Soltamox®

Soltamox® (tamoxifen citrate) is the only oral liquid formulation of tamoxifen available in the US. Soltamox is indicated for adjuvant treatment of breast cancer, metastatic breast cancer, ductal carcinoma in situ and to reduce breast cancer incidence in high risk women. Soltamox is an important option for breast cancer patients who may require a liquid formulation.

In the US over 230,000 new cases of breast cancer are diagnosed each year1, and over 1.9 million prescriptions are written for tamoxifen2. Soltamox was developed to offer breast cancer patients a new option for daily tamoxifen treatment. Patients may benefit from Soltamox if they find it easier to utilize liquid medications or if they have difficulty swallowing tablets. For patients with intolerance to gluten or lactose, Soltamox is gluten and lactose free.

Soltamox is available as a sugar-free oral solution (equivalent to 10mg/5mL). Each bottle contains 150 mL.

DARA has an exclusive license to market Soltamox® in the U.S. from Rosemont Pharmaceuticals, LTD, a UK-based manufacturer and marketer of oral liquid medicines. Soltamox is patent-protected through 2018.

Tamoxifen Important Safety Information

Tamoxifen citrate is contraindicated in women who require concomitant coumadin-type anticoagulant therapy, in women with a history of deep vein thrombosis or pulmonary embolus, and in women with known hypersensitivity to the drug or any of its ingredients. Serious and life-threatening events 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.

The most common adverse reactions to tamoxifen treatment are (incidence > 20%) hot flashes, fluid retention, vaginal discharge, vaginal bleeding, vasodilatation, nausea, irregular menses, weight loss, and musculoskeletal events.

Tamoxifen carries the following Boxed Warning: 

WARNING – For Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast Cancer:  Serious and life-threatening events 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. Incidence rates for these events were estimated from the NSABP P-1 trial (see CLINICAL PHARMACOLOGY, Clinical Studies, Reduction in Breast Cancer Incidence In High Risk Women).  Uterine malignancies consist of both endometrial adenocarcinoma (incidence rate per 1,000 women-years of 2.20 for tamoxifen vs. 0.71 for placebo) and uterine sarcoma (incidence rate per 1,000 women-years of 0.17 for tamoxifen vs. 0.0 for placebo)*.  For stroke, the incidence rate per 1,000 women-years was 1.43 for tamoxifen vs. 1.00 for placebo**.  For pulmonary embolism, the incidence rate per 1,000 women-years was 0.75 for tamoxifen versus 0.25 for placebo**.  Some of the strokes, pulmonary emboli, and uterine malignancies 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 tamoxifen to reduce their risk of developing breast cancer. The benefits of tamoxifen outweigh its risks in women already diagnosed with breast cancer.

*Updated long-term follow-up data (median length of follow-up is 6.9 years) from NSABP P-1 study.  See WARNINGS, Effects on the Uterus-Endometrial Cancer and Uterine Sarcoma in Prescribing Information. **See Table 3 under CLINICAL PHARMACOLOGY, Clinical Studies in Prescribing Information.

For a copy of the full Prescribing Information please click here.

For additional information about Soltamox (tamoxifen citrate) oral solution, please visit www.Soltamox.com.

References:

  1. Cancer Facts and Figures 2014; American Cancer Society®
  2. Symphony Health: Total Rx data 12 months ending May, 2014