Testolactone

TESLAC® (testolactone tablets, USP) is available for oral administration as tablets providing 50 mg testolactone per tablet. Testolactone is a synthetic antineoplastic agent that is structurally distinct from the androgen steroid nucleus in possessing a six-membered lactone ring in place of the usual five-membered carbocyclic D-ring. Testolactone is chemically designated as 13-hydroxy-3-oxo-13,17-secoandrosta-1,4-dien-17-oic acid δ-lactone. Graphic formula:

Inactive ingredients: calcium stearate, cornstarch, gelatin, and lactose. Testolactone is a white, odorless, crystalline solid, soluble in ethanol and slightly soluble in water.

In the U.S.

• Teslac

Available Dosage Forms:

• Tablet

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Androgen

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 testolactone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to testolactone 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.

Geriatric

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 or if they cause different side effects or problems in older people. There is no specific information comparing use of testolactone in the elderly with use in other age groups.

Pregnancy

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.

Interactions with 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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 testolactone. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart or kidney disease

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

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 as soon as possible if any of the following side effects occur:

• Numbness or tingling of fingers, toes, or face

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:

• Diarrhea
• loss of appetite
• nausea or vomiting
• pain or swelling in feet or lower legs
• swelling or redness of tongue

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.

Applies to testolactone: oral tablet

Gastrointestinal

Gastrointestinal effects including glossitis, anorexia, nausea, and vomiting have been reported.[Ref]

Cardiovascular

Cardiovascular effects including increase in blood pressure and edema of the extremities have been reported.[Ref]

Nervous system

Nervous system effects including paresthesia have been reported.[Ref]

Dermatologic

Dermatologic effects including maculopapular erythema have been reported. Alopecia, both with or without associated nail growth disturbance has been reported rarely.[Ref]

General

General effects including malaise and aches in the extremities have been reported.[Ref]

Some side effects of testolactone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.