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BIJUVA- estradiol and progesterone capsule


  1. Patient Information
  2. What Is Bijuva?
  3. What Is Bijuva Used For?
  4. Who Should Not Take Bijuva?
  5. Do Not Take Bijuva If You:
  6. What Are The Possible Side Effects Of Bijuva?
  7. Serious But Less Common Side Effects Include:
  8. Call Your Healthcare Provider Right Away If You Get Any Of The Following Warning Signs Or Any Other Unusual Symptoms That Concern You:
  9. The Most Common Side Effects Of Bijuva Include:
  10. What Can I Do To Lower My Chances Of A Serious Side Effect With Bijuva?
  11. What Are The Ingredients In Bijuva?
  12. Revised: 7/2019document Id:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Abnormal Vaginal Bleeding

Inform postmenopausal women of the importance of reporting abnormal vaginal bleeding to their healthcare provider as soon as possible[

  • Do not use estrogens with or without progestogens to prevent heart disease, heart attacks, strokes, or dementia (decline of brain function).
  • Taking estrogens with progestogens may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots.
  • Taking estrogens with progestogens may increase your chance of getting dementia, based on a study of women 65 years of age or older.
  • Taking estrogen-alone may increase your chance of getting cancer of the uterus.
  • Taking estrogen-alone may increase your chances of getting strokes or blood clots.
  • Taking estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older.
  • You and your healthcare provider should talk regularly about whether you still need treatment with BIJUVA.

What Is Bijuva? 


  • BIJUVA is a prescription medicine that contains two kinds of hormones, an estrogen and progesterone.

What Is Bijuva Used For? 


BIJUVA is used after menopause toreduce moderate to severe hot flashes.
Estrogens are hormones made by a woman's ovaries. The ovaries normally stop making estrogens when a woman is between 45 and 55 years old. This drop in body estrogen levels causes the change of life or menopause (the end of monthly menstrual periods). Sometimes, both ovaries are removed during an operation before natural menopause takes place. The sudden drop in estrogen levels causes surgical menopause.
When estrogen levels begin dropping, some women get very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden strong feelings of heat and sweating ( hot flashes or hot flushes ). In some women the symptoms are mild, and they will not need to take estrogens. In other women, symptoms can be more severe.

Who Should Not Take Bijuva? 


Do not take BIJUVA if you have had your uterus (womb) removed (hysterectomy).
BIJUVA contains progesterone to decrease the chance of getting cancer of the uterus. If you do not have a uterus, you do not need progesterone and you should not take BIJUVA.

Do Not Take Bijuva If You: 


  • have any unusual vaginal bleeding.
    Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause.
  • currently have or have had certain cancers.
    Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast or uterus. If you have or have had cancer, talk with your healthcare provider about whether you should take BIJUVA.
  • currently have or have had blood clots.
  • had a stroke or heart attack.
  • currently have or have had liver problems.
  • have been diagnosed with a bleeding disorder.
  • are allergic to BIJUVA or any of its ingredients.
    • Take BIJUVA exactly as your healthcare provider tells you to take it.
    • Take 1 capsule by mouth each evening with food.
    • If you miss a dose of BIJUVA, take the missed dose as soon as possible with food, unless it is within two hours of the next evening dose of BIJUVA.
    • Estrogens should be used at the lowest dose possible for your treatment and only as long as needed. You and your healthcare provider should talk regularly (for example, every 3 to 6 months) about whether you still need treatment with BIJUVA.

What Are The Possible Side Effects Of Bijuva? 


Side effects are grouped by how serious they are and how often they happen when you are treated.

Serious But Less Common Side Effects Include: 


  • heart attack
  • stroke
  • blood clots
  • breast cancer
  • cancer of the lining of the uterus (womb)
  • cancer of the ovary
  • dementia
  • gallbladder disease
  • high or low blood calcium levels
  • changes in vision
  • high blood pressure
  • high levels of fat in your blood (triglycerides)
  • liver problems
  • changes in thyroid hormone levels
  • swelling or fluid retention
  • enlargement of benign tumors of the uterus ( fibroids )
  • worsening swelling of face or tongue (angioedema) in women who have a history of angioedema
  • changes in laboratory test results such as bleeding time and high blood sugar levels

Call Your Healthcare Provider Right Away If You Get Any Of The Following Warning Signs Or Any Other Unusual Symptoms That Concern You: 


  • new breast lumps
  • unusual vaginal bleeding
  • changes in vision or speech
  • sudden new severe headaches
  • severe pains in your chest or legs with or without shortness of breath, weakness and fatigue
  • vomiting

The Most Common Side Effects Of Bijuva Include: 


  • breast tenderness
  • headache
  • vaginal bleeding
  • vaginal discharge
  • pelvic pain
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all of the possible side effects of BIJUVA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to TherapeuticsMDat 1-888-228-0150.

What Can I Do To Lower My Chances Of A Serious Side Effect With Bijuva? 


  • Talk with your healthcare provider regularly about whether you should continue taking BIJUVA.
  • If you have a uterus, talk with your healthcare provider about whether the addition of a progestogen is right for you.
  • The addition of a progestogen is generally recommended for a woman with a uterus to reduce the chance of getting cancer of the uterus (womb).

    • Store at room temperature between 68 F to 77 F (20 C to 25 C).
    • Keep BIJUVA and all medicines out of the reach of children.
    General information about the safe and effective use of BIJUVA.
    Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use BIJUVA for a condition for which it was not prescribed. Do not give BIJUVA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about BIJUVA that is written for health professionals.

What Are The Ingredients In Bijuva? 


Active ingredients: estradiol and progesterone.
Inactive ingredients: ammonium hydroxide, ethanol, ethyl acetate, FD&C Red #40, gelatin, glycerin, hydrolyzed gelatin, isopropyl alcohol, lauroyl polyoxyl-32 glycerides, lecithin, medium chain mono and di-glycerides, medium chain triglycerides, polyethylene glycol, polyvinyl acetate phthalate, propylene glycol, purified water, and titanium dioxide.
BIJUVA is supplied in blister cartons of 30 capsules.

For information, go to www.TherapeuticsMD.com or call TherapeuticsMD, Inc. at 1-877-833-0176.

Manufactured with SYMBODA technology for: TherapeuticsMD, Inc., Boca Raton, FL 33487
Manufactured by: Catalent Pharma Solutions, LLC, St Petersburg, FL 33716

For patent information: www.TherapeuticsMD.com/patents
BIJUVA is a trademark of TherapeuticsMD, Inc.
TherapeuticsMD, Inc. All rights reserved.
BJVA-LAB-20003.3
Revised 03/2019

Principal Display Panel - Bijuva Carton Label

NDC 50261-211-30

Rx Only

Bijuva

(estradiol and progesterone) capsules

1 mg/100 mg per capsule

TherapeuticsMD

30 capsules

Principal Display Panel - Bijuva Carton Label
BIJUVA
estradiol and progesterone capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50261-211
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
estradiol(UNII: 4TI98Z838E) (estradiol - UNII:4TI98Z838E)estradiol1 mg
progesterone(UNII: 4G7DS2Q64Y) (progesterone - UNII:4G7DS2Q64Y)progesterone100 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERYL CAPRYLOCAPRATE(UNII: U72Q2I8C85)
LAUROYL PEG-32 GLYCERIDES(UNII: H5ZC52369M)
GELATIN TYPE B BOVINE (200 BLOOM)(UNII: A7JR5F8DLH)
GLYCERIN(UNII: PDC6A3C0OX)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
WATER(UNII: 059QF0KO0R)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FD&C RED NO. 40(UNII: WZB9127XOA)
ALCOHOL(UNII: 3K9958V90M)
ETHYL ACETATE(UNII: 76845O8NMZ)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POLYVINYL ACETATE PHTHALATE(UNII: 58QVG85GW3)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
AMMONIA(UNII: 5138Q19F1X)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
Product Characteristics
ColorPINK (light pink) , PINK (dark pink)Scoreno score
ShapeOVAL (OVAL)Size15mm
FlavorImprint Code1C1
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50261-211-301 in 1 CARTON02/13/2019
130 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:50261-211-051 in 1 CARTON02/13/2019
25 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA21013201/15/2019
Labeler -TherapeuticsMD, Inc. (072998685)

Revised: 7/2019document Id: 

b9a33432-ec4a-4f92-8fc6-37738703dfe1Set id: bc52489a-5149-411d-9665-2c75405ad15dVersion: 5Effective Time: 20190718TherapeuticsMD, Inc.



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