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90 Cards in this Set
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- Back
- 3rd side (hint)
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What class of drugs does Soriatane belong to?
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retinoid
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pg 11 of emodule
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What is the generic name for Soriatane?
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acitretin
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pg 11
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What doses does Soriatane come in?
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10mg, 17.5mg, 25mg (The module still has 22.5mg)
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pg 11
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What form does Soriatane come in?
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gelatin capsules
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pg 11
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How should Soriatane therapy be initated?
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25 to 50 mg per day, given as a single dose with the main meal
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pg 11
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Acitretin is a metabolite of what?
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etretinate
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pg 11
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What is acitretin related to?
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retinoic acid and retinol (vitamin A)
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pg 11
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What color is acitretin powder?
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yellow to greenish-yellow
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pg 11
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What is the Soriatane indication?
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Soriatane is indicated for the treatment of severe plaque psoriasis in adults.
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pg 12
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Who should prescribe Soriatane?
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Because of significant adverse effects associated with its use, Soriatane should be prescribed only by those knowledgeable in the systemic use of retinoids and understand the risk of teratogenicity
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pg 26
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Should Soriatane be used in women of reproductive potential?
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In women of reproductive potential, Soriatane should be reserved for nonpregnant patients who are unresponsive to other therapies or whose clinical condition contraindicates the use of other treatments.
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pg 12
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What can patients expect if they discontinue and then restart taking Soriatane?
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Most patients experience relapse of psoriasis after discontinuing therapy. Subsequent courses, when clinically indicated, have produced efficacy similar to the initial course of therapy.
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pg 12
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What is the maintenance dose of Soriatane?
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Maintenance doses of 25 to 50mg per day may be given dependent upon an individual patient's response to initial treatment
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pg 14
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How should Soriatane be dosed if used with phototherapy?
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Soriatane is not indicated for use with phototherapy, however, there is some safety information on this topic in the Prescribing Information under DOSAGE & ADMINISTRATION: When Soriatane is used with phototherapy, the prescriber should decrease the phototherapy dose, dependent on the patient's individual response. and additional information under PRECAUTIONS: Significantly lower doses of phototherapy are required when Soriatane is used because Soriatane-induced effects on the stratum corneum can increase the risk of erythema(burning).
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pg 14
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How does intersubject variation in the pharmacokinetics, clinical efficacy and incidence of side effects affect dosing?
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A number of the more common side effects are dose related Individualization of dosage is required to achieve sufficient therapeutic response while minimizing side effects. Soriatane therapy should be initiated at 25 to 50 mg per day given as a single dose with the main meal
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pg 14
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How should Soriatane be stored?
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Store between 15 & 25 degrees C (59-77 F). Protect from light. Avoid exposure to high temperatures and humidity after the bottle is opened.
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pg 16
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What are the two black box warnings?
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Teratogenicity and Hepatotoxicity
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Can Soriatane be used in women of child bearning potential or who are pregnant?
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Soriatane must not be used by women who are pregnant, or who intend to become pregnant during therapy or any time for at least 3 years following discontinuation of therapy.
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pg 20
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How long must women use reliable contraception after discontinuing Soriatane therapy?
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3 years
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pg 20
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What is the brand name of etretinate?
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Tegison (no longer available in the US)
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pg 20
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Why can't Soriatane be given to women who are or may become pregnant?
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Major fetal abnormalities associated with acitretin and/or etretinate administration have been reported.
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What happens with concurrent ingestion of acitretin and ethanol?
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Clinical evidence has shown that concurrent ingestion of acitretin and ethanol has been associated with the formation of etretinate, which has a significantly longer elimination half-life than acitretin
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pg 22
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Should female patients avoid alcohol?
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Because the longer elimination half-life of etretinate would increase the duration of the teratogenic potential for female patients, ethanol must not be ingested by female patients either during treatment or for 2 months after cessation of therapy.
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pg 22
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How long after discontinuing Soriatane therapy should female patients wait before consuming alcohol?
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2 months
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pg 22
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What is the process called when acitretin converts to etretinate?
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transesterification
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pg 22
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What does Do Your P.A.R.T. stand for?
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Pregnancy Prevention Actively Required During and After Treatment
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pg 28
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Why was the Do Your PART program developed?
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To educated women of childbearing potential and their healthcare providers about the serious risks associated with acitretin and to help prevent pregnancies from occuring during the use of this drug and for 3 years after its discontinuation
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pg 28
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What are the 5 criteria that a woman of reproductive potential must meet before taking Soriatane?
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2 negative urine or serum pregnancy tests, pregnanacy test must be repeated every month during treatment and every 3 months for 3 years after discontinuing Soriatane, must use 2 effective forms of contraception simultaneously, must use 2 forms of birth control for 1 month prior to initiation of therapy, during therapy and for at least 3 years after discontinuing therapy, must have a signed Patient Agreement/Informed Consent for Female Patients
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pg 30
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Can patients take St John's Wort while on Soriatane?
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Patients should be prospectively cautioned not to self-medicate with the herbal supplement St John's Wort because of a possible interaction has been suggested with hormonal contraceptives. Pregnancies have been reported by users of combined hormonal contraceptives who also used some form of St John's Wort
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pg 31
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Is the microdosed "minipill" recommended for use with Soriatane?
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No
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pg 31
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Are progestational implants and injectables adequate methods of contraception?
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It is not known
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pg 31
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How many forms of effective birth control must a female patient for Soriatane therapy?
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two
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pg 32
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What is the mean elimination half-life of Soriatane?
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49 hours
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pg 35
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What is the mean elimination half-life of etretinate?
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120 days
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pg 35
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Etretinate was found in plasma and subcutaneous fat in 1 patient reported to have had sporadic alcohol intake how long after discontinuing Soriatane therapy?
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52 months (4 years and 4 months)
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pg 35
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How long should a patient wait to donate blood after discontinuing Soriatane & why?
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Patients should not donate blood during and for at least 3 years after the completion of therapy with Soriatane because women of childbearing potential must not receive blood from patients being treated with Soriatane.
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pg 36
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How much Soriatane is transferred to the female via semen?
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125ng, which is 1/200,000 of a single 25mg capsule
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pg 38
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If a male is taking Soriatane, will it harm the fetus if a child is conceived?
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Although it appears that residual acitretin in seminal fluid poses little if any risk to fetus while a male patient is tking the drug or after it has been discontinued, the no-effect limit for teratogenicity is unknown
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pg 38
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When should a Soriatane Medication Guide be given to the patient?
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Each time Soriatane is dispensed as required by law
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pg 41
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What is the pregnancy category for Soriatane?
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X
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pg 44
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What comorbidities are contraindications for Soriatane?
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Patients with severely impaired liver or kidney function and in patients with chronic abnormally elevated blood lipid values
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pg 44
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An increased risk of hepatitis has been reported to result from the combined use of what to drugs?
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methotrexate and etretinate, consequently, the combination of methotrexate and Soriatane is contraindicated.
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pg 44
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What two drugs can both cause increased intrcranial pressure and as a result their combined use is contraindicated?
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tetracyclines and Soriatane
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pg 44
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What did the US trial data show regarding Hepatotoxicity?
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Of the 525 patients treated in US clinical trials, 2 had clinical jaundice with elevated serum bilirubin and transaminases considered related to treatment with Soriatane. Liver function test results in these patients returned to normal after Soriatane was discontinued.
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pg 46
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What did the European clinical trial data show regarding Hepatoxicity?
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Two of the 1289 patients treated developed biopsy confirmed toxic hepatitis. A second biopsy in 1 of these patients revealed nodule formation suggestive of cirrhosis.
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pg 47
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What did the Canadian clinical trial data show regarding Hepatotoxicity?
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One patient out of 63 developed a three-fold increase of transaminases. A liver biopsy of this patient showed mild lobular disarray, multifocal hepatocyte loss, and mild triaditis of the portal tracts compatible with acute reversible hepatic injury. The patient's transaminase levels returned to normal 2 months after Soriatane was discontinued
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pg 48
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What were the liver biopsy results from the Open Label Hepatotoxicity Study?
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49 (58%) patients showed no change, 21 (25%) improved and 14 (17%) had a worsening of their liver biopsy status
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pg 49
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Is there a concern regarding hepatotoxicity and cummulative dose of Soriatane?
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No cummulative dose relationship was found
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pg 49
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Elevations of AST, ALT, GGT and LDH have occurred in approximately how many patients treated with Soriatane?
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1 in 3
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pg 50
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What percentage of patients discontinued clinical trials in the US due to elevated liver function test results?
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3.8% (20 patients)
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pg 50
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What should be done if hepatotoxicity is suspected during treatment with Soriatane?
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The drug should be discontinued and the cause further investigated
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pg 50
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Define hyperostosis
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Abnormal growth of bone
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pg 52/glossary
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How should patients be monitored for hyperostosis?
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In adults receiving long-term treatment with Soriatane, appropriate examinations should be periodically performed in view of possible ossification abnormalities. Because the frequency and severity of iatrogenic bony abnormality in adults is low, periodic radiography is warranted only in the presence of symptoms or long-term use of Soriatane.
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pg 52
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What is the warning for Lipids and Possible Cardiovascular Effects
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Blood lipid determinations should be perfromed before Soriatane is administered and again at intervals of 1 to 2 weeks until the lipid response to the drug is established, usually within 4-8 weeks.
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pg 55
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In clinical trials, what percent of patients experienced elevation in triglycerides and cholesterol respectively?
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66% elevation of triglycerides & 33% elevation of cholesterol
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pg 56
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What percentage of patients experienced a decrease in HDLs?
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40%
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pg 56
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Hypertriglyceridemia and lowered HDL may increase a patients….
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cardiovascular risk status
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pg 59
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What should be done to control significant elevations of triglycerides?
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Dietary modifications, reduction in dose of Soriatane, or drug therapy
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pg 59
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What are 5 ophthalmologic side effects of Soriatane?
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Dry eyes (23%), irritation of eyes (9%), brow & lash loss (5%), less than 5% blurred vision and decreased night vision
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pg 60
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What percentage of patients experienced lipid elevations?
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25 -50%
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pg 61
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Define psuedotumor cerebri
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benign intracranial hypertension
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pg 62
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What does DISH stand for?
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Diffuse idiopathic skeletal hyperostosis
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pg 63
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How long should patients be advised that they may have to wait before they experience the full benefit of Soriatane?
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2 to 3 months
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pg 74
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Concomitant administration of vitamin A and/or other oral retinoids with acitretin must be avoided because of the risk of what?
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hypervitaminosis A
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pg 89
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What are the symptoms of overdose?
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identical to acute hypervitaminosis A, ie headache and vertigo
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pg 101
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Hypervitaminosis A produces a wide spectrum of signs and symptoms, what are the primary systems affected?
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mucocutaneous, musculoskeletal, hepatic, neuropsychiatric and central nervous systems
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pg 102
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What adverse events were reported during postapproval use of Soriatane?
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Cardiovascular - Acute myocardial infarction, thromboembolism, stroke, Nervous System - Myopathy with peripheral neuropathy, Psychiatric - Aggressive feelings and/or thoughts of suicide, Reproductive - Vulvo-vaginitis due to Candida albicans, Skin & Appendages - Thinning of the skin, skin fragility, scaling, nail fragility
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pg 104
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During clinical trials with Soriatane what percentage of patients reported adverse events?
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98%
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pg 105
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What percentage of patients left the clinical trials prematurely due to adverse experiences involving the mucous membranes and skin?
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22%
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pg 105
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What was the most common adverse event reported?
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Cheilitis
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pg 107
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What lab test produced the most abnormal results in the clinical trials?
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Increased Triglycerides
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pg 113
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What two drugs are contraindicated with Soriatane?
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Methotrexate and tetracycline
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What is the most prevalent autoimmune disease?
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psoriasis
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What percentage of psoriasis patients have plaque psoriasis?
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80%
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What are the two causes of psoriasis?
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genetic and environmental factors
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What is another name for plaque psoriasis?
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psoriasis vulgaris
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Where is plaque psoriasis typically located?
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elbows, knees, scalp, lower back
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What are the 2 sub-layers of the epidermis?
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stratum corneum & basal layer
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What 3 types of cells make up the epidermis?
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keratynocytes, melanocytes, and Langerhans cells
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Why did 20 patients or 3.8% of the 525 patients treated in clinical trials in the US discontinue treatments?
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Elevated Liver Function Test Results
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A _______ increase in acitretin plasma concentrations was seen in elderly vs young subjects
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two-fold
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pg 114
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What is the mechanism of action of Soriatane?
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Unknown
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pg 116
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Maximum plasma concentrations were achieved in how many hours?
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2 to 5
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pg 118
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How is Soriatane and its metabolites excreted?
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both feces and urine
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pg 121
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When is oral absorption of acitretin optimized?
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When given with food
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pg 118
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What does a decreasing Physician's Global Evaluation Score indicate?
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Sypmtoms of psoriasis are improving
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pg 130
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What was the average daily dose of Soriatane during the open label phase of Study A?
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42.8mg
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pg 132
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What was the average daily dose of Soriatane during the open label phase of Study B?
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43.1mg
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pg 134
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What should a Soriatane patient do if they are experiencing visual difficulties?
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discontinue Soriatane therapy and undergo ophthalmologic evaluation
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pg 147
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What medication when taking concurrently with Soriatane may increase the risk of toxicity?
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Vitamin A supplements
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pg 148
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