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Apixaban
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Mechanism of Action

Pharmacokinetics

Dosing – Pediatric

Dose Recommendation in Pediatric Patients from Birth to less than 18 Years of Age for the Treatment of VTE and Reduction in the Risk of Recurrent VTE

 Days 1-7Days 8 and beyond
PresentationBody weight (kg)Dosing scheduleDosing schedule

Power in Capsule 0.15 mg

For pediatric use

2.6 to less than 40.3 mg twice daily0.15 mg twice daily

Tablet 0.5 mg

For pediatric use

4 to less than 61 mg twice daily0.5 mg twice daily
6 to less than 92 mg twice daily1 mg twice daily
9 to less than 123 mg twice daily1.5 mg twice daily
12 to less than 184 mg twice daily2 mg twice daily
18 to less than 256 mg twice daily3 mg twice daily
25 to less than 358 mg twice daily4 mg twice daily
Tablets 2.5 mg and 5 mggreater than or equal to 3510 mg twice daily5 mg twice daily

ELIQUIS is not recommended for use in pediatric patients less than 2.6 kg because ELIQUIS was not studied in these patients. 

 Initiating Therapy
Prior to initiation of therapy, but no longer than 48 hours before, the following labs should be checked: CBC, coagulation profile (PT, PTT, fibrinogen activity), hepatic function panel, creatinine, urine pregnancy if applicable

Administration:

Adult and pediatric patients weighing greater than or equal to 35 kg:  
Splitting/crushing If unable to swallow as a whole, tablets may be split or crushed and mixed in water, D5W, or apple juice, or mixed with applesauce; administer immediately. Crushed tablets are stable in water, D5W, apple juice, and apple sauce for up to 4 hours
Nasogastric/gastric feeding tube Crushed tablets may be suspended in 60 mL of water or D5W followed by immediate delivery. Following administration of the dose, the nasogastric tube should be flushed with an additional 20 mL of water or D5W. Crushed tablets are stable in water, D5W, apple juice, and applesauce for up to 4 hours. Absorption occurs primarily in the small intestine.

Pediatric patients weighing less than 35 kg * 

0.5 mg oral tablet  The 0.5 mg ELIQUIS tablet comes in a packet for oral suspension and should be mixed with water, infant formula, apple juice, or apple sauce. The liquid mixtures with water, infant formula or apple juice should be administered within 2 hours and the mixture in apple sauce should be administered immediately.  
0.15 mg capsule The 0.15 mg ELIQUIS SPRINKLE capsule must be opened, and the entire contents sprinkled in water or infant formula, mixed, and administered within 2 hours.  

Monitoring

Anticoagulation Monitoring Parameters and Reference Range
Routine coagulation testing is not required for monitoring of apixaban. If monitoring is indicated, apixaban anti-Xa activity assay is the preferred test to extrapolate apixaban concentrations in ng/ml. Therapeutic range not defined. Dose adjustment based on results not yet established. Observed peak and trough concentrations in patients exposed to therapeutic dosing have been reported.

Dosage Forms
Apixaban is available as oral tablet or capsule.

Tablets for oral use5 mg, 2.5 mg
Tablet for oral suspension 0.5 mg
Capsule for oral suspension 0.15 mg

Eliquis was approved as a 0.5 mg tablet for oral suspension and a 0.15 mg capsule for oral suspension for patients weighing less than 35 kg. However, availability might be limited.  

Patient assistance program for drug: Bristol Myers Squibb

Safety Precautions

In pediatric patients equal to or greater than 2 years of age, ELIQUIS is not recommended in patients with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 body surface area (BSA)  

 In patients less than 2 years of age, ELIQUIS is not recommended in patients with inadequate renal function defined by sex and postnatal age as used in the pediatric VTE trial for ELIQUIS (see Table  below).  

 To estimate GFR, the pediatric VTE trial for ELIQUIS used the updated Schwartz formula, eGFR (ml/min/1.73m2 ) = 0.413 * height (cm)/serum creatinine (mg/dL) for serum creatinine measured by an enzymatic creatinine method calibrated to be traceable to isotope dilution mass spectrometry (IDMS)

Inadequate renal function by sex and post-nasal age in pediatric patients <2 years of age as defined in the pediatric VTE trial for ELIQUIS
Postnatal age (gender)Threshold eGFR used to define inadequate renal function (mL/min/1.73 m2)
1 week (males and females)<8
2-8 weeks (males and females)<12
>8 weeks to <2 years (males and females)<22

Renal impairment: In adults, if serum creatinine ≥ 1.5 mg/dL and patient is either ≥ 80 years of age or weighs ≤ 60 kg dose, reduce to 2.5 mg PO BID. If serum creatinine ≥ 2.5 mg/dL or CrCl <25 mL/min, avoid use. Consider on individual basis in consultation with hematology, nephrology and pharmacy for patients with CrCl < 30 mL/minute.

Hepatic impairment: For mild hepatic impairment (Child-Pugh A), no adjustment necessary. For moderate hepatic impairment (Child-Pugh B), no adjustments provided by the manufacturer. For severe hepatic impairment (Child-Pugh C), avoid use.

Drug-Drug interactions: