Belviq XR

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• cabergoline;

• linezolid;

• lithium;

• St. John's wort;

• tramadol;

• tryptophan (also called L-tryptophan);

• any type of antidepressant;

• cold or cough medicine that contains dextromethorphan (a cough suppressant);

• erectile dysfunction medicine--avanafil, sildenafil, tadalafil, Cialis, Levitra, Viagra, and others;

• medicine to treat mental illness, anxiety, or a mood disorder; or

• a "triptan" migraine headache medicine--such as almotriptan, frovatriptan, rizatriptan, sumatriptan, zolmitriptan, Imitrex, Maxalt, Zomig, and others.

This list is not complete. Other drugs may interact with lorcaserin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

In the U.S.

• Belviq
• Belviq XR

Available Dosage Forms:

• Tablet, Extended Release
• Tablet

Therapeutic Class: Antiobesity Agent

Lorcaserin is used together with a reduced-calorie diet and proper exercise to help you lose weight. It is also used in overweight people who may also have diabetes, high blood pressure, high cholesterol, or heart disease.

This medicine is available only with your doctor's prescription.

• It is used to help you lose weight.

• Tell all of your health care providers that you take Belviq XR. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• Follow the diet and workout plan that your doctor told you about.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• If you have high blood sugar (diabetes) and take drugs to lower blood sugar, talk with your doctor. Weight loss may raise the chance of low blood sugar if you take drugs to lower blood sugar. Call your doctor right away if you have signs of low blood sugar like dizziness, headache, feeling sleepy, feeling weak, shaking, a fast heartbeat, confusion, hunger, or sweating.
• Certain drugs used for weight loss have been linked to very bad and sometimes deadly high blood pressure in the lungs (pulmonary hypertension). It is not known if Belviq XR raises the chance of this health problem. Talk with your doctor.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Some people taking drugs like this one have had heart valve problems. Call your doctor right away if you have dizziness, tiredness, or weakness that will not go away; fast heartbeat or a heartbeat that does not feel normal; swelling in your arms or legs; or trouble breathing.
• Call your doctor right away if you have a painful erection (hard penis) or an erection that lasts for longer than 4 hours. This may happen even when you are not having sex. If this is not treated right away, it may lead to lasting sex problems and you may not be able to have sex.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine, call your doctor right away.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

BELVIQ XR is provided as orange, film-coated, tablet for oral administration in the strength of 20 mg as lorcaserin hydrochloride. The tablets are round, biconvex, debossed with “A” on one side and “20” on the other side.

7.1       Use with Other Agents that Affect Serotonin Pathways

Based on the mechanism of action of lorcaserin and the theoretical potential for serotonin syndrome, use with extreme caution in combination with other drugs that may affect the serotonergic neurotransmitter systems, including, but not limited to, triptans, monoamine oxidase inhibitors (MAOIs, including linezolid, an antibiotic which is a reversible non-selective MAOI), selective serotonin reuptake inhibitors (SSRIs), selective serotonin-norepinephrine reuptake inhibitors (SNRIs), dextromethorphan, tricyclic antidepressants (TCAs), bupropion, lithium, tramadol, tryptophan, and St. John’s Wort [see Warnings and Precautions (5.1)].

7.2       Cytochrome P450 (2D6) substrates

Use caution when administering Belviq XR together with drugs that are CYP 2D6 substrates, as Belviq XR can increase exposure of these drugs [see Clinical Pharmacology (12.3)].

No experience with overdose of lorcaserin is available. In clinical studies that used doses that were higher than the recommended dose, the most frequent adverse reactions associated with lorcaserin were headache, nausea, abdominal discomfort, and dizziness. Single 40- and 60-mg doses of immediate-release lorcaserin hydrochloride caused euphoria, altered mood, and hallucination in some subjects. Treatment of overdose should consist of lorcaserin discontinuation and general supportive measures in the management of overdosage. Lorcaserin is not eliminated to a therapeutically significant degree by hemodialysis.