Jinteli

Menopause Symptoms

Jinteli is primarily used to treat moderate to severe symptoms associated with menopause. These symptoms are caused by the body producing less estrogen. The medication helps manage:

• Vasomotor symptoms: This includes common menopausal issues such as hot flashes and night sweats.
• Vaginal changes: It is used to treat moderate to severe vulvar and vaginal atrophy, which can cause symptoms like vaginal dryness, itching, and burning. If this medication is being used only to treat vaginal symptoms, healthcare providers often recommend considering topical vaginal products first.

Osteoporosis Prevention

Jinteli is also indicated for the prevention of postmenopausal osteoporosis. Osteoporosis is a condition that causes bones to become thin, weak, and more likely to break. This treatment is generally used for women who are at a high risk of bone fractures and when other non-estrogen medications are not considered appropriate.

Hormone Replacement

Jinteli contains two types of hormones: an estrogen (ethinyl estradiol) and a progestin (norethindrone acetate). These hormones work together to manage symptoms associated with menopause.

Relieving Menopausal Symptoms

During menopause, a woman's body naturally produces less estrogen. This decline can lead to symptoms such as hot flashes, night sweats, and vaginal dryness. The ethinyl estradiol in Jinteli replaces some of this lost estrogen, which helps reduce the frequency and severity of these symptoms.

Protecting the Uterus

For women who have not had a hysterectomy, taking estrogen alone can cause the lining of the uterus to thicken excessively. This overgrowth can increase the risk of developing uterine cancer. The progestin component, norethindrone acetate, works by counteracting the effects of estrogen on the uterine lining, helping to keep it thin and reducing the risk of cancer.

Common Side Effects

The following side effects are commonly reported with Jinteli use:

• Nausea, vomiting, stomach cramps, or bloating
• Breast tenderness, enlargement, or discharge
• Headache or migraine
• Weight changes
• Vaginal itching or discharge
• Changes in menstrual periods, breakthrough bleeding, or spotting
• Thinning of scalp hair or increased hair growth on the face
• Darkening of facial skin

Serious Side Effects

Seek medical attention immediately if you experience any of the following serious side effects:

• Signs of cardiovascular issues: Sudden numbness or weakness, severe headache, vision or speech problems, chest pain, or shortness of breath.
• Signs of blood clots: Pain, swelling, or warmth in one leg.
• Liver issues: Yellowing of the skin or eyes, dark urine, or upper stomach pain.
• High blood pressure: Severe headache, blurred vision, or buzzing in the ears.
• New physical changes: A lump in the breast, unusual or persistent vaginal bleeding, or significant swelling in the hands, ankles, or feet.
• Mental health changes: New or worsening depression or memory problems.

Get emergency medical help if you notice signs of an allergic reaction, including hives, difficulty breathing, or swelling of the face, lips, tongue, or throat.

Boxed Warnings

Estrogen plus progestin therapy, such as Jinteli, is associated with several serious health risks:

• Cardiovascular Disorders: There is an increased risk of heart attack, stroke, deep vein thrombosis (blood clots in the legs), and pulmonary embolism (blood clots in the lungs).
• Breast Cancer: Clinical studies have shown an increased risk of invasive breast cancer in women using estrogen plus progestin therapy.
• Dementia: For women aged 65 years or older, there may be an increased risk of developing probable dementia.

Contraindications

Jinteli should not be used by individuals with certain medical conditions, including:

• Undiagnosed abnormal genital bleeding.
• Known, suspected, or a history of breast cancer.
• Known or suspected estrogen-dependent cancer.
• Active or past history of blood clots (deep vein thrombosis or pulmonary embolism).
• Active or past history of arterial thromboembolic disease, such as stroke or heart attack.
• Liver disease or impaired liver function.
• Known blood clotting disorders, such as protein C, protein S, or antithrombin deficiency.
• Pregnancy or suspected pregnancy.

Other Precautions

Medical monitoring may be necessary for several other conditions while taking Jinteli:

• Gallbladder Disease: There is an increased risk of developing gallbladder disease requiring surgery.
• Vision Problems: Discontinuation may be necessary if there is a sudden partial or complete loss of vision, or a sudden onset of bulging eyes or double vision.
• Blood Pressure: Blood pressure should be monitored, as new or worsening high blood pressure may occur.
• High Triglycerides: Individuals with very high triglyceride levels may be at risk for pancreatitis.
• Fluid Retention: Estrogens may cause fluid retention, which could worsen conditions like heart failure or kidney disease.
• Other Conditions: Estrogen therapy may worsen symptoms of asthma, diabetes, epilepsy, migraines, or systemic lupus erythematosus.

Pregnancy

Jinteli should not be used by individuals who are pregnant or planning to become pregnant. If pregnancy occurs during treatment, the medication should be stopped immediately. While research into the accidental use of similar hormone combinations during early pregnancy has generally shown little to no increased risk of birth defects, this medication has no known clinical use during pregnancy.

Breastfeeding

The active ingredients in Jinteli can pass into breast milk. Additionally, the use of estrogen and progestin combinations may decrease the quantity and quality of breast milk produced. It is important to discuss the potential risks and benefits with a healthcare provider if you are breastfeeding or planning to breastfeed.

Dosage Forms

Jinteli is available as a tablet taken by mouth. It is a combination medication that contains an estrogen and a progestin.

The tablets are typically supplied in blister cards for daily administration.

FDA Approval and Indications

Jinteli is approved by the U.S. Food and Drug Administration (FDA) for two primary uses in postmenopausal women:

• Treatment of moderate to severe vasomotor symptoms, such as hot flashes and night sweats.
• Prevention of postmenopausal osteoporosis (bone loss).

When used solely for the prevention of osteoporosis, healthcare providers typically consider other non-estrogen medications first.

Boxed Warning

The FDA requires a boxed warning for Jinteli due to serious safety risks associated with estrogen and progestin therapy. These risks include:

• Cardiovascular Disorders: An increased risk of stroke and deep vein thrombosis (blood clots).
• Breast Cancer: An increased risk of invasive breast cancer in women using estrogen plus progestin therapy.
• Dementia: An increased risk of probable dementia in postmenopausal women aged 65 years and older.
• Endometrial Cancer: There is an increased risk of endometrial cancer in women with a uterus who use estrogen-only therapy. Jinteli contains a progestin to help reduce this specific risk.

The FDA recommends that these medications be prescribed at the lowest effective dose and for the shortest duration possible based on individual treatment goals and risks.

Factors Influencing Cost

The price of Jinteli is influenced by several factors, including your specific health insurance plan and the pharmacy's pricing. Since Jinteli is a generic form of the brand-name drug Femhrt, it is generally available at a lower cost than the brand-name version.

Insurance Coverage

Most insurance providers and Medicare Part D plans cover generic hormone replacement therapies like Jinteli. However, the amount you pay out-of-pocket will depend on your plan's copay structure and whether you have met your deductible.

Pharmacy and Savings Options

Prices can differ between retail pharmacies. You may find cost savings by comparing prices at different locations or using mail-order pharmacy services for larger supplies. If you are concerned about the cost, you can ask your pharmacist about available discount programs or patient assistance options.