Consumer medicine information

1. Why am I using DESVEN?

DESVEN contains the active ingredient desvenlafaxine. DESVEN is used in the treatment and prevention of relapse of depression. For more information, see Section 1. Why am I using DESVEN? in the full CMI.

2. What should I know before I use DESVEN?

Do not use if you have ever had an allergic reaction to desvenlafaxine, venlafaxine or any of the ingredients listed at the end of the CMI. Do not take DESVEN if you are taking other medications for depression known as monoamine oxidase inhibitors, even if you have stopped taking them, but have taken them within the last 14 days.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. DESVEN is not recommended for use during pregnancy or breastfeeding.
For more information, see Section 2. What should I know before I use DESVEN? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with DESVEN and affect how it works. These include medications for depression known as monoamine oxidase inhibitors, any other medications for bipolar disorder, depression, anxiety, obsessive-compulsive disorder or pre-menstrual dysphoric disorder, ADHD, drugs that affect serotonin levels, medicines for weight loss, triptans, aspirin or NSAIDs and warfarin. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I take DESVEN?

• Usual dose is 50 mg taken once daily with or without food. Swallow the tablets whole with a glass of water or other non-alcoholic liquid. Do not divide, crush, chew or place the tablets in water.

5. What should I know while using DESVEN?

6. Are there any side effects?

Common side effects of DESVEN include stomach, bowel or urinary tract problems (e.g. nausea, diarrhoea, constipation, difficulty passing urine), change in behaviour (e.g. difficulty/abnormal sleeping, anxiety, irritable), difficulty in thinking or working (due to yawning, disturbed concentration, fainting/dizziness, fatigue), excessive sweating, hot flushes, rash, weight gain/loss or changes to sensory (vision, hearing, taste). Seek emergency treatment if you experience symptoms of neuroleptic malignant syndrome or serotonin syndrome.
Tell your doctor immediately if you experience negative changes to mood or behaviour, worsening depression including thoughts of suicide.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Desvenlafaxine.

2 Qualitative and Quantitative Composition

Desven is formulated as an extended-release tablet for once-a-day oral administration. Two strengths of Desven tablets are available, containing 50 mg or 100 mg of desvenlafaxine.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Extended release tablet
50 mg. Light pink coloured, diamond shaped, biconvex tablets, debossed with '11I' on one side and plain on other side.
100 mg. Dark brown to red coloured, diamond shaped, biconvex tablets, debossed with '17I' on one side and plain on other side.

4 Clinical Particulars

4.9 Overdose

There is limited clinical experience with desvenlafaxine overdosage in humans. In clinical trials, no cases of fatal acute overdose of desvenlafaxine were reported.
Among the patients included in the major depressive disorder trials of desvenlafaxine, there were four adults who ingested doses greater than 800 mg of desvenlafaxine (4000 mg [desvenlafaxine alone], 900, 1800 mg and 5200 mg [in combination with other drugs]); all patients recovered. In addition, a patient's 11-month-old child accidentally ingested 600 mg of desvenlafaxine, was treated, and recovered.
In post-marketing experience, overdose cases (including cases with fatal outcome) have been reported with desvenlafaxine in combination with alcohol and/or other medicinal products.
Management of overdose. In managing an overdose, consider the possibility of multiple drug involvement. The physician should consider contacting a poison control centre for additional information on the treatment of any overdose. Treatment should consist of those general measures employed in the management of overdosage with any SSRI/SNRI.
General supportive and symptomatic measures are recommended. Ensure an adequate airway, oxygenation and ventilation. Cardiac rhythm and vital signs must be monitored. Administration of activated charcoal may also limit drug absorption. Where there is a risk of aspiration, induction of emesis is not recommended. No specific antidotes for desvenlafaxine are known. Forced diuresis, dialysis, haemoperfusion and exchange transfusion are unlikely to be of benefit.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Desvenlafaxine was not genotoxic in in vitro assays for bacterial gene mutation, mammalian gene mutation, chromosomal aberrations and cell transformation, or in in vivo tests for clastogenic activity in mice and rats.
Carcinogenicity. Desvenlafaxine did not increase the incidence of tumours in long-term mouse and rat carcinogenicity studies at oral doses up to 7 (mice), 14 (male rats) and 23 (female rats) times the maximal recommended human dose of 200 mg/day, on a mg/m² basis.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Desvenlafaxine is a white to off-white crystalline powder that is sparingly soluble in dimethyl sulphoxide. The solubility of desvenlafaxine is pH dependent.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSDESVLF.gif Chemical name: RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol.
Molecular formula: C₁₆H₂₅NO₂.
Molecular weight: 263.38.
CAS number. 93413-62-8.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes

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