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ACI Pharmaceuticals LtdProduct Description
**Nervion (Mirogabalin) Summary**
**Indications**
* Treatment of peripheral neuropathic pain (PNP), including diabetic peripheral neuropathic pain (DPNP) and postherpetic neuralgia (PHN).
**Mechanism & Pharmacology**
* Selectively binds to $\alpha_2\delta$ subunits of voltage-gated calcium channels (VGCCs) in presynaptic neurons, decreasing calcium influx and reducing neurotransmitter release to lower central nervous system hyper-excitability.
* **Pharmacokinetics:** Rapidly absorbed (peak concentration in 0.5–1.5 hours) with low plasma protein binding (~25%). Excreted mainly unchanged (61–72%) via the kidneys, with a half-life of 2.0–4.9 hours.
**Dosage & Administration**
* **Standard Adult Dose:** Starts at 5 mg twice daily, increased by 5 mg at weekly intervals to a target of 15 mg twice daily (maintained between 10–15 mg twice daily as needed).
* **Renal Adjustments:**
* Mild: Start 5 mg twice daily $\rightarrow$ max 10 mg twice daily.
* Moderate: Start 2.5 mg twice daily $\rightarrow$ max 7.5 mg twice daily.
* Severe: Start 2.5 mg once daily $\rightarrow$ max 7.5 mg once daily.
* **Children/Adolescents:** Safety and efficacy are not established.
**Key Interactions**
* **CNS Depressants & Alcohol:** Potentiates sedating effects, motor skill impairment, and CNS depression (e.g., when combined with Lorazepam or alcohol).
* **Transporter/UGT Inhibitors:** Cimetidine, Probenecid, or other OAT1, OAT3, OCT2, MATE1/2-K, and UGT inhibitors may increase drug exposure.
**Side Effects & Safety Precautions**
* **Common Side Effects:** Dizziness, somnolence (drowsiness), weight gain, and edema.
* **Serious Warnings:** Risk of loss of consciousness, liver dysfunction, blurred/double vision, and fall/fracture risks (especially in elderly patients). Avoid driving or operating machinery.
* **Pregnancy & Lactation:** Use only if the therapeutic benefit outweighs potential fetal/infant risks (excreted in animal milk and crosses the placenta).
* **Storage:** Store below 30°C in a dry place protected from light and moisture. Keep out of reach of children.
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