Vidaza

Vidaza,

a trademark for azacitidine.

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azacitidine Warning - Hazardous drug!

Vidaza

Pharmacologic class: Pyrimidine antimetabolite

Therapeutic class: Antineoplastic

Pregnancy risk category D

Action

Unclear. Thought to exert antineoplastic effect by causing DNA hypomethylation and direct cytotoxicity on abnormal hematopoietic bone marrow cells. Cytotoxicity causes death of rapidly growing cells, including cancer cells no longer responsive to normal growth control mechanisms.

Availability

Powder for injection (lyophilized): 100-mg single-use vials

⊘Indications and dosages

➣ Treatment of the following myelodysplastic syndrome subtypes: refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusion), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia

Adults: For first treatment cycle: 75 mg/m² subcutaneously daily for 7 days; for subsequent treatment cycles, repeat cycle every 4 weeks. Dosage may be increased to 100 mg/m² if beneficial effect doesn't occur after two cycles and no toxicity (other than nausea and vomiting) develops. Patient should be treated for at least four cycles. Continue therapy as long as patient benefits from it.

Dosage adjustment

• Based on hematologic response (after administration of recommended dosage for first cycle)
• Unexplained serum bicarbonate reduction below 20 mEq/L
• Unexplained blood urea nitrogen or serum creatinine elevation

Off-label uses

• Acute myeloid leukemia

Contraindications

• Hypersensitivity to drug or mannitol
• Advanced malignant hepatic tumor

Precautions

Use cautiously in:
• impaired renal or hepatic function, myelodysplastic syndrome
• pregnant or breastfeeding patients
• children (safety and efficacy not established).

Administration

• Obtain CBC, liver function tests, and serum creatinine level before starting drug.
• Give by subcutaneous injection only.
• Reconstitute with 4 ml sterile water for injection. Inject diluent slowly into vial; invert vial two or three times and rotate gently until uniform suspension appears. Resulting suspension (which will be cloudy) contains azacitidine 25 mg/ml.
• Invert syringe two to three times and gently roll between palms for 30 seconds immediately before administration.
• Divide doses above 4 ml equally in two syringes, and inject subcutaneously in separate sites.
• Administer within 1 hour after reconstitution.
• Rotate sites for each injection (thigh, abdomen, or upper arm). Give new injection at least 1'' from old site and never into tender, bruised, red, or hard area.

Route	Onset	Peak	Duration
Subcut.	Unknown	30 min	Unknown

Adverse reactions

CNS: fatigue, headache, confusion, dizziness, anxiety, aggravated fatigue, depression, insomnia, lethargy, weakness, rigors, malaise, hypoesthesia

CV: chest pain, cardiac murmur, tachycardia, hypotension, peripheral edema, syncope

EENT: rhinorrhea, epistaxis, sinusitis, nasopharyngitis, pharyngitis, postnasal drip

GI: nausea, vomiting, diarrhea, constipation, anorexia, abdominal pain or tenderness, abdominal distention, dyspepsia, hemorrhoids, dysphagia, gingival bleeding, oral mucosal petechiae, stomatitis, tongue ulcers, mouth hemorrhage

GU: dysuria, urinary tract infection

Hematologic: anemia, thrombocytopenia, leukopenia, neutropenia, febrile neutropenia, lymphadenopathy, aggravated anemia, postprocedural hemorrhage

Musculoskeletal: myalgia, muscle cramps, arthralgia, limb pain, back pain

Respiratory: cough (possibly productive), dyspnea, exertional or exacerbated dyspnea, upper respiratory tract infection, pneumonia, crackles, wheezing, decreased breath sounds, pleural effusion, rhonchi, atelectasis

Skin: lesion, rash, pruritus, herpes simplex, increased sweating, urticaria, dry skin, skin nodule, erythema, pallor, cellulitis

Other: decreased appetite, weight loss, fever, pitting edema, hematoma, night sweats, peripheral swelling, infection site reaction, transfusion reaction, chest-wall pain, postprocedural or other pain

Interactions

Drug-diagnostic tests. Potassium: decreased

Patient monitoring

• Monitor CBC during therapy.
• Monitor liver function tests and serum creatinine frequently.
• Watch for renal tubular acidosis (serum bicarbonate level below 20 mEq/L associated with alkaline urine and hypokalemia, and serum potassium level below 3 mEq/L).

Patient teaching

☞ Instruct patient to call prescriber immediately if rash, easy bruising or bleeding, or respiratory symptoms develop.
• Advise male patient not to father a child during therapy.
• Caution female of childbearing potential to avoid pregnancy and breastfeeding during therapy.
• As appropriate, review all other significant and life-threatening adverse reactions, especially those related to the tests mentioned above.