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VyLibra is a brand name for Norgestimate. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND USAGE VyLibra is a combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1.1 ) 1.1 Oral Contraceptive VyLibra tablets are indicated for use by females of reproductive potential to prevent pregnancy…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION Take one tablet daily by mouth at the same time every day. 1 ) Take tablets in the order directed on the blister pack. 1 ) Do not skip or delay tablet intake. 1 Recommended Dosage and Administration Take one tablet by mouth at the same time each day with or without food.
Table 1 provides the recommended dosage and administration instructions for VyLibra.
Table 1:
Instructions for Administration of VyLibra Starting COCs in women not currently using hormonal contraception (Day 1 Start or Sunday Start) Important: Consider the possibility of ovulation and conception prior to initiation of this product.
Tablet Color:
VyLibra active tablets are dark blue (Day 1 to Day 21). VyLibra has green inactive tablets (Day 22 to Day 28).
Day 1 Start:
Take first active tablet without regard to meals on the first day of menses. Take subsequent active tablets once daily at the same time each day for a total of 21 days. Take one green inactive tablet daily for 7 days and at the same time of day that active tablets were taken.
, on the day after taking the last inactive tablet) Sunday Start: Take first active tablet without regard to meals on the first Sunday after the onset of menses. Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient’s first cycle pack of VyLibra.
Take subsequent active tablets once daily at the same time each day for a total of 21 days. Take one green inactive tablet daily for the following 7 days and at the same time of day that active tablets were taken. , on the Sunday after taking the last inactive tablet) and additional non-hormonal contraceptive is not needed.
Switching to VyLibra from another oral contraceptive Start on the same day that a new pack of the previous oral contraceptive would have started. Switching from another contraceptive method to VyLibra Start VyLibra: • Transdermal patch On the day when next application would have been scheduled • Vaginal ring On the day when next insertion would have been scheduled • Injection On the day when next injection would have been scheduled • Intrauterine contraceptive On the day of removal If the IUD is not removed on first day of the patient’s menstrual cycle, additional non-hormonal contraceptive (such as condoms and spermicide) is needed for the first seven days of the first cycle pack.
2) ] The most common adverse reactions reported during clinical trials (≥2%) were: headache/migraine, abdominal/gastrointestinal pain, vaginal infection, genital discharge, breast issues (including breast pain, discharge, and enlargement), mood disorders (including depression and mood altered), flatulence, nervousness, rash.
gov/medwatch . 1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety of VyLibra was evaluated in 1,647 healthy women of child-bearing potential who participated in 3 clinical trials and received at least 1 dose of VyLibra for contraception. Two trials were randomized active-controlled trials and 1 was an uncontrolled open-label trial.
In all 3 trials, subjects were followed for up to 24 cycles. 6%).
Adverse Reactions Leading to Study Discontinuation :
Over the three trials, between 11 to 21% of subjects discontinued the trial due to an adverse reaction. 1%). Serious Adverse Reactions : breast cancer (1 subject), mood disorders including depression, irritability, and mood swings (1 subject), myocardial infarction (1 subject), and venous thromboembolic events including pulmonary embolism (1 subject) and deep vein thrombosis (DVT) (1 subject).
12 (Figure 1). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 1). One of these studies reported no association between breast cancer risk and COC use.
33 with current or recent use. 4 with more than 8 to 10 years of COC use.
5 WARNINGS AND PRECAUTIONS Thromboembolic Disorders and Other Vascular Problems : Stop VyLibra if a thrombotic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding.
1) Liver disease : Discontinue VyLibra if jaundice occurs. 2) High blood pressure : If used in women with well-controlled hypertension, monitor blood pressure and stop VyLibra if blood pressure rises significantly. 4 ) Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking VyLibra.
Consider an alternate contraceptive method for women with uncontrolled dyslipidemia. 6 ) Headache : Evaluate significant change in headaches and discontinue VyLibra if indicated. 7 ) Bleeding Irregularities and Amenorrhea : Evaluate irregular bleeding or amenorrhea.
1 Thromboembolic Disorders and Other Vascular Problems Stop VyLibra if an arterial thrombotic event or venous thromboembolic (VTE) event occurs. Stop VyLibra if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions.
2) ] . If feasible, stop VyLibra at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE as well as during and following prolonged immobilization. Start VyLibra no earlier than 4 weeks after delivery, in women who are not breastfeeding.
The risk of postpartum VTE decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week. The use of COCs increases the risk of VTE. However, pregnancy increases the risk of VTE as much or more than the use of COCs.
The risk of VTE in women using COCs is 3 to 9 cases per 10,000 woman-years. The risk of VTE is highest during the first year of use of COCs and when restarting hormonal contraception after a break of 4 weeks or longer. The risk of thromboembolic disease due to COCs gradually disappears after use is discontinued.
4 CONTRAINDICATIONS VyLibra is contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic diseases. 3) ] A high risk of arterial or venous thrombotic diseases ( 4 ) Liver tumors or liver disease ( 4 ) Undiagnosed abnormal uterine bleeding ( 4 ) Breast cancer ( 4 ) Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ( 4 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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• Implant On the day of removal Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling. Starting VyLibra after Abortion or Miscarriage First-trimester After a first-trimester abortion or miscarriage, VyLibra may be started immediately.
An additional method of contraception is not needed if VyLibra is started immediately. If VyLibra is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of her first cycle pack of VyLibra.
Second-trimester Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start VyLibra, following the instructions in Table 1 for Day 1 or Sunday start, as desired.
If using Sunday start, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient’s first cycle pack of VyLibra. 1) ]. Starting VyLibra after Childbirth Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease.
Start contraceptive therapy with VyLibra following the instructions in Table 1 for women not currently using hormonal contraception. 2) ] . If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of VyLibra.
2) ] . 2 Recommendations Regarding Missed Doses Contraceptive failure may occur when active tablets are missed. Table 2 describes instructions for VyLibra dosing and use of additional non-hormonal contraception (such as condoms) when active tablets are missed.
Table 2:
Instructions for Missed VyLibra Tablets If one active tablet is missed in Weeks 1, 2, or 3 Take the tablet as soon as possible. Continue taking one tablet a day until the pack is finished. If two active tablets are missed in Week 1 or Week 2 Take the two missed tablets as soon as possible and the next two active tablets the next day.
Continue taking one tablet a day until the pack is finished. Additional non-hormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. If two active tablets are missed in the third week or three or more active tablets are missed in a row in Weeks 1, 2, or 3 Day 1 start: Throw out the rest of the pack and start a new pack that same day.
Sunday start:
Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Additional non-hormonal contraception (such as condoms and spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets.
3 Dosage Recommendations if Vomiting or Diarrhea Occurs In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting or diarrhea occurs within 3 to 4 hours after taking an active tablet, handle this as a missed tablet.
Figure 1:
Risk of Breast Cancer with Combined Oral Contraceptive Use RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “never COC use” are females that never used COCs. The following additional adverse reactions have been reported from worldwide postmarketing experience with norgestimate/ethinyl estradiol.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Infections and Infestations :
Urinary tract infection; Neoplasms Benign, Malignant and Unspecified (Incl.
Cysts and Polyps) :
Breast cancer, benign breast neoplasm, hepatic adenoma, focal nodular hyperplasia, breast cyst; Immune System Disorders : Anaphylactic reaction, hypersensitivity; Metabolism and Nutrition Disorders : Dyslipidemia; Psychiatric Disorders : Anxiety, insomnia; Nervous System Disorders : Syncope, convulsion, paresthesia, dizziness; Eye Disorders : Visual impairment, dry eye, contact lens intolerance; Ear and Labyrinth Disorders : Vertigo; Cardiac Disorders : Tachycardia, palpitations; Vascular Events : Deep vein thrombosis, pulmonary embolism, retinal vascular thrombosis, hot flush, venous thrombosis (including Budd Chiari Syndrome and hepatic vein thrombosis); Arterial Events: Arterial thromboembolism, myocardial infarction, cerebrovascular accident; Respiratory, Thoracic and Mediastinal Disorders : Dyspnea; Gastrointestinal Disorders : Pancreatitis, abdominal distension, diarrhea, constipation; Hepatobiliary Disorders: Hepatitis; Skin and Subcutaneous Tissue Disorders : Angioedema, erythema nodosum, hirsutism, night sweats, hyperhidrosis, photosensitivity reaction, urticaria, pruritus, acne; Musculoskeletal, Connective Tissue, and Bone Disorders : Muscle spasms, pain in extremity, myalgia, back pain; Reproductive System and Breast Disorders : Ovarian cyst, suppressed lactation, vulvovaginal dryness; General Disorders and Administration Site Conditions : Chest pain, asthenic conditions.
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Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes).
This risk increases with age, particularly in women over 35 years of age who smoke. Use COCs with caution in women with cardiovascular disease risk factors. 2 Liver Disease Impaired Liver Function VyLibra is contraindicated in women with liver disease, such as acute viral hepatitis or severe (decompensated) cirrhosis of liver [see Contraindications (4) ] .
Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded. Discontinue VyLibra if jaundice develops. Liver Tumors VyLibra is contraindicated in women with benign and malignant liver tumors [see Contraindications (4) ] .
Hepatic adenomas are associated with COC use. 3 cases/100,000 COC users. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage. Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) COC users.
However, the risk of liver cancers in COC users is less than one case per million users. 3 Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications, such as COCs.
Discontinue VyLibra prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir [see Contraindications (4) ] . VyLibra can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen.
4 High Blood Pressure VyLibra is contraindicated in women with uncontrolled hypertension or hypertension with vascular disease [see Contraindications (4) ] . For women with well-controlled hypertension, monitor blood pressure and stop VyLibra if blood pressure rises significantly.
An increase in blood pressure has been reported in women taking COCs, and this increase is more likely in older women with extended duration of use. The incidence of hypertension increases with increasing concentrations of progestin.
5 Gallbladder Disease Studies suggest a small increased relative risk of developing gallbladder disease among COC users. Use of COCs may worsen existing gallbladder disease. A past history of COC-related cholestasis predicts an increased risk with subsequent COC use.
Women with a history of pregnancy-related cholestasis may be at an increased risk for COC related cholestasis. 6 Carbohydrate and Lipid Metabolic Effects Carefully monitor prediabetic and diabetic women who take VyLibra. COCs may decrease glucose tolerance.
Consider alternative contraception for women with uncontrolled dyslipidemia. A small proportion of women will have adverse lipid changes while on COCs. Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using COCs.
7 Headache If a woman taking VyLibra develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue VyLibra if indicated. Consider discontinuation of VyLibra in the case of increased frequency or severity of migraine during COC use (which may be prodromal of a cerebrovascular event).
8 Bleeding Irregularities and Amenorrhea Unscheduled Bleeding and Spotting Unscheduled (breakthrough or intracyclic) bleeding and spotting sometimes occur in patients on COCs, especially during the first three months of use. If bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy.
If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different contraceptive product. In clinical trials of VyLibra, the frequency and duration of breakthrough bleeding and/or spotting was assessed in 1,647 patients (21,275 evaluable cycles).
5%) women discontinued VyLibra, at least in part, due to bleeding or spotting. Based on data from the clinical trials, 14 to 34% of women using VyLibra experienced unscheduled bleeding per cycle in the first year. The percent of women who experienced breakthrough/unscheduled bleeding tended to decrease over time.
Amenorrhea and Oligomenorrhea Women who use VyLibra may experience amenorrhea. Some women may experience amenorrhea or oligomenorrhea after discontinuation of COCs, especially when such a condition was pre-existent. If scheduled (withdrawal) bleeding does not occur, consider the possibility of pregnancy.
If the patient has not adhered to the prescribed dosing schedule (missed one or more active tablets or started taking them on a day later than she should have), consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures.
If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. 9 Depression Carefully observe women with a history of depression and discontinue VyLibra if depression recurs to a serious degree.
10 Malignant Neoplasms Breast Cancer VyLibra is contraindicated in females who currently have or have had breast cancer because breast cancer may be hormonally sensitive [see Contraindications (4 )]. Epidemiology studies have not found a consistent association between use of combined oral contraceptives (COCs) and breast cancer risk.
Studies do not show an association between ever (current or past) use of COCs and risk of breast cancer. 2 )]. Cervical Cancer Some studies suggest that COC use has been associated with an increase in the risk of cervical cancer or intraepithelial neoplasia.
However, there continues to be controversy about the extent to which such findings may be due to differences in sexual behavior and other factors. 11 Effect on Binding Globulins The estrogen component of COCs may raise the serum concentrations of thyroxine-binding globulin, sex hormone-binding globulin, and cortisol-binding globulin.
The dose of replacement thyroid hormone or cortisol therapy may need to be increased. 12 Monitoring A woman who is taking COCs should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated healthcare.
13 Hereditary Angioedema In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema. 14 Chloasma Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum.
Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while taking VyLibra.