Xulane is a combined hormonal birth-control patch containing estrogen and progestin. It may not be suitable for everyone because these hormones can increase the risk of blood clots, stroke, heart attack, and other serious complications.
Before using Xulane, tell your healthcare provider about your complete medical history, current medications, smoking status, weight, and any previous problems with hormonal contraception.
Smoking and Age
Do not use Xulane if you are older than 35 and smoke cigarettes. Smoking while using a combined hormonal contraceptive significantly increases the risk of serious cardiovascular problems, including blood clots, heart attack, and stroke.
The risk increases with age and with the number of cigarettes smoked.
Body Mass Index and Body Weight
Xulane should not be used by people with a body mass index of 30 kg/m² or higher because the risk of blood clots may be greater.
The patch may also be less effective at preventing pregnancy in people who weigh 90 kg, or approximately 198 pounds, or more. A healthcare provider can help determine whether another contraceptive method would be safer or more reliable.
Blood Clots
Xulane may increase the risk of developing a serious blood clot in the legs or lungs. A clot may also lead to a stroke, heart attack, or sudden vision loss.
The risk may be higher if you:
- Have previously had a blood clot
- Have an inherited blood-clotting condition
- Recently had major surgery
- Must remain in bed or have limited movement for a long period
- Have obesity
- Smoke
- Have recently given birth
- Have certain heart or blood vessel conditions
Seek emergency medical attention if you develop pain or swelling in one leg, sudden shortness of breath, chest pain, coughing up blood, sudden weakness, difficulty speaking, or sudden vision changes.
Surgery or Prolonged Immobilization
Tell your surgeon that you use Xulane before any planned operation. Your healthcare provider may instruct you to stop using the patch before major surgery or during an extended period of limited movement to reduce the risk of blood clots.
Do not stop or restart Xulane without receiving specific medical instructions.
Heart and Blood Vessel Conditions
Xulane may not be appropriate if you have:
- Coronary artery disease
- A previous heart attack or stroke
- Heart-valve problems associated with blood clots
- Certain abnormal heart rhythms
- Severe or uncontrolled high blood pressure
- Diabetes that has damaged the blood vessels
Your blood pressure should be checked before starting Xulane and monitored during use. Contact your healthcare provider if you develop severe headaches, dizziness, blurred vision, or unusually high blood pressure readings.
Migraines and Severe Headaches
Tell your healthcare provider if you have migraines, especially migraines with aura. Aura may include flashing lights, blind spots, numbness, weakness, or difficulty speaking before or during a headache.
Xulane should generally not be used by people who experience migraine with aura because of the increased risk of stroke. Report any new, severe, frequent, or unusual headache promptly.
Pregnancy
Do not use Xulane if you are pregnant. Stop using the patch and contact your healthcare provider if you think you may be pregnant.
Xulane does not end an existing pregnancy and should not be used as emergency contraception.
Breastfeeding and After Childbirth
The hormones in Xulane may reduce breast-milk production, particularly when breastfeeding is first being established. Small amounts of the hormones may also pass into breast milk.
There is also an increased risk of blood clots during the weeks following childbirth. Ask your healthcare provider when it is safe to begin using Xulane after delivery and whether another contraceptive method would be more appropriate while breastfeeding.
Breast Cancer and Other Hormone-Sensitive Cancers
Do not use Xulane if you currently have breast cancer or another cancer that is sensitive to estrogen or progestin. Tell your healthcare provider about any personal or family history of breast cancer.
Report a new breast lump, nipple discharge, skin changes, or persistent breast pain.
Liver and Gallbladder Problems
Xulane may not be suitable for people with severe liver disease, liver tumours, or abnormal liver function.
Contact your healthcare provider if you develop yellow skin or eyes, dark urine, pale stools, severe upper abdominal pain, persistent nausea, or unusual tiredness.
Combined hormonal contraceptives may also increase the risk of gallbladder problems or worsen existing gallbladder disease.
Diabetes, Cholesterol, and Triglycerides
Xulane may affect blood sugar and blood-fat levels. Tell your healthcare provider if you have diabetes, high cholesterol, or high triglycerides.
People with diabetes may need closer blood sugar monitoring. Xulane may not be appropriate if diabetes has caused complications involving the kidneys, eyes, nerves, or blood vessels.
Unexplained Vaginal Bleeding
Tell your healthcare provider if you have vaginal bleeding that has not been evaluated. The cause of unexplained bleeding should be investigated before starting Xulane.
Spotting or breakthrough bleeding can occur during the first few months of use. Contact your provider if bleeding is very heavy, lasts a long time, repeatedly occurs after sex, or begins after previously regular cycles.
Mood Changes and Depression
Some people may experience mood changes or worsening depression while using hormonal contraception.
Tell your healthcare provider if you have a history of depression. Contact them if you develop persistent sadness, severe anxiety, unusual behavioural changes, or thoughts of self-harm.
Medication Interactions
Certain medications and herbal products can reduce Xulane’s effectiveness or increase the risk of side effects. These may include some treatments for:
- Seizures
- Tuberculosis
- HIV or hepatitis C
- Fungal infections
- High blood pressure
- Pulmonary hypertension
St. John’s wort may also make hormonal contraception less effective.
Tell your healthcare provider and pharmacist about all prescription medicines, non-prescription products, vitamins, and herbal supplements you use. A backup contraceptive method may be required during treatment and for a period after an interacting medication is stopped.
Xulane should not be used with certain hepatitis C treatment combinations containing ombitasvir, paritaprevir, and ritonavir, with or without dasabuvir, because of the risk of liver-enzyme elevations.
Skin Reactions and Patch Use
Apply Xulane only to clean, dry, healthy skin. Do not apply it to the breasts or to skin that is irritated, cut, oily, or covered with lotion, cream, powder, or makeup.
Do not cut, damage, or alter the patch, as this may reduce its contraceptive effectiveness. Check the patch daily to ensure that it remains fully attached.
Protection Against Sexually Transmitted Infections
Xulane does not protect against HIV or other sexually transmitted infections. Condoms may be used along with Xulane to help reduce the risk of infection.
When to Seek Emergency Medical Care
Seek immediate medical attention if you experience sudden chest pain, difficulty breathing, coughing up blood, pain or swelling in one leg, sudden weakness or numbness, difficulty speaking, a severe unusual headache, sudden vision loss, or swelling of the face, lips, tongue, or throat.
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