Drugs List

Therapeutic Indications

Uses

Severe thrombocytopenia with chronic liver disease

Treatment of severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures.

Contraindications

Children under 18 years
Breastfeeding
Pregnancy

Precautions and Warnings

Females of childbearing potential
Weight below 45kg
Coagulopathy
History of thromboembolic disorder
History of thrombosis
Portal vein obstruction
Severe hepatic impairment - Child-Pugh score greater than or equal to 10
Splenectomy
Thromboembolic disorder
Thrombosis

Monitor platelets before starting and during treatment
Perform liver function tests before commencing therapy and during therapy
Monitor for signs and symptoms of thrombosis
Monitor for signs of hepatic injury
Monitor patients at risk for signs & symptoms of thromboembolism
Treatment should be for a maximum period of 7 days
Female: Ensure adequate contraception during treatment

Monitor patients with thrombosis or thromboembolism, with a history of thrombosis or thromboembolism, with absence of hepatopetal blood flow in the main trunk of the portal vein, or patients with congenital coagulopathy.

Lusutrombopag should only be used in patients with severe hepatic impairment if the expected benefit outweighs the expected risk.

Monitor patients with severe hepatic impairment for early signs of worsening or new onset hepatic encephalopathy, ascites, and thrombotic or bleeding tendency, through monitoring of liver function tests, tests used for assessing clotting status and through imaging of portal vasculature as needed.

Discontinue lusutrombopag if platelet counts are 50 x 10 to the power of 9 per litre or greater, as a result of a 20 x 10 to the power of 9 per litre increase from baseline.

The efficacy and safety of lusutrombopag have not been established when administered before lapartotomy, thoracotomy, open-heart surgery, craniotomy or excision of organs.

Pregnancy and Lactation

Pregnancy

Lusutrombopag is contraindicated during pregnancy.

The manufacturer does not recommend using lusutrombopag during pregnancy. At the time of writing there is limited published information regarding the use of lusutrombopag during pregnancy. Potential risks are unknown.

Lactation

Lusutrombopag is contraindicated during breastfeeding.

Use of lusutrombopag when breastfeeding is contraindicated by the manufacturer. Animal data reports levels of lusutrombopag in the breast milk, however presence in human breast milk and the effect on exposed infants are unknown.

Side Effects

Headache
Nausea
Portal vein thrombosis
Rash

Presentation

Oral formulation of lusutrombopag.

Drugs List

Therapeutic Indications

Uses

Severe thrombocytopenia with chronic liver disease

Treatment of severe thrombocytopenia in adult patients with chronic liver disease undergoing invasive procedures.

Dosage

Adults

Additional Dosage Information

Contraindications

Children under 18 years
Breastfeeding
Pregnancy

Precautions and Warnings

Females of childbearing potential
Weight below 45kg
Coagulopathy
History of thromboembolic disorder
History of thrombosis
Portal vein obstruction
Severe hepatic impairment - Child-Pugh score greater than or equal to 10
Splenectomy
Thromboembolic disorder
Thrombosis

Monitor platelets before starting and during treatment
Perform liver function tests before commencing therapy and during therapy
Monitor for signs and symptoms of thrombosis
Monitor for signs of hepatic injury
Monitor patients at risk for signs & symptoms of thromboembolism
Treatment should be for a maximum period of 7 days
Female: Ensure adequate contraception during treatment

Monitor patients with thrombosis or thromboembolism, with a history of thrombosis or thromboembolism, with absence of hepatopetal blood flow in the main trunk of the portal vein, or patients with congenital coagulopathy.

Lusutrombopag should only be used in patients with severe hepatic impairment if the expected benefit outweighs the expected risk.

Monitor patients with severe hepatic impairment for early signs of worsening or new onset hepatic encephalopathy, ascites, and thrombotic or bleeding tendency, through monitoring of liver function tests, tests used for assessing clotting status and through imaging of portal vasculature as needed.

Discontinue lusutrombopag if platelet counts are 50 x 10 to the power of 9 per litre or greater, as a result of a 20 x 10 to the power of 9 per litre increase from baseline.

The efficacy and safety of lusutrombopag have not been established when administered before lapartotomy, thoracotomy, open-heart surgery, craniotomy or excision of organs.

Pregnancy and Lactation

Pregnancy

Lusutrombopag is contraindicated during pregnancy.

The manufacturer does not recommend using lusutrombopag during pregnancy. At the time of writing there is limited published information regarding the use of lusutrombopag during pregnancy. Potential risks are unknown.

Lactation

Lusutrombopag is contraindicated during breastfeeding.

Use of lusutrombopag when breastfeeding is contraindicated by the manufacturer. Animal data reports levels of lusutrombopag in the breast milk, however presence in human breast milk and the effect on exposed infants are unknown.

Side Effects

Headache
Nausea
Portal vein thrombosis
Rash

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: December 2019

Reference Sources

Summary of Product Characteristics: Mulpleo 3mg film-coated tablets. Shionogi Ltd. Revised February 2019.