FETZIMA 40 MG

What is FETZIMA?

FETZIMA 40 MG contains LEVOMILNACIPRAN (LEVOMILNACIPRAN HYDROCHLORIDE) : 40 MG. It is listed in the Health Canada Drug Product Database under DIN 02440989, held by ABBVIE CORPORATION, supplied as CAPSULE (EXTENDED RELEASE) for ORAL administration. Health Canada currently lists it as marketed, status dated 10-Oct-2023. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is FETZIMA used for?

FETZIMA (levomilnacipran extended release capsules) is indicated for the symptomatic relief of major depressive disorder (MDD).

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

Initiating Treatment: Adults should start with 20 mg once daily for 2 days, then increase to 40 mg once daily. The recommended dose range is 40 mg to 120 mg once daily. If a dose increase above 40 mg/day is warranted, it may be increased in increments of 40 mg, not exceeding 120 mg/day. Maintenance/Continuation/Extended Treatment: Long-term efficacy for up to 26 weeks has been established. Physicians should periodically reassess the need for continued treatment. Dosing in Special Populations and Conditions: Hepatic Impairment: No dose adjustment is required for mild, moderate, or severe hepatic impairment. Renal Impairment: No dose adjustment for mild renal impairment (creatinine clearance of 60-89 mL/min). For moderate renal impairment (creatinine clearance of 30-59 mL/min), the dose should not exceed 80 mg/day. For severe renal impairment (creatinine clearance of 15-29 mL/min), the dose should not exceed 40 mg/day. Not recommended for end-stage renal disease. Geriatric Patients (> 65 years of age): No dose adjustment is required based on age. Pediatrics (< 18 years of age): Not authorized for pediatric use. Sex: No dose adjustment is required based on sex. Discontinuing Treatment: Gradual dose reduction is recommended instead of abrupt discontinuation to avoid withdrawal symptoms. Monitor patients for symptoms. If intolerable symptoms occur, resume the previously prescribed dose and decrease more gradually. Administration: FETZIMA should be taken at approximately the same time each day, swallowed whole. Do not open, chew, or crush the capsule. Can be taken with or without food. Missed Dose: If a dose is missed, take it as soon as remembered. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take two doses at the same time.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Store at controlled room temperature (15-30°C). Keep out of reach and sight of children.

How is it supplied?

Bottles of 30 capsules: 20 mg, 40 mg, 80 mg and 120 mg.

Contraindications

FETZIMA is contraindicated in patients with: Hypersensitivity to levomilnacipran, milnacipran, any ingredient in the formulation, non-medicinal ingredients, or container components. Concomitant use with Monoamine Oxidase Inhibitors (MAOIs), including linezolid (antibiotic) and methylene blue (dye used in certain surgeries). MAOIs should not be started until 2 weeks after FETZIMA discontinuation, and FETZIMA should not be started until 2 weeks after MAOI discontinuation. Cardiovascular conditions including myocardial infarction or cardiac intervention within the past 12 months, NYHA Class III or IV congestive heart failure, uncontrolled tachyarrhythmia, uncontrolled hypertension, or a history of cerebrovascular accident.

Warnings and precautions

Increased risk of self-harm, harm to others, suicidal thinking and behavior with antidepressants use. Closely monitor all antidepressant-treated patients for clinical worsening and for emergence of agitation-type and/or suicidal thoughts and behaviors. Potential association with behavioural and emotional changes, including self-harm. Discontinuation Symptoms: Do not discontinue abruptly; gradual reduction is recommended. Monitor for dysphoric mood, irritability, agitation, dizziness, sensory disturbances, anxiety, confusion, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. Bone Fracture Risk: Increased risk of bone fractures with SSRIs/SNRIs, especially at initial stages of treatment. Consider fracture risk in patients, advise elderly and those with risk factors of increased fall risk (dizziness, orthostatic hypotension). Cardiovascular: Inhibition of NE and 5-HT reuptake can lead to cardiovascular effects. Excluded patients with severe cardiac function impairment, identified risk of serious cardiac arrhythmia, uncontrolled hypertension, or severe/unstable coronary heart disease from trials. Elevated Blood Pressure and Hypertension: Associated with mean increases in SBP and DBP. Sustained hypertension instances were more frequent. Discontinuation or medical intervention should be considered for sustained increases. Elevated Heart Rate: Associated with increased heart rate. Monitor heart rate prior to and periodically throughout treatment. Discontinuation or medical intervention should be considered for increased heart rate. Dependence/Tolerance: Not systematically studied for abuse or dependence potential. Physicians should evaluate patients for drug abuse history and monitor for signs of misuse or abuse. Driving and Operating Machinery: Caution patients about operating hazardous machinery until certain FETZIMA does not adversely affect ability. Diabetic Patients: Use with caution in diabetic patients on insulin or other antidiabetic drugs. Monitor glycemic control. Urinary Hesitation, Retention and Dysuria: Noradrenergic effect can affect urethral resistance. Higher rates of obstructive uropathies observed in male patients. Caution with concomitant medications affecting voiding and in patients with history of obstructive urinary disorders. Consider discontinuation or dose reduction if symptoms develop. Hyponatremia: May occur, especially in elderly, those taking diuretics, or volume depleted. Discontinue FETZIMA and intervene medically for symptomatic hyponatremia. Hematologic (Abnormal Bleeding): May increase risk of bleeding events by causing abnormal platelet aggregation. Caution with concomitant use of NSAIDs, ASA, or other anticoagulants. Caution in patients with bleeding disorders or predisposing conditions. Serum Cholesterol: Clinically relevant increases in total serum cholesterol observed. Periodic measurement of serum cholesterol levels should be considered. Serum Glucose: Cases of altered glycemic control and new onset diabetes mellitus reported. Monitor for glucose fluctuations. Seizures: Prescribe with caution in patients with a seizure disorder. Serotonin toxicity / serotonin syndrome: Potentially life-threatening condition. Characterized by neuromuscular excitation, autonomic stimulation, and altered mental state. Discontinuation of serotonergic agents should be considered if suspected. Ophthalmologic (Angle-Closure Glaucoma): Can cause mydriasis, potentially triggering angle-closure attack. Seek immediate medical assistance for eye pain, vision changes, swelling/redness around the eye. Psychiatric (Potential Association with Behavioural and Emotional Changes, Including Self-Harm): Increased risk of suicidal ideation and behavior in pediatric patients. Rigorous clinical monitoring for suicidal ideation or other indicators of potential for suicidal behavior is advised in patients of all ages. Activation of Mania/Hypomania: Reported in clinical studies. Use cautiously in patients with hi

What can be used instead?

Other Canadian products sharing ATC code N06AX28 LEVOMILNACIPRAN. 4 of 4 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.