Honvol (Diethylstilbestrol Diphosphate)

HONVOLĀ®

Carter Horner

Diethylstilbestrol Diphosphate

Prostatic Carcinoma Therapy

Indications And Clinical Uses: For intensive and selective palliative therapy of inoperable prostatic carcinoma.

Contra-Indications: Patients with active hepatic dysfunction or disease, especially of the obstructive type; a personal history of breast cancer, except in special circumstances; a history of cerebrovascular accident, coronary thrombosis or the presence of classical migraine; a history of thrombophlebitis or thromboembolic disease; partial or complete loss of vision or diplopia, from ophthalmic vascular disease.

Precautions: Before diethylstilbestrol diphosphate is administered, the patient should have a complete physical examination including a blood pressure determination. Breasts should be examined.

The first followup examination should be done within 6 months after initiation of treatment. Thereafter, examinations should be made once a year. At each annual visit, repeat those procedures outlined above.

If any surgical procedures are performed, advise the pathologist of the patient’s therapy when specimens are sent for examination. Liver function tests should be made periodically in subjects who have, or are suspected of having, hepatic disease.

Patients who develop visual disturbances, classical migraine, transient aphasia, paralysis, or loss of consciousness should discontinue medication.

If the patient develops any sign of phlebitis or thromboembolic complications, discontinue the medication.

Estrogen may cause fluid retention. Particular caution is indicated in cardiac or renal dysfunction, epilepsy, or asthma.

Elevation of blood pressure in previously normotensive or hypertensive patients necessitates cessation of medication.

Diabetic patients or those with a predisposition to diabetes should be observed closely to detect any alterations in carbohydrate metabolism.

When liver or endocrine function tests are indicated, the results should not be considered reliable unless therapy has been discontinued for 2 to 4 months.

Adverse Reactions: Although not all of the reactions listed below have been specially associated with the use of diethylstilbestrol diphosphate, they have generally been reported following estrogen therapy, and may be encountered in susceptible patients treated with a product containing an estrogen:

Gastrointestinal: nausea, anorexia, vomiting, abdominal cramps, bloating, cholestatic jaundice, increase or decrease in body weight.

Genitourinary: sodium and water retention.

Endocrine and metabolic: breast tenderness, gynecomastia, reduced potency and feminization.

CNS: headaches, mental depression, decrease of libido, nervousness, dizziness, fatigue, irritability.

Dermatologic – hypersensitivity: allergic reactions and rashes, chloasma.

Cardiovascular: an increase in blood pressure in susceptible individuals, aggravation of migraine headaches.

Hematologic: A statistically significant association has been demonstrated between the use of preparations containing estrogens and the following serious reactions: thrombophlebitis, pulmonary embolism and cerebral thrombosis. Although available evidence is suggestive of an association, such a relationship has been neither confirmed nor refuted for the following serious reactions: coronary thrombosis and neuro-ocular lesions (e.g., retinal thrombosis and optic neuritis); altered coagulation tests (increase in prothrombin and Factors VII, VIII, IX, X).

Miscellaneous: precipitation or aggravation of porphyria cutanea tarda in predisposed individuals.

Symptoms And Treatment Of Overdose: Symptoms: Estrogens may produce headache, nausea and vomiting, abdominal cramps, dizziness and general malaise.

Treatment: Symptomatic. Remove orally ingested drug by gastric lavage.

Dosage And Administration: Prostatic carcinoma is generally associated with elevated levels of serum acid and alkaline phosphatases, particularly if metastases have occurred. The therapeutic effects of diethylstilbestrol diphosphate can be estimated not only by the clinical picture but also by a return to normal values of the acid, and then the alkaline serum phosphatases. This normalization provides relevant criteria for dosage. Treatment is in 2 distinct stages: intensive initial dosage to induce palliation, followed by maintenance therapy to control further tumor growth.

Active tumor growth: 500 mg daily for 5 to 10 days, then 250 mg daily for 10 to 20 days by slow i.v. injection. Patients may experience mild pain or a sensation of tingling or warmth in the genito-anal area and frequently at metastatic sites during injections. Give the injection slowly in the supine position to avoid this problem as much as possible. Dilute the ampuls either with 5% dextrose in water or saline and administer by i.v. drip.

The total recommended daily dose should be added to 250 mL of 5% dextrose and water or saline. Allow infusion to proceed at a rate of 1 or 2 mL/minute during the first 10 to 15 minutes and then adjust the rate so that the remaining solution is infused within 1 hour.

Maintenance: I.V.: 250 to 500 mg 3 or 4 times weekly for 1 or 2 months, then 250 to 500 mg twice a week for 2 or 4 months, reducing to 250 mg weekly or at longer intervals, depending on clinical condition and/or serum phosphatase levels.

Oral: 83 or 166 mg 3 times daily, gradually reducing to the lowest daily dose that will control serum phosphatase levels.

Availability And Storage: Ampuls: Each ampul of injection contains: diethylstilbestrol diphosphate 250 mg (as diethylstilbestrol diphosphate sodium 300 mg). Nonmedicinal ingredients: none. pH: 7.5 to 9.0. Tartrazine-free. Ampuls of 5 mL, boxes of 10.

Tablets: Each white, round, flat, uncoated tablet, bisected on one side, with bevelled edge contains: diethylstilbestrol diphosphate 83 mg (as diethylstilbestrol diphosphate sodium 100 mg). Nonmedicinal ingredients: lactose, magnesium stearate, povidone and starch (contains gluten). Energy: 1.3 kJ (0.3 kcal). Tartrazine-free. Bottles of 25. (Shown in Product Recognition Section)

HONVOLĀ® Carter Horner Diethylstilbestrol Diphosphate Prostatic Carcinoma Therapy

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