Note: This document contains side effect information about hyaluronidase / rituximab. Some dosage forms listed on this page may not apply to the brand name Rituxan Hycela.
Applies to hyaluronidase / rituximab: subcutaneous solution.
Warning
Subcutaneous route (Solution)
Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab-containing products, including rituximab and hyaluronidase human, recombinant. Hepatitis B Virus (HBV) reactivation can occur in patients treated with rituximab-containing products, including rituximab and hyaluronidase human, recombinant, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with rituximab and hyaluronidase human, recombinant. Discontinue rituximab and hyaluronidase human, recombinant and concomitant medications in the event of HBV reactivation. Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab-containing products, including rituximab and hyaluronidase human, recombinant.
Serious side effects of Rituxan Hycela
Along with its needed effects, hyaluronidase / rituximab 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 while taking hyaluronidase / rituximab:
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
Other side effects of Rituxan Hycela
Some side effects of hyaluronidase / rituximab 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
For Healthcare Professionals
Applies to hyaluronidase / rituximab: subcutaneous solution.
Hematologic
Very common (10% or more): Neutropenia (32%), thrombocytopenia (20% or greater), anemia (15%)
Common (1% to 10%): Febrile neutropenia, leukopenia, lymphopenia
Postmarketing reports: Prolonged pancytopenia, marrow hypoplasia, Grade 3 to 4 prolonged or late onset neutropenia, hyperviscosity syndrome in Waldenstrom's macroglobulinemia, prolonged hypogammaglobulinemia
Hypersensitivity
Frequency not reported: Hypersensitivity[Ref]
Immunologic
Very common (10% or more): Infections (20% or greater)
Common (1% to 10%): Influenza, immunogenicity
Postmarketing reports: Lupus-like syndrome, serum sickness, viral infections (including progressive multifocal leukoencephalopathy [PML], increase in fatal infections in HIV-associated lymphoma, and an increased incidence of Grade 3 and 4 infections)[Ref]
Local
Very common (10% or more): Injection site erythema (13%)
Common (1% to 10%): Injection site pain, injection site edema[Ref]
Musculoskeletal
Very common (10% or more): Arthralgia (13%), bone pain (10%), pain in extremity (10%)
Common (1% to 10%): Back pain, muscle spasms, myalgia
Postmarketing reports: Polyarticular arthritis[Ref]
Ocular
Common (1% to 10%): Conjunctivitis
Postmarketing reports: Uveitis, optic neuritis[Ref]
Metabolic
Very common (10% or more): Arthralgia (13%)
Common (1% to 10%): Myalgia, anorexia, weight loss
Frequency not reported: Tumor lysis syndrome[Ref]
Psychiatric
Common (1% to 10%): Insomnia[Ref]
Genitourinary
Common (1% to 10%): Urinary tract infection[Ref]
Hepatic
Frequency not reported: Hepatitis B reactivation including fulminant hepatitis[Ref]
Oncologic
Postmarketing reports: Disease progression of Kaposi's sarcoma[Ref]
Respiratory
Very common (10% or more): Cough (23%), upper respiratory tract infection (15%), pneumonia (11%), dyspnea (11%), nasopharyngitis (10%)
Common (1% to 10%): Bronchitis, sinusitis, oropharyngeal pain, respiratory tract infection
Postmarketing reports: Pleuritis, fatal bronchiolitis obliterans, fatal interstitial lung disease[Ref]
Other
Very common (10% or more): Fatigue (20%), asthenia (17%), pyrexia (15%)[Ref]
Nervous system
Very common (10% or more): Paresthesia (16%), headache (13%), peripheral neuropathy (12%)
Common (1% to 10%): Chills, dizziness
Frequency not reported: Progressive multifocal leukoencephalopathy[Ref]
Renal
Frequency not reported: Renal toxicity
Cardiovascular
Common (1% to 10%): Flushing, chest pain, peripheral edema, hypertension
Frequency not reported: Cardiac arrhythmias
Postmarketing reports: Fatal cardiac failure, systemic vasculitis[Ref]
Dermatologic
Very common (10% or more): Alopecia (16%), pruritus (10%), rash (10%)
Common (1% to 10%): Erythema
Frequency not reported: Mucocutaneous reactions
Postmarketing reports: Vasculitis with rash[Ref]
Gastrointestinal
Very common (10% or more): Nausea (31%), constipation (25%), diarrhea (18%), abdominal pain (14%), vomiting (14%)
Common (1% to 10%): Dyspepsia, stomatitis, upper abdominal pain, throat irritation, mucosal inflammation
Frequency not reported: Bowel obstruction and perforation[Ref]
