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  1. What is LOMAIRA?LOMAIRA™ (phentermine hydrochloride USP) 8 mg tablets, CIV is a low-dose, low-cost appetite suppressant approved by the United States Food & Drug Administration (FDA) for weight reduction when used together with regular exercise and a reduced-calorie diet. LOMAIRA can help to suppress appetite, eat less, and lose weight.
  2. Why LOMAIRA?
    LOMAIRA is a low dose of the #1 prescribed medicine for weight loss for nearly 60 years and the only strength of phentermine that can be used up to three times a day before meals. Dosage should be individualized to obtain an adequate response with the lowest effective dose. The usual adult dose is one tablet three times a day 30 minutes before meals. This tablet is scored to facilitate administering one half of the usual dosage for patients not requiring the full dose. Phentermine hydrochloride is not recommended for use in pediatric patients 16 years of age or younger. Late evening medication should be avoided because of the possibility of resulting insomnia.
  3. Who should take LOMAIRA?
    LOMAIRA is for adults with an initial body mass index (BMI) of 30 or more or 27 or more with at least one weight-related condition such as controlled high blood pressure, diabetes, or high cholesterol. BMI measures the amount of fat in the body based on height and weight. BMI is measured in kg/m2. Talk to your healthcare provider and ask if LOMAIRA is right for you.
  4. How does LOMAIRA work?LOMAIRA is an appetite suppressant that works by releasing two chemicals in the brain called norepinephrine and epinephrine. When these chemicals are released, the feeling of hunger is minimized. 1
  5. How do I know if LOMAIRA is right for me?LOMAIRA is not for everyone. Your healthcare provider will know if LOMAIRA is right for you. LOMAIRA is for adults with an initial BMI of 30 or more or 27 or more with at least one weight-related condition such as controlled high blood pressure, diabetes, or high cholesterol and should be used together with regular exercise and a reduced-calorie diet. Patients should talk with their healthcare provider about their medical history and current weight-loss plan to determine if LOMAIRA is an appropriate option.
  6. How should I take LOMAIRA?Take LOMAIRA exactly how your healthcare provider tells you. LOMAIRA is FDA-approved to be used up to three times a day, as prescribed by a healthcare professional. Patients can work with their healthcare provider to customize a treatment plan of when and how often to take LOMAIRA to meet each patient’s unique lifestyle. Dosage should be individualized to obtain an adequate response with the lowest effective dose. The usual adult dose is one tablet three times a day 30 minutes before meals. This tablet is scored to facilitate administering one half of the usual dosage for patients not requiring the full dose. Phentermine hydrochloride is not recommended for use in pediatric patients 16 years of age or younger. Late evening medication should be avoided because of the possibility of resulting insomnia.
  7. What if my pharmacy says it doesn’t have LOMAIRA?If your pharmacy doesn’t have LOMAIRA in stock, please call the LOMAIRA customer service number at 1-844-LOMAIRA (1-844-566-2472) and a representative will contact your pharmacy to ensure they receive LOMAIRA within 24-48 hours.
  8. Can I take LOMAIRA before dinner?
    LOMAIRA can be taken before dinner, which might help some patients who struggle with appetite during the early evening hours when hunger can be greatest. Talk to your healthcare provider about a treatment plan that targets your daily eating pattern. Dosage should be individualized to obtain an adequate response with the lowest effective dose. The usual adult dose is one tablet three times a day 30 minutes before meals. This tablet is scored to facilitate administering one half of the usual dosage for patients not requiring the full dose. Phentermine hydrochloride is not recommended for use in pediatric patients 16 years of age or younger. Late evening medication should be avoided because of the possibility of resulting insomnia.
  9. How long should I take LOMAIRA?LOMAIRA is for short-term use(a few weeks), which is generally interpreted up to 12 weeks.
  10. How much weight can I expect to lose with LOMAIRA?Results vary depending on the individual patient.
  11. What are the benefits of LOMAIRA as compared to generic phentermine? LOMAIRA is the lowest strength of phentermine monotherapy and is the only formulation of phentermine that is FDA-approved to be used up to three times a day before meals. Generic phentermine is prescribed in doses as high as 37.5 mg and taken once a day before or shortly after breakfast. When generic phentermine is taken in the morning, the effect peaks approximately four hours after administration and can decline throughout the remainder of the day. LOMAIRA offers a unique opportunity for some patients to take a modest dose before dinner when appetite can be greatest. Dosage should be individualized to obtain an adequate response with the lowest effective dose. The usual adult dose is one tablet three times a day 30 minutes before meals. This tablet is scored to facilitate administering one half of the usual dosage for patients not requiring the full dose. Phentermine hydrochloride is not recommended for use in pediatric patients 16 years of age or younger. Late evening medication should be avoided because of the possibility of resulting insomnia.
  12. What if I’ve never used phentermine HCl?
    As with all controlled substances, treatment should be started at the lowest effective dose. LOMAIRA can be used up to 3x daily allowing for an individualized treatment plan for each unique patient. In addition, the LOMAIRA tablet is scored to supply one half of the usual dosage for patients not requiring the full dose. Dosage should be individualized to obtain an adequate response with the lowest effective dose. The usual adult dose is one tablet three times a day 30 minutes before meals. This tablet is scored to facilitate administering one half of the usual dosage for patients not requiring the full dose. Phentermine hydrochloride is not recommended for use in pediatric patients 16 years of age or younger. Late evening medication should be avoided because of the possibility of resulting insomnia.
  13. Are there any side effects associated with LOMAIRA?As with all medications, there are possible side effects associated when taking LOMAIRA. Some side effects of phentermine that have been reported include pulmonary hypertension, valvular heart disease, palpitations, increased heart rate or blood pressure, insomnia, restlessness, dry mouth, diarrhea, constipation and changes in sexual drive. These are not all of the potential side effects of phentermine. The lower dose of phentermine should produce lower peak blood levels, which may result in reduced side effects.  For the full prescribing information, visit www.lomaira.com.
  14. When did the FDA approve LOMAIRA?LOMAIRA was approved by the FDA in September 2016 and is available in all U.S. pharmacies.
  15. How does the cost of LOMAIRA compare to other prescription weight loss drugs?The cost for LOMAIRA is the lowest of all prescription brands for weight loss. LOMAIRA is priced to ensure that cost does not create a hurdle for patients. Through KVK Tech’s LOMAIRA Lo-Cost Access Program, eligible patients always pay less than 50 cents per tablet for the duration of treatment. The LOMAIRA Lo-cost Access program was created to enable KVK to absorb any price markups from other parties along the supply chain that would increase the financial burden to patients. The low price of LOMAIRA is in sharp contrast to some other prescription branded weight loss medications.
  16. Can I buy LOMAIRA on the Internet?LOMAIRA cannot be purchased on the Internet. Some websites may try to sell you counterfeit drugs, which are illegal. LOMAIRA is available by prescription only and can be picked up only at your pharmacy.
  17. Is LOMAIRA covered by Medicare or private insurers?Coverage of prescription weight-loss drugs varies widely. LOMAIRA is reasonably priced to ensure that price does not create a hurdle. Due to LOMAIRA’S low cost, some private insurers provide coverage as a Tier 1 generic co-pay.
  18. What is KVK Tech and where is the company located?Founded in 2004, KVK Tech is based in Newtown, PA and a leader in the development, manufacture, and marketing of high-quality, FDA-approved medicines that address unmet patient needs. The company takes pride in its ability to advance medical care and offer low-cost alternatives in response to today’s healthcare challenges.
  19. Where are KVK Tech’s products made?KVK Tech products are made in the U.S.A. in a state-of-the-art facility in Newtown, PA. As with all KVK Tech products, LOMAIRA is exclusively manufactured and packaged in the United States, in the strictest accordance with FDA, DEA, and DEP guidelines. It is rare for a pharmaceutical company to have all operations in the U.S. About 40 percent of the medications Americans use every day are made outside the U.S.2
  20. What makes KVK Tech stand apart in the industry? All of KVK’s products are made in the United States in a state-of-the-art facility in Newtown, PA. KVK is committed to maintaining our entire business op erations in America and continues to build strong, lasting relationships with the nation’s largest pharmacy chains, wholesalers and distributors. It is rare for a pharmaceutical company to have all operations in the U.S. About 40 percent of the medications Americans use every day are made outside the U.S.3
    KVK Tech has a special way of empowering families through two unique programs available to all of their employees. KVK Tech provides an annual $5,000 scholarship to all of its employees who have a child enrolled full-time in an accredited college or university. Additionally, the company offers an annual $3,000 scholarship per year to each employee that has a child under the age of six to help offset the expenses of child care.

1 Johnny Bowden. Living the Low-Carb Life: From Atkins to the Zone Choosing the Diet That’s Right for You 2003; 155.

2 Teresa Carr. Are generic drugs like Apotex medication made in India safe? Consumer Reports; April 25, 2014

3 Ibid.

INDICATION
Lomaira™ (phentermine hydrochloride USP) 8 mg tablets, CIV is a prescription medicine used for a short period of time (a few weeks) for weight reduction and should be used together with regular exercise and a reduced-calorie diet. Lomaira is for adults with an initial BMI* of 30 or more (obese) or 27 or more (overweight) with at least one weight-related medical condition such as controlled high blood pressure, diabetes, or high cholesterol. The limited usefulness of this drug class (anorectics), including Lomaira, should be measured against possible risk factors inherent in their use.

IMPORTANT SAFETY INFORMATION
Don’t take Lomaira™ if you have a history of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure or uncontrolled high blood pressure); are taking or have taken a monoamine oxidase inhibitor drug (MAOI) within the past 14 days; have overactive thyroid, glaucoma (increased pressure in the eyes), agitation or a history of drug abuse; are pregnant, nursing, or allergic to the sympathomimetic amines such as phentermine or any of the ingredients in Lomaira.

Taking phentermine with other drugs for weight loss is not recommended. Primary pulmonary hypertension (PPH), a rare fatal lung disease, has been reported in patients who had taken a combination of phentermine and fenfluramine or dexfenfluramine for weight loss. The possible association between phentermine use alone and PPH cannot be ruled out. Patients should report immediately if they experience any decrease in the amount of exercise that they can normally tolerate, shortness of breath, chest or heart pain, fainting or swelling in the lower legs.

Serious heart valve problems or disease have been reported in patients taking a combination of phentermine and fenfluramine or dexfenfluramine for weight loss. The possible role of phentermine has not been established, therefore the possibility of an association between heart valve disease and the use of phentermine alone cannot be ruled out.

If your body becomes adjusted to the maximum dose of phentermine so that its effects are experienced less strongly, the maximum dose should not be exceeded in an attempt to increase the effect.

Caution is advised when engaging in potentially hazardous activity such as driving or operating machinery while taking phentermine. Phentermine has the potential to be abused. Keep Lomaira in a safe place to prevent theft, accidental overdose, misuse or abuse. Using alcohol with phentermine may result in an adverse drug reaction.

Phentermine can cause an increase in blood pressure. Tell your doctor if you have high blood pressure, even if it’s mild. If you are taking medicines for type 2 diabetes, your doctor may have to adjust these medicines while taking phentermine.

Some side effects of phentermine that have been reported include pulmonary hypertension, valvular heart disease, palpitations, increased heart rate or blood pressure, insomnia, restlessness, dry mouth, diarrhea, constipation and changes in sexual drive. These are not all of the potential side effects of phentermine. For more information, ask your doctor or pharmacist.

To report negative side effects of prescription drugs, contact FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

*Body Mass Index (BMI) measures the amount of fat in the body based on height and weight. BMI is measured in kg/m2.

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IMPORTANT SAFETY INFORMATION Don’t take Lomaira™ if you have a history of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure or uncontrolled high blood pressure); are taking or have taken a monoamine oxidase inhibitor drug (MAOI) within the past 14 days; have overactive thyroid, glaucoma (increased pressure in the eyes), agitation or a history of drug abuse; are pregnant, nursing, or allergic to the sympathomimetic amines such as phentermine or any of the ingredients in Lomaira.