Azalia Special Precautions

If any of the conditions/risk factors mentioned as follows is present, the benefits of progestogen use should be weighed against the possible risks for each individual woman and discussed with the woman before she decides to start with Azalia. In the event of aggravation, exacerbation, or first appearance of any of these conditions, the woman should contact her physician. The physician should then decide on whether the use of Azalia should be discontinued.
The risk for breast cancer increases in general with increasing age. During the use of combined oral contraceptives (COCs) the risk of having breast cancer diagnosed is slightly increased. This increased risk disappears gradually within 10 years after discontinuation of COC use and is not related to the duration of use, but to the age of the woman when using the COC.
The risk in users of progestogen-only contraceptives (POCs), such as Azalia is possibly of similar magnitude as that associated with COCs. However, for POCs the evidence is less conclusive. Compared to the risk of getting breast cancer ever in life, the increased risk associated with COCs is low. The cases of breast cancer diagnosed in COC users tend to be less advanced than in those who have not used COCs. The increased risk in COC users may be due to an earlier diagnosis, biological effects of the pill or a combination of both.
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.
When acute or chronic disturbances of liver function occur the woman should be referred to a specialist for examination and advice.
The use of COCs 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, Azalia should be discontinued in the event of a thrombosis.
Discontinuation of Azalia should also be considered in case of long-term immobilisation due to surgery or illness.
Women with a history of thromboembolic 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.
If a sustained hypertension develops during the use of Azalia, or if a significant increase in blood pressure does not adequately respond to antihypertensive therapy, the discontinuation of Azalia should be considered.
Treatment with Azalia 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 Azalia 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 Azalia.
The following conditions have been reported both during pregnancy and during sex steroid use, but an association with the use of progestogens has not been established: jaundice and/or pruritus related to cholestasis; gallstone formation; porphyria; systemic lupus erythematosus; haemolytic uraemic syndrome; Sydenham's chorea; herpes gestationis; otosclerosis-related hearing loss; (hereditary) angioedema.
Azalia film-coated tablets contain 52.34 mg lactose (as lactose monohydrate) and therefore should not be administered to patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption.
Effects on ability to drive and use machines: Desogestrel has no or negligible influence on the ability to drive and use machines.