Xeomin

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 8/30/2021
Xeomin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Xeomin?

Xeomin (incobotulinumtoxinA) is botulinum toxin type A used to treat cervical dystonia (severe spasms in the neck muscles), and also to treat certain eye muscle conditions caused by nerve disorders. This includes uncontrolled blinking or spasm of the eyelids, and a condition in which the eyes do not point in the same direction.

What Are Side Effects of Xeomin?

Common side effects include:

  • neck pain
  • dry eyes
  • headache
  • tired feeling
  • diarrhea
  • eyelid swelling or bruising
  • blinking less than usual
  • pain, redness, or swelling where the injection was given

Dosage for Xeomin

The recommended initial total dose of Xeomin for cervical dystonia is 120 Units.

What Drugs, Substances, or Supplements Interact with Xeomin?

Xeomin may interact with cold or allergy medicines, muscle relaxers, sleeping pills, bronchodilators, bladder or urinary medicines, irritable bowel medicines, blood thinners, or injected antibiotics. Tell your doctor all medications and supplements you use.

Xeomin During Pregnancy and Breastfeeding

It is unknown if Xeomin will harm a fetus. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Additional Information

Our Xeomin (incobotulinumtoxinA) 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.

QUESTION

Medically speaking, the term "myalgia" refers to what type of pain? See Answer
Xeomin Consumer Information

3 pharmacies near 20147 have coupons for Xeomin (Brand Names:Xeomin for 50UNIT)

Walmart Pharmacy
Walmart Pharmacy
$400.99

Est. Regular Price

$260.47

with free coupon

View Coupon
Harris Teeter Pharmacy
Harris Teeter Pharmacy
$400.99

Est. Regular Price

$260.9

with free coupon

View Coupon
CVS Pharmacy
CVS Pharmacy
$400.99

Est. Regular Price

$261.99

with free coupon

View Coupon

Get emergency medical help if you have signs of an allergic reaction: hives; wheezing, difficulty breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

The botulinum toxin contained in this medication can spread to other body areas beyond where it was injected. This has caused serious life-threatening side effects in some people receiving botulinum toxin injections, even for cosmetic purposes.

Call your doctor at once if you have any of these side effects (up to several hours or several weeks after an injection):

  • unusual or severe muscle weakness (especially in a body area that was not injected with the medication);
  • trouble breathing, talking, or swallowing;
  • hoarse voice, drooping eyelids;
  • blurred vision, double vision;
  • seizure;
  • vision changes, eye pain or irritation;
  • wheezing, tightness in your chest;
  • eyelid swelling, crusting or drainage from your eyes, problems with vision;
  • feeling like you might pass out; or
  • loss of strength, loss of bladder control.

Common side effects may include:

  • pain where the medicine was injected;
  • dry mouth, tooth problems;
  • muscle weakness;
  • vision problems;
  • trouble swallowing;
  • dry eyes, drooping eyelids;
  • headache, neck pain, body aches;
  • a seizure;
  • increased blood pressure;
  • diarrhea; or
  • cold symptoms such as stuffy nose, sneezing, sore throat, cough, and chest congestion.

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.

Read the entire detailed patient monograph for Xeomin (Incobotulinumtoxin A for Injection)

SLIDESHOW

Back Pain: 16 Back Pain Truths and Myths See Slideshow
Xeomin Professional Information

SIDE EFFECTS

The following adverse reactions to XEOMIN are discussed in greater detail in other sections of the labeling:

  • Spread of Effects from Toxin [see WARNINGS AND PRECAUTIONS]
  • Lack of Interchangeability between Botulinum Toxin Products [see WARNINGS AND PRECAUTIONS]
  • Hypersensitivity Reactions [see WARNINGS AND PRECAUTIONS]
  • Dysphagia and Breathing Difficulties [see WARNINGS AND PRECAUTIONS]
  • Corneal Exposure, Corneal Ulceration, and Ectropion in Patients Treated with XEOMIN for Blepharospasm [see WARNINGS AND PRECAUTIONS]
  • Risk of Ptosis in Patients Treated for Glabellar Lines [see WARNINGS AND PRECAUTIONS]
  • Human Albumin and Transmission of Viral Diseases [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 rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Chronic Sialorrhea

Chronic Sialorrhea In Adult Patients

Table 6 lists the adverse reactions that occurred in ≥3% of XEOMIN-treated patients in the double-blind, placebo-controlled phase of the study in adult patients with chronic sialorrhea [see Clinical Studies]. The most common adverse reactions (≥4%) were tooth extraction, dry mouth, diarrhea, and hypertension. In the controlled portion of this study, 74 patients received 100 Units of XEOMIN, and 36 patients received placebo. XEOMIN-treated patients were 21-80 years old (mean 65 years), and were predominantly male (71%) and White (99.5%).

Table 6: Adverse Reactions (≥3%) and Greater for XEOMIN than Placebo: Double-Blind Phase of the Placebo-Controlled Adult Chronic Sialorrhea Study

Adverse Reaction XEOMIN 100 Units
(N = 74) %
Placebo
(N = 36) %
Tooth extraction 5 0
Dry mouth 4 0
Diarrhea 4 3
Hypertension 4 3
Fall 3 0
Bronchitis 3 0
Dysphonia 3 0
Back pain 3 0
Dry eye 3 0

Chronic Sialorrhea In Pediatric Patients

Table 7 lists the adverse reactions that occurred in ≥1% of XEOMIN-treated patients 6-17 years of age in the double-blind, placebo-controlled portion of the study in pediatric patients with chronic sialorrhea [see Clinical Studies]. Of the patients 6-17 years of age, 148 patients received a dose of XEOMIN according to body weight, and 72 patients received placebo. Thirty-five patients 2-5 years of age received an open-label dose of XEOMIN according to body weight. XEOMIN-treated patients were 2-17 years of age (mean 10 years), predominately male (63%) and White (100%).

Table 7: Adverse Reactions (≥1%) and Greater for XEOMIN than Placebo: Double-Blind Phase of the Placebo-Controlled Pediatric Chronic Sialorrhea Study

Adverse Reaction XEOMIN (6-17 years)
(N = 148) %
Placebo (6-17 years)
(N = 72) %
Bronchitis 1 0
Headache 1 0
Nausea/Vomiting 1 0

The most frequently reported adverse reaction in patients ages 2-5 years after XEOMIN injections was nasopharyngitis (6%).

In the open-label extension period, 222 patients 2-17 years of age received up to three additional treatments with XEOMIN every 16±2 weeks. The safety profile of XEOMIN during the open-label extension period was similar to that observed in the double-blind phase of the placebo-controlled pediatric chronic sialorrhea study.

Upper Limb Spasticity

Upper Limb Spasticity In Adult Patients

Table 8 lists the adverse reactions that occurred in ≥2% of XEOMIN-treated patients in two placebo-controlled studies in adult patients with upper limb spasticity. Study 1 and Study 2 were both double-blind, placebo-controlled studies, with an open-label extension [see Clinical Studies]. In the controlled portion of these studies, 283 patients received ≥120 Units to 400 Units, of which 217 patients received at least 400 Units of XEOMIN, and 182 patients received placebo. XEOMIN-treated patients were 20-79 years of age (mean 56 years), and were predominantly male (58%), and White (84%).

Table 8: Adverse Reactions (≥2%) and Greater for XEOMIN than Placebo: Double-Blind Phase of Placebo-Controlled Adult Upper Limb Spasticity Study 1 and Study 2

Adverse Reaction XEOMIN 400 Units
(N = 217) %
Placebo
(N = 182) %
Seizure 3 0
Nasopharyngitis 2 0
Dry mouth 2 1
Upper respiratory tract infection 2 1

Upper Limb Spasticity In Pediatric Patients

Table 9 lists the adverse reactions that occurred in ≥2% of XEOMIN-treated patients in Study 1 in pediatric patients 2 years of age and older with upper limb spasticity. In the controlled portion of Study 1, 350 patients were randomized to one of three doses of XEOMIN: 87 received 2 Units/kg per affected upper limb, 87 received 6 Units/kg per affected upper limb, and 176 received 8 Units/kg per affected upper limb [see Clinical Studies]. XEOMIN-treated patients were 2 to 17 years of age (mean 7 years), 63% were male, and 90% were White.

No relationship between increased dose and increased occurrence of adverse reactions was observed. The most common adverse reactions (≥3% of XEOMIN-treated patients) at the recommended dose of XEOMIN (8 Units/kg) were nasopharyngitis and bronchitis.

Table 9: Adverse Reactions (≥2%) in Patients Treated with XEOMIN 2 Units/kg or 8 Units/kg: Double-Blind Phase of Study 1 in Pediatric Upper Limb Spasticity

Adverse Reactions XEOMIN 2 Units/kg
N=87 %
XEOMIN 8 Units/kg
N=176 %
Infections and infestations
Nasopharyngitis 6 3
Bronchitis 2 3
Pharyngotonsillitis1 2 2
Upper respiratory tract infection 2 2
Respiratory tract infection viral 1 2
Injury, poisoning and procedural complications
Fall 0 2
Musculoskeletal and connective tissue disorders
Pain in extremity 0 2
1 Includes pharyngotonsillitis, pharyngitis and tonsillitis

Cervical Dystonia

The data described below reflect exposure to a single intramuscular dose of XEOMIN in a placebo-controlled, Phase 3 trial in patients with cervical dystonia [see Clinical Studies]. In this study, 159 patients received XEOMIN (78 were randomized to receive a total dose of 120 Units, and 81 were randomized to receive a total dose of 240 Units). XEOMIN-treated patients were 18 to 79 years old (mean 53 years), and were predominantly female (66%) and Caucasian (91%). At study baseline, approximately 25% had mild, 50% had moderate, and 25% had severe cervical dystonia. Approximately 61% of XEOMIN-treated patients had previously received another botulinum toxin type A product. Table 10 lists adverse reactions that occurred in ≥5% of XEOMIN-treated patients (in any treatment group) and greater than placebo.

Table 10: Adverse Reactions (≥5%) and Greater for XEOMIN than Placebo: Double-Blind Phase of the Placebo-Controlled Cervical Dystonia Study

Adverse Reaction XEOMIN 120 Units
(N=77)%
XEOMIN 240 Units
(N=82)%
Placebo
(N=74)%
Musculoskeletal and connective tissue disorders 23 32 11
Neck pain 7 15 4
Muscular weakness 7 11 1
Musculoskeletal pain 7 4 1
Gastrointestinal disorders 18 24 4
Dysphagia 13 18 3
Nervous system disorders 16 17 7
General disorders and administration site conditions 16 11 11
Injection site pain 9 4 7
Infections and infestations 14 13 11
Respiratory, thoracic and mediastinal disorders 13 10 3

Blepharospasm

Study 1 was a randomized, double-blind, placebo-controlled study that only included treatment-naive patients [see Clinical Studies]. In the controlled portion, 22 patients received XEOMIN 25 Units, 19 patients received 50 Units, and 20 patients received placebo. XEOMIN-treated patients were 23 to 78 years of age (mean 55 years). Fifty-nine percent of the patients were women, 77% were Asian, and 23% White. No patients withdrew prematurely because of an adverse event. Table 11 lists the adverse reactions that occurred in ≥6% of XEOMIN-treated patients and greater than placebo.

Table 11: Adverse Reactions (≥6%) and Greater for XEOMIN than Placebo: Double-Blind Phase of the Placebo-Controlled Blepharospasm Study 1

Adverse Reaction XEOMIN 50 U
(N=19)%
Placebo
(N=20)%
Eye disorders 21 10
Eyelid ptosis 16 0

Study 2 was a double-blind, placebo-controlled, flexible dose study with an open-label extension (OLEX) period. The study only included patients previously treated with onabotulinumtoxinA (Botox) [see Clinical Studies]. In the controlled portion, 74 patients received XEOMIN at a mean dose of approximately 33 Units per eye (minimum 10 Units, maximum 50 Units). XEOMIN-treated patients were 22 to 79 years of age (mean 62 years), predominantly female (65%) and Caucasian (60%). Table 12 lists the adverse reactions that occurred in ≥5% of XEOMIN-treated patients and greater than placebo.

Table 12: Adverse Reactions (≥5%) and Greater for XEOMIN than Placebo: Double-Blind Phase of the Placebo-Controlled Blepharospasm Study 2

Adverse Reaction XEOMIN
(N=74)%
Placebo
(N=34)%
Eye disorders 38 21
Eyelid ptosis 19 9
Dry eye 16 12
Visual impairment* 12 6
Gastrointestinal disorders 30 15
Dry mouth 16 3
Diarrhea 8 0
Infections and infestations 20 15
Nasopharyngitis 5 3
Respiratory tract infection 5 3
Nervous system disorders 14 9
Headache 7 3
General disorders and administration site conditions 11 9
Respiratory, thoracic and mediastinal disorders 11 3
Dyspnea 5 3
*including vision blurred

Glabellar Lines

In three placebo-controlled trials in 803 subjects with glabellar lines, 535 subjects received a single dose of 20 Units XEOMIN and 268 subjects received placebo. XEOMIN-treated subjects were 24 to 74 years old, and were predominantly female (88%). The most frequent adverse reactions in XEOMIN-treated subjects were: headache (5%), facial paresis (0.7%), injection site hematoma (0.6%) and eyelid edema (0.4%). Four serious adverse events occurred in two placebo-treated subjects. Six XEOMIN treated subjects experienced six serious adverse events. All serious adverse events were assessed as unrelated to study drug.

The adverse reactions below reflect exposure to XEOMIN with glabellar lines in placebo-controlled studies. Adverse reactions are adverse events in which there is some basis to believe there is a causal relationship between the drug and the occurrence of the adverse event.

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 rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Table 13: Adverse Reactions in Placebo-Controlled Glabellar Lines Trials

Adverse Reaction XEOMIN
(N=535) %
Placebo
(N=268) %
Nervous system disorders 6 2
Headache 5 2
Facial paresis (brow ptosis) 0.7 0
General disorders and administration site conditions 0.9 0.7
Injection site hematoma 0.6 0
Injection site pain 0.2 0
Facial pain 0.2 0
Injection site swelling Sensation of pressure 0 0 0.4 0.4
Eye disorders 0.9 0
Eyelid edema 0.4 0
Blepharospasm 0.2 0
Eye disorder 0.2 0
Eyelid ptosis 0.2 0

In open-label, multiple-dose trials, adverse reactions were reported for 105 of the 800 subjects (13%). Headache was the most common adverse reaction, reported in 7% of subjects, followed by injection site hematoma (1%). Adverse reactions reported in less than 1% of subjects were: facial paresis (brow ptosis), muscle disorder (elevation of eyebrow), injection site pain, and eyelid edema.

Immunogenicity

As with all therapeutic proteins, there is a potential for immunogenicity.

The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other botulinumtoxinA products may be misleading.

Of the 2649 patients treated with XEOMIN in clinical trials [see Clinical Studies], 9 (0.3%) patients were positive for neutralizing antibodies after treatment whose antibody status at baseline was unknown and 4 (0.2%) additional patients developed neutralizing antibodies after treatment. No patients demonstrated a secondary lack of treatment response due to neutralizing antibodies.

Chronic Sialorrhea

Chronic Sialorrhea In Adult Patients

Of the 180 patients treated with XEOMIN in the main phase and extension period of the adult chronic sialorrhea clinical trial [see Clinical Studies], 1 (0.6%) patient was positive for neutralizing antibodies after treatment. The patient had an antibody status unknown at baseline, and had not received a botulinum toxin treatment in the 12 months prior to enrollment in the study. No patients demonstrated a secondary lack of treatment response due to neutralizing antibodies.

Chronic Sialorrhea In Pediatric Patients

Of the 252 patients treated with XEOMIN in the main phase and open-label extension period of the pediatric chronic sialorrhea clinical trial [see Clinical Studies], antibody measurements were only performed in patients with body weight of 30 kg or more, resulting in 80 patients tested for antibodies at baseline. Three patients tested positive for neutralizing antibodies at baseline and remained positive at the end of the study. No additional patients developed neutralizing antibodies, and none of the patients demonstrated a secondary lack of treatment response.

Upper Limb Spasticity

Upper Limb Spasticity In Adult Patients

Of the 456 patients treated with XEOMIN in the main phase and open-label extension period of the adult upper limb spasticity clinical trials (Study 1 and Study 2) [see Clinical Studies], 4 patients were positive for neutralizing antibodies at baseline, and 2 (0.4%) additional patients (with unknown antibody status at baseline) were positive after treatment. Both patients had not received a botulinum toxin treatment in the 12 months prior to enrollment in the studies. No patients demonstrated a secondary lack of treatment response due to neutralizing antibodies.

Upper Limb Spasticity In Pediatric Patients

Of the 907 patients treated with XEOMIN in clinical trials for treatment of pediatric spasticity [see Clinical Studies], 7 patients were positive for neutralizing antibodies at baseline, and 4 (0.4%) additional patients (with unknown antibody status at baseline) were positive after treatment. All of these patients were treated with onabotulinumtoxinA and/or abobotulinumtoxinA prior to enrollment in the study. Patients who had never received a botulinum toxin treatment did not develop neutralizing antibodies after being treated with XEOMIN. Antibody measurements were not performed in patients with <21 kg body weight. No patients demonstrated a secondary lack of treatment response due to neutralizing antibodies.

Cervical Dystonia

Of the 227 patients treated with XEOMIN in the main phase and open-label extension period of the cervical dystonia clinical trial [see Clinical Studies], 5 patients were positive for neutralizing antibodies at baseline, 1 (0.4%) patient (with unknown antibody status at baseline) was positive after treatment, and 4 (1.8%) additional patients developed neutralizing antibodies after treatment. All of these patients were pre-treated with onabotulinumtoxinA and/or abobotulinumtoxinA prior to enrollment in the study. No patients demonstrated a secondary lack of treatment response due to neutralizing antibodies.

Blepharospasm

Of the 163 patients treated with XEOMIN in the main phase and open-label extension period of the blepharospasm clinical trials (Study 1 and Study 2) [see Clinical Studies], 1 (0.6%) patient (with unknown antibody status at baseline) was positive for neutralizing antibodies after treatment. The patient had not received a botulinum toxin treatment in the 12 months prior to enrollment in the studies. No patients demonstrated a secondary lack of treatment response due to neutralizing antibodies.

Glabellar Frown Lines

Of the 464 patients treated with XEOMIN in the main phase and open-label extension period of the glabellar frown lines clinical trials (GL-1 and GL-2) [see Clinical Studies], no patients developed neutralizing antibodies after treatment. No patients demonstrated a secondary lack of treatment response due to neutralizing antibodies.

Postmarketing Experience

The following adverse reactions have been reported during post-approval use of XEOMIN. 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: eye swelling, eyelid edema, dysphagia, nausea, flu-like symptoms, injection site pain, injection site reaction, allergic dermatitis, localized allergic reactions like swelling, edema, erythema, pruritus or rash, herpes zoster, muscular weakness, muscle spasm, dysarthria, myalgia, and hypersensitivity.

DRUG INTERACTIONS

Aminoglycosides And Other Agents Interfering With Neuromuscular Transmission

Co-administration of XEOMIN and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., tubocurarine-type muscle relaxants) should only be performed with caution as these agents may potentiate the effect of the toxin.

Anticholinergic Drugs

Use of anticholinergic drugs after administration of XEOMIN may potentiate systemic anticholinergic effects.

Other Botulinum Neurotoxin Products

The effect of administering different botulinum toxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.

Muscle Relaxants

Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of XEOMIN.

Read the entire FDA prescribing information for Xeomin (Incobotulinumtoxin A for Injection)

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

Health Solutions From Our Sponsors