Product image of Mysimba (Bupropion Hydrochloride, Naltrexone Hydrochloride) supplied by GNH India

Mysimba

Active Ingredient:
Bupropion Hydrochloride, Naltrexone Hydrochloride
Origin:
EU

Mysimba (Bupropion Hydrochloride, Naltrexone Hydrochloride)

Bupropion hydrochloride/naltrexone hydrochloride, the active ingredient in Mysimba, is a bupropion/naltrexone combination presented as a tablet for oral use. It is indicated for weight management in adults with obesity or overweight with associated comorbidities.

GNH India supplies Mysimba as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, ensuring quality, regulatory compliance and reliable logistics for global distribution.

Manufacturer / TM Owner

Orexigen Therapeutics Ireland Limited

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Indications & Clinical Uses

  • Mysimba is used in the management of obesity and overweight conditions by targeting the hypothalamic melanocortin pathway.
  • Obesity: helps reduce body weight when combined with a reduced‑calorie diet and increased physical activity.
  • Overweight with comorbidities: supports weight loss in patients who have a BMI ≥ 27 kg/m² with at least one weight‑related condition.
  • Weight management: contributes to overall weight control as part of a comprehensive lifestyle program.

How It Works

  • Mysimba combines bupropion, a norepinephrine‑dopamine reuptake inhibitor that stimulates pro‑opiomelanocortin (POMC) neurons, with naltrexone, an opioid‑receptor antagonist that blocks the autoinhibitory feedback on POMC cells. Together they enhance activity of the hypothalamic melanocortin pathway, leading to reduced appetite and increased energy expenditure.

Side Effects

Mysimba may cause a range of adverse reactions.

Common Side Effects

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

Serious or Rare Side Effects

  • Seizures
  • Hypertension or rapid increase in blood pressure
  • Suicidal thoughts or mood changes
  • Severe allergic reactions (anaphylaxis, angioedema)
  • Liver injury
  • Psychosis or severe agitation

Precautions & Warnings

  • Before prescribing Mysimba, clinicians should consider several safety aspects.
  • Assess cardiovascular status: evaluate blood pressure and heart disease before initiating.
  • Screen for seizure risk: avoid in patients with a history of seizures.
  • Monitor psychiatric status: watch for mood changes or suicidal ideation.
  • Avoid in patients using monoamine oxidase inhibitors: discontinue MAOI at least 14 days prior.
  • Pregnancy and lactation: use only if benefits outweigh risks and after professional consultation.
  • Store at ambient temperature: keep below 25 °C, retain original packaging, protect from moisture.

Avoid Interactions

Mysimba can interact with several drug classes; awareness of the interaction level guides management.

Major Interactions (Avoid)

  • MAO inhibitors: risk of hypertensive crisis; concurrent use must be avoided.
  • Other bupropion‑containing products: increased seizure risk.
  • Opioid analgesics: naltrexone antagonizes opioid effect and may precipitate withdrawal.

Moderate Interactions (Monitor Closely)

  • CYP2B6 inhibitors (e.g., clopidogrel): may raise bupropion plasma levels.
  • CYP2D6 substrates (e.g., SSRIs, tricyclic antidepressants): may alter metabolism of co‑administered drugs.
  • Alcohol: can enhance central nervous system side effects such as dizziness and sedation.

Frequently Asked Questions

Mysimba is prescribed for adults with obesity (BMI ≥ 30 kg/m²) or overweight (BMI ≥ 27 kg/m²) who have at least one weight‑related comorbidity such as hypertension, type 2 diabetes, or dyslipidaemia. It is used together with a reduced‑calorie diet and increased physical activity to achieve clinically meaningful weight loss.

The combination works by modulating the hypothalamic melanocortin pathway. Bupropion inhibits the reuptake of norepinephrine and dopamine, stimulating POMC neurons that reduce appetite. Naltrexone blocks opioid receptors that normally provide feedback inhibition to those neurons, prolonging the appetite‑suppressing signal and increasing energy expenditure.

The dosing regimen for Mysimba is individualized by the prescribing clinician based on the patient’s medical history, tolerability, and treatment response. The prescriber determines the appropriate titration schedule and maintenance dose, which should be followed exactly as instructed.

Safety data for Mysimba in pregnancy and lactation are limited. It should only be used if the potential benefit to the mother outweighs any possible risk to the fetus or infant, and this decision must be made by a qualified healthcare professional after a thorough risk‑benefit assessment.

To request Mysimba, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, and will ask for trade or institutional credentials. After verification, the team provides pricing, availability, shipping details (including any special handling) and assists with import documentation.

Mysimba differs from GLP‑1 receptor agonists such as liraglutide or semaglutide, which act primarily through gastrointestinal mechanisms and glucose regulation. Mysimba’s dual central‑acting mechanism targets appetite and energy expenditure via the melanocortin pathway, offering an alternative for patients who may not tolerate injectable therapies or who prefer an oral option.

Mysimba tablets should be stored at ambient temperature, preferably below 25 °C. Keep them in the original blister pack, protect from moisture and direct sunlight, and keep out of reach of children. Do not store in bathrooms or other humid environments.

Mysimba is taken orally as whole tablets with water. The usual practice is to start with a low dose and titrate upward over several weeks, as directed by the prescriber, to minimise side effects. It should be taken with or without food, according to the clinician’s instructions.

Serious risks include seizures, significant increases in blood pressure, suicidal thoughts or other severe psychiatric changes, and rare but severe allergic reactions such as anaphylaxis. Patients should be monitored closely for these events, especially during dose escalation, and seek immediate medical attention if they occur.

Mysimba is contraindicated in individuals with a known hypersensitivity to bupropion, naltrexone, or any tablet components; those currently using monoamine oxidase inhibitors; patients with uncontrolled hypertension; a history of seizures; or who are pregnant or breastfeeding unless the prescriber determines the benefit outweighs the risk.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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