Kynmobi Side Effects Center

Last updated on RxList: 9/29/2022
Kynmobi Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

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:

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

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.

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.

SLIDESHOW

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Kynmobi Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed in more detail in the Warnings and Precautions section of labeling:

  • 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]
  • Hemolytic Anemia [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]
  • Retinal Pathology in Albino Rats [see WARNINGS AND PRECAUTIONS]

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 reactions 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 reactions in 2% of patients treated with KYNMOBI, compared with 0% of patients who received placebo [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of apomorphine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hematologic and Lymphatic Systems: Hemolytic anemia [see WARNINGS AND PRECAUTIONS].

DRUG INTERACTIONS

5HT3 Antagonists

Based on reports of profound hypotension and loss of consciousness when subcutaneous apomorphine was administered with ondansetron, the concomitant use of KYNMOBI with 5HT3 antagonists, including antiemetics (e.g., ondansetron, granisetron, palonosetron) and alosetron, is contraindicated [see WARNINGS AND PRECAUTIONS].

Antihypertensive Medications And Vasodilators

In a study of healthy subjects, concomitant administration of 0.4 mg sublingual nitroglycerin with subcutaneous apomorphine caused greater decreases in blood pressure than with subcutaneous apomorphine alone [see CLINICAL PHARMACOLOGY].

Patients taking KYNMOBI should lie down before and after taking sublingual nitroglycerin [see WARNINGS AND PRECAUTIONS].

Alcohol

In a study of healthy subjects, concomitant administration of high-dose (0.6 g/kg) or low-dose (0.3 g/kg) ethanol with subcutaneous apomorphine caused greater decreases in blood pressure than with subcutaneous apomorphine alone [see CLINICAL PHARMACOLOGY].

Patients should avoid drinking alcohol after using KYNMOBI [see WARNINGS AND PRECAUTIONS].

Dopamine Antagonists

Since KYNMOBI is a dopamine agonist, it is possible that concomitant use of dopamine antagonists, such as the neuroleptics (e.g., phenothiazines, butyrophenones, thioxanthenes) or metoclopramide, may diminish the effectiveness of KYNMOBI. Antiemetics with antidopaminergic actions should be avoided [see WARNINGS AND PRECAUTIONS]. Patients with major psychotic disorders receiving neuroleptics should be treated with dopamine agonists only if the potential benefits outweigh the risks [see WARNINGS AND PRECAUTIONS].

Drugs Prolonging The QT/QTc Interval

Caution should be exercised when prescribing KYNMOBI concomitantly with drugs that prolong the QT/QTc interval [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Drug Abuse And 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.

Read the entire FDA prescribing information for Kynmobi (Apomorphine Hydrochloride Sublingual Film)

QUESTION

Parkinson's disease is only seen in people of advanced age. See Answer

© Kynmobi Patient Information is supplied by Cerner Multum, Inc. and Kynmobi Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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