Botulinum toxin

FDA label

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Titration No dose increase within a session; adjust only at the next treatment session, which must be ≥3 months later.

Renal Undefined

Hepatic Undefined

Administer no more frequently than every 3 months for any indication; account for cumulative dose and for any other botulinum toxin products the patient is receiving.

Instructions

• IM injection only, after reconstitution with preservative-free 0.9% Sodium Chloride Injection, USP.
• Units are NOT interchangeable with any other botulinum toxin product — do not convert doses.
• Reconstitution: 50 Unit vial + 0.6 mL diluent → 8 Units/0.1 mL (glabellar). 100 Unit vial + 1.2 mL → 8 Units/0.1 mL (glabellar); 100 Unit vial + 1 mL or 2 mL → 10 or 5 Units/0.1 mL (cervical dystonia).
• Inject diluent slowly; discard the vial if vacuum does not draw the diluent in. Mix by gentle rotation. Do not use if cloudy, discolored, or containing flakes/particles.
• Administer within 72 h of reconstitution; store reconstituted product at 2–8°C protected from light; do not freeze.
• Single-dose vial: one injection session, one patient; discard remaining solution immediately.
• Glabellar lines: do not inject less than 1 cm above the superior orbital rim; avoid injection near the levator palpebrae superioris to reduce ptosis; use a 30–33 gauge needle and expel air bubbles.
• Cervical dystonia: limit the dose injected into the sternocleidomastoid to reduce dysphagia.

Contraindications

• Infection at the proposed injection site(s)

Cautions

• Spread of toxin effect: asthenia, generalized weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, breathing difficulty — seek immediate care.
• Potency Units are not interchangeable with other botulinum toxin preparations.
• Dysphagia and breathing difficulty; dysphagia may persist months and aspiration/respiratory failure and death have occurred — caution with pre-existing swallowing or respiratory compromise (neck muscle weakening can remove accessory ventilation).
• Serious/immediate hypersensitivity including anaphylaxis, serum sickness, urticaria, soft-tissue edema, dyspnea — stop injecting and treat.
• Cardiovascular events (arrhythmia, MI), some fatal — caution with pre-existing cardiovascular disease.
• Pre-existing neuromuscular disease (peripheral motor neuropathy, ALS, myasthenia gravis, Lambert-Eaton) — monitor for increased neuromuscular compromise at typical doses.
• Serious adverse reactions (excessive weakness, dysphagia, aspiration pneumonia, deaths) reported with unapproved uses.
• Glabellar lines: caution with altered facial anatomy, marked asymmetry, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin, injection-site inflammation, pre-existing eyelid/brow ptosis, or target-muscle weakness/atrophy.
• Dry eye / reduced tear production, reduced blinking, corneal disorders — refer persistent symptoms to ophthalmology.

Adverse reactions

• Glabellar lines (≥1%): headache 6%, eyelid ptosis 2%, facial paresis 1%; injection-site reactions 6% (same as placebo).
• Cervical dystonia (≥5%): headache 9%, injection site pain 8%, injection site erythema 5%, muscular weakness 5%, upper respiratory tract infection 5%.
• Cervical dystonia, other ≥2%: musculoskeletal pain 4%, dysphagia 2–4%, nasopharyngitis 3%, spinal pain 2–3%, arthralgia 2%, UTI 2%, first-degree AV block 2%.
• Onset typically 1–2 weeks post-injection; generally transient but may last weeks to months. Repeat dosing did not increase incidence.

Pregnancy No human data; in animals, IM dosing in pregnancy decreased fetal body weight and skeletal ossification at maternally toxic doses ~40× the MRHD (no embryofetal toxicity at 15× in rats).

Lactation No data on presence in human or animal milk or effects on the breastfed infant — weigh benefits of breastfeeding against maternal need.