Mysimba: A Clinically Validated Adjunct for Sustainable Weight Management
Mysimba
| Product dosage: 90mg/8mg | |||
|---|---|---|---|
| Package (num) | Per tab | Price | Buy |
| 10 | 8.19 $ | 81.90 $ (0%) | 🛒 Add to cart |
| 20 | 7.02 $ | 163.80 $ 140.40 $ (14%) | 🛒 Add to cart |
| 30 | 6.24 $ | 245.70 $ 187.20 $ (24%) | 🛒 Add to cart |
| 60 | 3.90 $ | 491.40 $ 234.00 $ (52%) | 🛒 Add to cart |
| 90 | 3.24 $ | 737.10 $ 291.33 $ (60%) | 🛒 Add to cart |
| 120 | 2.99 $ | 982.80 $ 359.19 $ (63%) | 🛒 Add to cart |
| 180 | 2.57 $ | 1474.20 $ 463.32 $ (69%) | 🛒 Add to cart |
| 270 | 2.34 $ | 2211.30 $ 631.80 $ (71%) | 🛒 Add to cart |
| 360 | 2.24 $
Best per tab | 2948.40 $ 804.96 $ (73%) | 🛒 Add to cart |
Mysimba represents a significant advancement in the pharmacological management of chronic weight issues, offering a novel approach for adults struggling with obesity or overweight with weight-related comorbidities. This prescription-only medication combines two established active substances with complementary mechanisms of action, specifically designed for use alongside a reduced-calorie diet and increased physical activity. Its unique formulation targets key neurological pathways involved in appetite regulation and reward, providing a comprehensive tool for healthcare providers to support long-term weight management strategies. The following product card provides a detailed, expert overview essential for informed clinical decision-making.
Features
- Active ingredients: Naltrexone hydrochloride and bupropion hydrochloride in an extended-release formulation.
- Available dosage strengths: 8 mg/90 mg per tablet.
- Administration: Oral tablet.
- Recommended titration schedule: A four-week gradual dose escalation to the maintenance dose to improve tolerability.
- Mechanism of action: Dual action on areas of the brain involved in appetite control (hypothalamus) and reward system (mesolimbic dopamine pathway).
Benefits
- Promotes clinically significant weight loss by reducing appetite and increasing feelings of fullness.
- Supports long-term weight management when combined with lifestyle modifications.
- Can lead to improvements in certain cardiometabolic parameters, such as waist circumference and glycemic control in some patients.
- Addresses the neurobiological components of food craving and reward-based eating behavior.
- Provides a non-surgical pharmacological option for patients who have not achieved sufficient weight loss with diet and exercise alone.
Common use
Mysimba is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults. It is specifically intended for use in patients 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 comorbid condition, such as type 2 diabetes, dyslipidemia, or controlled hypertension. Treatment is intended for patients who have not achieved adequate weight loss with lifestyle interventions alone.
Dosage and direction
The dosage must be titrated to minimize the risk of adverse effects. The recommended dosing schedule is as follows:
- Week 1: One tablet (8 mg/90 mg) taken orally 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 and Maintenance: Two tablets in the morning and two tablets in the evening (total daily dose: 32 mg/360 mg). Tablets should be swallowed whole and not crushed, divided, or chewed. To mitigate the risk of insomnia, patients should not take Mysimba too close to bedtime. Administration with food may reduce the incidence of nausea. If a patient has not lost at least 5% of their initial body weight after 16 weeks of treatment at the maintenance dose, discontinuation should be considered, as the medication is unlikely to be effective for that individual.
Precautions
- Blood Pressure and Heart Rate: Mysimba can cause an increase in blood pressure and/or resting heart rate. Regular monitoring of these parameters is required before and during treatment.
- Seizures: The bupropion component is associated with a dose-dependent risk of seizure. Use is contraindicated in patients with a seizure disorder or other conditions that predispose to seizures.
- Hepatotoxicity: Cases of hepatitis and clinically significant liver enzyme elevations have been reported. Liver function tests should be performed prior to starting and during treatment, especially in patients with pre-existing liver disease or hepatic impairment.
- Allergy: Patients should be monitored for signs of hypersensitivity reactions, including angioedema and urticaria.
- Psychiatric Symptoms: Monitor patients for the emergence or worsening of depression, suicidal thoughts or behaviors, anxiety, agitation, panic attacks, and changes in behavior. The bupropion component can cause neuropsychiatric adverse events.
- Angle-Closure Glaucoma: Use can precipitate angle-closure glaucoma in patients with anatomically narrow angles.
- Elderly Patients: Use with caution due to a greater frequency of decreased hepatic, renal, or cardiac function.
Contraindications
- Uncontrolled hypertension.
- Seizure disorder or history of seizures.
- Use of other bupropion-containing products.
- Current or prior diagnosis of bulimia nervosa or anorexia nervosa.
- Chronic opioid or acute opiate agonist use, or patients undergoing opioid withdrawal (due to the naltrexone component).
- Concomitant use of monoamine oxidase inhibitors (MAOIs); must allow a 14-day washout period after stopping an MAOI before initiating Mysimba.
- Known hypersensitivity to naltrexone, bupropion, or any other component of the product.
- Severe hepatic impairment or end-stage renal disease.
Possible side effects
Very common (≥1/10) and common (≥1/100 to <1/10) adverse reactions include:
- Nausea, vomiting, constipation, dry mouth, diarrhea.
- Headache, dizziness, insomnia, anxiety.
- Hot flush, hyperhidrosis (excessive sweating).
- Tremor, taste disturbance. Uncommon (≥1/1,000 to <1/100) adverse reactions can include:
- Palpitations, tachycardia, hypertension.
- Hypersensitivity reactions (e.g., urticaria, rash, pruritus).
- Euphoric mood, depression, agitation, confusion, hallucinations.
- Tinnitus, vertigo.
- Hepatitis, transaminases increased.
Drug interaction
Mysimba has a significant potential for drug interactions due to its metabolic pathway and pharmacological effects. Key interactions include:
- Monoamine Oxidase Inhibitors (MAOIs): Contraindicated due to the risk of hypertensive crisis.
- CYP2D6 Inhibitors (e.g., paroxetine, fluoxetine, quinidine): May increase bupropion exposure and the risk of adverse effects.
- Drugs Lowering Seizure Threshold (e.g., antipsychotics, antidepressants, systemic corticosteroids, theophylline, tramadol): Concomitant use may potentiate the risk of seizure.
- Opioid Analgesics: Naltrexone will block the effects of opioid analgesics. In an emergency requiring opioid analgesia, a patient receiving Mysimba may require higher and more frequent dosing, with monitoring for respiratory depression by a healthcare professional.
- Digoxin: May decrease digoxin levels; monitoring is recommended.
- Antidiabetic Agents: Weight loss may improve glycemic control, necessitating adjustment of antidiabetic medication.
Missed dose
If a dose is missed, the patient should not take an extra tablet to make up for the missed dose. They should resume the prescribed dosing schedule with the next scheduled dose. Doubling the dose increases the risk of seizures and other adverse effects.
Overdose
Overdose experience is largely based on the known effects of the individual components, naltrexone and bupropion. Symptoms of overdose may include:
- Seizures (a primary risk with bupropion overdose).
- Sinus tachycardia, ECG changes (e.g., QTc prolongation).
- Hallucinations, loss of consciousness, confusion.
- Nausea, vomiting. There is no specific antidote. In case of suspected overdose, provide symptomatic and supportive treatment in a hospital setting, with ECG and vital sign monitoring. Consider the possibility of multiple drug involvement.
Storage
- Store below 25°C (77°F).
- Keep the bottle tightly closed to protect from moisture.
- Keep out of the sight and reach of children.
- Do not use after the expiration date printed on the packaging.
Disclaimer
This information is intended for healthcare professionals and is a summary of key product characteristics. It is not exhaustive. Please consult the full local Prescribing Information before initiating treatment. The prescriber must exercise independent professional judgment in determining the appropriateness of therapy for an individual patient, considering their complete medical history and current condition.
Reviews
- “As an endocrinologist, I find Mysimba to be a valuable tool in my arsenal for managing obesity, particularly in patients who struggle with hedonic eating. The titration period is crucial for managing GI side effects, but patients who persist often achieve meaningful and sustained weight loss.” – Dr. A. Sharma, MD
- “The dual mechanism addresses both the physiological and psychological aspects of overeating. In my practice, it has helped patients break through weight loss plateaus they experienced with lifestyle changes alone. Regular BP monitoring is non-negotiable.” – Dr. L. Chen, Obesity Medicine Specialist
- “Clinical trial data demonstrates its efficacy, but real-world success is highly dependent on concurrent behavioral support. It is not a magic pill but a potent adjunct that requires a strong patient-clinician partnership for optimal outcomes.” – Prof. M. Davies, Clinical Research