Lorcaserin (Oral)

Lorcaserin is used along with a lower-calorie diet and regular exercise to assist with weight loss. It is also used for overweight individuals who may have diabetes, high blood pressure, high cholesterol, or heart disease.

This medicine is available only with a prescription from your doctor.

It is very important that your doctor check your progress at regular visits to ensure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to avoid getting pregnant. If you think you may be pregnant while using this medicine, tell your doctor right away.

Make sure your doctor knows about all the other medicines you are using. This medicine may cause serious conditions, like serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions, when taken with certain medicines. Call your doctor right away if you have a fever, confusion, mental changes, restlessness, fast heartbeat, muscle spasms, trouble walking, nausea, vomiting, or diarrhea.

Check with your doctor right away if you experience rapid weight gain, swelling of the ankles, feet, or lower legs, or trouble breathing while using this medicine.

This medicine may cause dizziness, drowsiness, trouble thinking, or poor judgment. Make sure you know how this medicine affects you before you drive, operate machinery, or do other tasks that require alertness or good thinking.

If you develop any unusual or strange thoughts or behavior while taking this medicine, be sure to discuss it with your doctor. Some changes may be more unusual and extreme, such as confusion, worsening depression, hallucinations (seeing, hearing, or feeling things that are not there), suicidal thoughts, and unusual excitement, nervousness, or irritability.

For patients with diabetes: Weight loss may improve your condition but may increase your risk of hypoglycemia (low blood sugar). You should check your blood sugar more often before taking this medicine and during Belviq® treatment. If you notice any changes in your blood sugar levels, check with your doctor.

If you experience a prolonged or painful erection lasting 4 hours or more, contact your doctor immediately. This condition may require prompt medical treatment to prevent serious and permanent damage to your penis.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

In deciding to use a medicine, it’s important to consider the risks versus the benefits. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, inform your healthcare professional about any other types of allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to determine how lorcaserin affects children. Safety and effectiveness have not been established for pediatric patients.

Geriatric

Studies to date have not shown any specific problems in older adults that would limit the effectiveness of lorcaserin. However, older patients are more likely to have kidney issues, which may require caution and a dose adjustment for those taking lorcaserin.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might occur. In these instances, your doctor may adjust the dose or take other precautions. It is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been highlighted based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Thioridazine

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both of the medicines.

• Alfentanil
• Almotriptan
• Amitriptyline
• Amoxapine
• Amphetamine
• Benzhydrocodone
• Benzphetamine
• Brompheniramine
• Buprenorphine
• Buspirone
• Butorphanol
• Carbamazepine
• Chlorpheniramine
• Citalopram
• Clomipramine
• Cocaine
• Codeine
• Cyclobenzaprine
• Desipramine
• Desvenlafaxine
• Dextroamphetamine
• Dextromethorphan
• Dihydrocodeine
• Dolasetron
• Doxepin
• Duloxetine
• Eletriptan
• Escitalopram
• Fenfluramine
• Fentanyl
• Fluoxetine
• Fluvoxamine
• Frovatriptan
• Furazolidone
• Gepirone
• Granisetron
• Hydrocodone
• Hydromorphone
• Hydroxyamphetamine
• Hydroxytryptophan
• Imipramine
• Iproniazid
• Isocarboxazid
• Lasmiditan
• Levomilnacipran
• Levorphanol
• Linezolid
• Lisdexamfetamine
• Lithium
• Meperidine
• Metaxalone
• Methadone
• Methamphetamine
• Methylene Blue
• Milnacipran
• Mirtazapine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Naratriptan
• Nefazodone
• Nortriptyline
• Ondansetron
• Oxycodone
• Oxymorphone
• Palonosetron
• Paroxetine
• Pentazocine
• Phenelzine
• Procarbazine
• Propoxyphene
• Rasagiline
• Remifentanil
• Rizatriptan
• Selegiline
• Sertraline
• Sibutramine
• St John's Wort
• Sufentanil
• Sumatriptan
• Tapentadol
• Tramadol
• Tranylcypromine
• Trazodone
• Tryptophan
• Venlafaxine
• Vilazodone
• Vortioxetine
• Ziprasidone
• Zolmitriptan

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating or with certain types of food because interactions may happen. Using alcohol or tobacco with some medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical conditions may affect how you can use this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Bradycardia (slow heartbeat) or
• Congestive heart failure or
• Depression or
• Diabetes or
• History of heart block or
• Heart valvular disease or
• Hyperprolactinemia (high prolactin in the blood) or
• Hypoglycemia (low blood sugar) or
• History of mental illness or
• History of pulmonary hypertension—Use with caution. May worsen these conditions.

• Moderate kidney disease or
• Severe liver disease—Use with caution. The effects may be increased due to slower removal of the medicine from the body.

• Severe or end-stage kidney disease—Use is not recommended in patients with this condition.

• Abnormal penis, including curved penis, birth defects of the penis, and Peyronie's disease or
• Leukemia (blood-related cancer) or
• Multiple myeloma (blood-related cancer) or
• Sickle-cell anemia (blood disorder)—Lorcaserin should be used with caution in these patients as it may cause problems with prolonged erection of the penis.

Along with its needed effects, a medicine 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:

More common

• 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

Less common

• 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

Rare

• 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

Incidence not known

• 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:

Symptoms of overdose

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

Some side effects 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:

More common

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

Less common

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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Belviq
• Belviq XR

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

Carefully follow your doctor's instructions for a reduced-calorie diet plan and regular exercise. Talk with your doctor before starting any exercise program.

Your doctor should tell you to stop taking this medicine if you do not lose a certain amount of weight within the first 12 weeks of treatment.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For weight loss: Adults—10 milligrams (mg) two times a day. Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.