Rituxan Hycela

Name: Rituxan Hycela

What is the most important information I should know about hyaluronidase and rituximab?

Rituximab may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have changes in your mental state, vision changes, weakness on one side of your body, or problems with speech or walking.

Tell your doctor if you have ever had hepatitis B. Rituximab can cause this condition to come back or get worse.

Severe skin problems can also occur during treatment with rituximab. 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.

You should not use hyaluronidase and rituximab if you are pregnant. Avoid getting pregnant for at least 12 months after you stop using this medicine.

What should I discuss with my healthcare provider before receiving hyaluronidase and rituximab?

You should not be treated with this medicine if you are allergic to hyaluronidase or rituximab.

To make sure hyaluronidase and rituximab is safe for you, tell your doctor if you have ever had:

  • kidney disease;

  • lung disease;

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

  • an 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.

Using hyaluronidase and rituximab during pregnancy could harm the unborn baby. Tell your doctor if you are pregnant or if you become pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 12 months after your last dose.

It is not known whether hyaluronidase and rituximab passes into breast milk or if it could harm a nursing baby. Do not breast-feed while using hyaluronidase and rituximab, and for at least 6 months after your last dose.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of hyaluronidase and rituximab.

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Proper Use of Rituxan Hycela

A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given as a shot under your skin in the stomach area.

Before receiving this medicine, your doctor will give you at least 1 full dose of a rituximab product by IV infusion.

You may also receive medicines (eg, acetaminophen, antihistamine, steroid medicine) before each dose of rituximab and hyaluronidase human, recombinant combination to help prevent unwanted side effects from the injection.

Rituxan Hycela Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Back pain
  • black, tarry stools
  • bladder pain
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody or cloudy urine
  • blurred vision
  • body aches or pain
  • bone pain
  • chest pain
  • chills
  • cough
  • cough producing mucus
  • difficult or labored breathing
  • difficult, burning, or painful urination
  • difficulty in moving
  • dizziness
  • ear congestion
  • fever or chills
  • frequent urge to urinate
  • headache
  • joint pain
  • loss of voice
  • lower back or side pain
  • muscle aches or cramps
  • muscle pain or stiffness
  • muscle spasm
  • nasal congestion
  • nervousness
  • pale skin
  • pounding in the ears
  • rapid weight gain
  • severe pain
  • slow or fast heartbeat
  • sneezing
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stomach pain
  • stuffy or runny nose
  • swelling or inflammation of the mouth
  • swollen glands
  • swollen joints
  • tightness in the chest
  • tingling of the hands or feet
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
Less common
  • Cracked lips
  • difficulty in swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • general feeling of discomfort or illness
  • hoarseness
  • loss of appetite
  • nausea
  • shivering
  • sweating
  • trouble sleeping
  • upper stomach pain
  • vomiting
Incidence not known
  • Bloody, black, or tarry stools
  • blurred vision or other change in vision
  • dilated neck veins
  • extreme fatigue
  • eye pain
  • feeling of discomfort
  • high fever
  • inflammation of the joints
  • irregular breathing
  • irregular heartbeat
  • itching
  • rash
  • redness of the eye
  • sensitivity of the eye to light
  • severe stomach pain
  • severe vomiting, sometimes with blood
  • tearing
  • unexplained bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Belching
  • bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • constipation
  • hair loss
  • heartburn
  • indigestion
  • lack or loss of strength
  • pain in the mouth and throat
  • pain or tenderness around the eyes and cheekbones
  • stomach discomfort, upset, or pain
  • unsteadiness or awkwardness
  • weakness in the arms, hands, legs, or feet
Less common
  • Burning, dry, or itching of the eyes
  • discharge, excessive tearing
  • redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Contraindications

None

Important information

Rituxan Hycela may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have changes in your mental state, vision changes, weakness on one side of your body, or problems with speech or walking.

Tell your doctor if you have ever had hepatitis B. Rituxan Hycela can cause this condition to come back 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.

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

Rituxan Hycela dosing information

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)

What should I avoid while receiving Rituxan Hycela?

Do not receive a "live" vaccine while you are being treated with Rituxan Hycela. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

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