Cytadren®

Class: Hormonal therapy

Generic Name: Aminoglutethimide (uh-MEE-noe-gloo-TETH-I-mide)
Trade Name: Cytadren®

For which conditions is this drug approved?

Aminoglutethimide is FDA approved for the treatment of Cushing’s syndrome.

It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.

What is the mechanism of action?

Aminoglutethimide is classified as an adrenal steroid inhibitor. Aminoglutethimide produces its effects by suppressing hormones that are produced by the adrenal glands. Normally, the hormones produced by adrenal glands stimulate the production of other hormones in the body, including estrogen, androgens, and corticosteroids. Cancer of the adrenal glands may be associated with excess steroid production in the body, which may ultimately cause Cushing’s syndrome. Aminoglutethimide suppresses the production of the steroids, resulting in a decrease in symptoms. Furthermore, estrogens and androgens may play a role in the growth of some types of cancer cells. Inhibiting their production may reduce the growth of cancers such as hormone responsive advanced breast and prostate cancers.

How is aminoglutethimide typically given (administered)?

Aminoglutethimide is given orally in the form of a tablet. Some patients may also receive steroids while they are taking aminoglutethimide to replace the steroids normally produced by the body.

How are patients typically monitored?

Patients will usually have scheduled meetings with their healthcare provider while they are being treated with aminoglutethimide. Patients will typically have blood tests to monitor hormones and steroid levels in their body. Patients may also be monitored for specific signs that indicate a hormone or steroid deficiency, such as nausea, vomiting, weight loss, poor appetite, dizziness, diarrhea and weakness. Patients should contact their healthcare provider if they are experiencing these symptoms.

What are the common (occur in 30% or more of patients) side effects of treatment with aminoglutethimide?

• Fatigue
• Drowsiness
• Nausea and loss of appetite
• Skin rash

What are the less common (occur in 10% to 29% of patients) side effects of treatment with aminoglutethimide?

• Problems with balance, coordination and mobility
• Dizziness
• Low blood pressure
• Headache
• Jaundice
• Muscle aches
• Lung damage
• Kidney damage

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• Maintain adequate rest and nutrition.
• Take tablets with food or water in divided doses to reduce the risk of nausea
• Eat small meals frequently to help alleviate nausea
• Patients may feel dizzy when getting up quickly after sitting or lying down, so getting up slowly may reduce this effect.
• Patients should avoid drinking alcohol to reduce the risk of drowsiness and dizziness.

Are there any special precautions patients should be aware of before starting treatment?

• Patients should tell their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, infection, heart disease, kidney disease, liver disease, lung disease, thyroid disease, etc.) as they may worsen with this drug.
• Patients should inform their physician if they have ever had convulsions or seizures.
• Patients should inform their physician about any other medication they are taking (whether prescription or over the counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
• Patients should use caution when driving or operating heavy machinery, as aminoglutethimide may affect balance and coordination and may cause drowsiness.
• Patients who miss an oral dose should not double up the dose, but instead should contact their physician. • Patients should keep tablets out of the reach of children and return any unused tablets to the pharmacy for safe disposal if treatment is terminated.

When should patients notify their physician?

• Extreme weight loss
• Extreme loss of balance, coordination or dizziness
• Severe nausea
• Diarrhea
• Severe or prolonged fatigue or drowsiness
• Difficulty breathing or fast breathing
• Persistant skin rash
• Allergic reaction (hives, itching, tightness of chest, fast heart beat, swelling of tongue, lips or throat, etc)

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

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