Quasense

Pregnancy Prevention

Quasense is used as a hormonal method of birth control to prevent pregnancy. It is intended for use by females who are of reproductive age and have decided to use oral contraceptives as their primary method of contraception.

Extended-Cycle Use

This medication is specifically prescribed for those who wish to have fewer menstrual cycles per year. As an extended-cycle contraceptive, it is designed to provide continuous hormone delivery for a longer duration than traditional monthly birth control packs. This results in most users having only four scheduled periods per year, typically occurring once every three months.

Mechanism of Action

Quasense contains two types of female hormones: a progestin (levonorgestrel) and an estrogen (ethinyl estradiol). These hormones work together in several ways to prevent pregnancy:

• Inhibiting Ovulation: The primary way Quasense works is by suppressing the hormones that trigger the ovaries to release an egg each month. Without an egg, fertilization cannot occur.
• Thickening Cervical Mucus: The medication causes the mucus in the cervix to become thicker. This makes it more difficult for sperm to travel through the cervix and reach the uterus.
• Changing the Uterine Lining: Quasense alters the lining of the uterus. This change makes it less likely for a fertilized egg to attach to the uterine wall.

Extended-Cycle Regimen

Unlike traditional birth control pills that follow a 28-day cycle, Quasense is taken in a 91-day cycle. Active pills are taken for 84 consecutive days, followed by 7 days of inactive pills. This schedule is designed to reduce the frequency of menstrual periods to approximately once every three months.

Common Side Effects

Some people may experience mild side effects while taking Quasense. These often improve as the body adjusts to the medication. Common side effects include:

• Nausea, vomiting, or stomach bloating
• Headache or dizziness
• Breast tenderness or swelling
• Changes in weight or appetite
• Vaginal itching or discharge
• Decreased sex drive
• Freckles or darkening of facial skin
• Loss of scalp hair or increased hair growth

Because Quasense is an extended-cycle pill, it is common to experience breakthrough bleeding or spotting between periods, particularly during the first few months of treatment.

Serious Side Effects

Contact a healthcare provider immediately if you experience any of the following serious symptoms:

• Signs of a blood clot, such as sudden numbness or weakness, severe headache, vision or speech problems, chest pain, shortness of breath, or pain and swelling in one leg
• Liver problems, including upper stomach pain, loss of appetite, dark urine, or yellowing of the skin and eyes
• A change in the pattern or severity of migraine headaches
• Swelling in the hands, ankles, or feet
• A lump in the breast
• Symptoms of depression, such as sleep problems, weakness, or mood changes

Cigarette Smoking and Cardiovascular Risks

Cigarette smoking increases the risk of serious cardiovascular side effects from combination oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives are strongly advised not to smoke.

Thromboembolic Disorders and Other Vascular Problems

The use of oral contraceptives is associated with an increased risk of several serious conditions, including:

• Deep vein thrombosis and pulmonary embolism
• Myocardial infarction (heart attack)
• Stroke

The risk of these events is higher in women with other underlying risk factors, such as high blood pressure, high cholesterol, obesity, and diabetes. The risk of blood clots is highest during the first year a woman starts taking a combination oral contraceptive or when restarting the same or a different combination oral contraceptive after a break of four weeks or more.

Liver Disease

Discontinuation is necessary if jaundice (yellowing of the skin or eyes) develops. Oral contraceptives are also associated with a rare risk of developing benign but potentially ruptured liver tumors. Use is contraindicated in individuals with active liver disease or certain liver tumors.

High Blood Pressure

An increase in blood pressure has been reported in women taking oral contraceptives. For women with well-controlled hypertension, blood pressure should be monitored closely, and the medication should be stopped if blood pressure rises significantly.

Gallbladder Disease

Studies suggest an increased risk of gallbladder disease in users of oral contraceptives and estrogens.

Carbohydrate and Lipid Metabolic Effects

Glucose tolerance may decrease in some users. Prediabetic and diabetic women should be carefully observed while taking this medication. Some women may also experience changes in lipid levels, requiring close monitoring if they have existing lipid disorders.

Headache

The onset or exacerbation of migraine or the development of a new pattern of headache that is recurrent, persistent, or severe requires evaluation and may necessitate stopping the medication.

Bleeding Irregularities

Breakthrough bleeding and spotting are common, especially during the first few months of use. Because Quasense is an extended-cycle regimen, the pattern of bleeding may differ from traditional 28-day cycles. If bleeding is persistent or severe, evaluation for non-hormonal causes may be necessary.

Pregnancy

Quasense is used to prevent pregnancy and should not be taken by individuals who are already pregnant. If you suspect you have become pregnant while taking this medication, stop use immediately and consult a healthcare professional. Research has generally shown that accidental use of oral contraceptives during early pregnancy does not increase the risk of birth defects or harm the developing fetus.

Breastfeeding

Small amounts of the active hormones in Quasense can pass into breast milk. Additionally, estrogen-containing contraceptives may decrease the supply and nutritional quality of breast milk. Healthcare providers generally suggest using other forms of birth control until a nursing child is completely weaned.

Dosage Forms

Quasense is supplied as tablets for oral use. It is provided in a 91-day blister card dispenser designed for a continuous dosing schedule.

Tablet Types

Each dispenser contains two different types of tablets to be taken in a specific sequence:

• Active tablets: Each pack includes 84 white tablets that contain the active hormones levonorgestrel and ethinyl estradiol.
• Inactive tablets: Each pack includes 7 peach-colored tablets that do not contain any active medication.

FDA Approval and Indication

Quasense (levonorgestrel and ethinyl estradiol) is approved by the U.S. Food and Drug Administration (FDA) as a combination oral contraceptive. It is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

Boxed Warning

The FDA-approved labeling for Quasense includes a boxed warning regarding cigarette smoking and serious cardiovascular risks:

• Smoking Risk: Cigarette smoking increases the risk of serious cardiovascular side effects from combination oral contraceptive use.
• Age Factor: This risk increases with age and with heavy smoking (15 or more cigarettes per day).
• Age Restriction: The risk is significantly higher in women over 35 years of age.

Healthcare providers strongly advise women who use combination oral contraceptives like Quasense not to smoke.

Regulatory Considerations

As a prescription medication, Quasense must be used under medical supervision. It is an extended-cycle regimen, meaning it is designed to provide a specific dosing schedule over a 91-day period to reduce the frequency of menstrual periods. The FDA-approved labeling also includes specific contraindications for women with certain medical conditions, such as a history of blood clots, cardiovascular disease, or known or suspected pregnancy.

Weight Changes and Quasense

Weight gain is a documented side effect associated with the use of Quasense. Because this medication contains hormones, it can affect how the body retains fluid or manages metabolism in some individuals.

Clinical Trial Data

• In clinical studies of Quasense, weight increase was reported as a common adverse reaction.
• Specifically, weight changes were observed in at least 2% of the participants during the trials.

While some users may experience weight gain, others may not notice any significant changes. If you experience sudden or concerning weight gain while taking this medication, it is important to discuss these changes with a healthcare professional to determine the cause.