KYNMOBI Sublingual film Ref.[10859] Active ingredients: Apomorphine

Source: FDA, National Drug Code (US) Revision Year: 2020

Product 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 hemihydrate with a molecular formula of C₁₇H₁₇NO₂∙HCl∙½ H₂O. Its structural formula and molecular weight are:

Figure 1. Structural Formula and Molecular Weight of Apomorphine Hydrochloride:

The molecular weight is 312.79 (hydrochloride hemihydrate salt).

Apomorphine hydrochloride is white to grayish glistening crystals or white powder that is sparingly soluble in water and alcohol at ambient temperature.

KYNMOBI is intended for sublingual administration only and is available in five dosage strengths. Each film contains 10 mg, 15 mg, 20 mg, 25 mg, or 30 mg of apomorphine hydrochloride (equivalent to 8.8 mg, 13.2 mg, 17.6 mg, 22.0 mg, and 26.4 mg of apomorphine, respectively). Each film also contains the following inactive ingredients: disodium EDTA, dihydrate, FD&C Blue #1, glycerol, glyceryl monostearate, hydroxyethyl cellulose, hypromellose, maltodextrin, (-)-menthol, pyridoxine hydrochloride, sodium hydroxide, sodium metabisulfite, sucralose, and white ink.

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 30 mg. Each sublingual film is individually packaged in a sealed foil pouch.

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

Table 3. Package Configuration for KYNMOBI sublingual film:

Single Film Strength (NDC Code)	Package Configuration	NDC Code
Trade Titration Kit
10 mg (63402-010-01) 15 mg (63402-015-01) 20 mg (63402-020-01) 25 mg (63402-025-01) 30 mg (63402-030-01)	Each titration kit carton will contain a total of 10 individually packaged films of: 2 – single 10 mg films 2 – single 15 mg films 2 – single 20 mg films 2 – single 25 mg films 2 – single 30 mg films	63402-088-10
Trade Product
10 mg (63402-010-01)	30 films per carton	63402-010-30
15 mg (63402-015-01)	30 films per carton	63402-015-30
20 mg (63402-020-01)	30 films per carton	63402-020-30
25 mg (63402-025-01)	30 films per carton	63402-025-30
30 mg (63402-030-01)	30 films per carton	63402-030-30

Manufactured for: Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts 01752 USA

Drugs

Drug	Countries
KYNMOBI	Canada, United States

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