CovARYX®/CovARYX® HS Esterified Estrogen and Methyltestosterone Tablets

Overview

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Indication

CovARYX® and CovARYX® HS are Estrogen-Androgen Menopausal Hormone Therapy (MHT) tablets available by prescription that promote relief to women from vasomotor symptoms for whom estrogen-only therapies do not provide sufficient relief.

Patient Information

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Menopause is a natural biological process marking the end of menstruation when the female body no longer makes eggs.  It happens when the ovaries stop producing the hormones estrogen and progesterone.

Leading up to the final menstrual cycle, women may experience perimenopause, a transition period when they experience starts and stops in their menstrual flow.  Women who have not had their period for 12 months have gone through menopause.

The average age of menopause is 51.3 but it may arrive as early as 40 or as late as 55 years old.  Approximately 11 million women reach natural menopause each year.  85% of these women experience some symptom related to menopause each year.

Women begin the post-menopausal stage of life after progressing through perimenopause and menopause.  The entire transition from perimenopause through menopause and into post-menopause may take from two (2) to eight (8) years.

Consultation with a physician including a physical exam and review of symptoms and medical history may determine the menopausal stage of progression.

Savings Offer

For help purchasing CovARYX® and CovARYX® HS, patients may print out this mail-in savings offer and receive $30 off the price of a prescription.  This offer helps eligible patients save on out-of-pocket costs.  Certain restrictions apply.

 Symptoms

The process of menopause affects every woman differently.  This adds to confusion and apprehension because some women may show no symptoms or discomfort while others may experience symptoms that vary greatly in quantity and severity.

Vasomotor Symptoms including hot flashes and night sweats are attributed to changes in blood pressure and blood flow known as vasomotor function and from variances to normal body temperature, called homeostasis.

Menopausal Symptom Tracker

Be open and honest with your physician about any and all issues related to menopause and your personal experiences.  Print out and complete this Symptom Tracker to discuss your symptoms and decide on solutions and options to help you feel better.

How CovARYX® May Help

CovARYX® and CovARYX® HS are Estrogen-Androgen Menopausal Hormone Therapy (MHT) tablets available by prescription that promote relief to women from vasomotor symptoms for whom estrogen-only therapies are found not to provide sufficient relief.

The vasomotor center involves multiple systems in the body that regulate blood pressure and homeostasis which maintains a constant body temperature of 98.6 degrees Fahrenheit.

As women age, their ovaries produce less Estrogen, Testosterone and Progesterone.  Vasomotor symptoms of menopause occur due to changes in these hormone levels.

Hot flashes are a sudden feeling of intense heat or cold either in specific areas or all over the body.  Night sweats are hot flashes suffered at night often accompanied by sweating spells occurring without exertion or activity.  Hot flashes and night sweats are often triggered by thermoregulatory imbalance during menopause.

There is significant desire for products to treat vasomotor symptoms of menopause including hot flashes and night sweats.  Review uses, side effects, precautions and further details about CovARYX ® and CovARYX ® HS.

Menopausal Hormone Therapy (MHT) Explained

After consultation with their doctor, some women use Menopausal Hormone Therapy (MHT) to manage certain menopausal symptoms.  MHT involves taking the hormone estrogen alone or together with additional hormones including progesterone or androgen (testosterone).  Women experiencing perimenopause or menopause and also postmenopausal subjects may benefit from Menopausal Hormone Therapy.

There are benefits to and risks from Menopausal Hormone Therapy.  The Women’s Health Initiative is an organization that produced a report about many issues relating to MHT including health effects.

CovARYX® and CovARYX® HS and other Menopausal Hormone Therapy medicines increase the levels of Estrogen and Androgen that occur naturally in a woman’s body and which decrease significantly during menopause.

MHT pharmaceutical drug products have significant benefits and risks that may be reviewed here and in the Contraindications and Warnings section of this website.

MHT-Facts Infographic

Infographic – The Truth About Menopausal Hormone Therapy (MHT)

Purchasing Covaryx®

CovARYX® and CovARYX® HS are Estrogen-Androgen Menopausal Hormone Therapy (MHT) tablets available by prescription for relief from vasomotor symptoms of menopause when estrogen-only therapies do not provide sufficient relief.

For help purchasing CovARYX ® and CovARYX ® HS, print out this mail-in savings offer and receive $30 off the price of a prescription.  This offer helps eligible patients save on out-of-pocket costs.  Certain restrictions apply.  Ask your pharmacist whether your prescription is reimbursed by your health insurance provider..CovARYX ® is a combination of Esterified Estrogens and Methyltestosterone.  CovARYX® is supplied in bottles of 100 tablets.  Each ligh yellow, capsule-shaed, film-coated tablet is debossed “C010” on obverse and is plain on reverse. Each tablet contains 1.25 Mg of Esterified Estrogens, USP and 2.5 Mg of Methyltestosterone, USP.  The NDC number is 11528-010-01

CovARYX® HS is a combination of Esterified Estrogens and Methyltestosterone. CovARYX ® HS is supplied in bottles of 100 tablets.  Each light pink, capsule-shaped, film-coated tablet is debossed “C020” on obverse and is plain on reverse. Each tablet contains 0.625 Mg of Esterified Estrogens, USP and 1.25 Mg of Methyltestosterone, USP.  The NDC number is 11528-020-01.

Review uses, side effects, precautions and further details about CovARYX ® and CovARYX ® HS.

Review Full Prescribing Information

Savings Offer

For help purchasing CovARYX® and CovARYX® HS, patients may print out this mail-in savings offer and receive $30 off the price of a prescription.  This offer helps eligible patients save on out-of-pocket costs.  Certain restrictions apply.

 

For Healthcare Professionals

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Dosage and Administration

  • Given cyclically for short-term use only
  • The lowest dose that will control symptoms should be chosen and medication should be discontinued as promptly as possible
  • Administration should be cyclic [e.g. three (3) weeks on and one (1) week off]
  • Attempts to discontinue of taper medication should be made at 3-6 month intervals
  • 1 tablet of CovARYX® (1.25 Mg, 2.5 Mg) daily as recommended by the physician
  • 1 to 2 tablets of CovARYX® HS (0.625 Mg, 1.25 Mg) daily as recommended by the physician
  • CovARYX® and CovARYX® HS are Pregnancy Category X
  • The physician should instruct patients to report any of the following side effects of Androgens: hoarseness, acne, changes in menstrual periods or more hair on the face, any nausea, vomiting, changes in skin color or ankle swelling

How Supplied

  • CovARYX® is a combination of Esterified Estrogens and Methyltestosterone
  • CovARYX® is supplied in bottles of 100 tablets
  • Each light yellow, capsule-shaped, film-coated tablet debossed “CO10” on obverse and plain on the reverse
  • Contains 1.25 Mg of Esterified Estrogens, USP and 2.5 Mg of Methyltestosterone, USP
  • NDC 11528-010-01
  • CovARYX® HS is supplied in bottles of 100 tablets
  • Each light pink capsule-shaped film-coated tablet debossed “C020” on obverse and plain on the reverse contains 0.625 Mg of Esterified Estrogens, USP and 1.25 Mg of Methyltestosterone, USP
  • NDC 11528-020-01
  • Esterified Estrogens, USP is a mixture of the Estrogens, principally Estrone that are of the type excreted by pregnant mares
  • Methyltestosterone is a synthetic derivative of testosterone, the primary endogenous Androgen
  • Review images, uses, side effects, precautions and further details about CovARYX ® and CovARYX ® HS

Savings Offer

For help purchasing CovARYX® and CovARYX® HS, patients may print out this mail-in savings offer and receive $30 off the price of a prescription.  This offer helps eligible patients save on out-of-pocket costs.  Certain restrictions apply.

 

Safety and Prescribing Information

  1. ESTROGENS HAVE BEEN REPORTED TO INCREASE THE RISK OF ENDOMETRIAL CARCINOMA.

Three independent case control studies have reported an increased risk  of   endometrial  cancer  in  postmenopausal  women  exposed to exogenous estrogens for prolonged   periods.1-3  This   risk was independent of  the other known risk factors for endometrial cancer. These studies are further supported by the finding that incidence rates of endometrial cancer have increased  sharply since 1969 in eight different areas of the United States with population-based  cancer  reporting systems, an increase which may be related to the rapidly expanding use of estrogens during the last decade.4The three case control studies reported that the risk of endometrial  cancer in estrogen users was about 4.5 to 13.9 times greater than in nonusers. The risk appears to depend on both duration of treatment and on estrogen dose. In view of these findings, when estrogens are used for the treatment of menopausal symptoms, the lowest dose that will control symptoms should be utilized and medication should be discontinued as soon as possible.  When prolonged treatment is medically indicated, the patient should be reassessed on at least a semiannual basis to determine the need for continued therapy. Although the evidence must be considered preliminary, one study suggests that cyclic administration of low doses of estrogen may carry less risk than continuous administration;3  it therefore appears prudent to utilize such a regimen.  Close clinical surveillance of all women taking estrogens is important. In all cases of undiagnosed persistent or recurring abnormal vaginal bleeding, adequate diagnostic measures should be undertaken to rule out malignancy.  There is no evidence at present that “natural” estrogens are more or less hazardous than “synthetic” estrogens at equiestrogenic doses.

  1. ESTROGENS SHOULD NOT BE USED DURING PREGNANCY.

The use of female sex hormones, both estrogens and progestogens, during early pregnancy may seriously damage the offspring. It has been shown that females exposed in utero to diethylstilbestrol, a non-steroidal estrogen, have an increased risk of developing  in  later  life  a  form  of  vaginal or cervical cancer that is ordinarily extremely rare.5,6 This risk has been estimated as not greater than 4 per 1,000 exposures.7  Furthermore, a high percentage of  such exposed women (from 30 to 90 percent) have been found to have vaginal adenosis, 8-12  epithelial changes of  the vagina and cervix. Although these changes are histologically benign, it is not known whether they are precursors of malignancy. Although similar data are not available with the use of other estrogens, it cannot be presumed they would not induce similar changes.  Several reports suggest an association between intrauterine exposure to female sex hormones and congenital anomalies, including congenital heart defects and limb reduction defects. 13-16  One case control study 16  estimated a 4.7-fold increased risk of  limb reduction defects in infants exposed in utero to sex hormones (oral  contraceptives, hormone withdrawal tests for  pregnancy, or attempted treatment for threatened abortion). Some of these exposures were very short and involved only a few days of treatment. The data suggest that the risk of limb reduction defects in exposed fetuses is somewhat less than 1 per 1,000.  In the past, female sex hormones have been used during pregnancy in an attempt to treat threatened or habitual abortion.  There is considerable evidence that estrogens are ineffective for these indications, and there is no evidence from well controlled studies that progestogens are effective for these uses. If CovARYX® or CovARYX® H.S. is used during pregnancy, or if the patient becomes pregnant while taking this drug, she should be apprised of the potential risks to the fetus, and the advisability of pregnancy continuation.

  1. CARDIOVASCULAR AND OTHER RISKS.

CovARYX® and CovARYX®H.S. Tablets do not contain a progestin. CovARYX® and CovARYX® H.S. Tablets are an Estrogen/Androgen product.  Estrogens with or without progestins should not be used for the prevention of cardiovascular disease.The Women’s Health Initiative (WHI) study reported increased risks ofmyocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women during 5 years of treatment with conjugated equine estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo (See CLINICAL PHARMACOLOGY, Clinical Studies).  Other doses of conjugated estrogens with medroxyprogesterone and other combinations of estrogens and progestins were not studied in the WHI and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.

CONTRAINDICATIONS

Estrogens should not be used in women with any of the following conditions:

  1. Known or suspected cancer of the breast except in appropriately selected patients being treated for metastatic disease.
  2. Known or suspected estrogen-dependent neoplasia.
  3. Known or suspected pregnancy (See BOXED WARNINGS).
  4. Undiagnosed abnormal genital bleeding.
  5. Active thrombophlebitis or thromboembolic disorders.
  6. A past  history  of   thrombophlebitis,  thrombosis,  or  thromboembolic disorders  associated  with  previous  estrogen  use  (except  when  in  treatment of  breast malignancy).

Methyltestosterone should not be used in:

  1. The presence of severe liver damage.
  2. Pregnancy and in breast-feeding mothers because of the possibility of masculinization of the female fetus or breast-fed infant.

Please see Full Prescribing Information, including BOXED WARNING

CovARYX® and CovARYX® H.S. (esterified estrogen and methyltestosterone tablets) are indicated in the treatment of moderate to severe vasomotor symptoms associated with menopause in those patients for whom estrogen-only therapy does not provide sufficient relief. This product has a black box warning because prolonged exposure to exogenous estrogens has been reported to increase the risk of endometrial carcinoma in postmenopausal women. The risk correlates to both duration of treatment and the amount of the estrogen dose. In addition, estrogens should not be used during pregnancy. CovARYX ® and CovARYX ® H.S, tablets contain estrogen but do not contain a progestin.

Estrogens should not be used for the prevention of cardiovascular disease. The Women’s Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, breast cancer, pulmonary emboli and deep vein thrombosis in postmenopausal women. Estrogens should not be used in women with breast cancer, estrogen-dependent neoplasia, abnormal genital bleeding, thrombophlebitis, or thrombosis. Methyltestosterone, a synthetic form of testosterone, should not be used when severe liver damage is present or in pregnant mothers who are or are not breastfeeding.  Please review complete Patient Information.

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