What brand names are available for Nolvadex-D (Soltamox)?
Soltamox is currently the only brand available for Nolvadex-D. Nolvadex brand has been discontinued.
Q: When my doctor put me on Nolvadex-D a year and a half ago, he told me not to eat soy products. I have ulcerative colitis and had been taking an over the counter pill (Digestive Advantage for Colon Health) that worked well. A few months ago I noticed in the ingredient list that selenium (soy) was listed. I quit taking it but now my symptons have come back. (cramps, bloating, gas)Will this intefere with the effectiveness of the Nolvadex-D if I go back on this pill? Is there an over the counter product that does not contain soy? I was on Pentasa for several years (16 a day) but found this product worked just as well. I don't want to go back on Pentasa if there is something else that will help.
A: Soy has potential estrogen-like properties, so people receiving drugs like Nolvadex-D, which block the effects of estrogen, are often told to avoid soy products. The list of ingredients for Digestive Advantage for Colon Health shows that the product includes the following: Di Calcium Phosphate, GanedenBC30 (Bacillus coagulans GBI-30, 6086), Saccharomyces Boulardii, Sodium Starch Glycolate, Silicone Dioxide, Magnesium Stearate, Vitamins A, B, C, D, E, Folic Acid (Folate), Selenium (Soy), Lysine, FD&C Red 40, FD&C Blue 1.
How to use Nolvadex-D CITRATE
Read the Medication Guide provided by your pharmacist before you start using Nolvadex-D and each time you get a refill. If you have any questions, consult your doctor or pharmacist.
Take this medication by mouth with or without food, usually once or twice daily for 5 years, or as directed by your doctor. Daily dosages greater than 20 milligrams are usually divided in half and taken twice a day, in the morning and evening, or as directed by your doctor. If you are using the liquid, measure the dose carefully using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.
Dosage is based on your medical condition and response to treatment. The duration of treatment to prevent cancer from returning may be between 5 to 10 years, depending on your medical condition and response to treatment.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.
If you have breast cancer that has spread to other parts of the body, you may experience increased bone/cancer pain and/or disease flare-up as you start taking Nolvadex-D. In some cases, this may be a sign of a good response to the medication. Symptoms include increased bone pain, increased tumor size, or even new tumors. These symptoms usually disappear quickly. In any case, report these symptoms right away to your doctor.
Since this drug can be absorbed through the skin and lungs, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets. (See also Precautions section.)
Inform your doctor right away if your condition worsens (e.g., you get new breast lumps).
Chemical name: Nolvadex-D
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: Nolvadex-D, 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
Nolvadex-D 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 Nolvadex-D 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 Nolvadex-D or switch to an aromatase inhibitor for 5 years
- pre- and perimenopausal women would take another 5 years of Nolvadex-D
- take Nolvadex-D 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 Nolvadex-D for 5 years, then switch to an aromatase inhibitor for another 5 years (for a total of 10 years of hormonal therapy)
- take Nolvadex-D 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)
How it's given: Nolvadex-D 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 Nolvadex-D. 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 Nolvadex-D 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 Nolvadex-D 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 Nolvadex-D.
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 Nolvadex-D to make sure you get the full benefit of treatment.
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 Nolvadex-D 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 Nolvadex-D and about 11 percent of the women taking a placebo had a breast cancer recurrence or a new cancer.
Taking low-dose Nolvadex-D 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 Nolvadex-D 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 Nolvadex-D 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 Nolvadex-D 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.
Q: Does Nolvadex-D cause fluid retention?
A: According to drug information, peripheral edema (swelling in the lower limbs), as a side effect, has been reported in 11% of patients taking Nolvadex-D during clinical trials. Fluid retention was also reported at 32% and weight gain has been reported at 9%. As always, talk with your healthcare provider regarding possible side effects of your medication. Jen Marsico, RPh
Nolvadex-D side effects
Get emergency medical help if you have signs of an allergic reaction to Nolvadex-D: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Nolvadex-D can increase your risk of stroke or blood clots. Call your doctor at once if you have:
signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
signs of a blood clot in the lung - chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
signs of a blood clot in your leg - pain, swelling, warmth, or redness in one or both legs.
Also call your doctor at once if you have:
blurred vision, tunnel vision, eye pain, or seeing halos around lights;
unusual vaginal bleeding or discharge;
changes in your menstrual periods;
pain or pressure in your pelvic area;
a new breast lump;
liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
high levels of calcium in your blood - vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, confusion, lack of energy, or tired feeling.
Common Nolvadex-D side effects may include:
vaginal discharge; or
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Reasons some people may not get the full benefit of Nolvadex-D
The body uses an enzyme called CYP2D6 to convert Nolvadex-D into its active form. Two things can interfere with the body’s ability to make this happen: a flaw in the CYP2D6 enzyme and certain medications that block the effectiveness of this enzyme.
- Abnormal CYP2D6 enzyme: About 10% of people have a CYP2D6 enzyme that doesn’t function as well as it should. Having an abnormal CYP2D6 enzyme might keep a person from getting the full benefit of Nolvadex-D. You may want to ask your doctor about being tested for this enzyme abnormality if you are considering taking Nolvadex-D. Still, CYP2D6 testing is controversial because several large studies found that an abnormal CYP2D6 enzyme didn’t affect Nolvadex-D’s effectiveness. Together, you and your doctor can decide if CYP2D6 testing makes sense for your unique situation.
- Medications that can interfere with CYP2D6: There are medications that can block the activity of CYP2D6 to varying degrees (usually stated as “strong” or “moderate” inhibitors of CYP2D6). These medications include some of the antidepressants known as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). There are also other types of commonly prescribed medications, such as Cardioquin (chemical name: quinidine), Benadryl (chemical name: diphenhydramine), and Tagamet (chemical name: cimetidine), that can block CYP2D6. Blocking the activity of CYP2D6 can interfere with the activation of Nolvadex-D — reducing its effectiveness as an anti-cancer treatment. Most doctors recommend that you avoid taking strong and moderate inhibitors of CYP2D6 while you’re on Nolvadex-D.
If you have already finished Nolvadex-D and you were taking other medications at the same time, make an appointment to talk with your doctor about whether any of your other medications may have interfered with CYP2D6 and the potential benefit you received from Nolvadex-D. Your doctor may recommend no additional therapy or extended hormonal therapy (with Nolvadex-D or an aromatase inhibitor) depending on your risk of recurrence, your overall medical condition, and your preferences.
If you were taking Nolvadex-D because you are at high risk but have never been diagnosed, and you were also taking a CYP2D6 inhibitor, your doctor may now recommend additional anti-estrogen therapy with Nolvadex-D or raloxifene (brand name: Evista), depending on your menopausal status. Talk to your doctor about what’s best for your situation.
If you had progression of breast cancer while on both Nolvadex-D and a strong or moderate CYP2D6 inhibitor, you can’t assume that Nolvadex-D failed to work. Rather, it’s possible that Nolvadex-D never had a fair chance at getting the cancer under control because its action was blocked by the other medicine. Moving forward, Nolvadex-D, without a CYP2D6 inhibitor, may still provide significant benefit.
Q: Are there any side efects of taking Nolvadex-D over a five year period?
A: Nolvadex-D is a medication that is used to treat or prevent breast cancer. Nolvadex-D is in the group of medications called selective estrogen receptor modulator or SERMs. Nolvadex-D 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 Nolvadex-D works against the effects of estrogen on these cells. The prescribing information on Nolvadex-D 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 Nolvadex-D states that depending on your type of breast cancer the treatment length will vary. Patients with metastatic breast cancer may take Nolvadex-D for long periods of time depending on the cancer's response to the medication. When used in patients with early stage breast cancer, Nolvadex-D is generally prescribed for 5 years. Nolvadex-D 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 Nolvadex-D is not taken for longer than 5 years. Cataracts are a common eye issue as we age, but it is found that Nolvadex-D can increase the risk of developing this condition. If you are taking chemotherapy medications while taking Nolvadex-D, 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
Before taking Nolvadex-D, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before having surgery (especially breast reconstruction), tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using Nolvadex-D. Nolvadex-D may harm an unborn baby. Women using this medication should ask about reliable non-hormonal forms of birth control (such as condoms, diaphragms with spermicide) during treatment and for 2 months after stopping treatment. Men using this medication should ask about reliable forms of birth control during treatment and for 6 months after stopping treatment. If you or your partner become pregnant, talk to your doctor right away about the risks and benefits of this medication.
It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for 3 months after stopping treatment. Consult your doctor before breast-feeding.
What Is Nolvadex-D (Soltamox)?
Nolvadex-D is the generic form of the brand-name drug Soltamox, which is used to treat some types of breast cancer in men and women.
Nolvadex-D is prescribed to treat metastatic breast cancer, or cancer that has spread to other parts of the body. Nolvadex-D 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.
Nolvadex-D 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 Nolvadex-D..