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Cerazette Information:

Cerazette (Desogestrel) is indicated for contraception and each tablet contains 75 microgram desogestrel. The tablet is white, round, biconvex and 5 mm in diameter. On one side it is coded KV above 2 and on the reverse side Organon. Tablets must be taken every day at about the same time so that the interval between two tablets always is 24 hours. The first tablet should be taken on the first day of menstrual bleeding. Thereafter one tablet each day is to be taken continuously, without taking any notice on possible bleeding. A new blister is started directly the day after the previous one. The tablets are to be used as follows depending on the scenario: 1. No preceding hormonal contraceptive use [in the past month]- Tablet-taking has to start on day 1 of the woman's natural cycle (day 1 is the first day of her menstrual bleeding). Starting on days 2-5 is allowed, but during the first cycle a barrier method is recommended for the first 7 days of tablet-taking. 2. Following first-trimester abortion- After first-trimester abortion it is recommended to start immediately. In that case there is no need to use an additional method of contraception. 3. Following delivery or second-trimester abortion- Contraceptive treatment with Cerazette after delivery can be initiated before the menstruations have returned. If more than 21 days have elapsed pregnancy ought to be ruled out and an additional method of contraception should be used for the first week. To start Cerazette when changing from other contraceptive methods: 1. Changing from a combined oral contraceptive (COC)- The woman should start with Cerazette on the day after the last active tablet of her COC. In this case, the use of an additional contraceptive is not necessary. 2. Changing from a progestogen-only-method (minipill, injection, implant or from a progestogen-releasing intrauterine system [IUS]). The woman may switch any day from the minipill (from an implant or the IUS on the day of its removal, from an injectable when the next injection would be due). 4. Missed tablet- Contraceptive protection may be reduced if more than 36 hours have elapsed between two tablets. If the user is less than 12 hours late in taking any tablet, the missed tablet should be taken as soon as it is remembered and the next tablet should be taken at the usual time. If she is more than 12 hours late, she should use an additional method of contraception for the next 7 days. If tablets were missed in the first week and intercourse took place in the week before the tablets were missed, the possibility of a pregnancy should be considered. If vomiting occurs within 3-4 hours after tablet-taking, the same advice is applicable as for a missed tablet. For treatment surveillance- Before prescription, a thorough case history should be taken and a thorough gynaecological examination is recommended to exclude pregnancy. Bleeding disturbances, such as oligomenorrhoea and amenorrhoea should be investigated before prescription. The interval between check-ups depends on the circumstances in each individual case. If the prescribed product may conceivably influence latent or manifest disease, the control examinations should be timed accordingly. Despite the fact that Cerazette is taken regularly, bleeding disturbances may occur. If bleeding is very frequent and irregular, another contraceptive method should be considered. If the symptoms persist, an organic cause should be ruled out. Management of amenorrhoea during treatment depends on whether or not the tablets have been taken in accordance with the instructions and may include a pregnancy test. The treatment should be stopped if a pregnancy occurs.

Cerazette Side Effects:

The most commonly reported undesirable effect in the clinical trials is bleeding irregularity. Some kind of bleeding irregularity has been reported in up to 50% of women using Cerazette. Since Cerazette causes ovulation inhibition close to 100%, in contrast to other progestogen-only pills, irregular bleeding is more common than with other progestogen-only pills. In 20 - 30% of the women, bleeding may become more frequent, whereas in another 20% bleeding may become less frequent or totally absent. Vaginal bleeding may also be of longer duration. After a couple of months of treatment, bleedings tend to become less frequent. Information, counselling and a bleeding diary can improve the woman's acceptance of the bleeding pattern. The most commonly reported other undesirable effects in the clinical trials with Cerazette > 2.5%) were acne, mood changes, breast pain, nausea and weight increase. The undesirable effects mentioned in the table below have been judged, by the investigators, as having an established, probable or possible link to the treatment.

The risk for breast cancer increases in general with increasing age. During the use of oral contraceptives (OCs) the risk of having breast cancer diagnosed is slightly increased. This increased risk disappears gradually within 10 years after discontinuation of OC use and is not related to the duration of use, but to the age of the woman when using the OC. The expected number of cases diagnosed per 10 000 women who use combined OCs (up to 10 years after stopping) relative to never users over the same period have been calculated for the respective age groups to be: 4.5/4 (16-19 years), 17.5/16 (20-24 years), 48.7/44 (25-29 years), 110/100 (30-34 years), 180/160 (35-39 years) and 260/230 (40-44 years). The risk in POP users is possibly of similar magnitude as that associated with combined OCs. However, for POPs the evidence is less conclusive. Compared to the risk of getting breast cancer ever in life, the increased risk associated with OCs is low. The cases of breast cancer diagnosed in OC users tend to be less advanced than in those who have not used OCs. The increased risk in OC users may be due to an earlier diagnosis, biological effects of the pill or a combination of both. Since a biological effect cannot be excluded, an individual benefit/risk assessment should be made in women with pre-existing breast cancer and in women in whom breast cancer is diagnosed while using Cerazette. Since a biological effect of progestogens on liver cancer cannot be excluded an individual benefit/risk assessment should be made in women with liver cancer. Epidemiological investigations have associated the use of combined OCs with an increased incidence of venous thromboembolism (VTE, deep venous thrombosis and pulmonary embolism). Although the clinical relevance of this finding for desogestrel used as a contraceptive in the absence of an oestrogenic component is unknown, Cerazette should be discontinued in the event of a thrombosis. Discontinuation of Cerazette should also be considered in case of long-term immobilisation due to surgery or illness. Women with a history of thrombo-embolic disorders should be made aware of the possibility of a recurrence. Although progestogens may have an effect on peripheral insulin resistance and glucose tolerance, there is no evidence for a need to alter the therapeutic regimen in diabetics using progestogen-only pills. However, diabetic patients should be carefully observed during the first months of use. Treatment with Cerazette leads to decreased estradiol serum levels, to a level corresponding with the early follicular phase. It is as yet unknown whether the decrease has any clinically relevant effect on bone mineral density. The protection with traditional progestogen-only pills against ectopic pregnancies is not as good as with combined oral contraceptives, which has been associated with the frequent occurrence of ovulations during the use of progestogen-only pills. Despite the fact that Cerazette consistently inhibits ovulation, ectopic pregnancy should be taken into account in the differential diagnosis if the woman gets amenorrhoea or abdominal pain. Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation whilst taking Cerazette.