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Lunelle (Medroxyprogesterone Acetate / Estradiol Cypionate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

LUNELLE™ Monthly Contraceptive Injection is indicated for the prevention of pregnancy.

The efficacy of LUNELLE™ Monthly Contraceptive Injection is dependent on adherence to the recommended dosage schedule (e.g., intramuscular injections every 28 to 30 days, not to exceed 33 days). To ensure that LUNELLE™ Monthly Contraceptive Injection is not administered inadvertently to a pregnant woman, the first injection should be given during the first 5 days of a normal menstrual period. LUNELLE™ Monthly Contraceptive Injection should be administered no earlier than 4 weeks after delivery if not breastfeeding or 6 weeks after delivery if breastfeeding (see NURSING MOTHERS).

Several clinical trials of LUNELLE™ Monthly Contraceptive Injection have reported 12-month failure rates of < 1% by Life Table analysis (see also CLINICAL STUDIES). Pregnancy rates for various contraceptive methods are typically reported for the first year of use and are shown in Table 2.

Table 2. Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year: United States
Method % of Women Experiencing
an Unintended Pregnancy within
the First Year of Use
% of Women
Continuing Use at 1 Year 3
Typical
Use 1
Perfect
Use 2
Chance 4
85 85
Spermicides 5
26 6 40
Periodic Abstinence
Calendar
Ovulation Method Symptothermal 6
Post-ovulation
25
9 3 2 1
63
Cap7
Parous Women
Nulliparous Women

40 20

26 9

42 56
Sponge
Parous Women
Nulliparous Women

40 20

20 9

42 56
Diaphragm 7
20 6 56
Withdrawal
19 4
Condom 8
Female (Reality)
Male

21 14

5 3

56 61
Pill
Progestin only
Combined
5
0.5 0.1
71
IUD
Progesterone T
Copper T 380A
LNg 20

2.0 0.8 0.1

1.5 0.6 0.1

81 78 81
Depo-Provera
0.3 0.3 70
Norplant and
Norplant-2

0.05

0.05

88
Female Sterilization
0.5 0.5 100
Male Sterilization 0.15 0.10 100
Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%. 9
Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception. 10
Adapted from Hatcher et al., 1998. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for 1 year.4 The percentages becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within 1 year. This estimate was lowered slightly (to 85%) to represent the percentages who would become pregnant within 1 year among women now relying on reversible methods of contraception if they abandoned contraception altogether.5 Foams, creams, gels, vaginal suppositories, and vaginal film.6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.7 With spermicidal cream or jelly.8 Without spermicides.9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral (1 dose is 2 white pills), Alesse (1 dose is 5 pink pills), Nordette or Levlen (1 dose is 4 light-orange pills), Lo/Ovral (1 dose is 4 white pills), Triphasil or Tri-Levlen (1 dose is 4 yellow pills).10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age.

DOSAGE AND ADMINISTRATION

LUNELLE™ Monthly Contraceptive Injection is effective for contraception during the first cycle of use when administered as recommended.

The recommended dose of LUNELLE™ Monthly Contraceptive Injection is 0.5 mL administered by intramuscular injection, into the deltoid, gluteus maximus, or anterior thigh. The aqueous suspension must be vigorously shaken just before use to ensure a uniform suspension of 25 mg medroxyprogesterone acetate and 5 mg estradiol cypionate.

FIRST INJECTION

  • Within first 5 days of the onset of a normal menstrual period, or
  • Within 5 days of a complete first trimester abortion, or
  • No earlier than 4 weeks postpartum if not breastfeeding.
  • No earlier than 6 weeks postpartum if breastfeeding.

SECOND AND SUBSEQUENT INJECTIONS

  • Monthly (28 to 30 days) after previous injection, not to exceed 33 days.
  • If the patient has not adhered to the prescribed schedule (greater than 33 days since last injection), pregnancy should be considered and she should not receive another injection until pregnancy is ruled out.
  • Shortening the injection interval could lead to a change in menstrual pattern.
  • Do not use bleeding episodes to guide the injection schedule.

SWITCHING FROM OTHER METHODS OF CONTRACEPTION

When switching from other contraceptive methods, LUNELLE™ Monthly Contraceptive Injection should be given in a manner that ensures continuous contraceptive coverage based upon the mechanism of action of both methods, e.g., patients switching from oral contraceptives should have their first injection of LUNELLE™ Monthly Contraceptive Injection within 7 days after taking their last active pill.

HOW SUPPLIED

LUNELLE™ Monthly Contraceptive Injection (25 mg medroxyprogesterone acetate and 5 mg estradiol cypionate per 0.5 mL sterile aqueous injectable suspension) is available in vials and prefilled syringes. Each vial or prefilled syringe contains enough product to deliver 0.5 mL for single-dose administration. It is available in the following packages:

NDC 0009-3484-04 1 × 0.5 mL vial

NDC 0009-3484-10 3 × 0.5 mL vials

NDC 0009-3484-05 25 × 0.5 mL vials

NDC 0009-3484-06 1 × 0.5 mL prefilled syringe

NDC 0009-3484-07 3 × 0.5 mL prefilled syringe

NDC 0009-3484-08 6 × 0.5 mL prefilled syringe

NDC 0009-3484-09 24 × 0.5 mL prefilled syringe

Store at 20°-25°C (68°-77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Rx only

References available upon request.

Manufactured for: Pharmacia & Upjohn Company

A subsidiary of Pharmacia Corporation

Kalamazoo, MI 49001, USA

by: Pharmacia NV/SA

Puurs, Belgium

(prefilled syringes)

Pharmacia & Upjohn Company

Kalamazoo, MI 49001, USA

(vials)

Revised July 2001 817 821 001

692804

3484-04

Patient Information About

LUNELLE™ Monthly Contraceptive Injection

medroxyprogesterone acetate and estradiol cypionate injectable suspension

PHARMACIA

LUNELLE™ Monthly Contraceptive Injection (like all hormonal contraceptives) is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Every woman who considers using hormonal contraceptives must understand the benefits and risks of this type of birth control. This sheet contains important information about hormonal contraceptives that you need in order to decide if LUNELLE™ Monthly Contraceptive Injection is a good type of birth control for you. Please read this sheet carefully and ask your health care provider to help you compare LUNELLE™ Monthly Contraceptive Injection with other methods of birth control. This sheet is not meant to take the place of careful discussions with your health care provider. You should discuss the information provided in this sheet with him or her, both when you first start taking LUNELLE™ Monthly Contraceptive Injection and during your revisits. You should also follow your health care provider's advice with regard to regular check-ups while you are on LUNELLE™ Monthly Contraceptive Injection.

WHAT IS LUNELLE™ MONTHLY CONTRACEPTIVE INJECTION?

LUNELLE™ Monthly Contraceptive Injection is a type of hormonal birth control that is given as an injection (a shot) in your arm, thigh, or buttock once a month to prevent pregnancy. It contains hormones which have effects similar to the natural hormones, estrogen and progesterone, produced in your body. Similar combinations of hormones are found in some oral contraceptives also known as "birth control pills" or "the pill." When you receive your injections once a month as prescribed, LUNELLE™ Monthly Contraceptive Injection is as effective as birth control pills. When given according to the prescribed schedule, LUNELLE™ Monthly Contraceptive Injection is effective in preventing pregnancy during the cycle in which it is given. Clinical studies have shown that when women receive LUNELLE™ Monthly Contraceptive Injection according to the recommended schedule, the failure rate of this method of birth control is less than 1% per year.

The following table shows the typical failure rates for other methods of birth control during the first year of use:

Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Typical Use and the First Year of Perfect Use of Contraception and the Percentage Continuing Use at the End of the First Year: United States
Method % of Women
Experiencing
an Unintended
Pregnancy within
the First Year
of Use
% of
Women
Continuing
Use at
1 Year 3
Typical
Use 1
Perfect
Use 2
Chance 4
85 85
Spermicides 5
26 6 40
Periodic Abstinence
Calendar
Ovulation Method Symptothermal 6
Post-ovulation
25
9 3 2 1
63
Cap7
Parous Women
Nulliparous Women

40 20

26 9

42 56
Sponge
Parous Women
Nulliparous Women

40 20

20 9

42 56
Diaphragm 7
20 6 56
Withdrawal
19 4
Condom 8
Female (Reality)
Male

21 14

5 3

56 61
Pill
Progestin only
Combined
5
0.5 0.1
71
IUD
Progesterone T
Copper T 380A
LNg 20

2.0 0.8 0.1

1.5 0.6 0.1

81 78 81
Depo-Provera
0.3 0.3 70
Norplant and
Norplant-2

0.05

0.05

88
Female Sterilization
0.5 0.5 100
Male Sterilization 0.15 0.10 100
Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%. 9
Lactational Amenorrhea Method: LAM is a highly effective, temporary method of contraception. 10
Adapted from Hatcher et al., 1998. 1 Among typical couples who initiate use of a method (not necessarily for the first time), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.2 Among couples who initiate use of a method (not necessarily for the first time) and who use it perfectly (both consistently and correctly), the percentage who experience an accidental pregnancy during the first year if they do not stop use for any other reason.3 Among couples attempting to avoid pregnancy, the percentage who continue to use a method for 1 year.4 The percentages becoming pregnant in columns (2) and (3) are based on data from populations where contraception is not used and from women who cease using contraception in order to become pregnant. Among such populations, about 89% become pregnant within 1 year. This estimate was lowered slightly (to 85%) to represent the percentages who would become pregnant within 1 year among women now relying on reversible methods of contraception if they abandoned contraception altogether.5 Foams, creams, gels, vaginal suppositories, and vaginal film.6 Cervical mucus (ovulation) method supplemented by calendar in the pre-ovulatory and basal body temperature in the post-ovulatory phases.7 With spermicidal cream or jelly.8 Without spermicides.9 The treatment schedule is one dose within 72 hours after unprotected intercourse, and a second dose 12 hours after the first dose. The Food and Drug Administration has declared the following brands of oral contraceptives to be safe and effective for emergency contraception: Ovral (1 dose is 2 white pills), Alesse (1 dose is 5 pink pills), Nordette or Levlen (1 dose is 4 light-orange pills), Lo/Ovral (1 dose is 4 white pills), Triphasil or Tri-Levlen (1 dose is 4 yellow pills).10 However, to maintain effective protection against pregnancy, another method of contraception must be used as soon as menstruation resumes, the frequency or duration of breastfeeds is reduced, bottle feeds are introduced, or the baby reaches 6 months of age.

WHO SHOULD NOT TAKE LUNELLE™ MONTHLY CONTRACEPTIVE INJECTION

Cigarette smoking increases the risk of serious cardiovascular side effects from hormonal contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use hormonal contraceptives are strongly advised not to smoke.

Some women should not use hormonal contraceptives. For example, you should not take LUNELLE™ Monthly Contraceptive Injection if you are pregnant or think you may be pregnant. You should also not use LUNELLE™ Monthly Contraceptive Injection if you have any of the following conditions:

  • A history of heart attack or stroke
  • Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), or eyes
  • A history of blood clots in the deep veins of your legs
  • Chest pain (angina pectoris)
  • Known or suspected breast cancer or cancer of the lining of the uterus, cervix or vagina
  • Unexplained vaginal bleeding (until a diagnosis is reached by your doctor)
  • Yellowing of the whites of the eyes or of the skin (jaundice) during pregnancy or during previous use of the pill or other hormonal contraceptives
  • Liver tumor (benign or cancerous)
  • Known or suspected pregnancy
  • Allergy to any of the ingredients contained in LUNELLE™ Monthly Contraceptive Injection
  • Over age 35 and smoke 15 or more cigarettes per day

Tell your health care provider if you have ever had any of these conditions. Your health care provider can recommend a safer method of birth control.

OTHER CONSIDERATIONS BEFORE TAKING LUNELLE™ MONTHLY CONTRACEPTIVE INJECTION

For the majority of women, hormonal contraceptives can be taken safely. But there are some women who are at high risk of developing certain serious diseases that can be life-threatening or may cause temporary or permanent disability. Tell your health care provider if you have:

  • Breast nodules, fibrocystic disease of the breast, an abnormal breast x-ray or mammogram, strong family history of breast cancer
  • Diabetes
  • Elevated cholesterol or triglycerides
  • High blood pressure
  • Migraine or other headaches or epilepsy
  • Mental depression
  • Gallbladder, heart or kidney disease
  • History of scanty or irregular menstrual periods
  • Smoke, especially if 35 years or older

Women with any of these conditions should be checked often by their health care provider if they choose to use LUNELLE™ Monthly Contraceptive Injection.

Also, be sure to inform your doctor or health care provider if you smoke or are on any medications.

RISKS OF TAKING HORMONAL CONTRACEPTIVES

  1. Risk of developing blood clots, heart attacks, and strokes
    Blood clots and blockage of blood vessels are the most serious side effects of taking hormonal contraceptives. In particular, blood clots can occur in the legs and can travel to the lungs and can cause sudden blocking of the vessel carrying blood to the lungs. Rarely, clots occur in the blood vessels of the eye and may cause blindness, double vision, or impaired vision.
    If you take hormonal contraceptives such as LUNELLE™ Monthly Contraceptive Injection and need elective surgery, need to stay in bed for a prolonged illness, or have recently had a baby, you may be at risk of developing blood clots. You should consult your doctor about stopping hormonal contraceptives three to four weeks before surgery and not taking hormonal contraceptives for two weeks after surgery or during bed rest. You should also not take hormonal contraceptives soon after delivery of a baby. It is advisable to wait for at least four weeks after delivery before using hormonal contraceptives such as LUNELLE™ Monthly Contraceptive Injection. (See also the section on Breast Feeding in GENERAL PRECAUTIONS.)
    Hormonal contraceptives may also increase the tendency to develop strokes (stoppage or rupture of blood vessels in the brain) and angina pectoris and heart attacks (blockage of blood vessels in the heart). Any of these conditions can cause death or disability.
    Smoking greatly increases the possibility of developing blood clots or suffering heart attacks and strokes. Furthermore, smoking and the use of hormonal contraceptives greatly increase the chances of developing and dying of heart disease, particularly if you are over 35 years of age.
  2. Gallbladder disease
    Hormonal contraceptive users probably have a greater risk than non-users of having gallbladder disease.
  3. Liver tumors
    In rare cases, hormonal contraceptives can cause benign but dangerous liver tumors. These benign liver tumors can rupture and cause fatal internal bleeding. In addition, a possible but not definite association has been found with hormonal contraceptives and liver cancers in two studies, in which a few women who developed these very rare cancers were found to have used hormonal contraceptives for long periods. However, liver cancers are extremely rare. The chance of developing liver cancer from using hormonal contraceptives is thus even rarer.
  4. Cancer of the reproductive organs and breasts
    There is, at present, no confirmed evidence that oral hormonal contraceptives increase the risk of cancer of the reproductive organs in human studies. Studies to date of women taking the pill have reported conflicting findings on whether pill use increases the risk of developing cancer of the breast. Most of the studies on breast cancer and pill use have found no overall increase in the risk of developing breast cancer, although some studies have reported an increased risk of developing breast cancer in certain groups of women.
    Some studies have found an increase in the incidence of cancer of the cervix in women who use oral hormonal contraceptives. However, this finding may be related to factors other than the use of oral hormonal contraceptives.
    Studies have found that women who used injectable hormonal contraceptives (Depo-Provera Contraceptive Injection) had no increased overall risk of developing cancer of the breast, ovary, uterus, or cervix. However, women under 35 years of age whose first exposure to Depo-Provera Contraceptive Injection was within the previous 4 to 5 years may have a slightly increased risk of developing breast cancer similar to that seen with oral contraceptives.
    Women who use hormonal contraceptives and have a strong family history of breast cancer or who have breast nodules or abnormal mammogram should be closely followed by their doctors.
  5. Changes in bone mineral density
    Use of injectable hormonal contraceptives containing the progesterone-type hormone found in LUNELLE™ Monthly Contraceptive Injection may be associated with a decrease in the amount of mineral stored in your bones. This could increase your risk of developing bone fractures. The rate of bone mineral loss is greatest in the early years of use of this type of contraceptive, but after that, it begins to resemble the normal rate of age-related bone mineral loss.
    Formal studies on the effect of bone mineral density changes in women receiving LUNELLE™ Monthly Contraceptive Injection have not been conducted.
  6. Allergic reactions
    Severe allergic reactions have been reported in some women using injectable hormonal contraceptives containing the progesterone-type hormone found in LUNELLE™ Monthly Contraceptive Injection. Allergic reactions occurring in women using LUNELLE™ Monthly Contraceptive Injection have been mainly skin reactions, and not respiratory in nature. Serious allergic reactions require emergency medical treatment.

ESTIMATED RISK OF DEATH FROM A BIRTH CONTROL METHOD OR PREGNANCY

All methods of birth control and pregnancy are associated with a risk of developing certain diseases that may lead to disability or death. An estimate of the number of deaths associated with different methods of birth control and pregnancy has been calculated and is shown in the following table.

Annual Number of Birth-Related or Method-Related Deaths Associated with Control of Fertility per 100,000 Non-sterile Women, by Fertility Control Method According to Age
Method of Control & Outcome Range of Ages (years)
15-19 20-24 25-29 30-34 35-39 40-44
No fertility control * 7.0 7.4 9.1 14.8 25.7 28.2
Oral hormonal contraceptives **
(non-smoker)
0.3 0.5 0.9 1.9 13.8 31.6
Oral hormonal contraceptives **
(smoker)
2.2 3.4 6.6 13.5 51.1 117.2
IUD ** 0.8 0.8 1.0 1.0 1.4 1.4
Condom * 1.1 1.6 0.7 0.2 0.3 0.4
Diaphragm/spermicide * 1.9 1.2 1.2 1.3 2.2 2.8
Periodic abstinence 2.5 1.6 1.6 1.7 2.9 3.6
*Deaths are birth-related **Deaths are method-related

In the above table, the risk of death from any birth control method is less than the risk of childbirth, except for oral hormonal contraceptive users over the age of 35 who smoke and oral hormonal contraceptive users over the age of 40 even if they do not smoke. It can be seen in the table that for women aged 15 to 39, the risk of death was highest with pregnancy (7-26 deaths per 100,000 women, depending on age). Among oral hormonal contraceptive users who do not smoke, the risk of death is always lower than that associated with pregnancy for any age group, although over the age of 40, the risk increases to 32 deaths per 100,000 women, compared to 28 associated with pregnancy at that age. However, for oral hormonal contraceptive users who smoke and are over the age of 35, the estimated number of deaths exceeds those for other methods of birth control. If a woman is over the age of 40 and smokes, her estimated risk of death is four times higher (117/100,000 women) than the estimated risk associated with pregnancy (28/100,000 women) in that age group.

An Advisory Committee of the FDA discussed this issue in 1989 and recommended that the benefits of oral contraceptive use by healthy, non-smoking women over 40 years of age may outweigh the possible risks. However, women of all ages are cautioned to use the lowest dose oral contraceptive that is effective, and are strongly advised not to smoke.

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