Patient Counseling

The following will highlight resources and important topics to review with patients about SOLTAMOX or Tamoxifen.

Patient Resources about Soltamox

For patient education about SOLTAMOX, please mention this website homepage and that they should visit the Patient Resources tab for printable material such as the following:

Important safety topics to discuss with your tamoxifen patients

In addition to reviewing the following safety topics, please remember to advise your patients to read the medication guide, which is also included within the patient brochures mentioned above.

Uterine Malignancies

  • Inform women that SOLTAMOX increases the risk of uterine malignancies (endometrial carcinoma and uterine sarcoma), including fatal cases. Advise women to promptly inform a healthcare provider if they experience any abnormal gynecological symptoms (e.g., menstrual irregularities, abnormal vaginal bleeding, changes in vaginal discharge, or pelvic pain or pressure.) Advise women receiving or who have previously received tamoxifen to undergo annual gynecological examinations.

Thromboembolic Events

  • Inform patients that SOLTAMOX increases the risk of thromboembolic events (deep vein thrombosis, pulmonary embolism, and stroke), including fatal cases. Advise patients to seek medical attention immediately if signs or symptoms of a thromboembolic event occur.

Embryo-Fetal Toxicity

  • Advise pregnant women and females of reproductive potential of the potential that exposure during pregnancy or within 2 months prior to conception can result in fetal harm, including the potential long-term risk of a DES-like syndrome. Advise females to inform their healthcare provider of a known or suspected pregnancy.
  • Advise females of reproductive potential to use effective nonhormonal contraception while taking SOLTAMOX and for 2 months after the last dose.

Lactation

  • Advise women not to breastfeed during treatment and for 3 months after the last dose of SOLTAMOX.

Effects on the Liver

  • Inform patients that SOLTAMOX may increase the risk of liver cancer and liver abnormalities.

Other patient resources for your patients

There is an abundance of information out there for patients on the world wide web, therefore it may be helpful to your patients for you to direct them to reputable organizations that contain reliable information.  Here are some organizations that offer a wide array of information covering many cancer patient topics:

Related Links

Healthcare ProfessionalsPrescribing InformationClinical OverviewDosing & AdministrationSafety & TolerabilityPatient AccessRisk ToolEAT-10 Tool

SOLTAMOX® Important Safety Information - WARNING: UTERINE MALIGNANCIES and THROMBOEMBOLIC EVENTS

See more

WARNING: UTERINE MALIGNANCIES and THROMBOEMBOLIC EVENTS

  • Serious, life-threatening, and fatal events from use of tamoxifen include uterine malignancies, stroke, and pulmonary embolism. (5.1, 5.2)
  • Discuss risks and benefits of tamoxifen with women at high risk for breast cancer and women with ductal carcinoma in situ (DCIS) when considering tamoxifen use to reduce the risk of developing breast cancer. (5.1, 5.2)
  • For most patients already diagnosed with breast cancer, the benefits of tamoxifen outweigh its risks. (5.1, 5.2)

See full prescribing information for complete boxed warning.

SOLTAMOX® Important Safety Information

  • Tamoxifen citrate is contraindicated in patients who require concomitant warfarin therapy, or a history of deep vein thrombosis or pulmonary embolus, and in patients with known hypersensitivity to the drug or any of its ingredients.
  • Uterine malignancies: Promptly evaluate abnormal vaginal bleeding in a woman with current or past tamoxifen use.
  • Thromboembolic events: Risk increases with coadministered chemotherapy. For treatment of breast cancer, consider risks and benefits in patients with a history of thromboembolic events.
  • Embryo-fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
  • Effects on the liver: Liver cancer and liver abnormalities, some fatal, have occurred. Perform periodic liver function testing.
  • The most common adverse reactions (≥20% incidence) associated with tamoxifen are hot flashes, mood disturbances, vaginal discharge, vaginal bleeding, nausea, and fluid retention.
  • Anastrozole and letrozole: Should not be used in combination with tamoxifen.
  • Warfarin: Do not use in patients taking tamoxifen for DCIS and for reduction in breast cancer incidence in women at high risk. Closely monitor coagulation indices for increased anticoagulant effect when used with tamoxifen for metastatic breast cancer or as adjuvant therapy.
  • Do not use tamoxifen in lactating women.
  • Verify pregnancy status of females prior to initiation of tamoxifen.
  • Advise females and males to use effective contraception.

Please see full Prescribing Information for SOLTAMOX®.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.