or get medical help right away if you get any of these symptoms at anytime during your treatment:
  • 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.
• A brain infection. Rituxan Hycela can cause a rare, serious brain infection called Progressive Multifocal Leukoencephalopathy (PML). 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 doctor or get medical help right away if you get any of these symptoms at any time during your treatment:
  • 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
• Tumor lysis syndrome (TLS). TLS is a severe, sometimes life-threatening alteration in blood chemistry that occurs with the release of materials formerly contained within cancer cells into the bloodstream. It is important to stay hydrated and follow directions with any medications your doctor may prescribe in order to prevent TLS.
• Infections. Rituxan Hycela can cause serious infections, including fungal infections. Tell your healthcare provider right away if you have any new or worsening symptoms or if anyone close to you notices these symptoms: fever, chills, or rapid breathing. Do not administer infliximab during an active infection. If an infection develops, monitor carefully and stop Rituxan Hycela if the infection becomes serious.
• Heart problems. Rituxan Hycela may cause chest pain, irregular heartbeats, and heart attack. Your healthcare provider may monitor your heart during and after treatment with Rituxan Hycela if you have symptoms of heart problems or have a history of heart problems. Tell your healthcare provider right away if you have chest pain or irregular heartbeats during treatment with Rituxan Hycela. 
• Kidney problems. Rituxan Hycela can cause severe kidney problems that can lead to death. Your healthcare provider should do blood tests to check how well your kidneys are working.
• Stomach and serious bowel problems that can sometimes lead to death. Bowel problems, including blockage or tears in the bowel, can happen if you receive Rituxan Hycela with chemotherapy medicines. Tell your healthcare provider right away if you have severe stomach-area (abdomen) pain or repeated vomiting during treatment with Rituxan Hycela.
• Vaccines. Treatment with live virus vaccines is not recommended before or during Rituxan Hycela use.
• Harm to your unborn baby. It is recommended women use effective contraception when on Rituxan Hycela and for 12 months following the last dose of Rituxan Hycela.

Do not take Rituxan Hycela if you are allergic to rituximab or to any of its ingredients.

Medicines 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 rituximab there are no specific foods that you must exclude from your diet when receiving Rituxan Hycela.

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

• are allergic to Rituxan Hycela
• 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. Females who are able to become pregnant 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.
• 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 you are pregnant or plan to become pregnant. 

There are no adequate and well-controlled studies of Rituxan Hycela in pregnant women. Rituximab-containing products can cause adverse developmental outcomes including B-cell lymphocytopenia in infants. Women of childbearing potential should use effective contraception while receiving rituximab and for 12 months following treatment. Rituxan Hycela should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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

It is not known if Rituxan Hycela crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with 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 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. 
• If you miss a dose, call your healthcare provider right away to reschedule your appointment.

You must first receive at least one full dose of a rituximab product by intravenous infusion without experiencing severe adverse reactions before starting treatment with Rituxan Hycela.

You will be treated with acetaminophen (Tylenol) and an allergy medication (eg., cetirizine (Zyrtec)) before each dose of Rituxan Hycela.

The dose your doctor recommends may be based on the following:

• the condition being treated
• how you respond to this medication

Rituxan Hycela should be administered by injection under the skin by a healthcare professional with medical support to manage severe reactions if they occur during the injection.

The recommended dose of Rituxan Hylace for the treatment of refractory, Follicular Lymphoma is 1,400 mg/23,400 Units once weekly for 3 or 7 weeks.

The recommended dose of Rituxan Hylace for the retreatment of refractory, Follicular Lymphoma is 1,400 mg/23,400 Units once weekly for 3 weeks.

The recommended dose of Rituxan Hylace for the treatment of previously untreated, Follicular Lymphoma is 1,400 mg/23,400 Units every 21 days, for up to 7 cycles. In patients with a complete or partial response, Rituxan Hycela treatment provided every 8 weeks for 12 doses following completion of Rituxan Hycela in combination with chemotherapy. 

The recommended dose of Rituxan Hylace for the treatment of non-progressing, Follicular Lymphoma after first-line CVP chemotherapy is 1,400 mg/23,400 Units once weekly for 3 weeks (i.e., 4 weeks in total) at 6-month intervals to a maximum of 16 doses.

The recommended dose of Rituxan Hylace for the treatment of Diffuse Large B-Cell Lymphoma (DLBCL) is 1,400 mg/23,400 Units in combination with CHOP chemotherapy. It is administered on Day 1 of Cycles 2–8 of CHOP chemotherapy for up to 7 cycles.

The recommended dose of Rituxan Hylace for the treatment of CLL is 1,600 mg/26,800 Units, administered every 28 days for a total of 5 cycles in combination with fludarabine and cyclophosphamide.

If you take too much Rituxan Hycela, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

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

Store Rituxan Hycela vials in the refrigerator at 2°C–8°C (36°F–46°F) in the original carton to protect from light. Do not freeze.

Warning: severe mucocutaneous reactions, hepatitis B virus reaction and progressive multifocal leukoencephalopathy. 

Severe Mucocutaneous Reactions

Rituxan Hycela can cause severe skin and mouth reactions. These reactions may be life-threatening. 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.

Hepatitis B Virus (HBV) Reactivation

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 Rituxan Hycela 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 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. Rituxan Hycela will be discontinued in the event of hepatitis B reactivation.

Progressive Multifocal Leukoencephalopathy (PML), including fatal PML

Rituxan Hycela may cause 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. 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.