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Nolvadex Prescribing Information
Package Insert
Nolvadex: Package Insert / Prescribing Info
BOXED WARNING:
Nolvadex (tamoxifen) is a prescription medication. It should only be taken under the
guidance of a healthcare provider. This medication may cause serious side effects, including increased risk of uterine cancer,
endometrial cancer, and uterine sarcoma. Women with a history
of these conditions or who are at high risk should consult their doctor before taking Nolvadex.
Nolvadex Description
Nolvadex is an oral medication used to treat breast cancer in various forms, including metastatic, adjuvant, and ductal carcinoma in situ
(DCIS). It may also reduce the incidence of breast cancer in high-risk women aged
35 or older. The exact dosage and duration depend on the
patient's condition and medical history.
Nolvadex - Clinical Pharmacology
Nolvadex is metabolized in the liver and excreted primarily through
bile and stool. It has a long half-life, which means it remains in the system for several days after discontinuation. The drug exhibits
dose-dependent pharmacokinetics, with higher doses leading to higher concentrations.
Nolvadex Dosage and Administration
The dosage of Nolvadex is determined based on the patient's condition and response
to treatment. For metastatic breast cancer, the typical starting dose is 20-40 mg daily, often adjusted based on tolerability.
For adjuvant therapy, doses range from 5-25 mg daily.
The exact schedule (e.g., once or twice daily) depends on the prescribing physician's judgment.
Special Populations
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Contraindications
Nolvadex is contraindicated in women who are or may become pregnant, as well as those with a history of uterine cancer, endometrial cancer, or uterine sarcoma. The medication is also not recommended for men with premenopausal gynecomastia or for individuals with certain genetic conditions that increase the risk of blood clots.
Effects on the Liver
Long-term use of Nolvadex may increase the risk of hepatocellular carcinoma. Non-malignant liver effects, such as elevated liver enzymes, are common and usually reversible upon discontinuation of the medication.
Thromboembolic Effects
Nolvadex increases the risk of blood clots, which can lead to serious complications like pulmonary embolism or stroke. Patients should be monitored for signs of clotting, such as increased coughing or shortness of breath.
Non-Malignant Effects on the Uterus
The medication may cause endometrial thickening or other non-malignant uterine effects. Regular follow-ups are recommended to monitor for any changes in the uterus.
Effects on the Eye
Nolvadex may increase the risk of corneal edema, which can lead to visual disturbances. Patients should report any eye-related symptoms promptly.
Pregnancy Category D
Nolvadex is categorized as Pregnancy Risk Category D, meaning it is not recommended for use during pregnancy but may be necessary in some cases where the benefits outweigh the risks. Women who become pregnant while taking this medication should consult their healthcare provider immediately.
Nursing Mothers
Nolvadex is not recommended for breastfeeding mothers due to its potential to affect breastfed infants. The decision to discontinue breastfeeding and discontinue Nolvadex should be made in consultation with a healthcare provider.
Postmarketing Experience
Since its approval, Nolvadex has been associated with reports of increased fracture risk in older women, likely due to its effects on bone metabolism. Patients should be advised about the importance of maintaining bone health through regular exercise and calcium/vitamin D supplementation.
Overdosage
In case of an overdose, symptomatic management should be provided, such as supportive care and gastric lavage if necessary. If the patient is unable to tolerate the oral route, consider using IV fluids or other forms of support.
Nolvadex Storage
Store Nolvadex at room temperature (15°C–30°C) in a childproof container. Ensure that the medication is kept out of reach of children and pets. Proper storage ensures the effectiveness and safety of the medication.
Supplemental Patient Material
Patients should also be provided with supplementary materials, such as a medication guide and frequently asked questions (FAQs), to address common concerns and ensure proper adherence to treatment.
More About Nolvadex (Tamoxifen)
For further information, patients can visit the manufacturer's website or consult their healthcare provider. Additional resources include professional guidelines and related treatment summaries for healthcare providers.
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