QLAIRA

What it is

QLAIRA is a combined oral contraceptive (COC) pill containing the estrogen estradiol valerate and the progestogen dienogest. Each wallet contains 28 tablets consisting of dark yellow, medium red, light yellow and dark red active film-coated tablets, with two white placebo tablets. The dark yellow tablets contain 3 mg estradiol valerate; the medium red tablets contain 2 mg estradiol valerate and 2 mg dienogest; the light yellow tablets contain 2 mg estradiol valerate and 3 mg dienogest; and the dark red tablets contain 1 mg estradiol valerate.

Approved indications

— Oral contraception. — Treatment of heavy and/or prolonged menstrual bleeding in women without organic pathology who desire oral contraception.

Dosing overview

One tablet is to be taken daily for 28 consecutive days, with each subsequent pack started the day after the last tablet of the previous wallet. Treatment of heavy and/or prolonged menstrual bleeding with QLAIRA has been shown to result in a rapid normalisation of excessive menstrual blood losses. If the patient does not experience a reduction of menstrual bleeding after 3 treatment cycles then treatment with QLAIRA should be ceased and other treatment options should be considered.

Key safety warnings

The use of any combined hormonal contraceptive increases the risk of venous thromboembolism (VTE) compared with no use, with VTE risk highest in the first ever year of use and increased when a CHC is re-started after a break in use of 4 weeks or more. VTE may be life-threatening or may have a fatal outcome (in 1–2% of cases). Epidemiological studies have associated the use of combined hormonal contraceptives with an increased risk for arterial thromboembolism (such as myocardial infarction, angina pectoris, stroke or transient ischaemic attack). Women should be informed of the symptoms of VTE and be advised to seek urgent medical attention if VTE symptoms develop and to inform the healthcare professional that she is taking a combined hormonal contraceptive. An increase in frequency or severity of migraine during combined hormonal contraceptive use may be a reason for immediate discontinuation. In women with hereditary angioedema exogenous estrogens may induce or exacerbate symptoms of angioedema.

Contraindications

QLAIRA is contraindicated in the presence of current or history of venous or arterial thromboembolism, known hereditary or acquired predisposition for thromboembolism, major surgery with prolonged immobilisation, history of migraine with focal neurological symptoms, or high risk of arterial or venous thromboembolism due to multiple risk factors or one serious risk factor. QLAIRA is contraindicated in pancreatitis or a history thereof if associated with severe hypertriglyceridaemia, presence or history of severe hepatic disease whilst liver function values have not returned to normal, or presence or history of liver tumours (benign or malignant). QLAIRA is contraindicated in known or suspected sex-steroid influenced malignancies (for example of the genital organs or the breasts), undiagnosed vaginal bleeding, known or suspected pregnancy, and hypersensitivity to any of the ingredients contained in QLAIRA.

PBS listing

No source document contains information about PBS listing for QLAIRA.

Regulatory history

QLAIRA was first listed on the ARTG on 14 May 2009 as estradiol valerate / dienogest tablets in composite pack in wallet pack. In July 2024, PBAC recommended QLAIRA for endometriosis.