Kurvelo (Page 5 of 9)

10. Interactions with Laboratory Tests

Certain endocrine- and liver-function tests and blood components may be affected by oral contraceptives:

a. Increased prothrombin and factors VII, VIII, IX, and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggregability.

b. Increased thyroid-binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 by column or by radioimmunoassay. Free T3 resin uptake is decreased, reflecting the elevated TBG; free T4 concentration is unaltered.

c. Other binding proteins may be elevated in serum.

d. Sex-binding globulins are increased and result in elevated levels of total circulating sex steroids and corticoids; however, free or biologically active levels remain unchanged.

e. Triglycerides may be increased.

f. Glucose tolerance may be decreased.

g. Serum folate levels may be depressed by oral contraceptive therapy. This may be of clinical significance if a woman becomes pregnant shortly after discontinuing oral contraceptives.

11. Carcinogenesis

See WARNINGS section.

12. Pregnancy

Pregnancy Category X. See CONTRAINDICATIONS and WARNINGSsections.

13. Nursing Mothers

Small amounts of oral contraceptive steroids and/or metabolites have been identified in the milk of nursing mothers, and a few adverse effects on the child have been reported, including jaundice and breast enlargement. In addition, combination oral contraceptives given in the postpartum period may interfere with lactation by decreasing the quantity and quality of breast milk. If possible, the nursing mother should be advised not to use combination oral contraceptives but to use other forms of contraception until she has completely weaned her child.

14. Pediatric Use

Safety and efficacy of Kurvelo (levonorgestrel and ethinyl estradiol tablets) have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and users 16 and older. Use of this product before menarche is not indicated.

INFORMATION FOR PATIENTS

See Patient Labeling Printed Below.

ADVERSE REACTIONS

An increased risk of the following serious adverse reactions (see WARNINGS section for additional information) has been associated with the use of oral contraceptives:

Thromboembolic disorders and other vascular problems (including thrombophlebitis, arterial thromboembolism, pulmonary embolism, myocardial infarction, cerebral hemorrhage, cerebral thrombosis), carcinoma of the reproductive organs, hepatic neoplasia (including hepatic adenomas or benign liver tumors), ocular lesions (including retinal vascular thrombosis), gallbladder disease, carbohydrate and lipid effects, elevated blood pressure, and headache.

The following adverse reactions have been reported in patients receiving oral contraceptives and are believed to be drug-related:

Nausea

Vomiting

Gastrointestinal symptoms (such as abdominal pain, cramps and bloating)

Breakthrough bleeding

Spotting

Change in menstrual flow

Amenorrhea

Temporary infertility after discontinuation of treatment

Edema/fluid retention

Melasma/chloasma which may persist

Breast changes: tenderness, pain, enlargement, secretion

Change in weight or appetite (increase or decrease)

Change in cervical erosion and secretion

Diminution in lactation when given immediately postpartum

Cholestatic jaundice

Rash (allergic)

Mood changes, including depression

Vaginitis, including candidiasis

Change in corneal curvature (steepening)

Intolerance to contact lenses

Mesenteric thrombosis

Decrease in serum folate levels

Exacerbation of systemic lupus erythematosus

Exacerbation of porphyria

Exacerbation of chorea

Aggravation of varicose veins

Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms.

The following adverse reactions have been reported in users of oral contraceptives, and the association has been neither confirmed nor refuted:

Congenital anomalies

Premenstrual syndrome

Cataracts

Optic neuritis, which may lead to partial or complete loss of vision

Cystitis-like syndrome

Nervousness

Dizziness

Hirsutism

Loss of scalp hair

Erythema multiforme

Erythema nodosum

Hemorrhagic eruption

Impaired renal function

Hemolytic uremic syndrome

Budd-Chiari syndrome

Acne

Changes in libido

Colitis

Sickle-cell disease

Cerebral-vascular disease with mitral valve prolapse

Lupus-like syndromes

Pancreatitis

Dysmenorrhea

OVERDOSAGE

Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea, and withdrawal bleeding may occur in females.

NONCONTRACEPTIVE HEALTH BENEFITS

The following noncontraceptive health benefits related to the use of oral contraceptives are supported by epidemiological studies which largely utilized oral contraceptive formulations containing doses exceeding 0.035 mg of ethinyl estradiol or 0.05 mg of mestranol.

Effects on Menses

Increased menstrual cycle regularity.

Decreased blood loss and decreased incidence of iron-deficiency anemia.

Decreased incidence of dysmenorrhea.

Effects Related to Inhibition of Ovulation

Decreased incidence of functional ovarian cysts.

Decreased incidence of ectopic pregnancies.

Effects from Long-Term Use

Decreased incidence of fibroadenomas and fibrocystic disease of the breast.

Decreased incidence of acute pelvic inflammatory disease.

Decreased incidence of endometrial cancer.

Decreased incidence of ovarian cancer.

DOSAGE AND ADMINISTRATION

To achieve maximum contraceptive effectiveness, Kurvelo (levonorgestrel and ethinyl estradiol tablets, 0.15 mg/0.03 mg) must be taken exactly as directed and at intervals not exceeding 24 hours.

The dosage of Kurvelo is one light orange tablet daily for 21 consecutive days, followed by one pink inert tablet daily for 7 consecutive days, according to prescribed schedule.

It is recommended that tablets be taken at the same time each day, preferably after the evening meal or at bedtime.

During the first cycle of medication, the patient is instructed to begin taking Kurvelo on the first Sunday after the onset of menstruation. If menstruation begins on a Sunday, the first tablet (light orange) is taken that day. One light orange tablet should be taken daily for 21 consecutive days, followed by one pink inert tablet daily for 7 consecutive days. Withdrawal bleeding should usually occur within three days following discontinuation of light orange tablets and may not have finished before the next pack is started. During the first cycle, contraceptive reliance should not be placed on Kurvelo until a light orange tablet has been taken daily for 7 consecutive days and a nonhormonal back-up method of birth control should be used during those 7 days. The possibility of ovulation and conception prior to initiation of medication should be considered.

The patient begins her next and all subsequent 28-day courses of tablets on the same day of the week (Sunday) on which she began her first course, following the same schedule: 21 days on light orange tablets — 7 days on pink inert tablets. If in any cycle the patient starts tablets later than the proper day, she should protect herself by using another method of birth control until she has taken a light orange tablet daily for 7 consecutive days.

When the patient is switching from a 21-day regimen of tablets, she should wait 7 days after her last tablet before she starts Kurvelo. She will probably experience withdrawal bleeding during that week. She should be sure that no more than 7 days pass after her previous 21-day regimen. When the patient is switching from a 28-day regimen of tablets, she should start her first pack of Kurvelo on the day after her last tablet. She should not wait any days between packs. The patient may switch any day from a progestin-only pill and should begin Kurvelo the next day. If switching from an implant or injection, the patient should start Kurvelo on the day of implant removal or, if using an injection, the day the next injection would be due. In switching from a progestin-only pill, injection or implant, the patient should be advised to use a nonhormonal back-up method of birth control for the first 7 days of tablet-taking.

If spotting or breakthrough bleeding occurs, the patient is instructed to continue on the same regimen. This type of bleeding is usually transient and without significance; however, if the bleeding is persistent or prolonged, the patient is advised to consult her physician. Although the occurrence of pregnancy is highly unlikely if Kurvelo is taken according to directions, if withdrawal bleeding does not occur, the possibility of pregnancy must be considered. If the patient has not adhered to the prescribed schedule (missed one or more tablets or started taking them on a day later than she should have), the probability of pregnancy should be considered at the time of the first missed period and appropriate diagnostic measures taken before the medication is resumed. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out before continuing the contraceptive regimen.

For additional patient instructions regarding missed pills, see the “WHAT TO DO IF YOU MISS PILLS” section in the DETAILED PATIENT LABELING below.

Any time the patient misses two or more light orange tablets, she should also use another method of contraception until she has taken a light orange tablet daily for seven consecutive days. If the patient misses one or more pink tablets, she is still protected against pregnancy provided she begins taking light orange tablets again on the proper day.

If breakthrough bleeding occurs following missed light orange tablets, it will usually be transient and of no consequence. While there is little likelihood of ovulation occurring if only one or two light orange tablets are missed, the possibility of ovulation increases with each successive day that scheduled light orange tablets are missed.

Kurvelo may be initiated no earlier than day 28 postpartum in the non-lactating mother or after a second trimester abortion due to the increased risk for thromboembolism (see CONTRAINDICATIONS,” “WARNINGS” and “PRECAUTIONSconcerning thromboembolic disease). The patient should be advised to use a nonhormonal back-up method for the first 7 days of tablet taking. However, if intercourse has already occurred, pregnancy should be excluded before the start of combined oral contraceptive use or the patient must wait for her first menstrual period.

In the case of first trimester abortion, if the patient starts Kurvelo immediately, additional contraceptive measures are not needed. It is to be noted that early resumption of ovulation may occur if Parlodel® (bromocriptine mesylate) has been used for the prevention of lactation.

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