Atywia: composition and presentation
One film-coated tablet contains 0.03 mg of ethinylestradiol and 2.00 mg of dienogest. The regimen runs for three weeks: 21 tablets in a row, then seven days without tablets.
The composition includes lactose, and that is a restriction for one particular group of patients: in the rare hereditary galactose intolerance, Lapp lactase deficiency and glucose-galactose malabsorption syndrome the medicine is not used.
How Atywia works
The medicine is a combined hormonal contraceptive taken by mouth: ethinylestradiol as the oestrogen and dienogest as the progestogen. The contraceptive effect comes from several mechanisms acting together, the main ones being inhibition of ovulation and a change in the cervical secretion. Dienogest belongs to the nortestosterone derivatives and in vitro binds to the progesterone receptor 10–30 times more weakly than the other synthetic progestogens.
Another of its features matters more for this medicine. In vivo studies in animals show that dienogest has antiandrogenic activity amounting to roughly one third of that of cyproterone acetate, together with strong progestogenic activity. Significant androgenic, mineralocorticoid or glucocorticoid activity in vivo it does not have. That one third of cyproterone acetate is what explains the medicine's second indication: by damping the androgenic influence on the skin, dienogest works where an ordinary contraceptive would not.
Indications
The first indication is oral contraception. The second is treatment of moderate acne, and it is worded with two conditions at once.
- appropriate topical treatment or treatment with oral antibiotics has already proved unsuccessful;
- the woman has herself decided to use an oral contraceptive — the medicine is therefore not prescribed as a dermatological drug to someone who does not need contraception.
The decision to prescribe is taken on the basis of an individual assessment of the woman's risk factors, above all the risk of venous thromboembolic disease, and also the risk of that disease with this particular medicine compared with other combined products.
Method of use and dosage
The tablets are taken every day at a fixed time of day, with liquid if needed. One tablet a day is taken for 21 consecutive days; for the next 7 days no tablets are taken, and withdrawal bleeding begins during that break. It usually comes on the second or third day after the last tablet and may still be going on when the woman has already started the tablets from the next pack.
- if the tablets are started on the first day of menstruation, protection against pregnancy works immediately — no additional measures are needed in that case;
- in some women no withdrawal bleeding comes during the break: if the regimen has been followed exactly, pregnancy is unlikely, but if the regimen was broken and the bleeding was absent once or twice, it must be established before continuing that there is no pregnancy;
- the details of the regimen — starting after other methods, the rules for a missed tablet — are set out in the full summary of product characteristics.
It is worth remembering separately what lowers reliability: a missed tablet, vomiting or severe diarrhoea, and taking certain other medicines at the same time. Vomiting and diarrhoea matter here because the tablet may simply not have time to be absorbed, while they are perceived as an unpleasantness unrelated to contraception.
Contraindications
Listed below are the states in which combined oral products are not used; if any of them appears for the first time while the tablets are being taken, they are stopped at once. They include hypersensitivity to the active substances or excipients, pregnancy and its suspicion, genital bleeding of unexplained cause, and diagnosed or suspected hormone-dependent cancer of the breast or of the genital organs.
The vascular part of the list is divided into venous and arterial.
- on the venous side: deep vein thrombosis and pulmonary embolism — both those being treated with anticoagulants right now and those suffered earlier; a confirmed congenital or acquired predisposition to them — activated protein C resistance including factor V Leiden, antithrombin III, protein C or protein S deficiency;
- major surgery after which the woman remained immobile for a long time, and also a high venous risk overall, when the factors add up;
- on the arterial side: a current event, for example an infarction, or its forerunner in the form of angina; on the cerebral side — a stroke now or in the past, or a transient ischaemic attack in the history;
- a tendency to arterial thrombosis, inherited or acquired: hyperhomocysteinaemia, antiphospholipid antibodies; migraine that has run with focal neurological symptoms; a high arterial risk overall or one serious factor — diabetes with vascular complications, severe hypertension, severe dyslipoproteinaemia;
- severe liver disease now or in the past, until its parameters return to normal; a liver tumour, benign or malignant, found now or according to the history.
Special warnings and precautions
Before the first tablet, or after a break, a detailed medical and family history is taken, pregnancy is excluded, blood pressure is measured and an examination is carried out for contraindications. The doctor is obliged to draw the woman's attention to the information on venous and arterial thrombosis, including the risk of this medicine compared with other combined products, to the signs of thrombosis and to what to do if it is suspected; the frequency and type of later check-ups they set individually. What the tablets do not give also matters: oral contraception offers no protection against infection with HIV and other sexually transmitted diseases.
The second thing worth knowing in advance is which illnesses may appear or worsen while the tablets are being taken, even though no indisputable link with the medicine has been proved.
| What may worsen | What is done about it |
| Jaundice or itching from bile stasis | if they recur, and the first time they arose in pregnancy or with previous contraception, the medicine is withdrawn; acute and chronic liver dysfunction likewise calls for withdrawal until the liver returns to normal |
| Arterial hypertension | with a clinically significant rise in blood pressure the product is withdrawn at once; after the pressure normalises treatment may continue, and with persistent hypertension that does not respond to treatment it is stopped |
| Raised triglycerides, including in the family history | the risk of inflammation of the pancreas rises, which is taken into account with pain in the upper abdomen |
| Diabetes, Crohn's disease and ulcerative colitis | hormonal products affect insulin resistance and glucose tolerance: diabetes treatment need not be changed, but monitoring is strengthened, especially at the start; for the two inflammatory bowel diseases worsening has been described |
| Patches on the skin of the face | more often in those who had them during pregnancy; such women should avoid the sun and ultraviolet radiation |
| Gallstones, porphyria, lupus erythematosus, haemolytic-uraemic syndrome, Sydenham's chorea, herpes gestationis, otosclerosis with hearing loss | listed as capable of arising or worsening |
Interactions with other medicines
Interactions show themselves as intermenstrual bleeding and as loss of contraceptive protection. Two mechanisms are described in the literature: enhanced hepatic metabolism and disturbance of the enterohepatic circulation.
- the clearance of sex hormones is increased by inducers of microsomal enzymes: phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and probably also oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and preparations of St John's wort;
- St John's wort is singled out here: herbal products containing it must not be taken during treatment at all, because of the fall in serum concentration of the active substances and the loss of contraceptive protection;
- antibiotics of the penicillin and tetracycline groups, according to the results of several clinical studies, reduce the enterohepatic circulation of oestrogens and with it of ethinylestradiol;
- for the time inducers are taken and for a further 28 days a mechanical method of contraception is needed; with antibiotics, apart from rifampicin and griseofulvin, for up to 7 days after the course ends; if the period of extra protection runs past the pack, the next one is started at once, without the seven-day break;
- in the other direction: oral contraceptives can change the metabolism of other medicines, so that their concentration in plasma and tissues rises, as with ciclosporin, or falls, as with lamotrigine.
Taking steroid contraceptives also affects laboratory results: the biochemical parameters of liver, thyroid, adrenal and kidney function, the concentration of plasma carrier proteins, the lipid and lipoprotein fractions, and the parameters of carbohydrate metabolism, clotting and fibrinolysis. The altered results usually stay within normal values.
Pregnancy and breastfeeding
During pregnancy the medicine must not be taken; if pregnancy is discovered while it is being taken, it is withdrawn at once. Epidemiological studies have shown neither an increased risk of congenital malformations in the children of women who took oral contraceptives before becoming pregnant, nor a teratogenic effect from inadvertent use in early pregnancy. For the medicine itself no such studies have been carried out, and the data on its use in pregnancy are too few to draw conclusions about the effect on the fetus and the newborn.
In animal studies conducted during pregnancy and lactation adverse effects were seen, and on that basis effects linked to the hormonal active substances cannot be excluded. Experience with other oral contraceptives in pregnant women does not point to adverse effects. In deciding to restart the tablets, the increased risk of venous thromboembolism in the postpartum period is taken into account. Combined products should not be taken while breastfeeding: they may reduce lactation and change the composition of the milk, and small amounts of the steroids or their metabolites pass into the milk and may affect the child's health.
Adverse reactions
Commonly — in no more than one woman in ten — headache, pain in the upper abdomen and breast pain occurred. The remaining events are spread more thinly.
- uncommon, nervous system and psyche: migraine, dizziness, depressed mood, nervousness;
- uncommon, digestion and metabolism: stomach complaints, nausea, vomiting, increased appetite; rare: diarrhoea and anorexia;
- uncommon, skin: acne, acneiform dermatitis, rash, eczema, patches on the face, hair loss; rare: erythema multiforme, itching, excess hair;
- uncommon, reproductive system: intermenstrual bleeding, absence of menstruation, painful periods, breast enlargement, ovarian cyst, pain during intercourse, change in discharge; rare: scant and brief withdrawal bleeding, mastitis, cysts and discharge from the nipple;
- uncommon, other: vaginal and urinary tract infections, tiredness and weakness, change in body weight, swelling of the lower legs, cramps in the legs, back pain, rises and falls in blood pressure, venous disease;
- rare: anaemia, asthma, disturbances of vision and hearing, decreased sex drive, aggressive reactions, indifference, virilism, tachycardia, leiomyoma, venous thromboembolism and arterial thromboembolic disorders, thrombophlebitis, pulmonary embolism, cerebral circulatory disturbances.
Two long-term risks are discussed. Epidemiological studies showed a rise in the risk of cervical cancer with long-term use of oral contraceptives, though it may be linked not to the medicines themselves but to particular sexual behaviour or other factors, for example infection with the papillomavirus. A meta-analysis of 54 studies showed a slight increase in the relative risk of breast cancer — 1.24 — which gradually disappears within 10 years of stopping; a causal link is not proved by the studies, and part of the increase may be explained by earlier detection: in users of hormonal contraception it is found more often at an early stage.
Overdose
Overdose shows itself as nausea and vomiting; in teenage girls a slight discharge of blood from the genital tract is possible.
Such a state calls for no separate treatment — if needed, care is limited to relieving the symptoms.
How to get an Atywia prescription online
The medicine is available on prescription, and the conversation with the doctor depends on what it is being prescribed for. If it is contraception, the doctor assesses the risk factors for thrombosis. If it is acne, there is the added question of which topical treatment or which oral antibiotics were already used and why they did not help — without that the second indication is not met.
Prepare in advance information about thromboses, heart attacks and strokes in yourself and in close relatives, about migraine with focal symptoms, smoking, blood pressure, diabetes, lipid disorders, liver disease, tumours and planned operations. List separately the medicines and supplements you take: antiepileptics, rifampicin, griseofulvin, antibiotics and above all St John's wort, which is not combined with this medicine. The doctor will assess these circumstances at the online consultation and, if there are no contraindications, will issue an electronic prescription.
