Acellbia

Patients w/ relapsed or chemoresistant low-grade of follicular, CD20-+ve, B cell non-Hodgkin's lymphoma (NHL); previously untreated patients w/ stage III-IV follicular lymphoma in combination w/ chemotherapy; patients w/ follicular lymphoma maintenance treatment, after response to induction therapy; patients w/ CD20-+ve diffuse large B-cell NHL in combination w/ cyclophosphamide, doxorubicin, vincristine & prednisone chemotherapy. In combination w/ chemotherapy for patients w/ previously untreated & relapsed/refractory chronic lymphocytic leukemia (CLL). In combination w/ MTX for adults w/ moderate to severe, active RA when response to DMARDs including MTX has been inadequate; moderate to severe, active RA in patients w/ inadequate response or intolerance to ≥1 tumor necrosis factor inhibitor therapies. In combination w/ glucocorticoids for patients w/ severe active granulomatosis w/ polyangiitis (GPA, also known as Wegener's granulomatosis) & microscopic polyangiitis (MPA).

IV Recommended dose: 5 mg, 7.5 mg, 10 mg, or 15 mg/kg once every 2 or 3 wk depending on body wt & type of cancer to be treated. NHL Given once a wk for 4 wk if used alone. Repeated treatment courses are possible. Given on same day as chemotherapy usually 3 wk up to 8 times if w/ chemotherapy. Maintenance treatment may be given every 2 or 3 mth for 2 yr if responds well to treatment. CLL Infuse on day 0 cycle 1 then day 1 of each cycle for 6 cycles in total in combination w/ chemotherapy. Each cycle has a duration of 28 days. Give chemotherapy after infusion. GPA & MPA Use 4 separate infusions given at wkly intervals. Give corticosteroids by inj before start of treatment.

Hypersensitivity to rituximab, other proteins which are like rituximab. Patients who have severe infection at the moment, weak immune systems, & severe heart failure or severe uncontrolled heart disease.

Infusion/administration-related reactions, which may be related to release of cytokines &/or other chemical mediators. Anaphylactic & other hypersensitivity reactions following IV administration. Hypotension during administration; w/hold antihypertensive medications 12 hr prior to & throughout administration. Monitoring of blood counts. Limited clinical experience in patients w/ neutrophil counts <1.5 x 10⁹/L &/or platelet counts <75 x 10⁹/L. Do not initiate treatment in patients w/ severe active infections. Cases of hepatitis B reactivation, including reports of fulminant hepatitis; progressive multifocal leukoencephalopathy during use; severe skin reactions eg, TEN & SJS. Vaccination w/ live virus vaccines is not recommended. Pregnancy. Do not breastfeed while on treatment & for 12 mth after the last treatment.

NHL or CLL: Bacterial or viral infections, bronchitis; low number of WBC, w/ or w/o fever or low blood platelet count; nausea; bald spots on scalp, chills, headache; lower immunity. Sepsis, pneumonia, shingles, cold, bronchial tube infections, fungal infections, infections of unknown origin, sinus inflammation, hepatitis B; anemia, low number of WBC, allergic reactions (hypersensitivity); high blood sugar level, wt loss, swelling in face & body, high levels of enzyme LDH in blood, low Ca levels in blood; unusual feelings of the skin eg, numbness, tingling, pricking, burning, creeping skin feeling, reduced sense of touch; feeling restless, problems falling asleep; becoming very red in face & other areas of skin as consequence of dilation of blood vessels; feeling dizzy or anxious; producing more tears, tear duct problems, conjunctivitis; ringing sound in the ears, ear pain; heart problems eg, heart attack, uneven or fast heart rate; high or low BP; bronchospasm, inflammation, irritation in lungs, throat, or sinuses, shortness of breath, runny nose; vomiting, diarrhea, pain in stomach, irritation or ulcers in throat & mouth, problems swallowing, constipation, indigestion; eating disorders, not eating enough, leading to wt loss; hives, increased sweating, night sweats; muscle problems eg, tight muscles, joint or muscle pain, back & neck pain; general discomfort or feeling uneasy or tired, shaking, signs of flu; multiple-organ failure. RA: Infections eg, pneumonia (bacterial); UTI; allergic reactions that are most likely to occur during infusion, but can occur up-to 24-hr after infusion; changes in BP, nausea, rash, fever, feeling itchy, runny or blocked nose & sneezing, shaking, rapid heartbeat, & tiredness; headache; changes in lab tests including decrease in amount of some specific proteins in blood (Ig) which help protect against infection. Infections eg, bronchitis; sinusitis, pain in abdomen, vomiting & diarrhoea, breathing problems; athlete's foot; high cholesterol levels in blood; abnormal sensations of skin eg, numbness, tingling, pricking or burning, sciatica, migraine, dizziness; loss of hair; anxiety, depression; indigestion, diarrhoea, acid reflux, irritation &/or ulceration of throat & mouth; pain in the tummy, back, muscles &/or joints. GPA or MPA: Infections eg, chest infections, UTI, colds & herpes infections; allergic reactions that are most likely to occur during infusion, but can occur up-to 24-hr after infusion; diarrhea; coughing or shortness of breath; nose bleeds; raised BP; painful joints or back; muscle twitches or shakiness; feeling dizzy; tremors; insomnia; swelling of hands or ankles. Indigestion; constipation; skin rashes, including acne or spots; flushing or redness of skin; blocked nose; tight or painful muscles; pain in muscles or in hands or feet; anemia; low numbers of platelets in blood; increase in amount of K in blood; changes in rhythm of heart, or heart beating faster than normal.

Patients w/ human anti-mouse Ab or human anti-chimeric Ab titers may develop allergic or hypersensitivity reactions when treated w/ other diagnostic or therapeutic monoclonal Abs.

Targeted Cancer Therapy

L01FA01 - rituximab ; Belongs to the class of CD20 (Clusters of Differentiation 20) inhibitors. Used in the treatment of cancer.

Rx