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Letibotulinumtoxina-Wlbg

Also known as: Letybo

Acetylcholine Release InhibitorNeuromuscular BlockerAcetylcholine Release Inhibitors

Route: Intramuscular

Check Letibotulinumtoxina-Wlbg Interactions →

2 interactions on record⛔ Black Box Warning

Letibotulinumtoxina-Wlbg has 2 known drug interactions based on U.S. FDA drug labeling data. Notable interactions include combinations with Botulinum Toxin Type A, Muscle Relaxants. Patients taking Letibotulinumtoxina-Wlbg should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 2
Moderate: 2

Moderate (2)

Letibotulinumtoxina-Wlbg + Botulinum Toxin Type A— Botulinum neurotoxin products administered at the same time or within several months of LETYBO may potentiate excessive …
Letibotulinumtoxina-Wlbg + Muscle Relaxants— Muscle relaxants administered before or after LETYBO may potentiate excessive neuromuscular weakness. Use caution and mo…

Letibotulinumtoxina-Wlbg + Botulinum Toxin Type A🟡Moderate

Botulinum neurotoxin products administered at the same time or within several months of LETYBO may potentiate excessive neuromuscular weakness. Use caution and monitor closely.

Letibotulinumtoxina-Wlbg + Muscle Relaxants🟡Moderate

Muscle relaxants administered before or after LETYBO may potentiate excessive neuromuscular weakness. Use caution and monitor closely.

⛔ FDA Black Box Warning

WARNING: DISTANT SPREAD OF TOXIN EFFECT The effects of all botulinum toxin products, including LETYBO, may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. LETYBO is not approved for the treatment of spasticity or any conditions other than glabellar lines [see Warnings and Precautions ( 5.1 )] . WARNING: DISTANT SPREAD OF TOXIN EFFECT See full prescribing information for complete boxed warning. The effects of all botulinum toxin products, including LETYBO, may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. LETYBO is not approved for the treatment of spasticity or any conditions other than glabellar lines. ( 5.1 )

Contraindications

4 CONTRAINDICATIONS LETYBO is contraindicated in: Patients with known hypersensitivity to any botulinum toxin preparation or to any of the components in the LETYBO formulation [see Warnings and Precautions ( 5.4 )] . The presence of infection at the proposed injection site(s). Known hypersensitivity to any botulinum toxin preparation or to any of the components in the LETYBO formulation ( 4 ) Infection at the injection site ( 4 ) 4.1 Known Hypersensitivity to Botulinum Toxin BRANDNAME is contraindicated in individuals with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation [see Warnings and Precautions ( 5.4 )]. 4.2 Infection at the Injection Site(s) BRANDNAME is contraindicated in the presence of infection at the proposed injection site(s).

Pregnancy & Breastfeeding

8.1 Pregnancy Risk Summary Available data from case reports with LETYBO use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Systemic exposure following intramuscular injection of letibotulinumtoxinA-wlbg was not assessed [see Clinical Pharmacology ( 12.3 )] . In an animal reproduction study, intramuscular administration of letibotulinumtoxinA‑wlbg to rats during pregnancy resulted in adverse effects on fetal growth (decreased fetal body weight and skeletal ossification) at maternally toxic doses 3 times the maximum recommended human dose (MRHD) (see Data) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data An embryofetal development study was conducted in rats with letibotulinumtoxinA-wlbg. For comparison of animal to human doses based on a body weight comparison, the MRHD is set at 20 Units/subject (0.34 Units/kg for an average 60 kg subject). Administration to pregnant rats once daily during organogenesis (gestation days 5 to 16) caused decreased fetal body weight and decreased fetal skeletal ossification at doses ≥1 Unit/kg (3 times the MRHD. These treatment related effects were associated with maternal toxicity.

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.