Drug Detail:Kalliga (Ethinyl estradiol and desogestrel [ eh-thih-nill-ess-tra-dye-ole-and-des-oh-jess-trel ])
Generic Name: DESOGESTREL 0.15mg, ETHINYL ESTRADIOL 0.03mg;
Dosage Form: tablets
Drug Class: Contraceptives
To achieve maximum contraceptive effectiveness, KalligaTM must be taken exactly as directed and at intervals not exceeding 24 hours. KalligaTM is available in the blister pack which is preset for a Sunday Start. Day 1 Start is also provided.
Day 1 Start
The dosage of KalligaTM for the initial cycle of therapy is one white to off-white “active” tablet administered daily from the 1st day through the 21st day of the menstrual cycle, counting the first day of menstrual flow as "Day 1". Tablets are taken without interruption as follows: One white to off-white “active” tablet daily for 21 days, then one green “reminder” tablet daily for 7 days. After 28 tablets have been taken, a new course is started and a white to off-white “active” tablet is taken the next day.
The use of KalligaTM for contraception may be initiated 4 weeks postpartum in women who elect not to breastfeed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. (See CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease. See also PRECAUTIONS: Nursing Mothers.) If the patient starts on KalligaTM postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a white to off-white “active” tablet has been taken daily for 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered. If the patient misses one (1) white to off-white “active” tablet in Weeks 1, 2, or 3, the white to off-white “active” tablet should be taken as soon as she remembers. If the patient misses two (2) white to off-white “active” tablets in Week 1 or Week 2, the patient should take two (2) white to off-white “active” tablets the day she remembers and two (2) white to off-white “active” tablets the next day; and then continue taking one (1) white to off-white “active” tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control such as a condom or spermicide if she has sex in the seven (7) days after missing pills. If the patient misses two (2) white to off-white “active” tablets in the third week or misses three (3) or more white to off-white “active” tablets in a row, the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.
Sunday Start
When taking KalligaTM, the first white to off-white “active” tablet should be taken on the first Sunday after menstruation begins. If the period begins on Sunday, the first white to off-white “active” tablet is taken on that day. If switching directly from another oral contraceptive, the first white to off-white “active” tablet should be taken on the first Sunday after the last ACTIVE tablet of the previous product. Tablets are taken without interruption as follows: One white to off-white “active” tablet daily for 21 days, then one green “reminder” tablet daily for 7 days. After 28 tablets have been taken, a new course is started and a white to off-white “active” tablet is taken the next day (Sunday). When initiating a Sunday start regimen, another method of contraception should be used until after the first 7 consecutive days of administration.
The use of KalligaTM for contraception may be initiated 4 weeks postpartum. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered. (See CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease. See also PRECAUTIONS: Nursing Mothers.) If the patient starts on KalligaTM postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a white to off-white “active” tablet has been taken daily for 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered. If the patient misses one (1) white to off-white active tablet in Weeks 1, 2, or 3, the white to off-white “active” tablet should be taken as soon as she remembers. If the patient misses two (2) white to off-white “active” tablets in Week 1 or Week 2, the patient should take two (2) white to off-white “active” tablets the day she remembers and two (2) white to off-white “active” tablets the next day; and then continue taking one (1) white to off-white “active” tablet a day until she finishes the pack. The patient should be instructed to use a back-up method of birth control such as a condom or spermicide if she has sex in the seven (7) days after missing pills. If the patient misses two (2) white to off-white “active” tablets in the third week or misses three (3) or more white to off-white “active” tablets in a row, the patient should continue taking one white to off-white “active” tablet every day until Sunday. On Sunday the patient should throw out the rest of the pack and start a new pack that same day. The patient should be instructed to use a back-up method of birth control if she has sex in the seven (7) days after missing pills.
ADDITIONAL INSTRUCTIONS FOR ALL DOSING REGIMENS
Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing oral contraceptives. In breakthrough bleeding, as in all cases of irregular bleeding from the vagina, nonfunctional causes should be borne in mind. In undiagnosed persistent or recurrent abnormal bleeding from the vagina, adequate diagnostic measures are indicated to rule out pregnancy or malignancy. If pathology has been excluded, time or a change to another formulation may solve the problem. Changing to an oral contraceptive with a higher estrogen content, while potentially useful in minimizing menstrual irregularity, should be done only if necessary since this may increase the risk of thromboembolic disease.
Use of oral contraceptives in the event of a missed menstrual period:
1. If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period and oral contraceptive use should be discontinued if pregnancy is confirmed.
2. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out.