Genox tablets

Genox

  • Active Ingredient: Tamoxifen
  • 20 mg
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What is Genox?

The active ingredient of Genox brand is tamoxifen. Tamoxifen blocks the actions of estrogen, a female hormone. Certain types of breast cancer require estrogen to grow.

Used for

Genox is used to treat diseases such as: Breast Cancer, Breast Cancer, Adjuvant, Breast Cancer, Male, Breast Cancer, Metastatic, Breast Cancer, Palliative, Breast Cancer, Prevention, McCune-Albright Syndrome, Precocious Puberty.

Side Effect

Possible side effects of Genox include: dizziness; stomach or pelvic discomfort, aching, or heaviness; bluish color changes in skin color; blood in the urine or stools; fast heartbeat; constipation; pain or swelling in the legs.

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Before taking Genox,

  • tell your doctor and pharmacist if you are allergic to Genox or any other medications.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: aminoglutethimide (Cytadren); anastrozole (Arimidex), bromocriptine (Parlodel); cancer chemotherapy medication such as cyclophosphamide (Cytoxan, Neosar) letrozole (Femara); medroxyprogesterone (Depo-Provera, Provera, in Prempro); phenobarbital; and rifampin (Rifadin, Rimactane). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • in addition to the conditions listed in the IMPORTANT WARNING section, tell your doctor if you have or have ever had high blood levels of cholesterol.
  • tell your doctor if you are pregnant or plan to become pregnant. You should not plan to become pregnant while taking Genox or for 2 months after your treatment. Your doctor may perform a pregnancy test or tell you to begin your treatment during your menstrual period to be sure that you are not pregnant when you begin taking Genox. You will need to use a reliable nonhormonal method of birth control to prevent pregnancy while you are taking Genox and for 2 months after your treatment. Talk to your doctor about the types of birth control that are right for you, and continue to use birth control even if you do not have regular menstrual periods during your treatment. Stop taking Genox and call your doctor right away if you think you have become pregnant during your treatment. Genox may harm the fetus.
  • tell your doctor if you are breast-feeding. You should not breastfeed during your treatment with Genox.
  • tell all of your doctors and other health care providers that you are taking Genox.
  • you will still need to look for early signs of breast cancer since it is possible to develop breast cancer even during treatment with Genox. Talk to your doctor about how often you should examine your breasts yourself, have a doctor examine your breasts, and have mammograms (x-ray examinations of the breasts). Call your doctor right away if you find a new lump in your breast.

How should I take Genox?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Genox can be taken with or without food.

While using Genox, you may need frequent blood tests.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are taking Genox.

Have regular physical exams and mammograms, and self-examine your breasts for lumps on a monthly basis while using this medicine.

Use Genox regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely. You may need to keep using this medication for up to 5 years.

Store at room temperature away from moisture, heat, or cold. Do not freeze.

When is Genox prescribed?

Genox should be prescribed only for women at high risk for breast cancer and after a complete medical evaluation of a woman's individual risk factors. These risk factors include the woman's age, personal health history and family history of breast cancer.

However, Genox may not be suitable for all women at high risk of developing the disease. Women who should definitely not use Genox include pregnant women, women planning to become pregnant, women with a history of blood clots or stroke or those who are taking anticoagulants. An informed discussion between a woman and her physician is essential in determining the appropriateness of this treatment option.

Genox Interactions

Many drugs can interact with Genox. Tell your doctor if you are using any of these medications:

  • Bromocriptine (Parlodel)
  • Cimetidine (Tagamet)
  • Clozaril (Clozapine)
  • Cyclophosphamide (Cytoxan)
  • Isoniazid (Nydrazid) for treating tuberculosis
  • Letrozole (Femara)
  • Methimazole (Tapazole)
  • Nicardipine (Cardene)
  • Pioglitazone (Actos)
  • Rifampin (Rifadin)
  • Ropinirole (Requip)
  • Ticlopidine (Ticlid)
  • Tranylcypromine (Parnate)
  • Anti-malaria medication such as chloroquine (Aralen), pyrimethamine (Daraprm), or quinine (Qualaquine)
  • An antifungals such as terbinafine (Lamisil)
  • An antidepressant such as bupropion (Wellbutrin), clomipramine (Anafranil), desipramine (Treyzafagit, Norpramin and Pertofrane), duloxetine (Cymbalta), fluoxetine (Prozac, Sarafem), imipramine (Tofranil), paroxetine (Paxil, Paxil CR, Pexeva), sertraline (Zoloft), or tranylcypromine (Parnate)
  • A heart rhythm medication such as amiodarone (Cordarone) or quinidine (Quinidine)
  • HIV or AIDS medicine such as delavirdine (Rescriptor) or ritonavir (Norvir)
  • Medicine to treat psychiatric disorders (aripiprazole (Abilify), chlorpromazine (Thorazine), fluphenazine (Prolixin), haloperidol (Haldol), perphenazine (Trilafon), or thioridazine (Mellaril)

This list is not complete and other drugs may interact with Genox (Nolvadex). Tell your doctor about all medications you use. This includes prescription and over-the-counter (OTC) drugs, vitamin and herbal products, and recreational drugs. Do not start a new medication without telling your doctor.

Q: I have to make a decision on taking Genox and I am concerned about the side effects of blood clots, vision and other cancers. I am not sure the risks are worth the risks of changing the quality of my life if I suffer with side effects. My system is very sensitive to drugs in general.

A: The results of therapy with any drug can be both positive and negative and it is always important to weight the potential benefits against the potential risks of treatment. Depending on your diagnosis, and reason for taking Genox, the benefits may be well proven. You should discuss these with your healthcare provider to have a full understanding of them and then evaluate them against the risks. According to the package insert, Genox is generally well tolerated, with the most common side effects being hot flashes, vaginal dryness and a mild vaginal discharge. The risk of more serious side effects has been evaluated in scientific studies. Over a period of nearly 7 years, the risk of uterine cancer in people taking Genox is approximately 2 per 1,000 women-years. The risk of blood clots, including stroke and pulmonary embolism, is about 1-1.5 per 1,000 women-years. For more information, please contact your healthcare provider. Michelle McDermott, PharmD

Continued

The new study included 500 women. They all had either stage 0 breast cancer (called DCIS) or high-risk lesions in their breast tissue that could develop into breast cancer.

Half of the women took 5 milligrams of Genox daily for three years. The other half took a placebo. The average follow-up time was five years.

By that time, 5.5 percent of the women taking Genox and about 11 percent of the women taking a placebo had a breast cancer recurrence or a new cancer.

Taking low-dose Genox lowered the risk of recurrent or new breast cancer by 52 percent, the researchers reported. And the rates of side effects were similar between the two groups.

About 35 percent of women in the Genox group (and 39 percent in the placebo group) stopped treatment before the study was done. De Censi said if they had continued, it's possible that the low dose of Genox would have proven even more effective.

Dr. Douglas Marks is a clinical instructor in the oncology/hematology department at NYU Winthrop Hospital in Mineola, N.Y. He said the findings were impressive, and low-dose Genox is a "very worthy idea to be explored."

But, Marks added, the study doesn't have data for a long enough time period. He said he'd like to see 15 years of follow-up. And the study really needs to compare the 5 mg dose to the standard 20 mg dose to see if it's just as effective.

"Different strategies should be evaluated in hormonal therapy," Marks said.

However, women need to know that the current prevention strategies are very effective, he said. If you're taking one of these therapies, talk with your doctor if you're having trouble with side effects, he added.

"Before you stop taking a medication, let your doctor know about your side effects. There are a lot of strategies to deal with side effects. Even if you're between appointments, call your doctor to talk about it," Marks advised.

The study is to be presented on Thursday at the San Antonio Breast Cancer Symposium. Findings presented at meetings are typically viewed as preliminary until published in a peer-reviewed journal.

Summary

Genox (Soltamox) is an anti-estrogen medication prescribed for the prevention and treatment of breast cancer in men and breast cancer in women. Genox also is prescribed to stimulate ovulation. Side effects include headache, vomiting, nausea, cough, fatigue, fluid retention, and bone pain.

Chemical name: Genox

Pill brand names: Nolvadex, Apo-Tamox, Tamofen, Tamone

Liquid brand name: Soltamox

Class: SERM (selective estrogen receptor modulator) hormonal therapy. Evista and Fareston are other SERMs.

How it works: SERMs block the effects of estrogen in the breast tissue by attaching to the estrogen receptors in breast cells.

Uses: Genox, used to treat men and both premenopausal and postmenopausal women, typically is used to:

  • reduce the risk of early-stage, hormone-receptor-positive breast cancer coming back after surgery and other treatments
  • shrink large, hormone-receptor-positive breast cancers before surgery
  • treat advanced-stage, hormone-receptor-positive breast cancer, including metastatic breast cancer
  • reduce breast cancer risk in undiagnosed women at higher-than-average risk of developing breast cancer

Genox usually is taken for 5 to 10 years, depending on a woman’s menopausal status. The American Society of Clinical Oncology recommends that:

  • newly diagnosed premenopausal and perimenopausal women take 5 years of Genox as their first hormonal therapy; after this first 5 years is done, the hormonal therapy taken for the second 5 years (for a total of 10 years of hormonal therapy) would be determined by the woman’s menopausal status:
    • postmenopausal women could take another 5 years of Genox or switch to an aromatase inhibitor for 5 years
    • pre- and perimenopausal women would take another 5 years of Genox
  • take Genox for 10 years
  • take an aromatase inhibitor for 5 years; right now there isn’t enough evidence to recommend taking an aromatase inhibitor for 10 years
  • take Genox for 5 years, then switch to an aromatase inhibitor for another 5 years (for a total of 10 years of hormonal therapy)
  • take Genox for 2 to 3 years, then switch to an aromatase inhibitor for another 5 years (for a total of 7 to 8 years of hormonal therapy)
  • postmenopausal women who started taking an aromatase inhibitor but didn’t finish 5 years of treatment can switch to Genox to complete 5 years of hormonal therapy
  • postmenopausal women who started taking Genox but didn’t finish 5 years of treatment can switch to an aromatase inhibitor and take it for 5 years (for a total of 7 to 8 years of hormonal therapy)
  • How it's given: Genox is taken orally as a pill or as a liquid.

    Additional information: About 10% of people have an abnormal CYP2D6 gene that makes a version of the CYP2D6 enzyme that doesn’t function as well as it should. Having a low-functioning CYP2D6 enzyme might keep a person from getting the full benefit of Genox. In 2018, the Clinical Pharmacogenetics Implementation Consortium, an international group of scientists that issues guidelines on the effects of genetic factors on reactions to drugs, issued a guideline on using CYP2D6 genotype information to make decisions about prescribing Genox after surgery to treat hormone-receptor-positive breast cancer. The guideline strongly recommends that people with an abnormal CYP2D6 genotype that makes them less able to metabolize Genox be treated with a different type of hormonal therapy, such as an aromatase inhibitor. You may want to ask your doctor about being tested for this genetic abnormality if you are considering taking Genox.

    Also, certain medications can block the activity of the CYP2D6 enzyme, including antidepressants known as SSRIs and SNRIs, as well as Benadryl (chemical name: diphenhydramine) and Tagamet (chemical name: cimetidine). Make sure you tell your doctor about ALL other medicines you're taking if you're considering taking Genox to make sure you get the full benefit of treatment.

    Q: I am a breast cancer survivor taking Genox 20 mg daily. There isn't any warning on the label, but I heard that I should avoid products containing soy. Does this mean anything containing soy or just things like soybeans and soymilk?

    A: According to the American Cancer Society, the possible problem with soy products is the phytoestrogens that are contained in soy products, such as genistein. The fear is that these phytoestrogens could act as estrogen in the body. Phytoestrogens could possibly make Genox less effective which could theoretically result in the growth of breast cancer cells. Researchers have stated that better studies need to be performed to fully understand the extent of this possible interaction and to determine what doses of genistein will affect Genox. However, researchers recommend that women who are taking Genox should exercise caution with genistein. As always, talk with your health care provider regarding the questions and concerns you have about soy and your medical history and medications. Jen Marsico RPh www.cancer.org/June 6, 2010. //www.everydayhealth.com/drugs/Genox

    Introduction

    Genox is a nonsteroidal antiestrogen that is widely used in the treatment and prevention of breast cancer. Long term Genox therapy has been associated with development of fatty liver, steatohepatitis, cirrhosis, and rare instances of clinically apparent acute liver injury.

    Are there any other concerns I should be aware of while taking Genox?

    According to data from large treatment studies as well as the BCPT, women taking Genox may have a slightly increased risk of developing blood clots in the lungs or large veins. This may be especially true for women undergoing chemotherapy (anti-cancer drugs) while taking Genox. Women in the BCPT also had an increased risk of stroke. Additional risks may include:

    Endometrial cancer: Genox may increase a woman's risk of developing endometrial cancer (cancer of the lining of the uterus). However, this risk is less or the same as the risk of postmenopausal women taking single-agent estrogen replacement therapy.

    Cataracts: Taking Genox appears to put some women at increased risk for developing cataracts, a clouding of the lens inside the eye. A few patients have also reported eye problems such as corneal scarring or retinal changes.

    What Is Genox (Soltamox)?

    Genox is the generic form of the brand-name drug Soltamox, which is used to treat some types of breast cancer in men and women.

    Genox is prescribed to treat metastatic breast cancer, or cancer that has spread to other parts of the body. Genox is also used to lower the chance of breast cancer in high-risk women (for example, those with a family history of breast cancer).

    The drug may also be prescribed for off-label uses, such as treating certain brain cancers and McCune-Albright syndrome, a genetic disorder that can cause early puberty in girls.

    Genox belongs to a class of drugs called nonsteroidal antiestrogens, which block the actions of the hormone estrogen.

    In 2006, an FDA advisory panel recommended that a more specific warning label about its side effects be added to Genox..

    Cancer-fighting drugs

    Taking Genox with certain cancer drugs decreases the amount of the cancer drugs in your body. This means they won’t work as well. Taking Genox with these drugs also increases your risk of blood clots. You should not use Genox with these drugs.

    Examples of these cancer drugs include:

    Taking Genox with other cancer-fighting drugs increases your risk of blood clots. Examples of these drugs include:

    • doxorubicin
    • daunorubicin
    • vincristine
    • vinblastine
    • cyclophosphamide
    • cisplatin

    Warnings for other groups

    For pregnant women: Genox is a category D pregnancy drug. That means two things:

    1. Research in humans has shown adverse effects to the fetus when the mother takes the drug.
    2. This drug should only be used during pregnancy in serious cases where it's needed to treat a dangerous condition in the mother.

    Talk to your doctor if you’re pregnant or planning to become pregnant. Ask your doctor to tell you about the specific harm that may be done to the pregnancy. This drug should only be used if the potential risk to the pregnancy is acceptable given the drug’s potential benefit.

    For women who are breastfeeding: It isn’t known if Genox passes into breast milk. If it does, it may cause side effects in a child who is breastfed. Talk to your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this medication.

    For seniors: Older adults may process drugs more slowly. This can cause the drug to build up in your body, which may increase your risk of side effects.

    For children: This drug shouldn’t be used in people under the age of 18 years.

    Why is Genox (Soltamox) prescribed to patients?

    • Genox is used for the treatment of invasive breast cancer in men and women, the most common type of breast cancer, following surgery and/or radiation and for preventing invasive breast cancer in women at high risk for developing it.
    • Genox also is used for the treatment of women following surgery and radiation for a less common type of breast cancer called ductal carcinoma in situ (DCIS or intraductal carcinoma). Women who have had DCIS are at high risk for developing invasive breast cancer at a later date, and Genox prevents development of the invasive cancer in almost half of the women during the first five years of treatment.
    • Occasionally, Genox is used to stimulate ovulation.

    Q: Are there any side efects of taking Genox over a five year period?

    A: Genox is a medication that is used to treat or prevent breast cancer. Genox is in the group of medications called selective estrogen receptor modulator or SERMs. Genox interferes with the activity of estrogen, that may promote the growth of breast cancer. Some breast cancers are classified as estrogen receptor positive which means they have a protein that estrogen binds to. These breast cancers depend on estrogen to grow and Genox works against the effects of estrogen on these cells. The prescribing information on Genox lists the following as the most common side effects of the medication: hot flashes, headaches, fatigue, nausea/vomiting, vaginal dryness, and skin rash. The side effects are similar to those experienced during menopause. The prescribing information on Genox states that depending on your type of breast cancer the treatment length will vary. Patients with metastatic breast cancer may take Genox for long periods of time depending on the cancer's response to the medication. When used in patients with early stage breast cancer, Genox is generally prescribed for 5 years. Genox has been linked to endometrial cancer is some women, and the length of time taking the medication increases the risk. Patients who do not have a uterus are not at risk. This is one of the main reasons that Genox is not taken for longer than 5 years. Cataracts are a common eye issue as we age, but it is found that Genox can increase the risk of developing this condition. If you are taking chemotherapy medications while taking Genox, there is a small increase in the risk for developing blood clots. The total number of women who experienced this side effect was very small. The risk is similar to taking estrogen hormone replacement therapy. Lori Poulin, PharmD

    Q: I've experienced a racing heart and irregular heartbeat. Can Genox cause these symptoms?

    A: According to the package insert, common side effects of Genox include bone pain, constipation, coughing, hot flashes, muscle pain, nausea, tiredness, vaginal discharge, and weight loss. A review of medical literature did not show reports of rapid heart rate (or tachycardia) or irregular heartbeat in patients taking Genox. You are encouraged to report any negative side effects of prescription drugs to your health care practitioner and the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088. For more information, please consult with your health care provider and visit //www.everydayhealth.com/drugs/Genox. Michelle McDermott, PharmD

    TAMOXIFEN

    ive been on Genox for a couple of months. The first batch of pills had very little in the way of side effects, the second batch was a different brand and I got calf pain, so severe I couldn’t walk so was sent to hospital for possible DVT check, all tests came back clear and was told by consultant my chances of DVT from Genox are remote as i’ve never suffered from blood clots in the past and neither has any of my family. I did look on other cancer forums to find a number of women complaining of leg pain as a result of taking Genox,


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