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PHARMACEUTICALS
Lusutrombopag is an oral thrombopoietin receptor agonist (TPO-RA) indicated for adult patients with chronic liver disease and thrombocytopenia who are scheduled to undergo surgery.
AuthenticGuaranteeFast DeliveryPrivacy Lusutrombopag works by activating the TPO receptor on megakaryocytes, promoting platelet production, and reducing the need for preoperative platelet transfusions.
This product is indicated for adult patients with chronic liver disease and thrombocytopenia who are scheduled to undergo surgery (including diagnostic procedures).Chronic liver disease patients should not use this product to restore normal platelet counts.
3 mg once daily, with or without food, for 7 consecutive days.
1.Lusutrombopag should be initiated 8–14 days before surgery, and the procedure should be performed 2–8 days after the final dose.
2.If a dose is missed, take the missed dose as soon as possible on the same day, then resume the regular daily dosing schedule the following day.
3.In clinical trials involving patients with chronic liver disease, only the regimen of once-daily administration for 7 days has been studied (see [Clinical Trials]).
4.Monitor platelet counts before initiating treatment and within 2 days prior to surgery.
(1) Pregnant women should carefully consider the potential risk to the fetus when using this drug. There are no available data on the risk of lusutrombopag in pregnant women. In animal reproductive studies, oral administration of lusutrombopag to pregnant rats during organogenesis and lactation periods resulted in adverse developmental effects.
(2) The risk of neonatal malformations and miscarriage in pregnant women is unclear, as all pregnancies carry a risk of neonatal malformations, miscarriage, and other adverse outcomes.
(1) Breastfeeding is not recommended during treatment and for at least 28 days after the last dose, due to the potential risk of serious adverse reactions in breastfed infants. Currently, there is no information on whether lusutrombopag is excreted in human milk, its effects on breastfed infants, or its impact on milk production. Lusutrombopag was detected in the milk of lactating rats.
(2) To minimize drug exposure in breastfed infants, lactating women should interrupt breastfeeding during treatment and for 28 days after the last dose, and express and discard breast milk during this period.
The safety and efficacy of this product in pediatric patients have not been established.
The number of elderly subjects aged 65 years and older in clinical trials was limited, so it is not possible to evaluate whether their response differs from that of younger subjects. Other reported clinical experiences have not identified differences in responses between elderly and younger patients.
The following serious adverse reactions are discussed in greater detail in other sections of the label:
Thromboembolism and its complications see Precautions.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Common adverse reactions include headache, etc. For further information, please consult your doctor or refer to the package insert.
None.
1.This product is a thrombopoietin (TPO) receptor agonist, and TPO receptor agonists are associated with an increased risk of thrombosis and thromboembolic complications in patients with chronic liver disease. Cases of portal vein thrombosis have been reported in patients with chronic liver disease treated with TPO receptor agonists.
In 3 phase 3 randomized controlled trials, 1% (2/171) of patients receiving lusutrombopag were diagnosed with portal vein thrombosis via protocol-specified imaging, compared to 1% (2/170) of patients receiving placebo. These thrombotic events were not associated with a significant increase in platelet counts. No cases of portal vein thrombosis were reported in the Chinese phase 3 randomized, double-blind, placebo-controlled trial (M0636).
2.When administering this product to patients with known risk factors for thrombosis (including inherited thrombophilic conditions such as Factor V Leiden, prothrombin 20210A, antithrombin deficiency, or protein C/S deficiency), consider the potential risk of thrombosis.
For patients with a history of thrombosis, pre-thrombotic conditions, or hepatic blood flow impairment, this product should only be used when the potential benefit outweighs the risk of thrombosis.
3.Patients with chronic liver disease should not use this product to restore normal platelet counts.
If any issues arise, please contact us immediately.
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Other drugs may affect lusutrombopag, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Take the missed dose on the same day you remember it. Take your next dose at the regular time and stay on your once-daily schedule. Do not use 2 doses in one day.
Lusutrombopag is a man-made form of a protein that increases production of platelets (blood-clotting cells) in your body. Lusutrombopag can lower the risk of bleeding by increasing platelets in your blood.
Lusutrombopag is used to treat thrombocytopenia (a lack of platelets in the blood) in adults with chronic liver disease who are scheduled to undergo a medical procedure.
Lusutrombopag is not a cure for thrombocytopenia and it will not make your platelet counts normal.
Lusutrombopag may also be used for purposes not listed in this medication guide.
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