NUPLAZID Capsule (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

ACADIA Pharmaceuticals 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: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of ...

1. Indications and Usage

NUPLAZID is indicated for the treatment of hallucinations and delusions associated with Parkinsons disease psychosis.

2. Dosage and Administration

2.1 Recommended Dosage The recommended dose of NUPLAZID is 34 mg taken orally once daily, without titration. 2.2 Administration Information NUPLAZID can be taken with or without food [see Clinical ...

3. Dosage Forms and Strengths

NUPLAZID (pimavanserin) is available as: 34 mg strength capsules. The capsules are opaque white and light green with PIMA and 34 printed in black. 10 mg strength tablets. The orange, round, coated tablets ...

4. Contraindications

NUPLAZID is contraindicated in patients with a history of a hypersensitivity reaction to pimavanserin or any of its components. Rash, urticaria, and reactions consistent with angioedema (e.g., tongue swelling, ...

5. Warnings and Precautions

5.1 Increased Mortality in Elderly Patients with Dementia-Related Psychosis Antipsychotic drugs increase the all-cause risk of death in elderly patients with dementia-related psychosis. Analyses of 17 ...

6. Adverse Reactions

The following serious adverse reactions are discussed elsewhere in the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning and 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 ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during postapproval use of NUPLAZID. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

7.1 Drugs Having Clinically Important Interactions with NUPLAZID Table 2 Clinically Important Drug Interactions with NUPLAZID: QT Interval Prolongation Clinical Impact: Concomitant use of drugs ...

8. Use in Specific Populations

8.8 Other Specific Populations No dosage adjustment is required based on patients age, sex, ethnicity, or weight. These factors do not affect the pharmacokinetics of NUPLAZID [see Clinical Pharmacology ...

8.1. Pregnancy

Risk Summary There are no data on NUPLAZID use in pregnant women that would allow assessment of the drug-associated risk of major congenital malformations or miscarriage. In animal reproduction studies, ...

8.2. Lactation

Risk Summary There is no information regarding the presence of pimavanserin in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits ...

8.4. Pediatric Use

Safety and effectiveness of NUPLAZID have not been established in pediatric patients.

8.5. Geriatric Use

No dose adjustment is required for elderly patients. Parkinsons disease is a disorder occurring primarily in individuals over 55 years of age. The mean age of patients enrolled in the 6-week clinical studies ...

8.6. Renal Impairment

No dosage adjustment for NUPLAZID is needed in patients with mild to severe renal impairment or end stage renal disease (ESRD); however, increased exposure (Cmax and AUC) to NUPLAZID occurred ...

8.7. Hepatic Impairment

No dosage adjustment for NUPLAZID is recommended in patients with hepatic impairment based on the exposure differences observed in patients with and without hepatic impairment in a hepatic impairment study ...

9.1. Controlled Substance

NUPLAZID is not a controlled substance.

9.2. Abuse

NUPLAZID has not been systematically studied in humans for its potential for abuse, tolerance, or physical dependence. While short-term, placebo-controlled and long-term, open-label clinical trials did ...

10. Overdosage

10.1 Human Experience The pre-marketing clinical trials involving NUPLAZID in approximately 1200 subjects and patients do not provide information regarding symptoms with overdose. In healthy subject studies, ...

11. Description

NUPLAZID contains pimavanserin, an atypical antipsychotic, which is present as pimavanserin tartrate salt with the chemical name, urea, N-N(1-methyl-4-piperidinyl)N'[[4-(2-methylpropoxy)phenyl]methyl]-,(2 ...

12.1. Mechanism of Action

The mechanism of action of pimavanserin in the treatment of hallucinations and delusions associated with Parkinsons disease psychosis is unclear. However, the effect of pimavanserin could be mediated through ...

12.2. Pharmacodynamics

In vitro, pimavanserin acts as an inverse agonist and antagonist at serotonin 5-HT2A receptors with high binding affinity (Ki value 0.087 nM) and at serotonin 5-HT2C ...

12.3. Pharmacokinetics

Pimavanserin demonstrates dose-proportional pharmacokinetics after single oral doses from 17 to 255 mg (0.5- to 7.5-times the recommended dosage). The pharmacokinetics of pimavanserin are similar in both ...

13.1. Carcinogensis, Mutagenesis, Impairment of Fertility

Carcinogenesis There was no increase in the incidence of tumors following daily oral administration of pimavanserin to mice or rats for 2 years. Mice were administered pimavanserin at oral doses of 2.6, ...

13.2. Animal Toxicology and/or Pharmacology

Phospholipidosis (foamy macrophages and/or cytoplasmic vacuolation) was observed in multiple tissues and organs of mice, rats, and monkeys following oral daily administration of pimavanserin. The occurrence ...

14. Clinical Studies

The efficacy of NUPLAZID 34 mg as a treatment of hallucinations and delusions associated with Parkinsons disease psychosis was demonstrated in a 6-week, randomized, placebo-controlled, parallel-group study. ...

16.1. How Supplied

NUPLAZID (pimavanserin) is available as: 34 mg Capsule: Opaque white and light green capsule with PIMA and 34 printed in black. Bottle of 30: NDC 63090-340-30 10 mg Tablet: Orange, round, ...

16.2. Storage and Handling

34 mg Capsule: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature]. To prevent potential capsule color fading, ...

17. Patient Counseling Information

Concomitant Medication Advise patients to inform their healthcare providers if there are any changes to their current prescription or over-the-counter medications, since there is a potential for drug interactions ...