About Soltamox®

 

Soltamox ® (Tamoxifen Citrate) Oral Solutions

What is Soltamox® (tamoxifen citrate) Oral Solution?

Soltamox is the only FDA-approved oral liquid formulation of tamoxifen citrate, a medication widely used to treat breast cancer and to lower the incidence of breast cancer in women at high risk for the disease.

The active ingredient in Soltamox is tamoxifen citrate, a selective estrogen receptor modulator (SERM) that has been shown to inhibit estrogen-induced growth of breast cancer cells in estrogen-responsive breast cancers. Approximately 70% of breast cancers are estrogen-responsive.1 In 2012 over 1.8 million prescriptions were written for tamoxifen in the US alone.2

Soltamox is bioequivalent to tamoxifen tablets and is approved for the exact same indications. 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 tablets.3

Soltamox® - Bioequivalent to generic tamoxifen citrate

Mean 24-hour plasma concentrations following a single 20 mg dose (fasting conditions)

Soltamox - Bioequivalent to Generic Tamoxifen Citrate

Soltamox® - Favorable Monthly Cost vs Generic Tamoxifen Tablets*3

Monthly Rx Cost - Soltamox vs generic tamoxifen tablets

Soltamox - Monthly Cost vs. Generic Tamoxifen Tablets


Why Soltamox?

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.4

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 to patients and health care providers.

Having an oral liquid form of tamoxifen provides an important alternative. We have prescribed Soltamox to patients that find it difficult to take pills on a daily basis, or who simply prefer a liquid, and we believe it allows them to stay compliant with their daily tamoxifen therapy.

Stefan Gluck MD, PhD
Sylvester Distinguished Professor
Department of Medicine, Division of Hematology/Oncology
Sylvester Comprehensive Cancer Center
University of Miami, FL

References:

1. National Cancer Institute. Hormone Therapy for Breast Cancer. Available at: http://www.cancer.gov/cancertopics/factsheet/Therapy/hormone-therapy-breast. Reviewed
August 2, 2012. Accessed August 16, 2013.

2. Symphony Health Tamoxifen Retail TRx data Jan-Dec. 2012

3. 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.

4. 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

*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.

Warning

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.

Soltamox Co-Pay Card

Soltamox Co-Pay Card Support

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Having an oral liquid form of tamoxifen provides an important alternative. We have prescribed Soltamox to patients that find it difficult to take pills on a daily basis, or who simply prefer a liquid, and we believe it allows them to stay compliant with their daily tamoxifen therapy. quotemark

-Stefan Gluck MD, PhD