Rituxan Hycela Side Effects
Generic name: hyaluronidase / rituximab
Note: This document provides detailed information about Rituxan Hycela Side Effects associated with hyaluronidase / rituximab. Some dosage forms listed on this page may not apply specifically to the brand name Rituxan Hycela.
Applies to hyaluronidase / rituximab: subcutaneous solution.
Important warnings
This medicine can cause some serious health issues
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 side effects
- 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 side effects
- 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 side effects
- 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 side effects
- 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 adverse events
- 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]
References
1. (2017) "Product Information. Rituxan Hycela (hyaluronidase-rituximab)." Genentech
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Further information
Rituxan Hycela side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.