Qlaira

Qlaira is a combined oral contraceptive that uses estradiol valerate — a form of natural oestrogen — rather than the synthetic ethinylestradiol found in most other pills.

It is combined with dienogest, a progestogen with potent progestational and moderate anti-androgenic activity.

The four-phasic dosing regimen mimics the natural hormonal fluctuations of the menstrual cycle more closely than monophasic formulations.

Qlaira is also the first oral contraceptive licensed for the treatment of heavy menstrual bleeding (menorrhagia) in women who choose to use an oral contraceptive for contraception.

Clinical studies have demonstrated reductions in menstrual blood loss of approximately 70-80%. Contraceptive efficacy is comparable to other combined pills, with a Pearl Index of approximately 0.

73 per 100 woman-years.

The use of estradiol valerate rather than ethinylestradiol may offer theoretical advantages regarding hepatic protein synthesis and potentially a more favourable metabolic profile, though long-term outcome data are still accruing.

Qlaira is listed in the BNF and is a NICE-acknowledged option for heavy menstrual bleeding.

Take one tablet daily for 28 consecutive days in the order indicated on the blister pack — this is critical as the four phases contain different hormone doses.

Tablets must be taken at approximately the same time each day, swallowed whole with water. There is no tablet-free interval; start the next pack immediately after finishing the current one.

The last 2 white tablets in each pack are placebos; a withdrawal bleed typically occurs during these days.

If a tablet is missed by less than 12 hours, take it as soon as remembered and continue as normal.

If more than 12 hours late, follow the specific missed-pill rules in the patient leaflet, which differ from standard 21/7 pills due to the multi-phasic design.

The 28-tablet blister follows a four-phasic sequence: 2 dark yellow tablets (estradiol valerate 3 mg), 5 medium red tablets (estradiol valerate 2 mg + dienogest 2 mg), 17 light yellow tablets (estradiol valerate 2 mg + dienogest 3 mg), 2 dark red tablets (estradiol valerate 1 mg), and 2 white placebo tablets.

No dose adjustment is required by body weight. The pack must be taken in strict sequential order. Qlaira should be started on day 1 of the menstrual cycle.

If switching from another COC, begin on the day after the last active tablet of the previous pack.

Side effects are reported per SmPC frequency categories from the clinical programme.

Common (≥1/100 to <1/10): Headache, abdominal pain, nausea, acne, amenorrhoea (absent withdrawal bleed, reported in approximately 15-20% of cycles after the first few months), breast discomfort, irregular or unpredictable bleeding, weight gain.

Uncommon (≥1/1,000 to <1/100): Migraine, fluid retention, mood changes (depression, irritability), dizziness, hot flushes, hypertension, dyspepsia, increased appetite, musculoskeletal pain, ovarian cysts, vaginal dryness or discharge, fatigue.

Rare (≥1/10,000 to <1/1,000): Venous thromboembolism, arterial thromboembolism, cholecystitis, cholelithiasis.

Absence of a withdrawal bleed is more common with Qlaira than with ethinylestradiol-containing pills and does not indicate treatment failure or pregnancy in most cases, though pregnancy should be excluded if two consecutive withdrawal bleeds are missed.

Qlaira carries the same thromboembolism warnings as other combined hormonal contraceptives.

The VTE risk is believed to be comparable to dienogest/ethinylestradiol-containing pills, though specific epidemiological data for the estradiol valerate combination are limited.

Standard combined hormonal contraceptive risk assessments apply: evaluate for VTE risk factors, monitor blood pressure, and discontinue before prolonged immobilisation or major surgery.

The missed-pill rules for Qlaira differ from standard 21/7 COCs due to the four-phasic design; prescribers and patients should familiarise themselves with the specific guidance in the SmPC.

Hepatic enzyme-inducing drugs reduce efficacy. Women with a history of chloasma should avoid sun exposure during use.

Qlaira must not be used by women with current or past VTE or arterial thromboembolism, known thrombogenic disorders, migraine with aura, diabetes with vascular complications, severe hepatic disease or liver tumours, known or suspected sex steroid-sensitive malignancies, undiagnosed vaginal bleeding, pancreatitis associated with severe hypertriglyceridaemia, or hypersensitivity to estradiol valerate, dienogest, or any excipient.

It is contraindicated during pregnancy and should be stopped immediately if pregnancy is confirmed.