What is Rituxan Hycela?
Rituxan hycela is a combination product of hyaluronidase and rituximab. Hyaluronidase, a genetically engineered protein, is used to treat cancer. Rituximab, a cancer medication that inhibits the growth and spreading of cancerous cells in the body, is an example. Rituxan hycela can be used to treat diffuse large b-cell lymphoma or chronic lymphocytic leukemia. Rituxan hycela can be used in combination with other cancer medications. Rituxan hycela should only be given after you've received a minimum of one rituximab injection.
Warnings
Do not use rituxan hycela while pregnant. You should not become pregnant for 12 months following the cessation of this medication. Rituxan can cause a serious infection of the brain that may lead to death or disability. If you are experiencing problems with your speech, thoughts, vision, or muscle movements, call your doctor immediately. Rituxan can make the hepatitis b virus active or worsen if you have ever had it. Skin problems of severe severity can also develop during the treatment with rituxan hycela. If you experience painful mouth or skin sores or a severe rash that is blistering, peeling, or has pus, call your doctor. Some side effects can occur immediately after the injection or even during it. Inform your caregiver immediately in case you experience any of the following symptoms: itching, weakness, lightheadedness, shortness of breath, chills, fever, chest pain, wheezing, or sudden coughing.
Before you take this drug
Tell your doctor about any of the following to ensure that rituxan hycela will be safe for you:
- Kidney disease
- Lung disease;
- A severe reaction to either hyaluronidase or rituximab
- A weak immune system, caused by illness or certain medications.
- A severe infection, such as a herpes virus or shingles; cytomegaloviruses, chickenpoxes, parvoviruses, west nile viruses, or hepatitis b and c
- Heart disease, angina, heart rhythm disorder,
- If you have recently received a vaccination or are scheduled to get one, you should contact us.
The use of this medication for 12 months following your last dose can harm the unborn child. Inform your doctor immediately if you fall pregnant. Do not breastfeed for 6 months after the last dose of this medication.
How to take Rituxan Hycela?
Rituxan hycela can be injected into the stomach. This medicine should be injected over a period of 5 to 7 minutes. This injection will be given by a healthcare provider. After receiving rituxan, you will be closely monitored for 15 minutes to ensure that there is no allergic reaction. You may receive other medications before each injection to help prevent certain side effects. Read all the instructions and directions that come with your prescription. Follow the directions on the label. You may need to take antibiotics to prevent infection if you have leukemia. This medicine may be needed for up to a year after the last dose of rituxan hycela. Rituxan hycela lowers blood cells, which help your body fight infection. You will need to test your blood often. Rituximab may cause the virus to become more active or worse if you have ever had hepatitis b. You may require frequent liver function testing while taking this medication and for several months afterwards.
Details on dosage
Adult dose of rituxan for follicular lymphoma:
Relapsed or refractory follicular lymphoma 23400 units of human hyaluronidase and 1400 mg of rituximab once a week subcutaneously for 3 or seven weeks after a full-dose iv infusion of rituximab at week one (4 or 8 total weeks)
retreatment for relapsed or refractory follicular lymphoma: 23400 units of hyaluronidase and 1400 mg of rituximab once a week for 3 weeks after a full dose of rituximab by iv infusion during week one (4 weeks total).
Follicular lymphoma patients who were never treated prior to chemotherapy: for cycles 5-8 of chemotherapy treatment (every 21 days), subcutaneous administration of 23,400 units hyaluronidase human and 1400 mg rituximab was given on day one (every 21 days), for up to 8 cycles total; those exhibiting complete or partial response received maintenance therapy 8 weeks following completion of hyaluronidase-rituximab combined therapy by subcutaneous administration every 8 weeks for 12 doses total; patients not responding prior to starting chemotherapy should initiate maintenance therapy by subcutaneous administration of 23400 units hyaluronidase human and 1400 mg rituximab subcutaneously every 8 weeks in combination therapy until disease progression set in (up to 8 cycles total).
After first-line cvp chemotherapy, if the follicular lymphoma is not progressing after 6–8 cycles of cvp and a full dose of rituximab by iv infusion during week 1, administer 23400 units of hyaluronidase and 1400 mg of rituximab once a week for 4 weeks at intervals of 6 months to a maximum of 16 doses.
Comments:
prior to initiating therapy with hyaluronidase-rituximab, all patients must receive at least one full dose of an anti-cd20 product by iv infusion.
Premedicate with an antihistamine and acetaminophen before each dose. Consider premedicating with a glucocorticoid.
Use: to treat adult patients with:
relapsed or refractory follicular lymphoma treated with a single agent
patients who have achieved a complete or partially positive response to rituximab combined with chemotherapy as a single-agent treatment for maintenance
non-progressing (including stable disease) follicular lymphoma after first-line chemotherapy with cyclophosphamide, vincristine, and prednisone
Usual adult dose of rituxan hycela for lymphoma:
After a full dose of the rituximab by iv infusion on day 1, cycle 1, chop chemotherapy, up to seven cycles of subcutaneous hyaluronidase and 1400 mg of rituximab can be given.
Comments:
prior to initiating therapy with hyaluronidase-rituximab, all patients must receive at least one full dose of an anti-cd20 product by iv infusion.
Premedicate with an antihistamine and acetaminophen before each dose. Consider premedicating with a glucocorticoid.
Use: to treat adult patients with diffuse large b-cell lymphoma (dlbcl), previously untreated, in combination with cyclophosphamide (chop), doxorubicin (dov), vincristine (vin), prednisone, or other anthracycline-based chemotherapy regimens.
Adult dose for chronic lymphocytic leukemia:
After a full dose of fludarabine (fc) and cyclophosphamide (6 cycles), administer 26,800 units of hyaluronidase and 1600 mg of rituximab under the skin on day 1 of cycles 2 through 6.
Comments:
prior to initiating therapy with hyaluronidase-rituximab, all patients must receive at least one full dose of an anti-cd20 product by iv infusion.
Premedicate with an antihistamine and acetaminophen before each dose. Consider premedicating with a glucocorticoid.
Use: for the treatment of adults with chronic lymphocytic leukemia (cll), both previously untreated (before fc) and previously treated (previously fc).
What happens if i miss the dose?
If you missed a rituxan hycela dose, call your doctor to get instructions.
What happens if i overdose?
Overdoses are unlikely because this medicine is administered by a health professional in a medical environment.
What should be avoided?
Avoid receiving a "live vaccine" while taking rituxan. Live vaccines include measles, mumps and rubella (mmr), rotavirus, typhoid fever, yellow fever as well as varicella chickenpox zoster shingles vaccine and nasal flu (influenza) vaccinations.
Side effects of Rituxan Hycela
If you experience any of the following: hives, difficulty breathing, swelling around your mouth or face, or severe skin reactions (fever, burning eyes, sore throat, and skin pain), some side effects can occur immediately after the injection or within 24 hours. You should tell your caregiver if you experience any of the following symptoms: itching, weakness, feeling light-headed or dizzy, being short of breath or cold, feeling feverish, or experiencing chest pain or wheezing. The use of rituximab can cause serious brain infections that may lead to death or disability. If you experience problems with your speech, thoughts, vision, or muscle movements, call your doctor immediately.
Rituxan hycela can cause serious and even fatal infections.if you detect signs of infection, such as:
- Fever, sore throat, or cold symptoms
- Sores or white patches on your throat or mouth
- Pain or burning after urinating;
- Earaches, headaches,
- Painful skin lesions with swelling, redness, or warmth
If you experience any other side effects, call your doctor immediately. This is true even if the symptoms occur months after your last rituxan hycela dose.
- Severe stomach pain, severe vomiting;
- Right-sided upper abdominal pain, loss of appetite, yellowing skin or eyes, and feeling unwell
- Little or no urination
- Skin or mouth sores or severe skin rash, with blistering, peeling, or pus
- Chest pain and irregular heartbeats
- Anemia (low red blood cells): pale skin and unusual fatigue; light-headedness or feeling short-of-breath; cold hands, feet, and fingers;
- Low counts of white blood cells—fever, mouth ulcers, skin ulcers, sore throats, coughs, difficulty breathing,
- Signs that tumor cells are breaking down: fatigue, weakness, muscle pain, nausea vomiting, diarrhea. Fast or low heart rate.doing repetitive activities causes tingling or numbness in hands, feet or mouth.
Common rituxan hycela side effects may include:
- Low blood cell count
- Nausea, vomiting, constipation;
- hair loss;
- Feeling tired
- Cough;
- Redness at the injection site.
There may be other side effects. For medical advice on side effects, call your doctor. The fda can be contacted at 1-800-fda-1088 to report side effects.
Interaction with other drug
Other drugs, such as vitamins and herbal remedies, may also interact with hyaluronidase or rituximab.informing your physician of all medications you are currently taking and any you change or start to take is vitally important for their wellbeing and safety.
