Names and pronunciation
(a-za-sie-ti′deen) Onureg, Vidaza
PDF page 133
Loading InternPractice…
Drug reference
(a-za-sie-ti′deen) Onureg, Vidaza
PDF page 133
Func. class.: Antineoplastic
PDF page 133
Chem. class.: Pyrimidine nucleoside analogue
PDF page 133
Do not confuse: azaCITIDine/azaTHIOprine
PDF page 133
ACTION: Cytotoxic by producing damage to double-strand DNA during DNA synthesis
PDF page 133
USES: Myelodysplastic syndrome (MDS), acute myelogenous leukemia (AML)
PDF page 133
CONTRAINDICATIONS: Preg- nancy, hypersensitivity to product or mannitol, advanced malignant hepatic tumors Precautions: Breastfeeding, children, geriatric patients, renal/hepatic disease, baseline albumin <30 g/L; a man should not father a child while taking product
PDF page 133
SIDE EFFECTS CNS: Anxiety, depression, dizziness, fatigue, headache, fever, insomnia CV: Cardiac murmur, hypotension, tachy- cardia, peripheral edema, chest pain GI: Diarrhea, nausea, vomiting, anorexia, constipation, abdominal pain, distention, tenderness, hemorrhoids, mouth hemorrhage, tongue ulceration, stomatitis, dyspepsia, hepatotoxicity, hepatic coma GU: Renal failure, renal tubular acido- sis, dysuria, UTI HEMA: Leukopenia, anemia, thrombocy- topenia, neutropenia, febrile neutrope- nia, ecchymosis, petechiae INTEG: Irritation at site, rash, sweating, pyrexia, pruritus META: Hypokalemia MS: Weakness, arthralgia, muscle cramps, myalgia, back pain RESP: Cough, dyspnea, pharyngi tis, pleural effusion
PDF page 134
INTERACTIONS Increase: bone marrow suppression— other antineoplastics Increase: bleeding—anticoagulants Drug/Lab Increase: BUN, creatinine Decrease: WBC, platelets, neutrophils, potassium
PDF page 134
DOSAGE AND ROUTES Myelodysplastic syndrome/AML • Adult: PO 300 mg daily on days 1-14 (28- day cycle); SUBCUT/IV 75 mg/m2/day × 7 days q4wk, dose may be increased to 100 mg/m2 if no response seen after 2 treatment cycles; minimum treatment, 4 cycles
PDF pages 133, 134
Available forms: Powder for injection 100 mg; tablets 200, 300 mg
PDF page 134
Administer: • Use cytotoxic handling procedures SUBCUT route • Reconstitute with 4 mL sterile water for injection (25 mg/mL), inject diluents slowly into vial, invert vial 2-3 times, gently rotate; solution will be cloudy, use immediately; divide doses >4 mL into 2 syringes; invert contents 2-3 times, gently roll syringe between the palms for 30 sec immediately before administration, ro- tate injection site Intermittent IV INFUSION route • Reconstitute each vial with 10 mL sterile water for injection, shake well until all solids are dissolved, withdraw solution (10 mg/mL), inject in 50-100 NS or LR infusion, run over 10-40 min
PDF page 134
Assess: • For CNS symptoms: fever, headache, chills, dizziness • Bone marrow suppression/hemato- logic response: CBC with differential, baseline WBC ≥3000/mm3, absolute neu- trophil count (ANC) ≥1500/mm3, platelets >75,000/mm3, adjust dose based on na- dir; ANC <500/mm3, platelets <25,000/ mm3, give 50% dose next course; ANC 500-1500/mm3, platelets 25,000-50,000/ mm3, give 67% next course; bruising, bleeding, blood in stools, urine, sputum, emesis; myelodysplastic syndrome (MDS), splenomegaly • Buccal cavity for dryness, sores or ul- ceration, white patches, oral pain, bleed- ing, dysphagia • Myelodysplastic syndrome: severe anemia, cytopenias, splenomegaly • TLS: Monitor for TLS even with allopu- rinol, monitor electrolytes, uric acid, se- rum creatinine baseline and periodically • Blood studies: BUN, bicarbonate, cre- atine, LFTs • Increased fluid intake to 2-3 L/day to prevent dehydration unless contraindi- cated • Rinsing of mouth tid-qid with water, club soda; brushing of teeth bid-tid with soft brush or cotton-tipped applicator for stomatitis; use unwaxed dental floss
PDF page 134
Evaluate: • Therapeutic response: improvement in blood counts with refractory anemia, or refractory anemia with excess blasts
PDF page 134
CLINICAL CONSIDERATIONS
PDF page 134
Patient and caregiver information: • To avoid crowds, persons with known infections; not to receive immunizations • To avoid foods with citric acid or hot or rough texture if stomatitis is present; to drink adequate fluids • To report stomatitis; any bleeding, white spots, ulcerations in mouth; to ex- amine mouth daily, report symptoms, in- fection site reactions, pruritus, fever • Pregnancy/breastfeeding: to use con- traception during and for 6 mo after therapy; not to breastfeed; not to father a child while receiving product
PDF pages 134, 135
PHARMACOKINETICS Rapidly absorbed, peak ½ hr, metabo- lized in the liver, half-life 4 hr, excreted in urine
PDF page 134
• Adult: PO 300 mg daily on days 1-14 (28- day cycle); SUBCUT/IV 75 mg/m2/day × 7 days q4wk, dose may be increased to 100 mg/m2 if no response seen after 2 treatment cycles; minimum treatment, 4 cycles
PDF pages 133, 134