azacitidine (Rx)

Brand and Other Names:Vidaza
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 100mg/vial
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Myelodysplastic Syndrome

75 mg/m² SC/IV qDay for 7 days every 4 weeks 

May increase 100 mg/m² if no benefit after 2 treatment cycles and no toxicity (other than nausea/vomiting)

Monitor: CBC, hematologic responses, renal toxicity

Acute Myeloid Leukemia (Orphan)

Orphan indication sponsor

  • Celgene Corporation; 9900 W. 109th Street, Suite 300; Overland Park, KS 66210

Dosage Forms & Strengths

powder for injection

  • 100mg/vial
more...

Myelodysplastic Syndrome (Off-label)

AML and ANLL: 250 mg/m² days 4 and 5 q4Weeks 

AML induction: 300 mg/m² days 4 and 5 q4Weeks

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Adverse Effects

>10%

Nausea (70.5%)

Anemia (69.5%)

Thrombocytopenia (65.5%)

Pyrexia (51.8%)

Leukopenia (48.2%)

Diarrhea (36.4%)

Fatigue (35.9%)

Inj site erythema (35%)

Constipation (33.6%)

Neutropenia (32.3%)

Ecchymosis (30.5%)

Cough (29.5%)

Dyspnea (29.1%)

Weakness (29.1%)

Rigors (25.5%)

Petechiae (23.6%)

Injection site pain (22.7%)

Arthralgia (22.3%)

Headache (21.8%)

Anorexia (20.5%)

Pain in limb (20%)

Pharyngitis (20%)

Contusion (18.6%)

Edema peripheral (18.6%)

Back pain (18.6%)

Dizziness (18.6%)

Erythema (16.8%)

Chest pain (16.4%)

Epistaxis (16.4%)

Febrile neutropenia (16.4%)

Myalgia (15.9%)

Wt loss (15.9%)

Abd pain (15.5%)

Pallor (15.5%)

Nasopharyngitis (14.5%)

Pitting edema (14.5%)

Skin lesion (14.5%)

Dyspnea exertional (14.1%)

Inj site bruising (14.1%)

Rash (14.1%)

Anxiety (13.2%)

Appetite decr (12.7%)

Hypokalemia (12.7%)

Fatigue aggravated (12.7%)

URI (12.7%)

Pruritus (12.3%)

Abd tenderness (11.8%)

Depression (11.8%)

Productive cough (11.4%)

Abd pain upper (10.5%)

Crackles lung (10.5%)

Malaise (10.9%)

Pneumonia (10.9%)

Sweating incr (10.5%)

<10%

Cardiac murmur (10%)

Rhinorrhea (10%)

Gingival bleeding (9.5%)

Hematoma (8.6%)

Lethargy (7.7%)

Stomatitis (7.7%)

Hypotension (6.8%)

Injection site pruritus (6.8%)

Postprocedural hemorrhage (5.9%)

Urticaria (5.9%)

Loose stools (5.5%)

Chest wall pain (5%)

Dry skin (5%)

Injection site granuloma/swelling (5%)

Injection site pigmentation change (5%)

Mouth hemorrhage (5%)

Skin nodule (5%)

Postmarketing Reports

Interstitial lung disease

Tumor lysis syndrome

Injection site necrosis

Sweet’s syndrome (acute febrile neutrophilic dermatosis)

Necrotizing fasciitis (including fatal cases)

Embryo fetal risk

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Warnings

Contraindications

Hypersensitivity to azacitidine or mannitol

Advanced malignant hepatic tumors

Pregnancy/lactation

Cautions

Should not get pregnant/father children while on this drug

Renal tubular acidosis, and renal failure reported

Thrombocytopenia, neutropenia, and anemia are common occurrence

Hepatotoxicity reported

Thoroughly monitor hematologic responses

Females with reproductive potential should avoid pregnancy during treatment; men should be advised to not father a child while receiving therapy

Monitor liver chemistries prior to initiation of therapy and with each cycle

Monitor serum creatinine and electrolytes prior to initiation of therapy and with each cycle

May cause fatal or serious tumor lysis syndrome, including in patients with MDS; tumor lysis syndrome may occur despite concomitant use of allopurinol; assess baseline risk and monitor and treat as appropriate

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Pregnancy & Lactation

Pregnancy: Based on mechanism of action and findings in animals, therapy can cause fetal harm when administered to a pregnant woman; verify pregnancy status of females of reproductive potential prior to initiating; advise females of reproductive potential to avoid pregnancy during therapy

Lactation: There is no information regarding presence of azacitidine in human milk, effects of therapy on breastfed infant, or effects of therapy on milk production; because many drugs are excreted in human milk and because of potential for tumorigenicity shown for azacitidine in animal studies and potential for serious adverse reactions in nursing infants from therapy, advise patients not to breastfeed during therapy

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Hypomethylation of DNA and direct cytotoxic effect on abnl hematopoietic cells in bone marrow

Absorption

Bioavailability: 89%

Peak Plasma Concentration: 350-1150 ng/mL

Peak PlasmaTime: 0.5 hr

Distribution

Vd: 76 ± 26 L

Elimination

Half-Life: 4 hr

Excretion: primarily in urine (50-85%); feces (minor)

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Administration

IV Incompatibilities

Dextrose 5% solns, Hespan, bicarbonate-containing solns

IV Preparation

Reconstitute each vial with 10 mL SWI.

Vigorously shake or roll the vial until all solids are dissolved & clear. The resulting solution will contain azacitidine 10 mg/mL.

Withdraw the required amount & inject into a 50-100 mL infusion bag of either NS or LR

IV Administration

Infuse over 10-40 min

Infusion should be completed within 1 hr of reconstitution

SC Preparation

100 mg lyophilized powder reconstituted with 4 mL SWI

Contents of syringe must be resuspended by inverting syringe 2-3x & gently rolling syringe between palms for 30 sec immediately prior to administration

4 mL dose should be equally divided into 2 syringes & injected into 2 separate sites; rotate sites for each injection

May be stored for 1 hr at room temp & up to 8 hr in fridge

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.