Mysimba®

Mysimba (substance names: naltrexone and bupropion) is an oral medication used to help obese adults lose and maintain weight. This drug acts on areas of the brain involved in the regulation of food intake and energy consumption. Developed by the pharmaceutical company Goodlife, Mysimba is available by prescription only.

Naltrexone and bupropion are the substance names of the drug used in Mysimba. One controlled-release tablet contains 8 mg of naltrexone(hydrochloride) and 90 mg of bupropion(hydrochloride). Naltrexone reduces food cravings and bupropion acts on the reward system in the brain to reduce appetite.

Mysimba is a prescription drug, meaning it is available only with a doctor’s prescription. Mysimba is particularly effective when used in conjunction with a lifestyle plan.

The price of Saxenda is determined by the pharmacist.

Mysimba is prescribed in adult patients with an initial body mass index (BMI) of:

• ≥ 30 BMI (obesity), or
• ≥ 27 BMI to < 30 BMI (overweight) who have at least one weight-related condition, such as diabetes, hypertension, excessive cholesterol, osteoarthritis or sleep apnea.

Treatment with Mysimba should be discontinued if at least 5% of the initial body weight has not been lost after 16 weeks of use of the daily dose of 3.0 mg.

Mysimba is available by prescription from a physician only if the client meets the indications described above.

• The active ingredients in this drug are 8 mg of naltrexone and 90 mg of bupropion.
• Other substances in this medication are: microcrystalline cellulose, hydroxypropyl cellulose, anhydrous lactose, lactose monohydrate, cysteine hydrochloride, crospovidone type A, magnesium stearate, hypromellose, disodium deetate, colloidal silicon dioxide and indigo carmine aluminum lacquer.

Mysimba is approved by the FDA and the Department of Health. The Netherlands Healthcare Institute has assessed that Mysimba should be included in the Drug Reimbursement System for patients with severe obesity. Mysimba is available in the Netherlands only by prescription.

The drug Mysimba may be reimbursed from the basic package for the treatment of a small group of overweight people. Reimbursement applies only to people with a Body Mass Index (BMI) of 30 or higher, or 27 or higher with a weight-related condition, who have been participating in the combined lifestyle intervention (GLI) for at least 1 year and have not achieved sufficient weight loss as a result.

As with all medications, the use of Mysimba can cause side effects. Therefore, the dosage is built up slowly so that you have the least chance of side effects.
The most common side effects of Mysimba are:

• headache,
• nausea,
• diarrhea,
• constipation
• and vomiting.

Most side effects are mild and will disappear once you are on a continuous dose. It also helps to stick to certain eating and drinking recommendations. Your coach will discuss this with you.

A complete list of side effects can be found in the package insert in the package of Mysimba. If you have questions about side effects or get (too many) side effects, contact your doctor, pharmacist or coach. You can also report side effects directly through the Nederlands Bijwerkingen Centrum Lareb, website www.lareb.nl. By reporting side effects, you can help us learn more about the safety of this medicine.

Dosing schedule for adult use
The dosage of Saxenda is 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3 mg. The dosing schedule for adult use is shown below. You build up the dose slowly over 5 weeks from 0.6 mg to the maximum dose of 3.0 mg.

• Week 1 – 1 tablet, in the morning
• Week 2 – 1 tablet, morning and evening
• Week 3 – 2 tablets in the morning and 1 tablet in the evening
• Week 4 – 2 tablets, morning and evening

Maximum tolerated dosage is 2 tablets twice daily. Always use this medicine as your doctor has told you.

The dosing schedule is designed to minimize the risk of side effects when starting Mysimba. Because you increase the dosage slowly, your body can adjust to the medication and you are less likely to develop side effects. If you experience side effects, your doctor, in consultation with you, may adjust the dosing schedule.

You should not use Mysimba in the following cases:

• During pregnancy or lactation;
• in cases of blood pressure that is not well regulated or too high;
• in cases of epilepsy or a history of epileptic seizures;
• in case of a tumor in the central nervous system;
• in case of mental illness;
• in cases of severe liver failure;
• In end-stage renal failure;
• In case of an allergy to any of the substances in Mysimba;
• When you are over 75 years old.

Furthermore, some medications that should not be used together with Mysimba are certain antidepressants, antipsychotics, chronic use of sleep medications, 1st generation antihistamines, antimalarial drugs, opioids, quinolones, theophylline, corticosteroids and certain diabetes medications.

Keep out of the sight and reach of children. Do not use this medicine after the expiration date. It can be found on the box and strip after EXP. It says a month and a year there. The last day of that month is the expiration date.

Store below 30°C.

Do not flush medicines down the sink or toilet or throw them in the trash. Ask your pharmacist what to do with medicines you are no longer taking. They are then destroyed responsibly and do not enter the environment.

Did you forget to take Mysimba?
If you forget to take a dose, skip it and take the next tablet(s) at the usual time. Do not take a double dose to make up for a forgotten dose.

Did you take too much of this medicine?
If you have taken too many tablets, you are more likely to have a seizure or other side effects as described below. Do not delay, contact your doctor or the emergency room of the nearest hospital immediately.

Are you taking any other medications?
Are you taking, or have you recently taken or are you likely to take other medicines in the near future in addition to Mysimba? If so, tell the doctor.

If you stop taking Mysimba
You must take Mysimba for at least 16 weeks for its full effect. Do not stop taking Mysimba before talking to your doctor. You should phase out the use of the Mysimba as you have built it up.