Hospital Pharmacy - September 2017 - 539

539

Baker and Kim
increased blood pressure. Use with opioid drugs, antidepressants, or other drugs with serotonin-related activity may
result in life-threatening serotonin syndrome. Use with dextromethorphan may cause episodes of psychosis or abnormal
behavior.2
Safinamide is also contraindicated in patients who have a
history of a hypersensitivity (eg, swelling of the tongue and
oral mucosa, dyspnea) to safinamide.2 A potential contraindication is a history of hypersensitivity to other product ingredients (ie, colloidal silicon dioxide, crospovidone, hypromellose,
iron oxide [red], magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, potassium aluminum silicate,
and titanium dioxide).2
Safinamide is contraindicated in patients with severe
hepatic impairment (Child-Pugh class C).2

Warnings and Precautions
Hypertension or exacerbation of existing hypertension may
occur during safinamide therapy. Monitor patients for newonset hypertension or for hypertension not adequately controlled after starting safinamide. Concomitant use with
sympathomimetic drugs may increase blood pressure.
Medication adjustment may be necessary if elevated blood
pressure is sustained.2 Dietary tyramine restriction is not
required during treatment with recommended doses of safinamide, except with certain foods containing very high
amounts (ie, more than 150 mg) of tyramine, which may
increase blood pressure.2 Concurrent use with isoniazid may
also be associated with the potential for increased blood
pressure.2
Potentially life-threatening serotonin syndrome may
occur when patients receiving an MAOI (including selective
MAO-B inhibitors) receive concomitant treatment with
SNRIs; tricyclic, tetracyclic, or triazolopyridine antidepressants; cyclobenzaprine; opioid drugs (eg, meperidine and
meperidine derivatives, propoxyphene, tramadol); or methylphenidate, amphetamine, and their derivatives. Use of
safinamide with any of these drugs is contraindicated.2
Concomitant use of selective serotonin reuptake inhibitors (SSRIs) and safinamide has been associated with development of serotonin syndrome. If the patient requires
treatment with an SSRI and safinamide, the lowest effective
dose of the SSRI should be used.2
Use of dopaminergics has been associated with patients
falling asleep while engaged in activities of daily living (eg,
driving a motor vehicle, conversing, eating). Patients may
not perceive warning signs (ie, excessive drowsiness), or
they may report feeling alert immediately prior to the event.
If sleep attacks/sudden onset of sleep does occur, discontinuation is recommended. If safinamide treatment is continued,
the patient should be advised not to drive or engage in other
potentially dangerous activities.2
Dyskinesia or exacerbation of preexisting dyskinesia may
occur. The condition may be mitigated by reducing the

patient's daily levodopa dosage or the dosage of another
dopaminergic drug. Discontinuation of safinamide therapy
in clinical trials due to dyskinesia occurred in 1% of patients
receiving either dose of safinamide (50 mg or 100 mg).2
Patients with hallucinations or psychotic disorders are not
ideal candidates for safinamide therapy. Increased central
dopaminergic activity may cause an exacerbation of the
patient's psychosis, and the mechanism of action of some
antipsychotic medications may exacerbate the symptoms of
Parkinson disease. If safinamide and antipsychotic medication are used together, a dosage reduction or discontinuation
may be necessary if the patient develops hallucinations or
psychotic-like behavior.2
Changes in impulse control/compulsive behavior (intense
urges to gamble, increased sexual urges, intense urges to
spend money, binge eating, and/or other intense urges, and
the inability to control these urges) may occur in patients
treated with drugs that increase central dopaminergic activity. The patient may not recognize any changes in behavior.
If the patient develops such urges after the addition of safinamide to the drug regimen, a reduction in dose or discontinuation of safinamide may be necessary.2
Rapid dose reduction, or withdrawal of or changes in
drugs that increase central dopaminergic activity may result
in a symptom complex resembling neuroleptic syndrome.2
Retinal pathology (eg, retinal degeneration, loss of photoreceptor cells, retinal scarring, cataracts) was observed in
rats administered safinamide. Patients should be evaluated
periodically for changes in vision, especially if they have a
history of retinal/macular degeneration, uveitis, inherited
retinal conditions, family history of hereditary retinal disease, albinism, retinitis pigmentosa, or any active retinopathy (eg, diabetic retinopathy).2
There are no adequate and well-controlled studies of
safinamide in pregnant women. In animal studies, developmental toxicity and teratogenic effects were observed.2
It is not known whether safinamide is present in human
milk. Skin discoloration was observed in rat pups indirectly
exposed to safinamide through milk. The change in skin
color was thought to be related to hyperbilirubinemia resulting from hepatobiliary toxicity.2
The safety and effectiveness of safinamide in pediatric
patients have not been established.2
Table 2 provides a comparison of contraindications, warnings, and precautions for the MAO-B inhibitors approved for
the treatment of Parkinson disease.2-4

Adverse Reactions
The most common adverse reactions observed in clinical trials included dyskinesia (17%-21%), fall (4%-6%), nausea
(3%-6%), and insomnia (1%-4%).2,5-8,25 Discontinuation
occurred in 5% of patients receiving safinamide 50 mg/d, in
6% with safinamide 100 mg/d, and in 4% with placebo; the
most frequent reason for discontinuation was dyskinesia.2



Table of Contents for the Digital Edition of Hospital Pharmacy - September 2017

Pharmacy Transitions of Care and Culture
Bivalirudin Medication Use Evaluation and Cost Savings Initiative
Navigating the New Antimicrobial Stewardship Regulations
Safinamide
Biosimilar Substitution Laws
Evaluation of Corticosteroid Dose in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Hazardous Drug Contamination of Drug Preparation Devices and Staff: A Contamination Study Simulating the Use of Chemotherapy Drugs in a Clinical Setting
A Case of Metronidazole Injection Infiltration Without Sequelae
Doubling Pharmacist Coverage in the Intensive Care Unit: Impact on the Pharmacists’ Clinical Activities and Team Members’ Satisfaction
Extended Stability of Epinephrine Hydrochloride Injection in Polyvinyl Chloride Bags Stored in Amber Ultraviolet Light–Blocking Bags
Formation of a Citywide Pharmacy Residents’ Collaborative Committee
Hospital Pharmacy - September 2017 - 513
Hospital Pharmacy - September 2017 - 514
Hospital Pharmacy - September 2017 - 515
Hospital Pharmacy - September 2017 - 516
Hospital Pharmacy - September 2017 - 517
Hospital Pharmacy - September 2017 - 518
Hospital Pharmacy - September 2017 - 519
Hospital Pharmacy - September 2017 - Pharmacy Transitions of Care and Culture
Hospital Pharmacy - September 2017 - 521
Hospital Pharmacy - September 2017 - Bivalirudin Medication Use Evaluation and Cost Savings Initiative
Hospital Pharmacy - September 2017 - 523
Hospital Pharmacy - September 2017 - 524
Hospital Pharmacy - September 2017 - 525
Hospital Pharmacy - September 2017 - 526
Hospital Pharmacy - September 2017 - Navigating the New Antimicrobial Stewardship Regulations
Hospital Pharmacy - September 2017 - 528
Hospital Pharmacy - September 2017 - 529
Hospital Pharmacy - September 2017 - 530
Hospital Pharmacy - September 2017 - 531
Hospital Pharmacy - September 2017 - Safinamide
Hospital Pharmacy - September 2017 - 533
Hospital Pharmacy - September 2017 - 534
Hospital Pharmacy - September 2017 - 535
Hospital Pharmacy - September 2017 - 536
Hospital Pharmacy - September 2017 - 537
Hospital Pharmacy - September 2017 - 538
Hospital Pharmacy - September 2017 - 539
Hospital Pharmacy - September 2017 - 540
Hospital Pharmacy - September 2017 - 541
Hospital Pharmacy - September 2017 - 542
Hospital Pharmacy - September 2017 - 543
Hospital Pharmacy - September 2017 - Biosimilar Substitution Laws
Hospital Pharmacy - September 2017 - 545
Hospital Pharmacy - September 2017 - Evaluation of Corticosteroid Dose in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Hospital Pharmacy - September 2017 - 547
Hospital Pharmacy - September 2017 - 548
Hospital Pharmacy - September 2017 - 549
Hospital Pharmacy - September 2017 - 550
Hospital Pharmacy - September 2017 - Hazardous Drug Contamination of Drug Preparation Devices and Staff: A Contamination Study Simulating the Use of Chemotherapy Drugs in a Clinical Setting
Hospital Pharmacy - September 2017 - 552
Hospital Pharmacy - September 2017 - 553
Hospital Pharmacy - September 2017 - 554
Hospital Pharmacy - September 2017 - 555
Hospital Pharmacy - September 2017 - 556
Hospital Pharmacy - September 2017 - 557
Hospital Pharmacy - September 2017 - 558
Hospital Pharmacy - September 2017 - A Case of Metronidazole Injection Infiltration Without Sequelae
Hospital Pharmacy - September 2017 - 560
Hospital Pharmacy - September 2017 - 561
Hospital Pharmacy - September 2017 - 562
Hospital Pharmacy - September 2017 - 563
Hospital Pharmacy - September 2017 - Doubling Pharmacist Coverage in the Intensive Care Unit: Impact on the Pharmacists’ Clinical Activities and Team Members’ Satisfaction
Hospital Pharmacy - September 2017 - 565
Hospital Pharmacy - September 2017 - 566
Hospital Pharmacy - September 2017 - 567
Hospital Pharmacy - September 2017 - 568
Hospital Pharmacy - September 2017 - 569
Hospital Pharmacy - September 2017 - Extended Stability of Epinephrine Hydrochloride Injection in Polyvinyl Chloride Bags Stored in Amber Ultraviolet Light–Blocking Bags
Hospital Pharmacy - September 2017 - 571
Hospital Pharmacy - September 2017 - 572
Hospital Pharmacy - September 2017 - 573
Hospital Pharmacy - September 2017 - Formation of a Citywide Pharmacy Residents’ Collaborative Committee
Hospital Pharmacy - September 2017 - 575
Hospital Pharmacy - September 2017 - 576
Hospital Pharmacy - September 2017 - 577
Hospital Pharmacy - September 2017 - 578
Hospital Pharmacy - September 2017 - 579
Hospital Pharmacy - September 2017 - 580
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_december2020
https://www.nxtbook.com/nxtbooks/sage/psychologicalscience_demo
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_october2020
https://www.nxtbook.com/nxtbooks/sage/fai_202009
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_august2020
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_june2020
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_april2020
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_february2020
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_december2019
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_october2019
https://www.nxtbook.com/nxtbooks/sage/fai_201909
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_july2019
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_june2019
https://www.nxtbook.com/nxtbooks/sage/canadianpharmacistsjournal_05062019
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_april2019
https://www.nxtbook.com/nxtbooks/sage/sri_supplement_201903
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_february2019
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_december2018
https://www.nxtbook.com/nxtbooks/sage/tec_20180810
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_october2018
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_julyaugust2018
https://www.nxtbook.com/nxtbooks/sage/fai_201807
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_june2018
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_april2018
https://www.nxtbook.com/nxtbooks/sage/sri_supplement_201803
https://www.nxtbook.com/nxtbooks/sage/slas_discovery_201712
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_february2018
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_december2017
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_november2017
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_october2017
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_september2017
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_julyaugust2017
https://www.nxtbook.com/nxtbooks/sage/fai_supplement_201709
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_june2017
https://www.nxtbook.com/nxtbooks/sage/hospitalpharmacy_may2017
https://www.nxtbook.com/nxtbooks/sage/fai_201706
https://www.nxtbook.com/nxtbooks/sage/fai_201607
https://www.nxtbookmedia.com