IncobotulinumtoxinA

IncobotulinumtoxinA may be found in some form under the following brand names:

• Xeomin

You should not receive this medication if you are allergic to botulinum toxin, or if you have an infection, swelling, or muscle weakness in the area where the medicine will be injected. Tell your doctor if you have ever had a side effect after receiving a botulinum toxin in the past.

To make sure incobotulinumtoxinA is safe for you, tell your doctor if you have:

• amyotrophic lateral sclerosis (ALS, or "Lou Gehrig's disease");

• myasthenia gravis;

• Lambert-Eaton syndrome;

• a breathing disorder such as asthma or emphysema;

• problems with swallowing;

• facial muscle weakness (droopy eyelids, weak forehead, trouble raising your eyebrows);

• a change in the normal appearance of your face;

• a seizure disorder;

• bleeding problems;

• heart disease;

• if you have had or will have surgery (especially on your face); or

• if you have ever received other botulinum toxin injections such as Botox, Dysport, or Myobloc (especially in the last 4 months).

IncobotulinumtoxinA is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether incobotulinumtoxinA passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Use incobotulinumtoxinA as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• This medicine will be given to you by a doctor.
• It is given as a shot into a muscle.

What do I do if I miss a dose?

• Call the doctor for an office visit.

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Intramuscular [preservative free]:

Xeomin: 50 units (1 ea); 100 units (1 ea); 200 units (1 ea) [latex free; contains albumin human]

• Neuromuscular Blocker Agent, Toxin
• Ophthalmic Agent, Toxin

IncobotulinumtoxinA is a neurotoxin produced from Clostridium botulinum that inhibits acetylcholine release from peripheral cholinergic nerve endings. Inhibition occurs sequentially via binding and internalization of the neurotoxin into presynaptic cholinergic nerve terminals, translocation to the nerve terminal cytosol, and enzymatic cleavage of SNAP25, a protein necessary for acetylcholine release. Inhibition of acetylcholine release at the neuromuscular junction produces a state of denervation. Muscle inactivation persists until new fibrils grow from the nerve and form junction plates on new areas of the muscle-cell walls.

Absorption

Not expected to be present in peripheral blood at recommended doses following IM injection

Undiluted vials may be stored at room temperature 20°C to 25°C (68°F to 77°F), under refrigeration 2°C to 8°C (36°F to 46°F), or frozen -20°C to -10°C (-4°F to 14°F). After reconstitution, store in refrigerator at 2°C to 8°C (36°F to 46°F) and administer within 24 hours. Vial should only be used for one injection session and one patient.

-NOTE: This drug is not for intraocular use.
-The recommended initial dose should be the same as the patient's previous treatment, although responses may differ in individual patients. If the previous dose is not known, the initial dose should be between 1.25 and 2.5 units per injection site.
-The total initial dose of in both eyes should not exceed 70 units (35 units/eye).

Duration of therapy: The frequency of repeat treatments should be determined by clinical response, but should generally be no more frequent than every 12 weeks.

Comments:
-In a trial in which patients were dosed with the same number of units as they had received previously, the mean dose per eye was about 33 units (range 10 to 50 units), and the mean number of injections per eye was 6. The maximum dose per eye in the controlled trials was 50 units, with a range of 10 to 50 units. In the controlled trial, few patients received a total dose of greater than 75 units.
-The number and location of injection sites should be based on the severity of blepharospasm, and previous dose and response the injections. Subsequent dosing should be tailored to the individual patient, based on response, up to a maximum dose of 35 units per eye.
-Dosing has not been established in patients with blepharospasm who have not been previously treated with onabotulinumtoxinA.

Use: For the treatment of adults with blepharospasm who were previously treated with this drug.

No adjustment recommended

US BOXED WARNINGS:
-Botulinum toxin effects may be observed beyond the site of local injection. The symptoms are consistent with the mechanism of action of botulinum toxin and 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 or fatal. The risk is probably greatest in children treated for spasticity but symptoms can occur in adults treated for spasticity and other conditions, and 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, symptoms consistent with spread of toxin effect have been reported at doses comparable to or lower than doses used to treat cervical dystonia.
-Patients or caregivers should be advised to seek immediate medical care if swallowing, speech, or respiratory disorders occur.

Safety and effectiveness have not been established in pediatric patients younger than 18 years.

Consult WARNINGS section for additional precautions.