Class: Botulinum toxin
- Injection, lyophilized powder for solution 50 units
- Injection, lyophilized powder for solution 100 units
Blocks cholinergic transmission at the neuromuscular junction by inhibiting the release of acetylcholine from peripheral cholinergic nerve endings.
Not expected to be present in peripheral blood at measurable levels following IM injection at recommended doses.
Indications and Usage
Treatment of cervical dystonia in adults to decrease severity of abnormal head position and neck pain; treatment of adults with blepharospasm who were previously treated with onabotulinumtoxinA; for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults.
Known hypersensitivity to the active substance, botulinum neurotoxin type A, or to any of the excipients; infection at the injection site.
Dosage and AdministrationBlepharospasm
IM Initial total dose should be the same dose as the patient's previous treatment of onabotulinumtoxinA. If previous dose is unknown, use 1.25 to 2.5 units per injection site as the initial dose. Total initial dose in both eyes should not exceed 70 units (35 units per eye). Subsequent dosing should be tailored to the individual patient based on response, and should be no more frequent than every 12 wk.Cervical dystonia
IM 120 units initially. Individualize dose and number of injection sites in each treated muscle. Repeat treatments should generally be no more frequent than every 12 wk.Glabellar lines
IM 20 units per treatment session divided into 5 equal IM injections of 4 units each. The 5 injection sites are 2 injections in each corrugator muscle and 1 injection in the procerus muscle. Repeat treatments should generally be no more frequent than every 3 mo.
- The potency units of incobotulinumtoxinA are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of incobotulinumtoxinA cannot be compared with or converted into units of any other botulinum toxin products assessed with any other specific assay method.
- For IM use only. For blepharospasm, a suitable sterile needle (eg, 26-gauge [0.45 mm diameter], 37 mm length for superficial muscles; or 22-gauge [0.7 mm diameter], 75 mm length for injection into deeper muscles) should be used. For cervical dystonia, a suitable sterile needle (eg, 26-gauge [0.45 mm diameter], 37 mm length for superficial muscles; or 22-gauge [0.7 mm diameter], 75 mm length for injection into deeper muscles) should be used. For glabellar lines, a suitable sterile needle (eg, 30- to 33-gauge [0.3 to 0.2 mm diameter], 13 mm length) should be used.
- For cervical dystonia, injections are usually made into the sternocleidomastoid, levator scapulae, splenius capitis, scalenus, and/or trapezius muscle(s). Localization of the involved muscles with electromyographic guidance or nerve stimulation techniques may be useful.
- Reconstitute following manufacturer's guidelines for dilution using sterile, preservative-free sodium chloride 0.9% injection.
- Discard vial if vacuum does not pull diluent into vial.
- If proposed injection sites are marked with a pen, the product must not be injected through the pen marks; otherwise, a permanent tattooing effect may occur.
- The number of injection sites is dependent upon the size of the muscle to be treated and the volume injected.
- Inject carefully when administered at sites close to sensitive structures, such as the carotid artery, lung apices, and esophagus.
- The median first onset of effect occurs within 7 days after injection. Typical duration of effect of each treatment is up to 3 months; however, the effect may last significantly longer, or shorter, in individual patients.
Stored between 68° and 77°F, in a refrigerator between 36° and 46°F, or in a freezer between −4° and 14°F for up to 36 mo. Reconstituted solution should be stored in a refrigerator between 36° and 46°F and administered within 24 h. Discard any reconstituted solution that has been stored for more than 24 h, as well as any unused solution.
Drug InteractionsAminoglycosides, drugs interfering with neuromuscular transmission (eg, lincomycin, quinidine, succinylcholine)
The effects of incobotulinumtoxinA may be potentiated. Use with caution. Closely monitor the patient.Anticholinergic agents (eg, atropine)
Use of anticholinergic agents after incobotulinumtoxinA administration may potentiate systemic anticholinergic effects (eg, blurred vision). Use with caution.Botulinum neurotoxin (eg, botulinum toxin type B)
Administration of a different botulinum neurotoxin at the same time or within several months of each other may exacerbate excessive neuromuscular weakness. Use with caution. Closely monitor the patient.Muscle relaxants (eg, metaxalone)
Excessive weakness may be exaggerated. Use with caution. Closely monitor the patient.Nondepolarizing muscle relaxants (eg, tubocurarine)
Neuromuscular action may be enhanced, resulting in protracted respiratory depression. Use with caution. Closely monitor the patient.
CNS disorders (17%); asthenia (11%); headache (7%); dizziness (5%).
Eye disorders (38%); eyelid ptosis (19%); dry eye (16%); visual impairment (12%); nasopharyngitis (5%); facial paresis (brow ptosis) (1%); eye swelling, eyelid edema (postmarketing).
GI disorders (30%); dysphagia (21%); dry mouth (16%); diarrhea (8%); nausea (postmarketing).
Allergic dermatitis, hypersensitivity, localized allergic reactions, such as swelling, edema, erythema, pruritus, or rash (postmarketing).
Injection-site pain (9%); injection-site hematoma (1%); injection-site reaction (postmarketing).
Musculoskeletal and connective tissue disorders (32%); neck pain (15%); muscle weakness (11%); musculoskeletal pain (7%); dysarthria, muscle spasm, myalgia (postmarketing).
Respiratory, thoracic, and mediastinal disorders (13%); dyspnea, respiratory tract infection (5%).
Infections and infestations (20%); herpes zoster (postmarketing).
The effects of all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, blurred vision, breathing difficulties, diplopia, dysarthria, dysphagia, dysphonia, generalized muscle weakness, ptosis, and urinary incontinence. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life-threatening, and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have occurred at doses comparable with those used to treat cervical dystonia and at lower doses.
Closely monitor patients with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis (ALS), or neuromuscular junction disorders.
Category C .
Safety and efficacy in children younger than 18 y not established.
Serious and/or immediate hypersensitivity reactions have occurred.
Dysphagia and breathing difficulties
May occur within hours to weeks after injection. Dysphagia may persist for several months. Death as a complication of severe dysphagia has been reported. Risk may be increased in patients with smaller neck muscle mass and patients requiring bilateral injections into sternocleidomastoid muscle.
Treatment may cause formation of neutralizing antibodies.
Use in patients with an infection at the injection site could lead to severe local or disseminated infection.
Use with caution in patients with peripheral motor neuropathic disease, ALS, or neuromuscular junctional disorders (eg, myasthenia gravis, Lambert-Eaton syndrome) because of increased risk of systemic effects, including dysphagia and respiratory compromise.
Reduced blinking from injection of the orbicularis muscle can lead to corneal exposure, persistent epithelial defect, and corneal ulceration. To prevent ectropion, do not inject into the medial lower eyelid area. Use with caution in patients at risk of developing narrow angle glaucoma.
May occur. To reduce the complication of ptosis, avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes, and place corrugator injections at least 1 cm above the bony supraorbital ridge.
Transmission of viral disease
Because this product contains albumin, a derivative of human blood, it carries a remote risk of viral disease transmission.
Neuromuscular weakness with a variety of symptoms.
- Advise patients to read the Medication Guide before starting therapy and with each treatment.
- Advise previously immobile or sedentary patients to gradually resume activities following injection.
- Inform patients that injections may cause dyspnea, or mild to severe dysphagia, with the risk of aspiration.
- Counsel patients to avoid driving or engaging in other potentially hazardous activities if loss of strength, muscle weakness, blurred vision, or drooping eyelids occur.
- Inform patients that injections may cause reduced blinking or effectiveness of blinking and that they should seek immediate medical attention if eye pain or irritation occurs following treatment.
- Advise patients to seek immediate medical care if swallowing, speech, or respiratory disorders occur.
Copyright © 2009 Wolters Kluwer Health.
More about incobotulinumtoxinA
- Other brands: Xeomin