SINTETICA

What it is

Sintetica contains baclofen, a gamma-aminobutyric acid derivative, as its active ingredient. Sintetica Baclofen Intrathecal is available as injection solution in ampoules at strengths of 50 micrograms per 1 mL, 10 mg per 5 mL, 10 mg per 20 mL, and 40 mg per 20 mL.

Approved indications

Sintetica is indicated for suppression of voluntary muscle spasm in multiple sclerosis and spinal lesions of traumatic, infectious, degenerative, neoplastic and unknown origin, causing skeletal hypertonus and spastic and dyssynergic bladder dysfunction. Sintetica is not recommended in Parkinson's disease or spasticity arising from strokes, cerebral palsy or rheumatoid disorders.

Key safety warnings

Patients with psychotic disorders, schizophrenia, depressive or manic disorders or confusional states should be treated cautiously and kept under careful surveillance. Suicide and suicide-related events have been reported in patients treated with baclofen, particularly in those with additional risk factors such as alcohol use disorder, depression and prior suicide attempts. Close supervision of patients with additional risk factors for suicide should accompany drug therapy. Cases of misuse, abuse and dependence have been reported with baclofen. Caution should be exercised in patients with a history of substance abuse and the patient should be monitored for symptoms of baclofen misuse, abuse or dependence including dose escalation, drug-seeking behaviour, and development of tolerance. Caution is needed in patients with epilepsy or other convulsive conditions, cortical or subcortical brain damage or significant EEG abnormalities, since baclofen may cause deterioration of seizure control and may precipitate convulsions. In patients with epilepsy and muscle spasticity, Sintetica can be employed under appropriate supervision, provided adequate anticonvulsive therapy is continued. Cases of encephalopathy have been reported in patients treated with Sintetica, with symptoms including somnolence, depressed level of consciousness, confusion, myoclonus and coma, which are usually reversible after treatment discontinuation. If any signs or symptoms of encephalopathy are observed, baclofen should be discontinued. Abrupt withdrawal of Sintetica, especially after long-term medication, may result in anxiety, confusional states, delirium, hallucinations, psychotic disorders, mania, paranoia, convulsion, dyskinesia, tachycardia, hyperthermia and temporary aggravation of spasticity. Except in overdose-related emergencies or where serious adverse effects have occurred, treatment should always be gradually withdrawn by successive dosage reduction over a period of approximately one to two weeks.

Contraindications

Sintetica is contraindicated in patients with known hypersensitivity to baclofen or to any of the components of the formulation.

PBS listing

Sintetica Intrathecal injection 10 mg in 5 mL is listed on the PBS with streamlined restriction at an ex-manufacturer price of A$762.70. Sintetica Intrathecal injection 40 mg in 20 mL is listed on the PBS with streamlined restriction at an ex-manufacturer price of A$305.69.

Regulatory history

Sintetica Baclofen Intrathecal was first listed on the ARTG on 10 March 2017 in four formulations: 50 micrograms per 1 mL, 10 mg per 5 mL, 10 mg per 20 mL, and 40 mg per 20 mL injection solution ampoules.