KYNMOBI Sublingual film (2020)
Βιβλιογραφική αναφορά
Συγγραφείς
Sunovion Pharmaceuticals Inc.
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1. Indications and Usage
KYNMOBI is indicated for the acute, intermittent treatment of off episodes in patients with Parkinsons disease (PD).
2. Dosage and Administration
2.1 Important Administration Instructions Dose initiation should be supervised by a healthcare provider <em>[see Dosage and Administration (2.3)]</em>. KYNMOBI must be administered whole. Do not to cut, ...
3. Dosage Forms and Strengths
KYNMOBI sublingual film is a blue to green rectangular film with a white printed number identifying the strength (e.g., 10 is 10 mg). KYNMOBI comes in dosage strengths of 10 mg, 15 mg, 20 mg, 25 mg, and ...
4. Contraindications
KYNMOBI is contraindicated in patients: Using concomitant 5HT<sub>3</sub> antagonists, including antiemetics (e.g., ondansetron, granisetron, dolasetron, palonosetron) and alosetron <em>[see Drug Interactions ...
5. Warnings and Precautions
5.1 Nausea and Vomiting KYNMOBI may cause nausea and vomiting when administered at recommended doses. Because of the high incidence of nausea and vomiting with KYNMOBI when administered at recommended ...
6. Adverse Reactions
The following serious adverse reactions are discussed in more detail in the Warnings and Precautions section of labeling: Nausea and Vomiting <em>[see Warnings and Precautions (5.1)]</em> Falling Asleep ...
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 the rates in the clinical trials of ...
7. Drug Interactions
7.1 5-HT3 Antagonists Based on reports of profound hypotension and loss of consciousness when subcutaneous apomorphine was administered with ondansetron, the concomitant use of KYNMOBI with 5HT3 antagonists, ...
8.1. Pregnancy
Risk Summary There are no adequate data on the developmental risk associated with use of KYNMOBI in pregnant women. In animal reproduction studies, apomorphine had adverse developmental effects in rats ...
8.2. Lactation
Risk Summary There are no data on the presence of apomorphine in human milk, the effects of apomorphine on the breastfed infant, or the effects of apomorphine on milk production. The developmental and ...
8.4. Pediatric Use
The safety and effectiveness in pediatric patients have not been established.
8.5. Geriatric Use
Clinical studies of KYNMOBI did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In Study 1, 78 patients below 65 years of ...
8.6. Renal Impairment
Avoid use of KYNMOBI in patients with severe and end-stage renal disease (ESRD) (CLcr <30 mL/min). No dosage adjustment is required for patients with mild or moderate renal impairment. However, because ...
8.7. Hepatic Impairment
Avoid use of KYNMOBI in patients with severe hepatic impairment (Child-Pugh Class C). No dosage adjustment is required for patients with mild or moderate hepatic impairment (Child-Pugh Class A and B). ...
9.1. Controlled Substance
KYNMOBI contains apomorphine, which is not a controlled substance.
9.2. Abuse
In premarketing clinical experience, KYNMOBI did not reveal any tendency for a withdrawal syndrome or any drug-seeking behavior. However, there are rare postmarketing reports of abuse of medications containing ...
11. Description
KYNMOBI (apomorphine hydrochloride) sublingual film contains apomorphine hydrochloride, a non-ergoline dopamine agonist. Apomorphine hydrochloride is chemically designated as 6aβ-Aporphine-10,11-diol hydrochloride ...
12.1. Mechanism of Action
KYNMOBI is a non-ergoline dopamine agonist with high in vitro binding affinity for the dopamine D<sub>4</sub> receptor, and moderate affinity for the dopamine D<sub>2</sub>, D<sub>3</sub>, and D<sub>5 ...
12.2. Pharmacodynamics
Cardiac Electrophysiology In a thorough QT study with subcutaneous apomorphine at exposures similar to those achieved with the recommended subcutaneous apomorphine dosing (i.e, 6 mg), apomorphine resulted ...
12.3. Pharmacokinetics
Absorption Following sublingual administration of 15 mg of apomorphine, the time to maximum concentration (T<sub>max</sub>) ranged from 0.5 to 1 hour. Apomorphine exhibits less than dose proportional increase ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis Lifetime carcinogenicity studies of apomorphine were conducted in male (0.1, 0.3, or 0.8 mg/kg/day) and female (0.3, 0.8, or 2 mg/kg/day) rats. Apomorphine was administered by subcutaneous ...
14. Clinical Studies
The efficacy of KYNMOBI for the acute, intermittent treatment of off episodes in patients with Parkinsons disease was established in one randomized, double-blind, placebo-controlled, parallel-group study ...
16.1. How Supplied
KYNMOBI sublingual film is a blue to green rectangular film with a white printed number identifying the strength (e.g., 10 is 10 mg). Each sublingual film is individually packaged in a sealed foil pouch. ...
16.2. Storage and Handling
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature]. Keep KYNMOBI in the foil pouch until ready to use.
17. Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Administration of KYNMOBI Advise patients that KYNMOBI is for sublingual use only <em>[see Dosage ...