Lorcaserin

• Belviq^®

Pregnancy

Contraindicated during pregnancy, because weight loss offers no benefit to a pregnant woman and may result in fetal harm; limited data on lorcaserin use in pregnant women are not sufficient to determine drug-associated risk of major congenital malformations or miscarriage; 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; in rats, maternal exposure to lorcaserin in late pregnancy resulted in lower body weight in offspring which persisted to adulthood; advise pregnant women of potential risk to a fetus

Lactation

There are no data on presence of lorcaserin in human milk, effects on breastfed infant, or effects on milk production; because of potential for serious adverse reactions in breastfed infant, advise women receiving therapy that product is not recommended while breastfeeding

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of Belviq (lorcaserin) for weight management is 10 mg twice a day.

Lorcaserin affects chemical signals in the brain that control appetite. Lorcaserin works by helping you feel full with smaller meals.

Lorcaserin is used together with diet and exercise to treat obesity.

Lorcaserin is sometimes used to treat obesity that may be related to diabetes, high cholesterol, or high blood pressure.

Lorcaserin will not treat any underlying health condition (such as heart disease, diabetes, high blood pressure). Keep taking any other medications your doctor has prescribed to treat these conditions.

Lorcaserin may also be used for purposes not listed in this medication guide.

Do not use lorcaserin if you are pregnant. Weight loss during pregnancy can harm an unborn baby.

Serious drug interactions can occur when certain medicines are used together with lorcaserin. Tell each of your healthcare providers about all medicines you use now, and any medicine you start or stop using.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

The regular tablet is usually taken 2 times per day. The extended-release tablet is taken only once per day. Follow your doctor's instructions.

Do not crush, chew, or break an extended-release tablet. Swallow it whole.

You may take lorcaserin with or without food.

You should lose at least 5% of your starting weight during the first 12 weeks of taking lorcaserin and eating a low calorie diet. Call your doctor if you do not lose at least 5% of your starting weight after taking the medicine for 12 weeks.

Lorcaserin is only part of a complete program of treatment that also includes diet, exercise, weight control, and possibly testing your blood sugar. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Lorcaserin is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not share lorcaserin with another person. Keep the medication in a place where others cannot get to it.

• Lorcaserin HCl
• Lorcaserin Hydrochloride

• Belviq
• Belviq XR

Weight management: Oral: Note: Evaluate response by week 12; if patient has not lost ≥5% of baseline body weight, discontinue therapy

Extended release: 20 mg once daily (maximum: 20 mg/day).

Immediate release: 10 mg twice daily (maximum: 20 mg/day).

Refer to adult dosing.

Applies to lorcaserin: oral tablet, oral tablet extended release

Along with its needed effects, lorcaserin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking lorcaserin:

• Anxiety
• bladder pain
• bloody or cloudy urine
• blurred vision
• body aches or pain
• chills
• cold sweats
• coma
• confusion
• cool, pale skin
• cough
• depression
• difficult, burning, or painful urination
• difficulty with breathing
• dizziness
• ear congestion
• fast heartbeat
• fever
• frequent urge to urinate
• headache
• increased hunger
• loss of voice
• lower back or side pain
• nasal congestion
• nausea
• nightmares
• pounding in the ears
• runny nose
• seizures
• shakiness
• slow or fast heartbeat
• slurred speech
• sneezing
• sore throat
• swelling of the breasts or breast soreness in both females and males
• unexpected or excess milk flow from the breasts
• unusual tiredness or weakness

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• decreased ability to exercise
• dry mouth
• flushed, dry skin
• fruit-like breath odor
• increased hunger
• increased sensitivity to sunlight
• increased thirst
• increased urination
• itching, pain, redness, or swelling of the eye or eyelid
• joint pain
• loss of consciousness
• rapid weight gain
• severe skin rash or hives
• stomachache
• sweating
• swollen glands
• tingling of the hands or feet
• trouble with breathing
• trouble with sleeping
• unexplained weight loss
• unusual weight gain or loss
• vomiting
• watering of the eyes

• Black, tarry, stools
• chest pain
• cough or hoarseness
• pale skin
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• unusual bleeding or bruising

• Agitation
• confusion
• convulsions
• diarrhea
• high fever
• increased sweating
• loss of bladder control
• overactive reflexes
• painful or prolonged erection of the penis
• poor coordination
• restlessness
• severe muscle stiffness
• shivering
• talking or acting with excitement you cannot control
• trembling or shaking
• twitching
• unusually pale skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking lorcaserin:

• Abdominal or stomach discomfort
• false or unusual sense of well-being
• seeing, hearing, or feeling things that are not there

Some side effects of lorcaserin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Back pain
• difficulty having a bowel movement (stool)
• muscle aches

• Decreased appetite
• difficulty with concentration
• dry eyes
• muscle spasms
• muscle, joint, or bone pain
• problems with memory
• rash
• sleeplessness
• stress
• toothache
• trouble seeing

-Hemodialysis: This drug is not eliminated to a therapeutically significant degree by hemodialysis; no dose adjustment guidelines have been reported.
-Peritoneal Dialysis: Data not available.

Administration Advice:
-Do not exceed recommended dose.
-Take with or without food.

General:
-The effect of this drug on cardiovascular morbidity and mortality has not been established.
-The safety and effectiveness of this drug in combination with other weight loss products, including prescription and over-the-counter drugs and herbal preparations, have not been established.
-This drug's ability to produce hallucinations, euphoria, and positive subjective responses at supratherapeutic doses suggest this drug may produce psychic dependence. There are no controlled data in animal or human studies that evaluate dependence.

Monitoring:
Endocrine: Blood glucose levels (prior to and during treatment in type 2 diabetic patients), prolactin (when prolactin excess is suspected)
Hematologic: CBC (periodically during treatment)
Nervous: Serotonin syndrome/Neuroleptic Malignant Syndrome-like signs and symptoms
Psychiatric: Depression, suicidal thoughts or behavior, unusual changes in mood or behavior