RITUXAN (rituximab)

There are 2 contraindications. Absolute contraindication.

Contraindication List
Lactation
Progressive multifocal leukoencephalopathy

There are 22 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Acute renal failure
Cytomegalovirus disease
Disease due to west nile virus
Fungal infection
Gastrointestinal obstruction
Gastrointestinal perforation
Hepatitis B immune due to latent hepatitis B infection
Herpes simplex infection
Hyperkalemia
Hyperphosphatemia
Hypocalcemia
Hypogammaglobulinemia
Kidney disease with reduction in glomerular filtration rate (GFr)
Neutropenic disorder
Parvovirus infection
Pneumocystis jirovecii pneumonia
Pregnancy
Reactivation of hepatitis B
Severe infection
Thrombocytopenic disorder
Varicella zoster virus infection
Viral hepatitis C

There are 3 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Anemia
Angina
Ventricular arrhythmias

There are 79 severe adverse reactions.

More Frequent	Less Frequent
Angioedema Bacterial sepsis Bronchospastic pulmonary disease Chills Dyspnea Fatigue Fever Flushing Hypogammaglobulinemia Hypotension Infection Leukopenia Lymphopenia Nausea Neutropenic disorder Peripheral neuropathy Pruritus of skin Rhinitis Skin rash Thrombocytopenic disorder Vomiting	Anemia Chest tightness Fungal sepsis Herpes zoster Hypertension Hypophosphatemia Injection site sequelae Peripheral edema Respiration changes Sinusitis Urticaria

Rare/Very Rare

Acute myocardial infarction Acute renal failure Acute respiratory distress syndrome Anaphylaxis Angina Bone marrow hypoplasia Bronchiolitis obliterans Bullous dermatitis Cardiac arrhythmia Cardiogenic shock Enteroviral meningoencephalitis Gastrointestinal obstruction Gastrointestinal perforation Heart failure Hepatic failure Hyperkalemia Hyperphosphatemia Hypersensitivity drug reaction Hypocalcemia Hypoxia Ileus Interstitial lung disease Intestinal perforation Lichenoid dermatitis drug eruption Lupus-like syndrome Muscle weakness in limbs Nephrotoxicity Optic neuritis Pancytopenia Paraneoplastic pemphigus Pleuritis Pneumocystis jirovecii pneumonia Pneumonia Posterior reversible encephalopathy syndrome Progressive multifocal leukoencephalopathy Pulmonary infiltrates Pyoderma gangrenosum Reactivation of hepatitis B Serum sickness Stevens-johnson syndrome Supraventricular arrhythmias Toxic epidermal necrolysis Tumor lysis syndrome Uveitis Vasculitis Ventricular fibrillation Viral infection

There are 32 less severe adverse reactions.

More Frequent	Less Frequent
Acute abdominal pain Alopecia Back pain Bronchitis Constipation Cough General weakness Headache disorder Muscle spasm Night sweats Paresthesia Upper respiratory infection Urinary tract infection	Abdominal distension Arthralgia Conjunctivitis Cutaneous papilloma Depression Diarrhea Dizziness Dyspepsia Herpes simplex infection Hyperglycemia Insomnia Irritability Musculoskeletal pain Myalgia Pain Sore throat Symptoms of anxiety Tachycardia Weight gain

Rare/Very Rare
None.

Although rituximab has been shown to cross the monkey placenta, results of an embryofetal developmental toxicity study in which IV rituximab was administered to pregnant cynomolgus monkeys during early gestation did not indicate teratogenicity. However, a decrease in levels of lymphoid tissue B cells was observed in the offspring of treated dams. In another developmental toxicity study in cynomolgus monkeys receiving rituximab during prenatal and postnatal periods, decreased levels of B cells and immunosuppression were observed in the offspring; levels of B cells and immune function returned to normal within 6 months of birth.

There are no adequate and well-controlled studies in pregnant women. Postmarketing data indicate that B-cell lymphocytopenia generally lasting less than 6 months can occur in infants exposed to rituximab in utero. Rituximab was detected postnatally in the serum of infants exposed to the drug in utero.

The manufacturer states that rituximab should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Individuals of childbearing potential should use effective contraception during treatment and for up to 12 months following rituximab therapy.

Rituximab is distributed into milk in lactating cynomolgus monkeys. It is not known whether rituximab is distributed into milk in humans. IgG is distributed into human milk; however, published data suggest that antibodies in breast milk do not enter the neonatal and infant circulations in substantial amounts. The unknown risks to the infant from oral ingestion of rituximab should be weighed against the known benefits of breastfeeding.

No enhanced Geriatric Use information available for this drug.