Important Safety Information

INDICATION
TYBLUME is indicated for use by females of reproductive potential to prevent pregnancy.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
TYBLUME is contraindicated in females who are known to have or develop the following conditions:

• A high risk of arterial or venous thrombotic diseases
• Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive
• Liver tumors, acute viral hepatitis, or severe (decompensated) cirrhosis
• Undiagnosed abnormal uterine bleeding
• Use of hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations

WARNINGS and PRECAUTIONS

Thromboembolic Disorders and Other Vascular Problems
TYBLUME is contraindicated in females with a high risk of arterial or venous thrombotic/thromboembolic diseases. Consider cardiovascular risk factors before initiating in all females, particularly those over 35 years.

• Stop TYBLUME if an arterial or venous thrombotic/thromboembolic event occurs.
• Stop TYBLUME if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions and evaluate for retinal vein thrombosis immediately.
• Discontinue TYBLUME during prolonged immobilization. If feasible, stop TYBLUME at least four weeks before and through two weeks after major surgery, or other surgeries known to have an elevated risk of thromboembolism.
• Start TYBLUME no earlier than four weeks after delivery in females who are not breastfeeding.

Liver Disease
TYBLUME is contraindicated in females with acute viral hepatitis or severe (decompensated) cirrhosis of the liver. TYBLUME may cause elevated liver enzymes. Discontinue TYBLUME if jaundice develops. Acute liver test abnormalities may necessitate the discontinuation of CHC use until liver tests return to normal and CHC causation has been excluded.

Hypertension
TYBLUME is contraindicated in females with uncontrolled hypertension or hypertension with vascular disease. For all females, including those with well-controlled hypertension, monitor blood pressure at routine visits and stop TYBLUME if blood pressure rises significantly.

Gallbladder Disease
Studies suggest an increased risk of developing or worsening gallbladder disease among CHC users. Females with a history of pregnancy-related cholestasis may be at an increased risk of CHC-related cholestasis.

Adverse Carbohydrate and Lipid Metabolic Effects
TYBLUME is contraindicated in diabetic women over 35 or females who have diabetes with hypertension, nephropathy, retinopathy, neuropathy, or other vascular diseases, or diabetes for >20 years. TYBLUME may decrease glucose tolerance. Carefully monitor prediabetic and diabetic females who are using TYBLUME.

Consider alternative contraception for females with uncontrolled dyslipidemia.

Headache
TYBLUME is contraindicated in females who have headaches with focal neurological symptoms, migraine headaches with aura, or women over 35 years who have migraine headaches. Evaluate significant change in headaches and discontinue TYBLUME if indicated.

Bleeding Irregularities and Amenorrhea
TYBLUME may cause irregular bleeding or amenorrhea. Evaluate for other causes if symptoms persist.

Additional warnings include depression, malignant neoplasms, increased serum concentrations of binding globulins, hereditary angioedema, chloasma (females who tend to develop chloasma should avoid exposure to the sun or UV radiation while using TYBLUME), and risk of liver enzyme elevations with concomitant Hepatitis C treatment.

ADVERSE REACTIONS
Common adverse reactions are headache, abdominal pain, nausea, metrorrhagia, vaginal moniliasis and pain, acne, and vaginitis.

Counsel patients that TYBLUME does not protect against HIV-infection (AIDS) and other sexually transmitted infections.

This is not a complete list of risks.

Please see full Prescribing Information including BOXED WARNING for detailed information [here].