Broaden counseling with addition of injectable
With the addition of a new monthly injectable contraceptive, U.S. family planners must broaden their contraceptive counseling to include yet another option in birth control. Federal regulatory approval of Lunelle, marketed by Pharmacia Corp. of Peapack, NJ, came in early October. As of Contraceptive Technology Update press time, drug shipments were scheduled to begin this year, according to Kristin Elliott, Pharmacia spokeswoman.
The combined hormonal injectable method has contraceptive benefits similar to those of the Pill but offers the convenience of once-a-month dosing.
"The continued high unintended pregnancy rate for women in the United States underscores the need for new birth control options that are not tied to daily pill-taking and give American women the flexibility they need," says Susan Wysocki, RNC, NP, president and chief executive officer of the Washington, DC-based National Association of Nurse Practitioners in Women’s Health (NPWH). "NPWH believes that Lunelle fills a valuable void in birth control."
Each 0.5 cc aqueous solution of Lunelle contains 5 mg estradiol cypionate (E2C) and 25 mg medroxyprogesterone acetate (MPA). Since the drug contains an estrogen and progestin, it is very important to distinguish it from Depo-Provera (depot medroxyprogesterone acetate or DMPA), the progestin-only contraceptive injectable also manufactured by Pharmacia.
Lunelle is not the next generation of Depo Provera; instead, it is akin to an injectable Pill, says Lee Shulman, MD, professor of obstetrics/ gynecology and molecular genetics at the University of Illinois at Chicago.
Women who want the side effect profile and the reversibility comparable to an oral contraceptive (OC) will be the most interested in Lunelle, observes Shulman, an investigator for the U.S. clinical trial and lead author for the patient acceptability study.1
Be clear when distinguishing Depo-Provera from Lunelle, says Shulman. When women come in asking for "the birth control shot," make sure which product is requested and double-check that the correct drug is administered, he recommends.
Manage side effects
Side effects with Lunelle are fairly minimal, says Kim Bartley, ARNP, a women’s health nurse practitioner at the University of Florida and Medicus Women’s Diagnostic Center, both in Jacksonville. Women who have used OCs successfully in the past and are familiar with common Pill side effects such as breast tenderness have few, if any, problems with the injection’s side effect profile, says Bartley, who served as coordinator for the clinical study’s Jacksonville site.
"MPA/E2C fortunately has few side effects; however, irregular bleeding can occur," notes Sharon Schnare, RN, FNP, CNM, MSN, women’s health consultant and clinician with the Seattle King County Health Department and the International District Community Health Center in Seattle. "Two-thirds of women using MPA/E2C will have a more regular menstrual patterns after six months of use."
Menstrual changes occur in the first 90 days or first three injection cycles, says Schnare. In counseling patients, note that irregular bleeding may occur within the first three months and then subside in most women, with a more typical pattern of four to five days of bleeding occurring after 10 to 20 days of each injection.
"I think it helps to wheel it out [roughly 18 days after her injection] and tell the patient that she should expect her period to start about that time," explains Anita Nelson, MD, professor in the obstetrics and gynecology department at the University of California in Los Angeles and an investigator in the clinical trial. "This will help her understand what is normal’ and reduce her anxiety about breakthrough bleeding,’ which is really her withdrawal bleed."
Keep women in window’
When women are considering Lunelle as a contraception option, help them explore whether they realistically will be able to come in every month for their contraceptive shot, says Shulman. Explain to them that the shot must be given every 28 to 30 days and no later than 33 days after the last injection, he notes. The time for the next injection is determined by the number of days since the previous injection and not by the timing or amount of menstrual bleeding.
Patients in the clinical study carefully monitored their appointments, reports Nelson. More than 70% of women returned for all their 60 months of visits within three days of the specified reinjection date, and nearly 90% returned within the labeled reinjection window time frame.2
Nelson anticipates that clinics will be able to schedule Lunelle reinjections with the same ease of Depo-Provera shots.
"Our nurse practitioners write the first order to inject and provide orders for reinjections, just as they do refill orders for birth control pills," Nelson states. "When the patient returns, the nurses are able to screen the patients and rapidly provide reinjections."
Make the patient’s appointment for the next reinjection at the time the shot is given, suggests Bartley. Give your patients a reminder card to help them keep track of appointments, she says.
Self-injection of Lunelle is under research,3 says Shulman. Until other avenues of injection are open, providers will need to work with women in the delivery of the new contraceptive. "I think this offers a considerable large step forward in making a method that will be well-accepted by many women and yet not require a detailed ritual — daily or coital-related — that is really associated with poor continuation numbers," he observes.
References
1. Shulman LP, Oleen-Burkey M, Willke RJ. Patient acceptability and satisfaction with Lunelle monthly contraceptive injection (medroxyprogesterone acetate and estradiol cypionate injectable suspension). Contraception 1999; 60:215-222.
2. Kaunitz AM, Garceau RJ, Cromie MA. Comparative safety, efficacy, and cycle control of Lunelle monthly contraceptive injection (medroxyprogesterone acetate and estradiol cypionate injectable suspension) and Ortho-Novum 7/7/7 oral contraceptive (norethindrone/ethinyl estradiol triphasic). Lunelle Study Group. Contraception 1999; 60:179-87.
3. Bahamondes L, Marchi NM, Nakagava HM, et al. Self-administration with UniJect of the once-a-month injectable contraceptive Cyclofem. Contraception 1997; 56:301-304.
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