Botulinum toxin type a
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. 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 lower limb spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses [see Warnings and Precautions (5.1) ] . WARNING: DISTANT SPREAD OF TOXIN EFFECT See full prescribing information for complete boxed warning.
The effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. 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, particularly in those patients who have underlying conditions that would predispose them to these symptoms. ( 5.1 )
Acetylcholine Release Inhibitor, Neuromuscular Blocker
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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Instructions for Safe Use The potency Units of XEOMIN for injection are specific to the preparation and assay method utilized. Units of biological activity of XEOMIN cannot be compared to or converted into Units of any other botulinum toxin products assessed with any other specific assay method [see Warnings and Precautions and Description ] .
Reconstituted XEOMIN is intended for intramuscular or intra-salivary gland injection only. Do not exceed the recommended maximum cumulative dose in a treatment session for any indication.
Units/0.1 mL and 5 Units/0.1 mL is recommended [see Dosage and Administration ] . Determine the timing for repeat treatment based on the clinical need of the patient; administer repeat treatments no sooner than every 12 weeks. Most patients in clinical studies were retreated between 12 and 16 weeks. Table 4 includes the recommended dose ranges for the treatment of the clinical patterns of flexed elbow, flexed wrist, pronated forearm, clenched fist, and thumb-in-palm. [See table below.] -2 50 1-2 Biceps 2-3 75 1-3 Brachialis 1-2 50 1-2 Flexed Wrist Flexor carpi radialis 1 25 1 Flexor carpi ulnaris 1 25 1 Pronated Forearm Pronator quadratus 0.5 12.5 1 Pronator teres 1-2 50 1-2 Clenched Fist Flexor digitorum superficialis 1 25 1 Flexor digitorum profundus 1 25 1 Thumb-in-Palm Flexor pollicis longus 1 25 1 Adductor pollicis 0.5 12.5 1 Flexor pollicis brevis/ opponens pollicis 0.5 12.5 1 Figure 4: Muscles Injected for Pediatric Upper Limb Spasticity Figure 4
Preparation and Reconstitution Technique Prior to injection, reconstitute each vial of XEOMIN with sterile, preservative-free 0.9% Sodium Chloride Injection, USP [see Dosage Form and Strengths ] . A 20-27 gauge short bevel needle is recommended for reconstitution. Draw up an appropriate amount of preservative-free 0.9% Sodium Chloride Injection, USP into a syringe (see Table 5 ).
Clean the exposed portion of the rubber stopper of the vial with alcohol (70%) prior to insertion of the needle. After vertical insertion of the needle through the rubber stopper, the vacuum will draw the saline into the vial. Gently inject any remaining saline into the vial to avoid foam formation. If the vacuum does not pull the saline into the vial, then XEOMIN must be discarded.
Remove the syringe from the vial and mix XEOMIN with the saline by carefully swirling and inverting/flipping the vial – do not shake vigorously. Reconstituted XEOMIN is a clear, colorless solution free of particulate matter. Do not use XEOMIN if the reconstituted solution has a cloudy appearance or contains floccular or particulate matter.
After reconstitution, use XEOMIN for only one injection session and for only one patient. Administer reconstituted XEOMIN within 24 hours after dilution. During this time period, store unused reconstituted XEOMIN in the original container in a refrigerator 2°C -8°C (36°F -46°F) for up to 24 hours until time of use. XEOMIN vials are for single-dose only.
Discard any unused portion. Diluent volumes for reconstitution of XEOMIN are indicated in Table 5. [See table below.]
Administration Reconstituted XEOMIN is intended for intramuscular or intra-salivary gland injection only. If proposed injection sites are marked with a pen, DO NOT inject XEOMIN through the pen marks; otherwise a permanent tattooing effect may occur. For intramuscular injections, the number of injection sites is dependent upon the size of the muscle to be treated and the volume of reconstituted XEOMIN injected.
Inject XEOMIN carefully when injected at sites close to sensitive structures, such as the carotid artery, lung apices, and esophagus. Before administering XEOMIN, the healthcare provider should be familiar with the patient's anatomy and any anatomic alterations, e.g., due to prior surgical procedures. Chronic Sialorrhea Chronic Sialorrhea in Adult Patients Use a sterile needle (e.g., 27-30 gauge (0.30-0.40 mm diameter), 12.5 mm length) for intra-salivary gland administration for the treatment of chronic sialorrhea.
Inject XEOMIN close to the center of the gland. The salivary glands can be located using ultrasound imaging or surface anatomical landmarks [see Dosage and Administration ]. Chronic Sialorrhea in Pediatric Patients Use a sterile needle (e.g., 27-30 gauge (0.30-0.40 mm diameter), 12.5 mm length) for intra-salivary gland administration for the treatment of chronic sialorrhea.
Inject XEOMIN close to the center of the gland. Ultrasound guidance is recommended for the localization of the involved salivary glands [see Clinical Studies ] . Upper Limb Spasticity Upper Limb Spasticity in Adult Patients Use a sterile needle (e.g., 26-gauge (0.45 mm diameter), 37 mm length for superficial muscles; or 22-gauge (0.70 mm diameter), 75 mm length for deeper musculature) in the intramuscular administration in the treatment of upper limb spasticity in adults.
Localization of the involved muscles with electromyographic guidance, nerve stimulation, or ultrasound techniques is recommended. Upper Limb Spasticity in Pediatric Patients Use a sterile needle (e.g., 30-gauge (0.30 mm diameter), 25 mm length for superficial muscles; or 27-gauge (0.40 mm diameter), 37 mm length for deeper musculature) in the intramuscular administration in the treatment of upper limb spasticity in pediatric patients.
Localization of the involved muscles with techniques such as electromyographic guidance, nerve stimulation, or ultrasound is recommended. Cervical Dystonia Use a sterile needle (e.g., 26-gauge (0.45 mm diameter), 37 mm length for superficial muscles; or 22-gauge (0.70 mm diameter), 75 mm length for deeper musculature) in the intramuscular administration in the treatment of cervical dystonia.
Localization of the involved muscles with electromyographic guidance, ultrasound, or nerve stimulation techniques may be useful. Blepharospasm Use a sterile needle (e.g., 30-gauge (0.40 mm diameter), 12.5 mm length) in the intramuscular administration in the treatment of blepharospasm. Upper Facial Lines (Glabellar Lines, Horizontal Forehead Lines, and Lateral Canthal Lines) Use a sterile needle [e.g., 30-33 gauge (0.3-0.2 mm diameter)], 13 mm length) for the intramuscular administration in the treatment of upper facial lines.
| Body weight | Parotid gland, each side | Submandibular gland, each side | Total dose, both glands, both sides | ||
|---|---|---|---|---|---|
| Dose per gland | Volume per injection | Dose per gland | Volume per injection | ||
| 12 kg or more to less than 15 kg | 6 Units | 0.24 mL | 4 Units | 0.16 mL | 20 Units |
| 15 kg or more to less than 19 kg | 9 Units | 0.36 mL | 6 Units | 0.24 mL | 30 Units |
| 19 kg or more to less than 23 kg | 12 Units | 0.48 mL | 8 Units | 0.32 mL | 40 Units |
| 23 kg or more to less than 27 kg | 15 Units | 0.6 mL | 10 Units | 0.4 mL | 50 Units |
| 27 kg or more to less than 30 kg | 18 Units | 0.72 mL | 12 Units | 0.48 mL | 60 Units |
| 30 kg or more | 22.5 Units | 0.9 mL | 15 Units | 0.6 mL | 75 Units |
| Volume of preservative-free 0.9% Sodium Chloride Injection, USP | 50 Unit Vial: Resulting dose in Units per 0.1 mL | 100 Unit Vial: Resulting dose in Units per 0.1 mL | 200 Unit Vial: Resulting dose in Units per 0.1 mL |
|---|---|---|---|
| 0.25 mL | 20 Units | - | - |
| 0.5 mL | 10 Units | 20 Units | 40 Units |
| 1 mL | 5 Units | 10 Units | 20 Units |
| 1.25 mL | 4 Units | 8 Units | 16 Units |
| 2 mL | 2.5 Units | 5 Units | 10 Units |
| 2.5 mL | 2 Units | 4 Units | 8 Units |
| 4 mL | 1.25 Units | 2.5 Units | 5 Units |
| 5 mL | 1 Unit | 2 Units | 4 Units |
| 8 mLWhen using 8 mL of diluent for a 100 Unit or 200 Unit vial of XEOMIN, complete the following steps:Reconstitute a 100 Unit or 200 Unit vial of XEOMIN with 4 mL of preservative-free 0.9% Sodium Chloride Injection, USP, following instructions above.Withdraw 4 mL of preservative-free 0.9% Sodium Chloride Injection, USP, into an appropriately sized syringe for 8 mL in total.Using the same syringe, draw up the 4 mL of XEOMIN solution from the reconstituted vial and mix gently. | - | 1.25 Units | 2.5 Units |
| 16 mLWhen using 16 mL of diluent for a 200 Unit vial of XEOMIN, complete the following steps:Reconstitute a 200 Unit vial of XEOMIN with 4 mL of preservative-free 0.9% Sodium Chloride Injection, USP, following instructions above.Withdraw 12 mL of preservative-free 0.9% Sodium Chloride Injection, USP, into an appropriately sized syringe for 16 mL in total.Using the same syringe, draw up the 4 mL of XEOMIN solution from the reconstituted vial and mix gently. | - | - | 1.25 Units |
Drug interactions
Check botulinum toxin type a against a medication listLabel text (5 paragraphs)
Aminoglycosides or other agents that interfere with neuromuscular transmission may potentiate the effect of XEOMIN; co-administer only with caution and close observation ( 7 )
7.1 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.
7.2 Anticholinergic Drugs Use of anticholinergic drugs after administration of XEOMIN may potentiate systemic anticholinergic effects.
7.3 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.
7.4 Muscle Relaxants Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of XEOMIN.
Contraindications
4 CONTRAINDICATIONS XEOMIN is contraindicated in patients with: Known hypersensitivity to any botulinum toxin product or to any of the components in the formulation [see Warnings and Precautions (5.3) and Description (11) ] . Infection at the proposed injection site(s) because it could lead to severe local or disseminated infection. Known hypersensitivity to the active substance botulinum neurotoxin type A or to any of the excipients ( 4 , 5.3 ) Infection at the proposed injection sites ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for botulinum toxin type a. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of XEOMIN in pregnant women. XEOMIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. XEOMIN was embryotoxic in rats and increased abortions in rabbits when given at doses higher than the maximum recommended human dose (MRHD) for cervical dystonia (120 Units), on a body weight basis. In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data When XEOMIN was administered intramuscularly to pregnant rats during organogenesis (3 Units/kg, 10 Units/kg, or 30 Units/kg on gestational days [GDs] 6, 12, and 19; or 7 Units/kg on GDs 6 to 19; or 2 Units/kg, 6 Units/kg, or 18 Units/kg on GDs 6, 9, 12, 16, and 19), decreases in fetal body weight and skeletal ossification were observed at doses that were also maternally toxic. The no-effect level for embryotoxicity in rats was 6 Units/kg (3 times the MRHD for cervical dystonia on a body weight basis).
Intramuscular administration to pregnant rabbits during organogenesis (1.25 Units/kg,
2.5 Units/kg, or
5.0 Units/kg on GDs 6, 18, and 28) resulted in an increased rate of abortion at the highest dose, which was also maternally toxic. In rabbits, the no-effect level for increased abortion was
2.5 Units/kg (similar to the MRHD for cervical dystonia on a body weight basis).
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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