News Alert-Monthly combined injectable becomes first new method of U.S. contraceptive since '93
November 1, 2000 5 minutes read
News Alert-Monthly combined injectable becomes first new method of U.S. contraceptive since '93
FDA approves Lunelle from Pharmacia Corp.
By Rebecca Bowers
Editor, Contraceptive Technology Update
Atlanta
The cafeteria of contraceptive choices just expanded in the United States with the regulatory approval of Lunelle, a monthly combined injectable from Pharmacia Corp. in Peapack, NJ. The drug, approved Oct. 5 by the Food and Drug Administration, represents the first new method of birth control in the United States since 1993, when the Reality female condom was introduced by Female Health Co. of Chicago.
Lunelle will be available later this fall, according to Kristin Elliott, Pharmacia spokeswoman. Lunelle's cost, including cost of the injection, will be comparable to the monthly cost of birth control pills, she says. [Providers who would like more details on Lunelle should contact Pharmacia at (800) 253-8600, ext. 38244 or visit the company's Web site at http://www.pharmacia.com.]
Developed in the late 1960s, this combination injectable has been widely tested. More than 17,000 women have participated in controlled trials worldwide, and the drug is in routine use in several countries. The drug is marketed in other countries under the brand names Cyclofem and Cyclo-Provera. (Read more about the drug's history in CTU, June 1996, p. 71, and November 1999, p. 125.)
Who can use Lunelle? A Personal Guide for Managing Contraception for Women and Men notes that suitable candidates include those who have no medical contraindications to combined pills, desire a highly effective reversible method, want to have a child in one or two years, and do not want to take pills every day.1
As with other hormonal contraceptives, Lunelle is not appropriate for women with known or suspected pregnancies; thrombophlebitis or thromboembolic disorders; a past history of deep-vein thrombophlebitis or thromboembolic disorders, cerebral vascular, or coronary artery disease; or undiagnosed abnormal genital bleeding. As with other hormonal contraceptives, menstrual bleeding patterns might be disrupted with initial use of Lunelle. In addition, the method does not protect against HIV and other sexually transmitted diseases.
Once-a-month dosing offers convenience
Lunelle offers women a reliable form of birth control that prevents unintended pregnancy with the convenience of once-a-month dosing, notes Andrew Kaunitz, MD, professor and assistant chair in the obstetrics and gynecology department at the University of Florida Health Science Center/Jacksonville. Kaunitz served as an investigator for the U.S. clinical trial.2 Monthly estrogen/progestin contraception, he says, combines the high effectiveness of long-acting methods with the regular cycles and easy return to fertility characteristic of oral contraceptives.
"At our University of Florida/Jacksonville site, some of our original research participants have chosen, almost two years after the initial 60-week comparative component was completed, to continue their monthly injections," he reports. "Their preference for Lunelle speaks to the advantage and security of not having to worry about missing a pill and the [attending] consequences."
Each 0.5 cc aqueous solution of Lunelle contains 5 mg estradiol cypionate (E2C) and 25 mg medroxyprogesterone acetate (MPA). The intramuscular injection is commonly administered to the gluteus or deltoid muscles, but it can be administered safely and effectively in the anterior thigh. Ideally, it is administered every 28 to 30 days, but effective contraception is maintained with a 10-day reinjection window (at least 23 days and no more than 33).
According to two studies based on the U.S. clinical trial, Lunelle is highly effective, safe, and well-accepted among women.2,3 In the Phase III 60-week trial, which compared Lunelle with Ortho-Novum 7/7/7, an oral contraceptive manufactured by Ortho-McNeil Pharmaceuticals of Raritan, NJ, the data showed two unintended pregnancies in the oral contraceptive group and none in the Lunelle group.
Compared with the progestin-only injectable, depot medroxyprogesterone acetate (DMPA or Depo-Provera, also manufactured by Pharmacia Corp.), Lunelle offers a more regular bleeding pattern, and women using Lunelle maintain estrogen levels normal for ovulatory women.1 Another advantage of Lunelle is that its effects are reversed relatively rapidly. MPA is cleared within 60 to 90 days, restoring ovulation. This return to fertility is about twice as fast as that achieved after the last progesterone-only injection.4
The most common adverse events leading to discontinuation of Lunelle in the clinical trial were hormone-related. Complaints of excessive bleeding were recorded in 2.5%, breast pain in 1.8%, menorrhagia in 1.5%, and dysmenorrhea in 1.2%. The study found that discontinuation rates for any adverse event were low in the injectable and pill study groups.2
Family planners hail the expansion of contraceptive choices represented by Lunelle's introduction. "I think Lunelle can be a worthwhile addition for women who need less structure in their lives," says David Archer, MD, professor of obstetrics and gynecology and director of the Clinical Research Center at the Eastern Virginia Medical School in Norfolk. "Remembering to take a pill a day can be difficult; a monthly reminder for an injection could be easier with the reduction in need for motivation."
While providers like the advantages of the new method, they note the need for monthly injections as a potential disadvantage.
"The major problem is the monthly injection," says Archer. "A technique that could allow the recipient to self-inject is sorely needed."
Research of such auto-injection is proceeding, says 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. A Brazilian study indicates that women can be trained to self-administer the monthly injectable contraceptive and generally respond positively to the auto-injection device.5
To enhance success with Lunelle, providers should discuss all of the method's benefits and side effects, says Schnare. Prepare patients to deal with side effects, and be prepared to manage such side effects with them, she advises.
"When patients know what to expect and know that providers are available to help them if side effects occur, they tolerate side effects much better," she says.
In addition, with the advent of two injectable contraceptives in the U.S. market, when patients present for their "birth control shot," it will be important to determine which one is used.
Help patients plan how they will return for reinjections and discuss scheduling issues, Schnare suggests. Most women who participated in the clinical trial found the monthly treatment schedule easy to comply with and would recommend this form of contraception to others.3
"In my judgment, Lunelle will prove to be a popular choice," says Kaunitz. "Clinicians and facilities that provide easy injection access will find this to be an attractive method for many women."
References
1. Hatcher RA, Pluhar E, Zieman M, et al. A Personal Guide to Managing Contraception for Women and Men. Decatur, GA: Bridging the Gap Communications; 2000.
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). Contraception 1999; 60:179-187.
3. 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.
4. Thompson S. New Developments in Contraception Featuring Monthly Combination Injectables. Washington, DC: Association of Reproductive Health Professionals; 2000.
5. 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.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content