TM Owner Currax Pharmaceuticals
Mysimba 8mg + 90mg Tablet
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Indications & Clinical Uses
- Mysimba 8 mg/90 mg (naltrexone hydrochloride/bupropion hydrochloride) is a prolonged-release combination tablet used as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adults with a body mass index of 30 kg/m² or above (obesity), or 27 kg/m² or above with a weight-related condition such as type 2 diabetes or controlled hypertension.
- It is authorised in Europe; in the United States, the same combination at a similar strength is marketed as Contrave rather than Mysimba.
- The sheet's therapeutic category listed this as a diabetes medicine, which is incorrect: Mysimba is a weight-management medicine, not a treatment for diabetes itself, though it may be used in some people who also have type 2 diabetes.
- Naltrexone and bupropion act together on appetite-regulating centres in the brain to reduce hunger and cravings.
Side Effects
- Mysimba's EU label does not use FDA-style boxed warnings, but Contrave, the US-approved brand of the identical naltrexone/bupropion combination, carries an FDA BOXED WARNING for suicidal thoughts and behaviour linked to the bupropion component, and this risk applies equally to Mysimba: mood and behaviour must be monitored closely, especially in the first weeks of treatment or after a dose change, in patients of any age.
- Bupropion also carries a recognised seizure risk, occurring in about 0.06% of patients in the Mysimba clinical programme; this risk rises with head trauma, alcohol misuse, cocaine use, or other seizure-threshold-lowering drugs.
- The most common side effects are nausea (affecting roughly 1 in 3 patients), constipation and vomiting, most noticeable in the first four weeks and usually easing afterward.
- Seek urgent help for a seizure or any thoughts of self-harm.
Precautions & Warnings
- Mysimba is contraindicated in uncontrolled hypertension, any current or past seizure disorder, known CNS tumour, current or recent eating disorders such as bulimia or anorexia, opioid dependence or acute opioid withdrawal, bipolar disorder, severe hepatic impairment, and end-stage renal failure.
- Blood pressure and heart rate should be checked before starting and periodically during treatment.
- Opioid pain medicines must not be used during Mysimba treatment because of a serious interaction risk, and at least 7 to 10 days should pass after stopping Mysimba before opioids are restarted.
- Mysimba must never be combined with a monoamine oxidase inhibitor (MAOI); at least 14 days must separate the two.
- It is not recommended in pregnancy, and effective contraception is advised during treatment.
Avoid Interactions
- Mysimba must never be combined with an MAOI, and at least 14 days should pass after stopping an MAOI before starting Mysimba, because of a risk of serious blood pressure reactions.
- Opioid-containing medicines, including some cough and pain preparations, are contraindicated during treatment and can trigger seizures or a serotonin-type reaction if combined.
- Bupropion inhibits the CYP2D6 enzyme, meaningfully raising blood levels of drugs broken down this way, such as certain antidepressants, antipsychotics and beta-blockers like metoprolol, so their doses may need lowering.
- Medicines that lower the seizure threshold, including other antidepressants, antipsychotics, systemic corticosteroids and stimulants, increase seizure risk when combined with Mysimba.
- Alcohol should be limited or avoided, since heavy or abrupt reduction in alcohol use can also raise seizure risk.
- Tell the prescriber about all other medicines and supplements.
References
Frequently Asked Questions
Mysimba (naltrexone/bupropion) helps adults manage their weight alongside a reduced-calorie diet and more exercise. It is for people with a BMI of 30 or more, or 27 or more with a weight-related condition. It is a weight-management medicine, not a diabetes treatment.
Mysimba prolonged-release tablets are swallowed whole, usually building up gradually to two tablets twice daily. Do not crush or chew them, and avoid high-fat meals right before dosing, as this can increase side effects. It is taken by mouth, not injected.
Mysimba (naltrexone/bupropion) most often causes nausea, constipation and vomiting in the first month. Its US-equivalent product Contrave carries an FDA boxed warning for suicidal thoughts and behaviour, which applies to Mysimba too. Bupropion also carries a seizure risk. Seek urgent help for either.
Never combine Mysimba with an MAOI or with opioid pain or cough medicines, as both combinations are contraindicated. Avoid alcohol misuse or sudden alcohol withdrawal, since this raises seizure risk. Tell your prescriber about all other medicines you take.
Mysimba is not for people with uncontrolled high blood pressure, any seizure history, an eating disorder, opioid dependence, bipolar disorder, severe liver disease or kidney failure. It is not recommended in pregnancy, and reliable contraception is advised during treatment.
Your prescriber reviews weight loss after 16 weeks; if you have not lost at least 5% of your starting weight, Mysimba is usually stopped, since it is unlikely to give further benefit. If it is effective, treatment can continue longer under regular medical review.
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