KYNMOBI apomorphine hydrochloride
Refer to the “Also Known As” section to reference different products that include the same medication as KYNMOBI.
Drug Basics
Brand Name: KYNMOBI
Generic Name: APOMORPHINE HYDROCHLORIDE
Drug Type: HUMAN PRESCRIPTION DRUG
Route: SUBLINGUAL
Dosage Form: FILM, SOLUBLE
Packager: Sunovion Pharmaceuticals Inc.
Data Current As Of: 2021-04-26
Indications & Usage
KYNMOBI is indicated for the acute, intermittent treatment of “off” episodes in patients with Parkinson's disease (PD).
KYNMOBI is a non-ergoline dopamine agonist indicated for the acute, intermittent treatment of “off” episodes in patients with Parkinson's disease (1)
Drug Abuse & Dependence
controlled substance
KYNMOBI contains apomorphine, which is not a controlled substance.
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 apomorphine. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. In general, these reports for apomorphine consist of patients taking increasing doses of medication in order to achieve a euphoric state.
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)].
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 (5.8)].
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 (5.9)].
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 (5.10)].
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 (5.12)].
Manufactured for:
Sunovion Pharmaceuticals Inc.
Marlborough, Massachusetts 01752 USA
KYNMOBI is a trademark of Sunovion Pharmaceuticals Inc.
SUNOVION and 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.
For more information, go to www.KYNMOBI.com or call Sunovion Customer Service at 1-888-394-7377.
10413-01
This Patient Information has been approved by the U.S. Food and Drug Administration Issued: 5/2020 |
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Patient Information KYNMOBI™ (kin-moe′-bee) (apomorphine hydrochloride) sublingual film |
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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. |
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Do not take KYNMOBI if you are:
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Before you start taking KYNMOBI, tell your healthcare provider about all of your medical conditions, including if you:
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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.
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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?
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What should I avoid while taking KYNMOBI?
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What are the possible side effects of KYNMOBI? KYNMOBI can cause serious side effects, including:
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These signs and symptoms may go away if KYNMOBI treatment is stopped.
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Do not stop taking KYNMOBI or change your dose unless you are told to do so by your healthcare provider.
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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: |
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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. |
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How should I store KYNMOBI?
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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. |
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What are the ingredients in KYNMOBI?
KYNMOBI is a trademark of Sunovion Pharmaceuticals Inc. |
INSTRUCTIONS FOR USE KYNMOBI TM (kin-moe′-bee) (apomorphine hydrochloride) Sublingual Film |
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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
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How to store KYNMOBI | |
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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 ). |
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Figure A |
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Figure B | |
ATTENTION: Read the Instructions for Use on the other side of this leaflet. | |
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INSTRUCTIONS FOR USE | |||||||
Instructions on How to Use the Child-Resistant Carton | |||||||
STEP 1 Open Carton Open 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 Pouch Push 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 Carton To close, slide tray in until it clicks. (See Figure G .) This ensures the carton remains child resistant (see Figure H ). |
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Figure C | Figure E | Figure G | |||||
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Figure D | Figure F | Figure H | |||||
Instructions for Taking KYNMOBI | |||||||
Step 4
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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. |
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Step 8
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Step 9 Keep KYNMOBI in place until it has completely dissolved (see Figure M ).
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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. |
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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. |
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Manufactured for Sunovion Pharmaceuticals Inc. Marlborough, Massachusetts 01752 USA. are trademarks of Sunovion Pharmaceuticals Inc. are registered trademarks of Sumitomo Dainippon Pharma Co. Ltd. Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Sumitomo Dainippon Pharma Co. Ltd. |
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(See reverse side for additional information) |
PRINCIPAL DISPLAY PANEL – TRADE POUCH LABEL – 10 mg
NDC 63402-010-01 1 sublingual film
Apomorphine HCl
sublingual film
10 mg
For Sublingual Use Only
Rx only
SUNOVION
PRINCIPAL DISPLAY PANEL – TRADE POUCH LABEL – 15 mg
NDC 63402-015-01 1 sublingual film
Apomorphine HCl
sublingual film
15 mg
For Sublingual Use Only
Rx only
SUNOVION
PRINCIPAL DISPLAY PANEL – TRADE POUCH LABEL – 20 mg
NDC 63402-020-01 1 sublingual film
Apomorphine HCl
sublingual film
20 mg
For Sublingual Use Only
Rx only
SUNOVION
PRINCIPAL DISPLAY PANEL – TRADE POUCH LABEL – 25 mg
NDC 63402-025-01 1 sublingual film
Apomorphine HCl
sublingual film
25 mg
For Sublingual Use Only
Rx only
SUNOVION
PRINCIPAL DISPLAY PANEL – TRADE POUCH LABEL – 30 mg
NDC 63402-030-01 1 sublingual film
Apomorphine HCl
sublingual film
30 mg
For Sublingual Use Only
Rx only
SUNOVION
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 – 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 – 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 – 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 – 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 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 – SAMPLE 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 film
KYNMOBI 30 mg: 2 pouches, each containing 1 sublingual film
SUNOVION
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