Safety | Mulpleo (lusutrombopag)

Mulpleo is generally well-tolerated, with no additional safety concerns identified in over 5 years of real-world experience^1,2*

Mulpleo is generally well-tolerated, with rates of adverse events that are comparable to placebo in two Phase III trials,* and no known drug-drug interactions^1,3**

Common adverse reactions (≥1/100 to <1/10 patients)	Mulpleo (%, n/N)	Placebo (%, n/N)
Headache	4.7 (8/171)	3.5 (6/170)
Nausea	2.3 (4/171)	4.1 (7/170)
PVT^†	1.2 (2/171)	1.2 (2/170)
Rash	1.2 (2/171)	0 (0/170)

*This may not represent the overall safety profile of Mulpleo.¹ Mulpleo has been approved in Japan since September 2015 and marketed in Japan since December 2015.²
**Potential interaction with P-gp or BCRP inhibitors cannot be excluded, but no dose adjustment is necessary at the recommended clinical dosage.¹
^†PVT, Portal vein thrombosis

Thrombotic and thromboembolic adverse events occurred in comparable proportions of patients receiving Mulpleo (3/171) vs. placebo (4/170) across two Phase III and one Phase IIb study⁴

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All studies
L-PLUS 1
L-PLUS 2
Phase IIb (M0626)

Study	L-PLUS 1
Adverse event	PVT^† (Female)	MVT^†^† (Male)
Treatment group	Mulpleo (n=48)	Placebo (n=48)
Day of onset	14	20
Duration (days)	72	23
Onset in relation to ﬁrst invasive procedure (days)	After (5)	After (8)
Maximum platelet count (x10⁹/L)	79	60
Severity	Severe	Moderate
Seriousness	Serious	Not serious
Treatment-related	Yes	No
Outcome	Resolved	Not resolved

^†PVT, Portal vein thrombosis
^†^†MVT, Mesenteric venous thrombosis

Study	L-PLUS 2
Adverse event	PVT^† (Male)	CVT^§ (Male)	PVT^† (Male)	PVT^† (Female)
Treatment group	Mulpleo (n=107)	Mulpleo (n=107)	Placebo (n=107)	Placebo (n=107)
Day of onset	14	14	12	14
Duration (days)	27	114	N/A	28
Onset in relation to ﬁrst invasive procedure (days)	After (6)	After (4)	After (4)	After (5)
Maximum platelet count (x10⁹/L)	62	119	53	167
Severity	Moderate	Mild	Moderate	Mild
Seriousness	Serious	Serious	Not serious	Not serious
Treatment-related	No	Yes	No	Yes
Outcome	Resolved	Resolved	Resolving	Resolved with sequelae

^†PVT, Portal vein thrombosis
^§CVT, Cardiac ventricular thrombosis

Study	Phase IIb (M0626)
Adverse event	MVT^†^† (Male)
Treatment group	Placebo (n=15)
Day of onset	19
Duration (days)	103
Onset in relation to ﬁrst invasive procedure (days)	After (11)
Maximum platelet count (x10⁹/L)	62
Severity	Moderate
Seriousness	Not serious
Treatment-related	No
Outcome	Resolved

^†^†MVT, Mesenteric venous thrombosis

Post-marketing data demonstrates an adverse event profile consistent with clinical trials given underreporting of spontaneous AEs in clinical practice, which is generally well-tolerated^2‡

Most common adverse events	Spontaneous safety data N=Approx. 4000^‡	Pooled analysis Phase II (M0626) L-PLUS 1 & 2 N=171
PVT	17	2
Pyrexia	3	7
Hepatic failure	3	1
White blood cell count decreased	3	1
Blood bilirubin increased	3	9

Table adapted from Izumi N, et al. Data on file.²
^‡The number of packets shipped by Shionogi as of April 30, 2018.

Note: All spontaneous reported adverse events by HCPs and consumers for lusutrombopag were retrieved from the Shionogi Global Safety database.
PVT, portal vein thrombosis
It is also useful to note that patients taking Mulpleo had a lower incidence of bleeding-related adverse events vs. placebo, with a study by Afdhal et al. demonstrating a 44.8% relative risk reduction of bleeding related adverse events (absolute risk reduction = 0.07).⁴

94% (282/300) of patients did not require a platelet transfusion prior to their invasive procedure and 100% (21/21) of patients who received a second or third round of treatment of Mulpleo avoided platelet transfusion prior to their invasive procedure.^5,§

^§There is limited information on the use of lusutrombopag in patients previously exposed to lusutrombopag.¹

References

1

Mulpleo (lusutrombopag) Summary of Product Characteristics.

2

Izumi N, Shrestha P, Sasaki R, et al. Data on file (R-1767).

3

Katsube T, Inoue Y, Fukuhara T, et al. Eur J Clin Pharmacol. 2020;76:1659–1665.

4

Afdhal N, Brown RS, Izumi N, et al. Lusutrombopag Is a Safe Treatment Option for Thrombocytopenia in Patients With Chronic Liver Disease Undergoing an Invasive Procedure: Pooled Safety Analysis From Three Studies. Poster presented at EASL 2019 (#SAT-002).

5

Sasaki R, Shiino C, Imawari M, et al. Hepatol Res. 2019;49(10):1169–1181.

Safety Data

94% (282/300) of patients did not require a platelet transfusion prior to their invasive procedure and 100% (21/21) of patients who received a second or third round of treatment of Mulpleo avoided platelet transfusion prior to their invasive procedure.^5,§

Efficacy

Dosing

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Safety Data

94% (282/300) of patients did not require a platelet transfusion prior to their invasive procedure and 100% (21/21) of patients who received a second or third round of treatment of Mulpleo avoided platelet transfusion prior to their invasive procedure.5,§

Efficacy

Dosing

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94% (282/300) of patients did not require a platelet transfusion prior to their invasive procedure and 100% (21/21) of patients who received a second or third round of treatment of Mulpleo avoided platelet transfusion prior to their invasive procedure.^5,§