Aprend ®

Prevention of chemotherapy-induced nausea and vomiting:

Capsules: 125 mg 1 hour prior to chemotherapy on day 1, followed by 80 mg once daily on days 2 and 3 (in combination with a 5-HT antagonist antiemetic on day 1 and dexamethasone on days 1 to 4).

Prevention of postoperative nausea and vomiting:

40 mg within 3 hours prior to anesthesia induction.

Contraindications

Hypersensitivity to aprepitant or any component of the formulation; concurrent use with pimozide

Interactions

ALfentanil: CYP3A4 Inhibitors (Moderate) may increase the serum concentration of ALfentanil. Management: If use of alfentanil and moderate CYP3A4 inhibitors is necessary, consider dosage reduction of alfentanil until stable drug effects are achieved. Frequently monitor patients for respiratory depression and sedation when these agents are combined. Risk D: Consider therapy modification

ALPRAZolam: CYP3A4 Inhibitors (Moderate) may increase the serum concentration of ALPRAZolam. Management: Consider alternatives to this combination when possible. If combined, consider an alprazolam dose reduction and monitor for increased alprazolam effects and toxicities (eg, sedation, lethargy). Risk D: Consider therapy modification

Apixaban: CYP3A4 Inhibitors (Moderate) may increase the serum concentration of Apixaban. Risk C: Monitor therapy

Atorvastatin: CYP3A4 Inhibitors (Moderate) may increase the serum concentration of Atorvastatin. Risk C: Monitor therapy

Bromocriptine: CYP3A4 Inhibitors (Moderate) may increase the serum concentration of Bromocriptine. Management: The bromocriptine dose should not exceed 1.6 mg daily with use of a moderate CYP3A4 inhibitor. The Cycloset brand specifically recommends this dose limitation, but other bromocriptine products do not make such specific recommendations. Risk D: Consider therapy modification

Cilostazol: CYP3A4 Inhibitors (Moderate) may increase the serum concentration of Cilostazol. Management: Decrease the dose of cilostazol to 50 mg twice daily when combined with moderate CYP3A4 inhibitors. Risk D: Consider therapy modification

CYP3A4 Inducers (Strong): May decrease the serum concentration of Aprepitant. Risk X: Avoid combination

CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Aprepitant. Risk X: Avoid combination

CYP3A4 Inhibitors (Strong): May increase the serum concentration of Aprepitant. Risk X: Avoid combination

Pregnancy and Lactation

Insufficient data on use in pregnant women to inform a drug associated risk.

It is not known if Aprepitant is present in breast milk, the decision to breastfeed during therapy should consider the risk of infant.

exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Warning and Precaution

• Hypersensitivity: Hypersensitivity reactions, including anaphylactic reactions, have been reported. Symptoms have included dyspnea, erythema, eye swelling, flushing, hypotension, pruritus, syncope, and wheezing.
• Drug-drug interactions: A clinically significant decrease in INR or PT may occur with concurrent warfarin therapy.

Adverse Reactions

>10%:

Hematologic & oncologic: Neutropenia (children and adolescents: 13%; adults: <3%)

Nervous system: Fatigue (children and adolescents: 5%; adults: 13% [PONV: 6%])

Storage

Store below 30°C and protect from light and moisture.