AUSTEDO Coated tablet (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Teva Neuroscience, Inc.

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

BOXED WARNING SECTION

WARNING: DEPRESSION AND SUICIDALITY IN PATIENTS WITH HUNTINGTONS DISEASE AUSTEDO can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington ...

1. Indications and Usage

AUSTEDO is indicated for the treatment of: chorea associated with Huntingtons disease [see Clinical Studies (14.1)] tardive dyskinesia in adults [see Clinical Studies (14.2)]

2. Dosage and Administration

2.1 Dosing Information The dose of AUSTEDO is determined individually for each patient based on reduction of chorea or tardive dyskinesia and tolerability. When first prescribed to patients who are not ...

3. Dosage Forms and Strengths

AUSTEDO tablets are available in the following strengths: The 6 mg tablets are round, purple-coated tablets, with SD over 6 printed in black ink on one side. The 9 mg tablets are round, blue-coated tablets, ...

4. Contraindications

AUSTEDO is contraindicated in patients: With Huntingtons disease who are suicidal, or have untreated or inadequately treated depression [see Warnings and Precautions (5.1)]. With hepatic impairment ...

5. Warnings and Precautions

5.1 Depression and Suicidality in Patients with Huntingtons Disease Patients with Huntingtons disease are at increased risk for depression, and suicidal ideation or behaviors (suicidality). AUSTEDO may ...

6. Adverse Reactions

The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Depression and Suicidality in Patients with Huntingtons disease [see Warnings and Precautions ...

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 ...

7. Drug Interactions

7.1 Strong CYP2D6 Inhibitors A reduction in AUSTEDO dose may be necessary when adding a strong CYP2D6 inhibitor in patients maintained on a stable dose of AUSTEDO. Concomitant use of strong CYP2D6 inhibitors ...

8. Use in Specific Populations

8.7 Poor CYP2D6 Metabolizers Although the pharmacokinetics of deutetrabenazine and its metabolites have not been systematically evaluated in patients who do not express the drug metabolizing enzyme, it ...

8.1. Pregnancy

Risk Summary There are no adequate data on the developmental risk associated with the use of AUSTEDO in pregnant women. Administration of deutetrabenazine to rats during organogenesis produced no clear ...

8.2. Lactation

Risk Summary There are no data on the presence of deutetrabenazine or its metabolites in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. The developmental ...

8.4. Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

8.5. Geriatric Use

Clinical studies of AUSTEDO 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 not ...

8.7. Hepatic Impairment

The effect of hepatic impairment on the pharmacokinetics of deutetrabenazine and its primary metabolites has not been studied; however, in a clinical study conducted with tetrabenazine, a closely related ...

10. Overdosage

Overdoses ranging from 100 mg to 1 g have been reported in the literature with tetrabenazine, a closely related VMAT2 inhibitor. The following adverse reactions occurred with overdosing: acute dystonia, ...

11. Description

AUSTEDO (deutetrabenazine) is a vesicular monoamine transporter 2 (VMAT2) inhibitor for oral administration. The molecular weight of deutetrabenazine is 323.46; the pKa is 6.31. Deutetrabenazine is a hexahydro-dimethoxybenzoquinolizine ...

12.1. Mechanism of Action

The precise mechanism by which deutetrabenazine exerts its effects in the treatment of tardive dyskinesia and chorea in patients with Huntingtons disease is unknown but is believed to be related to its ...

12.2. Pharmacodynamics

Cardiac Electrophysiology The effect of a single 12-mg or 24-mg dose of AUSTEDO on the QT interval was studied in a randomized, double-blind, placebo-controlled crossover study in healthy male and female ...

12.3. Pharmacokinetics

After oral dosing up to 25 mg, plasma concentrations of deutetrabenazine are generally below the limit of detection because of the extensive hepatic metabolism of deutetrabenazine to the active deuterated ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis No carcinogenicity studies were performed with deutetrabenazine. No increase in tumors was observed in p53+/– transgenic mice treated orally with tetrabenazine at doses of 0, ...

14. Clinical Studies

14.1 Chorea Associated with Huntingtons Disease Double-Blind, Placebo-Controlled Study The efficacy of AUSTEDO as a treatment for chorea associated with Huntingtons disease was established primarily in ...

16.1. How Supplied

AUSTEDO tablets are available in the following strengths and packages: 6 mg: round, purple-coated tablets, with SD over 6 printed in black ink on one side. Bottles of 60 tablets: NDC 68546-170-60. 9 mg: ...

16.2. Storage and Handling

Store at 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [see USP Controlled Room Temperature]. Protect from light and moisture.

17. Patient Counseling Information

Advise the patient or caregiver to read the FDA-approved patient labeling (Medication Guide). Administration Instructions Advise patients to take AUSTEDO with food. AUSTEDO tablets should be swallowed ...