Product Description

Drug Name
 Novaldex is a hormone therapy. This medication is classified as an "anti-estrogen."

Drug Uses

• Novaldex may be given as adjuvant therapy (treatment after successful surgery) in women or men with lymph node negative or lymph node positive breast cancer. Cancers with positive estrogen and progesterone receptors are more likely to benefit from Novaldex. Novaldex reduces the risk of getting breast cancer in the opposite breast.
• Novaldex may be prescribed in metastatic (cancer that has spread) breast cancer in both women and men.
• Novaldex may be prescribed in women with ductal carcinoma in situ (DCIS) who have completed surgery and radiation therapy. Novaldex may reduce the risk of invasive breast cancer. Risks and benefits of Novaldex therapy should be discussed in this setting.
• Novaldex may be prescribed for women at high risk of breast cancer to reduce the incidence of developing breast cancer. Risks and benefits of Novaldex therapy should be discussed in this setting.
• Novaldex may also be prescribed for treatment of ovarian cancer.

Drug Class and Mechanism
Hormones are chemical substances that are produced by glands in the body, which enter the bloodstream and cause effects in other tissues. For example, the hormone testosterone, made in the testicles and is responsible for male characteristics such as deepening voice and increased body hair. The use of hormone therapy to treat cancer is based on the observation that receptors for specific hormones that are needed for cell growth are on the surface of some tumor cells. Hormone therapy can work by stopping the production of a certain hormone, blocking hormone receptors, or substituting chemically similar agents for the active hormone, which cannot be used by the tumor cell. The different types of hormone therapies are categorized by their function and/or the type of hormone that is affected.

Novaldex is an antiestrogen. Antiestrogens bind to estrogen receptor site on cancer cells thus blocking estrogen from going into the cancer cell. This interferes with cell growth and eventually leads to cell death. The following are antiestrogen medications.

How Taken

• Novaldex is a pill, given by mouth. The pill should be swallowed whole.
• Novaldex should be taken at about the same time each day with a full glass of water. If you miss a dose, do not take a double dose the next day.
• The amount of Novaldex that you will receive depends on many factors, including your general health or other health problems, and the type of cancer or condition being treated. Your doctor will determine your dose, schedule and duration of treatment.

Safety Information

Warnings/Precautions

• Before starting Novaldex treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.). Do not take aspirin, or products containing aspirin unless your doctor specifically permits this.
• Let your health care professional know if you have ever had a blood clot that required medical treatment.
• Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category D (Novaldex may be hazardous to the fetus. Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus).
• For both men and women: Do not conceive a child (get pregnant) while taking Novaldex. Barrier methods of contraception, such as condoms, are recommended. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
• Do not breast feed while taking this medication.
• Do not stop taking this medication unless your healthcare provider tells you. You may be on it for as long as 5 years.
• If you are experiencing hot flashes, wearing light clothing, staying in a cool environment, and putting cool cloths on your head may reduce symptoms. Consult you health care provider if these worsen, or become intolerable
• This medication causes little nausea. But if you should experience nausea, take anti-nausea medications as prescribed by your doctor, and eat small frequent meals. Sucking on lozenges and chewing gum may also help.
• Avoid sun exposure. Wear SPF 15 (or higher) sunblock and protective clothing.
• In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
• Get plenty of rest.
• Maintain good nutrition.
• If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Side Effects

Possible Side Effects

• Most people do not experience all of the side effects listed.
• Side effects are often predictable in terms of their onset and duration.
• Side effects are almost always reversible and will go away after treatment is complete.
• There are many options to help minimize or prevent side effects.
• There is no relationship between the presence or severity of side effects and the effectiveness of the medication.
• Hot flashes (see sexuality)
• Vaginal discharge (see sexuality)
• Swelling (fluid retention in feet, ankles, or hands)
• Loss of libido (particularly in men) (see sexuality)
• Nausea
• Menstrual irregularities
• Vaginal bleeding
• Weight loss
• Mood changes (see anxiety and/or depression)

A rare, but serious side effect of Novaldex is blood clots, including deep vein thrombosis (DVT) and pulmonary embolus. You should seek emergency help and notify your health care provider immediately if you develop sudden chest pain and shortness of breath. Notify your health care provider within 24 hours if you notice that one leg is swollen, red, painful and/or warm to touch and the other is not.

A rare, but serious side effect of Novaldex can be the development of uterine cancer. Women who have not had a hysterectomy should have regular pap smears and gyn examinations. Abnormal vaginal bleeding should be reported to your health care provider.

Your fertility, meaning your ability to conceive or father a child, may be affected by Novaldex. Please discuss this issue with your health care provider.

Not all side effects are listed above. Some that are rare (occurring in less than 10% of patients) are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms.

More Information
We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.