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presents

NUCEIVA®
(BOTULINUM TOXIN TYPE A)

NUCEIVA® is indicated for the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines), when the severity of the above facial lines has an important psychological impact in adults below 65 years of age. Prescribing information can be found at the end of this page.

What’s in a

Nuceiva
Generic blank white vial.

vial?

900kDa Molecule
A proprietary purified botulinum toxin type A formulation produced from fermentation of Clostridium botulinum

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Adverse events should be reported.

Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search MHRA Yellow Card in the Google Play or Apple App store. Adverse events should also be reported to Evolus International Ltd. Please contact Evolus Europe medical information by emailing Evoluseurope@druginfo.com or calling 08000541302.

Established in California

2012

Prescribing information

NUCEIVA® 50 Units powder for solution for injection

Presentation: Each vial contains 50 Units botulinum toxin type A produced by Clostridium botulinum.

Indications: For the temporary improvement in the appearance of moderate to severe vertical lines between the eyebrows seen at maximum frown (glabellar lines), when the severity of the above facial lines has an important psychological impact in adults below 65 years of age.

Dosage & Administration: Reconstituted Nuceiva (50 Units/1.25 ml) is injected via intramuscular injection using a sterile 30 gauge needle. Four Units (4 Units/ 0.1 ml) are administered in each of the 5 injection sites: 2 injections in each corrugator muscle (inferior medial and superior medial aspect) and 1 injection in the procerus muscle for a total dose of 20 Units. Injection near the levator palpebrae superioris should be avoided, particularly in patients with larger brow depressor complexes. Lateral corrugator injections should be placed at least 1 cm above the bony supraorbital ridge. (See Section 4.2 for administration instructions for glabellar lines seen at maximum frown). Botulinum toxin units are not interchangeable from one product to another.

Doses recommended are different from other botulinum toxin preparations. In the absence of adverse reactions during the initial treatment, an additional course of treatment can be performed subject to a minimum interval of 3 months between the initial and repeat treatment. In the event of treatment failure one month after the first course of treatment, the following approaches may be considered: Examination of the causes of failure and re-evaluation of the appropriateness of treatment with botulinum toxin type A. The efficacy and safety of repeat injections beyond 12 months has not been evaluated. Nuceiva is not recommended for use in patients over 65 years of age. Once reconstituted, Nuceiva should only be used to treat a single patient during a single session. Physical manipulation (such as rubbing) of the injection site in the immediate post-administration period should be avoided.

Contraindications: Hypersensitivity to the active substance or to any of the excipients listed insection 6.1 of the SmPC. Generalised disorders of muscle activity (e.g., myasthenia gravis or Eaton Lambert Syndrome). Infection or inflammation at the proposed injection sites.

Warnings & Precautions:

General: Injection into vulnerable anatomical structures, such as nerves and blood vessels, must be avoided. Localised pain, inflammation, paraesthesia, hypoaesthesia, tenderness, swelling/oedema, erythema, localised infection, bleeding and/or bruising have been associated with the injection. Needle-related pain and/or anxiety have resulted in vasovagal responses, including transient symptomatic hypotension and syncope. Caution should be taken when the targeted muscle shows pronounced weakness or atrophy. Care should be taken to ensure that Nuceiva is not injected into a blood vessel (see section 4.2). There is a risk of eyelid ptosis following treatment (see section 4.2). Caution should be taken if complications have resulted with previous botulinum toxin injections.

Bleeding disorders: Caution should be exercised when Nuceiva is used in patients with bleeding disorders as injection may lead to bruising.

Local and distant spread of toxin effect: Adverse reactions possibly related to the spread of toxin distant from the site of administration have been reported very rarely with botulinum toxin. Swallowing and breathing difficulties are serious and can result in death. Injection of Nuceiva is not recommended in patients with a history of dysphagia and aspiration. Patients or caregivers should be advised to seek immediate medical care if swallowing, speech or respiratory disorders arise.

Pre-existing neuromuscular disorders: Patients with unrecognised neuromuscular disorders may be at increased risk of clinically significant systemic effects, including severe dysphagia and respiratory compromise from typical doses of botulinum toxin type A. Caution should also be exercised when botulinum toxin type A is used for treatment of patients with amyotrophic lateral sclerosis or with peripheral neuromuscular disorders.

Hypersensitivity reactions: An anaphylactic reaction may occur very rarely after injection of botulinum toxin. Epinephrine (adrenaline) or any other anti-anaphylactic measures should therefore be available.

Antibody formation: Neutralising antibodies to botulinum toxin type A may develop during treatment with botulinum toxin which may lead to treatment failure. Interactions: Theoretically, the effect of botulinum toxin may be potentiated by aminoglycoside antibiotics, spectinomycin, or other medicinal products that interfere with neuromuscular transmission (e.g., neuromuscular blocking medicinal products). 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 administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.

Fertility, Pregnancy and lactation: Animal/human studies are insufficient with respect to reproductive toxicity. Nuceiva is not recommended during pregnancy and in women of childbearing potential not using contraception. There is no information on whether Nuceiva is excreted in human breast milk. Nuceiva should not be used during breast-feeding. The effect of Nuceiva on human fertility is unknown. Another botulinum toxin type A has been shown to impair the fertility of male and female animals.

Undesirable effects: Serious undesirable effects that may occur include eyelid ptosis, an immune response, distant spread of toxin, development or exacerbation of a neuromuscular disorder, and hypersensitivity reactions. The most commonly reported are headache, eyelid ptosis, application site bruising, influenza like illness, injection site bruising, injection site pain, and injection site swelling. Prescribers should consult the SmPC for a full list of undesirable effects.

Legal Category: POM Presentation, list price and Marketing Authorisation numbers: 50 Units powder for solution for injection per vial: £75.50, (exc VAT) PLGB 55681/0002, Marketing Authorisation Holder: Evolus Pharma B.V. Apollolaan 151 1077 AR Amsterdam The Netherlands. NUCEIVA® is a registered trademark. UKNUC00002, Date of preparation: June 2022.

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