Mulpleta (lusutrombopag)

In patients with chronic liver disease and thrombocytopenia scheduled to undergo a procedure, the recommended dosage of lusutrombopag is 3 mg once daily for 7 days.

If a dose is missed, it should be administered as soon as it is remembered on the same day. The next dose should be administered at the regularly scheduled time the following day.

Lusutrombopag should not be used to normalize platelet counts.

Lusutrombopag is administered orally once daily for 7 days without regard to food.

The drug should be initiated 8-14 days prior to the scheduled procedure; patients should undergo their procedure 2-8 days after the last dose of the drug.

No dosing information is available for this tab.

Lusutrombopag is metabolized by cytochrome P-450 (CYP) isoenzymes, including CYP4A11. In vitro studies indicate that lusutrombopag has low potential to inhibit CYP isoenzymes (1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 3A4/5). Lusutrombopag does not induce CYP1A2, CYP2C9, or CYP3A4, or uridine diphosphate-glucuronosyltransferase (UGT) enzymes UGT1A3, UGT1A6, or UGT2B7 in vitro.

In vitro studies indicate that lusutrombopag is a substrate of p-glycoprotein (P-gp) and breast cancer resistance protein (BCRP). The drug also has a low potential to inhibit P-gp, BCRP, organic anion transporting polypeptide (OATP) 1B or 1B3, organic cation transporter (OCT) 1 or 2, organic anion transporter (OAT) 1 or 3, multidrug and toxin extrusion transporter (MATE) 1 or 2K, or bile salt export pump (BSEP).

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*None.

• Lactation

• Thromboembolic disorder

• Antithrombin III deficiency
• Factor V leiden mutation
• Protein C deficiency disease
• Prothrombin g20210A mutation

The most common adverse effect reported in >=3% of patients with chronic liver disease receiving lusutrombopag prior to a scheduled procedure in clinical studies was headache.

Rare or Very Rare

• Portal vein thrombosis
• Thromboembolic disorder
• Thrombotic disorder

More Frequent

• Headache disorder

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Safety and efficacy of lusutrombopag have not been established in pediatric patients.

There are no available data to inform a drug-associated risk when lusutrombopag is used during pregnancy. Adverse developmental and postnatal outcomes (e.g., low body weight, teratogenicity, prolonged gestation, delayed growth) were observed in rats administered lusutrombopag orally during organogenesis and the lactation period at dosages resulting in systemic exposures substantially higher (approximately 89 times) than the exposure from the recommended human dosage. Advise pregnant women of the potential fetal risk.

It is not known whether lusutrombopag is distributed into human milk; the drug is distributed into milk in rats. Because of the potential for serious adverse reactions to lusutrombopag in breast-fed infants, advise women not to breast-feed while receiving the drug and for at least 28 days after the last dose. If lusutrombopag is used in a lactating woman, the manufacturer states that breast-feeding should be interrupted and the affected milk discarded during treatment and for 28 days after the last dose.

The effects of the drug on breast-fed infants or on milk production are not known.

Clinical studies of lusutrombopag did not include sufficient numbers of patients >=65 years of age to determine whether geriatric patients respond differently than younger adults. No clinically important differences in responses have been observed between geriatric patients and younger adults in other reported clinical experience.