GNH USA

Europe — EMA

Lionova

GNH USA supplies Lionova (Baclofen), a GABA_B receptor agonist for spasticity in multiple sclerosis, spinal cord injury and cerebral palsy.

Baclofen

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What is Baclofen?

Baclofen, the active ingredient in Lionova, is a GABA_B receptor agonist presented as a intrathecal solution for intrathecal use. It treats spasticity associated with multiple sclerosis, spinal cord injury, and cerebral palsy, helping to reduce muscle tone and improve functional mobility.

GNH USA supplies Lionova as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, clinics and transplant centres worldwide.

What is Baclofen used for?

Baclofen is used to manage spasticity disorders affecting the central nervous system.

- Multiple sclerosis‑related spasticity: reduces muscle tone and improves mobility for patients with MS. - Spinal cord injury‑related spasticity: decreases involuntary muscle contractions and facilitates rehabilitation. - Cerebral palsy‑related spasticity: helps control muscle stiffness and supports physiotherapy outcomes.

What are the side effects of Baclofen?

Baclofen may cause a range of adverse reactions, from mild to severe.

Common Side Effects: - Dizziness: sensation of light‑headedness or unsteadiness. - Fatigue: generalized tiredness or reduced energy. - Nausea: feeling of queasiness, sometimes with vomiting. - Headache: mild to moderate cranial pain. - Hypotension: lowered blood pressure, may cause faintness. - Constipation: reduced bowel movements.

Serious or Rare Side Effects: - Respiratory depression: marked reduction in breathing effort. - Severe hypotension: significant drop in blood pressure requiring medical attention. - Seizures: occurrence of convulsive episodes. - Allergic reactions: rash, itching, swelling, or anaphylaxis. - Hallucinations or psychosis: altered perception or mental status. - Urinary retention: difficulty emptying the bladder.

What precautions apply to Baclofen?

Before initiating intrathecal baclofen therapy, several safety considerations are recommended.

- Renal function monitoring: assess kidney status as baclofen is renally excreted. - Blood pressure assessment: watch for hypotension, especially when combined with other depressants. - Seizure risk evaluation: avoid abrupt discontinuation that may precipitate seizures. - Concomitant CNS depressant caution: use with opioids, benzodiazepines, or alcohol only under close supervision. - Depression screening: monitor for mood changes or suicidal thoughts. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake the solution.

What does Baclofen interact with?

Baclofen can interact with other medicines, influencing its safety and effectiveness.

Major Interactions (Avoid): - Opioids or benzodiazepines: combined CNS depression may cause respiratory failure. - Alcohol: additive sedative effect can increase dizziness and hypotension. - Antiepileptic drugs (e.g., phenobarbital): may enhance sedation and impair coordination.

Moderate Interactions (Monitor Closely): - NSAIDs: concurrent use may increase risk of renal impairment. - Antihypertensive agents: may potentiate baclofen‑induced hypotension. - CYP450 inhibitors (e.g., erythromycin): may modestly raise baclofen plasma levels, requiring dose adjustment.

Frequently asked questions

What conditions is Lionova used to treat?+
Lionova, containing baclofen, is indicated for the management of spasticity associated with multiple sclerosis, spinal cord injury, and cerebral palsy. It helps reduce abnormal muscle tone and improves functional movement in these neurological conditions.
How does baclofen work to relieve spasticity?+
Baclofen binds to GABA_B receptors in the spinal cord and brainstem, activating inhibitory pathways that reduce excitatory neurotransmitter release. This dampens neuronal firing, leading to decreased muscle tone and alleviation of spasticity.
What is the usual dose of Lionova?+
The dose of intrathecal baclofen is individualized. A qualified prescriber determines the appropriate concentration and infusion rate based on the patient’s clinical response, severity of spasticity, and tolerance.
Is Lionova safe to use during pregnancy or breastfeeding?+
Safety data for intrathecal baclofen in pregnancy and lactation are limited. The product should only be used if the potential benefit justifies any potential risk to the fetus or infant, and decisions should be made by the treating physician.
How do I order Lionova from GNH USA?+
To request Lionova, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including cold‑chain if needed) and import documentation.
How does Lionova compare with other antispastic agents?+
Compared with oral antispastic drugs, intrathecal baclofen delivers the medication directly to the spinal fluid, allowing lower systemic exposure and often better control of severe spasticity. It is generally more effective for refractory cases but requires surgical implantation of a delivery pump.
What are the storage requirements for Lionova?+
Lionova should be stored at 2‑8 °C, protected from light, and kept in its original container. Do not freeze or shake the solution, and ensure the temperature remains within the recommended range throughout transport and storage.
How is Lionova administered?+
Lionova is supplied as an intrathecal solution that is delivered via an implanted infusion pump directly into the cerebrospinal fluid. The pump is programmed by a healthcare professional to provide a continuous, adjustable dose.
What are the most serious risks associated with Lionova?+
Serious risks include respiratory depression, severe hypotension, seizures, and allergic reactions such as anaphylaxis. Patients should be monitored closely for signs of these events, especially during dose adjustments or when combined with other CNS depressants.
Who should not use Lionova?+
Lionova is contraindicated in patients with known hypersensitivity to baclofen or any formulation component, and it should be used with caution in individuals with severe renal impairment, uncontrolled epilepsy, or unstable cardiovascular conditions. The prescribing clinician must evaluate suitability on a case‑by‑case basis.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Baclofen
Route
Intrathecal Use
Manufacturer
Alternova A/S
Origin
EU

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