HIGHLIGHTS OF PRESCRIBING INFORMATION

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

apomorphine hydrochloride (UNII: F39049Y068) (apomorphine - UNII:N21FAR7B4S)

Available from:

Sunovion Pharmaceuticals Inc.

Administration route:

SUBLINGUAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

KYNMOBI is indicated for the acute, intermittent treatment of “off” episodes in patients with Parkinson's disease (PD). KYNMOBI is contraindicated in patients: - Using concomitant 5HT3 antagonists, including antiemetics (e.g., ondansetron, granisetron, dolasetron, palonosetron) and alosetron [see Drug Interactions (7.1)]. There have been reports of profound hypotension and loss of consciousness when subcutaneous apomorphine was administered with a 5HT3 antagonist. - With hypersensitivity/allergic reaction to apomorphine or to any of the ingredients of KYNMOBI. Angioedema or anaphylaxis may occur [see Warnings and Precautions (5.3)]. 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 (increased neonatal deaths) and rabbits (increased incidence of malformation) when administered during pregnancy at clinically relevant doses. These doses were also associated with

Product summary:

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. Films are supplied in the following strengths and package configurations (Table 3): 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.

Authorization status:

New Drug Application

Summary of Product characteristics

KYNMOBI- APOMORPHINE HYDROCHLORIDE FILM, SOLUBLE
KYNMOBI- APOMORPHINE HYDROCHLORIDE
SUNOVION PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
KYNMOBI SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR KYNMOBI.
KYNMOBI (APOMORPHINE HYDROCHLORIDE) SUBLINGUAL FILM
INITIAL U.S. APPROVAL: 2004
RECENT MAJOR CHANGES
Dosage and Administration,
Important Administration Instructions (2.1)
9/2022
Warnings and Precautions, Nausea and Vomiting (5.1)
9/2022
Warnings and Precautions, Hemolytic Anemia (5.8)
5/2022
INDICATIONS AND USAGE
KYNMOBI is a non-ergoline dopamine agonist indicated for the acute,
intermittent treatment of “off”
episodes in patients with Parkinson's disease (1)
DOSAGE AND ADMINISTRATION
For sublingual administration only (2.1)
Dose initiation should be supervised by a healthcare provider (2.1,
2.3)
Trimethobenzamide may be considered for nausea and/or vomiting, if
needed (2.1, 5.1)
The dose range for KYNMOBI is 10 mg to 30 mg per dose, administered
sublingually, as needed (2.2)
KYNMOBI doses should be separated by at least 2 hours (2.2)
Maximum of 5 doses per day; maximum single dose is 30 mg (2.2)
DOSAGE FORMS AND STRENGTHS
KYNMOBI sublingual film: 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg of
apomorphine hydrochloride (3, 16)
CONTRAINDICATIONS
Concomitant use of KYNMOBI with 5HT3 antagonists (4)
Hypersensitivity to apomorphine or any of its ingredients including
sodium metabisulfite (4)
WARNINGS AND PRECAUTIONS
Nausea and vomiting may occur (2.1, 5.1)
Falling asleep during activities of daily living and daytime
somnolence may occur; discontinue KYNMOBI
if this occurs (5.2)
Syncope and hypotension/orthostatic hypotension may occur; monitor
blood pressure (5.4)
Oral mucosal irritation may occur, which may require pausing or
discontinuing treatment (5.5)
Falls may occur or increase (5.6)
May cause hallucinations and psychotic-like behavior (5.7)
May cause hemolytic anemia (5.8)
May cause impulse control and impuls