Apixaban is a factor xa inhibitor sold in the U.S. under 3 brand and generic names, for pulmonary embolism and venous thrombosis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Apixaban (application ANDA210091). Other apixaban products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Reduction of risk of stroke and systemic embolism in nonvalvular atrial fibrillation: • The recommended dose is 5 mg orally twice daily. ( 2.1 ) • In patients with at least 2 of the following characteristics: age greater than or equal to 80 years, body weight less than or equal to 60 kg, or serum creatinine greater than or equal to 1.5 mg/dL, the recommended dose is 2.5 mg orally twice daily. ( 2.1 ) • Prophylaxis of DVT following hip or knee replacement surgery: • The recommended dose is 2.5 mg orally twice daily. ( 2.1 ) • Treatment of DVT and PE: • The recommended dose is 10 mg taken orally twice daily for 7 days, followed by 5 mg taken orally twice daily. ( 2.1 ) • Reduction in the risk of recurrent DVT and PE following initial therapy: • The recommended dose is 2.5 mg taken orally twice daily. ( 2.1 ) 2.1 Recommended Dose Reduction of Risk of Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation The recommended dose of apixaban tablets for most patients is 5 mg taken orally twice daily. The recommended dose of apixaban tablets is 2.5 mg twice daily in patients with at least two of the following characteristics: • age greater than or equal to 80 years • body weight less than or equal to 60 kg • serum creatinine greater than or equal to 1.5 mg/dL Prophylaxis of Deep Vein Thrombosis Following Hip or Knee Replacement…
The following clinically significant adverse reactions are discussed in greater detail in other sections of the prescribing information. • Increased Risk of Thrombotic Events After Premature Discontinuation [see Warnings and Precautions ( 5.1 )] • Bleeding [see Warnings and Precautions ( 5.2 )] • Spinal/Epidural Anesthesia or Puncture [see Warnings and Precautions ( 5.3 )] Most common adverse reactions (>1%) are related to bleeding. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc., at 1-888-943-3210 or 1-855-926-3384 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Reduction of Risk of Stroke and Systemic Embolism in Patients with Nonvalvular Atrial Fibrillation The safety of apixaban was evaluated in the ARISTOTLE and AVERROES studies [see Clinical Studies ( 14 )], including 11,284 patients exposed to apixaban tablets 5 mg twice daily and 602 patients exposed to apixaban tablets 2.5 mg twice daily. The duration of apixaban exposure was ≥12 months for 9375 patients and ≥24 months for 3369 patients in the two studies. In ARISTOTLE, the mean duration of…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
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Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| 893;2;1;2 | 2.5 mg | yellow | round | — |
| 894;5 | 5 mg | pink | oval | — |
| 894;5 | 5 mg | pink | oval | — |
| 893;2;1;2 | 2.5 mg | yellow | round | — |
| 894;5 | 5 mg | pink | oval | — |
| F51 | 2.5 mg | yellow |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Apixaban tablets are contraindicated in patients with the following conditions: • Active pathological bleeding [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.1 )] • Severe hypersensitivity reaction to apixaban tablets (e.g., anaphylactic reactions) [see Adverse Reactions ( 6.1 )] • Active pathological bleeding ( 4 ) • Severe hypersensitivity to apixaban tablets ( 4 )
Apixaban is a substrate of both CYP3A4 and P-gp. Inhibitors of CYP3A4 and P-gp increase exposure to apixaban and increase the risk of bleeding. Inducers of CYP3A4 and P-gp decrease exposure to apixaban and increase the risk of stroke and other thromboembolic events. • Combined P-gp and strong CYP3A4 inhibitors increase blood levels of apixaban. Reduce apixaban tablets dose or avoid coadministration. ( 2.5 , 7.1 , 12.3 ) • Simultaneous use of combined P-gp and strong CYP3A4 inducers reduces blood levels of apixaban: Avoid concomitant use. ( 7.2 , 12.3 ) 7.1 Combined P-gp and Strong CYP3A4 Inhibitors For patients receiving apixaban tablets 5 mg or 10 mg twice daily, the dose of apixaban tablets should be decreased by 50% when coadministered with drugs that are combined P-gp and strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir) [see Dosage and Administration ( 2.5 ) and Clinical Pharmacology ( 12.3 )]. For patients receiving apixaban tablets at a dose of 2.5 mg twice daily, avoid coadministration with combined P-gp and strong CYP3A4 inhibitors [see Dosage and Administration ( 2.5 ) and Clinical Pharmacology ( 12.3 )]. Clarithromycin Although clarithromycin is a combined P-gp and strong CYP3A4 inhibitor, pharmacokinetic data suggest that no dose adjustment is necessary with concomitant administration with apixaban tablets [see Clinical Pharmacology ( 12.3 )].…
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| 3 | Not yet rated | Prescription | Capsule | — | — | View → |
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| F52 | 5 mg | pink | capsule | — |
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| M;2;5 | 2.5 mg | yellow | round | — |
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| M;5 | 5 mg | pink | oval | — |
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