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Transcript

ReachMD Announcer:
Welcome to ReachMD. This medical industry feature, titled “An Approach for Counseling Patients On Bleeding Pattern Changes That May Occur With a Contraceptive Option,” is paid for and brought to you by Organon. This program is intended for health care professionals in the United States. Here’s your host, Dr. Toni Marengo.

Dr. Marengo:
Hi, I’m Dr. Toni Marengo, a comprehensive gynecologist specializing in reproductive healthcare.

I am also a trained and experienced provider for NEXPLANON.

Announcer:
INDICATION
NEXPLANON is indicated for use by women to prevent pregnancy.

SELECTED SAFETY INFORMATION
Who is not appropriate for NEXPLANON
NEXPLANON should not be used in women who have known or suspected pregnancy; current or past history of thrombosis or thromboembolic disorders; liver tumors or active liver disease; undiagnosed abnormal genital bleeding; known or suspected breast cancer, personal history of breast cancer, or other progestin-sensitive cancer now or in the past; or allergy to any component of NEXPLANON.

WARNING and PRECAUTIONS
Complications of insertion and removal
Palpate immediately after insertion to ensure proper placement. Undetected failure to insert the implant may lead to unintended pregnancy.

Insertion and removal-related complications may include pain, paresthesias, bleeding, hematoma, scarring, or infection. If NEXPLANON is inserted too deeply (intramuscular or in the fascia), neural or vascular injury may occur. Implant removal may be difficult or impossible if the implant is not inserted correctly, inserted too deeply, not palpable, encased in fibrous tissue, or has migrated. If at any time the implant cannot be palpated, it should be localized and removed.

There have been postmarketing reports of implants located within the vessels of the arm and the pulmonary artery; in these cases, endovascular or surgical procedures may be needed for removal.

Failure to remove the implant may result in continued effects of etonogestrel, such as compromised fertility, ectopic pregnancy, or persistence or occurrence of a drug-related adverse event.

Dr. Marengo:
As with most progestin-only contraception, including progestin-only long-acting reversible contraception, otherwise known as LARC, we may not be able to predict how NEXPLANON will affect a patient’s bleeding pattern and this can impact how patients make decisions about starting or keeping an implant.^1-3

Today, I want to share an approach for counseling patients about unscheduled bleeding.³

When patients are first considering NEXPLANON, it’s important to set expectations about potential changes to bleeding patterns they may experience.³

When counseling your patients, let them know that these changes could range from prolonged bleeding to frequent, infrequent, spotting episodes or no bleeding, which may change over time.^4,5

In clinical trials, one in five women experienced no bleeding and/or spotting and one in five women experienced frequent and/or prolonged bleeding.

For many women, the bleeding pattern experienced during the first 3 months of using NEXPLANON is broadly predictive of the future bleeding pattern.

You can also let them know that while the bleeding pattern may be unpredictable, experiencing more or less bleeding will not affect the efficacy of the implant.²

It is important that we do not minimize or dismiss the potential side effects of treatment and that we frame it as a balance between those potential side effects and the benefits that the implant may provide.⁶

When done in an empathetic and proactive manner, contraceptive counseling can be key for patients to make the right choice for themselves and feel comfortable with their decision.⁷

I will often say to my patients, “There’s a chance NEXPLANON could impact your cycle, and you may have more or less frequent bleeding. If you do experience a side effect you’re not comfortable with, reach out to me, so we can talk about your options for managing it.”^3,5

When a patient does express concerns about unscheduled bleeding, there are several questions you can consider asking to better understand their situation.⁸

Some examples might be: What are your main concerns?; What was your bleeding pattern like prior to using NEXPLANON?; How many days per month are you bleeding or spotting?⁸

Taking a careful history of your patients can help you better address their concerns and advise them on the next steps.⁸

As with all patient care, setting expectations and establishing an open dialogue will help our patients feel comfortable coming to us with any issues that may arise and working together to find the best solutions for their care.^3,5

Announcer:
SELECTED SAFETY INFORMATION (continued)
WARNING and PRECAUTIONS (continued)

NEXPLANON and pregnancy
Should pregnancy or lower abdominal pain occur while using NEXPLANON, be alert to the possibility of an ectopic pregnancy.

Rule out pregnancy before inserting NEXPLANON.

Educate her about the risk of serious vascular events
There have been postmarketing reports of serious arterial thrombotic and venous thromboembolic events, including cases of pulmonary emboli (some fatal), deep vein thrombosis, myocardial infarction, and strokes, in women using etonogestrel implants. Assess women with known risk factors. NEXPLANON should be removed if thrombosis occurs.

NEXPLANON should not be used prior to 21 days postpartum due to risk of thromboembolism.

Women with a history of thromboembolic disorders should be made aware of the possibility of a recurrence.

In case of long-term immobilization, consider removing NEXPLANON.

Counsel her about changes in bleeding patterns
Women are likely to have changes in their menstrual bleeding pattern with NEXPLANON, including changes in frequency, intensity, or duration. Evaluate abnormal bleeding as needed to exclude pathologic conditions or pregnancy. In clinical studies of the non-radiopaque etonogestrel implant, the most common reason for discontinuation was changes in bleeding patterns (11.1%).

Be aware of other serious complications, adverse reactions, and drug interactions
Remove NEXPLANON if jaundice occurs or blood pressure rises significantly and becomes uncontrolled.

Monitor prediabetic and diabetic women using NEXPLANON.

Observe women with a history of depressed mood. Consider removing NEXPLANON in patients who become significantly depressed.

The most common adverse reactions (≥10%) reported in clinical trials were headache (24.9%), vaginitis (14.5%), weight increase (13.7%), acne (13.5%), breast pain (12.8%), abdominal pain (10.9%), and pharyngitis (10.5%).

Drugs or herbal products that induce enzymes, including CYP3A4, may decrease the effectiveness of NEXPLANON or increase breakthrough bleeding.

The efficacy of NEXPLANON in women weighing more than 130% of their ideal body weight has not been studied. Serum concentrations of etonogestrel are inversely related to body weight and decrease with time after implant insertion. NEXPLANON may be less effective in overweight women.

NEXPLANON does not protect against HIV or other STDs.

Before prescribing NEXPLANON, please read the accompanying Prescribing Information. The Patient Information also is available.

ReachMD Announcer:
This program was brought to you by Organon. If you missed any part of this discussion, visit ReachMD.com/industryfeature. This is ReachMD. Be part of the knowledge.

The references for the information discussed today are available in the transcript, which can be accessed on the site where you listened to this podcast.

References:

Centers for Disease Control and Prevention. Contraception. Accessed May 4, 2023. www.cdc.gov/reproductivehealth/contraception/index.htm

Curtis KM et al. MMWR Recomm Rep. 2016;65:1-66.

Data available on request from Professional Services-DAP (Marketing Operations), 30 Hudson Street, Jersey City, NJ 07302. Please specify information package US-XPL-115555.

Dehlendorf C, Fox E, Sobel L, Borrero S. Curr Obstet Gynecol Rep. 2016;5:55-63.

Edwards AJ, DiVasta AD, Pitts S. Curr Opin Pediatr. 2020;32:461-470.

Friedlander E, Kaneshiro B. Obstet Gynecol Clin North Am. 2015;42:593-603.

The American College of Obstetricians and Gynecologists. Committee on Practice Bulletins-Gynecology, Long-Acting Reversible Contraception: Implants and Intrauterine Devices. Practice Bulletin No. 186. Obstet Gynecol. 2017; 30:e251-e269.

Trussell J et al. In: Hatcher RA. Contraceptive Technology. 21st ed. New York, NY: Ayer Company Publishers, Inc. 2018:95-128.

Villavicencio J, Allen RH. Open Access J Contraception. 2016;7:42-52.

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US-XPL-116433 06/23