Valdoxan

(Agomelatine)

The active ingredient in Valdoxan is agomelatine. Agomelatine has a unique mechanism of action compared with selective serotonin reuptake inhibitors (SSRIs) such as sertraline or paroxetine, or selective serotonin norepinephrine reuptake inhibitors (SNRIs). It works as an agonist at melatonin receptors and as an antagonist at the 5-HT2C receptor. This combination helps reset the circadian rhythm and increases the release of noradrenaline and dopamine in certain parts of the brain. Together, these effects support mood improvement and help reduce symptoms of major depressive disorder.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Valdoxan. However, the following is a synopsis of the general guidelines for the use of Valdoxan:

• Take it once daily, at bedtime.
• Your healthcare provider may increase your dose if needed after two weeks of treatment.
• Swallow the film-coated tablets whole with water.
• Blood tests, including liver function tests, are required before treatment, at baseline, routinely, and after dose increase.
• Treatment should continue for several months to prevent relapse of major depressive episodes.
• If you miss a dose, take the next dose at your usual time. Do not take double doses.
• If you stop Valdoxan for more than two weeks, consult your healthcare provider before restarting.

Some mild or common side effects of Valdoxan seen in placebo-controlled clinical trials include:

• Nausea.
• Headache.
• Dizziness.
• Fatigue or sleepiness.
• Anxiety or agitation.
• Back pain.

Some individuals may experience serious side effects while using Valdoxan. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Signs of liver injury, such as jaundice, dark urine, pale stools, right-sided abdominal pain, or itching.
• Hypomania or manic symptoms.
• Severe allergic reaction, including swelling or difficulty breathing.
• Suicidal thoughts.
• Serious skin reactions.

These are not all of the possible adverse reactions of Valdoxan. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Valdoxan, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

Liver disease, liver impairment, or elevated transaminases.

Risk factors for liver injury, such as obesity or diabetes.

A history of mania, bipolar disorder, or hypomania.

Renal impairment.

A history of alcohol misuse or toxicity.

Known hypersensitivity to agomelatine or any component of the formulation.

Liver impairment or transaminases above the upper limit of normal.

Concurrent use with strong CYP1A2 inhibitors such as fluvoxamine or ciprofloxacin.

Some patients may begin to notice sleep and mood improvements within 1–2 weeks, but the full antidepressant effect often develops over several weeks. Treatment should continue long enough to maintain recovery and reduce relapse risk.

When Valdoxan is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

Fluvoxamine, fluoxetine, ciprofloxacin, and estrogens are strong CYP1A2 inhibitors that greatly increase agomelatine levels (bioavailability); concurrent use is contraindicated.

Propranolol, enoxacin, and other moderate CYP1A2 inhibitors may increase agomelatine levels; caution is required.

Rifampicin is an enzyme inducer and may decrease levels of agomelatine.

Smoking induces CYP1A2 and may reduce the antidepressant effect of agomelatine.

Alcohol increases the risk of liver injury and should be avoided during treatment.

There is no experience of concurrent use of agomelatine with electroconvulsive therapy (ECT).

It is available as tablets containing Valdoxan 25mg of agomelatine.

It should be stored at room temperature, away from the reach of children or pets.

Valdoxan is manufactured by Servier Laboratories.

Yes, it is available from many manufacturers of generic drugs.

Do not stop taking Valdoxan without speaking to your healthcare provider. Treatment discontinuation should only be considered after a long enough period to prevent relapse of major depression. Although Valdoxan has a low risk of discontinuation symptoms, your healthcare provider may still guide you in safely stopping therapy.

Limited data are available in pregnant women, so your healthcare provider will determine if the benefits outweigh the risks.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is not known whether agomelatine or its metabolites pass into breast milk, so your healthcare provider will decide whether treatment is appropriate.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.