Important Safety Information About Beyaz
Important Safety Information About SAFYRAL
Important Safety Information About Natazia

Prescribing Information including boxed WARNING for Beyaz
Prescribing Information including boxed WARNING for SAFYRAL
Prescribing Information including Boxed WARNING for Natazia

WARNING-CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS: Women over 35 years old who smoke should not use Beyaz, SAFYRAL, or Natazia. Smoking increases the risk of serious cardiovascular side effects from Beyaz, SAFYRAL, or Natazia use. This risk increases with age and the number of cigarettes smoked.
See additional important risk information for Beyaz and SAFYRAL below
See additional important risk information for Natazia below

Assess the benefits of Beyaz and SAFYRAL and the risks of VTE before initiating therapy

Before initiating Beyaz and SAFYRAL in a new combination oral contraceptive (COC) user or a woman who is switching from a contraceptive that does not contain drospirenone (drsp®), consider the risks and benefits of a drsp-containing COC in light of her venous thromboembolism (VTE) risk (eg, smoking, obesity, family history of VTE).


Based on epidemiologic studies evaluating the relative risk of thromboembolism in women using COCs

  • COCs containing drsp may be associated with a higher risk of VTE than those containing levonorgestrel or some other progestins
  • Reported VTE risk in these studies ranged from no increase to a 3-fold increase for drsp-containing COCs

Counsel patients about the information regarding the risk of VTE with drsp-containing COCs compared to COCs that contain levonorgestrel or some other progestins.

Indications

Beyaz and SAFYRAL are indicated for women who choose an oral contraceptive for contraception for:

  • Prevention of pregnancy
    • 99% contraceptive efficacy when used as directed
  • Raising folate levels for the purpose of reducing the risk of a neural tube defect (NTD) in a pregnancy conceived while taking the product or shortly after discontinuing the product

Beyaz is also indicated for women who choose an oral contraceptive for contraception for:

  • Treatment of the emotional and physical symptoms of premenstrual dysphoric disorder (PMDD)
    • The effectiveness of Beyaz for PMDD when used for more than 3 menstrual cycles has not been evaluated. Beyaz has not been evaluated for the treatment of premenstrual syndrome (PMS)
  • Treatment of moderate acne for women at least 14 years of age who have achieved menarche

Important Safety Information about Beyaz and SAFYRAL

Patients who should not take Beyaz or SAFYRAL

Women over 35 years old who smoke should not use Beyaz or SAFYRAL. Smoking increases the risk of serious cardiovascular side effects from Beyaz or SAFYRAL use. This risk increases with age and the number of cigarettes smoked.

  • Beyaz and SAFYRAL are contraindicated in women with a high risk of arterial or venous thrombotic diseases, undiagnosed abnormal uterine bleeding, breast cancer or other hormone-sensitive cancer, liver tumors (benign or malignant) or liver disease, conditions that predispose to hyperkalemia (ie, renal impairment, hepatic dysfunction, and adrenal insufficiency), or who are pregnant

Know serious risks with Beyaz and SAFYRAL

  • Thromboembolic and Other Vascular Events:Stop Beyaz or SAFYRAL if an arterial or venous thrombotic event occurs. The risk of venous thromboembolism (VTE) is highest during the first year of combination oral contraceptive (COC) use. This increased risk is greatest after initially starting a COC or restarting the same or a different COC following a 4 week or greater Pill-free interval. Epidemiologic studies suggest drospirenone (drsp®)‐containing COCs may be associated with a higher risk of VTE than COCs containing levonorgestrel or some other progestins. These studies reported the risk of VTE ranged from no increase to a 3‐fold increase. Before initiating Beyaz or SAFYRAL in a new COC user or in a woman switching from a contraceptive not containing drsp, consider the risks and benefits of Beyaz or SAFYRAL in light of her VTE risk (eg, smoking, obesity, family history of VTE)

    COC use also increases risk of arterial thromboses (eg, stroke and myocardial infarction), especially in women with risk factors for these events. Use COCs with caution in women with cardiovascular disease risk factors. If feasible, stop Beyaz or SAFYRAL at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism. Start Beyaz or SAFYRAL no earlier than 4 weeks after delivery in women not breastfeeding

  • Hyperkalemia: Beyaz and SAFYRAL contain drospirenone that has the potential for hyperkalemia in high-risk patients and are contraindicated in patients with conditions that predispose to hyperkalemia. Check serum potassium level during the first treatment cycle in women who receive long-term treatment with medications that may increase serum potassium (eg, ACE inhibitors, angiotensin-II receptor antagonists, potassium-sparing diuretics, potassium supplementation, heparin, aldosterone antagonists, and NSAIDs)
  • Liver Disease: Discontinue Beyaz or SAFYRAL if jaundice develops
  • High Blood Pressure (BP): Women with uncontrolled hypertension or hypertension with vascular disease should not use COCs. Monitor BP in women with well-controlled hypertension and stop Beyaz or SAFYRAL if BP rises significantly. BP may increase in COC users, more likely occurring in older women and with extended use
  • Gallbladder Disease: Studies suggest a small increased relative risk of developing gallbladder disease among COC users
  • Carbohydrate and Lipid Metabolic Effects: Monitor prediabetic and diabetic COC users. Consider alternative contraception for women with uncontrolled dyslipidemia
  • Headache: If a Beyaz or SAFYRAL user develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Beyaz or SAFYRAL if indicated
  • Bleeding Irregularities: Evaluate irregular bleeding or amenorrhea; check for causes such as pregnancy or malignancy
  • Folates may mask vitamin B12 deficiency
  • Counsel patients that Beyaz and SAFYRAL do not protect against HIV infection and other sexually transmitted diseases

Serious adverse reactions in Beyaz clinical trials:

  • Cervix carcinoma stage 0, cervical dysplasia, and migraine

Most common adverse reactions (≥2%) in Beyaz clinical trials:

  • In contraception, moderate acne, and folate clinical trials: headache/migraine (5.9%), menstrual irregularities (4.1%), nausea/vomiting (3.5%), and breast pain/tenderness (3.2%)
  • In PMDD clinical trials: menstrual irregularities (24.9%), nausea (15.8%), headache (13.0%), breast tenderness (10.5%), fatigue (4.2%), irritability (2.8%), decreased libido (2.8%), increased weight (2.5%), and affect lability (2.1%)

Serious adverse reactions in SAFYRAL clinical trials:

  • Depression, pulmonary embolism, toxic skin eruption, and uterine leiomyoma

Most common adverse reactions (≥2%) in SAFYRAL clinical trials:

  • In contraception and folate clinical trials were: premenstrual syndrome (12.4%), headache/migraine (10.3%), breast pain/tenderness/discomfort (8.1%), nausea/vomiting (4.4%), and abdominal pain/discomfort/tenderness (2.2%)

Drug interactions (see Prescribing Information of concomitant drugs)

  • Effects of Other Drugs on COCs: Drugs or herbal products that induce certain enzymes (eg, CYP3A4) may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up or alternate method of contraception during use and for 28 days following discontinuation of concomitant use. Certain drugs (eg, atorvastatin, CYP3A4 inhibitors) may increase plasma levels of COCs. HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors may increase or decrease plasma levels of COCs. There have been reports of pregnancy while taking hormonal contraceptives and antibiotics concomitantly
  • Effects of COCs on Other Drugs: COCs may inhibit or induce metabolism of other drugs (eg, lamotrigine)
  • Effects on Serum Potassium: See hyperkalemia information in full PI
  • Effects of Folates on Other Drugs: Folates may decrease the pharmacological effect of certain antifolate drugs
  • Effects of Other Drugs on Folates: Several drugs (eg, methotrexate and sulfasalazine, cholestyramine, certain antiepileptics) may reduce folate levels via various mechanisms

Indications for Natazia

Natazia is indicated for women who choose an oral contraceptive for contraception for:

  • Use by Women to Prevent Pregnancy
  • Natazia is also indicated for treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive for birth control.
    • The contraceptive efficacy of Natazia in women with a body mass index (BMI) of >30 kg/m2 has not been evaluated.

Important Safety Information About Natazia®

Patients who should not take Natazia

Natazia should not be used in women with a high risk of arterial or venous thrombotic diseases, undiagnosed abnormal uterine bleeding, breast cancer or other estrogen- or progestin-sensitive cancer, liver tumors (benign or malignant) or liver disease, or who are pregnant.

Know the most serious risks

Women over 35 years old who smoke should not use Natazia. Smoking increases the risk of serious cardiovascular side effects from Natazia use. This risk increases with age and the number of cigarettes smoked.

Thromboembolic and Other Vascular Events: Stop Natazia if an arterial or venous thrombotic event occurs. The risk of venous thromboembolism (VTE) is highest during the first year of combination oral contraceptive (COC) use. This increased risk is greatest after initially starting a COC or restarting the same or a different COC following a 4 week or greater Pill-free interval.

COC use also increases the risk of arterial thromboses (eg, stroke and myocardial infarction) especially in women with other risk factors for these events. If feasible, stop Natazia at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism. Start Natazia no earlier than 4 weeks after delivery, in women who are not breastfeeding. COCs must be used with caution in women with cardiovascular disease risk factors.

Liver Disease: Discontinue Natazia if jaundice develops. Hepatic adenomas are associated with COC use.

High Blood Pressure (BP): For women with well-controlled hypertension, monitor blood pressure and stop Natazia if blood pressure rises significantly. Women with uncontrolled hypertension or hypertension with vascular disease should not use COCs. An increase in blood pressure has been reported in women taking COCs, and this increase is more likely in older women and with extended duration of use.

Carbohydrate and Lipid Metabolic Effects: Carefully monitor prediabetic and diabetic COC users. Consider alternative contraception for women with uncontrolled dyslipidemia.

Headache: If a Natazia user develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Natazia if indicated. Increased frequency or severity of migraines may be reason for immediate discontinuation.

Bleeding Irregularities: If irregular bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy. Rule out pregnancy in the event of amenorrhea occurring in 2 or more consecutive cycles.

Drug Interactions: Women taking strong CYP3A4 inducers (eg, carbamazepine, phenytoin, rifampicin, and St. John’s wort) should not use Natazia during and for at least 28 days after discontinuation of these inducers due to the possibility of decreased contraceptive efficacy.

Counsel patients that Natazia does not protect against HIV infection and other sexually transmitted diseases.

Serious adverse reactions in clinical trials

Myocardial infarction, ruptured ovarian cyst, deep vein thrombosis, focal nodular hyperplasia of the liver, uterine leiomyoma, acute cholecystitis, and chronic acalculous cholecystitis.

Most common adverse reactions (≥2%) in clinical trials

Headache (including migraines) (12.7%), breast pain, discomfort or tenderness (7.0%), menstrual disorders (6.9%), nausea or vomiting (6.0%), acne (3.9%), mood changes (3.0%), and increased weight (2.9%).

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