Qlairista Film Coated Tablet

Qlairista is a film-coated tablet that serves as a combined oral contraceptive, containing two active ingredients: estradiol valerate and dienogest. This medication represents a modern approach to contraception while also offering therapeutic benefits for women experiencing heavy menstrual bleeding. Unlike many traditional contraceptive pills that contain ethinyl estradiol, Qlairista contains estradiol valerate, which is metabolized to produce estradiol identical to that naturally produced by a woman’s body.

Composition and Formulation

Qlairista is uniquely formulated with a dynamic dosing schedule represented by differently colored tablets containing varying amounts of hormones. Each wallet contains 28 film-coated tablets arranged in a specific sequence to optimize both contraceptive efficacy and menstrual cycle regulation.

Active Ingredients

The two primary active ingredients in Qlairista are:

1. Estradiol valerate: A synthetic form of estrogen that is converted to estradiol in the body, closely resembling the natural estrogen produced by women. This component helps regulate the menstrual cycle and supports the contraceptive effects of the medication.

2. Dienogest: A progestogen that acts as an agonist at the progesterone receptor and exhibits antiandrogenic properties. This component helps prevent ovulation, thickens cervical mucus, and alters the endometrial lining to prevent implantation.

Tablet Composition

Each wallet of Qlairista contains 28 film-coated tablets in the following sequence:

• 2 dark yellow tablets: Each containing 3 mg estradiol valerate

• 5 medium red tablets: Each containing 2 mg estradiol valerate and 2 mg dienogest

• 17 light yellow tablets: Each containing 2 mg estradiol valerate and 3 mg dienogest

• 2 dark red tablets: Each containing 1 mg estradiol valerate

• 2 white tablets: Hormone-free (placebo tablets)

The tablets also contain several inactive ingredients including lactose monohydrate, maize starch, pregelatinized maize starch, povidone K25, magnesium stearate, hypromellose, macrogol 6000, talc, titanium dioxide, and iron oxide pigments (yellow and/or red).

Mechanism of Action

Qlairista works through multiple mechanisms to prevent pregnancy and reduce menstrual bleeding. The primary mode of action is the inhibition of ovulation, preventing the release of an egg from the ovaries. Additionally, the medication changes the consistency of cervical mucus, making it thicker and more difficult for sperm to penetrate and reach a potential egg.

The estradiol valerate component helps maintain the stability of the endometrial lining, while dienogest, with its potent progestagenic effect, causes endometrial atrophy after prolonged use. This combination results in reduced menstrual bleeding volume and a more predictable bleeding pattern. Furthermore, dienogest exhibits antiandrogenic properties, which may help improve androgenic symptoms such as acne and hirsutism in some women.

Therapeutic Uses

Contraception

Qlairista is primarily indicated for oral contraception to prevent pregnancy. When taken correctly, it provides effective protection against unintended pregnancy through its combined hormonal action. It’s important to note that like other hormonal contraceptives, Qlairista does not protect against sexually transmitted infections (STIs), including HIV/AIDS.

Management of Heavy Menstrual Bleeding

A significant secondary indication for Qlairista is the treatment of heavy menstrual bleeding (not caused by any disease of the womb) in women who desire oral contraception. Clinical trials have demonstrated that Qlairista can substantially reduce menstrual blood loss in women with idiopathic heavy menstrual bleeding. In one study, 79.2% of Qlairista users experienced a significant fall in blood loss compared to only 7.4% of those on placebo. The mean reduction in menstrual blood loss volume was 69.4% (median 79.2%) versus 5.8% (median 7.4%) in placebo recipients.

Dosage and Administration

Qlairista tablets should be taken orally once daily, preferably at the same time each day, with or without food. The tablets must be taken in the exact sequence as provided in the wallet, following the direction indicated by the arrows on the packaging.

Starting Qlairista

For women not currently using hormonal contraception, Qlairista should be started on the first day of menstrual bleeding. For those transitioning from another combined hormonal contraceptive (pill, vaginal ring, or patch), Qlairista should be started the day after taking the last active tablet of the previous contraceptive package.

For women transitioning from a progestogen-only method (mini-pill, injection, implant, or progestogen-releasing IUD), Qlairista can be started on any day after stopping the mini-pill, on the day of removal of an implant or IUD, or when the next injection would be due. However, additional contraceptive measures should be used for the first 9 days of tablet-taking in these cases.

After childbirth, Qlairista can be started 21-28 days after delivery if not breastfeeding. After a miscarriage or abortion in the first trimester, Qlairista can be started immediately.

Missed Dose Instructions

If a hormone-containing tablet is missed by less than 12 hours, contraceptive protection is not reduced. The missed tablet should be taken as soon as remembered, and subsequent tablets should be taken at the usual time.

If a hormone-containing tablet is missed by more than 12 hours, contraceptive protection may be reduced. The missed tablet should be taken as soon as remembered, even if this means taking two tablets at the same time. Subsequent tablets should be taken at the usual time, and additional contraceptive measures (such as condoms) should be used for the next 9 days.

Missing white placebo tablets can be disregarded as they do not contain active ingredients. However, they should be discarded to avoid accidentally extending the placebo tablet phase.

Contraindications

Qlairista is contraindicated in several conditions to ensure patient safety. These include:

• Presence or history of venous or arterial thrombotic events (e.g., deep vein thrombosis, pulmonary embolism, myocardial infarction)

• Presence or history of cerebrovascular accidents or conditions that may increase the risk of cardiovascular events

• Presence of severe or multiple risk factors for venous or arterial thrombosis

• Known or suspected pregnancy

• Breastfeeding within the first six weeks postpartum

• Active liver disease or history of severe liver disease as long as liver function values have not returned to normal

• Known or suspected sex hormone-influenced malignancies (e.g., genital or breast cancer)

• Undiagnosed vaginal bleeding

• Hypersensitivity to any of the active substances or excipients in Qlairista

Side Effects

Like all medications, Qlairista may cause side effects, although not everyone experiences them. Understanding potential side effects is crucial for informed decision-making.

Common Side Effects

Based on user reviews and clinical data, common side effects of Qlairista include:

• Headaches (24% of users)

• Period-like cramps (29% of users)

• Lower back pain (29% of users)

• Breast tenderness or enlargement (24% of users)

• Vaginal discharge (24% of users)

• Nausea or vomiting (14% of users)

• Weight gain

• Metrorrhagia (irregular menstrual bleeding)

• Acne

• Hair loss (19% of users)

• Dizziness (10% of users)

Rare Side Effects

Less frequently reported side effects include:

• Migraines (5% of users)

• Increased body hair (5% of users)

• Thrush (5% of users)

• Discomfort wearing contact lenses (5% of users)

• Increased sweating (5% of users)

In rare cases, serious adverse events such as blood clots, stroke, or heart attack may occur. Users should seek immediate medical attention if they experience symptoms such as severe headache, chest pain, swelling or pain in the legs, or shortness of breath.

Special Precautions

Certain populations require special consideration when using Qlairista:

• Women over 35 years who smoke should not use Qlairista due to increased cardiovascular risk

• Women with hypertension, diabetes, hyperlipidemia, or obesity should be closely monitored

• Women with a history of depression should be monitored for mood changes

• The medication should be discontinued if jaundice, significant increase in blood pressure, or migraine occurs for the first time

• Temporary discontinuation may be advisable before major surgery or during prolonged immobilization

Drug Interactions

Several medications may interact with Qlairista, potentially reducing its contraceptive effectiveness or altering its effects:

• Enzyme inducers (e.g., rifampicin, phenytoin, carbamazepine, St. John’s wort)

• Some antibiotics (e.g., penicillins, tetracyclines)

• HIV/HCV protease inhibitors and non-nucleoside reverse transcriptase inhibitors

• Medications that may increase serum potassium (e.g., ACE inhibitors, angiotensin-II receptor antagonists)

Women taking these medications should use additional contraceptive methods and consult their healthcare provider for guidance.

Storage and Handling

Qlairista should be stored at room temperature, away from direct sunlight and moisture. Keep the medication out of reach of children and in its original packaging to protect from light and damage.

Summary Table