Botox Product

How do I store Botox?

Unopened vials of BOTOX ® should be stored in a refrigerator (2° to 8°C) for up to 24 months. Do not use after the expiration date on the vial. Administer BOTOX ® within 4 hours of reconstitution; during this period reconstituted BOTOX ® should be stored in a refrigerator (2° to 8°C). Reconstituted BOTOX ® should be clear, colorless and free of particulate matter.

Can I still store my vials in the freezer?

You may continue to store the product as you have in the past in a freezer if you choose to do so.

Does this mean I can store BOTOX® Therapeutic or BOTOX® Cosmetic in the refrigerator for 24 months?

You may store and use the product until the listed expiration date on the vial and/or carton. Please keep in mind that 24 months from the time the product is shipped and the remaining time until expiration may be different. Always follow the listed expiration date on the vial and carton.

After reconstitution may I store the vial and continue to use for 24 months?

No, the product, once reconstituted, should be administered within four hours of reconstitution with non-preserved saline. Please refer to our package insert for administration and dosing guidelines.

Someone said that if I shake the vial after reconstituting, the toxin may fall apart, is this true?

It is very unlikely, that shaking the vial of toxin after reconstituting will disrupt the structure. The rationale for "gently mixing" the toxin is due to the formation of foaming that occurs following agitation of any protein which can make it difficult to extract all of the toxin. This toxin is derived from an organism that has existed for over a million years and is unlikely to "break following agitation.

How do I reconstitute and dose BOTOX®?

Dilution Technique: Prior to injection, reconstitute vacuum-dried BOTOX ® , with sterile normal saline without a preservative; 0.9% Sodium Chloride Injection is the recommended diluent. Draw up the proper amount of diluent in the appropriate size syringe, and slowly inject the diluent into the vial (while keeping foaming to a minimum). Discard the vial if a vacuum does not pull the diluent into the vial. Gently mix BOTOX ® with the saline by rotating the vial. Record the date and time of reconstitution on the space on the label. BOTOX ® should be administered within four hours after reconstitution. During this time period, reconstituted BOTOX ® should be stored in a refrigerator (2° to 8°C). Reconstituted BOTOX ® should be clear, colorless and free of particulate matter. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration and whenever the solution and the container permit.

Dilution Table for BOTOX® - ONLY

Diluent Added (0.9% Sodium Chloride Injection)

Resulting dose

(Units per 0.1 ml)

1.0 ml

10.0

2.0 ml

5.0

4.0 ml

2.5

8.0 ml

1.25

Note: These dilutions are calculated for an injection volume of 0.1 ml. A decrease or increase in the BOTOX ® dose is also possible by administering a smaller or larger injection volume-from 0.05 ml (50% decrease in dose) to 0.15 ml (50% increase in dose). Source: Allergan, BOTOX ® -Therapeutic PI.

I heard that some clinicians use an anesthetic to reconstitute BOTOX®, what is recommended?

The safety of concomitant use of anesthetic agents (lidocaine, marcaine, etc.) and other agents either in solution as a diluent with BOTOX ® Therapeutic / BOTOX ® Cosmetic, or when administered together in a consecutive sequence has not been established BOTOX ® Therapeutic and BOTOX ® Cosmetic in combination with a local anesthetic (e.g., lidocaine, marcaine), or in combination with any other product. BOTOX ® Therapeutic and BOTOX ® Cosmetic are NOT labeled for combination use with a local anesthetic or any other product. These agents carry their own risks and benefits associated with clinical use that should be reviewed before administration. The safe and effective use of BOTOX ® Therapeutic and BOTOX ® Cosmetic depends upon proper storage of the product, selection of the proper dose, and proper reconstitution and administration techniques. The recommended diluent for BOTOX ® Therapeutic / BOTOX ® Cosmetic is normal saline (0.9%) without a preservative. It is recommended that the product be used within four hours after reconstitution. . It is recommended that the product be used within four hours after reconstitution. During this time period, reconstituted BOTOX ® should be stored in a refrigerator (2° to 8°C). Refreezing BOTOX ® Therapeutic or BOTOX ® Cosmetic after reconstitution is not recommended.

Are there any side effects associated with BOTOX®?

The most common side effect of BOTOX ® treatment is a temporary bruising at the injection site. This disappears within several days, and can be covered with makeup. In rare cases, BOTOX ® may travel and cause a droop in an eyelid; however, these effects are completely temporary. Your doctor can discuss any side effects that can be caused by BOTOX ® injections. Side effects most often reported during clinical trials of BOTOX ® Cosmetic included headache (13.3%), respiratory infection (3.5%), temporary eyelid droop (blepharoptosis, 3.2%), nausea (3.0%), and flu syndrome (2.0%).

Are there any contraindications to BOTOX®?

Co-administration of BOTOX ® and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. The effect of administering different botulinum neurotoxin serotypes at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by Individuals with peripheral motor neuropathic diseases (e.g., amyotrophic lateral sclerosis, or motor neuropathy) or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome). These individuals should only receive BOTOX ® with caution. Patients with neuromuscular disorders may be at increased risk of clinically significant systemic effects including severe dysphagia and respiratory compromise from typical doses of BOTOX ® . Published medical literature has reported rare cases of administration of a botulinum toxin to patients with known or unrecognized neuromuscular disorders such as myasethenia gravis, where the patients have shown extreme sensitivity to the systemic effects of typical clinical doses (Tarsy et al. 2000) . In some of these cases, dysphagia has lasted several months and required placement of a gastric feeding tube.

What are the adverse reactions to BOTOX®?

There have been rare spontaneous reports of death, sometimes associated with dysphagia, pneumonia, and/or other significant debility, after treatment with botulinum toxin. There have also been rare reports of adverse events involving the cardiovascular system, including arrhythmia and myocardial infarction, some with fatal outcomes. Some of these patients had risk factors including cardiovascular disease. The exact relationship of these events to the botulinum toxin injection has not been established. The following events have been reported since the drug has been marketed and a causal relationship to the botulinum toxin injected is unknown: skin rash (including erythema multiforme, urticaria and psoriasiform eruption), pruritus, and allergic reaction. In general, adverse events occur within the first week following injection of BOTOX ® and while generally transient, may have duration of several months. Localized pain, tenderness and/or bruising may be associated with the injection. Local weakness of the injected muscle(s) represents the expected pharmacological action of botulinum toxin. However, weakness of adjacent muscles may also occur due to spread of toxin. There have been four reported incidences coded as anaphylactoid reaction during the past thirteen and a half-year period. In two cases, there were concomitant medications that could be associated with anaphylactoid reactions. In a third case, there were contributing circumstances due to antipsychotic medications resulting in patient admisssion to a psychiatric facility. It was felt this event was not related to BOTOX ® . The relationship of BOTOX ® in the fourth case was not reported. For your additional information, the incidence rate of reported allergic reaction, coded as allergic reaction, was 0.0010% over this same period. This represents millions of vials and several thousand patient injections. Other reactions that could possibly be associated with allergic reaction include, but are not limited to, dermatitis (0.0001%), injection site hypersensitivity (0.0006%), maculopapular rash (0.0003%), pruritus (0.0019%), and urticaria (0.0010%). Please note that the data reflected in these incidence reports represent all patient groups and could involve multiple injections up to a maximum recommended total body dose of 400-600 Units per treatment session.

Are there any reports of transmission of viral disease from BOTOX®?

This product contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.

Is BOTOX® found in the systemic circulation?

Botulinum Toxin Type A is not expected to be present in the peripheral blood at measurable levels following IM injection at the recommended doses. The recommended quantities of neurotoxin administered at each treatment session are not expected to result in systemic, overt distant clinical effects (muscle weakness) in patients without other neuromuscular dysfunction. However, sub-clinical systemic effects have been shown by single-fiber electromyography after IM doses of botulinum toxins appropriate to produce clinically observable local muscle weakness. These side effects may be due to local spread of toxin from the injection site and/or misplaced injections. Clinical studies have reported changes in clinical electromyographic parameters (i.e., jitter) in muscles distant to the site of BOTOX ® injection. This may indicate spread of the toxin via circulation, retrograde or orthograde axonal transport, or some action of the toxin at a third, central, or unidentified site.

 

References:

  • Allergan, I. (2004). “ BOTOX ® Cosmetic Product Insert.”
  • Allergan, I. (2004). “ BOTOX ® Therapeutic Product Insert.”
  • Elan, I. (2000). Myobloc Product Insert.
  • Ipsen, L. (2004). Dysport Product Insert.
  • Merz (2011) http://www.xeomin.com/files/Xeomin_PI.pdf
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