Rx Item-Eliquis 5MG apixaban 60 Tab by Bristol-Myers Squibb Pharma USA

Rx Item-Eliquis 5MG 60 Tab by Bristol-Myers Squibb Pharma USA , Clinical Information:
Generic Code And Description: 70414 Apixaban Oral Tablet 5 Mg
Strength: 5 Mg
Dose Form: Tablet
Product Category: : Rx Pharmaceuticals
Fine Line Class: 850085008510 All Rx Products
DEA Class: None Omp Family:
Drug Class: 20120414 Direct Factor Xa Inhibitors
Active Ingredients: 13857 Apixaban 503612473
Inactive Ingredients: 2432 Lactose 64044515 Drug Class: Drug Class: 20120414 Direct Factor Xa Inhibitors , OMP Family: Waiting for Details, Temparature Zone: 10 Room Temperature, Unit Dose Indicator: NO, Item Size: 60 , Brand Label Flag: BRAND , Storage Temperature Zone: 10 Room Temperature, Item Size Code:60 , Item Strength Code:5MG , Item Abbreviation: Eliquis , Generic Form: TAB

These highlights do not include all the information needed to use ELIQUIS safely and effectively. See full prescribing information for ELIQUIS.

ELIQUIS® (apixaban) tablets, for oral use
Initial U.S. Approval: 2012
WARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS
(B) SPINAL/EPIDURAL HEMATOMA
See full prescribing information for complete boxed warning.

(A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS: Premature discontinuation of any oral anticoagulant, including ELIQUIS, increases the risk of thrombotic events. To reduce this risk, consider coverage with another anticoagulant if ELIQUIS is discontinued for a reason other than pathological bleeding or completion of a course of therapy. (2.4, 5.1, 14.1)

(B) SPINAL/EPIDURAL HEMATOMA: Epidural or spinal hematomas may occur in patients treated with ELIQUIS who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. (5.3)
INDICATIONS AND USAGE

ELIQUIS is a factor Xa inhibitor indicated:

•
to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. (1.1)
•
for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. (1.2)
•
for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. (1.3, 1.4, 1.5)

DOSAGE AND ADMINISTRATION

•
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)

DOSAGE FORMS AND STRENGTHS

•
Tablets: 2.5 mg and 5 mg (3)

CONTRAINDICATIONS

•
Active pathological bleeding (4)
•
Severe hypersensitivity to ELIQUIS (4)

WARNINGS AND PRECAUTIONS

•
ELIQUIS can cause serious, potentially fatal, bleeding. Promptly evaluate signs and symptoms of blood loss. An agent to reverse the anti-factor Xa activity of apixaban is available. (5.2)
•
Prosthetic heart valves: ELIQUIS use not recommended. (5.4)
•
Increased Risk of Thrombosis in Patients with Triple Positive Antiphospholipid Syndrome: ELIQUIS use not recommended. (5.6)

ADVERSE REACTIONS

Most common adverse reactions (>1%) are related to bleeding. (6.1)


To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS

•
Combined P-gp and strong CYP3A4 inhibitors increase blood levels of apixaban. Reduce ELIQUIS 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)

USE IN SPECIFIC POPULATIONS

•
Pregnancy: Not recommended. (8.1)
•
Lactation: Discontinue drug or discontinue nursing. (8.2)
•
Severe Hepatic Impairment: Not recommended. (8.7, 12.2)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 4/2021

Rx Item-Eliquis 5MG 60 Tab by Bristol-My
Item No. RX203596, 203596, NDC No.: 00003-0894-21, 00003-894-21, 0000389421, 00003089421, 0894-21, 089421 UPC No. 3-00030-89421-2, 300030-894212, 300030894212

Rx Item-Eliquis 5MG 60 Tab by
Item No. RX203596, 203596, NDC No.: 00003-0894-21, 00003-894-21, 0000389421, 00003089421, 0894-21, 089421 UPC No. 3-00030-89421-2, 300030-894212, 300030894212

Rx Item-Eliquis 5MG 60 Tab by Bristol-My
Rx items can only be ordered by a valid licence holder in scope of practice by-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physica

Rx Item-Eliquis 5MG 60 Tab by Bristol-My
Item No. RX203596, 203596, NDC No.: 00003-0894-21, 00003-894-21, 0000389421, 00003089421, 0894-21, 089421 UPC No. 3-00030-89421-2, 300030-894212, 300030894212