- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulations of safinamide.
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.
Initially 50mg per day, increased to 100mg per day if required.
Patients with Hepatic Impairment
Moderate hepatic impairment
A lower dose of 50mg daily is recommended.
Severe hepatic impairment
Children under 18 years
Severe hepatic impairment
Severe progressive diabetic retinopathy
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
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 ).
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
Abnormal liver function tests
Basal cell carcinoma
Blood pressure changes
Changes in libido
Changes in mood
Disturbances of appetite
Elevated triglyceride levels
Loss of balance
Nervous system effects
Prolongation of QT interval
Sensation of cold
Sensation of heaviness
Subcutaneous tissue disorders
Urinary tract infections
Worsening of Parkinson's disease
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 ).
Last Full Review Date: November 2018
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.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.