FDA Approves Rivaroxaban in an Oral Suspension Dosage Form

By Jessica Pyhtila, PharmD, BCGP, BCPS

The FDA recently approved a new oral suspension dosage form of the factor Xa inhibitor Xarelto (rivaroxaban). Besides remaining available as an oral tablet, the medication is now also available as an oral suspension. The new dosage form may benefit adults with dysphagia as well as allow more accurate weight-based dosing to be administered to children.

Rivaroxaban is approved for multiple indications, including nonvalvular atrial fibrillation, coronary artery disease, peripheral arterial disease, and both the prevention and treatment of deep vein thrombosis and pulmonary embolism. It can be used in adult as well as in pediatric patients.

While rivaroxaban oral tablets are available in strengths of 2.5 mg, 10 mg, 15 mg, and 20 mg, the oral suspension is available at a strength of 1mg/mL once reconstituted. A single bottle of reconstituted rivaroxaban contains 155 mg of the drug.

Rivaroxaban is now the only factor Xa inhibitor that is available in an oral suspension. Although other orally administered factor Xa inhibitors can be crushed and administered in soft foods or via enteral tubes, they are not commercially available as liquids and would either need to be specially compounded into liquids by pharmacies or mixed into liquids by the patient or caregiver. Notably, dabigatran (Pradaxa) is a direct thrombin inhibitor that is available in an oral solution dosage form as well as oral capsules.

As an anticoagulant, the most common side effect of rivaroxaban is bleeding. Other side effects, specifically in children, include cough, vomiting, and gastroenteritis. The drug should be avoided if it would be used concomitantly with P-gp and strong CYP3A inhibitors and inducers.

Rivaroxaban oral suspension is a sweet-tasting liquid flavored with sucralose that is usable within 60 days of its preparation by a pharmacy. It does not need to be refrigerated and can be stored at room temperature, between 68°F and 77°F.

References:

Food and Drug Administration. “Xarelto.” December 2021. Retrieved from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215859s000lbl.pdf