Soltamox® (tamoxifen citrate) Oral Solution
Now, Tamoxifen Patients Have a New Choice
Soltamox contains the active ingredient tamoxifen citrate, indicated for the treatment of breast cancer and to reduce the incidence of breast cancer in women at high risk for the disease. Tamoxifen is usually administered once-daily for up to 5 years. However, studies have shown that compliance to treatment is less than optimal, with between 31% to 61% of women discontinuing treatment at the end of 5 years.1
Giving tamoxifen patients the ability to choose between a tablet and a liquid may improve long-term adherence, as some patients prefer a liquid formulation, or need a liquid due to physiological or psychological factors that limit their ability to swallow tablets. Tamoxifen tablets should not be broken, crushed or chewed. Soltamox therefore offers a new, safe, and convenient choice for patients.
The only FDA-approved liquid formulation of tamoxifen citrate
For patients who prefer or need to take their tamoxifen as a liquid rather than a tablet
Bioequivalent to tamoxifen tablets with the same exact indications
Gluten and sugar free
Simple, once-a-day dosing
Affordable for patients. With free co-pay assistance the monthly cost of Soltamox for most patients is $10.00 per prescription*, which compares favorably to the monthly cost of generic tamoxifen tablets2
About DARA BioSciences Inc.
DARA BioSciences Inc. is an oncology supportive care pharmaceutical company dedicated to providing healthcare professionals a synergistic portfolio of medicines to help cancer patients adhere to their therapy and manage side effects arising from their cancer treatment.
DARA’s product portfolio currently includes Soltamox® (tamoxifen citrate) oral solution, Gelclair® (bioadherent oral rinse gel for oral mucositis) and Bionect® (a topical treatment for skin irritation and burns associated with radiation therapy).
For more information about DARA and its products please visit our web site at www.darabio.com.
For information about Gelclair visit www.Gelclair.com
For information about Bionect visit www.Bionect.com
1. Murphy CC, et al. Adherence to adjuvant hormonal therapy among breast cancer survivors in clinical practice: a systematic review. Breast Cancer Res Treat. 2012;134:459-478.
2. Healthcare Analytics, Insight Prescriber November 2011-October 2012. Average calculated using all days supply, average approved co-pay dollars for commercial claims only, without nulls and voids.
*Terms and Conditions:
Certain patients in Federal programs may not qualify. Qualified patients will pay $10 per Soltamox prescription. After a maximum reimbursement allowance of $75.00, any remaining costs will be the responsibility of the patient. Co-pay assistance is not valid for prescriptions reimbursed in whole, or in part under Medicaid, Medicare, including Medicare Advantage and Part D prescription drug plans, or any other federal or state program (including state pharmaceutical assistance programs) or where prohibited, taxed or otherwise restricted. DARA BioSciences reserves the right to rescind, revoke or amend this offer without notice. Patients understand and agree to comply with the terms and conditions of this offer as set forth here.
Important Safety Information
Tamoxifen citrate is contraindicated in patients with known hypersensitivity and also in women who require concomitant coumarin-type anticoagulant therapy or in women with a history of deep vein thrombosis or pulmonary embolus. As with other additive hormonal therapy (estrogens and androgens), 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. There is evidence of an increased incidence of thromboembolic events, including deep vein thrombosis and pulmonary embolism, during tamoxifen therapy. When tamoxifen is coadministered with chemotherapy, there may be a further increase in the incidence of thromboembolic effects. Adverse reactions to tamoxifen are relatively mild and rarely severe enough to require discontinuation of treatment in breast cancer patients.
In Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast Cancer Serious and life-threatening events were associated with tamoxifen in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism. (see CLINICAL PHARMACOLOGY, Clinical Studies, Reduction in Breast Cancer Incidence In High Risk Women). 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 tamoxifen to reduce their risk of developing breast cancer. The benefits of tamoxifen outweigh its risks in women already diagnosed with breast cancer.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-855-273-0468
Indications and Uses of Tamoxifen
Metastatic Breast Cancer
Tamoxifen citrate is effective in the treatment of metastatic breast cancer in women and men.
Adjuvant Treatment of Breast Cancer
Tamoxifen citrate is indicated for the treatment of node-positive breast cancer in postmenopausal women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. In some tamoxifen citrate adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes.
Tamoxifen citrate is indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. The estrogen and progesterone receptor values may help to predict whether adjuvant tamoxifen citrate therapy is likely to be beneficial.
Tamoxifen citrate reduces the occurrence of contralateral breast cancer in patients receiving adjuvant tamoxifen citrate therapy for breast cancer.
Ductal Carcinoma in Situ (DCIS)
Following breast surgery and radiation, tamoxifen citrate is indicated to reduce the risk of invasive breast cancer in women with DCIS (see BOXED WARNING in the full Prescribing Information).The decision regarding therapy with tamoxifen for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of tamoxifen therapy.
Reduction in Breast Cancer Incidence in High Risk Women
Tamoxifen citrate is indicated to reduce the incidence of breast cancer in women at high risk for breast cancer (see BOXED WARNING in the full Prescribing Information). Tamoxifen citrate is indicated only for high-risk women. High risk is defined as women at least 35 years of age with a 5-year predicted risk of breast cancer of 1.67%, as calculated by the Gail Model.
See Complete Black Box Warning and Full Prescribing Information