Xulane

Pregnancy Prevention

Xulane is a combination hormonal contraceptive patch used to prevent pregnancy. It is intended for women who choose a transdermal patch as their method of birth control rather than a daily oral medication.

Usage Considerations

Xulane is specifically indicated for women with a body mass index (BMI) of less than 30 kg/m². Clinical evidence indicates that the patch may be less effective in preventing pregnancy in women who weigh more than 198 pounds (90 kg). Healthcare providers typically evaluate a patient's weight and BMI when determining if this medication is the most appropriate contraceptive option.

It is important to note that Xulane is used strictly for the prevention of pregnancy and does not provide protection against HIV or other sexually transmitted infections.

Mechanism of Action

Xulane contains two types of hormones: an estrogen (ethinyl estradiol) and a progestin (norelgestromin). These hormones are absorbed through the skin and into the bloodstream to prevent pregnancy in several ways:

• Stopping Ovulation: The primary way Xulane works is by preventing the ovaries from releasing an egg each month. Without an egg, fertilization cannot occur.
• Thickening Cervical Mucus: The hormones cause the mucus in the cervix to become thicker and stickier. This creates a physical barrier that makes it difficult for sperm to swim into the uterus.
• Thinning the Uterine Lining: Xulane changes the lining of the uterus (the endometrium). This change makes it less likely for a fertilized egg to attach to the uterine wall.

The patch provides a continuous flow of these hormones over a seven-day period, maintaining steady levels in the body to ensure consistent protection against pregnancy.

Common Side Effects

Many individuals using the Xulane patch experience mild side effects as their bodies adjust to the hormones. These symptoms often improve after a few months of use. Common side effects include:

• Skin reactions at the application site, such as redness, irritation, or itching
• Nausea and vomiting
• Breast tenderness, pain, or enlargement
• Headache or migraine
• Menstrual cramps or breakthrough bleeding between periods
• Mood swings or anxiety
• Acne
• Weight gain
• Vaginal discharge or itching

Serious Side Effects

Xulane can cause serious and potentially life-threatening health problems. Contact a healthcare provider immediately or seek emergency care if you experience:

• Signs of a blood clot: Pain, swelling, or warmth in the leg; sudden shortness of breath; chest pain; or coughing up blood.
• Signs of a stroke or heart attack: Sudden numbness or weakness (especially on one side of the body), severe headache, vision changes, or difficulty speaking.
• Liver problems: Yellowing of the skin or eyes (jaundice), dark urine, or upper right-sided abdominal pain.
• High blood pressure: Severe headaches, blurred vision, or pounding in the neck or ears.
• Gallbladder disease: Severe stomach pain, fever, and nausea.
• Severe allergic reactions: Hives, swelling of the face or throat, and difficulty breathing.
• Mental health changes: New or worsening depression or sleep problems.

Boxed Warnings

Cigarette Smoking and Cardiovascular Events: Using combination hormonal contraceptives like Xulane increases the risk of serious cardiovascular side effects, such as heart attack, blood clots, and stroke. This risk is significantly higher in people over 35 years old who smoke. Xulane is contraindicated in individuals in this age group who smoke.

Body Mass Index (BMI): Xulane is contraindicated in individuals with a BMI of 30 kg/m² or greater. Clinical data indicates these individuals have a higher risk of developing venous thromboembolism (blood clots) and that the patch may be less effective in preventing pregnancy in this population.

Thromboembolic Disorders and Other Vascular Problems

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

• Venous thromboembolism (blood clots in the legs or lungs)
• Strokes and heart attacks
• Deep vein thrombosis

Xulane delivers higher levels of estrogen into the bloodstream compared to many typical birth control pills. Higher estrogen exposure is linked to an increased risk of blood clots. The risk is highest during the first year of use or when restarting hormonal contraception after a break of four weeks or longer.

Liver and Cancer Risks

Xulane should not be used by individuals with a history of or current breast cancer or other estrogen-sensitive cancers. It is also contraindicated in those with liver tumors (benign or malignant) or active liver disease, such as hepatitis.

Other Precautions

• Gallbladder Disease: Hormonal contraceptives may increase the risk of gallbladder disease or stones.
• Hypertension: An increase in blood pressure may occur. Blood pressure should be monitored regularly.
• Migraines: New or worsening migraines, especially those with aura, may require discontinuation of the patch.
• Fluid Retention: Estrogen and progestin may cause fluid retention; caution is advised for individuals with conditions like heart or kidney dysfunction.
• Glucose and Lipid Metabolism: Xulane may affect blood sugar levels and lipid profiles. People with diabetes or pre-diabetes should be monitored closely.

Pregnancy

Xulane is a birth control patch and is not intended for use during pregnancy. If you suspect you are pregnant or have a confirmed pregnancy, you should remove the patch and contact your healthcare provider. Studies have not found an increased risk of birth defects in children born to individuals who accidentally used hormonal contraceptives during early pregnancy.

Breastfeeding

The use of Xulane while breastfeeding is generally discouraged, particularly before the infant is fully weaned. The estrogen in the patch can decrease the production and nutritional quality of breast milk. Small amounts of the active hormones may also pass into the breast milk. It is recommended to discuss alternative non-hormonal or progestin-only contraceptive options with a healthcare provider while nursing.

Dosage Form

Xulane is available as a transdermal system, commonly referred to as a skin patch. The patch is a thin, beige, multi-layered adhesive system that is applied directly to the skin of the abdomen, buttocks, upper outer arm, or upper torso.

Strengths

The patch contains two active medications that are released continuously into the bloodstream:

• Norelgestromin
• Ethinyl estradiol

Xulane is available in a single strength. It is designed to release a steady daily dose of hormones over the course of seven days. Each patch delivers 150 micrograms of norelgestromin and 35 micrograms of ethinyl estradiol every 24 hours.

FDA Approval and Indications

Xulane was approved by the U.S. Food and Drug Administration (FDA) in April 2014 as a generic version of the Ortho Evra patch. It is indicated for the prevention of pregnancy in women who choose to use a transdermal patch as a method of contraception.

Boxed Warnings

The FDA has required a Boxed Warning for Xulane due to several serious safety concerns:

• Cigarette Smoking and Cardiovascular Risks: Women over 35 who smoke should not use Xulane, as smoking increases the risk of serious cardiovascular side effects from hormonal contraceptives.
• Venous Thromboembolism (VTE): Users of the patch may have a higher risk of developing blood clots in the legs or lungs compared to users of certain birth control pills. This is attributed to higher steady-state concentrations of estrogen compared to some oral contraceptives.
• Body Mass Index (BMI) Limitations: Xulane is contraindicated in women with a BMI of 30 kg/m² or greater. Clinical trials indicated that the patch is less effective in this population and carries a higher risk of VTE.

Regulatory History and Safety Communications

The FDA has monitored the safety profile of transdermal contraceptive patches closely, leading to labeling updates that clarify the differences in estrogen exposure between the patch and oral tablets. While the patch delivers a continuous dose of hormones through the skin, the total estrogen exposure is higher than that of many 35-microgram estrogen pills.

Patch Application and Placement

The Xulane patch should be applied to clean, dry skin on the buttock, abdomen, upper outer arm, or upper torso. It should never be placed on the breasts or on skin that is red, irritated, or cut. To ensure the patch stays in place, avoid applying makeup, creams, lotions, powders, or other topical products to the area where the patch is located or where it will be applied.

Weekly Schedule

The patch is used on a 28-day cycle:

• Week 1: Apply a new patch and wear for 7 days.
• Week 2: Replace the old patch with a new one on the same day of the week.
• Week 3: Replace the old patch with a new one on the same day of the week.
• Week 4: Remove the patch and do not wear one for 7 days. This is when a menstrual period usually occurs.

Maintenance and Disposal

It is important to check the patch every day to make sure the edges are sticking well. The patch is designed to stay in place during exercise, bathing, and swimming. If a patch becomes loose or falls off, follow the specific instructions provided in the patient labeling regarding replacement and the possible need for backup contraception.

When removing a used patch, fold it in half so the adhesive sides stick together. This helps prevent the release of remaining hormones into the environment. Dispose of the folded patch in a sturdy container away from children and pets.