Soltamox

Soltamox is a prescription medication used to treat breast cancer as well as lower the chance of developing breast cancer in certain populations. Certain types of breast cancers require estrogen to grow. Soltamox belongs to a group of drugs called anti-estrogens which can block estrogen’s effects, slowing the growth of cancer cells. 

Soltamox comes in an oral solution form and is usually taken once or twice a day, with or without food. 

Soltamox is usually taken for 5 years unless your doctor tells you otherwise. 

Common side effects of Soltamox include hot flashes, altered menstrual period timing, and vaginal discharge.

Soltamox can also cause dizziness. Do not drive or operate heavy machinery until you know how Soltamox affects you.

Soltamox is a prescription medicine used:

• to lower the risk of getting breast cancer in women with a higher than normal risk of getting breast cancer in the next 5 years (high-risk women)
• to lower the risk of getting invasive (spreading) breast cancer in women who had surgery and radiation for ductal carcinoma in situ (DCIS); DCIS means the cancer is only inside milk ducts
• to treat breast cancer in women after they have finished early treatment. Early treatment can include surgery, radiation, and chemotherapy
• in women and men to treat breast cancer that has spread to other parts of the body (metastatic breast cancer)

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• DARA BioSciences, Inc.

Serious side effects have been reported with Soltamox. See the "Soltamox Precautions" section.

Common side effects of Soltamox include the following:

• Hot flashes  
• Vaginal discharge
• Absence of menstrual periods  
• Altered menstrual period timing
• Abnormally light menstrual periods  
• Bone Pain    
• Nausea  
• Cough
• Swelling of extremities  
• Fatigue  
• Muscle pain

This is not a complete list of Soltamox side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• aminoglutethimide (Cytadren)
• anastrozole (Arimidex)
• bromocriptine (Parlodel)
• cancer chemotherapy medication such as cyclophosphamide (Cytoxan, Neosar) letrozole (Femara)
• medroxyprogesterone (Depo-Provera, Provera, in Prempro)
• phenobarbital
• rifampin (Rifadin, Rimactane)

This is not a complete list of Soltamox drug interactions. Ask your doctor or pharmacist for more information.

Soltamox can cause serious side effects which include:

• Changes in the lining (endometrium) or body of your uterus. These changes may mean serious problems are starting, including cancer of the uterus. The symptoms of these changes in the uterus include:
  • 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).
• Blood clots in your veins or lungs. These can cause serious problems, including death. You may get clots up to 2-3 months after you stop taking Soltamox. The symptoms of blood clots include:
  • sudden chest pain, shortness of breath, coughing up blood
  • pain, tenderness, or swelling in one or both of your legs
• Stroke. Stroke can cause serious medical problems, including death. The symptoms of stroke include:
  • 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 seeing in one or both eyes
  • 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 symptoms of these problems include slow blurring of your vision.
• Liver problems, including jaundice. The symptoms of liver problems include lack of appetite and yellowing of your skin or whites of your eyes.

Do not take Soltamox for any reason if you:

• Are pregnant or plan to become pregnant while taking Soltamox or during the 2 months after you stop taking Soltamox. Soltamox may harm your unborn baby. It takes about 2 months to clear Soltamox from your body. To be sure you are not pregnant, you can start taking Soltamox while you are having your menstrual period. Or, you can take a pregnancy test to be sure you are not pregnant before you begin. If you get pregnant while taking Soltamox, stop taking it right away and contact your doctor. Soltamox may harm your unborn baby.
• Are breastfeeding. We do not know if Soltamox can pass through your milk and harm your baby.
• Have had an allergic reaction to Soltamox or to any of its inactive ingredients.

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.

Soltamox can also cause dizziness. Do not drive or operate heavy machinery until you know how Soltamox affects you.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Soltamox there are no specific foods that you must exclude from your diet when receiving Soltamox.

Before taking Soltamox, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to any ingredient in Soltamox
• have ever had a blood clot in the lungs or legs, a stroke, or a heart attack
• have high blood pressure
• have diabetes
• take blood thinners such as warfarin (Coumadin)
• smoke
• have high cholesterol
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the prescription medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Soltamox falls into category D. In animal studies, pregnant animals were given this medication and had some babies born with problems. There are no adequate and well-controlled studies done in humans. Soltamox can cause harm to your unborn baby. 

Women should not become pregnant while taking Soltamox or within 2 months of stopping Soltamox. Women should use contraception while taking Soltamox and for 2 months after stopping Soltamox. It takes about 2 months to clear Soltamox from your body. To be sure you are not pregnant, you can start taking Soltamox while you are having your menstrual period. Or, you can take a pregnancy test to be sure you are not pregnant before you begin. If you get pregnant while taking Soltamox, stop taking it right away and contact your doctor. Soltamox may harm your unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Soltamox crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, women taking Soltamox should not breastfeed. 

Take Soltamox exactly as prescribed.

Soltamox comes in an oral solution form and is usually taken once or twice a day. Take with or without food. 

Soltamox is typically taken for a period of 5 years unless your doctor instructs you otherwise.

Use only the supplied dosing cup measuring device to measure Soltamox doses.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Soltamox at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your age

The recommended dose of Soltamox for the treatment of breast cancer is 20-40 mg daily for 5 years.

The recommended dose of Soltamox for the treatment of Ductal Carcinoma in Situ (DCIS) is 20 mg daily for 5 years.

The recommended dose of Soltamox for the prevention of breast cancer in high-risk patients is 20 mg daily for 5 years.

If you take too much Soltamox, call your local Poison Control Center or seek emergency medical attention right away.

• Have regular gynecology check-ups, breast exams and mammograms. Your doctor will tell you how often. These will check for signs of breast cancer and cancer of the endometrium (lining of the uterus). Because Soltamox 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.
• Tell all of the doctors that you see that you are taking Soltamox.
• Tell your doctor right away if you have any new breast lumps.
• Store at temperatures up to 25°C (77°F).
• DO NOT freeze or refrigerate.
• Store in original packaging in order to protect from light. Use within 3 months of opening.
• Keep this and all medicines out of reach of children.

For women with a condition called Ductal Carcinoma in Situ (DCIS) and women at high risk for breast cancer:

Serious and life-threatening events have been associated with Soltamox in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine cancers, stroke and lung blood clots. Uterine cancers can consist of both endometrial adenocarcinoma and uterine sarcoma. Some of the strokes, blood clots, and uterine malignancies seen in clinical trials were fatal.

Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of breast cancer and women with DCIS considering Soltamox to reduce their risk of developing breast cancer.

The benefits of Soltamox outweigh its risks in women already diagnosed with breast cancer.