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pralatrexate
Overview
What is Folotyn?
FOLOTYN (pralatrexate injection) contains pralatrexate, which is an antineoplastic folate analog. Pralatrexate has the chemical name (2)-2-[[4-[(1)-1-[(2, 4-diaminopteridin-6-yl)methyl]but-3-ynyl]benzoyl]amino]pentanedioic acid. The structural formula is as follows:
Pralatrexate is a 1:1 racemic mixture of - and - diastereomers at the C10 position (indicated with *).
The molecular formula is CHNO and the molecular weight is 477.48 g/mol.
Pralatrexate is an off-white to yellow solid. It is soluble in aqueous solutions at pH 6.5 or higher. Pralatrexate is practically insoluble in chloroform and ethanol. The pKa values are 3.25, 4.76, and 6.17.
FOLOTYN is supplied as a preservative-free, sterile, isotonic, non-pyrogenic clear yellow aqueous parenteral solution contained in a single-dose clear glass vial (Type I) for intravenous administration. Each 1 mL of solution contains 20 mg of pralatrexate, sufficient sodium chloride to achieve an isotonic (280-300 mOsm) solution, and sufficient sodium hydroxide, and hydrochloric acid if needed, to adjust and maintain the pH at 7.5-8.5. FOLOTYN is supplied as either 20 mg (1 mL) or 40 mg (2 mL) single-dose vials at a concentration of 20 mg/mL.
What does Folotyn look like?
What are the available doses of Folotyn?
FOLOTYN is available as a clear yellow solution in sterile, single-dose vials containing pralatrexate at a concentration of 20 mg/mL in the following presentations:
20 mg of pralatrexate in 1 mL solution in a vial (20 mg / 1 mL)40 mg of pralatrexate in 2 mL solution in a vial (40 mg / 2 mL)
What should I talk to my health care provider before I take Folotyn?
How should I use Folotyn?
FOLOTYN is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is based on overall response rate. Clinical benefit such as improvement in progression-free survival or overall survival has not been demonstrated.
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What interacts with Folotyn?
Sorry No Records found
What are the warnings of Folotyn?
Sorry No Records found
What are the precautions of Folotyn?
Sorry No Records found
What are the side effects of Folotyn?
Sorry No records found
What should I look out for while using Folotyn?
None
What might happen if I take too much Folotyn?
No specific information is available on the treatment of overdosage of FOLOTYN. If an overdose occurs, general supportive measures should be instituted as deemed necessary by the treating physician. Based on FOLOTYN's mechanism of action, consider the prompt administration of leucovorin.
How should I store and handle Folotyn?
Protect VISIPAQUE from direct exposure to sunlight.Store VISIPAQUE at controlled room temperature, 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].VISIPAQUE may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.Protect VISIPAQUE from direct exposure to sunlight.Store VISIPAQUE at controlled room temperature, 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].VISIPAQUE may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.Protect VISIPAQUE from direct exposure to sunlight.Store VISIPAQUE at controlled room temperature, 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].VISIPAQUE may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.Protect VISIPAQUE from direct exposure to sunlight.Store VISIPAQUE at controlled room temperature, 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].VISIPAQUE may be stored in a contrast media warmer for up to one month at 37°C (98.6°F).Do not freeze. Discard any product that is inadvertently frozen, as freezing may compromise the closure integrity of the immediate container.FOLOTYN is available in single-dose clear glass vials containing pralatrexate at a concentration of 20 mg/mL as a preservative-free, sterile, clear yellow solution individually packaged for intravenous use in the following presentations: NDC 48818-001-01:NDC 48818-001-02:Vials must be stored refrigerated at 2-8°C (36-46°F) ( USP Controlled Cold Temperature) in original carton to protect from light. Handle and dispose of FOLOTYN according to guidelines issued for cytotoxic drugs, including the use of gloves and other protective clothing to prevent skin contact []. Each vial of FOLOTYN is intended for single use only. Any unused drug remaining after injection must be discarded. FOLOTYN is available in single-dose clear glass vials containing pralatrexate at a concentration of 20 mg/mL as a preservative-free, sterile, clear yellow solution individually packaged for intravenous use in the following presentations: NDC 48818-001-01:NDC 48818-001-02:Vials must be stored refrigerated at 2-8°C (36-46°F) ( USP Controlled Cold Temperature) in original carton to protect from light. Handle and dispose of FOLOTYN according to guidelines issued for cytotoxic drugs, including the use of gloves and other protective clothing to prevent skin contact []. Each vial of FOLOTYN is intended for single use only. Any unused drug remaining after injection must be discarded. FOLOTYN is available in single-dose clear glass vials containing pralatrexate at a concentration of 20 mg/mL as a preservative-free, sterile, clear yellow solution individually packaged for intravenous use in the following presentations: NDC 48818-001-01:NDC 48818-001-02:Vials must be stored refrigerated at 2-8°C (36-46°F) ( USP Controlled Cold Temperature) in original carton to protect from light. Handle and dispose of FOLOTYN according to guidelines issued for cytotoxic drugs, including the use of gloves and other protective clothing to prevent skin contact []. Each vial of FOLOTYN is intended for single use only. Any unused drug remaining after injection must be discarded. FOLOTYN is available in single-dose clear glass vials containing pralatrexate at a concentration of 20 mg/mL as a preservative-free, sterile, clear yellow solution individually packaged for intravenous use in the following presentations: NDC 48818-001-01:NDC 48818-001-02:Vials must be stored refrigerated at 2-8°C (36-46°F) ( USP Controlled Cold Temperature) in original carton to protect from light. Handle and dispose of FOLOTYN according to guidelines issued for cytotoxic drugs, including the use of gloves and other protective clothing to prevent skin contact []. Each vial of FOLOTYN is intended for single use only. Any unused drug remaining after injection must be discarded. FOLOTYN is available in single-dose clear glass vials containing pralatrexate at a concentration of 20 mg/mL as a preservative-free, sterile, clear yellow solution individually packaged for intravenous use in the following presentations: NDC 48818-001-01:NDC 48818-001-02:Vials must be stored refrigerated at 2-8°C (36-46°F) ( USP Controlled Cold Temperature) in original carton to protect from light. Handle and dispose of FOLOTYN according to guidelines issued for cytotoxic drugs, including the use of gloves and other protective clothing to prevent skin contact []. Each vial of FOLOTYN is intended for single use only. Any unused drug remaining after injection must be discarded. FOLOTYN is available in single-dose clear glass vials containing pralatrexate at a concentration of 20 mg/mL as a preservative-free, sterile, clear yellow solution individually packaged for intravenous use in the following presentations: NDC 48818-001-01:NDC 48818-001-02:Vials must be stored refrigerated at 2-8°C (36-46°F) ( USP Controlled Cold Temperature) in original carton to protect from light. Handle and dispose of FOLOTYN according to guidelines issued for cytotoxic drugs, including the use of gloves and other protective clothing to prevent skin contact []. Each vial of FOLOTYN is intended for single use only. Any unused drug remaining after injection must be discarded.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Pralatrexate is a folate analog metabolic inhibitor that competitively inhibits dihydrofolate reductase. It is also a competitive inhibitor for polyglutamylation by the enzyme folylpolyglutamyl synthetase. This inhibition results in the depletion of thymidine and other biological molecules the synthesis of which depends on single carbon transfer.
Non-Clinical Toxicology
NoneSerotonergic Drugs
Based on the mechanism of action of SNRIs and SSRIs including citalopram, and the potential for serotonin syndrome, caution is advised when citalopram is coadministered with other drugs that may affect the serotonergic neurotransmitter systems, such as triptans, linezolid (an antibiotic which is a reversible non-selective MAOI), lithium, tramadol, or St. John's Wort (see -Serotonin Syndrome). The concomitant use of citalopram with other SSRIs, SNRIs or tryptophan is not recommended (see - ).
Triptans
There have been rare postmarketing reports of serotonin syndrome with use of an SSRI and a triptan. If concomitant treatment of citalopram with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases (see - Serotonin Syndrome).
CNS Drugs
Given the primary CNS effects of citalopram, caution should be used when it is taken in combination with other centrally acting drugs.
Alcohol
Although citalopram did not potentiate the cognitive and motor effects of alcohol in a clinical trial, as with other psychotropic medications, the use of alcohol by depressed patients taking citalopram is not recommended.
Monoamine Oxidase Inhibitors (MAOIs) - See and .
Drugs That Interfere With Hemostasis (NSAIDs, Aspirin, Warfarin, etc.)
Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have also shown that concurrent use of an NSAID or aspirin may potentiate the risk of bleeding. Altered anticoagulant effects, including increased bleeding, have been reported when SSRIs and SNRIs are coadministered with warfarin. Patients receiving warfarin therapy should be carefully monitored when citaloram is initiated or discontinued.
Cimetidine
In subjects who had received 21 days of 40 mg/day citlaopram, combined administration of 400 mg/day cimetidine for 8 days resulted in an increase in citalopram AUC and C of 43% and 39%, respectively.
Citalopram 20 mg/day is the maximum recommended dose for patients taking concomitant cimetidine because of the risk of QT prolongation (see and ).
Digoxin
In subjects who had received 21 days of 40 mg/day citalopram, combined administration of citalopram and digoxin (single dose of 1 mg) did not significantly affect the pharmacokinetics of either citalopram or digoxin.
Lithium
Coadministration of citalopram (40 mg/day for 10 days) and lithium (30 mmol/day for 5 days) had no significant effect on the pharmacokinetics of citalopram or lithium. Nevertheless, plasma lithium levels should be monitored with appropriate adjustment to the lithium dose in accordance with standard clinical practice. Because lithium may enhance the serotonergic effects of citalopram, caution should be exercised when citalopram and lithium are coadministered.
Pimozide
In a controlled study, a single dose of pimozide 2 mg co-administered with citalopram 40 mg given once daily for 11 days was associated with a mean increase in QTc values of approximately 10 msec compared to pimozide given alone. Citalopram did not alter the mean AUC or C of pimozide. The mechanism of this pharmacodynamic interaction is not known.
Theophylline
Combined administration of citalopram (40 mg/day for 21 days) and the CYP1A2 substrate theophylline (single dose of 300 mg) did not affect the pharmacokinetics of theophylline. The effect of theophylline on the pharmacokinetics of citalopram was not evaluated.
Sumatriptan
There have been rare postmarketing reports describing patients with weakness, hyperreflexia, and incoordination following the use of a SSRI and sumatriptan. If concomitant treatment with sumatriptan and an SSRI (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram) is clinically warranted, appropriate observation of the patient is advised.
Warfarin
Administration of 40 mg/day citalopram for 21 days did not affect the pharmacokinetics of warfarin, a CYP3A4 substrate. Prothrombin time was increased by 5%, the clinical significance of which is unknown.
Carbamazepine
Combined administration of citalopram (40 mg/day for 14 days) and carbamazepine (titrated to 400 mg/day for 35 days) did not significantly affect the pharmacokinetics of carbamazepine, a CYP3A4 substrate. Although trough citalopram plasma levels were unaffected, given the enzyme-inducing properties of carbamazepine, the possibility that carbamazepine might increase the clearance of citalopram should be considered if the two drugs are coadministered.
Triazolam
Combined administration of citalopram (titrated to 40 mg/day for 28 days) and the CYP3A4 substrate triazolam (single dose of 0.25 mg) did not significantly affect the pharmacokinetics of either citalopram or triazolam.
Ketoconazole
Combined administration of citalopram (40 mg) and ketoconazole (200 mg) decreased the C and AUC of ketoconazole by 21% and 10%, respectively, and did not significantly affect the pharmacokinetics of citalopram.
CYP2C19 Inhibitors
Citalopram 20 mg/day is the maximum recommended dose for patients taking concomitant CYP2C19 inhibitors because of the risk of QT prolongation (see , , AND ).
Metoprolol
Administration of 40 mg/day citlaopram for 22 days resulted in a two-fold increase in the plasma levels of the beta-adrenergic blocker metoprolol. Increased metoprolol plasma levels have been associated with decreased cardioselectivity. Coadministration of citalopram and metoprolol had no clinically significant effects on blood pressure or heart rate.
Imipramine and Other Tricyclic Antidepressants (TCAs)
In vitro
Electroconvulsive Therapy (ECT)
There are no clinical studies of the combined use of electroconvulsive therapy (ECT) and citalopram.
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 . Administer vitamin B and instruct patients to take folic acid to reduce the risk of treatment-related hematological toxicity [].
The following serious adverse reactions are described below and elsewhere in the labeling:
The most common adverse reactions observed in patients with peripheral T-cell lymphoma (PTCL) treated with FOLOTYN were mucositis, thrombocytopenia, nausea, and fatigue.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
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