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Welcome to the

Qsymia® (phentermine and topiramate extended-release) capsules CIV
Healthcare Provider Training Program

Click below to begin the presentation

Welcome to the

Qsymia® (phentermine and topiramate extended-release) capsules CIV
Healthcare Provider Training Program

Overview

FDA has required a Risk Evaluation and Mitigation Strategy (REMS) for Qsymia so that healthcare providers can be informed about the increased risk of teratogenicity associated with Qsymia therapy.

Purpose

The purpose of the REMS is to inform prescribers and females of reproductive potential (FRP) about the:

  • Increased risk of congenital malformations, specifically orofacial clefts, in infants exposed to Qsymia during the first trimester of pregnancy
  • Importance of pregnancy prevention for FRP
  • Need to discontinue Qsymia immediately if pregnancy occurs

This is an audio program. You will hear its entire contents via voice-over narration.

This program should take approximately 20 minutes of your time to complete.

Before you consider prescribing Qsymia, it is important to be aware of the increased risk of teratogenicity associated with Qsymia therapy.


The information presented in this Training Program does not include a complete list of all risks and safety information on Qsymia.


Before prescribing Qsymia, please read the Qsymia Prescribing Information and Qsymia Medication Guide available within this presentation.


Further information is also available on the Web site www.QsymiaREMS.com

Complete the Qsymia Healthcare Provider Training Program in 3 easy steps:

Register

Register for the program
(which includes providing your
NPI or DEA # for validation)

Read

Read through the REMS
information for Qsymia

Review

Review your knowledge by answering
some true or false questions

Once you complete the program, you will have the opportunity to print out all the Qsymia materials, including:

  • Healthcare Provider Counseling Tool
    for Females of Reproductive Potential
  • Prescriber Dosing and Management
    Checklist
  • Risk of Birth Defects with Qsymia
    patient brochure
  • Dear Healthcare Provider Letter
  • Qsymia Prescribing Information
  • Qsymia Medication Guide
  • Certificate of Completion

Complete the registration form below

Are you a:

I am a Kaiser Permanente Healthcare Provider:

MM/DD/YYYY

Why do we need this information?

As part of the Qsymia REMS, it is important to ensure that physicians who are prescribing Qsymia have received training on the teratogenic risks associated with Qsymia.

Please provide your address to complete your registration

Indication and Patient Selection

Qsymia is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of:

  • 30 kg/m2 or greater (obese), or
  • 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia

Limitations of use:

  • The effect of Qsymia on cardiovascular morbidity and mortality has not been established
  • The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription and over-the-counter drugs, and herbal preparations, have not been established

Increased Risk of Teratogenicity

Qsymia is classified as Pregnancy Category X

  • Qsymia is contraindicated in pregnant women because the use of Qsymia can cause fetal harm. Available data indicate an increase in oral clefts (cleft lip with or without cleft palate) in infants exposed to topiramate, one of the components of Qsymia, during the first trimester of pregnancy.

Increased Risk of Teratogenicity (con’t)

Studies evaluating the risk of major congenital malformations and/or oral clefts with exposure to topiramate, a component of Qsymia, during pregnancy include the following:

  • The North American Anti-Epileptic Drug (NAAED) Pregnancy Registry (2010) analysis
  • A retrospective evaluation of a Wolters Kluwer claims database (January 2003-December 2010 from the United States)
  • A retrospective observational study using 4 U.S. electronic healthcare databases (FORTRESS)
  • A case-control study using data from the Slone Epidemiology Center Birth Defects Study (BDS, 1997-2009) and the Centers for Disease Control's (CDC’s) National Birth Defects Prevention Study (NBDPS, 1996-2007)

Increased Risk of Teratogenicity (con’t)

The NAAED Pregnancy Registry reports an estimated increase in risk for oral clefts of 9.60 (95% CI 3.60-25.70).

An increase in oral clefts was observed with all dose strengths of topiramate.

These data show that exposure to topiramate, a component of Qsymia, in pregnancy is associated with a 2- to 5-fold increase in risk of oral clefts.

Other data sources confirm the increased risk of oral clefts with topiramate exposure during pregnancy (ie, animal studies and Adverse Event Reporting System data).

Counseling for Females of Reproductive Potential*

Qsymia can cause fetal harm.

Advise females of reproductive potential that you recommend:

  • Pregnancy testing prior to beginning Qsymia and monthly during therapy
  • Use of effective contraception consistently during Qsymia therapy; even females who believe they cannot become pregnant should use effective contraception while taking Qsymia
  • If you become pregnant while taking Qsymia, stop Qsymia immediately and notify your healthcare provider
*
Females of reproductive potential are women who have NOT had a hysterectomy, bilateral oophorectomy, or medically documented spontaneous ovarian failure, and have not gone through menopause. Menopause should be clinically confirmed by an individual’s healthcare provider.

Advise nursing mothers not to use Qsymia. Qsymia may be present in human milk because topiramate and amphetamines (phentermine has pharmacologic activity and a chemical structure similar to amphetamines) are excreted in human milk.

Counseling for Females of Reproductive Potential (con’t)

Counseling for Females of Reproductive Potential (con’t)

Dispensed to Patients Through Certified Pharmacies

Qsymia is available only through certified pharmacies that provide a Qsymia Medication Guide and Risk of Birth Defects with Qsymia patient brochure with every prescription and refill as required by the REMS.

Please note that Qsymia is not available outside this network of certified pharmacies. (A full listing of certified pharmacies can be accessed at the end of this presentation.)

Dosage and Administration

Initiation of Treatment

  • Qsymia should be taken in the morning, with or without food
  • Avoid dosing with Qsymia in the evening due to the possibility of insomnia
  • For patients with moderate hepatic impairment or moderate/severe renal impairment, the Qsymia dose should not exceed the recommended dose of Qsymia 7.5 mg/46 mg (phentermine 7.5 mg/ topiramate 46 mg extended-release)
  • The suggested follow-up after administration of initial treatment is 2 to 8 weeks
  • To initiate treatment: Start with one Qsymia
    3.75 mg/23 mg (phentermine 3.75 mg/ topiramate 23 mg extended-release) capsule each morning for the first 14 days; then increase to recommended dose of one Qsymia 7.5 mg/
    46 mg capsule each morning

Dosage and Administration (con't)

Evaluate weight loss with the recommended dose of Qsymia, 7.5 mg/46 mg, at week 12 of treatment

If a patient has not lost at least 3% of baseline body weight on the recommended dose of Qsymia, 7.5 mg/46 mg, discontinue Qsymia or escalate the dose as directed, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss at the Qsymia 7.5 mg/46 mg dose.

To escalate the dose: Increase to one Qsymia 11.25 mg/69 mg (phentermine 11.25 mg/ topiramate 69 mg extended-release) capsule each morning for 14 days, followed by dosing one Qsymia 15 mg/92 mg (phentermine 15 mg/ topiramate 92 mg extended-release) capsule each morning.

Dosage and Administration (con't)

Evaluate weight loss following dose escalation to Qsymia 15 mg/92 mg after 12 weeks of treatment

If a patient has not lost at least 5% of baseline body weight on Qsymia 15 mg /92 mg, discontinue Qsymia, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.

To discontinue Qsymia 15 mg/92 mg, have the patient take a dose every other day for at least 1 week prior to stopping treatment altogether, due to the possibility of precipitating a seizure with abrupt cessation of dosing.

Please complete your certification by taking the following brief quiz.

True or False: The major risk for females of reproductive potential (FRP) being treated with Qsymia is that of teratogenicity (birth defects), specifically the risk of cleft lip with or without cleft palate.

True or False: The major risk for females of reproductive potential (FRP) being treated with Qsymia is that of teratogenicity (birth defects), specifically the risk of cleft lip with or without cleft palate.

The correct answer is TRUE.

Topiramate, a component of Qsymia, has been associated with an increased risk of cleft lip with or without cleft palate in infants exposed to topiramate during the first trimester of pregnancy.

True or False: If a patient hasn’t achieved 3% weight loss following 12 weeks of treatment on the recommended dose of Qsymia 7.5 mg/46 mg (phentermine 7.5 mg/topiramate 46 mg extended-release), discontinuation of therapy or dose escalation should be considered.

True or False: If a patient hasn’t achieved 3% weight loss following 12 weeks of treatment on the recommended dose of Qsymia 7.5 mg/46 mg (phentermine 7.5 mg/topiramate 46 mg extended-release), discontinuation of therapy or dose escalation should be considered.

The correct answer is TRUE.

If a patient has not lost at least 3% of baseline body weight on Qsymia 7.5 mg/46 mg, discontinue Qsymia or escalate the dose as directed, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss at the Qsymia 7.5 mg/46 mg dose.

True or False: Women taking Qsymia should use contraception unless they have had infertility or trouble getting pregnant in the past.

True or False: Women taking Qsymia should use contraception unless they have had infertility or trouble getting pregnant in the past.

The correct answer is FALSE.

ALL women, except those who have gone through menopause or undergone surgical sterilization, should be advised to consistently use effective contraception, even women who have had difficulty getting pregnant in the past.

True or False: If I don’t think a patient is at risk for pregnancy, I don’t need to discuss contraception.

True or False: If I don’t think a patient is at risk for pregnancy, I don’t need to discuss contraception.

The correct answer is FALSE.

It is important to have this conversation with all patients. It is important to know whether a patient is:

  • Trying to get pregnant and not using contraception, in which case do not prescribe Qsymia
  • Sexually active and what contraception she is using, in which case reinforce the importance of consistent use of effective contraception
  • Surgically sterilized or has gone through menopause that has been clinically confirmed, in which case no contraception is required

It is important to have this conversation with all patients, so that if there is a female of reproductive potential in the house, the patient knows to keep Qsymia in a secure location and not share it with anyone else.

True or False: If a woman thinks she is pregnant, she should continue taking Qsymia until the pregnancy is confirmed.

True or False: If a woman thinks she is pregnant, she should continue taking Qsymia until the pregnancy is confirmed.

The correct answer is FALSE.

If a woman believes she might be pregnant, she should stop taking Qsymia immediately and contact her healthcare provider.

True or False: If a woman thinks that she is pregnant, she should continue taking Qsymia until the pregnancy is confirmed.

The correct answer is FALSE.

If a woman believes she might be pregnant, she should stop taking Qsymia immediately and contact her healthcare provider.

Congratulations!

You have completed the Qsymia Healthcare Provider Training Program. Take this opportunity to review printable versions of the Qsymia REMS materials by clicking on the links below or learn more about Qsymia by going to www.QsymiaREMS.com.

For more information, contact VIVUS Medical Information
at 1-888-998-4887 or visit
www.QsymiaREMS.com

Important Safety Information

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Please see the full Prescribing Information by clicking on the link in the navigation bar.

References

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  1. de Bono JS, Logothetis CJ, Molina A, et al. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011;364(21):1995-2005.