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APO-DESVENLAFAXINE is a brand name for Desvenlafaxine, supplied as a tablet (extended-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: APO-DESVENLAFAXINE (desvenlafaxine extended-release tablets (as base)) is indicated for: • symptomatic relief of major depressive disorder in adults. The short-term efficacy of desvenlafaxine has been demonstrated in placebo-controlled trials of up to 8 weeks. The efficacy of desvenlafaxine in maintaining an…
Verbatim from this product's HC label. Tap a section to expand.
) APO-DESVENLAFAXINE (Desvenlafaxine Extended-Release Tablets) Page 6 of 64 • APO-DESVENLAFAXINE is not indicated for use in children under the age of 18. 1 Pregnant Women). • Due to the potential for life-threatening serotonin toxicity: − Concurrent use with MAOIs is contraindicated.
− Washout periods are necessary if switching between desvenlafaxine and MAOIs. − Use with other serotonergic agents is not recommended (see 7 WARNINGS AND PRECAUTIONS, Neurologic, Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-Like Reactions).
− Dose tapering is recommended when switching between antidepressants, including venlafaxine. • Dosing: − Reduced doses may be needed for the elderly, and those with renal impairment. − All dose changes should be gradual, including discontinuation.
− Monitor for discontinuation symptoms when decreasing or stopping treatment. • Periodically reassess the need for ongoing therapy. • Monitor for agitation, suicidal tendencies. Rigorous clinical monitoring for suicidal ideation or other indicators of potential for suicidal behaviour is advised in patients of all ages, especially when initiating therapy or during any change in dose or dosage regimen.
This includes monitoring for agitation-type emotional and behavioural changes. See 7 WARNINGS AND PRECAUTIONS, Psychiatric, Potential Association with Behavioural and Emotional Changes, Including Self-Harm. 2 Recommended Dose and Dosage Adjustment • Initial Treatment The recommended starting dose of APO-DESVENLAFAXINE (desvenlafaxine (as base) extended- release tablets) is 50 mg once daily, with or without food.
In clinical studies, no additional benefit was demonstrated at doses greater than 50 mg/day. If the physician, based on clinical judgment, decides a dose increase above 50 mg/day is warranted for an individual patient, the maximum recommended dose should not exceed 100 mg/day.
In clinical studies, doses of 50 to 400 mg/day were shown to be effective, although no additional benefit was demonstrated at doses greater than 50 mg/day, and adverse events and discontinuations were more frequent at higher doses.
Patients should be periodically reassessed to determine the need for continued treatment. APO-DESVENLAFAXINE (Desvenlafaxine Extended-Release Tablets) Page 7 of 64 • Maintenance/Continuation/Extended Treatment It is generally agreed that acute episodes of major depression require several months or longer of sustained pharmacologic therapy beyond response to the acute episode.
, Vital Sign Changes). • Serum Lipids Increases in cholesterol (total and LDL) and triglycerides were observed in some patients treated with desvenlafaxine in placebo-controlled pre-marketing clinical trials, particularly with higher doses.
Measurement of serum lipid levels should be considered during treatment. Musculoskeletal Epidemiological studies show an increased risk of bone fractures following exposure to some antidepressants, including SSRIs/SNRIs. The risks appear to be greater at the initial stages of treatment, but significant increased risks were also observed at later stages of treatment.
The possibility of fracture should be considered in the care of patients treated with APO- DESVENLAFAXINE. Elderly patients and patients with important risk factors for bone fractures should be advised of possible adverse events which increase the risk of falls, such as dizziness and orthostatic hypotension, especially at the early stages of treatment but also soon after withdrawal.
Preliminary data from observational studies show association of SSRIs/SNRIs and low bone mineral density in older men and women. Until further information becomes available, a possible effect on bone mineral density with long term treatment with SSRIs/SNRIs, including APO-DESVENLAFAXINE, cannot be excluded, and may be a potential concern for patients with osteoporosis or major risk factors for bone fractures.
APO-DESVENLAFAXINE (Desvenlafaxine Extended-Release Tablets) Page 16 of 64 Neurologic • Seizures Cases of seizures have been reported in trials with desvenlafaxine. APO-DESVENLAFAXINE should be prescribed with caution in patients with a seizure disorder.
Desvenlafaxine has not been systematically evaluated in patients with a seizure disorder. 4 Drug-Drug Interactions, Serotonergic Agents). g. g. anxiety, agitation, hypomania). In accordance with the Hunter Criteria, serotonin toxicity diagnosis is likely when, in the presence of at least one serotonergic agent, one of the following is observed: • Spontaneous clonus • Inducible clonus or ocular clonus with agitation or diaphoresis • Tremor and hyperreflexia • Hypertonia and body temperature > 38°C and ocular clonus or inducible clonus.
, General, Neurologic 10/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS .................................................................................................................. 1 Pediatrics ....................................................................................................................
2 Geriatrics .................................................................................................................... 4 2 CONTRAINDICATIONS .....................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................ 5 4 DOSAGE AND ADMINISTRATION .................................................................................... 1 Dosing Considerations ................................................................................................
2 Recommended Dose and Dosage Adjustment ........................................................... 4 Administration ............................................................................................................ 5 Missed Dose ...............................................................................................................
9 Discontinuation .......................................................................................................... 9 5 OVERDOSAGE .................................................................................................................
• Monoamine Oxidase Inhibitors (MAOIs) APO-DESVENLAFAXINE must not be used concomitantly in patients taking monoamine oxidase inhibitors (MAOIs), or in patients who have taken MAOIs within the preceding 14 days. APO-DESVENLAFAXINE (Desvenlafaxine Extended-Release Tablets) Page 5 of 64 There is a risk of serious, sometimes fatal, drug interactions with selective serotonin reuptake inhibitor (SSRI) or serotonin norepinephrine reuptake inhibitor (SNRI) treatments, or with other serotonergic drugs when they are used concomitantly or within 14 days after an MAOI.
2 Recommended Dose and Dosage Adjustment, Use of Reversible MAOIs, such as Linezolid or Methylene Blue. These interactions have been associated with symptoms that include tremor, myoclonus, diaphoresis, nausea, vomiting, flushing, dizziness, hyperthermia with features resembling neuroleptic malignant syndrome, seizures, rigidity, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma.
Based on the half-life of desvenlafaxine, at least 7 days should be allowed after stopping desvenlafaxine and before starting an MAOI. 4 Drug-Drug Interactions, Serotonergic Agents. • Hypersensitivity APO-DESVENLAFAXINE is contraindicated in patients who are hypersensitive to venlafaxine, or to this drug (desvenlafaxine), or to any ingredient in the APO-DESVENLAFAXINE formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Long-term efficacy of desvenlafaxine (50 mg daily) for up to 26 weeks, following response during 20 weeks of acute, open-label treatment, was established in a placebo-controlled trial. Patients should be periodically reassessed to determine the need for maintenance treatment.
9 Discontinuation). • Switching Patients from Other Antidepressants to APO-DESVENLAFAXINE Discontinuation symptoms have been reported when switching patients from other antidepressants, including venlafaxine, to desvenlafaxine. Tapering of the initial antidepressant may be necessary to minimize discontinuation symptoms (see 2 CONTRAINDICATIONS).
• Switching Patients to or from a Monoamine Oxidase Inhibitor At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with APO-DESVENLAFAXINE. In addition, based on the half-life of desvenlafaxine, at least 7 days should be allowed after stopping desvenlafaxine before starting an MAOI.
• Use of Reversible MAOIs, such as Linezolid or Methylene Blue Do not start APO-DESVENLAFAXINE in a patient who is being treated with a reversible MAOI such as linezolid or in whom intravenous methylene blue has been administered because there is increased risk of serotonin syndrome (see 2 CONTRAINDICATIONS).
In a patient who requires more urgent treatment of a psychiatric condition, non-pharmacological interventions, including hospitalization, should be considered. In some cases, a patient already receiving APO-DESVENLAFAXINE therapy may require urgent treatment with linezolid or intravenous methylene blue.
If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue are judged to outweigh the risks of serotonin syndrome in a particular patient, APO-DESVENLAFAXINE should be stopped promptly, and linezolid or intravenous methylene blue can be administered.
The patient should be monitored for symptoms of serotonin syndrome for two weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first (see 7 WARNINGS AND PRECAUTIONS). Therapy with APO-DESVENLAFAXINE may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue.
APO-DESVENLAFAXINE (Desvenlafaxine Extended-Release Tablets) Page 8 of 64 Special Populations • Severe renal impairment and end-stage renal disease The recommended dose in patients with severe renal impairment (24-hr CrCl < 30 mL/min) or end-stage renal disease (ESRD) is 50 mg every other day.
Because of individual variability in clearance in these patients, individualization of dosage may be desirable. 3 Pharmacokinetics, Renal Insufficiency). 3 Pharmacokinetics, Hepatic Insufficiency). • Geriatrics (≥ 65 years of age) No dosage adjustment is required solely on the basis of age; however, possible reduced renal […]
Neuroleptic malignant syndrome has also been rarely reported with desvenlafaxine, particularly during combined use with neuroleptic/antipsychotic drugs. The clinical manifestations of neuroleptic malignant syndrome often overlap with those of serotonin toxicity, including hyperthermia, hypertonia, altered mental status, and autonomic instability.
In contrast to serotonin toxicity, patients with neuroleptic malignant syndrome may present with “lead pipe” muscle rigidity as well as hyporeflexia. The concomitant use of APO-DESVENLAFAXINE with MAOIs, including linezolid and methylthioninium chloride (methylene blue) is contraindicated (see 2 CONTRAINDICATIONS).
4 Drug-Drug Interactions, Serotonergic Agents). If concomitant treatment with APO- DESVENLAFAXINE and other serotonergic agents is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.
If serotonin toxicity is suspected, discontinuation of the serotonergic agents should be considered. Ophthalmologic APO-DESVENLAFAXINE (Desvenlafaxine Extended-Release Tablets) Page 17 of 64 • Angle-Closure Glaucoma As with other antidepressants, APO-DESVENLAFAXINE can cause mydriasis, which may trigger an angle-closure attack in a patient with anatomically narrow ocular angles.
Healthcare providers should inform patients to seek immediate medical assistance if they experience eye pain, changes in vision or swelling or redness in or around the eye. Psychiatric • POTENTIAL ASSOCIATION WITH BEHAVIOURAL AND EMOTIONAL CHANGES, INCLUDING SELF-HARM.
• Pediatrics: Placebo-Controlled Clinical Trial Data Recent analyses of placebo-controlled clinical trial safety databases from Selective Serotonin Reuptake Inhibitors (SSRIs) and other newer anti-depressants suggest that use of these drugs in patients under the age of 18 may be associated with behavioural and emotional changes, including an increased risk of suicidal ideation and behaviour over that of placebo.
The small denominators in the clinical trial database, as well as the variability in placebo rates, preclude reliable conclusions on the relative safety profiles among the drugs in the class. APO-DESVENLAFAXINE is not indicated for use in pediatric patients (see 1 INDICATIONS).
• Adults and Pediatrics: Additional data There are clinical trial and post-marketing reports with SSRIs and other newer antidepressants in both pediatrics and adults of severe agitation-type adverse events coupled with self-harm or harm to others.
The agitation-type events include: akathisia, agitation, disinhibition, emotional lability, hostility, aggression, depersonalization. In some cases, the events occurred within several weeks of starting treatment. An FDA meta-analysis of placebo-controlled clinical trials of antidepressant drugs in adult patients ages 18 to 24 years with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo.
Rigorous clinical monitoring for suicidal ideation or other indicators of potential for suicidal behaviour is advised in patients of all ages especially when initiating therapy or during […]
9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................. 11 7 WARNINGS AND PRECAUTIONS .................................................................................... 1 Special Populations...................................................................................................
1 Pregnant Women ..................................................................................................... 2 Breast-feeding ..........................................................................................................
3 Pediatrics .................................................................................................................. 4 Geriatrics ..................................................................................................................
20 8 ADVERSE REACTIONS .................................................................................................... 1 Adverse Reaction Overview ......................................................................................
2 Clinical Trial Adverse Reactions ................................................................................ 1 Clinical Trial Adverse Reactions - Pediatrics.............................................................. 5 Post-Market Adverse Reactions ...............................................................................
31 9 DRUG INTERACTIONS ................................................................................................... 1 Serious Drug Interactions .........................................................................................
2 Drug Interactions Overview ...................................................................................... 3 Drug-Behavioural Interactions.................................................................................. 4 Drug-Drug Interactions .............................................................................................
5 Drug-Food Interactions............................................................................................. 6 Drug-Herb Interactions .............................................................................................
7 Drug-Laboratory Test Interactions............................................................................ 38 10 CLINICAL PHARMACOLOGY ........................................................................................... 1 Mechanism of Action ................................................................................................
2 Pharmacodynamics .................................................................................................. 3 Pharmacokinetics .....................................................................................................
38 11 STORAGE, STABILITY AND DISPOSAL............................................................................. 42 12 SPECIAL HANDLING INSTRUCTIONS .............................................................................. 42 PART II: SCIENTIFIC INFORMATION ........................................................................................
43 13 PHARMACEUTICAL INFORMATION ............................................................................... 43 14 CLINICAL TRIALS ...........................................................................................................
1 Trial Design and Study Demographics ...................................................................... 2 Study Results ............................................................................................................
3 Comparative Bioavailability Studies.......................................................................... 45 15 MICROBIOLOGY […]