Applies to the following strength(s): 500 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Adrenal Cortical Carcinoma
-Initial Dose: 2 to 6 g orally per day in 3 to 4 divided doses
-Maintenance Dose: 9 to 10 g orally per day in 3 to 4 divided doses
-Maximum Dose: May increase up to 16 g orally per day, if tolerated, in 3 to 4 divided doses; the highest doses used in studies were 18 to 19 g per day.
-Duration of Therapy: Treatment should be continued as long as clinical benefits are observed.
-Increase total daily dose incrementally.
-Treatment should be instituted in the hospital until a stable dosage regimen is achieved.
-Data suggests continuous treatment with the maximum possible dosage is the best approach; patients who have been treated intermittently (i.e., therapy restarted when severe symptoms have reappeared) often do not respond after the third or fourth such course.
Use: Treatment of inoperable adrenal cortical carcinoma of both functional and nonfunctional types
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Use with caution in patients with liver disease.
Severe Side Effects Occur During Treatment:
-Reduce dose until the maximum tolerated dose is achieved; if the patient can tolerate higher doses and improved clinical response appears possible, increase dose until adverse reactions interfere.
US BOXED WARNING:
-Adrenal Insufficiency: This drug should be temporarily discontinued immediately following shock or severe trauma since adrenal suppression is its prime action. In such circumstances, exogenous steroids should be administered since the depressed adrenal may not immediately start to secrete steroids.
-Experienced Physician: This drug should be administered under the supervision of a qualified physician experienced in the uses of cancer chemotherapeutic agents.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available; however, this drug is not likely to be dialyzable because of its lipophilic nature.
-Drug tablets should not be crushed.
-If contact with crushed and/or broken tablets occurs, the affected area should be immediately washed.
-Handling and disposal of this drug should be performed in a manner consistent with safe procedures for cytotoxic agents.
-Impervious gloves should be worn when handling bottles containing this drug to minimize the risk of dermal exposure.
-Clinical benefits/effectiveness may include maintenance of clinical status; slowing of metastatic lesion growth; tumor mass reduction; pain reduction, weakness or anorexia; reduction of symptoms and signs due to excessive steroid production.
-If no clinical benefits are observed after 3 months at the maximum tolerated dose (MTD), the case would be considered a clinical failure; however, 10% of patients who showed a measurable response required more than 3 months at the MTD.
-Early diagnosis and prompt treatment institution improve the probability of a positive clinical response.
-No proven antidotes have been established for overdosage with this drug. Prolonged observation for toxicity is required due to this drug's long half-life.
-Endocrine: Signs/symptoms of adrenal insufficiency; free cortisol and corticotropin (ACTH) levels (if steroid replacement therapy needed)
-Hematological: Red blood cell, white blood cell, and platelet counts (during treatment)
-Hepatic: Liver function tests (periodically, especially during the first months of treatment or during dose increases)
-Nervous System: Behavioral and neurological assessments (regular intervals, especially when plasma levels of this drug exceed 20 mg/L)
-Toxicity: Plasma levels of drug (during treatment to avoid toxic levels; after treatment discontinuation to determine when contraception use can be stopped)
-Talk with your doctor if you have a fever, infection, surgery, or are hurt while taking this drug as you may need extra doses of oral steroids to help your body deal with these stresses.
-This drug may cause harm to an unborn baby; talk to your doctor about birth control that you should use during treatment and how long you need to use this birth control after you stop taking this drug.
-Rise slowly from a sitting or lying down position and use care when climbing stairs to lower the chances of feeling dizzy or passing out while taking this drug.
-If any area of your body comes into contact with broken or crushed tablets, wash that area right away and contact your doctor.
-You should not take extra doses or 2 doses at the same time; talk to your doctor about how to handle missed doses.
-This drug may cause side effects such as drowsiness and confusion that can affect your ability to perform certain activities; avoid driving and activities such as operating machinery until you know how this drug affects you.
-Caregivers should wear disposable gloves when handling this drug.
-Pregnant women should not touch or have any contact with this drug.
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