Consumer medicine information

1. Why am I using NUCEIVA?

NUCEIVA contains the active ingredient prabotulinumtoxinA. NUCEIVA is used to temporarily improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults.
For more information, see Section 1. Why am I using NUCEIVA? in the full CMI.

2. What should I know before I use NUCEIVA?

Do not use if you have ever had an allergic reaction to prabotulinumtoxinA or any of the ingredients listed at the end of the CMI.
Do not use if you have a skin infection at the planned injection site.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use NUCEIVA? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with NUCEIVA and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use NUCEIVA?

• NUCEIVA should only be injected by doctors with appropriate qualifications and expertise in the treatment of frown lines.

• 4 Units of NUCEIVA will be injected into 5 different sites by your doctor, totaling to 20 Units.

• Unit doses for NUCEIVA are not interchangeable with those used for other preparations of botulinum toxin.

5. What should I know while using NUCEIVA?

6. Are there any side effects?

Common but usually mild potential side effects include headache and eyelid drooping.
Serious potential side effects can include problems swallowing, speaking, breathing, or spread of toxin effects including loss of strength and all-over muscle weakness. While rare, these may occur at any time (hours to weeks) and could be life threatening requiring medical attention right away.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Nuceiva (prabotulinumtoxinA) 100 units powder for solution for injection.

2 Qualitative and Quantitative Composition

Each vial contains 100 units prabotulinumtoxinA produced by Clostridium botulinum.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder for solution for injection.
Nuceiva is a white to yellowish vacuum dried powder in a colorless and transparent vial. When reconstituted in sodium chloride (solution for) injection, it is a clear and transparent solution.

4 Clinical Particulars

4.9 Overdose

Signs of overdose may not be apparent immediately post-injection. Should accidental injection or ingestion occur, the patient should be medically monitored for several days for signs and symptoms of general weakness or muscle paralysis. Admission to hospital should be considered in patients presenting with symptoms of botulinum toxin type A poisoning (generalized weakness, ptosis, diplopia, swallowing and speech disorders, or paresis of the respiratory muscles).
Too frequent or excessive dosing may enhance the risk of antibody formation. Antibody formation may lead to treatment failure.
Overdose of Nuceiva depends upon dose, site of injection, and underlying tissue properties. No cases of systemic toxicity resulting from accidental injection of botulinum toxin type A have been observed. Excessive doses may produce local or distant generalized and profound neuromuscular paralysis. No cases of ingestion of botulinum toxin type A have been reported.
In the event of overdose the patient should be medically monitored for symptoms of excessive muscle weakness or muscle paralysis. Symptomatic treatment should be instigated if necessary.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No genotoxicity studies have been conducted with prabotulinumtoxinA.
Carcinogenicity. No long term carcinogenicity studies in animals have been conducted with prabotulinumtoxinA.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Nuceiva is a 900 kDa botulinum toxin type A, produced from fermentation of Clostridium botulinum. Each vial of Nuceiva contains 100 units of prabotulinumtoxinA, albumin (0.5 mg), and sodium chloride (0.9 mg) in a sterile, vacuum-dried form without a preservative.
The primary release procedure for Nuceiva uses an animal-based potency assay to determine the potency relative to a reference standard. The assay is specific to Nuceiva. One unit of Nuceiva corresponds to the calculated median intraperitoneal lethal dose (LD₅₀) in mice. Due to specific details of this assay, units of biological activity of Nuceiva cannot be converted into units of any other botulinum toxin or any toxin assessed with any other specific assay method.
CAS number. 93384-43-1.

7 Medicine Schedule (Poisons Standard)

S4: Prescription only medicine.

Summary Table of Changes

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