For individuals struggling with weight loss through diet and exercise alone, weight-loss medications like Mysimba can offer additional support. Mysimba is a weight management aid suitable for adults with a body mass index (BMI) of 30 or above, or those with a BMI between 27 and 30 who also have weight-related health complications. This article provides a comprehensive overview of Mysimba, including its effectiveness, potential side effects, and crucial considerations for its use.
What is Mysimba?
Mysimba is a combination medicine containing two active ingredients: naltrexone and bupropion. These drugs have separate uses on their own. Naltrexone helps manage alcohol and opioid dependence, while bupropion hydrochloride is indicated for use in addictions to nicotine. Mysimba is approved in Europe for weight management, but in the UK, it's only available for purchase privately.
How Does Mysimba Work?
While the exact mechanism is still being investigated, it is understood that naltrexone and bupropion work on the areas of the brain that control pleasure, food intake, and energy balance. These areas are the hypothalamus and the mesolimbic reward system, which is involved with pleasure and reward experiences and connected to intense cravings. By affecting these areas, Mysimba helps to:
- Reduce appetite
- Control cravings
- Increase energy expenditure
This can assist individuals in adhering to a calorie-controlled diet and achieving weight loss.
Mysimba vs. Ozempic for Weight Loss
When researching weight-loss medicines, you may have come across Mysimba and Ozempic. Although both can be used as medicines for weight loss, Mysimba and Ozempic are very different in the way they work, and the patients one is suitable for will not be the patients the other is suitable for. Mysimba (naltrexone/buproprion) acts directly on the brain to help patients control intense cravings and limit emotional eating. Ozempic (semaglutide) mimics the hormone GLP-1 which is normally found in the pancreas, stomach, and brain and increases the levels of some hormones (incretins) that your stomach produces naturally when you eat. Mysimba is suited for patients whose main challenge with weight loss involves controlling intense cravings, binge eating, or emotional triggers that lead to overeating. Ozempic is a medicine indicated for patients with type 2 diabetes and is most likely to be prescribed to patients with underlying metabolic issues, such as prediabetes or insulin resistance, that contribute significantly to their obesity when used off-label for weight loss.
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Dosage and Administration
Mysimba comes in tablet form and is taken orally with water. The dosage is gradually increased over four weeks:
- Week 1: 1 tablet in the morning
- Week 2: 1 tablet in the morning and 1 in the evening
- Week 3: 2 tablets in the morning and 1 in the evening
- Week 4: 2 tablets in the morning and 2 in the evening
Following this schedule is important. If a dose is missed, it should be skipped, and the regular schedule resumed.
Effectiveness of Mysimba
Clinical trials involving obese or overweight patients have demonstrated Mysimba's effectiveness in reducing body weight. These studies involved a weight loss program with counselling and advice on diet and exercise.
- In three studies, the average weight loss with Mysimba was around 3.7 to 5.7%, compared to 1.3 to 1.9% with a placebo.
- The proportion of patients who achieved at least a 5% weight reduction ranged from 28 to 42% with Mysimba, compared to 12 to 14% with a placebo.
- One study, with more intensive patient counselling, showed an overall weight loss of 8.1% with Mysimba and 4.9% with placebo.
The Committee for Medicinal Products for Human Use (CHMP) considered that the effectiveness of Mysimba in promoting weight loss was limited, but it was sufficient to be clinically significant. They also recommended that treatment should be stopped after 16 weeks if patients have not lost at least 5% of their initial body weight.
A systematic review of clinical study reports revealed that a greater proportion of participants taking naltrexone-bupropion achieved a ≥5% reduction in body weight, representing a 2.53 kg reduction in baseline body weight compared with placebo.
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Potential Side Effects
Like all medications, Mysimba can cause side effects. It's important to be aware of these potential effects and how to manage them.
Common Side Effects
These side effects affect more than 1 in 10 people and tend to occur in the first few weeks of taking Mysimba. They include:
- Nausea
- Vomiting
- Constipation
- Headache
These side effects are completely normal and happen because Mysimba can impact parts of your brain and the gastrointestinal system, which can affect your bowel movements and certain receptors related to food. Once your body adjusts to taking Mysimba, they'll generally go away or become milder. If these side effects persist after a few weeks, consult your clinician.
Serious Side Effects
While serious side effects are rare, it's crucial to be aware of them:
- Suicidal thoughts or depression: There have been reports of depression, suicidal thoughts, and suicide attempts during treatment with Mysimba. If you experience these feelings, contact your doctor immediately or go to the hospital straight away.
- Seizures (epileptic seizures): Symptoms include convulsions and usually loss of consciousness. Seizures are more likely if you take too much, are taking other medicines, or are at increased risk of seizures.
- Erythema multiforme and Stevens-Johnson syndrome: Erythema multiforme is a serious skin condition that can affect the mouth and other parts of the body, with red, usually itchy patches appearing. Stevens-Johnson syndrome is a rare skin disease with severe blistering and bleeding on the lips, eyes, mouth, nose, and genitals.
- Rhabdomyolysis: This is an abnormal breakdown of muscle tissue, which can lead to kidney problems. Symptoms include severe muscle cramps, muscle pain, or muscle weakness.
- Lupus rash or worsening of lupus symptoms: If you experience lupus flare-ups, rashes, or lesions (especially in areas exposed to the sun) while taking Mysimba, contact your doctor immediately as treatment may need to be stopped.
- Serotonin syndrome: This condition may be manifested by changes in mental status (e.g., agitation, hallucinations, coma) and other effects such as increased body temperature, accelerated heartbeat, fluctuating blood pressure, increased reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms.
Managing Side Effects
Several strategies can help manage Mysimba side effects:
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- Gradual dosing: Starting on a lower dose and gradually increasing it will help your body adjust to the medication.
- Take Mysimba with food: This may help reduce the risk of nausea and other gastrointestinal side effects.
- Stay hydrated: Drinking plenty of water can help with various side effects, including constipation and headaches.
- Avoid caffeine: Excessive caffeine consumption can cause dehydration and worsen some side effects, like agitation and mood.
- Limit or avoid alcohol: Alcohol can increase the risk of side effects, such as fits and mental conditions, and also increase calorie intake.
Post-Treatment Considerations
When stopping Mysimba, there's a possibility of experiencing side effects for a few days as the active drugs are processed by the body. There's also a chance of regaining some of the weight lost. It's important to adopt sustainable lifestyle changes that can be maintained after treatment.
Important Precautions
Before taking Mysimba, consider the following precautions:
- Contraindications: Mysimba must not be used in certain patients at particular risk of side effects, including patients with severely reduced kidney or liver function, those with high blood pressure that is not under control, those who have ever had seizures (fits), certain psychological problems, or who have a brain tumor or are undergoing withdrawal from alcohol or certain drugs.
- Monoamine oxidase (MAO) inhibitors: Do not take naltrexone and bupropion combination with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]).
- Other medications: Do not use naltrexone and bupropion combination if you are also using Zyban® to quit smoking or Aplenzin® or Wellbutrin® for depression, because they also contain bupropion. Also, do not take this medicine if you are using or have used narcotic drugs (eg, buprenorphine, methadone, or other habit-forming painkillers) within the past 7 to 10 days.
- Mental health: This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed.
- Overdose risk: You have a higher risk of accidental overdose, serious injury, or death if you use heroin or any other narcotic medicine while you are being treated with naltrexone and bupropion combination.
- Blood pressure: Your blood pressure might get too high while you are using this medicine.
- Allergic reaction: This medicine may cause a serious allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention.
- Liver problems: Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
- Vision changes: Check with your doctor right away if blurred vision, eye pain, or any other change in vision occurs during or after treatment.
- Hypoglycemia: This medicine may increase the risk of hypoglycemia (low blood sugar) in patients with diabetes.
- Alcohol: Drinking alcoholic beverages should be limited or avoided, if possible, with this medicine.
- Medical tests: Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.
Mysimba and Opioid Interactions
It is important to note that Mysimba can block the effect of opioid medicines, including painkillers. The European Medicines Agency (EMA) advises that Mysimba must not be used in people receiving treatment with opioid medicines. Patients should be warned against the concomitant use of opioids during treatment with Mysimba.
Postmarketing Surveillance
A rigorous process of postmarketing surveillance is required to monitor the benefit-harm profile of Naltrexone-bupropion.
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