Drugs List

Therapeutic Indications

Uses

Idiopathic Parkinsonism

Idiopathic Parkinson's disease (PD) as add on therapy to a stable dose of levodopa (alone or in combination with other PD medicinal products) in mid to late stage fluctuating patients.

Contraindications

Children under 18 years
Albinism
Breastfeeding
Hereditary retinopathy
Pregnancy
Retinal degeneration
Retinitis pigmentosa
Retinopathy
Severe hepatic impairment
Severe progressive diabetic retinopathy
Uveitis

Precautions and Warnings

Females of childbearing potential
Patients over 75 years
Moderate hepatic impairment

Advise ability to drive/operate machinery may be affected by side effects
Monitor patients for impulse control disorders
Review treatment if impulse control disorders symptoms occur
When used with SSRIs, risk of Serotonin syndrome
Consider dose reduction in hepatic impairment
Female: Ensure adequate contraception during treatment
Advise patient/carer about symptoms of impulse control disorders

Due to the increased risk of serotonin syndrome, use with selective serotonin re-uptake inhibitors (SSRIs) (in particular fluoxetine or fluvoxamine) is not recommended. Following discontinuation of an SSRI, a washout period of 5 half lives is recommended before initiating treatment with safinamide.

Impulse control disorders can occur in patients treated with dopamine agonists and/or dopaminergic treatments although this has not been reported with safinamide.

Safinamide may potentiate the side effects of levodopa including exacerbation of pre-existing dyskinesia. A decrease in the dose of levodopa may be required.

Pregnancy and Lactation

Pregnancy

Safinamide is contraindicated in pregnancy.

At the time of writing there is no clinical data for safinamide on exposed pregnancies is available. Animal studies have shown adverse reactions when exposed to safinamide during pregnancy.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Safinamide is contraindicated in breastfeeding.

Safinamide is expected to be excreted in milk as adverse reactions have been observed in rat pups exposed via milk. A risk for the breastfed child cannot be excluded.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abnormal liver function tests
Alopecia
Anaemia
Ankylosing spondylitis
Anxiety
Arrhythmias
Attention disturbances
Basal cell carcinoma
Blood disorders
Blood pressure changes
Blurred vision
Breast pain
Bronchospasm
Cataracts
Changes in libido
Changes in mood
Cognitive impairment
Compulsive disorders
Confusion
Conjunctivitis
Constipation
Cough
Disturbances of appetite
Dizziness
Dream abnormalities
Dysarthria
Dyskinesia
Dyspnoea
Dystonia
Ejaculatory dysfunction
Elevated triglyceride levels
Erectile dysfunction
Erythema
Eye disorder
Eyelid oedema
Falls
Feeling hot
Gait abnormality
Gastrointestinal disorder
Glaucoma
Hallucinations
Headache
Hyperbilirubinaemia
Hypercholesterolaemia
Hyperglycaemia
Hyperhidrosis
Hypersalivation
Hypertension
Hypotension
Impaired co-ordination
Increased lacrimation
Infections
Insomnia
Leukopenia
Loss of balance
Metabolic disorders
Musculoskeletal disturbances
Myocardial infarction
Nausea
Nervous system effects
Night blindness
Night sweats
Ocular haemorrhage
Oropharyngeal spasm
Orthostatic hypotension
Pain
Palpitations
Paraesthesia
Paranoia
Pathological gambling
Peripheral oedema
Photosensitivity
Prolongation of QT interval
Prostatic hyperplasia
Pruritus
Psychiatric disorders
Psychosis
Respiratory disorders
Restless legs
Restlessness
Retinopathy
Rhinorrhoea
Sedation
Sensation of cold
Sensation of heaviness
Sinus bradycardia
Skin disorder
Skin neoplasm
Subcutaneous tissue disorders
Suicidal tendencies
Syncope
Tachycardia
Urinary dysfunction
Urinary tract infections
Varicose veins
Vascular disorders
Vertigo
Weight changes
Worsening of Parkinson's disease

Presentation

Oral formulations of safinamide.

Drugs List

Therapeutic Indications

Uses

Idiopathic Parkinsonism

Idiopathic Parkinson's disease (PD) as add on therapy to a stable dose of levodopa (alone or in combination with other PD medicinal products) in mid to late stage fluctuating patients.

Dosage

Adults

Patients with Hepatic Impairment

Contraindications

Children under 18 years
Albinism
Breastfeeding
Hereditary retinopathy
Pregnancy
Retinal degeneration
Retinitis pigmentosa
Retinopathy
Severe hepatic impairment
Severe progressive diabetic retinopathy
Uveitis

Precautions and Warnings

Females of childbearing potential
Patients over 75 years
Moderate hepatic impairment

Advise ability to drive/operate machinery may be affected by side effects
Monitor patients for impulse control disorders
Review treatment if impulse control disorders symptoms occur
When used with SSRIs, risk of Serotonin syndrome
Consider dose reduction in hepatic impairment
Female: Ensure adequate contraception during treatment
Advise patient/carer about symptoms of impulse control disorders

Due to the increased risk of serotonin syndrome, use with selective serotonin re-uptake inhibitors (SSRIs) (in particular fluoxetine or fluvoxamine) is not recommended. Following discontinuation of an SSRI, a washout period of 5 half lives is recommended before initiating treatment with safinamide.

Impulse control disorders can occur in patients treated with dopamine agonists and/or dopaminergic treatments although this has not been reported with safinamide.

Safinamide may potentiate the side effects of levodopa including exacerbation of pre-existing dyskinesia. A decrease in the dose of levodopa may be required.

Pregnancy and Lactation

Pregnancy

Safinamide is contraindicated in pregnancy.

At the time of writing there is no clinical data for safinamide on exposed pregnancies is available. Animal studies have shown adverse reactions when exposed to safinamide during pregnancy.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Safinamide is contraindicated in breastfeeding.

Safinamide is expected to be excreted in milk as adverse reactions have been observed in rat pups exposed via milk. A risk for the breastfed child cannot be excluded.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abnormal liver function tests
Alopecia
Anaemia
Ankylosing spondylitis
Anxiety
Arrhythmias
Attention disturbances
Basal cell carcinoma
Blood disorders
Blood pressure changes
Blurred vision
Breast pain
Bronchospasm
Cataracts
Changes in libido
Changes in mood
Cognitive impairment
Compulsive disorders
Confusion
Conjunctivitis
Constipation
Cough
Disturbances of appetite
Dizziness
Dream abnormalities
Dysarthria
Dyskinesia
Dyspnoea
Dystonia
Ejaculatory dysfunction
Elevated triglyceride levels
Erectile dysfunction
Erythema
Eye disorder
Eyelid oedema
Falls
Feeling hot
Gait abnormality
Gastrointestinal disorder
Glaucoma
Hallucinations
Headache
Hyperbilirubinaemia
Hypercholesterolaemia
Hyperglycaemia
Hyperhidrosis
Hypersalivation
Hypertension
Hypotension
Impaired co-ordination
Increased lacrimation
Infections
Insomnia
Leukopenia
Loss of balance
Metabolic disorders
Musculoskeletal disturbances
Myocardial infarction
Nausea
Nervous system effects
Night blindness
Night sweats
Ocular haemorrhage
Oropharyngeal spasm
Orthostatic hypotension
Pain
Palpitations
Paraesthesia
Paranoia
Pathological gambling
Peripheral oedema
Photosensitivity
Prolongation of QT interval
Prostatic hyperplasia
Pruritus
Psychiatric disorders
Psychosis
Respiratory disorders
Restless legs
Restlessness
Retinopathy
Rhinorrhoea
Sedation
Sensation of cold
Sensation of heaviness
Sinus bradycardia
Skin disorder
Skin neoplasm
Subcutaneous tissue disorders
Suicidal tendencies
Syncope
Tachycardia
Urinary dysfunction
Urinary tract infections
Varicose veins
Vascular disorders
Vertigo
Weight changes
Worsening of Parkinson's disease

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: November 2018

Reference Sources

Summary of Product Characteristics: Xadago 50mg film-coated tablets. Profile Pharma Ltd. Revised July 2018.
Summary of Product Characteristics: Xadago 100mg film-coated tablets. Profile Pharma Ltd. Revised July 2018.