Rituxan Hycela

Generic name: Hyaluronidase And Rituximab
Drug class: CD20 monoclonal antibodies

Usage of Rituxan Hycela

Rituxan Hycela contains a combination of hyaluronidase and rituximab. Hyaluronidase is a genetically designed protein. Rituximab is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Rituxan Hycela is used to treat follicular lymphoma, diffuse large B-cell lymphoma, or chronic lymphocytic leukemia.

Rituxan Hycela is sometimes used together with other cancer medicines.

Rituxan Hycela is usually given only after you have received at least 1 injection of rituximab alone.

Rituxan Hycela side effects

Get emergency medical help if you have signs of an allergic reaction to Rituxan Hycela (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Some side effects may occur during the injection (or within 24 hours afterward). Tell your caregiver right away if you feel itchy, dizzy, weak, light-headed, short of breath, chilled, feverish, or if you have chest pain, wheezing, a sudden cough, or pounding heartbeats or fluttering in your chest.

Rituximab may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement.

Serious and sometimes fatal infections may occur during treatment with Rituxan Hycela. Call your doctor right away if you have signs of infection such as:

fever, sore throat, cold or flu symptoms;

sores or white patches in your mouth or throat;

pain or burning when you urinate;

earaches, headaches; or

painful skin sores with redness, warmth, or swelling.

Call your doctor at once if you have any of these other side effects, even if they occur several months after your last dose of Rituxan Hycela:

severe stomach pain, severe vomiting;

right-sided upper stomach pain, loss of appetite, yellowing of your skin or eyes, and not feeling well;

little or no urination;

skin or mouth sores, or a severe skin rash with blistering, peeling, or pus;

chest pain, irregular heartbeats;

low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet;

low white blood cell counts - fever, mouth sores, skin sores, sore throat, cough, trouble breathing; or

signs of tumor cell breakdown - tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.

Common Rituxan Hycela side effects may include:

low blood cell counts;

nausea, vomiting, constipation;

hair loss;

feeling tired;

cough; or

redness where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Before taking Rituxan Hycela

To make sure Rituxan Hycela is safe for you, tell your doctor if you have ever had:

kidney disease;

lung disease;

a severe reaction to hyaluronidase or rituximab;

a weak immune system (caused by disease or by using certain medicines);

a severe infection such as herpes, shingles, cytomegalovirus, chickenpox, parvovirus, West Nile virus, or hepatitis B or C;

heart disease, angina (chest pain), or heart rhythm disorder; or

if you recently received any vaccine, or you are are scheduled to receive a vaccine.

Rituximab may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 12 months after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while using this medicine, and for at least 6 months after your last dose.

Relate drugs

How to use Rituxan Hycela

Usual Adult Dose of Rituxan Hycela for Follicular Lymphoma:

Relapsed or Refractory, Follicular Lymphoma: 23,400 Units hyaluronidase human and 1400 mg rituximab suBCutaneously once a week for 3 or 7 weeks following a full dose of a rituximab product by IV infusion at week 1 (4 or 8 weeks total) Retreatment for Relapsed or Refractory, Follicular Lymphoma: 23,400 Units hyaluronidase human and 1400 mg rituximab subcutaneously once a week for 3 weeks following a full dose of a rituximab product by IV infusion at week 1 (4 weeks total) Previously Untreated, Follicular Lymphoma: 23,400 Units hyaluronidase human and 1400 mg rituximab subcutaneously on Day 1 of Cycles 2 through 8 of chemotherapy (every 21 days), for up to 7 cycles following a full dose of a rituximab product by IV infusion on Day 1 of Cycle 1 of chemotherapy (up to 8 cycles total); in patients with complete or partial response, initiate maintenance treatment 8 weeks following completion of hyaluronidase-rituximab in combination with chemotherapy; administer 23,400 Units hyaluronidase human and 1400 mg rituximab subcutaneously as a single agent every 8 weeks for 12 doses Non-progressing, Follicular Lymphoma after first line CVP chemotherapy: Following completion of 6 to 8 cycles of CVP chemotherapy and a full dose of a rituximab product by IV infusion at week 1, administer 23,400 Units hyaluronidase human and 1400 mg rituximab subcutaneously once a week for 3 weeks (4 weeks total) at 6 month intervals to a maximum of 16 doses Comments: -All patients must receive at least one full dose of a rituximab product by IV infusion before starting therapy with hyaluronidase-rituximab. -Premedicate before each dose with acetaminophen and an antihistamine. Premedication with a glucocorticoid should also be considered. Use: For the treatment of adult patients with: -Relapsed or refractory, follicular lymphoma as a single agent -Previously untreated follicular lymphoma in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy -Non-progressing (including stable disease), follicular lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy

Usual Adult Dose Rituxan Hycela for Lymphoma:

23,400 Units hyaluronidase human and 1400 mg rituximab subcutaneously on Day 1 of Cycles 2 through 8 of CHOP chemotherapy for up to 7 cycles following a full dose of a rituximab product by IV infusion at Day 1, Cycle 1 of CHOP chemotherapy (up to 6 to 8 cycles total) Comments: -All patients must receive at least one full dose of a rituximab product by IV infusion in combination with CHOP chemotherapy before starting therapy with hyaluronidase-rituximab. -Premedicate before each dose with acetaminophen and an antihistamine. Premedication with a glucocorticoid should also be considered. Use: For the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL) in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens

Usual Adult Dose for Chronic Lymphocytic Leukemia:

26,800 Units hyaluronidase human and 1600 mg rituximab subcutaneously on Day 1 of Cycles 2 through 6 (every 28 days) for a total of 5 cycles following a full IV dose at Day 1, Cycle 1 (6 cycles total) in combination with fludarabine and cyclophosphamide (FC) chemotherapy Comments: -All patients must receive at least one full dose of a rituximab product by IV infusion in combination with CHOP chemotherapy before starting therapy with hyaluronidase-rituximab. -Premedicate before each dose with acetaminophen and an antihistamine. Premedication with a glucocorticoid should also be considered. Use: In combination with fludarabine and cyclophosphamide (FC) for the treatment of adult patients with previously untreated and previously treated chronic lymphocytic leukemia (CLL)

Warnings

Do not use Rituxan Hycela if you are pregnant. Avoid getting pregnant for at least 12 months after you stop using this medicine.

Rituxan Hycela may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement.

If you've ever had hepatitis B, using Rituxan Hycela can cause this virus to become active or get worse.

Severe skin problems can also occur during treatment with Rituxan Hycela. Call your doctor if you have painful skin or mouth sores, or a severe skin rash with blistering, peeling, or pus.

Some side effects may occur during the injection or within 24 hours afterward. Tell your caregiver right away if you feel itchy, dizzy, weak, light-headed, short of breath, chilled, feverish, or if you have chest pain, wheezing, a sudden cough, or pounding heartbeats or fluttering in your chest.

What other drugs will affect Rituxan Hycela

Other drugs may interact with hyaluronidase and rituximab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

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