View source for Pralatrexate

{{DrugProjectFormSinglePage
|authorTag={{AP}}
|genericName=Pralatrexate
|aOrAn=an
|drugClass=[[antimetabolite]], [[antineoplastic agent]]
|indicationType=treatment
|indication=patients with relapsed or refractory [[peripheral T-cell lymphoma]] ([[PTCL]])
|adverseReactions=[[edema]], [[constipation]], [[nausea]], [[anemia]], [[neutropenia]], [[thrombocytenia]], [[cough]] and [[fatigue]]
|blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b>
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Pralatrexate in adult patients.
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Pralatrexate in adult patients.
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Pralatrexate in pediatric patients.
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Pralatrexate in pediatric patients.
|contraindications=None
|warnings=====Bone Marrow Suppression====
*FOLOTYN can cause [[bone marrow suppression]], manifested by [[thrombocytopenia]], [[neutropenia]], and/or [[anemia]]. Monitor complete blood counts and omit and/or reduce the dose based on [[ANC]] and [[platelet]] count prior to each dose as outlined in Section 2.2 TABLE 2. Administer [[vitamin B12]] and instruct patients to take [[folic acid]] to reduce the risk of treatment-related hematological toxicity. 

====Mucositis====
*FOLOTYN can cause [[mucositis]]. Monitor for [[mucositis]] weekly and if ≥ Grade 2 [[mucositis]] is observed, omit and/or reduce the dose as outlined in Section 2.2 TABLE 1. Administer [[vitamin B12]] and instruct patients to take folic acid to reduce the risk of [[mucositis]].

====Dermatologic Reactions====
*FOLOTYN can cause severe dermatologic reactions, which may result in death. These dermatologic reactions have been reported in clinical studies (14/663 patients [2.1%]) and post marketing experience, and have included [[skin exfoliation]], [[ulceration]], and [[toxic epidermal necrolysis]] ([[TEN]]).  They may be progressive and increase in severity with further treatment, and may involve skin and subcutaneous sites of known [[lymphoma]].  Monitor patients with dermatologic reactions closely, and if severe, withhold or discontinue FOLOTYN. 

====Tumor Lysis Syndrome====
*FOLOTYN can cause [[tumor lysis syndrome]] ([[TLS]]). Monitor patients who are at increased risk of [[TLS]] and treat promptly.

====Hepatic Toxicity====
*FOLOTYN can cause [[hepatic toxicity]] and [[liver function test]] abnormalities. Persistent liver function test abnormalities may be indicators of hepatic toxicity and require dose modification or discontinuation. Monitor [[liver function tests]]. Omit dose until recovery, adjust or discontinue therapy based on the severity of the hepatic toxicity. 

====Risk of Increased Toxicity in the Presence of Impaired Renal Function====
*Patients with moderate to severe [[renal function impairment]] may be at greater risk for increased exposure and toxicity. Monitor patients for renal function and systemic toxicity and adjust dosing accordingly.
*Serious adverse drug reactions including [[toxic epidermal necrolysis]] and [[mucositis]] were reported in patients with [[end stage renal disease]] ([[ESRD]]) undergoing dialysis who were administered FOLOTYN therapy. Avoid FOLOTYN use in patients with [[end stage renal disease]] including those undergoing [[dialysis]] unless the potential benefit justifies the potential risk.

====Embryo-Fetal Toxicity====
*FOLOTYN can cause fetal harm when administered to a pregnant woman. FOLOTYN was embryotoxic and fetotoxic in rats and rabbits. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
|clinicalTrials=The following serious adverse reactions are described below and elsewhere in the labeling:
*[[Bone Marrow Suppression]]
*[[Mucositis]]
*[[Dermatologic Reactions]] 
*[[Tumor Lysis Syndrome]]
*[[Hepatic Toxicity]] 

The most common adverse reactions observed in patients with [[peripheral T-cell lymphoma]] ([[PTCL]]) treated with FOLOTYN were [[mucositis]], [[thrombocytopenia]], [[nausea]], and [[fatigue]].

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. The safety of FOLOTYN was evaluated in 111 PTCL patients in a single-arm clinical study in which patients received a starting dose of 30 mg/m2 once weekly for 6 weeks in 7-week cyc

====Most Frequent Adverse Reactions====
TABLE 4 summarizes the most frequent adverse reactions, regardless of causality, using the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE, version 3.0).

[[file:Pralatrexate AR1.png|none|400px]]
|alcohol=Alcohol-Pralatrexate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
}}
{{Refimprove|date=June 2007}}
{{drugbox |
| IUPAC_name        = ''N''-[4-[1-[(2,4-Diamino-6-pteridinyl)methyl]<br>-3-butynyl]benzoyl]-L-glutamic acid 
| image             = Pralatrexate.png
| CAS_number        = 146464-95-1
| ATC_prefix        = 
| ATC_suffix        = 
| PubChem           = 725808
| DrugBank          = 
| C = 23 | H = 23 | N = 7 | O = 5
| molecular_weight  = 477.47 g/mol
| bioavailability   = 
| protein_bound     = 
| metabolism        = 
| elimination_half-life = 
| excretion         = 
| pregnancy_AU      =  <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_US      =  <!-- A / B            / C / D / X -->
| pregnancy_category=  
| legal_AU          =  <!-- Unscheduled / S2 / S3 / S4 / S5 / S6 / S7 / S8 / S9 -->
| legal_CA          =  <!--             / Schedule I, II, III, IV, V, VI, VII, VIII -->
| legal_UK          =  <!-- GSL         / P       / POM / CD / Class A, B, C -->
| legal_US          =  <!-- OTC                   / Rx-only  / Schedule I, II, III, IV, V -->
| legal_status      = 
| routes_of_administration = 
}}

'''Pralatrexate''' ([[International Nonproprietary Name|rINN]]), also known as '''10-propargyl-10-deazaaminopterin''', common name PDX, is a drug candidate being studied for the treatment of cancer. PDX is a [[folate]] [[analog (chemistry)|analog]] [[Enzyme inhibitor|inhibitor]] of [[dihydrofolate reductase]]. As of July [[2005]], it is undergoing Phase 1 and Phase 2 [[clinical trials]] for treatment of [[non-Hodgkin lymphoma]] and non-small cell [[lung cancer]].

==External links==
*[http://www.allos.com/index.cfm?p2=26014210&category1=prod&category2=pdx&category3=x&category4=x&category5=x&category6=x Allos Therapeutics Information on PDX]

{{DEFAULTSORT:Propargyl-10-deazaaminopterin, 10-}}
[[Category:Dihydrofolate reductase inhibitors]]

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