Lomaira – New Obesity Medication Now Available

by Donna H. Ryan, MD

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In 2016, a “new” version of an “old” medication was approved by the U.S. Food and Drug Administration (FDA). This medication is called Lomaira, and it consists of an 8 milligram tablet of Phentermine.

Phentermine was first approved in 1959 for a short- term (generally interpreted as up to 12 weeks) treatment for weight management, and it is currently the most-prescribed medication for weight management in the United States. Lomaira’s new dosage form allows for more flexibility and tailoring of treatment approaches, and it is more affordable than most medications approved for weight management. However, physicians and patients need to be aware of all of the information surrounding Lomaira in order to prescribe it both safely and appropriately.

Let’s start by answering a few important questions:

Who is an Appropriate Patient for Lomaira?
        • First, patients who need to lose weight for health improvement, as opposed to reaching some cosmetic ideal, are candidates for Lomaira. The FDA-approved indication is for a BMI of 30 kg/m2 or greater, or when patients have obesity-related health issues like abnormal lipids or glucose or a BMI of 27 kg/m2 or greater. It is not a good idea to take medications strictly for cosmetic reasons.
        • Second, it’s important to note that Lomaira won’t work on its own. Because of this, patients should be on a diet regiment before considering Lomaira. This medication is for patients who struggle with maintaining adherence to dietary goals, and it works through the brain’s regulation of appetite to help patients better adhere to their dietary plan.
        • Third, the special instance where patients may be good candidates for Lomaira at 8 milligrams is related to the fact that it can be prescribed up to three times a day. Lomaira can be taken at times during the day when patients struggle with hunger and find it hard to resist eating. Because of this, Lomaira dosage should be individualized.
What Does Individualized Dosage Mean?

All patients are different and have individual issues with hunger and with staying on a diet. Therefore, doctors can personalize a treatment dose. Some patients may not need Lomaira in the morning, but will want to take it before lunch and again before dinner. Those patients may only need a total dose of two 8 milligram tablets each day. Other patients may need three tablets. Because of this, doctors and patients can make an individual dosing schedule for the individual patient. This means that patients can take the exact dose they need – when they need it.

Who Should NOT Take Lomaira?

Patients who have one or more of the following conditions should not take Lomaira:

        • History of cardiovascular disease (stroke, heart attack, arrhythmia, heart failure, etc.)
        • Uncontrolled hypertension
        • Within 14 days of taking a monoamine oxidase inhibitor
        • Hyperthyroidism
        • Glaucoma
        • Agitated states
        • History of drug abuse
        • Pregnancy
        • Nursing
        • History of allergy to sympathomimetic amines

Patients should discuss their medical history and have an exam with a healthcare professional before starting Lomaira.

What Side Effects Can I Expect When I Take Lomaira?

Patients usually experience some stimulatory properties of Phentermine, especially in the first few days or weeks of starting the medication. These may include:

        • Feelings of excitement
        • Increased energy
        • Slight agitation
        • Difficulty sleeping in the first few days or weeks of treatment

These symptoms usually go away within a short period of time. However, if patients notice more extreme agitation, an irregular heartbeat or chest palpitations, they should stop the medication and consult their physician as soon as possible. Other side effects may also be seen with weight- loss, such as constipation. Patients should drink six to eight glasses of water a day to help alleviate constipation.

One of the advantages of the 8 milligram tablet of Lomaira is that stimulatory side effects can be minimized by appropriate dosing. If patients only need one tablet a day to help with their appetite at dinner, there is no need to increase the dose. This allows for lower exposure to the stimulatory effects of Phentermine. Since other formulations are in doses of either 15 milligrams or 30 milligrams of Phentermine, Lomaira at 8 milligrams can produce a better safety margin.

How Much Weight Can I Expect to Lose with Lomaira?

As is always the case with medications that are used for weight management, the total amount of weight-loss will depend on the intensity of weight-loss efforts that the patient puts in.

You can expect to lose more weight than you would on your diet effort without a medication, but the weight-loss will vary from person-to-person. Patients should undertake their best effort at diet, physical activity and behavior change, but Lomaira can help them stick to their efforts so long as they do not expect the medication to work on its own.

How Long Can Lomaira be Continued?

When the FDA approved Phentermine 50 years ago, medicines for weight management were only studied for a few months. As a result, there are currently no long- term studies with Phentermine or Lomaira. It is generally recommended that Lomaira only be continued for a few months, so it is not intended to be taken forever.

In a study of Phentermine at doses similar to Lomaira, weight-loss at 28 weeks for the placebo group was -1.7% from baseline. For Phentermine at 7.5mg/d, it was -5.5%, and for Phentermine at 15 mg/d, it was -6.1%.

The appropriate patient for Lomaira will take the prescription for a few months and then begin to try other treatment approaches. Patients can use strategies like initiating a lot of moderate physical activity (45 minutes or more a day) to maintain weight-loss after using Lomaira to achieve their goals with diet. Lomaira and other forms of Phentermine are controlled substances and a special prescription is required.

How Much Does Lomaira Cost?

Lomaira is the least expensive of the newer medications for weight management and will be marketed to cost about $0.50 cents a pill. For patients who need three pills a day, that equates to only $1.50 a day. For patients who need less, the cost could be $1.00 or even $0.50 cents a day.

Summing it Up

It is true that not every patient needs medication to be successful with weight-loss, but many patients do struggle. Physicians can help their patients achieve health benefits through weight-loss, and they should not hesitate to prescribe appropriate treatment for patients who need greater help achieving their goals.

Lomaira can help patients who meet appropriate guidelines (no history of heart diseases, not pregnant or nursing, controlled blood pressure, etc.) and who are undertaking a dietary program. Patients can take Lomaira for a few weeks or months to lose weight and then switch to weight- loss maintenance approaches. The chief advantages of Lomaira are that the medication improves the safety and efficacy profile of Phentermine by allowing physicians to tailor treatment to an individual patient’s needs, thus giving them the minimum dose needed for efficacy and timing that dose to the patient’s hunger profile.

About the Author: 

Donna H. Ryan, MD, is Professor Emerita at Pennington Biomedical Research Center. Dr. Ryan’s scholarly activities include authorship of more than 200 original publications and 45 chapters and reviews, primarily in the field of obesity. She is Associate Editor-in-Chief for “Obesity.” She served as Co-chair of the Expert Panel that produced the AHA/ACC/TOS 2013 Guidelines for the Diagnosis and Management of Obesity and was a panel member of the 2015 Endocrine Society Systematic Evidence Review and Guidelines for Medications that Affect Body Weight. She is President-Elect of the World Obesity Federation.

 

 

 



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