DOPTELET Film-coated tablet (2020)
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AkaRx, Inc.
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1. Indications and Usage
Treatment of Thrombocytopenia in Patients with Chronic Liver Disease (CLD) DOPTELET is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to ...
2. Dosage and Administration
2.1 Recommended Dosage for Patients with Chronic Liver Disease Begin DOPTELET dosing 10 to 13 days prior to the scheduled procedure. The recommended daily dose of DOPTELET is based on the patients platelet ...
3. Dosage Forms and Strengths
Tablets: 20 mg as round, biconvex, yellow, film-coated tablets debossed with AVA on one side and 20 on the other side.
4. Contraindications
None.
5. Warnings and Precautions
5.1 Thrombotic/Thromboembolic Complications DOPTELET is a thrombopoietin (TPO) receptor agonist and TPO receptor agonists have been associated with thrombotic and thromboembolic complications in patients ...
6. Adverse Reactions
The following clinically significant adverse reactions are discussed in detail in other sections of the labeling: Thrombotic/Thromboembolic Complications <em>[see Warnings and Precautions (5.1)]</em>. ...
6.1. Clinical Trials Experience
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 ...
6.2. Postmarketing Experience
The following adverse reactions have been identified during post approval use of DOPTELET. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...
7. Drug Interactions
7.1 Effect of Other Drugs on DOPTELET in Patients with Chronic Immune Thrombocytopenia Moderate or Strong Dual Inhibitors of CYP2C9 and CYP3A4 Concomitant use with a moderate or strong dual inhibitor of ...
8.1. Pregnancy
Risk Summary Based on findings from animal reproduction studies, DOPTELET may cause fetal harm when administered to a pregnant woman (<em>see Data</em>). The available data on DOPTELET in pregnant women ...
8.2. Lactation
Risk Summary There is no information regarding the presence of avatrombopag in human milk, the effects on the breastfed child, or the effects on milk production. Avatrombopag was present in the milk of ...
8.4. Pediatric Use
Safety and effectiveness in pediatric patients have not been established. In a 10-week juvenile toxicology study in rats, avatrombopag was administered at doses ranging from 20 to 300 mg/kg/day. There ...
8.5. Geriatric Use
Clinical studies of DOPTELET did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has ...
10. Overdosage
In the event of overdose, platelet count may increase excessively and result in thrombotic or thromboembolic complications. Closely monitor the patient and platelet count. Treat thrombotic complications ...
11. Description
The active ingredient in DOPTELET is avatrombopag maleate, a thrombopoietin receptor agonist. The chemical name of avatrombopag maleate is 4-piperidinecarboxylic acid, 1-[3-chloro-5-[[[4-(4-chloro-2-thienyl) ...
12.1. Mechanism of Action
Avatrombopag is an orally bioavailable, small molecule TPO receptor agonist that stimulates proliferation and differentiation of megakaryocytes from bone marrow progenitor cells, resulting in an increased ...
12.2. Pharmacodynamics
Platelet Response DOPTELET administered to adult patients resulted in dose- and exposure-dependent elevations in platelet counts. The onset of the platelet count increase was observed within 3 to 5 days ...
12.3. Pharmacokinetics
Avatrombopag demonstrated dose-proportional pharmacokinetics after single doses from 10 mg (0.25 times the lowest approved dosage) to 80 mg (1.3 times the highest recommended dosage). Healthy subjects ...
12.5. Pharmacogenomics
The CYP2C9*2 and CYP2C9*3 loss-of-function polymorphisms result in reduced CYP2C9 enzymatic activity. In a pooled pharmacogenomic analysis of avatrombopag studies, subjects heterozygous for CYP2C9 loss-of-function ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
In two-year carcinogenicity studies, avatrombopag was administered orally at doses of 20, 60, and 160 mg/kg/day in mice and doses of 20, 50, and 160 mg/kg/day in rats. Avatrombopag induced a statistically ...
14. Clinical Studies
14.1 Patients with Chronic Liver Disease The efficacy of DOPTELET for the treatment of thrombocytopenia in patients with chronic liver disease who are scheduled to undergo a procedure was established in ...
16.1. How Supplied
DOPTELET 20 mg tablets are supplied as round, biconvex, yellow, film-coated tablets, and debossed with AVA on one side and 20 on the other side. NDC 71369-020-10: carton of one blister card with 10 tablets. ...
16.2. Storage and Handling
Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Store tablets in the original package.
17. Patient Counseling Information
Advise the patient or caregiver to read the FDA-approved patient labeling (Patient Information). Prior to treatment, patients should fully understand and be informed of the following risks and considerations ...