Fintepla
Fintepla
Generic Name
Fintepla
Brand Names
for pregabalin marketed specifically for the treatment of hyperphagia and obesity in patients with Prader‑Willi syndrome (PWS).
Mechanism
- Grab? Pregabalin is a gabapentinoid that binds with high affinity to the α2δ subunit of voltage‑gated calcium channels (VGCCs) in CNS neurons.
- Binding reduces calcium influx, thus diminishing release of excitatory neurotransmitters such as glutamate, norepinephrine, and substance‑P.
- In PWS, this activity attenuates central drive to food‑seeking behavior, lowering hyperphagia and slowing weight gain.
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Pharmacokinetics
| Parameter | Key Points |
| Absorption | Rapid oral absorption, bioavailability ≈ 90 %, dose‑dependent. |
| Distribution | Widely distributed; crosses the blood‑brain barrier. Excretion largely renal (≈ 60 % unchanged). |
| Metabolism | Minimal; undergoes non‑enzymatic hydrolysis → inactive metabolites. |
| Half‑life | 6–7 h; steady state reached in 1–2 days. |
| Renal Dosing | Dose adjustment needed for CrCl < 30 mL/min. |
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Indications
- Prader‑Willi syndrome (PWS) in patients ≥6 years to mitigate hyperphagia and reduce weight gain.
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Contraindications
- Contraindications
- *Hypersensitivity* to pregabalin or any excipients.
- Warnings
- Renal impairment: Renal clearance dominates elimination → dose reduction essential.
- Psychiatric: Risk of mood changes, depression, suicidal ideation (especially in adolescents).
- CNS depression/Sedation: Close monitoring in patients on CNS‑acting drugs.
- Edema: Peripheral oedema is common.
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Dosing
- Initial dosing: *0.7 mg/kg/day* (e.g., 200 mg for a 70‑kg patient) in 2–3 divided doses.
- Titration: Increase by 1 – 2 mg/kg every 4–5 days up to a maximum of 600 mg/day (or 0.6 mg/kg/day, whichever is lower).
- Administration: Oral, with or without food.
- Long‑term use: Current FDA approval is for up to 12 months; further data will inform beyond‑year usage.
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Adverse Effects
| Category | Notable AEs |
| Common (< 10 %) | Somnolence, dizziness, peripheral edema, weight gain (counterintuitive), headache. |
| Moderate (10‑30 %) | Anxiety, mood swings, constipation, dry mouth. |
| Serious (≥ 30 %) | Suicidal ideation/behavior, significant CNS depression, severe edema, renal dysfunction, allergic reactions. |
| Special | Enlarged kidneys on imaging in some pediatric cases (benign). |
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Monitoring
- Weight & BMI – at baseline and every 4–6 weeks.
- Renal Function – Serum creatinine and eGFR at baseline and every 3 months (or sooner if clinically indicated).
- Mood & Behavior – standardized questionnaire at baseline and quarterly.
- Edema – check circumference of ankles/legs; adjust dose if > 15 % increase.
- Drug Interactions – review concurrent CNS depressants, lithium, or SSRIs.
- Laboratory – periodic CBC, CMP, and lipid profile if clinically justified.
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Clinical Pearls
- Start Low, Go Slow – Because of CNS depression, titrate over 4–5 day intervals even in children.
- Renal Dosing – Use CrCl to guide dosing; limit to ≤ 600 mg/day even if weight would suggest more.
- Combination Therapy – Pair with structured diet, behavioral therapy, and exercise program; pregabalin alone is insufficient.
- Adherence Tips – Splitting doses (morning/evening) reduces daytime somnolence; use a pill‑box schedule.
- Family Education – Inform caregivers about watching for mood changes and to report any self‑harm thoughts immediately.
- Switching to Generic – Generic pregabalin has identical PK; no impact on efficacy or safety.
- Pregnancy & Lactation – Limited data; risk–benefit analysis should guide therapy in pregnant PWS patients.
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• This drug card offers a succinct, evidence‑based summary for medical students and clinicians who need a quick reference to the pharmacological profile of Fintepla (pregabalin) in Prader‑Willi syndrome.