In 2012, following a family vacation, Julie Megee, a 42-year-old married mother of two and busy owner of a hair salon in Norton, Massachusetts, found a small lump while performing routine breast self-examination. Julie quickly made an appointment to see her physician and following a mammogram and biopsy she was diagnosed with breast cancer. These were the longest 2 weeks in Julie’s life.
Following consultation with an oncologist, a lumpectomy was performed, followed by radiation treatment. Julie was then prescribed tamoxifen tablets and was told she would need to take the medication every day for 5 years to reduce the risk of her breast cancer reoccurring.
Julie had always disliked taking pills. Since tamoxifen tablets must not be broken, crushed, or chewed, Julie spoke with her physician about the option of taking her medication as a liquid. Julie’s physician gave her a prescription for Soltamox (tamoxifen citrate) oral solution which she takes on a daily basis.
If you are currently taking, or have recently been prescribed, tamoxifen tablets, DARA BioSciences Inc., is pleased to inform you tamoxifen is available as an oral solution. Soltamox may be suitable for patients who find it easier to take liquid medications and those who have difficulty swallowing. Soltamox® (tamoxifen citrate) oral solution has the same exact medical indications, safety profile and side-effects as tamoxifen tablets.
Soltamox® (soul-ta-mox) (tamoxifen citrate)
Oral liquid solution
Read this guide carefully before you start Soltamox® (tamoxifen citrate) oral solution. It is important to read the information you get each time you get more medicine. There may be something new. This guide does not tell you everything about Soltamox® and does not take the place of talking with your doctor. Only you and your doctor can determine if Soltamox® is right for you.
What is the most important information I should know about using Soltamox®?
In the studies described in the “What are the benefits of Soltamox®?” section, high-risk women who took tamoxifen citrate tablets experienced certain side effects at a higher rate than those who took a placebo (a substance with no drug-like effects). Some of these side effects can cause death.
- Risk of Uterine Cancer. In one study, in women who still had their uterus:
- Each year, out of every 1,000 women who took a placebo, 1 got endometrial cancer (cancer originating in the lining of the uterus) and none got uterine sarcoma (cancer originating in the body of the uterus).
- Each year, out of every 1,000 women who took tamoxifen, 2 got endometrial cancer and fewer than 1 got uterine sarcoma.
These results show that, on average, in high-risk women who still had their uterus, tamoxifen doubled their chances of getting endometrial cancer from 1 in 1,000 to 2 in 1,000 and it increased to a slightly lesser extent the chance of getting uterine sarcoma. This does not mean that taking tamoxifen will double your personal chance of getting endometrial cancer or increase your chance of getting uterine sarcoma. We do not know what this risk will be for any one woman. The risk does not relate to women who no longer have their uterus.
- Risk of Blood Clots: For all women in this study, taking tamoxifen citrate tablets increased the risk of having a blood clot in their lungs or veins, or of having a stroke. In some cases, women died from these complications.
- Risk of Cataracts: Tamoxifen increased the risk of getting cataracts (clouding of the lens of the eye) or needing cataract surgery
- Other Risks: See the Warnings and Precautions sections for more details about possible side effects of Soltamox®
Soltamox® (tamoxifen citrate) oral solution is a prescription medicine that is like estrogen (female hormone) in some ways and different in other ways. In the breast, tamoxifen can block estrogen’s effects. Because it does this, tamoxifen may block the growth of breast cancers that need estrogen to grow (cancers that are estrogen- or progesterone-receptor positive).
Tamoxifen can lower the chance of getting breast cancer in women with a higher than normal chance of getting breast cancer in the next five years (high-risk women) and women with DCIS. Because high-risk women don’t have cancer yet, it is important to talk to your doctor about whether the possible benefit of tamoxifen in lowering the chance of getting breast cancer is greater than its possible risks.
Call your doctor right away if you have any signs of side effects listed below:
- Vaginal bleeding or bloody discharge that could be a rusty or brown color. You should call your doctor even if only a small amount of bleeding occurs
- Change in your monthly bleeding, such as in the amount or timing of bleeding or increased clotting
- Pain or pressure in your pelvis (below your belly button).
- These problems may relate to changes in the lining (endometrium) or body of your uterus. These changes may mean serious problems are starting, including cancer of the uterus.
- Blood clots in your veins or lungs. These can cause serious problems, including death. You may get clots up to 2 to 3 months after you stop taking tamoxifen. The signs of blood clots are:
- pain, tenderness, or swelling in one or both of your legs
- sudden chest pain, shortness of breath, coughing up blood
- Stroke. Stroke can cause serious medical problems, including death. The signs of stroke are:
- sudden weakness, tingling, or numbness in your face, arm or leg, especially on one side of your body
- sudden confusion, trouble speaking or understanding
- sudden trouble walking, dizziness, loss of balance or coordination
- sudden severe headache with no known cause
- Cataracts or increased chance of needing cataract surgery. The sign of this problem is slow blurring of your vision or progressive trouble seeing in one or both eyes.
- Liver problems, including jaundice. The signs of liver problems include lack of appetite and yellowing of your skin or whites of your eyes. These signs should be evaluated by your doctor, as three cases of liver cancer were reported in the tamoxifen group vs. 1 case in the observation group in a trial using adjuvant tamoxifen. One case of liver cancer was reported in another trial in a participant receiving tamoxifen. No other cases of liver cancer have been reported to date in other clinical trials evaluating tamoxifen.
- Contact your doctor if you develop signs and symptoms that may indicate hypercalcemia (elevated blood calcium)-such as being extremely thirsty, urinating frequently and having abdominal pain. Hypercalcemia has been reported in some breast cancer patients with bone metastases within a few weeks of starting treatment with tamoxifen. If hypercalcemia does occur, appropriate measures should be taken and, if severe, tamoxifen should be discontinued.
These are not all the possible side effects of tamoxifen. For a complete list, ask your doctor or pharmacist.
What is Soltamox®?
Soltamox® (tamoxifen citrate) oral solution is a medicine used to treat several medical conditions:
- To lower the chances of getting breast cancer in women with a higher than normal level of risk for developing breast cancer in the next 5 years (high-risk women)
- To lower the chances of getting invasive (spreading) breast cancer in women who have had surgery and radiation for ductal carcinoma in situ (DCIS). DCIS means the cancer is only inside the milk ducts.
- To treat breast cancer following earlier treatment. Earlier treatment can include surgery, radiation, and chemotherapy. Tamoxifen may keep the cancer from spreading to other parts of the body. It may also reduce chances of getting a new breast cancer.
- To treat breast cancer that has spread to other parts of the body (metastatic breast cancer).
Who should not take Soltamox®?
Tamoxifen citrate should not be taken if you are receiving coumadin (warfarin)-type anticoagulant therapy, if you have had deep vein thrombosis or pulmonary embolus, or if you know you are hypersensitive to tamoxifen or any of the ingredients in Soltamox®.
Do not take tamoxifen for any reason if you:
- Are pregnant or plan to become pregnant while taking tamoxifen or during the 2 months after you stop taking tamoxifen. Tamoxifen may harm your unborn baby. It takes about 2 months to clear tamoxifen from your body. To be sure you are not pregnant, you can start taking tamoxifen while you are having your menstrual period. Or, you can take a pregnancy test to be sure you are not pregnant before you begin.
- Are breast feeding. We do not know if tamoxifen can pass through your milk and harm your baby.
- Have had an allergic reaction to tamoxifen or Soltamox™ (the other name for tamoxifen) or to any of its inactive ingredients.
- If you get pregnant while taking Soltamox®, stop taking it right away and contact your doctor. Soltamox® may harm your unborn baby.
Do not take Soltamox® to lower your chance of getting breast cancer if:
- You ever had a blood clot that needed medical treatment.
- You are taking medicines to thin your blood, like warfarin (also called coumadin).
- Your ability to move around is limited for most of your waking hours.
- You are at risk for blood clots. Your doctor can tell you if you are at high risk for blood clots.
- You do not have a higher than normal chance of getting breast cancer. Your doctor can tell you if you are a high risk woman.
How should I take Soltamox®?
Take Soltamox® as directed by your physician.
You can take Soltamox® with or without food. Take your medicine every day.
It may be easier to remember if you take it at the same time each day.
If you forget a dose, take it when you remember, then take the next dose as usual. If it is almost time for your next dose or you remember at your next dose, do not take extra medication to make up the missed dose.
Take Soltamox® every day for 5 years, unless your doctor tells you otherwise.
What should I avoid while taking Soltamox® (tamoxifen citrate) oral solution?
- Do not become pregnant while taking Soltamox® or for 2 months after you stop.
- Tamoxifen can stop hormonal birth control methods from working. Hormonal methods include birth control pills, patches, injections, rings and implants. Therefore, while taking tamoxifen, use birth control methods that don’t use hormones, such as condoms, diaphragms with spermicide, or plain IUDs. If you get pregnant, stop taking tamoxifen right away and call your doctor.
- Do not breast feed. We do not know if tamoxifen can pass through your milk and if it can harm the baby.
What are the possible side effects of Soltamox®?
The most common side effect of tamoxifen is hot flashes. This is not a sign of a serious problem. The next most common side effect is vaginal discharge. If the discharge is bloody, it could be a sign of a serious problem. Other common side effects are fluid retention, vaginal bleeding, vasodilatation, nausea, irregular menses, weight loss, and musculoskeletal pain.
What should I do while taking Soltamox®?
- Have regular gynecologic check-ups (“Female exams”), breast exams and mammograms. Your doctor will tell you how often. These will check for signs of breast cancer and cancer of the uterus. Because tamoxifen does not prevent all breast cancers, and you may get other types of cancers, you need these exams to find any cancers as early as possible.
- Because tamoxifen can cause serious side effects, pay close attention to your body. Signs you should look for are listed in “what are the possible side effects of Soltamox®?
- Tell all the doctors that you see that you are taking Soltamox®.
- Tell your doctor right away if you have any new breast lumps.
General information about the safe and effective use of Soltamox®
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Your doctor has prescribed Soltamox® only for you. Do not give it to other people, even if they have a similar condition, because it may harm them. Do not use it for a condition for which it was not prescribed.
If you want more information about Soltamox®, ask your doctor or pharmacist. They can give you information about Soltamox® that is written for health professionals. For more information about Soltamox®, please visit www.Soltamox.com or call 1-843-216-4828.
Ingredients: tamoxifen citrate, ethanol, glycerol, sorbitol solution, licorice flavor, aniseed flavor, purified water.
Manufactured by Rosemont Pharmaceuticals, Ltd UK.
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