Kynmobi
- Generic Name: apomorphine hydrochloride sublingual film
- Brand Name: Kynmobi
Kynmobi (Apomorphine Hydrochloride Sublingual Film) side effects drug center
- Related Drugs
- nausea,
- mouth/throat soft tissue swelling,
- mouth/throat soft tissue pain and numbness and tingling,
- dizziness,
- drowsiness,
- lightheadedness/fainting,
- low blood pressure (hypotension),
- headache,
- runny nose,
- falls,
- fatigue, and
- sweating
- antihypertensive medications,
- vasodilators,v
- dopamine antagonists,
- antiemetics (e.g., ondansetron, granisetron, palonosetron),
- alosetron,
- alcohol, and
- drugs that prolong the QT/QTc interval
- Nausea and Vomiting [see WARNINGS AND PRECAUTIONS]
- Falling Asleep During Activities of Daily Living and Somnolence [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity [see WARNINGS AND PRECAUTIONS]
- Syncope/Hypotension/Orthostatic Hypotension [see WARNINGS AND PRECAUTIONS]
- Oral Mucosal Irritation [see WARNINGS AND PRECAUTIONS]
- Falls [see WARNINGS AND PRECAUTIONS]
- Hallucinations/Psychotic Behavior [see WARNINGS AND PRECAUTIONS]
- Impulse Control/Compulsive Behaviors [see WARNINGS AND PRECAUTIONS]
- Withdrawal-Emergent Hyperpyrexia and Confusion [see WARNINGS AND PRECAUTIONS]
- QTc Prolongation and Potential for Proarrhythmic Effects [see WARNINGS AND PRECAUTIONS]
- Fibrotic Complications [see WARNINGS AND PRECAUTIONS]
- Priapism [see WARNINGS AND PRECAUTIONS]
- Oral Adverse Events [see WARNINGS AND PRECAUTIONS]
What Is Kynmobi?
Kynmobi (apomorphine hydrochloride) is a non-ergoline dopamine agonist indicated for the acute, intermittent treatment of "off" episodes in patients with Parkinson's disease
What Are Side Effects of Kynmobi?
Side effects of Kynmobi include:
Dosage for Kynmobi
The dose range for Kynmobi is 10 mg to 30 mg per dose, administered sublingually, as needed.
Kynmobi In Children
The safety and effectiveness of Kynmobi in pediatric patients have not been established.
What Drugs, Substances, or Supplements Interact with Kynmobi?
Kynmobi may interact with other medicines such as:
Tell your doctor all medications and supplements you use.
Kynmobi During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Kynmobi; it may harm a fetus. It is unknown if Kynmobi passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Kynmobi (apomorphine hydrochloride) Sublingual Film Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Kynmobi Professional Information
SIDE EFFECTS
The following serious adverse reactions are discussed in more detail in the Warnings and Precautions section of labeling:
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 another drug and may not reflect the rates observed in clinical practice.
KYNMOBI safety data presented below is derived from a randomized, double blind, placebo-controlled study in patients with Parkinson’s disease (Study 1) [see Clinical Studies]. Study 1 included a titration phase, in which 141 patients received at least one dose of KYNMOBI, followed by a placebo-controlled 12-week maintenance phase. The mean age of patients in Study 1 was 63 years (range 43 to 86 years); 63% of patients were male, and 93% were Caucasian.
The most common adverse reactions (incidence at least 10% in patients treated with KYNMOBI and with an incidence greater than placebo) were nausea, oral/pharyngeal soft tissue swelling, oral/pharyngeal soft tissue pain and paraesthesia, dizziness, and somnolence.
Adverse reactions led to discontinuation of KYNMOBI in 9% of patients in the titration phase, and 28% of patients in the maintenance phase, compared with 7% of patients on placebo (in the maintenance phase). The most common adverse reactions leading to discontinuation during the maintenance phase were oral/pharyngeal soft tissue swelling, oral mucosal erythema, and nausea/vomiting.
Table 1 presents the adverse reactions that occurred in at least 5% of patients treated with KYNMOBI during the maintenance phase of Study 1, and with an incidence greater than in patients who received placebo.
Table 1: Adverse Reactions Reported by at Least 5% of Patients Treated with KYNMOBI during the Maintenance Phase of Study 1, and with an Incidence Greater than Placebo
| Titration | Maintenance | ||
| KYNMOBI (N=141) % | KYNMOBI (N=54) % | Placebo (N=55) % | |
| Gastrointestinal disorders | |||
| Nausea | 21 | 28 | 4 |
| Oral/pharyngeal soft tissue swelling1 | 1 | 15 | 0 |
| Oral/pharyngeal soft tissue pain and paraesthesia2 | 2 | 13 | 2 |
| Oral ulceration and stomatitis3 | 2 | 7 | 0 |
| Oral mucosal erythema | 4 | 7 | 4 |
| Vomiting | 4 | 7 | 0 |
| Dry mouth | 1 | 6 | 0 |
| Nervous system disorders | |||
| Somnolence | 11 | 13 | 2 |
| Dizziness | 11 | 9 | 0 |
| Headache | 8 | 6 | 0 |
| Respiratory, thoracic, and mediastinal disorders | |||
| Rhinorrhea | 6 | 7 | 0 |
| General disorders and administration site conditions | |||
| Fatigue | 3 | 7 | 0 |
| Injury, poisoning, and procedural complications | |||
| Fall | 4 | 6 | 2 |
| Laceration | 1 | 6 | 0 |
| Skin and subcutaneous tissue disorders | |||
| Hyperhidrosis | 4 | 6 | 4 |
| Immune system disorders | |||
| Hypersensitivity4 | 0 | 6 | 0 |
| 1 Includes lip swelling, lip edema, oropharyngeal swelling, gingival edema, edema mouth, swollen tongue, and pharyngeal edema 2 Includes throat irritation, glossodynia, oral pain, oral paresthesia, oropharyngeal pain, gingival pain, and oral hypoesthesia 3 Includes lip ulceration, oral mucosal blistering, stomatitis, cheilitis, and tongue ulceration 4 Includes hypersensitivity, swelling face, oral allergy syndrome and urticaria | |||
Less Common Adverse Reactions
Other adverse reactions including hallucinations, delusions, and impulse control disorder have been reported in patients treated with KYNMOBI [see WARNINGS AND PRECAUTIONS].
Vital Sign Changes
Blood Pressure
Decreases in blood pressure have been observed in patients treated with KYNMOBI. During the titration phase of Study 1, syncope, pre-syncope, hypotension, or orthostatic hypotension were reported as adverse reaction in 4% of patients treated with KYNMOBI. During the maintenance phase of Study 1, syncope, pre-syncope, hypotension, or orthostatic hypotension were reported as adverse reaction in 2 % of patients treated with KYNMOBI, compared with 0% of patients who received placebo [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].
Read the entire FDA prescribing information for Kynmobi (Apomorphine Hydrochloride Sublingual Film)