Apixaban (ELIQUIS)

Generic Name: Apixaban

ELIQUIS (apixaban), a factor Xa (FXa) inhibitor, is chemically described as 1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3,4c]pyridine-3-carboxamide. Its molecular formula is C25H25N5O4, which corresponds to a molecular weight of 459.5. Apixaban has the following structural formula:

ELIQUIS® (apixaban) - Structural Formula  - Illustration

Apixaban is a white to pale-yellow powder. At physiological pH (1.2-6.8), apixaban does not ionize; its aqueous solubility across the physiological pH range is ~0.04 mg/mL.

ELIQUIS tablets are available for oral administration in strengths of 2.5 mg and 5 mg of apixaban with the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, and magnesium stearate. The film coating contains lactose monohydrate, hypromellose, titanium dioxide, triacetin, and yellow iron oxide (2.5 mg tablets) or red iron oxide (5 mg tablets).

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Apixaban acts by directly inhibiting, in a reversible manner, free and clot-bound factor Xa to inhibit coagulation. Apixaban is a highly selective, orally bioavailable, and reversible direct inhibitor of free and clot-bound factor Xa. Factor Xa catalyzes the conversion of prothrombin to thrombin, the final enzyme in the coagulation cascade that is responsible for fibrin clot formation. Apixaban has no direct effect on platelet aggregation, but by inhibiting factor Xa, it indirectly decreases clot formation induced by thrombin.

Apixaban is indicated for the following:

  • To lower the risk of stroke and embolism in patients with nonvalvular atrial fibrillation.
  • Deep vein thrombosis (DVT) prophylaxis. DVTs may lead to pulmonary embolism (PE) in knee or hip replacement surgery patients.
  • Treatment of both DVT and PE.
  • To reduce the risk of recurring DVT and PE after initial therapy.

Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
  • Dizziness or passing out.
  • Feeling tired or weak.
  • Feeling confused.
  • Headache
  • Joint pain or swelling.
  • Chest pain or pressure.
  • Wheezing

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Recommended Dose

Reduction Of Risk Of Stroke And Systemic Embolism In Patients With Nonvalvular Atrial Fibrillation

The recommended dose of ELIQUIS for most patients is 5 mg taken orally twice daily.

The recommended dose of ELIQUIS 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 Surgery

The recommended dose of ELIQUIS is 2.5 mg taken orally twice daily. The initial dose should be taken 12 to 24 hours after surgery.

  • In patients undergoing hip replacement surgery, the recommended duration of treatment is 35 days.
  • In patients undergoing knee replacement surgery, the recommended duration of treatment is 12 days.

Treatment Of DVT And PE

The recommended dose of ELIQUIS is 10 mg taken orally twice daily for the first 7 days of therapy. After 7 days, the recommended dose is 5 mg taken orally twice daily.

Reduction In The Risk Of Recurrence Of DVT And PE

The recommended dose of ELIQUIS is 2.5 mg taken orally twice daily after at least 6 months of treatment for DVT or PE

Missed Dose

If a dose of ELIQUIS is not taken at the scheduled time, the dose should be taken as soon as possible on the same day and twice-daily administration should be resumed. The dose should not be doubled to make up for a missed dose.

Temporary Interruption For Surgery And Other Interventions

ELIQUIS should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of unacceptable or clinically significant bleeding. ELIQUIS should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding or where the bleeding would be non-critical in location and easily controlled. Bridging anticoagulation during the 24 to 48 hours after stopping ELIQUIS and prior to the intervention is not generally required. ELIQUIS should be restarted after the surgical or other procedures as soon as adequate hemostasis has been established.

Converting From Or To ELIQUIS

Switching From Warfarin To ELIQUIS

Warfarin should be discontinued and ELIQUIS started when the international normalized ratio (INR) is below 2.0.

Switching From ELIQUIS To Warfarin

ELIQUIS affects INR, so that initial INR measurements during the transition to warfarin may not be useful for determining the appropriate dose of warfarin. One approach is to discontinue ELIQUIS and begin both a parenteral anticoagulant and warfarin at the time the next dose of ELIQUIS would have been taken, discontinuing the parenteral anticoagulant when INR reaches an acceptable range.

Switching From ELIQUIS To Anticoagulants Other Than Warfarin (oral or parenteral)

Discontinue ELIQUIS and begin taking the new anticoagulant other than warfarin at the usual time of the next dose of ELIQUIS.

Switching From Anticoagulants Other Than Warfarin (oral or parenteral) To ELIQUIS

Discontinue the anticoagulant other than warfarin and begin taking ELIQUIS at the usual time of the next dose of the anticoagulant other than warfarin.

Combined P-gp And Strong CYP3A4 Inhibitors

For patients receiving ELIQUIS doses of 5 mg or 10 mg twice daily, reduce the dose by 50% when ELIQUIS is coadministered with drugs that are combined P-glycoprotein (P-gp) and strong cytochrome P450 3A4 (CPY3A4) inhibitors (e.g., ketoconazole, itraconazole, ritonavir)

In patients already taking 2.5 mg twice daily, avoid coadministration of ELIQUIS with combined P-gp and strong CYP3A4 inhibitors.

What drugs may interact with Apixaban?

Apixaban may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Apixaban?

Apixaban may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Apixaban?

Apixaban may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Apixaban is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Apixaban in the bathroom or the freezer. There may be different brands of Apixaban that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Apixaban down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Before using this drug, tell your doctor if:

  • You are pregnant or breastfeeding. This is because, while you are expecting or feeding a baby, you should only take medicines on the recommendation of a doctor.
  • You are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, such as herbal and complementary medicines.
  • You have allergy with any of active or inactive ingredients of Apixaban or other medications.
  • You have any other illnesses, disorders, or medical conditions.
  • You have any of these health problems: Active bleeding or liver problems.
  • You have had a heart valve replaced.
  • You are taking any of these drugs: Carbamazepine, clarithromycin, itraconazole, ketoconazole, phenytoin, rifampin, ritonavir, St. John’s wort, telithromycin, or voriconazole.

Tell all of your health care providers that you take apixaban. This includes your doctors, nurses, pharmacists, and dentists. This medicine may need to be stopped before certain types of surgery as your doctor has told you. If this medicine is stopped, your doctor will tell you when to start taking apixaban again after your surgery or procedure.

Have blood work checked as you have been told by the doctor. Talk with the doctor.

Do not run out of this medicine.

You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.

Very bad and sometimes deadly bleeding problems have happened with apixaban. Talk with the doctor.

If you fall or hurt yourself, or if you hit your head, call your doctor right away. Talk with your doctor even if you feel fine.

Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.

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