ELIQUIS- apixaban tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

APIXABAN (UNII: 3Z9Y7UWC1J) (APIXABAN - UNII:3Z9Y7UWC1J)

Available from:

REMEDYREPACK INC.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ELIQUIS is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. ELIQUIS is indicated 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. ELIQUIS is indicated for the treatment of DVT. ELIQUIS is indicated for the treatment of PE. ELIQUIS is indicated to reduce the risk of recurrent DVT and PE following initial therapy. ELIQUIS is 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 ELIQUIS (e.g., anaphylactic reactions) [see Adverse Reactions (6.1)] The limited available data on ELIQUIS use in pregnant women are insufficient to inform drug-associated risks of major birth defects, miscarriage, or adverse developmental outcomes. Treatment may increase the risk of bleeding during pregnancy and delivery. In animal reproduction studies, no adverse developmental effects were seen when apixaban was administered to rats (orally), rabbits (intravenously) and mice (orally) during organogenesis at unbound apixaban exposure levels up to 4, 1 and 19 times, respectively, the human exposure based on area under plasma-concentration time curve (AUC) at the Maximum Recommended Human Dose (MRHD) of 5 mg twice daily. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Pregnancy confers an increased risk of thromboembolism that is higher for women with underlying thromboembolic disease and certain high-risk pregnancy conditions. Published data describe that women with a previous history of venous thrombosis are at high risk for recurrence during pregnancy. Fetal/Neonatal adverse reactions Use of anticoagulants, including ELIQUIS, may increase the risk of bleeding in the fetus and neonate. Labor or delivery All patients receiving anticoagulants, including pregnant women, are at risk for bleeding. ELIQUIS use during labor or delivery in women who are receiving neuraxial anesthesia may result in epidural or spinal hematomas. Consider use of a shorter acting anticoagulant as delivery approaches [see Warnings and Precautions (5.3)] . Data Animal Data No developmental toxicities were observed when apixaban was administered during organogenesis to rats (orally), rabbits (intravenously) and mice (orally) at unbound apixaban exposure levels 4, 1, and 19 times, respectively, the human exposures at the MRHD. There was no evidence of fetal bleeding, although conceptus exposure was confirmed in rats and rabbits. Oral administration of apixaban to rat dams from gestation day 6 through lactation day 21 at maternal unbound apixaban exposures ranging from 1.4 to 5 times the human exposures at the MRHD was not associated with reduced maternal mortality or reduced conceptus/neonatal viability, although increased incidences of peri-vaginal bleeding were observed in dams at all doses. There was no evidence of neonatal bleeding. Risk Summary There are no data on the presence of apixaban or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. Apixaban and/or its metabolites were present in the milk of rats (see Data). Because human exposure through milk is unknown, breastfeeding is not recommended during treatment with ELIQUIS. Data Animal Data Maximal plasma concentrations were observed after 30 minutes following a single oral administration of a 5 mg dose to lactating rats. Maximal milk concentrations were observed 6 hours after dosing. The milk to plasma AUC (0-24) ratio is 30:1 indicating that apixaban can accumulate in milk. The concentrations of apixaban in animal milk does not necessarily predict the concentration of drug in human milk. Females of reproductive potential requiring anticoagulation should discuss pregnancy planning with their physician. The risk of clinically significant uterine bleeding, potentially requiring gynecological surgical interventions, identified with oral anticoagulants including ELIQUIS should be assessed in females of reproductive potential and those with abnormal uterine bleeding. Safety and effectiveness in pediatric patients have not been established. Of the total subjects in the ARISTOTLE and AVERROES clinical studies, >69% were 65 years of age and older, and >31% were 75 years of age and older. In the ADVANCE-1, ADVANCE-2, and ADVANCE-3 clinical studies, 50% of subjects were 65 years of age and older, while 16% were 75 years of age and older. In the AMPLIFY and AMPLIFY-EXT clinical studies, >32% of subjects were 65 years of age and older and >13% were 75 years of age and older. No clinically significant differences in safety or effectiveness were observed when comparing subjects in different age groups. The recommended dose is 2.5 mg twice daily in patients with at least two of the following characteristics [see Dosage and Administration (2.1)] : - 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 Clinical efficacy and safety studies with ELIQUIS did not enroll patients with end-stage renal disease (ESRD) on dialysis. In patients with ESRD maintained on intermittent hemodialysis, administration of ELIQUIS at the usually recommended dose [see Dosage and Administration (2.1)] will result in concentrations of apixaban and pharmacodynamic activity similar to those observed in the ARISTOTLE study [see Clinical Pharmacology (12.3)] . It is not known whether these concentrations will lead to similar stroke reduction and bleeding risk in patients with ESRD on dialysis as was seen in ARISTOTLE. No dose adjustment is recommended for patients with renal impairment, including those with ESRD on dialysis [see Dosage and Administration (2.1)] . Clinical efficacy and safety studies with ELIQUIS did not enroll patients with ESRD on dialysis or patients with a CrCl <15 mL/min; therefore, dosing recommendations are based on pharmacokinetic and pharmacodynamic (anti-FXa activity) data in subjects with ESRD maintained on dialysis [see Clinical Pharmacology (12.3) ] . No dose adjustment is required in patients with mild hepatic impairment (Child-Pugh class A). Because patients with moderate hepatic impairment (Child-Pugh class B) may have intrinsic coagulation abnormalities and there is limited clinical experience with ELIQUIS in these patients, dosing recommendations cannot be provided [see Clinical Pharmacology (12.2)] . ELIQUIS is not recommended in patients with severe hepatic impairment (Child-Pugh class C) [see Clinical Pharmacology (12.2)] .

Product summary:

ELIQUIS (apixaban) tablets are available as listed in the table below. Pink, oval, biconvex, Debossed with “894” on one side and “5” on the other side NDC: 70518-1861-00 NDC: 70518-1861-01 NDC: 70518-1861-02 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 60 in 1 BOTTLE, PLASTIC PACKAGING: 180 in 1 BOTTLE, PLASTIC Storage and Handling Store at 20°C to 25°C (68°F-77°F); excursions permitted between 15°C and 30°C (59°F-86°F) [see USP Controlled Room Temperature]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762 Store at 20°C to 25°C (68°F-77°F); excursions permitted between 15°C and 30°C (59°F-86°F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Patient Information leaflet

REMEDYREPACK INC.
----------
MEDICATION GUIDE
ELIQUIS ® (ELL eh kwiss)
(apixaban)
tablets
What is the most important information I should know about ELIQUIS?
•
For people taking ELIQUIS for atrial fibrillation:
People with atrial fibrillation (a type of irregular heartbeat) are at
an increased risk of forming a
blood clot in the heart, which can travel to the brain, causing a
stroke, or to other parts of the body.
ELIQUIS lowers your chance of having a stroke by helping to prevent
clots from forming. If you
stop taking ELIQUIS, you may have increased risk of forming a clot in
your blood.
Do not stop taking ELIQUIS without talking to the doctor who
prescribes it for you. Stopping
ELIQUIS increases your risk of having a stroke.
ELIQUIS may need to be stopped, if possible, prior to surgery or a
medical or dental procedure.
Ask the doctor who prescribed ELIQUIS for you when you should stop
taking it. Your doctor will
tell you when you may start taking ELIQUIS again after your surgery or
procedure. If you have to
stop taking ELIQUIS, your doctor may prescribe another medicine to
help prevent a blood clot
from forming.
•
ELIQUIS can cause bleeding which can be serious and rarely may lead to
death. This is because
ELIQUIS is a blood thinner medicine that reduces blood clotting.
You may have a higher risk of bleeding if you take ELIQUIS and take
other medicines that
increase your risk of bleeding, including:
•
aspirin or aspirin-containing products
•
long-term (chronic) use of nonsteroidal anti-inflammatory drugs
(NSAIDs)
•
warfarin sodium (COUMADIN ®, JANTOVEN ®)
•
any medicine that contains heparin
•
selective serotonin reuptake inhibitors (SSRIs) or serotonin
norepinephrine reuptake
inhibitors (SNRIs)
•
other medicines to help prevent or treat blood clots
Tell your doctor if you take any of these medicines. Ask your doctor
or pharmacist if you
are not sure if your medicine is one listed above.
While taking ELIQUIS:
•
you may bruise more easily
•
it may take longer than usual for any bleeding to

Summary of Product characteristics

ELIQUIS- APIXABAN TABLET, FILM COATED
REMEDYREPACK INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
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
recommen