What is LOMAIRA?

LOMAIRA is a prescription medication containing phentermine hydrochloride 8mg, an appetite suppressant used to aid weight loss. It is typically prescribed for short-term use in adults with obesity or those who are overweight with weight-related health conditions.

When did the FDA approve LOMAIRA?

The U.S. Food and Drug Administration (FDA) approved LOMAIRA (phentermine hydrochloride 8 mg tablets) on September 13, 2016.

Why choose LOMAIRA?

Flexible Dosing with Smaller Doses:

• LOMAIRA comes as an 8 mg tablet designed to be taken up to 3 times daily, typically before meals.
• This allows for more flexible and personalized control over appetite throughout the day compared to a single, larger dose (like 37.5 mg once daily).
• Patients can start with lower total daily doses and increase as tolerated, which can help reduce exposure to side effects.

Tolerability:

• The lower per-dose amount can result in lower exposure to stimulant-related side effects such as jitteriness, nervousness, or insomnia.
• Ideal for people sensitive to stimulants or those who want to avoid a big "hit" of medication at once.

FDA-Approved Specifically for Weight Loss:

• LOMAIRA is specifically FDA-approved for short-term weight loss, to be used as an adjunct to diet and exercise.
• The active ingredient (phentermine HCL) has over 65 years of real-world experience, with millions of doses taken per year, resulting in a well-studied and established safety profile.

Meal-Time Dosing Can Help Manage Hunger:

• Taking LOMAIRA right before meals can target hunger spikes, helping some patients further control portions and cravings.

Scored Tablet for Dose Adjustment:

• The tablet is scored, so it can be split in half for 4 mg doses, allowing even finer dosing adjustments under your doctor’s supervision.
• In addition, LOMAIRA may be a helpful, affordable option for patients discontinuing GLP-1 medications. It could help reduce the risk of weight regain by supporting appetite suppression with a well-established safety profile and a low dose that minimizes exposure to stimulatory effects.

An Affordable Option:

• Through KVK Tech’s LOMAIRA Lo Cost Access Program, eligible uninsured or cash paying patients can secure LOMAIRA for no more than 50¢ per tablet ($15-$45 for once-a-day to three times a day) for the duration of treatment.

Who should take LOMAIRA?

Adults with obesity:

• Body Mass Index (BMI) ≥ 30 kg/m²

Adults who are overweight with weight-related health conditions:

• BMI ≥ 27 kg/m² plus at least one weight-related comorbidity such as:
  • Controlled high blood pressure
  • Type 2 diabetes
  • High cholesterol (dyslipidemia)

Those committed to lifestyle changes:

• LOMAIRA is meant to be used alongside a reduced-calorie diet, increased physical activity, and behavioral changes.

Patients needing short-term help to initiate weight loss:

• LOMAIRA is approved for short-term use (a few weeks) as an adjunct to diet and exercise.

How does LOMAIRA work?

Drug Class: Sympathomimetic amine anorectic (appetite suppressant)

Stimulates the Central Nervous System (CNS)

• LOMAIRA activates the sympathetic nervous system by increasing the release of certain brain chemicals called norepinephrine and dopamine.

Appetite Suppression:

• The elevated norepinephrine levels signal the brain’s hypothalamus (the area controlling hunger) to reduce appetite and increase feelings of fullness.
  • It has not been established that the primary action of such drugs in treating obesity is one of appetite suppression since other central nervous system actions, or metabolic effects, may also be involved.

How do I know if LOMAIRA is right for me?

• You have a BMI ≥ 30 (obese) or A BMI ≥ 27 (overweight) with related health conditions like high blood pressure, diabetes, or high cholesterol.
• You’ve struggled to lose weight through diet and exercise alone.
• You’re ready and willing to commit to lifestyle changes including a calorie-restricted diet and increased physical activity.
• You want a medication option that can be taken multiple times a day to help control appetite before meals.
• You do not have any contraindications such as heart disease, uncontrolled hypertension, glaucoma, or a history of drug abuse.

Why should I take an 8mg dose of LOMAIRA instead of 37.5mg of generic phentermine?

Flexible Dosing with Smaller Doses:

• LOMAIRA comes as an 8 mg tablet designed to be taken up to 3 times daily, typically before meals.
• This allows for more flexible and personalized control over appetite throughout the day compared to a single, larger dose (like 37.5 mg once daily).
• Patients can start with lower total daily doses and increase as tolerated, which can help reduce exposure to side effects.

Tolerability:

• The lower per-dose amount can result in lower exposure to stimulant-related side effects such as jitteriness, nervousness, or insomnia.
• Ideal for people sensitive to stimulants or those who want to avoid a big "hit" of medication at once.

FDA-Approved Specifically for Weight Loss:

• LOMAIRA is specifically FDA-approved for short-term weight loss, to be used as an adjunct to diet and exercise.
• The active ingredient (phentermine HCL) has over 65 years of real-world experience, with millions of doses taken per year, resulting in a well-studied and established safety profile.

Meal-Time Dosing Can Help Manage Hunger:

• Taking LOMAIRA right before meals can target hunger spikes, helping some patients further control portions and cravings.

Scored Tablet for Dose Adjustment:

• The tablet is scored, so it can be split in half for 4 mg doses, allowing even finer dosing adjustments under your doctor’s supervision.
• In addition, LOMAIRA may be a helpful, affordable option for patients discontinuing GLP-1 medications. It could help reduce the risk of weight regain by supporting appetite suppression with a well-established safety profile and a low dose that minimizes exposure to stimulatory effects.

How is LOMAIRA different than a GLP-1 receptor agonist?

LOMAIRA:

• Fast-acting, short-term therapy (12 weeks) classified as a sympathomimetic amine (stimulant). While the mechanism of action is not fully understood, it is believed to work in the Central Nervous System to suppress appetite.
• The active ingredient (phentermine HCL) has over 65 years of real-world experience, with millions of doses taken per year, resulting in a well-studied and established safety profile.
• Dosed as an 8mg oral tablet which allows for flexible, up to TID dosing.
• Associated with a lower cost when compared to GLP-1 agonists, available as low as $15 for 30 tablets/month and $45 dollars for 90 tablets/month using the LOMAIRA Lo-Cost Access Program for duration of treatment.

GLP-1 Agonists:

• Long-term therapy that functions as an incretin mimetic (hormone-based) that mimics the GLP-1 hormone to slow digestion, boost satiety, and reduce hunger.
• Approved in 2014, their safety profile has significantly less real-world data with on-going updates that reveal new side effects as real world use progresses.
• Typically dosed as an injectable.
• Associated with higher costs, often exceeding $500/month without insurance.

How should I take LOMAIRA?

Dosage strength:

• 8 mg per tablet

Typical dosing:

• Take one 8 mg tablet approximately 30 minutes before each meal, up to three times a day (breakfast, lunch, and dinner).

Tablet splitting:

• The tablets are scored and can be split in half to take a 4 mg dose if recommended by your doctor.

Avoid late evening dosing to minimize susceptibility to insomnia.

What is the half-life of LOMAIRA?

• The half-life of LOMAIRA is approximately 20 hours. This means that it takes about 20 hours for the concentration of phentermine in your bloodstream to reduce by half.

Can I split LOMAIRA mg tablets?

• Yes, LOMAIRA is scored, meaning the tablet is designed to be split in half.
• Taking half a tablet equals 4 mg, which could allow for a lower dose if you are sensitive to stimulants or are starting treatment and would like to initiate 4mg. The scored tablet also allows for dose titration in 4mg increments.

Can I take LOMAIRA before dinner?

• Because LOMAIRA contains a stimulant, it can cause insomnia or trouble sleeping if taken too late in the day.
• If you do, take it before dinner:
  • Try to take it early in the evening to minimize insomnia risk.

How long should I take LOMAIRA?

• LOMAIRA is typically prescribed for short-term use, generally a few weeks (often up to 12 weeks), as part of a comprehensive weight-loss plan including diet and exercise.

Why is LOMAIRA short-term?

• LOMAIRA is intended as a short-term adjunct to initiate weight loss.
• Its effectiveness and safety for long-term use have not been established.
• Using it longer than recommended may increase the risk of side effects, tolerance, or dependence.

Are there any side effects associated with LOMAIRA?

Common Side Effects

These are usually mild to moderate and may improve over time:

• Dry mouth
• Insomnia or trouble sleeping
• Increased heart rate
• Nervousness or restlessness
• Constipation
• Headache
• Elevated blood pressure
• Dizziness

LOMAIRA’s lower dose can help to lower exposure to stimulatory effects

• LOMAIRA 8mg can be scored in half to 4mg to further minimize exposure to stimulant.
• The active ingredient (phentermine HCL) has over 65 years of real-world experience, with millions of doses taken per year, resulting in a well-studied and established safety profile.

How do I reduce the risk of insomnia while taking LOMAIRA?

• Avoid taking doses in the late evening unless your doctor instructs otherwise

Skip the evening dose if needed:

• Some patients only take it once or twice daily to minimize sleep disruption

Monitor your response:

• If insomnia develops, discuss dose timing or reduction with your provider

Avoid other stimulants:

• Limit caffeine, nicotine, and other stimulating medications or supplements

What if my pharmacy says it doesn’t have LOMAIRA?

Check Other Pharmacies:

• Call or visit nearby pharmacies, including big chains and local ones, to see if they have LOMAIRA in stock.

Talk to Your Doctor:

• Your doctor can send your prescription to a different pharmacy

How does the cost of LOMAIRA compare to other prescription weight loss drugs?

Wholesale Acquisition Cost (WAC) of branded weight loss drugs.

• LOMAIRA: $57.95 ($45 with Lo-Cost Savings Program)
• Wegovy: $1,349.02
• Zepbound: $1,086.37
• Contrave: $625
• Qsymia: $225

What coupons are available for LOMAIRA?

LOMAIRA Lo-Cost Access Program:

Offer:

• Pay no more than $0.50 per tablet for the duration of treatment.
• $15/month if dosed once-a-day; $30month if dosed twice-a-day, $45/month if dosed three times a day

Eligibility:

• Available to patients who meet specific criteria.
• The LOMAIRA Lo-Cost Access Program savings card is good towards the purchase of a prescription for LOMAIRA. No substitutions permitted. Minimum 30 tablets. Most pharmacies accept the savings card. Patients must reside in the United States, Washington D.C., Puerto Rico, Virgin Islands, or Guam. Other restrictions may apply.

Requirements:

• Minimum purchase of 30 tablets.

Can I buy LOMAIRA on the internet?

• LOMAIRA is a controlled substance and cannot be purchased directly over the internet without a valid prescription.
• Online Telehealth Consultations: Services like LOMAIRA Telehealth offer virtual consultations with licensed healthcare providers. If deemed appropriate, they can prescribe LOMAIRA, which is then shipped directly to you. LOMAIRA Telehealth is the only online telehealth service associated with LOMAIRA.

Is LOMAIRA covered by Medicare or private insurers?

Medicare Part D:

• Does not typically cover weight loss medications, including LOMAIRA, unless prescribed for a medically necessary condition such as obesity-related complications. Even then, coverage is not guaranteed and may depend on specific plan formularies and individual circumstances. Additionally, if you use the LOMAIRA Lo-Cost Access Program savings card, you cannot submit a claim to Medicare or any other federal, state, or government program.

Private Insurance:

• Coverage for LOMAIRA by private insurers varies widely. Some insurers may classify LOMAIRA as a Tier 1 generic, resulting in low co-pays, while others may not cover it at all. Factors influencing coverage include the insurer's formulary, the specific plan's structure, and medical necessity criteria. It's advisable to contact your insurance provider directly to determine if LOMAIRA is covered under your plan.