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Drug reference

Apixaban

Eliquis · Eliquis Sprinkle

An oral direct factor Xa inhibitor for atrial fibrillation and venous thromboembolism. This reference separates adult indication-specific regimens from pediatric weight-based treatment, with current interruption, bleeding and formulation guidance.

Therapeutic class
Direct factor Xa inhibitor
Common brand
Eliquis · Pediatric Sprinkle formulation
Reference focus
Current U.S. oral adult and pediatric label
Essential safety

Prevent gaps in anticoagulation and recognize bleeding.

Premature discontinuation increases thrombotic risk; spinal or epidural procedures can cause hematoma and paralysis. Use a planned interruption or transition, and urgently assess significant bleeding or new neurologic symptoms after a spinal procedure.

Warnings and precautions
01

Indications

The regimen depends on the indication and population.

Adult approved uses

Eliquis reduces stroke/systemic embolism risk in adult nonvalvular AF; prevents DVT after adult hip or knee replacement; treats adult DVT and PE; and reduces recurrent DVT/PE risk after initial treatment. These uses have separate dosing and treatment-duration requirements.

Pediatric approved use and boundaries

Treatment of VTE and reduction of recurrence are approved from birth after at least 5 days of initial anticoagulant therapy. Pediatric use below 2.6 kg is not recommended because it was not studied. The pediatric approval does not extend adult AF or orthopedic-prophylaxis regimens to children.

Situations needing another treatment strategy

The label does not recommend apixaban for prosthetic heart valves or triple-positive antiphospholipid syndrome. It is not an alternative to unfractionated heparin for initial PE treatment with hemodynamic instability or anticipated thrombolysis/embolectomy.

02

Dosage and administration

Adult regimens and pediatric weight bands must stay distinct.

Adult dosing

Take orally twice daily. Food does not materially affect bioavailability. Select the regimen by indication.

IndicationRegimen
Nonvalvular AF5 mg twice daily; 2.5 mg twice daily only when ≥2 apply: age ≥80 years, weight ≤60 kg, serum creatinine ≥1.5 mg/dL
Hip / knee replacement prophylaxis2.5 mg twice daily, starting 12–24 hours after surgery; 35 days after hip or 12 days after knee replacement
Acute adult DVT / PE10 mg twice daily for the first 7 days, then 5 mg twice daily
Adult recurrence reduction2.5 mg twice daily after at least 6 months of DVT / PE treatment

Pediatric VTE weight-based dosing

Begin the apixaban regimen after at least 5 days of initial anticoagulation. The day numbers in this table refer to apixaban treatment, not the preceding therapy. Reassess the weight tier as the child grows and individualize total duration. All entries below are twice-daily doses.

WeightApixaban days 1–7Day 8 onward
2.6 to <4 kg0.3 mg0.15 mg
4 to <6 kg1 mg0.5 mg
6 to <9 kg2 mg1 mg
9 to <12 kg3 mg1.5 mg
12 to <18 kg4 mg2 mg
18 to <25 kg6 mg3 mg
25 to <35 kg8 mg4 mg
≥35 kg10 mg5 mg

Tablets, mixtures and feeding tubes

Adults and children ≥35 kg may use 2.5 or 5 mg tablets. They can be crushed into water, D5W or apple juice, or mixed with applesauce and promptly given. For a 12 French NG tube, suspend crushed tablets in 60 mL water or D5W and flush afterward with 20 mL. Stability of these crushed-tablet preparations is up to 4 hours; do not substitute this method for the pediatric packet/capsule instructions.

Pediatric suspension preparation

For 2.6 to <4 kg use the 0.15 mg Sprinkle capsules: open and mix the entire prescribed contents with water or infant formula; do not swallow the capsule. For 4 to <35 kg use 0.5 mg tablets supplied in packets; mix with water, formula, apple juice or applesauce, not swallowed whole. Liquid mixtures must be administered within 2 hours; applesauce mixtures immediately. Use the exact IFU volumes, oral syringe and rinse steps to deliver the full dose. The 0.5 mg packet-tablet liquid mixture has specified NG/G-tube options; obtain tube-size and preparation instructions rather than extrapolating to Sprinkle capsules.

Missed or vomited doses

Take a missed dose as soon as possible on the same day and resume twice-daily dosing; never double. For a child vomiting or spitting up within 30 minutes, repeat the dose; after more than 30 minutes, do not repeat and give the next scheduled dose. Repeated vomiting requires clinician advice.

Elective procedures

The label calls for at least 48 hours of interruption before procedures with moderate/high bleeding risk, or at least 24 hours for low-risk procedures with readily controlled bleeding. Bridging during this short interruption is generally unnecessary; restart once adequate hemostasis is established. Neuraxial procedures require a separate anesthesia plan; these general surgical intervals are not a complete neuraxial protocol.

Anticoagulant transitions

From warfarin, start apixaban when INR is below 2.0. Apixaban affects INR during the reverse transition; one labeled approach starts both warfarin and a parenteral anticoagulant when the next apixaban dose would be due, stopping the parenteral drug when INR is acceptable. For transitions with other oral/parenteral anticoagulants, start the replacement at the next scheduled dose time. Use a supervised plan to avoid gaps or unintended overlap.

03

Safety

Bleeding and interruption safety require clinical planning.

Warnings and precautions

Clinical alert

Serious or fatal bleeding can occur; stop apixaban for active pathological hemorrhage and assess promptly. Other antithrombotics, NSAIDs and SSRIs/SNRIs can increase bleeding risk. Premature cessation without alternative anticoagulation increases thrombotic risk.

Neuraxial hematoma may cause permanent paralysis. The label specifies no catheter removal earlier than 24 hours after the last dose, no next dose earlier than 5 hours after removal, and a 48-hour delay after traumatic puncture. These are label precautions, not a complete anesthesia protocol; optimal timing is not established and pediatric catheter timing has no supporting data. New leg weakness/numbness or bowel/bladder dysfunction needs urgent evaluation.

Contraindications

Active pathological bleeding and severe hypersensitivity to apixaban or the product are contraindications. Renal/hepatic and indication-specific restrictions require additional review even when they are not formal contraindications.

Boxed warning · Thrombosis and spinal hematoma

Boxed warning

The boxed warning addresses increased thrombosis after premature discontinuation and spinal/epidural hematoma with neuraxial anesthesia or spinal puncture. Risk rises with indwelling catheters, other hemostasis-altering drugs, traumatic/repeated puncture and spinal deformity or surgery. Plan interruption and observe neurologic status.

Adverse reactions

Bleeding is the principal adult adverse reaction. Pediatric trial events commonly included headache, vomiting and excessive menstrual bleeding. Investigate blood loss, anemia or abnormal uterine bleeding rather than dismissing these as routine nuisance effects.

04

Drug interactions

Exposure interactions can change either bleeding or clotting risk.

Combined P-gp and strong CYP3A4 inhibitors

For adults taking 5 or 10 mg twice daily, reduce the apixaban dose by 50% with combined P-gp/strong CYP3A4 inhibitors such as ketoconazole, itraconazole or ritonavir. Avoid these combinations when already taking 2.5 mg twice daily. Pediatric coadministration has not been studied; do not invent an adult-style weight-based adjustment. The label specifically states that clarithromycin does not require adjustment on pharmacokinetic grounds.

Inducers and hemostasis combinations

Avoid combined strong CYP3A4/P-gp inducers such as rifampin, carbamazepine, phenytoin and St. John’s wort: lower exposure can increase stroke or thrombosis risk. Antiplatelets, anticoagulants, thrombolytics, chronic NSAIDs and SSRIs/SNRIs increase bleeding risk and need an explicit benefit/risk review.

05

Use in specific populations

Renal evidence limits differ between adults and children.

Adult kidney function

For AF, use the two-of-three reduction criteria rather than serum creatinine alone. For adult surgical prophylaxis and VTE, the label recommends no renal dose adjustment, including ESRD on dialysis; however, clinical studies excluded dialysis and CrCl below 15 mL/min, so those recommendations rely on PK/PD evidence. AF outcome equivalence on dialysis remains unknown.

Pediatric kidney function

Apixaban is not recommended at eGFR below 30 mL/min/1.73 m² for age ≥2 years. For younger children, apply the label’s age-specific renal adequacy criteria; these are not the adult AF rule. The label table gives thresholds for both sexes: at 1 week, eGFR <8; at 2–8 weeks, <12; and after 8 weeks to <2 years, <22 mL/min/1.73 m². Specialist assessment is needed for neonatal ages not explicitly covered in that table.

Hepatic impairment

Child-Pugh A needs no adjustment. No dosing recommendation can be provided for Child-Pugh B because of coagulation abnormalities and limited experience. Use is not recommended in Child-Pugh C; pediatric hepatic impairment has not been studied.

Pregnancy and reproductive planning

Use in pregnancy is not recommended; human data are limited and maternal/fetal bleeding is a concern. Discuss pregnancy plans and abnormal uterine bleeding. As delivery approaches, a shorter-acting anticoagulant may be considered under a coordinated obstetric/anticoagulation plan.

Breastfeeding and older adults

Breastfeeding is not recommended on apixaban. Although the product label retains an older absence-of-human-data statement, current LactMed documents substantial milk transfer and prefers an alternative, especially for newborn/preterm infants. Older adults still need the indication-specific dose criteria and assessment of organ function and interacting therapy.

06

Clinical pharmacology

Selective factor Xa inhibition suppresses thrombin generation.

Mechanism and laboratory interpretation

Apixaban inhibits free and clot-bound factor Xa and prothrombinase activity without requiring antithrombin. PT/INR/aPTT changes at therapeutic doses are small and variable, making these tests unsuitable for routine assessment of anticoagulant effect. Specialized assays require a clinical question and local interpretation.

Disposition

Oral bioavailability is about 50%, with peaks at 3–4 hours. Protein binding is about 87% and adult half-life about 12 hours. CYP3A4 is the main metabolic pathway; renal excretion contributes about 27% of total clearance, with intestinal/biliary elimination also contributing. The pediatric label reports a peak around 2 hours after a single dose; adult PK values must not replace pediatric weight-tier dosing.

Adult half-life
Approximately 12 hours
Renal clearance contribution
Approximately 27%
07

Monitoring and counseling

Follow adherence, bleeding and changes in organ function or treatment.

Monitoring and counseling

Review the indication, dose, weight when relevant, renal/hepatic status, bleeding history and full medicine list. Follow bleeding or anemia symptoms and new interacting drugs. Do not stop without a plan; report blood in urine/stool, prolonged bleeding, faintness or neurologic symptoms. Tell dentists and procedural teams about treatment. Caregivers need hands-on preparation training and weight-tier review.

Major bleeding and current reversal context

Anticoagulant effects can persist for at least 24 hours after a dose. Vitamin K and protamine do not reverse apixaban; dialysis has little effect. The current label allows consideration of PCC-based management but does not establish its clinical efficacy. FDA found Andexxa’s risks outweighed benefits and reported the end of U.S. sales on December 22, 2025; do not rely on older labels describing routine availability. Emergency specialists should use the current local protocol.

Overdose

Suspected overdose or accidental ingestion requires urgent poison-center/medical assessment. Activated charcoal can reduce absorption in selected circumstances; this is a supervised toxicology decision, not a home treatment. Continue bleeding surveillance and supportive management.

08

Product identification

Confirm the product and pediatric packet contents.

Representative product

Eliquis 5 mg tablets are pink, oval and biconvex with 894 / 5 imprints. Example bottle of 60: NDC 0003-0894-21. Pediatric packets and Sprinkle capsules have different strengths and preparation requirements; appearance alone does not establish the correct dose.

Dosage forms and strengths

Adult/≥35 kg tablets contain 2.5 or 5 mg. Pediatric 0.5 mg tablets for suspension are supplied as packets containing 1, 3 or 4 tablets, corresponding to 0.5, 1.5 or 2 mg per packet. Sprinkle capsules contain 0.15 mg powder and are opened for suspension. Verify both tablet count and packet total.

Storage and handling

Store Eliquis and Sprinkle at 20–25°C with excursions to 15–30°C. Follow formulation-specific mixture timing: pediatric liquids within 2 hours, applesauce mixtures immediately, and crushed 2.5/5 mg preparations up to 4 hours. Keep medicines away from children and use prescribed oral dosing equipment.

09

References

Original sources for the clinical and product information.

  1. Bristol Myers Squibb / PfizerEliquis · Current prescribing information

    Manufacturer PI revised August 2026; adult tablets and pediatric oral-suspension formulations.

  2. U.S. Food and Drug AdministrationAndexxa · U.S. safety and sale update

    December 18, 2025: risks outweighed benefits; U.S. commercial sales ended December 22, 2025.

  3. LactMed / National Library of MedicineApixaban · Lactation

    Revised May 15, 2026; human milk measurements and infant-exposure concerns.

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