Avalet Tablet
Avatrombopag
20 mg
Drug International Ltd.
| Pack size | 10's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 275.00 AED |
Indications
Avalet Tablet is used for:
Thrombocytopenia
Adult Dose
Thrombocytopenia
Patients with chronic liver disease
Indicated for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a procedure
Taken orally once daily for 5 consecutive days with food
Initiate dosing 10-13 days prior to the scheduled procedure
Patients should undergo their procedure 5-8 days after the last dose
Dose based on pre-procedure platelet count
Platelet count <40 x10^9/L: 60 mg PO once daily x 5 days
Platelet count 40 to <50 x10^9/L: 40 mg PO once daily x 5 days
Patients with chronic immune thrombocytopenia
Indicated for thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment
Use the lowest dose needed to achieve and maintain a platelet count <50 x10^9/L as necessary to reduce the risk for bleeding
Initial dose: 20 mg PO once daily
Dose adjustments by platelet count for chronic ITP
Platelet count <50 x10^9/L after >2 weeks: Increase by 1 dose level; wait 2 wk to assess effects before further adjustment
Platelet count 200-400 x10^9/L: Decrease 1 dose level; wait 2 wk to assess effects before further adjustment
Platelet count >400 x10^9/L: Stop avatrombopag and increase platelet monitoring to twice weekly; may reinitiated by decreasing 1 dose level when platelets <150 x10^9/L
Platelet count <50 x10^9/L after 4 weeks at 40 mg/day: Discontinue avatrombopag
Platelet count >400 x10^9/L after 2 weeks at 20 mg/week: Discontinue avatrombopag
Dose levels for titration in ITP
Dose level 6: 40 mg/day
Dose level 5: 40 mg 3x/week AND 20 mg on the 4 remaining days each week
Dose level 4: 20 mg/day
Dose level 3: 20 mg 3x/week
Dose level 2: 20 mg 2x/week OR 40 mg once a Week
Dose level 1: 20 mg once a Week
Child Dose
Renal Dose
Renal impairment
Mild-to-moderate (CrCl >30 mL/min): No dose adjustment required; minimally excreted by the kidneys
Severe (CrCl <30 mL/min) or hemodialysis: Unknown
Administration
Take with food
Contra Indications
Precautions
Thrombotic/thromboembolic complications
Thrombopoietin (TPO) receptor agonists associated with thrombotic and thromboembolic complications in patients with chronic liver disease or chronic ITP
Portal vein thrombosis reported with chronic liver disease in patients treated with thrombopoietin (TPO) receptor agonists (ADAPT-1 and ADAPT-2 clinical trials)
Consider the potential increased thrombotic risk when administering to patients with known risk factors for thromboembolism, including genetic prothrombotic conditions (eg, factor V Leiden, prothrombin 20210A, antithrombin deficiency, or protein C or S deficiency)
Not to be administered to patients with chronic liver disease or chronic immune thrombocytopenia in an attempt to normalize platelet counts; thromboembolic events (arterial or venous) reported
Follow dosing guidelines to achieve target platelet counts; monitor patients receiving therapy for signs and symptoms of thromboembolic events and institute treatment promptly
Monitoring Parameters
Monitor platelet counts and follow dosing guidelines to achieve target platelet counts; monitor patients receiving therapy for signs and symptoms of thromboembolic events and institute treatment promptly.
Pregnancy-Lactation
Pregnancy
Based on findings from animal reproduction studies, may cause fetal harm when administered to pregnant women
In animal reproduction studies, administration resulted in adverse developmental outcomes when administered during organogenesis in rabbits and during organogenesis and the lactation period in rats
However, these findings were observed at exposures based on AUC substantially higher than the AUC observed in patients at the recommended dose of 60 mg once daily
Advise pregnant women of the potential risk to a fetus
Lactation
No data are available regarding the presence of the drug in human milk, the effects on the breastfed child, or the effects on milk production
In studies, avatrombopag was present in the milk of lactating rats; when a drug is present in animal milk, it is likely the drug will be present in human milk
Owing to the potential for serious adverse reactions in a breastfed child, breastfeeding is not recommended during treatment and for at least 2 weeks after the last dose
Interactions
Avatrombopag is a CYP2C9 and CYP3A4 substrate; it inhibits organic anion transporter (OAT) 3 and breast cancer resistance protein (BCRP)
Moderate or strong dual CYP2C9 and CYP3A4 inhibitors
Coadministration with a moderate or strong dual CYP2C9 and CYP3A4 inhibitor increases avatrombopag AUC, which may increase the risk of avatrombopag toxicities
If starting a moderate or strong dual CYP2C9 and CYP3A4 inhibitor during treatment, monitor platelet counts and adjust avatrombopag dose as necessary
Moderate or strong dual CYP2C9 and CYP3A4 inducers
Coadministration with a moderate or strong dual CYP2C9 and CYP3A4 inducers decreases avatrombopag AUC, which may reduce efficacy of avatrombopag
If starting a moderate or strong dual CYP2C9 and CYP3A4 inducer during treatment, monitor platelet counts and adjust avatrombopag dose as necessary
Contraindicated (0)
Serious - Use Alternative (7)
fexinidazole
lonafarnib
ritonavir
sotorasib
tepotinib
tucatinib
voxelotor
Adverse Effects
Side effects of Avatrombopag :
>10%
Chronic liver disease
Pyrexia (8-11%)
Chronic ITP
Headache (31%)
Fatigue (28%)
Contusion (26%)
Epistaxis (19%)
Upper respiratory tract infection (15%)
Arthralgia (13%)
Gingival bleeding (13%)
Petechiae (11%)
1-10%
Chronic liver disease
Abdominal pain (6-7%)
Nausea (6-7%)
Fatigue (3-4%)
Peripheral edema (2-4%)
Chronic ITP
Nasopharyngitis (10%)
Headache (1.6%)
<1%
Chronic liver disease
Anemia (0.4%)
Pyrexia (0.4%)
Myalgia (0.4%)
Frequency Not Defined
Chronic liver disease
Hyponatremia
Mechanism of Action
Second-generation orally administered thrombopoietin receptor agonist (TPO-RA)
Stimulates proliferation and differentiation of megakaryocytes from bone marrow progenitor cells, resulting in an increased production of platelets
Does not compete with TPO for binding to the TPO receptor and has an additive effect with TPO on platelet production
Note
Avalet 20 mg Tablet manufactured by Drug International Ltd.. Its generic name is Avatrombopag. Avalet is availble in Bangladesh.
Farmaco BD drug index information on Avalet Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.