NURTEC ODT Orally disintegrating tablet (2020)
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Biohaven Pharmaceuticals, Inc
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1. Indications and Usage
NURTEC ODT is indicated for the acute treatment of migraine with or without aura in adults. <u>Limitations of Use:</u> NURTEC ODT is not indicated for the preventive treatment of migraine.
2. Dosage and Administration
The recommended dose of NURTEC ODT is 75 mg taken orally. The maximum dose in a 24-hour period is 75 mg. The safety of treating more than 15 migraines in a 30-day period has not been established. 2.2 Administration ...
3. Dosage Forms and Strengths
<u>NURTEC ODT</u> Orally disintegrating tablets: white to off-white, circular, and debossed with the symbol , each containing 75 mg of rimegepant.
4. Contraindications
NURTEC ODT is contraindicated in patients with a history of hypersensitivity reaction to rimegepant, NURTEC ODT, or any of its components. Delayed serious hypersensitivity has occurred <em>[see Warnings ...
5. Warnings and Precautions
Hypersensitivity reactions, including dyspnea and rash, have occurred with NURTEC ODT in clinical studies. Hypersensitivity reactions can occur days after administration, and delayed serious hypersensitivity ...
6. Adverse Reactions
The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Hypersensitivity Reactions <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 ...
7. Drug Interactions
7.1 CYP3A4 Inhibitors Concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4 results in a significant increase in rimegepant exposure. Avoid concomitant administration of NURTEC ODT ...
8.1. Pregnancy
Risk Summary There are no adequate data on the developmental risk associated with the use of NURTEC ODT in pregnant women. In animal studies, oral administration of rimegepant during organogenesis resulted ...
8.2. Lactation
There are no data on the presence of rimegepant or its metabolites in human milk, the effects of rimegepant on the breastfed infant, or the effects of rimegepant on milk production. There are no animal ...
8.4. Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
8.5. Geriatric Use
In pharmacokinetic studies, no clinically significant pharmacokinetic differences were observed between elderly and younger subjects. Clinical studies of NURTEC ODT did not include sufficient numbers of ...
8.6. Renal Impairment
No dosage adjustment of NURTEC ODT is required in patients with mild, moderate, or severe renal impairment. NURTEC ODT has not been studied in patients with end-stage renal disease and in patients on dialysis. ...
8.6. Hepatic Impairment
No dosage adjustment of NURTEC ODT is required in patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment. Plasma concentrations of rimegepant were significantly higher in subjects ...
10. Overdosage
There is limited clinical experience with NURTEC ODT overdosage. Treatment of an overdose of NURTEC ODT should consist of general supportive measures including monitoring of vital signs and observation ...
11. Description
NURTEC ODT contains rimegepant sulfate, a calcitonin gene-related peptide receptor antagonist. Rimegepant sulfate is described chemically as (5S,6S,9R)-5-amino-6-(2,3-difluorophenyl)-6,7,8,9-tetrahydro-5H-cyclohepta[b]pyridin-9-yl ...
12.1. Mechanism of Action
Rimegepant is a calcitonin gene-related peptide receptor antagonist.
12.2. Pharmacodynamics
The relationship between pharmacodynamic activity and the mechanism(s) by which rimegepant exerts its clinical effects is unknown. No clinically relevant differences in resting blood pressure were observed ...
12.3. Pharmacokinetics
Absorption Following oral administration of NURTEC ODT, rimegepant is absorbed with the maximum concentration at 1.5 hours. The absolute oral bioavailability of rimegepant is approximately 64%. Effects ...
12.5. Pharmacogenomics
CYP2C9 activity is reduced in individuals with genetic variants such as the CYP2C9*2 and CYP2C9*3 alleles. Rimegepant C<sub>max</sub> and AUC<sub>0-inf</sub> were similar in CYP2C9 intermediate metabolizers ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis Oral administration of rimegepant to Tg.rasH2 mice (0, 10, 100, or 300 mg/k/day) for 26 weeks and to rats (0, 5, 20, or 45 mg/kg/day) for 91-100 weeks resulted in no evidence of drug-induced ...
14. Clinical Studies
The efficacy of NURTEC ODT for the acute treatment of migraine with and without aura in adults was demonstrated in a randomized, double-blind, placebo-controlled trial: Study 1 (NCT03461757). The study ...
16.1. How Supplied
NURTEC ODT 75 mg orally disintegrating tablets are white to off-white, circular, debossed with the symbol ?renderMultiMedia?, and supplied in cartons containing a blister pack of 8 orally disintegrating ...
16.2. Storage and Handling
Store NURTEC ODT at controlled room temperature, 20°C to 25°C (68°F to 77°F); with excursions permitted between 15°C to 30°C (59°F to 86°F) <em>[see USP controlled room temperature]</em>.
17. Patient Counseling Information
Advise patients to read the FDA-approved patient labeling (Patient Information). Handling of Orally Disintegrating Tablets Packaging Instruct patients not to remove the blister from the outer aluminum ...