Prescription Drug Information: KYNMOBI (Page 4 of 4)

13 NONCLINICAL TOXICOLOGY

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 injection for 22 months or 23 months, respectively. In males, there was an increase in Leydig cell tumors at the highest dose tested. This finding is of questionable significance because the endocrine mechanisms believed to be involved in the production of Leydig cell tumors in rats are not relevant to humans. No drug-related tumors were observed in females.

In a 26-week carcinogenicity study in P53-knockout transgenic mice, there was no evidence of carcinogenic potential when apomorphine was administered by subcutaneous injection at doses up to 20 mg/kg/day (male) or 40 mg/kg/day (female).

Mutagenesis

Apomorphine was mutagenic in the in vitro bacterial reverse mutation (Ames) and the in vitro mouse lymphoma tk assays. Apomorphine was clastogenic in the in vitro chromosomal aberration assay in human lymphocytes and in the in vitro mouse lymphoma tk assay. Apomorphine was negative in the in vivo micronucleus assay in mice.

Impairment of Fertility

Apomorphine was administered subcutaneously at doses up to 3 mg/kg/day to male and female rats prior to and throughout the mating period and continuing in females through gestation day 6. There was no evidence of adverse effects on fertility or on early fetal viability. A significant decrease in testis weight was observed in a 39-week study in cynomolgus monkey at all subcutaneous doses tested (0.3, 1, or 1.5 mg/kg/day).

In a published fertility study, apomorphine was administered to male rats at subcutaneous doses of 0.2, 0.8, or 2 mg/kg prior to and throughout the mating period. Fertility was reduced at the highest dose tested.

14 CLINICAL STUDIES

The efficacy of KYNMOBI for the acute, intermittent treatment of “off” episodes in patients with Parkinson’s disease was established in one randomized, double-blind, placebo-controlled, parallel-group study (Study 1; NCT02469090).

The study enrolled patients with a mean duration of Parkinson’s disease of approximately 9 years (range: 2 years to 22 years) who were Hoehn and Yahr Stage III or less in the “on” state, and who were all receiving concomitant levodopa with a stable dose for at least 4 weeks before screening. The most commonly used concomitant Parkinson’s disease medications in addition to levodopa were oral dopaminergic agonists (51%), monoamine oxidase B inhibitors (41%), amantadine derivatives (21%), and other dopaminergic agents (8%).

At baseline, the mean number of daily “off” episodes was 4 and the mean duration of “off” episodes was slightly over an hour in both groups. The study included a titration phase and a 12-week maintenance phase. Patients were titrated to the dose that achieved a full “on” response and was tolerated during the titration phase. Patients were treated with an oral antiemetic starting 3 days before the titration phase. In the titration phase, patients (N=141) arrived at the study site in an “off” state having not taken their regular morning dose of carbidopa/levodopa or any other adjunctive PD medications, as well as having taken their last dose of carbidopa/levodopa and any other adjunctive PD medications no later than midnight the night before. Treatment was initiated in the clinic with a 10 mg dose of KYNMOBI. If the patient responded to treatment and tolerated the 10 mg KYNMOBI dose, the patient was randomized in a blinded fashion to KYNMOBI or placebo in a 1:1 ratio. If the patient tolerated the dose but did not adequately respond, the patient was asked to return to the clinic within 3 days and the dose was increased by 5 mg. The titration process was continued up to a maximum KYNMOBI dose of 35 mg or until a full “on” was achieved as determined by the investigator and the patient [see Dosage and Administration (2.2)]. Dose administration was permitted up to 5 times per day in the maintenance phase. The Movement Disorder Society-Unified Parkinson’s Disease Rating Scale, Part III (MDS-UPDRS III) (motor examination) was measured predose, and at 15, 30, 45, 60, and 90 minutes postdose.

The primary endpoint of the study was the mean change from predose to 30 minutes postdose in the MDS-UPDRS III at the 12-week visit of the maintenance phase.

A total of 54 patients were randomized to KYNMOBI and 55 patients to placebo. The KYNMOBI treatment group showed a least-square mean improvement (i.e., reduction in score) of -11.1 points (95% CI: -14.0, -8.2), versus -3.5 points for the placebo group (95% CI: -6.1, -0.9). The least-square mean treatment difference between KYNMOBI and placebo was -7.6 (95% CI: -11.5, -3.7; p = 0.0002) (Table 2).

Table 2: Change from Predose to 30 Minutes Postdose in the MDS-UPDRS III Score at Week 12 (Least-Square Mean) in Study 1
Treatment Number of Patients at Week 12 Observed Predose MDS-UPDRS III Score at Week 12 Least-Square Mean Change from Predose to 30 Minutes Postdose Least-Square Mean Difference from placebo
Placebo 46 42.2 – 3.5 N/A
KYNMOBI 34 37.2 – 11.1 – 7.6 (p=0.0002)

Figure 2 describes the least-square mean change from predose in MDS-UPDRS Part III Motor Scores after administration of KYNMOBI versus placebo at week 12.

Figure 2: Estimated Least-Square Mean Change in MDS-UPDRS Part III Motor Score After Administration of KYNMOBI vs Placebo (at Week 12) in Study 1

Figure 2
(click image for full-size original)

16 HOW SUPPLIED/STORAGE AND HANDLING

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. 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 films2 – single 15 mg films2 – single 20 mg films2 – single 25 mg films2 – 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

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 [see Dosage and Administration (2.1)].

KYNMOBI must be administered whole. Advise patients not to cut, chew, or swallow KYNMOBI.

Nausea and Vomiting

Advise patients that KYNMOBI may cause nausea and vomiting when it is administered at recommended doses. Treatment with an antiemetic (e.g., trimethobenzamide) may be used, as needed, if nausea or vomiting occurs. Inform patients that they should discuss with their healthcare provider when the antiemetic can be discontinued [see Warnings and Precautions (5.1)].

Falling Asleep During Activities of Daily Living and Somnolence

Alert patients to the potential sedating effects of KYNMOBI, including somnolence and falling asleep while engaged in activities of daily living. Instruct patients not to drive a car or engage in other potentially dangerous activities until they have gained sufficient experience with KYNMOBI to gauge whether or not it affects their mental and/or motor performance adversely. Advise patients that if increased somnolence or episodes of falling asleep during activities of daily living (e.g., watching television, passenger in a car, etc.) occur, they should not drive or participate in potentially dangerous activities until they have discussed this with their healthcare provider. Because of possible additive effects of alcohol use, advise patients to limit their alcohol intake [see Warnings and Precautions (5.2)].

Hypersensitivity/Allergic Reactions

Advise patients that hypersensitivity/allergic reaction (e.g., swelling of the lips, tongue and mouth, flushing, and, infrequently, urticaria and throat tightness) may occur because of apomorphine, sodium metabisulfite, or any KYNMOBI excipients. Inform patients with a sulfite sensitivity that KYNMOBI contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes [see Warnings and Precautions (5.3)]. Advise patients who experience any hypersensitivity/allergic reaction to KYNMOBI that they should avoid taking KYNMOBI again [see Contraindications (4)].

Hypotension/Orthostatic Hypotension

Advise patients that they may develop postural (orthostatic) hypotension with or without symptoms, such as dizziness, nausea, syncope, and sweating. Instruct patients to rise slowly after sitting or lying down after taking KYNMOBI. Instruct patients to limit their alcohol intake because it may potentiate the hypotensive effect of KYNMOBI. Instruct patients to lie down before and after taking sublingual nitroglycerin because it may potentiate the hypotensive effect of KYNMOBI [see Warnings and Precautions (5.4)].

Oral Mucosal Irritation

Inform patients that KYNMOBI may result in oral mucosal adverse reactions such as irritation, erythema, lip swelling, mouth ulceration, dry mouth, stomatitis, glossodynia, oropharyngeal pain, swollen tongue, ageusia, oral pain, lip ulceration, oral disorder and hypoaesthesia oral [see Warnings and Precautions (5.5) and Adverse Reactions (6.1)].

Falls

Alert patients that they may have increased risk for falling when using KYNMOBI [see Warnings and Precautions (5.6)].

Hallucinations and/or Psychotic-Like Behavior

Inform patients that KYNMOBI may cause hallucinations or other manifestations of psychotic-like behavior. Advise patients to inform their healthcare provider if they have a major psychotic disorder or are taking any treatments for psychosis [see Warnings and Precautions (5.7)].

Hemolytic Anemia

Inform patients and caregivers that hemolytic anemia may occur and to contact their healthcare provider if they develop any signs or symptoms [see Warnings and Precautions (5.8)].

Impulse Control/Compulsive Behaviors

Patients and their caregivers should be alerted to the possibility that they may experience intense urges to spend money uncontrollably, intense urges to gamble, increased sexual urges, binge eating and/or other intense urges and the inability to control these urges while taking KYNMOBI [see Warnings and Precautions (5.9)].

Withdrawal-Emergent Hyperpyrexia and Confusion

Advise patients to contact their healthcare provider if they wish to discontinue KYNMOBI or decrease the dose of KYNMOBI [see Warnings and Precautions (5.10)].

QTc Prolongation and Potential for Proarrhythmic Effects

Alert patients that KYNMOBI may cause QTc prolongation and might produce proarrhythmic effects that could cause torsades de pointes and sudden death. Palpitations and syncope may signal the occurrence of an episode of torsades de pointes [see Warnings and Precautions (5.11)].

Priapism

Advise patients that KYNMOBI may cause prolonged painful erections and that if this occurs that they should seek medical attention immediately [ see Warnings and Precautions (5.13)].

Figure 3

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

KYNMOBI and Figure
are registered trademarks of Sunovion Pharmaceuticals Inc.
SUNOVION and Figure
are registered trademarks of Sumitomo Pharma Co., Ltd.
Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Pharma Co., Ltd.
© 2022 Sunovion Pharmaceuticals Inc. All rights reserved.For more information, go to www.KYNMOBI.com or call Sunovion Customer Service at 1-888-394-7377.

10413-03

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 5/2022

Patient Information KYNMOBI® (kin-moe′-bee)(apomorphine hydrochloride)sublingual film
Read this Patient Information before you start taking KYNMOBI and each time you get a refill. There may be new information. This Patient Information does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is KYNMOBI? KYNMOBI is a prescription medicine used to treat short-term (acute), intermittent “off” episodes in people with Parkinson’s disease (PD).It is not known if KYNMOBI is safe and effective in children.
Do not take KYNMOBI if you are:
  • taking certain medicines to treat nausea called 5HT3 antagonists, including ondansetron, granisetron, dolasetron, palonosetron, and alosetron. People taking ondansetron together with apomorphine, the active ingredient in KYNMOBI, have had very low blood pressure and lost consciousness or “blacked out.”
  • allergic to apomorphine hydrochloride or to any of the ingredients in KYNMOBI. See the end of the Patient Information leaflet for a complete list of ingredients in KYNMOBI.KYNMOBI also contains a sulfite called sodium metabisulfite. Sulfites can cause severe, life-threatening allergic reactions in some people. An allergy to sulfites is not the same as an allergy to sulfa. People with asthma are more likely to be allergic to sulfites. Call your healthcare provider or get emergency help right away if you get any of the following symptoms of a severe life-threatening allergic reaction:
  • hives
  • itching
  • rash
  • swelling of the lips, tongue, and mouth
  • redness of your face (flushing)
  • throat tightness
  • trouble breathing or swallowing
Before you start taking KYNMOBI, tell your healthcare provider about all of your medical conditions, including if you:
  • have difficulty staying awake during the daytime.
  • have dizziness.
  • have fainting spells.
  • have low blood pressure.
  • have asthma.
  • are allergic to any medicines containing sulfites.
  • have liver problems.
  • have kidney problems.
  • have heart problems.
  • have had a stroke or other brain problems.
  • have a mental problem called a major psychotic disorder.
  • drink alcohol.
  • are pregnant or plan to become pregnant. It is not known if KYNMOBI will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if KYNMOBI passes into your breast milk. You and your healthcare provider should decide if you will take KYNMOBI or breastfeed.
  • Tell your healthcare provider about all the medicines you take , including prescription medicines and over-the-counter medicines, vitamins, and herbal supplements.
KYNMOBI may affect the way other medicines work, and other medicines can affect how KYNMOBI works.Taking KYNMOBI with other medicines may cause serious side effects.
  • If you take nitroglycerin under your tongue (sublingual) while using KYNMOBI, your blood pressure may decrease and cause dizziness. You should lie down before and after taking sublingual nitroglycerin.
Know the medicines you take. Keep a list of your medicines with you and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I take KYNMOBI?
  • Read the step-by-step Instructions for Use that comes with your KYNMOBI prescription.
  • Take KYNMOBI exactly as your healthcare provider tells you to take it.
  • Your healthcare provider will tell you how much KYNMOBI to take and teach you the right way to take it.
  • Your healthcare provider may change your dose if needed.
  • Do not change your dose of KYNMOBI or take it more often than prescribed unless your healthcare provider has told you to.
  • Do not take more than 1 dose of KYNMOBI to treat an “OFF” episode.
  • Do not take another dose of KYNMOBI sooner than 2 hours after the last dose.
  • Do not take KYNMOBI more than 5 times a day.
  • Do not cut, chew, or swallow KYNMOBI.
  • Your healthcare provider may prescribe another medicine for nausea called an antiemetic to take while you are taking KYNMOBI. Antiemetic medicines help to decrease the symptoms of nausea and vomiting that can happen when you take KYNMOBI.
What should I avoid while taking KYNMOBI?
  • Do not drink alcohol while you are taking KYNMOBI. It can increase your chance of developing serious side effects.
  • Do not take medicines that make you sleepy while you are using KYNMOBI.
  • Do not drive, operate machinery, or do other dangerous activities until you know how KYNMOBI affects you.
  • Do not change your body position too fast. Get up slowly from sitting or lying. KYNMOBI can lower your blood pressure and cause dizziness or fainting.
What are the possible side effects of KYNMOBI? KYNMOBI can cause serious side effects, including:
  • nausea and vomiting. Nausea is a common side effect of KYNMOBI. Nausea and vomiting can happen with KYNMOBI. Your healthcare provider may prescribe a medicine called an antiemetic, such as trimethobenzamide, to help prevent nausea and vomiting. Some patients can stop taking trimethobenzamide after using KYNMOBI, when advised by your healthcare provider. Some patients may need to keep taking trimethobenzamide to help treat nausea and vomiting. Talk to your healthcare provider before you stop taking trimethobenzamide.
  • sleepiness or falling asleep during the day. Sleepiness is a serious and common side effect of KYNMOBI. Some people treated with KYNMOBI may get sleepy during the day or fall asleep without warning while doing everyday activities such as talking, eating, or driving a car.
  • allergic reactions. See the “Do not take KYNMOBI if you are ” section.
  • dizziness. Dizziness is a serious and common side effect of KYNMOBI. KYNMOBI may lower your blood pressure and cause dizziness. Dizziness can happen when KYNMOBI treatment is started or when the KYNMOBI dose is increased. Do not get up too fast from sitting or after lying down, especially if you have been sitting or lying down for a long period of time.
  • mouth (oral) irritation. Mouth (oral) irritation is a common side effect of KYNMOBI. You should call your healthcare provider if you develop any of these signs or symptoms:
  • redness
  • swelling
  • mouth sores (ulceration)
  • pain
  • dryness of the mouth, lips, or tongue
  • pain with swallowing
These signs and symptoms may go away if KYNMOBI treatment is stopped.
  • falls. The changes that can happen with PD, and the effects of some PD medicines, can increase the risk of falling. KYNMOBI may also increase your risk of falling.
  • hallucinations or psychotic-like behavior. KYNMOBI may cause or make psychotic-like behavior worse, including hallucinations (seeing or hearing things that are not real), confusion, excessive suspicion, aggressive behavior, agitation, delusional beliefs (believing things that are not real), and disorganized thinking.
  • Low red blood cells (hemolytic anemia). Tell your healthcare provider if you have any of the following signs or symptoms:
  • you become pale
  • dizziness
  • fast heartbeat
  • confusion
  • skin or eyes look yellow
  • fever
  • feel more tired or weaker than usual
  • chest pain
  • dark-colored urine
  • shortness of breath or trouble breathing
  • strong (intense) urges. Some people with PD have reported new or strong uncontrollable urges to gamble, increased sexual urges, increased urges to spend money (compulsive shopping), and other intense urges, while taking PD medicines, including KYNMOBI. If you or your family members notice that you have strong urges, talk to your healthcare provider. The strong urges may go away if your KYNMOBI dose is lowered or stopped.
  • high fever and confusion. KYNMOBI may cause a problem that can happen in people who suddenly lower their dose, stop using, or change their dose of KYNMOBI. Symptoms include:
  • very high fever
  • stiff muscles
  • confusion
  • changes in breathing and heartbeat
Do not stop taking KYNMOBI or change your dose unless you are told to do so by your healthcare provider.
  • heart problems. If you have shortness of breath, fast heartbeat, chest pain, or feel like you are going to pass out (faint) while taking KYNMOBI, call your healthcare provider or get emergency help right away.
  • tissue changes (fibrotic complications). Some people have had changes in the tissues of their pelvis, lungs, and heart valves when taking medicines called non-ergot-derived dopamine agonists like KYNMOBI.
  • prolonged painful erections (priapism). KYNMOBI may cause prolonged, painful erections in some people. If you have a prolonged and painful erection you should call your healthcare provider or go to the nearest hospital emergency room right away.
If you have any of these symptoms, stop taking KYNMOBI and call your healthcare provider right away before taking another dose.
The most common side effects of KYNMOBI include:
  • nausea
  • sleepiness
  • dizziness
  • mouth swelling, pain, or sores
These are not all of the possible side effects of KYNMOBI.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store KYNMOBI?
  • Store KYNMOBI at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep KYNMOBI in the foil pouch until you are ready to take it.
Keep KYNMOBI and all medicines out of the reach of children.
General information about the safe and effective use of KYNMOBI.Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use KYNMOBI for a condition for which it was not prescribed. Do not give KYNMOBI to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about KYNMOBI that is written for health professionals.

What are the ingredients in KYNMOBI? Active ingredient: apomorphine hydrochlorideInactive ingredients: disodium EDTA dihydrate, FD&C Blue #1, glycerol, glyceryl monostearate, hydroxyethyl cellulose, hydroxypropyl cellulose, maltodextrin, (-)-menthol, pyridoxine hydrochloride, sodium hydroxide, sodium metabisulfite, sucralose, and white ink.Figure
Manufactured for:Sunovion Pharmaceuticals Inc.Marlborough, Massachusetts 01752 USAKYNMOBI and Figure
are registered trademarks of Sunovion Pharmaceuticals Inc.SUNOVION and Figure
are registered trademarks of Sumitomo Pharma Co., Ltd.Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Pharma Co., Ltd.© 2022 Sunovion Pharmaceuticals Inc. All rights reserved.For more information, go to www.KYNMOBI.com or call Sunovion Customer Service at 1-888-394-7377.

INSTRUCTIONS FOR USE KYNMOBI TM (kin-moe′-bee) (apomorphine hydrochloride)Sublingual Film
Read this Instructions for Use before you start taking KYNMOBI and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
Important
  • KYNMOBI is for sublingual (under your tongue) use only.
  • KYNMOBI must be taken whole. Do not cut, chew, or swallow KYNMOBI.
  • Do not take KYNMOBI until you talk with your healthcare provider about how to take it.
  • Check the expiration date printed on the foil pouch. Do not use KYNMOBI if the expiration date has passed.
  • Do not take more than 1 dose of KYNMOBI every 2 hours.
  • Do not take more than 5 doses of KYNMOBI each day.
How to store KYNMOBI
  • Store KYNMOBI at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep KYNMOBI in the foil pouch until you are ready to take it.
  • Keep KYNMOBI and all medicines out of the reach of children.
How KYNMOBI is packaged Inside each child-resistant carton is a plastic tray with a pull-out handle that holds the sealed pouches of KYNMOBI sublingual film (see Figure A). Each KYNMOBI sublingual film comes in a sealed foil pouch (see Figure B).
Figure A
(click image for full-size original)
Figure B Figure B
ATTENTION: Read the Instructions for Use on the other side of this leaflet.

Figure

INSTRUCTIONS FOR USE
Instructions on How to Use the Child-Resistant Carton
STEP 1 Open CartonOpen carton from the end with the arrow. Push in both tabs to unlock. Hold tabs in. (See Figure C.)Lift up tray handle. Pull out tray (see Figure D). STEP 2 Remove PouchPush finger up through the hole in the bottom of tray. (See Figure E.)Firmly pull one (1) pouch from the tray (see Figure F). STEP 3 Close CartonTo close, slide tray in until it clicks. (See Figure G.)This ensures the carton remains child resistant (see Figure H).
Figure C
Figure D
Figure E
Figure C Figure E Figure G
Figure F
Figure G
Figure H
Figure D Figure F Figure H
Instructions for Taking KYNMOBI
Step 4
  • Your healthcare provider has told you to take KYNMOBI 10 mg, 15 mg, 20 mg, 25 mg, or 30 mg. Complete Steps 5 through 10 to take KYNMOBI.
Step 5 Drink water. Before taking each KYNMOBI, drink water to moisten your mouth. This helps the film dissolve more easily (see Figure I).Step 6 Open the KYNMOBI foil pouch. Hold the wing tabs on the pouch between your thumb and pointer finger of each hand. Make sure to place your fingers directly on the raised dots on each wing tab.Gently pull the wing tabs apart to open the pouch (see Figure J). Step 7 Take KYNMOBI out of the pouch. Hold KYNMOBI between your fingers by the outside edges and remove the entire KYNMOBI from the pouch (see Figure K).KYNMOBI must be taken whole. Throw away KYNMOBI if it is broken or missing pieces. Use a new KYNMOBI for your dose.
Figure I
Figure I
Figure K
Figure K
Figure J
Figure J
Step 8 Place entire KYNMOBI under your tongue. Place KYNMOBI as far back under your tongue as you can (see Figure L).Close your mouth.Step 9 Keep KYNMOBI in place until it has completely dissolved (see Figure M).
  • Do not chew or swallow KYNMOBI.
  • Do not swallow your saliva or talk while KYNMOBI is dissolving because this can affect how well the medicine in KYNMOBI is absorbed.
Step 10 Open your mouth to check if KYNMOBI has completely dissolved. It can take about 3 minutes for KYNMOBI to dissolve.After the film completely dissolves, you may swallow.
Figure L
Figure L Figure M
Figure M
For assistance with the KYNMOBI child-resistant carton, please ask your care partner for help.You may also contact your doctor or Sunovion Customer Service at 1-888-394-7377 with questions or for support.This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Manufactured for Sunovion Pharmaceuticals Inc. Marlborough, Massachusetts 01752 USA.KYNMOBI and Figure
are trademarks of Sunovion Pharmaceuticals Inc.SUNOVION and Figure
are registered trademarks of Sumitomo Dainippon Pharma Co. Ltd. Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon Pharma Co. Ltd.©2020 Sunovion Pharmaceuticals Inc. All rights reserved.Issued 5/202010414-01

(See reverse side for additional information)

PRINCIPAL DISPLAY PANEL – TRADE POUCH LABEL – 10 mg

NDC 63402-010-01 1 sublingual film

KYNMOBI

(apomorphine HCl) sublingual film

10 mg

For Sublingual Use Only

Rx only

SUNOVION

PRINCIPAL DISPLAY PANEL – TRADE POUCH LABEL – 10 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – TRADE POUCH LABEL – 15 mg

NDC 63402-015-01 1 sublingual film

KYNMOBI

(apomorphine HCl) sublingual film

15 mg

For Sublingual Use Only

Rx only

SUNOVION

PRINCIPAL DISPLAY PANEL – TRADE POUCH LABEL – 15 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – TRADE POUCH LABEL – 20 mg

NDC 63402-020-01 1 sublingual film

KYNMOBI

(apomorphine HCl) sublingual film

20 mg

For Sublingual Use Only

Rx only

SUNOVION

PRINCIPAL DISPLAY PANEL – TRADE POUCH LABEL – 20 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – TRADE POUCH LABEL – 25 mg

NDC 63402-025-01 1 sublingual film

KYNMOBI

(apomorphine HCl) sublingual film

25 mg

For Sublingual Use Only

Rx only

SUNOVION

PRINCIPAL DISPLAY PANEL – TRADE POUCH LABEL – 25 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – TRADE POUCH LABEL – 30 mg

NDC 63402-030-01 1 sublingual film

KYNMOBI

(apomorphine HCl) sublingual film

30 mg

For Sublingual Use Only

Rx only

SUNOVION

PRINCIPAL DISPLAY PANEL – TRADE POUCH LABEL – 30 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – TRADE CARTON – 10 mg

NDC 63402-010-30 30 pouches each containing 1 sublingual film

KYNMOBI

(apomorphine HCl) sublingual film

10 mg

For Sublingual Use Only

ATTENTION DISPENSER:

Each time KYNMOBI is dispensed give the patient the Instructions for Use, also provided at www.kynmobi.com/cr-ifu.pdf

Rx only

SUNOVION

PRINCIPAL DISPLAY PANEL – TRADE CARTON – 10 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – TRADE CARTON – 15 mg

NDC 63402-015-30 30 pouches each containing 1 sublingual film

KYNMOBI

(apomorphine HCl) sublingual film

15 mg

For Sublingual Use Only

ATTENTION DISPENSER:

Each time KYNMOBI is dispensed give the patient the Instructions for Use, also provided at www.kynmobi.com/cr-ifu.pdf

Rx only

SUNOVION

PRINCIPAL DISPLAY PANEL – TRADE CARTON – 15 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – TRADE CARTON – 20 mg

NDC 63402-020-30 30 pouches each containing 1 sublingual film

KYNMOBI

(apomorphine HCl) sublingual film

20 mg

For Sublingual Use Only

ATTENTION DISPENSER:

Each time KYNMOBI is dispensed give the patient the Instructions for Use, also provided at www.kynmobi.com/cr-ifu.pdf

Rx only

SUNOVION

PRINCIPAL DISPLAY PANEL – TRADE CARTON – 20 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – TRADE CARTON – 25 mg

NDC 63402-025-30 30 pouches each containing 1 sublingual film

KYNMOBI

(apomorphine HCl) sublingual film

25 mg

For Sublingual Use Only

ATTENTION DISPENSER:

Each time KYNMOBI is dispensed give the patient the Instructions for Use, also provided at www.kynmobi.com/cr-ifu.pdf

Rx only

SUNOVION

PRINCIPAL DISPLAY PANEL – TRADE CARTON – 25 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – TRADE CARTON – 30 mg

NDC 63402-030-30 30 pouches each containing 1 sublingual film

KYNMOBI

(apomorphine HCl) sublingual film

30 mg

For Sublingual Use Only

ATTENTION DISPENSER:

Each time KYNMOBI is dispensed give the patient the Instructions for Use, also provided at www.kynmobi.com/cr-ifu.pdf

Rx only

SUNOVION

PRINCIPAL DISPLAY PANEL – TRADE CARTON – 30 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – TRADE OUTER TITRATION CARTON – 10 mg, 15 mg, 20 mg, 25 mg, 30 mg

NDC 63402-088-10 10 pouches each containing 1 sublingual film

KYNMOBI

(apomorphine HCl) sublingual film

10 mg 15 mg 20 mg 25 mg 30 mg

For Sublingual Use Only

Rx only

READ THE INSTRUCTIONS INSIDE THE TOP PANEL AND READ THE COMPLETE INSTRUCTIONS FOR USE BEFORE TAKING KYNMOBITM

SUNOVION

PRINCIPAL DISPLAY PANEL – TRADE OUTER TITRATION CARTON – 10 mg, 15 mg, 20 mg, 25 mg, 30 mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – TRADE OUTER TITRATION CARTON – 10 mg, 15 mg, 20 mg, 25 mg, 30 mg

NDC 63402-188-10 10 pouches each containing 1 sublingual film

PROFESSIONAL SAMPLE – NOT FOR SALE OR REIMBURSEMENT

KYNMOBI

(apomorphine HCl) sublingual film

10 mg 15 mg 20 mg 25 mg 30 mg

For Sublingual Use Only

Rx only

READ THE INSTRUCTIONS INSIDE THE TOP PANEL AND READ THE COMPLETE INSTRUCTIONS FOR USE BEFORE TAKING KYNMOBITM.

CONTENTS OF THIS KIT:

KYNMOBI 10 mg: 2 pouches, each containing 1 sublingual film
KYNMOBI 15 mg: 2 pouches, each containing 1 sublingual film
KYNMOBI 20 mg: 2 pouches, each containing 1 sublingual film
KYNMOBI 25 mg: 2 pouches, each containing 1 sublingual filmKYNMOBI 30 mg: 2 pouches, each containing 1 sublingual film

SUNOVION

PRINCIPAL DISPLAY PANEL – TRADE OUTER TITRATION CARTON – 10 mg, 15 mg, 20 mg, 25 mg, 30 mg
(click image for full-size original)
KYNMOBI apomorphine hydrochloride film, soluble
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63402-010
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
apomorphine hydrochloride (apomorphine) apomorphine hydrochloride 10 mg
Inactive Ingredients
Ingredient Name Strength
Pyridoxine hydrochloride
sodium hydroxide
sodium metabisulfite
edetate disodium
menthol
glyceryl monostearate
Glycerin
maltodextrin
Sucralose
Hydroxyethyl cellulose (280 MPA.S AT 2%)
hydroxyethyl cellulose (140 MPA.S AT 5%)
hydroxypropyl cellulose (45000 wamw)
FD&C Blue no. 1
water
acetone
alcohol
Product Characteristics
Color blue (blue) Score no score
Shape RECTANGLE (RECTANGLE) Size 22mm
Flavor Imprint Code 10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63402-010-30 30 POUCH in 1 CARTON contains a POUCH (63402-010-01)
1 NDC:63402-010-01 1 FILM, SOLUBLE in 1 POUCH This package is contained within the CARTON (63402-010-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210875 05/21/2020
KYNMOBI apomorphine hydrochloride film, soluble
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63402-110
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
apomorphine hydrochloride (apomorphine) apomorphine hydrochloride 10 mg
Inactive Ingredients
Ingredient Name Strength
Pyridoxine hydrochloride
sodium hydroxide
sodium metabisulfite
edetate disodium
menthol
glyceryl monostearate
Glycerin
maltodextrin
Sucralose
Hydroxyethyl cellulose (280 MPA.S AT 2%)
hydroxyethyl cellulose (140 MPA.S AT 5%)
hydroxypropyl cellulose (45000 wamw)
FD&C Blue no. 1
water
acetone
alcohol
Product Characteristics
Color blue (blue) Score no score
Shape RECTANGLE (RECTANGLE) Size 22mm
Flavor Imprint Code 10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63402-110-30 30 POUCH in 1 CARTON contains a POUCH (63402-110-01)
1 NDC:63402-110-01 1 FILM, SOLUBLE in 1 POUCH This package is contained within the CARTON (63402-110-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210875 05/21/2020
KYNMOBI apomorphine hydrochloride film, soluble
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63402-015
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
apomorphine hydrochloride (apomorphine) apomorphine hydrochloride 15 mg
Inactive Ingredients
Ingredient Name Strength
Pyridoxine hydrochloride
sodium hydroxide
sodium metabisulfite
edetate disodium
menthol
glyceryl monostearate
Glycerin
maltodextrin
Sucralose
Hydroxyethyl cellulose (280 MPA.S AT 2%)
hydroxyethyl cellulose (140 MPA.S AT 5%)
hydroxypropyl cellulose (45000 wamw)
FD&C Blue no. 1
water
acetone
alcohol
Product Characteristics
Color blue (blue) Score no score
Shape RECTANGLE (RECTANGLE) Size 22mm
Flavor Imprint Code 15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63402-015-30 30 POUCH in 1 CARTON contains a POUCH (63402-015-01)
1 NDC:63402-015-01 1 FILM, SOLUBLE in 1 POUCH This package is contained within the CARTON (63402-015-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210875 05/21/2020
KYNMOBI apomorphine hydrochloride film, soluble
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63402-115
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
apomorphine hydrochloride (apomorphine) apomorphine hydrochloride 15 mg
Inactive Ingredients
Ingredient Name Strength
Pyridoxine hydrochloride
sodium hydroxide
sodium metabisulfite
edetate disodium
menthol
glyceryl monostearate
Glycerin
maltodextrin
Sucralose
Hydroxyethyl cellulose (280 MPA.S AT 2%)
hydroxyethyl cellulose (140 MPA.S AT 5%)
hydroxypropyl cellulose (45000 wamw)
FD&C Blue no. 1
water
acetone
alcohol
Product Characteristics
Color blue (blue) Score no score
Shape RECTANGLE (RECTANGLE) Size 22mm
Flavor Imprint Code 15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63402-115-30 30 POUCH in 1 CARTON contains a POUCH (63402-115-01)
1 NDC:63402-115-01 1 FILM, SOLUBLE in 1 POUCH This package is contained within the CARTON (63402-115-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210875 05/21/2020
KYNMOBI apomorphine hydrochloride film, soluble
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63402-020
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
apomorphine hydrochloride (apomorphine) apomorphine hydrochloride 20 mg
Inactive Ingredients
Ingredient Name Strength
Pyridoxine hydrochloride
sodium hydroxide
sodium metabisulfite
edetate disodium
menthol
glyceryl monostearate
Glycerin
maltodextrin
Sucralose
Hydroxyethyl cellulose (280 MPA.S AT 2%)
hydroxyethyl cellulose (140 MPA.S AT 5%)
hydroxypropyl cellulose (45000 wamw)
FD&C Blue no. 1
water
acetone
alcohol
Product Characteristics
Color blue (blue) Score no score
Shape RECTANGLE (RECTANGLE) Size 22mm
Flavor Imprint Code 20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63402-020-30 30 POUCH in 1 CARTON contains a POUCH (63402-020-01)
1 NDC:63402-020-01 1 FILM, SOLUBLE in 1 POUCH This package is contained within the CARTON (63402-020-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210875 05/21/2020
KYNMOBI apomorphine hydrochloride film, soluble
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63402-120
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
apomorphine hydrochloride (apomorphine) apomorphine hydrochloride 20 mg
Inactive Ingredients
Ingredient Name Strength
Pyridoxine hydrochloride
sodium hydroxide
sodium metabisulfite
edetate disodium
menthol
glyceryl monostearate
Glycerin
maltodextrin
Sucralose
Hydroxyethyl cellulose (280 MPA.S AT 2%)
hydroxyethyl cellulose (140 MPA.S AT 5%)
hydroxypropyl cellulose (45000 wamw)
FD&C Blue no. 1
water
acetone
alcohol
Product Characteristics
Color blue (blue) Score no score
Shape RECTANGLE (RECTANGLE) Size 22mm
Flavor Imprint Code 20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63402-120-30 30 POUCH in 1 CARTON contains a POUCH (63402-120-01)
1 NDC:63402-120-01 1 FILM, SOLUBLE in 1 POUCH This package is contained within the CARTON (63402-120-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210875 05/21/2020
KYNMOBI apomorphine hydrochloride film, soluble
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63402-025
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
apomorphine hydrochloride (apomorphine) apomorphine hydrochloride 25 mg
Inactive Ingredients
Ingredient Name Strength
Pyridoxine hydrochloride
sodium hydroxide
sodium metabisulfite
edetate disodium
menthol
glyceryl monostearate
Glycerin
maltodextrin
Sucralose
Hydroxyethyl cellulose (280 MPA.S AT 2%)
hydroxyethyl cellulose (140 MPA.S AT 5%)
hydroxypropyl cellulose (45000 wamw)
FD&C Blue no. 1
water
acetone
alcohol
Product Characteristics
Color blue (blue) Score no score
Shape RECTANGLE (RECTANGLE) Size 22mm
Flavor Imprint Code 25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63402-025-30 30 POUCH in 1 CARTON contains a POUCH (63402-025-01)
1 NDC:63402-025-01 1 FILM, SOLUBLE in 1 POUCH This package is contained within the CARTON (63402-025-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210875 05/21/2020
KYNMOBI apomorphine hydrochloride film, soluble
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63402-125
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
apomorphine hydrochloride (apomorphine) apomorphine hydrochloride 25 mg
Inactive Ingredients
Ingredient Name Strength
Pyridoxine hydrochloride
sodium hydroxide
sodium metabisulfite
edetate disodium
menthol
glyceryl monostearate
Glycerin
maltodextrin
Sucralose
Hydroxyethyl cellulose (280 MPA.S AT 2%)
hydroxyethyl cellulose (140 MPA.S AT 5%)
hydroxypropyl cellulose (45000 wamw)
FD&C Blue no. 1
water
acetone
alcohol
Product Characteristics
Color blue (blue) Score no score
Shape RECTANGLE (RECTANGLE) Size 22mm
Flavor Imprint Code 25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63402-125-30 30 POUCH in 1 CARTON contains a POUCH (63402-125-01)
1 NDC:63402-125-01 1 FILM, SOLUBLE in 1 POUCH This package is contained within the CARTON (63402-125-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210875 05/21/2020
KYNMOBI apomorphine hydrochloride film, soluble
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63402-030
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
apomorphine hydrochloride (apomorphine) apomorphine hydrochloride 30 mg
Inactive Ingredients
Ingredient Name Strength
Pyridoxine hydrochloride
sodium hydroxide
sodium metabisulfite
edetate disodium
menthol
glyceryl monostearate
Glycerin
maltodextrin
Sucralose
Hydroxyethyl cellulose (280 MPA.S AT 2%)
hydroxyethyl cellulose (140 MPA.S AT 5%)
hydroxypropyl cellulose (45000 wamw)
FD&C Blue no. 1
water
acetone
alcohol
Product Characteristics
Color blue (blue) Score no score
Shape RECTANGLE (RECTANGLE) Size 26mm
Flavor Imprint Code 30
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63402-030-30 30 POUCH in 1 CARTON contains a POUCH (63402-030-01)
1 NDC:63402-030-01 1 FILM, SOLUBLE in 1 POUCH This package is contained within the CARTON (63402-030-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210875 05/21/2020
KYNMOBI apomorphine hydrochloride film, soluble
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63402-130
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
apomorphine hydrochloride (apomorphine) apomorphine hydrochloride 30 mg
Inactive Ingredients
Ingredient Name Strength
Pyridoxine hydrochloride
sodium hydroxide
sodium metabisulfite
edetate disodium
menthol
glyceryl monostearate
Glycerin
maltodextrin
Sucralose
Hydroxyethyl cellulose (280 MPA.S AT 2%)
hydroxyethyl cellulose (140 MPA.S AT 5%)
hydroxypropyl cellulose (45000 wamw)
FD&C Blue no. 1
water
acetone
alcohol
Product Characteristics
Color blue (blue) Score no score
Shape RECTANGLE (RECTANGLE) Size 26mm
Flavor Imprint Code 30
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63402-130-30 30 POUCH in 1 CARTON contains a POUCH (63402-130-01)
1 NDC:63402-130-01 1 FILM, SOLUBLE in 1 POUCH This package is contained within the CARTON (63402-130-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210875 05/21/2020
KYNMOBI apomorphine hydrochloride kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63402-088
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63402-088-10 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 2 POUCH 2
Part 2 2 POUCH 2
Part 3 2 POUCH 2
Part 4 2 POUCH 2
Part 5 2 POUCH 2
Part 1 of 5
KYNMOBI apomorphine hydrochloride film, soluble
Product Information
Item Code (Source) NDC:63402-010
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
apomorphine hydrochloride (apomorphine) apomorphine hydrochloride 10 mg
Inactive Ingredients
Ingredient Name Strength
Pyridoxine hydrochloride
sodium hydroxide
sodium metabisulfite
edetate disodium
menthol
glyceryl monostearate
Glycerin
maltodextrin
Sucralose
Hydroxyethyl cellulose (280 MPA.S AT 2%)
hydroxyethyl cellulose (140 MPA.S AT 5%)
hydroxypropyl cellulose (45000 wamw)
FD&C Blue no. 1
water
acetone
alcohol
Product Characteristics
Color blue (blue) Score no score
Shape RECTANGLE (RECTANGLE) Size 22mm
Flavor Imprint Code 10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63402-010-02 2 POUCH in 1 CARTON contains a POUCH (63402-010-01)
1 NDC:63402-010-01 1 FILM, SOLUBLE in 1 POUCH This package is contained within the CARTON (63402-010-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210875 05/21/2020
Part 2 of 5
KYNMOBI apomorphine hydrochloride film, soluble
Product Information
Item Code (Source) NDC:63402-015
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
apomorphine hydrochloride (apomorphine) apomorphine hydrochloride 15 mg
Inactive Ingredients
Ingredient Name Strength
Pyridoxine hydrochloride
sodium hydroxide
sodium metabisulfite
edetate disodium
menthol
glyceryl monostearate
Glycerin
maltodextrin
Sucralose
Hydroxyethyl cellulose (280 MPA.S AT 2%)
hydroxyethyl cellulose (140 MPA.S AT 5%)
hydroxypropyl cellulose (45000 wamw)
FD&C Blue no. 1
water
acetone
alcohol
Product Characteristics
Color blue (blue) Score no score
Shape RECTANGLE (RECTANGLE) Size 22mm
Flavor Imprint Code 15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63402-015-02 2 POUCH in 1 CARTON contains a POUCH (63402-015-01)
1 NDC:63402-015-01 1 FILM, SOLUBLE in 1 POUCH This package is contained within the CARTON (63402-015-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210875 05/21/2020
Part 3 of 5
KYNMOBI apomorphine hydrochloride film, soluble
Product Information
Item Code (Source) NDC:63402-020
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
apomorphine hydrochloride (apomorphine) apomorphine hydrochloride 20 mg
Inactive Ingredients
Ingredient Name Strength
Pyridoxine hydrochloride
sodium hydroxide
sodium metabisulfite
edetate disodium
menthol
glyceryl monostearate
Glycerin
maltodextrin
Sucralose
Hydroxyethyl cellulose (280 MPA.S AT 2%)
hydroxyethyl cellulose (140 MPA.S AT 5%)
hydroxypropyl cellulose (45000 wamw)
FD&C Blue no. 1
water
acetone
alcohol
Product Characteristics
Color blue (blue) Score no score
Shape RECTANGLE (RECTANGLE) Size 22mm
Flavor Imprint Code 20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63402-020-02 2 POUCH in 1 CARTON contains a POUCH (63402-020-01)
1 NDC:63402-020-01 1 FILM, SOLUBLE in 1 POUCH This package is contained within the CARTON (63402-020-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210875 05/21/2020
Part 4 of 5
KYNMOBI apomorphine hydrochloride film, soluble
Product Information
Item Code (Source) NDC:63402-025
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
apomorphine hydrochloride (apomorphine) apomorphine hydrochloride 25 mg
Inactive Ingredients
Ingredient Name Strength
Pyridoxine hydrochloride
sodium hydroxide
sodium metabisulfite
edetate disodium
menthol
glyceryl monostearate
Glycerin
maltodextrin
Sucralose
Hydroxyethyl cellulose (280 MPA.S AT 2%)
hydroxyethyl cellulose (140 MPA.S AT 5%)
hydroxypropyl cellulose (45000 wamw)
FD&C Blue no. 1
water
acetone
alcohol
Product Characteristics
Color blue (blue) Score no score
Shape RECTANGLE (RECTANGLE) Size 22mm
Flavor Imprint Code 25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63402-025-02 2 POUCH in 1 CARTON contains a POUCH (63402-025-01)
1 NDC:63402-025-01 1 FILM, SOLUBLE in 1 POUCH This package is contained within the CARTON (63402-025-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210875 05/21/2020
Part 5 of 5
KYNMOBI apomorphine hydrochloride film, soluble
Product Information
Item Code (Source) NDC:63402-030
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
apomorphine hydrochloride (apomorphine) apomorphine hydrochloride 30 mg
Inactive Ingredients
Ingredient Name Strength
Pyridoxine hydrochloride
sodium hydroxide
sodium metabisulfite
edetate disodium
menthol
glyceryl monostearate
Glycerin
maltodextrin
Sucralose
Hydroxyethyl cellulose (280 MPA.S AT 2%)
hydroxyethyl cellulose (140 MPA.S AT 5%)
hydroxypropyl cellulose (45000 wamw)
FD&C Blue no. 1
water
acetone
alcohol
Product Characteristics
Color blue (blue) Score no score
Shape RECTANGLE (RECTANGLE) Size 26mm
Flavor Imprint Code 30
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63402-030-02 2 POUCH in 1 CARTON contains a POUCH (63402-030-01)
1 NDC:63402-030-01 1 FILM, SOLUBLE in 1 POUCH This package is contained within the CARTON (63402-030-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210875 05/21/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210875 05/21/2020
KYNMOBI apomorphine hydrochloride kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63402-188
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63402-188-10 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 2 POUCH 2
Part 2 2 POUCH 2
Part 3 2 POUCH 2
Part 4 2 POUCH 2
Part 5 2 POUCH 2
Part 1 of 5
KYNMOBI apomorphine hydrochloride film, soluble
Product Information
Item Code (Source) NDC:63402-110
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
apomorphine hydrochloride (apomorphine) apomorphine hydrochloride 10 mg
Inactive Ingredients
Ingredient Name Strength
Pyridoxine hydrochloride
sodium hydroxide
sodium metabisulfite
edetate disodium
menthol
glyceryl monostearate
Glycerin
maltodextrin
Sucralose
Hydroxyethyl cellulose (280 MPA.S AT 2%)
hydroxyethyl cellulose (140 MPA.S AT 5%)
hydroxypropyl cellulose (45000 wamw)
FD&C Blue no. 1
water
acetone
alcohol
Product Characteristics
Color blue (blue) Score no score
Shape RECTANGLE (RECTANGLE) Size 22mm
Flavor Imprint Code 10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63402-110-01 1 FILM, SOLUBLE in 1 POUCH None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210875 05/21/2020
Part 2 of 5
KYNMOBI apomorphine hydrochloride film, soluble
Product Information
Item Code (Source) NDC:63402-115
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
apomorphine hydrochloride (apomorphine) apomorphine hydrochloride 15 mg
Inactive Ingredients
Ingredient Name Strength
Pyridoxine hydrochloride
sodium hydroxide
sodium metabisulfite
edetate disodium
menthol
glyceryl monostearate
Glycerin
maltodextrin
Sucralose
Hydroxyethyl cellulose (280 MPA.S AT 2%)
hydroxyethyl cellulose (140 MPA.S AT 5%)
hydroxypropyl cellulose (45000 wamw)
FD&C Blue no. 1
water
acetone
alcohol
Product Characteristics
Color blue (blue) Score no score
Shape RECTANGLE (RECTANGLE) Size 22mm
Flavor Imprint Code 15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63402-115-01 1 FILM, SOLUBLE in 1 POUCH None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210875 05/21/2020
Part 3 of 5
KYNMOBI apomorphine hydrochloride film, soluble
Product Information
Item Code (Source) NDC:63402-120
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
apomorphine hydrochloride (apomorphine) apomorphine hydrochloride 20 mg
Inactive Ingredients
Ingredient Name Strength
Pyridoxine hydrochloride
sodium hydroxide
sodium metabisulfite
edetate disodium
menthol
glyceryl monostearate
Glycerin
maltodextrin
Sucralose
Hydroxyethyl cellulose (280 MPA.S AT 2%)
hydroxyethyl cellulose (140 MPA.S AT 5%)
hydroxypropyl cellulose (45000 wamw)
FD&C Blue no. 1
water
acetone
alcohol
Product Characteristics
Color blue (blue) Score no score
Shape RECTANGLE (RECTANGLE) Size 22mm
Flavor Imprint Code 20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63402-120-01 1 FILM, SOLUBLE in 1 POUCH None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210875 05/21/2020
Part 4 of 5
KYNMOBI apomorphine hydrochloride film, soluble
Product Information
Item Code (Source) NDC:63402-125
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
apomorphine hydrochloride (apomorphine) apomorphine hydrochloride 25 mg
Inactive Ingredients
Ingredient Name Strength
Pyridoxine hydrochloride
sodium hydroxide
sodium metabisulfite
edetate disodium
menthol
glyceryl monostearate
Glycerin
maltodextrin
Sucralose
Hydroxyethyl cellulose (280 MPA.S AT 2%)
hydroxyethyl cellulose (140 MPA.S AT 5%)
hydroxypropyl cellulose (45000 wamw)
FD&C Blue no. 1
water
acetone
alcohol
Product Characteristics
Color blue (blue) Score no score
Shape RECTANGLE (RECTANGLE) Size 22mm
Flavor Imprint Code 25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63402-125-01 1 FILM, SOLUBLE in 1 POUCH None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210875 05/21/2020
Part 5 of 5
KYNMOBI apomorphine hydrochloride film, soluble
Product Information
Item Code (Source) NDC:63402-130
Route of Administration SUBLINGUAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
apomorphine hydrochloride (apomorphine) apomorphine hydrochloride 30 mg
Inactive Ingredients
Ingredient Name Strength
Pyridoxine hydrochloride
sodium hydroxide
sodium metabisulfite
edetate disodium
menthol
glyceryl monostearate
Glycerin
maltodextrin
Sucralose
Hydroxyethyl cellulose (280 MPA.S AT 2%)
hydroxyethyl cellulose (140 MPA.S AT 5%)
hydroxypropyl cellulose (45000 wamw)
FD&C Blue no. 1
water
acetone
alcohol
Product Characteristics
Color blue (blue) Score no score
Shape RECTANGLE (RECTANGLE) Size 26mm
Flavor Imprint Code 30
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63402-130-01 1 FILM, SOLUBLE in 1 POUCH None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210875 05/21/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA210875 05/21/2020
Labeler — Sunovion Pharmaceuticals Inc. (131661746)

Revised: 05/2022 Sunovion Pharmaceuticals Inc.

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