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DAXXIFY daxibotulinumtoxinA 100 units powder for injection vial

DAXXIFY daxibotulinumtoxinA 100 units powder for injection vial

DAXXIFY

Prescription-only botulinum toxin type A injectable medicine
  • United States: U.S. Food and Drug Administration (FDA) Biologics License Approval (BLA) for DAXXIFY (daxibotulinumtoxinA Lanm) for the temporary improvement in the appearance of moderate to severe glabellar lines in adults and for the treatment of cervical dystonia in adults.
  • Australia: Listed in the Australian Register of Therapeutic Goods (ARTG ID 420430) as "DAXXIFY daxibotulinumtoxinA 100 units powder for injection vial" with Revance Australia Pty Ltd as sponsor; TGA Product Information and Australian Public Assessment Report (AusPAR) are publicly available.
  • China: Approved by the National Medical Products Administration (NMPA) for launch for the temporary improvement in the appearance of moderate to severe glabellar lines and for the treatment of cervical dystonia in adults, as reported in corporate regulatory filings.
  • Classified as a prescription Only medicine (Rx Only) in the United States and as a prescription medicine in Australia; administration is restricted to appropriately qualified healthcare professionals.
  • Subject to ongoing pharmacovigilance and risk management plans in all approved territories, including boxed warning and safety communications consistent with class labelling for botulinum toxin products.
Botulinum neurotoxin type A neuromuscular blocking agent; intramuscular injection

Description

DAXXIFY (daxibotulinumtoxinA-lanm) is a prescription botulinum toxin type A neuromuscular blocking agent supplied as a sterile, preservative-free, white to off-white lyophilized powder for intramuscular injection after reconstitution. The 100-unit presentation is a single-dose vial containing 100 Units of daxibotulinumtoxinA formulated with a proprietary 35-amino-acid peptide excipient (RTP004), histidine buffer, polysorbate 20 and trehalose. DAXXIFY is indicated in adults for the temporary improvement in the appearance of moderate to severe glabellar (frown) lines associated with corrugator and/or procerus muscle activity and for the treatment of cervical dystonia. It acts as an acetylcholine release inhibitor at the neuromuscular junction, leading to temporary relaxation of treated muscles. Clinical studies have shown a median duration of glabellar line effect of around 6 months, with some patients maintaining response for up to about 9 months, although treatment intervals and dosing must follow the approved product information and the prescriber’s clinical judgement.

Bnefits

  • Provides temporary improvement of moderate to severe glabellar (frown) lines associated with corrugator and/or procerus muscle activity in adult patients.
  • Approved for the treatment of cervical dystonia in adult patients, helping to reduce abnormal head posture and neck muscle spasms.
  • Peptide-formulated botulinum toxin type A (RTP004 excipient) designed to enhance product stability and support a prolonged clinical duration of effect compared with conventional human serum albumin–stabilised toxins.
  • Supplied as a single-dose 100-unit vial of lyophilized powder, allowing reconstitution to concentrations appropriate for both aesthetic and therapeutic use under official dosing recommendations.
  • Demonstrated median duration of effect of approximately 24 weeks for glabellar lines in pivotal trials, with a substantial proportion of patients maintaining none-to-mild frown lines for 6 months or longer.
  • Well-characterised safety profile in Phase 3 studies of glabellar lines and cervical dystonia, with adverse reactions typical for botulinum toxin products and detailed in regulatory product information.
  • FDA- and TGA-approved product with comprehensive prescribing information, including boxed warning on distant spread of toxin effects and detailed guidance on safe use.

Indications

  • Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.
  • Treatment of cervical dystonia in adult patients.

Composition

  • Active ingredient: daxibotulinumtoxinA-lanm (botulinum toxin type A neurotoxin, 150 kDa) – 100 Units per single-dose vial.
  • Each 100-unit vial of DAXXIFY powder for injection contains daxibotulinumtoxinA 100 Units, histidine 0.14 mg, histidine hydrochloride monohydrate 0.65 mg, polysorbate 20 0.1 mg, RTP004 peptide 11.7 micrograms, and trehalose dihydrate 36 mg.
  • DaxibotulinumtoxinA is a 150 kDa botulinum toxin type A without accessory proteins, purified from Clostridium botulinum type A.
  • The product is supplied as a sterile, preservative-free lyophilized powder intended for reconstitution with sterile, preservative-free 0.9% sodium chloride injection.

Formulation

  • Pharmaceutical form: Powder for solution for injection (white to off-white sterile lyophilized powder).
  • Dosage form and strength: 100 Units daxibotulinumtoxinA-lanm per single-dose glass vial (this presentation); also available as 50-Unit vials in some markets.
  • Route of administration: Intramuscular injection after reconstitution with sterile, preservative-free 0.9% sodium chloride.
  • Formulation characteristics: Botulinum toxin type A neurotoxin free of complexing proteins, stabilised with a synthetic 35-amino-acid peptide (RTP004), histidine buffer, polysorbate 20 and trehalose dihydrate; no human or animal serum-derived components are used as stabilisers.

Packaging

  • Single-dose 100-Unit vial of DAXXIFY lyophilized powder for injection supplied in an individual carton.
  • Outer carton packaging includes product name, strength, route of administration, storage conditions, batch number and expiry date as required by regulatory authorities.
  • In Australia, DAXXIFY daxibotulinumtoxinA 100 units powder for injection vial is listed in the Australian Register of Therapeutic Goods (ARTG ID 420430) as a single-dose 100-Unit vial with pack size of 1 vial per carton.
  • In the United States, cartons correspond to NDC-coded single-dose vials (50 or 100 Units per vial) as identified in FDA product listings.

Usage

  • DAXXIFY is a prescription botulinum toxin type A product that must only be prepared and administered intramuscularly by physicians or suitably qualified healthcare professionals experienced with botulinum toxin injections and familiar with relevant neuromuscular anatomy.
  • Before use, the lyophilized powder must be reconstituted with sterile, preservative-free 0.9% sodium chloride injection to an appropriate concentration as described in the official prescribing information for the specific indication; the reconstituted solution is clear to slightly opalescent and colourless.
  • Reconstituted DAXXIFY must be used for a single patient and a single treatment session; any unused solution remaining in the vial after the procedure should be discarded in accordance with local requirements for biological/medical waste.
  • DAXXIFY is indicated for intramuscular injection only and must not be administered intravascularly; injections are made into specific facial muscles for glabellar lines and into affected neck and shoulder muscles for cervical dystonia, following the dosing and anatomical guidance in the approved product information.
  • The potency units of DAXXIFY are specific to this preparation and assay method; they are not interchangeable with, and cannot be directly converted to, units of any other botulinum toxin product.
  • DAXXIFY should not be administered more frequently than every 3 months for any indication, and clinicians should consider total cumulative botulinum toxin exposure if patients receive other botulinum toxins for different indications.
  • Patients must be counselled on the boxed warning regarding possible distant spread of toxin effects and instructed to seek immediate medical attention if they experience symptoms such as swallowing difficulties, speech changes, breathing problems, generalised muscle weakness or vision changes after treatment.
  • Detailed preparation, dilution, dose selection and injection technique must be taken from the latest FDA Prescribing Information or TGA Product Information rather than general summaries.

Contraindications

  • Known hypersensitivity to any botulinum toxin preparation, to DAXXIFY (daxibotulinumtoxinA-lanm) or to any of the excipients in the formulation (histidine, histidine hydrochloride monohydrate, polysorbate 20, RTP004 peptide, trehalose dihydrate).
  • Presence of infection at the proposed injection site(s).

Adverse Effects

  • Class boxed warning for all botulinum toxin products, including DAXXIFY: Effects of the toxin may spread from the area of injection to produce symptoms consistent with systemic botulism (e.g. asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, breathing difficulties). Swallowing and breathing difficulties can be life-threatening and deaths have been reported with botulinum toxin products.
  • Glabellar lines (from controlled clinical trials; adverse reactions occurring in at least 1% of patients and more frequently than with placebo): headache, eyelid ptosis and facial paresis (including facial asymmetry). Injection-site reactions such as pain, erythema, oedema, bruising, hematoma and pruritus have also been reported.
  • Cervical dystonia (from pivotal trials; adverse reactions occurring in at least 5% of patients and more frequently than with placebo): headache, injection-site pain, injection-site erythema, muscular weakness and upper respiratory tract infection. Other reactions observed include musculoskeletal pain, nasopharyngitis and arthralgia.
  • Hypersensitivity reactions reported with botulinum toxin products (including DAXXIFY) include anaphylaxis, serum sickness, urticaria, soft tissue oedema and dyspnoea; if such reactions occur, further injections should be discontinued and appropriate medical therapy instituted.
  • Adverse cardiovascular events (including arrhythmia and myocardial infarction, some with fatal outcomes) have been reported with botulinum toxin products, often in patients with pre-existing cardiovascular disease; caution is advised in such patients.
  • Patients with pre-existing neuromuscular disorders (e.g. myasthenia gravis, Lambert–Eaton syndrome, motor neuropathies, amyotrophic lateral sclerosis) may be at increased risk of clinically significant generalized muscle weakness, dysphagia and respiratory compromise following treatment with botulinum toxin products.
  • Dysphagia and breathing difficulties can occur after botulinum toxin administration, sometimes severe, and may appear hours to weeks after injection; symptoms may persist for several months and may require medical support.
  • Ophthalmic adverse reactions in patients treated for glabellar lines include dry eye, reduced blink rate and corneal exposure; patients with persistent ocular symptoms should be evaluated by an eye specialist.
  • Safety information in the full prescribing information and local product information should be consulted for comprehensive listings of adverse reactions, warnings and precautions.

Storage Conditions

  • Unopened vials: Store in the original carton to protect from light at 2°C to 8°C (36°F to 46°F) or at controlled room temperature (typically 20°C to 25°C) as specified in the FDA Prescribing Information and TGA Product Information. Do not freeze unopened vials.
  • After reconstitution: Store the reconstituted solution at 2°C to 8°C (36°F to 46°F) protected from light and use within 72 hours; do not freeze reconstituted solution. Any unused solution after this time or at the end of the treatment session must be discarded.
  • Store out of the reach of children and handle in accordance with applicable regulations for storage and disposal of biological medicinal products.

Duration

In pivotal clinical trials, DAXXIFY produced a median duration of effect of approximately 24 weeks (about 6 months) for glabellar lines, with some patients maintaining none or mild frown lines for up to around 6\u20139 months. In cervical dystonia studies, clinically meaningful improvements were typically maintained for several months between treatment sessions. However, dosing intervals and retreatment timing must be individualised and DAXXIFY should not be administered more frequently than every 3 months for any indication.

Onset

Specific quantified onset-of-effect times (e.g. median time to onset in days) are not stated in the FDA Prescribing Information or TGA Product Information; consumer-facing information from the brand reports that some patients notice improvements within a few days, but no official regulatory document provides an exact onset time.

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