FETZIMA 80 MG

What is FETZIMA?

FETZIMA 80 MG contains LEVOMILNACIPRAN (LEVOMILNACIPRAN HYDROCHLORIDE) : 80 MG. It is listed in the Health Canada Drug Product Database under DIN 02440997, 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?

Adults: The recommended dose range for FETZIMA is 40 mg to 120 mg once daily. FETZIMA should be initiated at 20 mg once daily for 2 days and then increased to 40 mg once daily. If the physician decides a dose increase above 40 mg/day is warranted, the dose may be increased in increments of 40 mg. The maximum recommended dose should not exceed 120 mg/day. FETZIMA should be taken at approximately the same time each day, swallowed whole (do not open, chew or crush the capsule), and can be taken with or without food. For patients with moderate renal impairment (creatinine clearance of 30-59 mL/min), the dose should not exceed 80 mg/day. For patients with more severe renal impairment (creatinine clearance of 15-29 mL/min), the dose should not exceed 40 mg/day. FETZIMA is not recommended for patients with end stage renal disease. Gradual dose reduction is recommended when discontinuing treatment to avoid discontinuation symptoms.

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

How is it stored and handled?

FETZIMA should be stored 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 who are hypersensitive to levomilnacipran, milnacipran or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. FETZIMA should not be used in combination with MAOIs, including linezolid, an antibiotic, methylene blue, a dye used in certain surgeries, or within two weeks of terminating treatment with MAOIs. Treatment with MAOIs should not be started until 2 weeks after discontinuation of FETZIMA therapy. FETZIMA should not be used in patients with: myocardial infarction or cardiac intervention within the past 12 months, NYHA Class III or IV congestive heart failure, uncontrolled tachyarrhythmia, uncontrolled hypertension, 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. Patients should NOT be discontinued abruptly due to risk of discontinuation symptoms. Serotonin toxicity (serotonin syndrome) is a potentially life-threatening condition, especially with concomitant use of other serotonergic drugs or MAOIs. Elevated Blood Pressure and Hypertension: FETZIMA was associated with mean increases in systolic and diastolic blood pressure. Blood pressure should be measured prior to and periodically throughout treatment. Elevated Heart Rate: SNRIs, including FETZIMA, have been associated with increased heart rate. Heart rate should be measured prior to and periodically throughout treatment. Patients with serious or uncontrolled tachyarrhythmias, ischemic heart disease, or congestive heart failure should not receive FETZIMA. Hyponatremia: May occur, especially in elderly patients, those taking diuretics, or who are volume depleted. Abnormal Bleeding: SSRIs and SNRIs, including FETZIMA, may increase the risk of bleeding events. Concomitant use with NSAIDs, ASA, or other anticoagulants may add to this risk. Seizures: Use with caution in patients with a seizure disorder. Angle-Closure Glaucoma: May cause mydriasis, triggering an angle-closure attack in patients with anatomically narrow ocular angles. Activation of Mania/Hypomania: Use cautiously in patients with a history or family history of bipolar disorder, mania, or hypomania. Not approved for use in treating bipolar depression.

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.