Dosage & Administration
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Balcoltra Prescribing Information
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs are contraindicated in women who are over 35 years of age and smoke [see Contraindications ].
Balcoltra is indicated for use by females of reproductive potential to prevent pregnancy.
How to Start Balcoltra
Balcoltra is dispensed in a blister card [see How Supplied/Storage and Handling ]. Balcoltra may be started using either a Day 1 start or a Sunday start (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception should be used until after the first 7 consecutive days of administration.
How to Take Balcoltra
Balcoltra (orange active tablets and blue placebo tablets) is swallowed whole once a day
| Complete instructions to facilitate patient counseling on proper tablet usage are located in the FDA-Approved Patient Labeling. | |
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: •Balcoltra active tablets are orange (Day 1 to Day 21). •Balcoltra placebo tablets are blue (Day 22 to Day 28). | Day 1 Start: •Take first orange active tablet on the first day of menses. •Take subsequent orange active tablets once daily at the same time each day for a total of 21 days. •Take one blue placebo tablet daily for 7 days and at the same time of day that active tablets were taken. •Begin each subsequent pack on the same day of the week as the first cycle pack (i.e. on the day after taking the last inactive tablet). Sunday Start: •Take first active tablet 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 or spermicide) for the first seven days of the patient’s first cycle pack of Balcoltra. •Take subsequent orange tablets once daily at the same time each day for a total of 21 days. •Take one blue placebo tablet daily for the following 7 days and at the same time of day that active tablets were taken. •Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the Sunday after taking the last inactive tablet) and additional non-hormonal contraceptive is not needed. |
Switching to Balcoltra from another hormonal contraceptive | Start on the same day that a new pack of the previous hormonal contraceptive would have started. |
Switching from another contraceptive method to Balcoltra | Start Balcoltra: |
| •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 or spermicide) is needed for the first seven days of the first cycle pack. |
| •Implant | •On the day of removal |
Starting Balcoltra after Abortion or Miscarriage
First-trimester
•After a first-trimester abortion or miscarriage, Balcoltra may be started immediately. An additional method of contraception is not needed if Balcoltra is started within 5 days after termination of the pregnancy.
•If Balcoltra is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms or spermicide) for the first seven days of her first cycle pack of Balcoltra.
Second-trimester
•Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Balcoltra, 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 or spermicide) for the first seven days of the patient’s first cycle pack of Balcoltra. [See Contraindications , Warnings and Precautions , and FDA-Approved Patient Labeling.]
Starting Balcoltra after Childbirth
•Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Balcoltra following the instructions in Table 1for women not currently using hormonal contraception.
•If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Balcoltra.
[See Contraindications , Warnings and Precautions , Use in Specific Populations , and FDA-Approved Patient Labeling].
Missed Tablets
| •If one orange 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 orange 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 or spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. |
| •If two orange tablets are missed in Week 3 or three or more orange 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 or spermicide) should be used as back-up if the patient has sex within 7 days after missing tablets. |
Advice in Case of Gastrointestinal Disturbances
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 [see FDA-Approved Patient Labeling].
Balcoltra (levonorgestrel and ethinyl estradiol tablets, USP and ferrous bisglycinate tablets) is available in a 28-tablet compact blister card with:
•21 orange, round biconvex tablets (active) debossed with “A3” on one side and each containing levonorgestrel 0.10 mg and ethinyl estradiol 0.02 mg
•7 blue, round biconvex tablets (inactive placebo) debossed with “F1” on one side and each containing ferrous bisglycinate 36.5 mg
The ferrous bisglycinate tablets do not serve any therapeutic purpose.
Pregnancy
Risk Summary
Balcoltra is contraindicated in pregnancy because there is no reason to use combined hormonal contraceptives (CHCs) in pregnancy. Discontinue Balcoltra if pregnancy occurs. Based on epidemiologic studies and meta-analyses, there is little or no increased risk of birth defects in the children of females who inadvertently use COCs during early pregnancy (See Data).
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively.
Human Data
Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to COCs before conception or during early pregnancy.
Lactation
Risk Summary
Combined hormonal contraceptives (CHCs) and/or metabolites are present in human milk and in breast-fed infants. CHCs, including Balcoltra, can reduce milk production in breast-feeding females. This reduction can occur at any time but is less likely to occur once breast-feeding is well-established. When possible, advise the nursing female to use other methods of contraception until she discontinues breast-feeding. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Balcoltra and any potential adverse effects on the breast-fed child from Balcoltra or from the underlying maternal condition.
Pediatric Use
Safety and efficacy of Balcoltra have been established in women of reproductive age. Efficacy is expected to be the same in post-pubertal adolescents under the age of 18 years as for users 18 years and older. Use of this product before menarche is not indicated.
Geriatric Use
Balcoltra has not been studied in postmenopausal women and is not indicated in this population.
Hepatic Impairment
The pharmacokinetics of Balcoltra has not been studied in women with hepatic impairment. However, steroid hormones may be poorly metabolized in patients with hepatic impairment. 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 [see Contraindications and Warnings and Precautions ].
Balcoltra is contraindicated in females who are known to have or develop the following conditions:
•A high risk of arterial or venous thrombotic disease. Examples include women who are known to:
- Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions ].
- Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions ].
- Have inherited or acquired hypercoagulopathies [see Warnings and Precautions ].
- Have cerebrovascular disease [see Warnings and Precautions ].
- Have coronary artery disease [see Warnings and Precautions ].
- Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions ].
- Have uncontrolled hypertension [see Warnings and Precautions ].
- Have diabetes mellitus with vascular disease [see Warnings and Precautions ].
- Have headaches with focal neurological symptoms or have migraine headaches with aura [see Warnings and Precautions ].
•Women over age 35 with any migraine headaches [see Warnings and Precautions ].
•Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions ]
•Undiagnosed abnormal uterine bleeding [see Warnings and Precautions ].
•Pregnancy, because there is no reason to use COCs during pregnancy [see Warnings and Precautions and Use in Specific Populations ].
•Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see Warnings and Precautions ].
•Hypersensitivity to any of the components.
•Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations [see Warnings and Precautions ]