Mysimba

Mysimba weight loss tablets are a medication used to help people who are overweight lose weight.

Product dosage: 90mg/8mg
Package (num)	Per tab	Price	Buy
10	$7.00	$70.00 (0%)	🛒 Add to cart
20	$6.00	$140.00 $120.00 (14%)	🛒 Add to cart
30	$5.33	$210.00 $160.00 (24%)	🛒 Add to cart
60	$3.33	$420.00 $200.00 (52%)	🛒 Add to cart
90	$2.77	$630.00 $249.00 (60%)	🛒 Add to cart
120	$2.56	$840.00 $307.00 (63%)	🛒 Add to cart
180	$2.20	$1260.00 $396.00 (69%)	🛒 Add to cart
270	$2.00	$1890.00 $540.00 (71%)	🛒 Add to cart
360	$1.91 Best per tab	$2520.00 $688.00 (73%)	🛒 Add to cart

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Mysimba (naltrexone HCl and bupropion HCl) extended-release tablets represent a significant advancement in the pharmacological management of chronic weight management in adults. This combination product is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m² or greater (obesity), or 27 kg/m² or greater (overweight) in the presence of at least one weight-related comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia. Its dual-mechanism action targets key areas of the brain involved in hunger control and reward systems, offering a novel approach to a complex physiological challenge. This product card provides a comprehensive, evidence-based overview for healthcare professionals to support informed prescribing decisions and patient counseling.

Features

• Active Ingredients: Naltrexone hydrochloride (8 mg) and Bupropion hydrochloride (90 mg) in an extended-release formulation.
• Pharmacological Class: Opioid antagonist (naltrexone) and aminoketone antidepressant (bupropion).
• Dosage Form: Bilayer, extended-release tablet for oral administration.
• Mechanism of Action: Synergistic action on hypothalamic melanocortin system and mesolimbic dopamine pathway. Naltrexone, an opioid receptor antagonist, blocks the inhibitory effect of opioid tone on POMC neurons. Bupropion, a norepinephrine and dopamine reuptake inhibitor, stimulates POMC neurons. This combined action increases the release of α-MSH, leading to reduced appetite and increased energy expenditure.
• Dosing Schedule: Requires a 4-week titration period to the maintenance dose of two tablets twice daily (total daily dose: 32 mg naltrexone/360 mg bupropion).
• Prescription Status: Schedule IV controlled substance (due to bupropion component).

Benefits

• Sustained Weight Loss: In pivotal clinical trials, patients on Mysimba, in conjunction with lifestyle modification, achieved significantly greater weight loss compared to placebo over 56 weeks, with many patients achieving clinically meaningful (≥5%) and substantial (≥10%) weight loss.
• Dual-Neuropathway Targeting: Addresses weight regulation through two complementary central nervous system pathways, modulating both hunger/satiety signals and reward-based eating behaviors.
• Improvement in Cardiometabolic Parameters: Associated with improvements in weight-related comorbidities, including positive effects on glycemic control in patients with type 2 diabetes and improvements in lipid profiles and waist circumference.
• Adjunct to Lifestyle Therapy: Provides a pharmacological tool to enhance the efficacy of foundational lifestyle interventions (diet and exercise), helping patients overcome physiological barriers to adherence.
• Long-Term Management Option: Approved for chronic weight management, supporting a long-term treatment strategy for a chronic, relapsing condition.

Common use

Mysimba is prescribed for the chronic weight management of adult patients. Its use is specifically targeted for individuals who have not achieved sufficient weight loss through diet and exercise alone. It is most commonly initiated for patients with a BMI ≥30 kg/m² (obese) or for those with a BMI ≥27 kg/m² (overweight) who present with one or more weight-related comorbidities. These comorbidities typically include established hypertension, type 2 diabetes mellitus, or dyslipidemia. The decision to prescribe should be based on a comprehensive patient assessment, considering the individual’s overall health status, weight history, and commitment to concurrent lifestyle changes.

Dosage and direction

Administration: Must be taken orally. Tablets should be swallowed whole and must not be crushed, divided, or chewed, as this alters the extended-release properties and increases the risk of adverse effects.

Titration Schedule (Weeks 1-4):

• Week 1: One tablet in the morning.
• Week 2: One tablet in the morning and one tablet in the evening.
• Week 3: Two tablets in the morning and one tablet in the evening.
• Week 4 (Maintenance Dose): Two tablets in the morning and two tablets in the evening.

Dosing Instructions:

• To minimize the risk of nausea, administer with food.
• Do not take with a high-fat meal, as this significantly increases bupropion and naltrexone exposure.
• The doses should be taken at least 8 hours apart.
• The maximum daily dose is two tablets twice daily (32 mg naltrexone/360 mg bupropion).
• If a dose is missed, the patient should not take an extra dose. They should wait and take the next dose at the regular time.

Discontinuation: Patients should be assessed after 16 weeks of treatment at the maintenance dose. If a patient has not lost at least 5% of baseline body weight, discontinuation of Mysimba should be considered, as they are unlikely to achieve and sustain clinically meaningful weight loss with continued treatment.

Precautions

• Suicidal Thoughts and Behaviors: Bupropion, a component of Mysimba, carries a boxed warning for suicidal thoughts and behaviors. Patients of all ages started on antidepressant therapy should be monitored appropriately for clinical worsening, suicidality, and unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber.
• Neuropsychiatric Reactions: Monitor patients for neuropsychiatric reactions including anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, and hypomania.
• Seizures: Mysimba can cause seizures. The risk is dose-related. Use is contraindicated in patients with a seizure disorder or other conditions that predispose to seizures. Caution is advised in patients with concomitant medications or conditions that may lower the seizure threshold.
• Increase in Blood Pressure and Heart Rate: Regular monitoring of blood pressure and heart rate is recommended, especially in patients with controlled hypertension prior to treatment. Dose escalation may be limited if sustained hypertension or tachycardia occurs.
• Hepatotoxicity: Cases of hepatitis and clinically significant liver dysfunction have been observed with naltrexone. Liver enzyme levels should be monitored before starting and during treatment.
• Angle-Closure Glaucoma: The pupillary dilation that can occur with bupropion may trigger an angle-closure attack in patients with anatomically narrow angles.
• Allergic Reactions: Discontinue at first sign of rash, urticaria, or other allergic reaction.

Contraindications

Mysimba is contraindicated in patients with:

• Uncontrolled hypertension.
• Seizure disorder or history of seizures.
• Current or prior diagnosis of bulimia or anorexia nervosa.
• Use of monoamine oxidase inhibitors (MAOIs) within 14 days. Initiating Mysimba is contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs.
• Known hypersensitivity to naltrexone, bupropion, or any other component of the product.
• Chronic opioid use or acute opioid withdrawal. Patients must be opioid-free for a minimum of 7-10 days before initiation.

Possible side effect

Common adverse reactions (incidence ≥5% and more frequent than placebo) include:

• Nausea
• Constipation
• Headache
• Vomiting
• Dizziness
• Insomnia
• Dry mouth
• Diarrhea

Serious side effects requiring immediate medical attention include:

• Suicidal thoughts or behaviors
• Seizures
• Neuropsychiatric reactions (severe anxiety, panic, aggression)
• Significant increases in blood pressure or heart rate
• Severe allergic reactions (angioedema, urticaria)
• Hepatotoxicity
• Angle-closure glaucoma

Drug interaction

Mysimba has a significant potential for drug-drug interactions due to the metabolic pathways of its components.

• Monoamine Oxidase Inhibitors (MAOIs): Contraindicated. Risk of hypertensive crisis.
• CYP2D6 Inhibitors: Concomitant use with drugs that inhibit CYP2D6 (e.g., paroxetine, fluoxetine, quinidine) may increase bupropion exposure but decrease the exposure to active metabolites. Dose reduction of Mysimba may be required.
• Drugs Lowering Seizure Threshold: Concurrent use with other agents that lower seizure threshold (e.g., antipsychotics, antidepressants, theophylline, systemic corticosteroids) may potentiate risk.
• Opioids: Naltrexone will block the effects of opioid analgesics. Patients may require higher doses of opioids for analgesia, which increases the risk of opioid overdose if naltrexone is discontinued. Mysimba may also precipitate acute opioid withdrawal.
• Dopaminergic Drugs: Bupropion may increase the risk of adverse effects of levodopa and amantadine.
• Alcohol: Avoid excessive use of alcohol or abrupt withdrawal, as this may increase the risk of seizure.

Missed dose

Patients should be instructed to take the next dose at the regularly scheduled time if a dose is missed. They should not take an extra dose to “make up” for the missed dose. Taking more than the prescribed dose increases the risk of seizure and other adverse effects.

Overdose

Overdose with Mysimba is primarily associated with the bupropion component and carries a significant risk of seizure. Symptoms of overdose may include seizures, hallucinations, loss of consciousness, sinus tachycardia, ECG changes (e.g., QTc prolongation), and fever. There is no specific antidote. Management involves ensuring an adequate airway, oxygenation, and ventilation. Continuous ECG monitoring is essential. Gastric lavage may be considered if performed soon after ingestion. Activated charcoal may be useful. Management of seizures with intravenous benzodiazepines is standard; status epilepticus should be managed accordingly.

Storage

• Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).
• Dispense in a tight, light-resistant container as defined in the USP.
• Keep out of reach of children and pets.
• Due to its bupropion content, Mysimba has the potential to be misused and abused. It should be stored securely to prevent accidental ingestion or misuse.

Disclaimer

This information is intended for educational purposes for healthcare professionals and is not a substitute for professional medical advice, diagnosis, or treatment. The prescribing physician should be thoroughly familiar with the full Prescribing Information, including Boxed Warnings, before initiating therapy with Mysimba. Always seek the advice of a qualified health provider with any questions regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read herein. The information presented is based on the product’s labeling at the time of writing and may be subject to change.

Reviews

Clinical Trial Data (Aggregate): Large-scale, phase 3 clinical trials (e.g., COR-I, COR-II, COR-BMOD, COR-Diabetes) demonstrated that a significantly higher proportion of patients on Mysimba achieved ≥5% and ≥10% weight loss compared to placebo over 56-112 weeks. Weight loss was sustained in long-term extension studies. Common patient-reported outcomes in trial data include reduced preoccupation with food and improved sense of control over eating.

Expert Consensus: Obesity medicine specialists often regard Mysimba as a valuable tool, particularly for patients who struggle with hunger and cravings. Its unique mechanism is noted for being distinct from other anti-obesity medications. Experts emphasize the critical importance of the 4-week titration to manage gastrointestinal side effects and the necessity of combining it with structured lifestyle intervention for optimal efficacy.

Patient Reported Outcomes (General Themes): In clinical practice, patient experiences vary. Many report a significant reduction in appetite and food cravings, which facilitates adherence to a reduced-calorie diet. The initial side effects, particularly nausea, are a common challenge during the titration phase, but they often subside with continued use and proper administration with food. Patients who successfully titrate to the maintenance dose often report sustained benefits in weight management and improved quality of life.