Sexual Health

CMECNE

Prescribing Bremelanotide for Low Desire: How, When and Where?

Learning Objectives and CME/Disclosure Information

This activity is intended for healthcare providers delivering care to women and their families.

After completing this activity, the participant should be better able to:

1. Describe how bremelanotide is administered
2. Discuss contraindications, warnings and precautions in the use of bremelanotide

Estimated time to complete activity: 0.25 hours

Faculty:

Susan J. Gross, MD, FRCSC, FACOG, FACMG
President and CEO, The ObG Project

Disclosure of Conflicts of Interest

Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high quality CME activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

Faculty: Susan J. Gross, MD, receives consulting fees from Cradle Genomics, and has financial interest in The ObG Project, Inc.

Planners and Managers: The PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, MBA, MSN, RN, and Jan Schultz, MSN, RN, CHCP have nothing to disclose.

Method of Participation and Request for Credit

Fees for participating and receiving CME credit for this activity are as posted on The ObG Project website. During the period from 1/15/2020 through 1/15/2021, participants must read the learning objectives and faculty disclosures and study the educational activity.

If you wish to receive acknowledgment for completing this activity, please complete the post-test and evaluation. Upon registering and successfully completing the post-test with a score of 100% and the activity evaluation, your certificate will be made available immediately.

For Pharmacists: Upon successfully completing the post-test with a score of 100% and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks.

Joint Accreditation Statement

In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and The ObG Project. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Physician Continuing Medical Education

Postgraduate Institute for Medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Continuing Nursing Education

The maximum number of hours awarded for this Continuing Nursing Education activity is 0.2 contact hours.

Designated for 0.1 contact hours of pharmacotherapy credit for Advance Practice Registered Nurses.

Read Disclaimer & Fine Print

CLINICAL ACTIONS:

A new treatment has been approved by the FDA for hypoactive sexual desire disorder (HSDD).

HSDD: Characterized by
- Low sexual desire
- Marked distress or interpersonal difficulty
- Note: Not due to a co-existing problem (e.g. medical, psychiatric, relationship issues, drug use etc.)
Acquired HSDD
- No previous issues related to sexual desire are identified
Generalized HSDD
- HSDD occurs regardless of type of sexual activity, situation or partner
Prior to prescribing this medication, consider the following to ensure that HSDD is not a symptom of a more significant medical problem
- Obtain a thorough history and evaluation in order to diagnose HSDD (see Related ObG Topics below)
- A general physical examination, CBC and chemistry panel

SYNOPSIS:

Bremelanotide is a melanocortin receptor agonist for the treatment of HSDD in premenopausal women. Bremelanotide is self-administered with a prefilled autoinjector pen 45 minutes before anticipated sexual activity.

KEY POINTS:

Dosage
- Subcutaneous injection: 1.75 mg/0.3 mL solution (abdomen or thigh)
- Patients should not use more than one dose within 24 hours or more than eight doses per month
Contraindications
- Uncontrolled hypertension or known cardiovascular disease
- Not recommended in patients at high risk for cardiovascular disease
- Discontinue if pregnancy is suspected
- Advise women of reproductive potential to use effective contraception
Warnings and Precautions
- Transient increase in blood pressure and decrease in heart rate occurs after each dose and usually resolves within 12 hours
- Consider the patient’s cardiovascular risk before initiating medication and periodically during treatment and ensure blood pressure is well-controlled
Commonly reported adverse reactions (incidence >4%)
- Nausea: 40% (13% required anti-emetic)
- Flushing: 20.3%
- Injection site reactions: 13.2%
- Headache: 11.3%
- Vomiting: 4.8%
Concomitant behavioral and psychotherapy can be extremely helpful in the process of treatment
- Consider simultaneous referral to sex therapist
Clinical trials
- Sexual desire score (range of 1.2 to 6.0 with higher scores indicating greater sexual desire)
  - Treated patients: 25% had an increase of ≥1.2
  - Placebo: 17% had an increase of ≥1.2
Bremelanotide can be used in conjunction with hormone therapy

Diagnosis Codes: Sexual interest/arousal disorder: DSM-5 302.72 (F52.22)

Learn More – Primary Sources :

FDA approves new treatment for hypoactive sexual desire disorder in premenopausal women

ClinicalTrials.gov: Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder

Bremelanotide for female sexual dysfunctions in premenopausal women: a randomized, placebo-controlled dose-finding trial.

FDA: VYLEESI – Highlights of Prescribing Information

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Prescribing Bremelanotide for Low Desire: How, When and Where?