SUNOSI- solriamfetol tablet, film coated

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

SOLRIAMFETOL (UNII: 939U7C91AI) (SOLRIAMFETOL - UNII:939U7C91AI)

Verfügbar ab:

Jazz Pharmaceuticals, Inc.

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

SUNOSI is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) [see Clinical Studies (14)]. Limitations of Use SUNOSI is not indicated to treat the underlying airway obstruction in OSA. Ensure that the underlying airway obstruction is treated (e.g., with continuous positive airway pressure (CPAP)) for at least one month prior to initiating SUNOSI for excessive daytime sleepiness. Modalities to treat the underlying airway obstruction should be continued during treatment with SUNOSI. SUNOSI is not a substitute for these modalities. SUNOSI is contraindicated in patients receiving concomitant treatment with monoamine oxidase (MAO) inhibitors, or within 14 days following discontinuation of monoamine oxidase inhibitor, because of the risk of hypertensive reaction [see Drug Interactions (7.1)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to SUNOSI during pregnancy. Healthcare providers are encouraged to register pregnant patients, or pregnant women may enroll themselves in the registry by calling 1-877-283-6220 or contacting the company at www.SunosiPregnancyRegistry.com. Risk Summary Available data from case reports are not sufficient to determine drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproductive studies, oral administration of solriamfetol during organogenesis caused maternal and fetal toxicities in rats and rabbits at doses ≥ 4 and 5 times and was teratogenic at doses 19 and ≥ 5 times, respectively, the maximum recommended human dose (MRHD) of 150 mg based on mg/m2 body surface area. Oral administration of solriamfetol to pregnant rats during pregnancy and lactation at doses ≥ 7 times the MRHD based on mg/m2 body surface area resulted in maternal toxicity and adverse effects on fertility, growth, and development in offspring (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. Data Animal Data Solriamfetol was administered orally to pregnant rats during the period of organogenesis at 15, 67, and 295 mg/kg/day, which are approximately 1, 4, and 19 times the MRHD based on mg/m2 body surface area. Solriamfetol at ≥ 4 times the MRHD caused maternal toxicity that included hyperactivity, significant decreases in body weight, weight gain, and food consumption. Fetal toxicity at these maternally toxic doses included increased incidence of early resorption and post-implantation loss, and decreased fetal weight. Solriamfetol was teratogenic at 19 times the MRHD; it increased the incidence of fetal malformations that included severe sternebrae mal-alignment, hindlimb rotation, bent limb bones, and situs inversus. This dose was also maternally toxic. The no-adverse-effect level for malformation is 4 times and for maternal and embryofetal toxicity is approximately 1 times the MRHD based on mg/m2 body surface area. Solriamfetol was administered orally to pregnant rabbits during the period of organogenesis at 17, 38, and 76 mg/kg/day, which are approximately 2, 5, and 10 times the MRHD based on mg/m2 body surface area. Solriamfetol at 10 times the MRHD caused maternal toxicity of body weight loss and decreased food consumption. Solriamfetol was teratogenic at ≥ 5 times the MRHD, it caused fetal skeletal malformation (slight-to-moderate sternebrae mal-alignment) and decreased fetal weight. The no-adverse-effect level for malformation and fetal toxicity is approximately 2 times and for maternal toxicity is approximately 5 times the MRHD based on mg/m2 body surface area. Solriamfetol was administered orally to pregnant rats during the period of organogenesis from gestation day 7 through lactation day 20 post-partum, at 35, 110, and 350 mg/kg/day, which are approximately 2, 7, and 22 times the MRHD based on mg/m2 body surface area. At ≥ 7 times the MRHD, solriamfetol caused maternal toxicity that included decreased body weight gain, decreased food consumption, and hyperpnea. At these maternally toxic doses, fetal toxicity included increased incidence of stillbirth, postnatal pup mortality, and decreased pup weight. Developmental toxicity in offspring after lactation day 20 included decreased body weight, decreased weight gain, and delayed sexual maturation. Mating and fertility of offspring were decreased at maternal doses 22 times the MRHD without affecting learning and memory. The no-adverse-effect level for maternal and developmental toxicity is approximately 2 times the MRHD based on mg/m2 body surface area. Risk Summary There are no data available on the presence of solriamfetol or its metabolites in human milk, the effects on the breastfed infant, or the effect of this drug on milk production. Solriamfetol is present in rat milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for SUNOSI and any potential adverse effects on the breastfed child from SUNOSI or from the underlying maternal condition. Clinical Considerations Monitor breastfed infants for adverse reactions, such as agitation, insomnia, anorexia and reduced weight gain. Safety and effectiveness in pediatric patients have not been established. Clinical studies of SUNOSI in pediatric patients have not been conducted. Of the total number of patients in the narcolepsy and OSA clinical studies treated with SUNOSI, 13% (123/930) were 65 years of age or over. No clinically meaningful differences in safety or effectiveness were observed between elderly and younger patients. Solriamfetol is predominantly eliminated by the kidney. Because elderly patients are more likely to have decreased renal function, dosing may need to be adjusted based on eGFR in these patients. Consideration should be given to the use of lower doses and close monitoring in this population [see Dosage and Administration (2.5)] . Dosage adjustment is not required for patients with mild renal impairment (eGFR 60‑89 mL/min/1.73 m2 ). Dosage adjustment is recommended for patients with moderate to severe renal impairment (eGFR 15‑59 mL/min/1.73 m2 ). SUNOSI is not recommended for patients with end stage renal disease (eGFR <15 mL/min/1.73 m2 ) [see Dosage and Administration (2.5), Warnings and Precautions (5.1, 5.2), Clinical Pharmacology (12.3)] . SUNOSI contains solriamfetol, a Schedule IV controlled substance. SUNOSI has potential for abuse. Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. The abuse potential of SUNOSI 300 mg, 600 mg, and 1200 mg (two, four, and eight times the maximum recommended dose, respectively) was assessed relative to phentermine, 45 mg and 90 mg, (a Schedule IV controlled substance) in a human abuse potential study in individuals experienced with the recreational use of stimulants. Results from this clinical study demonstrated that SUNOSI produced Drug Liking scores similar to or lower than phentermine. In this crossover study, elevated mood was reported by 2.4% of placebo‑treated subjects, 8 to 24% of SUNOSI‑treated subjects, and 10 to 18% of phentermine‑treated subjects. A ‘feeling of relaxation’ was reported in 5% of placebo-treated subjects, 5 to 19% of SUNOSI‑treated subjects and 15 to 20% of phentermine-treated subjects. Physicians should carefully evaluate patients for a recent history of drug abuse, especially those with a history of stimulant (e.g., methylphenidate, amphetamine, or cocaine) or alcohol abuse, and follow such patients closely, observing them for signs of misuse or abuse of SUNOSI (e.g., incrementation of doses, drug-seeking behavior). In a long-term safety and maintenance of efficacy study, the effects of abrupt discontinuation of SUNOSI were evaluated following at least 6 months of SUNOSI use in patients with narcolepsy or OSA. The effects of abrupt discontinuation of SUNOSI were also evaluated during the two-week safety follow‑up periods in the Phase 3 studies. There was no evidence that abrupt discontinuation of SUNOSI resulted in a consistent pattern of adverse events in individual subjects that was suggestive of physical dependence or withdrawal.

Produktbesonderheiten:

SUNOSI is packaged in 30‑count and 100‑count white, high density polyethylene (HDPE) bottles. SUNOSI tablets, 75 mg ‑ dark yellow oblong tablet with “75” debossed on one side and a functional score line on the opposite side. NDC 68727‑350-01: Bottles of 30 with child‑resistant closure NDC 68727-350-02: Bottles of 100 with child‑resistant closure SUNOSI tablets, 150 mg ‑ yellow oblong tablet with “150” debossed on one side. NDC 68727‑351-01: Bottles of 30 with child‑resistant closure NDC 68727-351-02: Bottles of 100 with child‑resistant closure Store SUNOSI at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) (see USP controlled room temperature).

Berechtigungsstatus:

New Drug Application

Gebrauchsinformation

Jazz Pharmaceuticals, Inc.
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MEDICATION GUIDE
SUNOSI® (suh-NOH-see)
(solriamfetol)
tablets, for oral use, CIV
What is SUNOSI?
SUNOSI is a prescription medicine used to improve wakefulness in
adults with excessive daytime sleepiness
that is associated with narcolepsy or obstructive sleep apnea (OSA).
•
It is not known if SUNOSI is safe and effective in children.
•
SUNOSI is not for use to treat the underlying cause of airway
obstruction in people with OSA.
SUNOSI does not take the place of using your continuous positive
airway pressure (CPAP) machine or
other devices that your healthcare provider has prescribed for the
treatment of OSA. It is important that
you continue to use these treatments as prescribed by your healthcare
provider.
SUNOSI is a federally controlled substance (CIV) because it contains
solriamfetol that can be a target for
people who abuse prescription medicines or street drugs. Keep SUNOSI
in a safe place to protect it from
theft. Never give your SUNOSI to anyone else, because it may cause
death or harm them. Selling or giving
away SUNOSI may harm others and is against the law. Tell your
healthcare provider if you have ever
abused or been dependent on alcohol, prescription medicines or street
drugs.
Do not take SUNOSI if you are taking or have stopped taking within the
past 14 days a medicine used to
treat depression called a monoamine oxidase inhibitor (MAOI).
Before taking SUNOSI, tell your healthcare provider about all your
medical conditions, including if you:
•
have heart problems or have had a heart attack
•
have had a stroke
•
have high blood pressure
•
have kidney problems or diabetes
•
have high cholesterol in your blood
•
have a history of mental health problems, including psychosis and
bipolar disorders
•
have a history of drug or alcohol abuse or addiction
•
are pregnant or planning to become pregnant. It is not known if SUNOSI
will harm your unborn baby.
o
Pregnancy Registry: There is a pregnancy registry for women who take
SUNOSI during
pregnancy. The

Fachinformation

SUNOSI- SOLRIAMFETOL TABLET, FILM COATED
JAZZ PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SUNOSI SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SUNOSI.
SUNOSI (SOLRIAMFETOL) TABLETS, FOR ORAL USE, CIV
INITIAL U.S. APPROVAL: 2019
INDICATIONS AND USAGE
SUNOSI is a dopamine and norepinephrine reuptake inhibitor (DNRI)
indicated to improve wakefulness in
adult patients with excessive daytime sleepiness associated with
narcolepsy or obstructive sleep apnea
(OSA). (1)
Limitations of Use
SUNOSI is not indicated to treat the underlying airway obstruction in
OSA. Ensure that the underlying
airway obstruction is treated (e.g., with continuous positive airway
pressure (CPAP)) for at least one month
prior to initiating SUNOSI for excessive daytime sleepiness.
Modalities to treat the underlying airway
obstruction should be continued during treatment with SUNOSI. SUNOSI
is not a substitute for these
modalities. (1)
DOSAGE AND ADMINISTRATION
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•
•
•
•
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DOSAGE FORMS AND STRENGTHS
Tablets: 75 mg (functionally scored) and 150 mg. (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (≥ 5% and greater than placebo):
headache, nausea, decreased
appetite, insomnia, and anxiety. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT JAZZ PHARMACEUTICALS,
INC. AT 1-800-
520-5568 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
®
Administer once daily upon awakening. Avoid administration within 9
hours of planned bedtime
because of the potential to interfere with sleep. (2.2)
Starting dose for patients with narcolepsy: 75 mg once daily. (2.3)
Starting dose for patients with OSA: 37.5 mg once daily. (2.4)
Dose may be increased at intervals of at least 3 days. (2.3, 2.4)
Maximum dose is 150 mg once daily. (2.3, 2.4)
Renal impairment (2.5, 8.6, 12.3):
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•
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Moderate impairment: Starting dose is 37.5 mg once daily.
o
May increase to 75 mg once d