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PHARMACEUTICALS
Oral administration with high convenience and strong patient compliance.
Rapid platelet elevation with good predictability.
AuthenticGuaranteeFast DeliveryPrivacy Avatrombopag is an oral small-molecule thrombopoietin receptor agonist (TPO-RA). It stimulates the proliferation and differentiation of bone marrow megakaryocytes and promotes platelet production by selectively binding to and activating the human TPO receptor.
This product is indicated for adult patients with chronic liver disease-related thrombocytopenia scheduled to undergo a diagnostic procedure or surgery.
Patients with chronic liver disease must not use this product to restore normal platelet counts.
This product is indicated for adult patients with chronic primary immune thrombocytopenia (ITP) who have had an insufficient response to previous treatments such as corticosteroids or intravenous immunoglobulin, to increase platelet counts and reduce or prevent bleeding.
This product is only used in ITP patients with increased bleeding risk due to thrombocytopenia and clinical conditions.
This product is administered orally, with food. Once daily, for 5 consecutive days.
If a dose is missed, take it immediately upon remembering, and take the next dose at the scheduled time the following day. Do not take an extra single dose to make up for the missed one.
Start taking this product 10 to 13 days before an elective invasive procedure or surgery. The recommended dose is selected based on the patient’s platelet count. Only the once-daily, 5-day dosing regimen has been studied in clinical trials in patients with chronic liver disease. Patients should complete the full 5‑day treatment and undergo surgery 5 to 8 days after the last dose.
When platelet count is < 40 × 10⁹/L:
60 mg (3 tablets) once daily, orally for 5 days.
When platelet count is 40 × 10⁹/L to < 50 × 10⁹/L:
40 mg (2 tablets) once daily, orally for 5 days.
Measure platelet count before treatment and on the day of the diagnostic procedure or surgery to ensure platelets have risen to the target level.
The recommended starting dose of this product in ITP patients is 20 mg (1 tablet) once daily, with food.
If a dose is missed, take it immediately upon remembering. Do not take two doses at the same time to make up for a missed dose; take the next dose according to the current schedule.
Use the lowest effective dose to achieve and maintain a platelet count ≥ 50 × 10⁹/L to reduce bleeding risk. This product is not intended to restore normal platelet counts. The recommended dose is selected based on the patient’s platelet count. The maximum daily dose is 40 mg (2 tablets).
Platelet count < 50 × 10⁹/L:
After at least 2 consecutive weeks of dosing, if the count remains below this level, increase by one dose level per the dose‑level table. Continue treatment for 2 weeks, assess response, and consider further adjustment.
Platelet count 50 × 10⁹/L to 150 × 10⁹/L:
Maintain current dose.
Platelet count > 150 × 10⁹/L to ≤ 250 × 10⁹/L:
Decrease by one dose level per the dose‑level table. Continue treatment for 2 weeks, assess response, and consider further adjustment.
Platelet count ≥ 250 × 10⁹/L:
Interrupt treatment. Monitor platelet count twice weekly.
When platelet count falls to < 100 × 10⁹/L, decrease by one dose level and resume dosing.
Discontinue if platelet count remains < 50 × 10⁹/L after 4 weeks of treatment at 40 mg once daily.
Discontinue if platelet count exceeds 250 × 10⁹/L after 2 weeks of treatment at 20 mg once weekly.
Dose Level 1: 20 mg once weekly.
Dose Level 2: 20 mg twice weekly (on non‑consecutive days, e.g., Monday and Friday); or 40 mg once weekly (on a fixed day, e.g., Monday).
Dose Level 3: 20 mg three times weekly (on non‑consecutive days, e.g., Monday, Wednesday, Friday).
Dose Level 4: 20 mg once daily.
This is the initial regimen for all chronic ITP patients (except those on concomitant specific medications).
Dose Level 5: 40 mg on 3 days per week, and 20 mg on the remaining 4 days.
Dose Level 6: 40 mg once daily.
Note: Patients taking avatrombopag less frequently than once daily should use a consistent weekly dosing schedule.
After starting treatment, measure platelet count weekly until stable at 50 × 10⁹/L to 150 × 10⁹/L.
During the initial weeks, patients receiving once‑ or twice‑weekly dosing should be monitored twice weekly.
Monitor twice weekly also if the avatrombopag dose is adjusted during treatment.
Due to the potential risk of platelet counts exceeding 400 × 10⁹/L in the initial weeks, carefully monitor for any signs or symptoms of thrombocytosis.
Once a stable platelet count is achieved, monitor at least monthly.
After discontinuation, monitor platelet count weekly for at least 4 weeks.
Recommended starting dose for ITP patients on concomitant specific medications:
Concomitant moderate or strong dual CYP2C9 and CYP3A4 inhibitors:
Starting dose: 20 mg (1 tablet) three times weekly.
Concomitant moderate or strong dual CYP2C9 and CYP3A4 inducers:
Starting dose: 40 mg (2 tablets) once daily.
Insufficient data are available on the use of this product in pregnant women.
Based on the results of animal reproductive studies, the use of this product by pregnant women may cause fetal harm (see Pharmacology and Toxicology).
If a pregnant woman still requires treatment with this product after a benefit-risk assessment by a physician, she should be fully informed of the potential risks to the fetus.
No information is available on the presence of avatrombopag in human milk or the effects of avatrombopag on the breastfed infant.
Based on animal studies, avatrombopag is very likely to be excreted in human milk and may cause serious adverse reactions in breastfed infants.
Therefore, breastfeeding is not recommended during treatment with this product and for at least 2 weeks after the last dose.
To minimize exposure, lactating women should interrupt breastfeeding, pump and discard breast milk during treatment and for 2 weeks after the last dose of this product.
Clinical trial data for this product in patients under 18 years of age are not available.
Clinical studies of this product did not include sufficient numbers of subjects aged 65 and over to determine whether safety and efficacy differ from those of younger subjects.
The following adverse reactions have been identified during post-approval use of this product. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune system disorders:
Hypersensitivity reactions, including pruritus, rash, chest discomfort, erythema, pharyngeal edema, generalized pruritus, maculopapular rash, facial swelling and tongue swelling.
It is contraindicated in patients with hypersensitivity to the active ingredient or any of the excipients in this product.
Avatrombopag is a thrombopoietin (TPO) receptor agonist. TPO receptor agonists have been associated with thrombosis and thromboembolic complications in patients with chronic liver disease. Portal vein thrombosis has been reported in chronic liver disease patients treated with TPO receptor agonists.
In the two clinical trials of this product, ADAPT-1 and ADAPT-2, one chronic liver disease patient with thrombocytopenia treated with avatrombopag (n=1/274, 0.4%) experienced a portal vein thrombosis event during treatment.
In patients with chronic immune thrombocytopenia treated with this product, thromboembolic events (arterial or venous thromboembolism) occurred in 7% (9/128) of patients.
Patients with known thromboembolic risk factors, including inherited prothrombotic conditions (Factor V Leiden mutation, prothrombin gene 20210A mutation, antithrombin deficiency, protein C deficiency, or protein S deficiency), are at increased risk of thrombosis when treated with avatrombopag.
Patients with chronic liver disease or chronic immune thrombocytopenia must not be treated with avatrombopag to restore normal platelet counts.This product should be administered according to Dosage and Administration to achieve the target platelet count.
Patients should be monitored for signs and symptoms of thromboembolism during treatment, and prompt treatment should be initiated if they occur.
If any issues arise, please contact us immediately.
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The effectiveness of Avatrombopag maleate tablets can vary depending on the dosage and individual absorption. After starting treatment, the platelet count will begin to rise within 3-5 days, typically reaching its peak around days 10-13. Afterwards, it will gradually decrease, returning to approximately pre-treatment levels by around day 35. This pattern of change helps doctors determine the optimal timing and course of treatment.
If you remember missing a dose on the same day, you should take it immediately. However, if you only remember the next day, you should not take the missed dose. It is particularly important not to take a double dose at your next scheduled time to compensate for a missed one, as this can easily lead to drug toxicity. For example, if your usual dose is at 8:00 AM and you remember later in the afternoon, you should take it immediately. If you remember the next day, just take your regular dose at the usual time. If you are unsure how to proceed, please consult your doctor or pharmacist promptly.
An overdose can lead to an excessive increase in platelets, significantly raising the risk of blood clots. In this situation, patients need to be closely monitored for symptoms of thrombosis, such as chest pain or numbness in the limbs, and have their platelet levels checked regularly.
Important note: There is no specific antidote for this medication. It is primarily metabolized by the liver (with only about 6% excreted through urine), so conventional detoxification methods like hemodialysis have limited effectiveness. If an accidental overdose occurs, contact your doctor immediately for timely electrocardiogram monitoring and relevant examinations. The doctor will take appropriate treatment measures based on the specific situation.
You should stop taking the medication and seek medical attention immediately if you experience the following:
Symptoms of anemia, such as general fatigue or pale complexion;
Persistent fever that does not subside;
Muscle pain severe enough to affect normal activities.
It is recommended that patients bring complete medication records and relevant test reports when visiting the doctor. This will help the physician accurately determine whether adjustments to the treatment plan or other medical interventions are necessary.
For chronic immune thrombocytopenia: If you miss a dose, take it as soon as you remember. Then, take your next dose at the usual time and continue with your once-daily schedule. Do not take two doses at the same time.
Before a scheduled medical procedure: If you miss a dose, contact your doctor for instructions.
If you take more avatrombopag tablets or sprinkle than prescribed, contact your healthcare provider or call the Poison Help Line immediately, or go to the nearest hospital emergency room.
Follow your doctor’s guidance regarding any restrictions on food, beverages, or activities.
Certain medications may interact with avatrombopag, including prescription drugs, over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all the medications you are currently taking, as well as any new medications you start or stop using.
This medicine may interact with:
Moderate or strong dual inhibitors of CYP2C9 and CYP3A
Moderate or strong dual inducers of CYP2C9 and CYP3A4
Please note that this list does not include all possible drug interactions.
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