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Soltamox™ is the only oral liquid solution for hormonal breast cancer therapy. It is an easy-to-swallow oral solution that contains tamoxifen citrate. Soltamox provides an option for breast cancer patients who prefer liquids.

Tamoxifen is prescribed for women in every stage of breast cancer and to those with metastatic breast cancer (cancer that has spread to other parts of the body), as well as for women at risk for breast cancer.

Tamoxifen has been used as a breast cancer treatment for almost 40 years and clinical trials have shown that tamoxifen helps reduce the chance of getting breast cancer by 44%.¹ Tamoxifen is the gold standard of hormonal therapy.

Talk to your healthcare provider to see if Soltamox is right for you.

Please see full prescribing information.

Please see important safety information.

References
1. Food and Drug Administration. Tamoxifen Approved for Reducing Breast Cancer Incidence. HHS News. October 29, 1998.

© 2008 Cytogen Corporation. All rights reserved. S-0020-06

Important Safety Information about SOLTAMOX (tamoxifen citrate) Oral Solution

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 Prescribing Information: 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 Prescribing Information: WARNINGS, Effects on the Uterus-Endometrial Cancer and Uterine Sarcoma.

** See Table 3 under Prescribing Information: CLINICAL PHARMACOLOGY, Clinical Studies.

Tamoxifen citrate is contraindicated in patients with known hypersensitivity to the drug or any of its ingredients. Tamoxifen citrate is also contraindicated in high-risk women and women with ductal carcinoma in situ who require concomitant coumarin-type anticoagulant therapy or in women with a history of deep vein thrombus or pulmonary embolus. Tamoxifen citrate may cause fetal harm when administered to pregnant women. Women should be advised not to become pregnant while taking tamoxifen citrate or within 2 months of discontinuing tamoxifen citrate.

Adverse reactions to tamoxifen are relatively mild and are rarely severe enough to require discontinuation of treatment in breast cancer patients.

In the P-1 Breast Cancer Prevention Trial, the most common adverse events were hot flashes (reported by 80 of 6441 women with tamoxifen citrate and 68 of 6469 women with placebo), vaginal discharge (55 and 35 women in the tamoxifen citrate and placebo groups, respectively), and vaginal bleeding (23 and 22 women in the tamoxifen citrate and placebo groups, respectively).

In one single-dose pharmacokinetic study of SOLTAMOX in healthy perimenopausal and postmenopausal female volunteers, throat irritation was reported by 3 of 60 subjects (5.0%) in the SOLTAMOX treatment groups, while none of the subjects who received tamoxifen tablets reported this event. All events were mild and occurred within an hour after dosing. All events were resolved within 24 hours.

Patients should be instructed to read the complete Medication Guide supplied as required by law when tamoxifen citrate is dispensed. The Medication Guide is reprinted with the prescribing information for SOLTAMOX.