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Tamoxifen (Oral route)

Pronunciation:

ta-MOX-i-fen

Brand Names:

  • Nolvadex
  • Soltamox

Dosage Forms:

  • Solution
  • Tablet

Warnings:

Oral route(Tablet)

Serious and life-threatening uterine malignancies, stroke, and pulmonary embolism have been associated with tamoxifen use in the risk reduction setting (women with Ductal Carcinoma in Situ (DCIS) and women at high risk for breast cancer). Some of these adverse events 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 .

Classifications:

Therapeutic—

Antiestrogen

Uses of This Medicine:

Tamoxifen is a medicine that blocks the effects of the estrogen hormone in the body. It is used to treat breast cancer in women or men. It may also be used to treat other kinds of cancer, as determined by your doctor.

Tamoxifen also may be used to reduce the risk of developing breast cancer in women who have a high risk of developing breast cancer. Women at high risk for developing breast cancer are at least 35 years of age and have a combination of risk factors that make their chance of developing breast cancer 1.67% or more over the next 5 years. Your doctor will help to determine your risk of developing breast cancer.

  • If you have close family members (mother, sister, or daughter) with breast cancer.
  • If you have ever had a breast biopsy or if high-risk changes in your breast(s) have been found from a breast biopsy.
  • If you have never been pregnant or if your first pregnancy occurred at a late age.
  • If your first menstrual period occurred at an early age.

The exact way that tamoxifen works against cancer is not known, but it may be related to the way it blocks the effects of estrogen on the body.

Before you begin treatment with tamoxifen, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Tamoxifen is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, tamoxifen is used in certain patients with the following medical conditions:

  • Breast cancer, neoadjuvant treatment for hormone receptor-positive disease in postmenopausal women.
  • Cancer of the endometrium (lining of the uterus).
  • Malignant melanoma (a certain type of skin cancer).

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of tamoxifen in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Amifampridine
  • Piperaquine
  • Posaconazole
  • Warfarin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abiraterone Acetate
  • Acenocoumarol
  • Aprepitant
  • Carbamazepine
  • Chlorpromazine
  • Clobazam
  • Cobicistat
  • Crizotinib
  • Cyclophosphamide
  • Dabrafenib
  • Desipramine
  • Dicumarol
  • Eslicarbazepine Acetate
  • Fluorouracil
  • Fluoxetine
  • Fluphenazine
  • Fluvoxamine
  • Fosaprepitant
  • Genistein
  • Ipriflavone
  • Ivabradine
  • Methotrexate
  • Mitomycin
  • Mitotane
  • Ondansetron
  • Paroxetine
  • Pazopanib
  • Phenprocoumon
  • Primidone
  • Quetiapine
  • Red Clover
  • Ritonavir
  • Sertraline
  • St John's Wort
  • Vemurafenib
  • Vinflunine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aldesleukin
  • Aminoglutethimide
  • Anastrozole
  • Bexarotene
  • Letrozole
  • Rifampin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Blood problems or
  • Cataracts or other eye problems—Tamoxifen may also cause these problems.
  • High cholesterol levels in the blood—Tamoxifen can increase cholesterol levels.
  • Blood clots (or history of) or
  • Pulmonary embolism (or history of) or
  • Stroke or
  • Uterine (womb) cancer—May increase risk of serious side effects from tamoxifen.

Proper Use of This Medicine:

Use this medicine only as directed by your doctor. Do not use more or less of it, and do not use it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Taking too much may increase the chance of side effects, while taking too little may not improve your condition.

Tamoxifen sometimes causes mild nausea and vomiting. However, it may have to be taken for several weeks or months to be effective. Even if you begin to feel ill, do not stop using this medicine without first checking with your doctor. Ask your health care professional for ways to lessen these effects.

Swallow the tablets whole with a drink of water. You can take the tablets with or without food.

If you vomit shortly after taking a dose of tamoxifen, check with your doctor. You will be told whether to take the dose again or to wait until the next scheduled dose.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For breast cancer in women or men:
      • Adults—20 to 40 milligrams (mg) daily.
      • Children—Use and dose must be determined by your doctor.
    • For reducing the risk of developing breast cancer in high-risk women:
      • Adults—20 milligrams (mg) a day for five years.
      • Children—Use and dose must be determined by your doctor.
    • For reducing the risk of developing invasive breast cancer in women with ductal carcinoma in situ:
      • Adults—20 milligrams (mg) a day for five years.
      • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Call your doctor or pharmacist for instructions.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

A woman should contact her doctor right away if she develops:

  • Changes in vaginal discharge or
  • Changes in vision or
  • Coughing up blood or
  • Leg swelling or tenderness or
  • Menstrual irregularities or
  • New breast lumps or
  • Pelvic pain or pressure or
  • Sudden chest pain or
  • Unexplained shortness of breath or
  • Vaginal bleeding

If you seek medical attention for any reason, be sure to tell your doctor that you take tamoxifen or have taken tamoxifen.

For women: Tamoxifen may make you more fertile. It is best to use some type of birth control while you are taking it. However, do not use oral contraceptives (“the Pill”) since they may change the effects of tamoxifen. Tell your doctor right away if you think you have become pregnant while taking this medicine.

Side Effects of This Medicine:

Because of the way this medicine acts on the body, there is a chance that it might cause unwanted effects that may not occur until months or years after the medicine is used. Tamoxifen increases the chance of cancer of the uterus (womb) in some women taking it. Tamoxifen may cause blockages to form in a vein, lung, or brain. In women, tamoxifen may cause cancer or other problems of the uterus (womb). It also causes liver cancer in rats. In addition, tamoxifen has been reported to cause cataracts and other eye problems. Discuss these possible effects with your doctor.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common or rare
Anxiety
blistering, peeling, or loosening of the skin and mucous membranes
blurred vision
cataracts in the eyes or other eye problems
change in vaginal discharge
chest pain
chills
confusion
cough
dizziness
fainting
fast heartbeat
fever
hoarseness
lightheadedness
lower back or side pain
pain or feeling of pressure in the pelvis
pain or swelling in the legs
pain, redness, or swelling in your arm or leg
painful or difficult urination
rapid shallow breathing
shortness of breath or trouble with breathing
skin rash or itching over the entire body
sweating
weakness or sleepiness
wheezing
vaginal bleeding
yellow eyes or skin
Incidence not known
Bloating
constipation
darkened urine
diarrhea
difficulty with breathing
indigestion
itching
joint or muscle pain
large, hard skin blisters
large hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, and sex organs
loss of appetite
nausea
pain in the stomach or side, possibly radiating to the back
red, irritated eyes
red skin lesions, often with a purple center
sore throat
sores, ulcers or white spots in the mouth or on the lips
unusual tiredness or weakness
vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
Absent, missed, or irregular periods
decrease in the amount of urine
feeling of warmth
menstrual changes
noisy, rattling breathing
redness of the face, neck, arms and occasionally, upper chest
skin changes
stopping of menstrual bleeding
swelling of the fingers, hands, feet, or lower legs
troubled breathing at rest
weight gain or loss
white or brownish vaginal discharge
Less common or rare
Abdominal or stomach cramps
black, tarry stools
bleeding gums
blood in the urine or stools
bluish color changes in skin color
bone pain
decreased interest in sexual intercourse
discouragement
feeling sad or empty
hair loss or thinning of the hair
headache
inability to have or keep an erection
irritability
itching in the genital area
loss of interest or pleasure
loss in sexual ability, desire, drive, or performance
nausea or vomiting (mild)
pain
pinpoint red spots on the skin
skin rash or dryness
stomach or pelvic discomfort, aching, or heaviness
swelling
trouble concentrating
trouble with sleeping
unusual bleeding or bruising

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


Last Updated: 4/4/2014

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