Belviq

Unless your doctor tells you otherwise, continue your normal diet.

Lorcaserin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• constipation
• dry mouth
• excessive tiredness
• pain in the back or muscles
• headache
• dizziness
• difficulty falling asleep or staying asleep
• anxiety
• difficult, painful, or frequent urination
• cough
• toothache
• blurred vision or other vision changes
• dry eyes

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• agitation
• confusion
• hallucinations (seeing things or hearing voices that are not there)
• difficulty with coordination
• muscle spasms, stiffness, or twitching
• restlessness
• fast, slow, or irregular heartbeat
• sweating
• fever
• nausea
• vomiting
• diarrhea
• difficulty breathing
• swelling of the hands, arms, feet, or legs
• difficulty paying attention or remembering information
• depression
• thinking about harming or killing yourself or planning or trying to do so
• feeling high or unusually happy
• feeling as though you are outside of your body
• erection that lasts longer than 4 hours
• discharge from the breast
• breast enlargement in males

Lorcaserin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to lorcaserin.

Do not let anyone else take your medication. Lorcaserin is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

The most common side effects are:

• headache,
• dizziness,
• fatigue,
• nausea,
• dry mouth,
• constipation, and
• hypoglycemia (low blood sugar).

Other less common but serious side effects associated with lorcaserin include:

• heart valve problems,
• changes in attention or memory,
• mental problems,
• depression or thoughts of suicide,
• painful erections,
• slow heartbeat,
• a drop in blood cell count, and
• an increase in the hormone, prolactin.

Belviq is part of the drug class:

• Centrally acting antiobesity products

Serious side effects have been reported with Belviq including the following:

• Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS) like reactions. Tell your healthcare provider right away if you have some or all of the following symptoms:
  • mental changes such as agitation, hallucinations, confusion, or other changes in mental status
  • coordination problems, uncontrolled muscle spasms, or muscle twitching (overactive reflexes)
  • restlessness
  • racing or fast heart beat, high or low blood pressure
  • sweating or fever
  • nausea, vomiting, or diarrhea
  • muscle rigidity (stiff muscles)
• Valvular Heart disease. Some people taking medications like Belviq have had problems with the valves in their heart. Tell your healthcare provider right away if you have some or all of the following symptoms:
  • trouble breathing
  • swelling of the arms, legs, ankles, or feet
  • dizziness, fatigue, or weakness that will not go away
  • fast or irregular heart beat
• Changes in your attention or memory.
• Mental problems. Tell your doctor if you notice:
  • hallucinations
  • feeling high or in a very good mood (euphoria)
  • feelings of standing next to yourself or out of your body
• Depression or thoughts of suicide. Pay attention to any mental changes, especially sudden changes, in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.
• Low blood sugar (hypoglycemia) in people with type 2 diabetes mellitus who also take medications, such as insulin or sulfonylureas, used to treat type 2 diabetes mellitus. Monitor your blood sugar before you start Belviq and during your treatment with Belviq .
• Painful erections (priapism). Belviq can cause painful erections that last more than 6 hours. If you have an erection lasting more than 4 hours whether it is painful or not, stop using Belviq and call your doctor or go to the nearest emergency room right away.
• Slow heart beat. Tell your doctor if have a history of your heart beating slow or heart block.
• Decreases in blood cell counts. Belviq can cause your red and white blood cell counts to decrease. Your doctor may do tests to check your blood counts while taking Belviq.
• Increase in prolactin. Tell your doctor if your breasts begin to make milk or a milky discharge or if you are a male and your breasts begin to increase in size.

Belviq can slow your thinking and cause dizziness. Do not drive a car or operate heavy machinery until you know how Belviq affects you.

Do not take Belviq if you:

• are allergic to Belviq or to any of its ingredients
• are pregnant or planning to become pregnant

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Belviq crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Belviq.

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

• It is used to help you lose weight.

• Tell all of your health care providers that you take Belviq. 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 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.

Use Belviq as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• To gain the most benefit, do not miss doses.
• Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

● Pregnancy: Weight loss in a pregnant woman offers no benefit and may result in fetal harm [see Use in Specific Populations (8.1)].

● Hypersensitivity: Belviq/Belviq XR is contraindicated in patients with prior hypersensitivity reactions to lorcaserin or to any of the product components. Hypersensitivity reactions have been reported [see Adverse Reactions (6.2)]. 

8.1       Pregnancy

Risk Summary
Belviq/Belviq XR is contraindicated during pregnancy, because weight loss offers no benefit to a pregnant woman and may result in fetal harm [see Clinical Considerations]. Limited data on lorcaserin use in pregnant women are not sufficient to determine a drug-associated risk of major congenital malformations or miscarriage. No adverse developmental effects were observed when lorcaserin was administered to pregnant rats and rabbits during organogenesis at exposures up to 44- and 19-times the clinical dose of 20 mg daily, respectively. In rats, maternal exposure to lorcaserin in late pregnancy resulted in lower body weight in offspring which persisted to adulthood [see Data]. Advise pregnant women of the potential risk to a fetus.

The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage of clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Clinical Considerations
Disease-associated maternal and/or embryofetal risk
Appropriate weight gain based on pre-pregnancy weight is currently recommended for all pregnant women, including those who are already overweight or obese, due to the obligatory weight gain that occurs in maternal tissues during pregnancy.

Data
Animal Data
Reproduction studies were performed in pregnant rats and rabbits that were administered lorcaserin hydrochloride during the period of embryofetal organogenesis. Plasma exposures up to 44 and 19 times the clinical dose of 20 mg daily in pregnant rats and rabbits, respectively, did not reveal evidence of teratogenicity or embryolethality with lorcaserin hydrochloride.

In a pre- and postnatal development study, maternal rats were dosed from gestation through post-natal day 21 at 5, 15, and 50 mg/kg lorcaserin hydrochloride; pups were indirectly exposed in utero and throughout lactation. Stillborns and lower pup viability was observed at 50 mg/kg, or 44 times the clinical dose of 20 mg daily, based on AUC. All other doses lowered pup body weight similarly at birth which persisted to adulthood; however, no developmental abnormalities were observed and reproductive performance was not affected.

8.2       Lactation

Risk Summary
There are no data on the presence of lorcaserin in human milk, the effects on the breastfed infant, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed infant, advise women that use of Belviq/Belviq XR is not recommended while breastfeeding. 

8.4       Pediatric Use

The safety and effectiveness of Belviq/Belviq XR in pediatric patients below the age of 18 have not been established and the use of Belviq/Belviq XR is not recommended in pediatric patients.

8.5       Geriatric Use

In the Belviq clinical trials, a total of 135 (2.5%) of the patients were 65 years of age and older. Clinical studies of Belviq did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects, but greater sensitivity of some older individuals cannot be ruled out.

Since elderly patients have a higher incidence of renal impairment, use of Belviq/Belviq XR in the elderly should be made on the basis of renal function [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. Elderly patients with normal renal function should require no dose adjustment.

8.6       Renal Impairment

No dose adjustment of Belviq/Belviq XR is required in patients with mild renal impairment. Use Belviq/Belviq XR with caution in patients with moderate renal impairment. Use of Belviq/Belviq XR in patients with severe renal impairment or end stage renal disease is not recommended [see Clinical Pharmacology (12.3)].

8.7       Hepatic Impairment

Dose adjustment is not required for patients with mild hepatic impairment (Child-Pugh score 5-6) to moderate hepatic impairment (Child-Pugh score 7-9). The effect of severe hepatic impairment on lorcaserin was not evaluated. Use Belviq/Belviq XR with caution in patients with severe hepatic impairment [see Clinical Pharmacology (12.3)].

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