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Continuous SC levodopa/carbidopa Pregnancy: §4.6, verbatim: 'There are no data from the use of Produodopa in pregnant women. Studies of levodopa and carbidopa in animals have shown reproduction toxicity… Produodopa is not recommended during pregnancy and in women of childbearing potential not using contraception unless the benefits for the mother outweigh the possible risks to the foetus.' Breast-feeding: 'Levodopa and possibly levodopa metabolites are excreted in human milk. There is evidence that lactation is suppressed during treatment with levodopa… Breast-feeding should be discontinued during treatment with Produodopa.' Fertility: 'In reproduction studies, no effects on fertility were observed in rats receiving levodopa/carbidopa.'

Foslevodopa with foscarbidopa

Brand names: Vyalev, Produodopa

Foslevodopa with foscarbidopa is a continuous subcutaneous infusion of levodopa and carbidopa prodrugs used for advanced Parkinson's disease with motor fluctuations.

Adult dose

Dose: Parkinson's disease, in patients already on a stable dose of oral levodopa (§4.2: 'Produodopa is intended for use in Parkinson's disease patients who are already on a stable dose of oral levodopa') — continuous subcutaneous infusion, 24 hours per day. THERE IS NO SINGLE FIXED DOSE: §4.2 verbatim — 'The recommended starting infusion rate of Produodopa is determined by converting the daytime levodopa intake to levodopa equivalents (LE) and then increasing it to account for a 24-hour administration.' STEP 1, calculate LE from all levodopa-containing medicines taken during the patient's awake time (typically 16 h/day) using the Table 1 multiplication factors: immediate-release including enteral suspension × 1; sustained-, controlled- or prolonged-release × 0.75; then, if any COMT inhibitor is used in the 24-hour period, multiply the summed LE × 1.33. Rescue levodopa, night-time doses and other anti-Parkinsonian medicines are excluded from the calculation. STEP 2, read the starting hourly rate from Table 2, which runs from 0.15 ml/hr for LE16 below 400 mg up to 1.04 ml/hr for LE16 above 3100 mg (e.g. LE16 1000–1099 → 0.34–0.37 ml/hr; LE16 2000–2099 → 0.68–0.71 ml/hr), or calculate it with the SPC's formula: 'Hourly infusion rate (ml/hr) = [(LE ∙ 0.92 ∙ 1.41) ∕ 240] ∕ X', where X is the patient's awake hours per day. This rate is entered as the pump's Base infusion rate. STEP 3, optional loading dose immediately before the hourly infusion starts (Table 3): 0.6 ml ≈ 100 mg levodopa; 0.9–1.2 ml ≈ 150–200 mg; 1.5–1.8 ml ≈ 250–300 mg; 2.0 ml ≈ 350 mg; '0.1 ml of Produodopa contains 24 mg foslevodopa (equivalent to approximately 17 mg of levodopa)' and 'The pump is capable of delivering a loading dose ranging from 0.1 ml to a maximum of 3.0 ml, in increments of 0.1 ml.' EXTRA DOSES for acute 'Off' symptoms, if enabled (Table 4): 0.10 ml = 17 mg, 0.15 ml = 25.5 mg, 0.20 ml = 34 mg, 0.25 ml = 42.5 mg or 0.30 ml = 51 mg levodopa equivalents, 'limited to no more than 1 extra dose per hour'.
Route: Continuous subcutaneous infusion via the Vyafuser pump only. §4.2 verbatim: 'Produodopa is administered subcutaneously, preferably in the abdomen, avoiding a 5-cm radius area from the navel… The infusion set (cannula) can remain in place for up to 3 days when the medication is infused continuously. Rotate the infusion site and use a new infusion set at least every 3 days. It is recommended that new infusion sites be at least 2.5 cm from sites used within the previous 12 days.' Do not infuse into tender, bruised, red or hard sites. Once the vial contents are transferred to the syringe they 'should be administered within 24 hours'; vials are single use.
Frequency: Continuous, 24 hours per day, at the programmed base hourly rate. §4.2: 'All infusion rates may be adjusted in increments of 0.01 ml/hr (which is equivalent to approximately 1.7 mg of levodopa/hour)'. Two alternative pre-programmed rates (Low/High) may be enabled by the healthcare professional. INTERRUPTIONS: brief interruptions (e.g. showering) need no further action; for interruptions longer than 1 hour a new infusion set and a different site are required; if interrupted for longer than 3 hours the patient may self-administer a loading dose if enabled; if interrupted for more than 24 hours or stopped permanently the healthcare professional must arrange alternative dopaminergic treatment. §4.2/§4.4: sudden discontinuation or rapid dose reduction without alternative dopaminergic therapy should generally be avoided.
Max: 6000 mg of foslevodopa per 24 hours. §4.2 verbatim: 'The maximum recommended daily dose of foslevodopa is 6000 mg (or 25 ml of Produodopa per day equivalent to approximately 4260 mg levodopa per day).' The same ceiling is expressed as a rate limit: infusion rates 'should not exceed 1.04 ml/hr (or approximately 4260 mg levodopa per day [6000 mg of foslevodopa per day])'. The loading-dose ceiling is separate and device-bound: 'The pump is capable of delivering a loading dose ranging from 0.1 ml to a maximum of 3.0 ml, in increments of 0.1 ml.'
SCOPE WARNING: every millilitre figure above is specific to this 240 mg/ml + 12 mg/ml concentration and to the Vyafuser pump, and must not be applied to any other product, concentration or device. The bundle contains NO SPC for 'Vyalev', the other brand name carried on this page — nothing here has been verified against a Vyalev label. §4.2 also states: 'Produodopa replaces levodopa-containing medications and catechol-O-methyl transferase (COMT)-inhibitors. If required, other classes of medicinal products for Parkinson's disease can be taken concurrently', and that concomitant use with other levodopa-containing medicines or with medicines that significantly regulate synaptic dopamine levels 'has not been studied'. Patients (or their carer) must be capable of understanding and using the delivery system and must be trained before initiation. §4.2 'Special populations' states only that the pharmacokinetics 'has not been evaluated in any special population' — there is no separate elderly, renal or hepatic dose in the fetched text.

Paediatric dose

NO PAEDIATRIC DOSE EXISTS IN THE FETCHED LABEL: §4.2 was retrieved in full and contains no paediatric population paragraph at all — its only 'Special populations' statement is that 'The pharmacokinetics of Produodopa has not been evaluated in any special population' and that the product 'is intended for use in Parkinson's disease patients who are already on a stable dose of oral levodopa'. dosePerKg is deliberately null; the adult regimen is a pump rate derived from the patient's own oral levodopa intake, not a per-kilogram dose, and must never be fed to a weight calculator. Verify any paediatric use against a current children's formulary.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • §4.3, verbatim: 'hypersensitivity to the active substances or to any of the excipients listed in section 6.1'.
  • §4.3, verbatim: 'narrow-angle glaucoma'.
  • §4.3, verbatim: 'severe heart failure'.
  • §4.3, verbatim: 'acute stroke'.
  • §4.3, verbatim: 'severe cardiac arrhythmia'.
  • §4.3, verbatim: 'non-selective MAO inhibitors and selective MAO type A inhibitors are contraindicated for use with Produodopa. These inhibitors must be discontinued at least two weeks prior to initiating therapy with Produodopa. Produodopa may be administered concomitantly with the manufacturer's recommended dose of a MAO inhibitor with selectivity for MAO type B (e.g., selegiline HCl).'
  • §4.3, verbatim: 'conditions in which medication with adrenergic activity are contraindicated, e.g., pheochromocytoma, hyperthyroidism and Cushing's syndrome.'
  • §4.3, verbatim: 'Because levodopa may activate malignant melanoma, Produodopa should not be used in patients with suspicious undiagnosed skin lesions or a history of melanoma.'

Side effects

  • §4.8 summary, verbatim: 'The most frequent adverse reactions (≥10%) reported in all Phase 3 studies in patients exposed to Produodopa were infusion site events (infusion site erythema, infusion site cellulitis, infusion site nodule, infusion site pain, infusion site oedema, infusion site reaction, and infusion site infection), hallucination, fall, and anxiety.'
  • Very common (≥1/10): infusion site cellulitis, infusion site infection, urinary tract infection; anxiety, depression, hallucination.
  • Common (≥1/100 to <1/10): infusion site abscess; anaemia; decreased appetite; abnormal dreams, agitation, confusional state, delusion, impulse control disorder, insomnia, paranoia, psychotic disorder, sleep attacks, sleep disorder, suicidal ideation; cognitive disorder, dizziness, postural dizziness, dyskinesia, dystonia, headache, hypoaesthesia, on and off phenomenon, paraesthesia, polyneuropathy, somnolence, syncope, tremor; irregular heart rate; hypertension, hypotension, orthostatic hypotension; dyspnoea, oropharyngeal pain; abdominal distension, abdominal pain, constipation, diarrhoea, dry mouth, dysgeusia, dyspepsia, dysphagia, flatulence, nausea, vomiting; contact dermatitis, hyperhidrosis, pruritus, rash.
  • Uncommon (≥1/1,000 to <1/100): leukopenia, thrombocytopenia; completed suicide, dementia, disorientation, dopamine dysregulation syndrome, euphoric mood, fear, increased libido, nightmare, suicide attempt; ataxia, convulsion, gait disturbance; angle closure glaucoma, blepharospasm, diplopia, optic ischaemic neuropathy, blurred vision; palpitations; phlebitis; dysphonia; salivary hypersecretion; alopecia, erythema, urticaria.
  • Rare and not known: abnormal thinking; abnormal respiration; bruxism, saliva discolouration, glossodynia, hiccups; anaphylactic reaction (frequency not known).
  • INCOMPLETE LIST — §4.8 was cut at the source-fetch limit inside the skin and subcutaneous tissue disorders block, so every system organ class after that point was never retrieved.

Monitoring

  • §4.2, verbatim: 'If 5 or more extra doses are used by the patient during the 24-hour/day treatment period, a revision of the Base Infusion Rate should be considered.'
  • §4.4, verbatim: 'In patients with a history of myocardial infarction who have residual atrial nodal or ventricular arrhythmias, cardiac function should be monitored with particular care during the period of initial dosage adjustments.'
  • §4.4, verbatim: 'All patients treated with Produodopa should be monitored carefully for the development of mental changes, depression with suicidal tendencies, and other serious mental changes. Patients with past or current psychosis should be treated with caution.'
  • §4.4, verbatim: 'Patients should be regularly monitored for the development of impulse control disorders.' (This sentence is where §4.4 was cut at the source-fetch limit — the remainder of the monitoring guidance was never retrieved.)
  • §4.4, chronic wide-angle glaucoma: treat with caution 'provided the intra-ocular pressure is well controlled and the patient is monitored carefully for changes in intra-ocular pressure during therapy'.
  • §4.4, withdrawal: a neuroleptic-malignant-syndrome-like symptom complex has been reported when anti-Parkinsonian medicines were withdrawn abruptly, so 'patients should be carefully observed when the dose of levodopa/carbidopa combinations are abruptly reduced or discontinued, especially if the patient is receiving antipsychotics.'
  • Inspect and rotate infusion sites (see route) — infusion site infection and cellulitis are very common reactions.

Clinical monograph

How it works

The prodrugs are converted to levodopa and carbidopa; levodopa is decarboxylated to dopamine in the brain to replenish striatal dopamine, while carbidopa inhibits peripheral decarboxylation to improve central availability and reduce side effects.

Prescribing in practice

  • Infusion-site reactions including cellulitis and infection are common, so site rotation and inspection are essential and patients should be taught aseptic technique.
  • It can cause impulse-control disorders, hallucinations and excessive daytime sleepiness, and sudden withdrawal risks a neuroleptic malignant-like syndrome.
  • Doses of other dopaminergic and Parkinson's medicines usually need adjustment when transferring to continuous infusion.

Monitoring

Monitor motor response and 'off' time, inspect infusion sites regularly for infection, and watch for impulse-control disorders, neuropsychiatric effects and somnolence.

Counselling the patient

  • Change and rotate your infusion site as instructed and report redness, pain or swelling at the site.
  • Tell us about any new gambling, compulsive shopping or other urges, or excessive daytime sleepiness.
  • Do not stop the infusion abruptly without medical advice.

Evidence & guidelines

Continuous subcutaneous foslevodopa-foscarbidopa reduced 'off' time in clinical trials of advanced Parkinson's disease compared with oral levodopa therapy.

Reference: NICE NG71; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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