Estramustin-Uropharm

Estramustin-Uropharm (Estramustin-Uropharm) Capsules are indicated in the palliative treatment of patients with metastatic and/or progressive carcinoma of the prostate.

Estramustin-Uropharm belongs to the general group of medicines called antineoplastics. It is used to treat some cases of prostate cancer.

Estramustin-Uropharm is a combination of two medicines, an estrogen and mechlorethamine. The way that Estramustin-Uropharm works against cancer is not completely understood. However, it seems to interfere with the growth of cancer cells, which are eventually destroyed.

Estramustin-Uropharm is available only with your doctor's prescription.

The recommended daily dose is 14 mg per kg of body weight (ie, one 140 mg capsule for each 10 kg or 22 lb of body weight), given in 3 or 4 divided doses. Most patients in studies in the United States have been treated at a dosage range of 10 to 16 mg per kg per day.

Patients should be instructed to take Estramustin-Uropharm (Estramustin-Uropharm) Capsules at least 1 hour before or 2 hours after meals. Estramustin-Uropharm (Estramustin-Uropharm) should be swallowed with water. Milk, milk products, and calcium-rich foods or drugs (such as calcium-containing antacids) must not be taken simultaneously with Estramustin-Uropharm (Estramustin-Uropharm).

Patients should be treated for 30 to 90 days before the physician determines the possible benefits of continued therapy. Therapy should be continued as long as the favorable response lasts. Some patients have been maintained on therapy for more than 3 years at doses ranging from 10 to 16 mg per kg of body weight per day.

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published. There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

How supplied

White opaque capsules, each containing Estramustin-Uropharm phosphate sodium as the disodium salt monohydrate equivalent to 140 mg Estramustin-Uropharm phosphate-bottle of 100 (NDC 0013-0132-02).

Note

Estramustin-Uropharm (Estramustin-Uropharm) Capsules should be stored in the refrigerator at 36° to 46°F (2° to 8°C).

REFERENCES

1. Recommendations for the Safe Handling of

Parenteral Antineoplastic Drugs. NIH Publication No. 83-2621. For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, DC, 20402.

2. AMA Council Report, Guidelines for Handling

Parenteral Antineoplastics, JAMA. 1985; 253 (11):1590-1592.

3. National Study Commission on Cytotoxic Exposure-Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, Sc. D., Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115.

4. Clinical Oncological Society of Australia. Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia. 1983; 1:426-428.

5. Jones RB, et al. Safe Handling of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. CA-A Cancer Journal for Clinicians. 1983; (Sept/Oct) 258-263.

6. American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J Hosp Pharm. 1990; 47:1033- 1049.

7. OSHA Work-Practice Guidelines for Personnel Dealing with Cytotoxic (Antineoplastic) Drugs. Am J Hosp Pharm. 1986; 43:1193-1204.

8. ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice. Pittsburgh, Pa: Oncology Nursing Society; 1999:32-41.

Pharmacia & Upjohn Company, Division of Pfizer Inc, NY, NY 10017. Revised June 2007. FDA Rev date: 07/09/08.

See also:
What is the most important information I should know about Estramustin-Uropharm?

You should not use this medication if you are allergic to Estramustin-Uropharm, or if you have a blood clot, swelling of a vein caused by a blood clot, or if you have ever had an allergic reaction to estradiol or nitrogen mustard.

Before taking Estramustin-Uropharm, tell your doctor if you have a history of stroke or heart attack, diabetes, heart disease, high blood pressure, migraine headaches, seizures, liver or kidney disease, or Paget's disease.

Take Estramustin-Uropharm on an empty stomach, at least 1 hour before or 2 hours after a meal.

Do not take this medication with milk, milk products, or calcium-rich foods such as ice cream, yogurt, broccoli, and others. Also avoid using antacids or vitamin/mineral supplements that contain calcium. Calcium can make it harder for your body to absorb Estramustin-Uropharm, which could make it less effective.

If a man fathers a child while taking Estramustin-Uropharm, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment. Ask your doctor how long you should continue using condoms after you stop taking Estramustin-Uropharm.

Use Estramustin-Uropharm as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

• Take Estramustin-Uropharm on an empty stomach at least 1 hour before or 2 hours after meals.
• Swallow Estramustin-Uropharm with water.
• Do not take antacids containing calcium, or eat or drink dairy products within 1 hour before or 2 hours after taking Estramustin-Uropharm.
• If nausea, vomiting, or loss of appetite occurs, ask your doctor or pharmacist for ways to lessen these effects.
• Several days to weeks may pass before you feel the full benefit of Estramustin-Uropharm. Do not stop taking Estramustin-Uropharm without checking with your doctor.
• If you miss a dose of Estramustin-Uropharm, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Estramustin-Uropharm.

Estramustin-Uropharm is used in the treatment of metastatic (cancer which has spread to other parts of the body), progressive or unresponsive prostate cancer or that has relapsed after conventional anti-cancer treatment.

See also:
What other drugs will affect Estramustin-Uropharm?

Baricitinib: Immunosuppressants may enhance the immunosuppressive effect of Baricitinib. Management: Use of baricitinib in combination with potent immunosuppressants such as azathioprine or cyclosporine is not recommended. Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted. Consider therapy modification

BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

Calcium Salts: May decrease the absorption of Estramustin-Uropharm. Management: Administer Estramustin-Uropharm on an empty stomach, at least 1 hour before or 2 hours after the dose of an oral calcium supplement. If coadministered with calcium salts, monitor for decreased Estramustin-Uropharm therapeutic effects. Exceptions: Calcium Chloride. Consider therapy modification

Cladribine: May enhance the immunosuppressive effect of Immunosuppressants. Avoid combination

Clodronate: May increase the serum concentration of Estramustin-Uropharm. Monitor therapy

Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Monitor therapy

Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Monitor therapy

Echinacea: May diminish the therapeutic effect of Immunosuppressants. Management: Consider avoiding Echinacea in patients receiving therapeutic immunosuppressants. If coadministered, monitor for reduced efficacy of the immunosuppressant during concomitant use. Consider therapy modification

Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Consider therapy modification

Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Consider therapy modification

Lenograstim: Antineoplastic Agents may diminish the therapeutic effect of Lenograstim. Management: Avoid the use of lenograstim 24 hours before until 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Consider therapy modification

Lipegfilgrastim: Antineoplastic Agents may diminish the therapeutic effect of Lipegfilgrastim. Management: Avoid concomitant use of lipegfilgrastim and myelosuppressive cytotoxic chemotherapy. Lipegfilgrastim should be administered at least 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Consider therapy modification

Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination

Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Consider therapy modification

Ocrelizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy

Ozanimod: Immunosuppressants may enhance the immunosuppressive effect of Ozanimod. Monitor therapy

Palifermin: May enhance the adverse/toxic effect of Antineoplastic Agents. Specifically, the duration and severity of oral mucositis may be increased. Management: Do not administer palifermin within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy. Consider therapy modification

Pidotimod: Immunosuppressants may diminish the therapeutic effect of Pidotimod. Monitor therapy

Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Consider therapy modification

Siponimod: Immunosuppressants may enhance the immunosuppressive effect of Siponimod. Monitor therapy

Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Management: Evaluate patients to see if it is medically appropriate to reduce or discontinue therapy with immunosuppressants prior to initiating sipuleucel-T therapy. Consider therapy modification

Smallpox and Monkeypox Vaccine (Live): Immunosuppressants may diminish the therapeutic effect of Smallpox and Monkeypox Vaccine (Live). Monitor therapy

Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination

Tertomotide: Immunosuppressants may diminish the therapeutic effect of Tertomotide. Monitor therapy

Tofacitinib: Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Management: Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted, and this warning seems particularly focused on more potent immunosuppressants. Consider therapy modification

Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Monitor therapy

Upadacitinib: Immunosuppressants may enhance the immunosuppressive effect of Upadacitinib. Avoid combination

Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification

Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Exceptions: Smallpox and Monkeypox Vaccine (Live). Avoid combination

See also:
What are the possible side effects of Estramustin-Uropharm?

Applies to Estramustin-Uropharm: oral capsule

In addition to its needed effects, some unwanted effects may be caused by Estramustin-Uropharm (the active ingredient contained in Estramustin-Uropharm). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking Estramustin-Uropharm:

Rare

• Black, tarry stools
• blood in urine or stools
• cough or hoarseness
• fever or chills
• headaches (severe or sudden)
• loss of coordination (sudden)
• lower back or side pain
• painful or difficult urination
• pains in chest, groin, or leg (especially calf of leg)
• pinpoint red spots on skin
• shortness of breath (sudden, for no apparent reason)
• slurred speech (sudden)
• unusual bleeding or bruising
• vision changes (sudden)
• weakness or numbness in arm or leg

Severity: Moderate

If any of the following side effects occur while taking Estramustin-Uropharm, check with your doctor or nurse as soon as possible:

More common:

• Swelling of feet or lower legs

• Skin rash or fever
• unusual tiredness or weakness

Minor Side Effects

Some of the side effects that can occur with Estramustin-Uropharm may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:

• Breast tenderness or enlargement
• decreased interest in sex
• diarrhea
• nausea

• Trouble in sleeping
• vomiting

Each capsule contains Estramustine phosphate disodium salt equivalent to Estramustin-Uropharm phosphate 140 mg.

Excipients/Inactive Ingredients: Sodium lauryl sulphate, colloidal silica anhydrous, magnesium stearate, talc, gelatin and titanium dioxide (E171).