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YONDELIS

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Overview

What is YONDELIS?

Trabectedin is an alkylating agent with the chemical name (1',6,6a,7,13,14,16)-5-(acetyloxy)-3',4',6,6a,7,13,14,16-octahydro-6',8,14-trihydroxy-7',9-dimethoxy-4,10,23-trimethyl-spiro[6,16-(epithiopropanoxymethano)-7,13-imino-12-1,3-dioxolo[7,8]isoquino[3,2-][3]benzazocine-20,1'(2')-isoquinolin]-19-one. The molecular formula is CHNOS. The molecular weight is 761.84 daltons. The chemical structure is shown below:

Trabectedin is hydrophobic and has a low solubility in water.

YONDELIS (trabectedin) for injection is supplied as a sterile lyophilized white to off-white powder/cake in a single-dose vial. Each single-dose vial contains 1 mg of trabectedin, 27.2 mg potassium dihydrogen phosphate, 400 mg sucrose, and phosphoric acid and potassium hydroxide (for pH adjustment to 3.6 – 4.2).



What does YONDELIS look like?



What are the available doses of YONDELIS?

For injection: 1 mg sterile lyophilized powder in a single-dose vial ()

What should I talk to my health care provider before I take YONDELIS?

How should I use YONDELIS?

YONDELIS is indicated for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen .

The recommended dose is 1.5 mg/m administered as an intravenous infusion over 24 hours through a central venous line every 21 days (3 weeks), until disease progression or unacceptable toxicity, in patients with normal bilirubin and AST or ALT less than or equal to 2.5 times the upper limit of normal.


What interacts with YONDELIS?

Sorry No Records found


What are the warnings of YONDELIS?

Sorry No Records found


What are the precautions of YONDELIS?

Sorry No Records found


What are the side effects of YONDELIS?

Sorry No records found


What should I look out for while using YONDELIS?

YONDELIS is contraindicated in patients with known severe hypersensitivity, including anaphylaxis, to trabectedin.


What might happen if I take too much YONDELIS?

There is no specific antidote for YONDELIS. Hemodialysis is not expected to enhance the elimination of YONDELIS because trabectedin is highly bound to plasma proteins (97%) and not significantly renally excreted.


How should I store and handle YONDELIS?

Store YONDELIS vials in a refrigerator at 2°C to 8°C (36°F to 46°F).YONDELIS is a cytotoxic drug. Follow applicable special handling and disposal procedures. Store YONDELIS vials in a refrigerator at 2°C to 8°C (36°F to 46°F).YONDELIS is a cytotoxic drug. Follow applicable special handling and disposal procedures. Etodolac Tablets USP, for oral administration, are available as:EStore at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].Store tablets in original container until ready to use.Dispense in light-resistant container.KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN.Etodolac Tablets USP, for oral administration, are available as:EStore at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].Store tablets in original container until ready to use.Dispense in light-resistant container.KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN.Etodolac Tablets USP, for oral administration, are available as:EStore at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].Store tablets in original container until ready to use.Dispense in light-resistant container.KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN.Etodolac Tablets USP, for oral administration, are available as:EStore at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].Store tablets in original container until ready to use.Dispense in light-resistant container.KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN.Etodolac Tablets USP, for oral administration, are available as:EStore at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].Store tablets in original container until ready to use.Dispense in light-resistant container.KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN.Etodolac Tablets USP, for oral administration, are available as:EStore at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].Store tablets in original container until ready to use.Dispense in light-resistant container.KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Trabectedin is an alkylating drug that binds guanine residues in the minor groove of DNA, forming adducts and resulting in a bending of the DNA helix towards the major groove. Adduct formation triggers a cascade of events that can affect the subsequent activity of DNA binding proteins, including some transcription factors, and DNA repair pathways, resulting in perturbation of the cell cycle and eventual cell death.

Non-Clinical Toxicology
YONDELIS is contraindicated in patients with known severe hypersensitivity, including anaphylaxis, to trabectedin.

Since bacteriostatic drug may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline in conjunction with penicillin or other bactericidal antibiotics.

Because the tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

Absorption of tetracyclines is impaired by antacids containing aluminum, calcium or magnesium and preparations containing iron, zinc, or sodium bicarbonate.

Concurrent use of tetracycline may render oral contraceptives less effective.

Neutropenic sepsis, including fatal cases, can occur with YONDELIS. In Trial 1, the incidence of Grade 3 or 4 neutropenia, based on laboratory values, in patients receiving YONDELIS was 43% (161/378). The median time to the first occurrence of Grade 3 or 4 neutropenia was 16 days (range: 8 days to 9.7 months); the median time to complete resolution of neutropenia was 13 days (range: 3 days to 2.3 months). Febrile neutropenia (fever ≥38.5°C with Grade 3 or 4 neutropenia) occurred in 18 patients (5%) treated with YONDELIS. Ten patients (2.6%) experienced neutropenic sepsis, 5 of whom had febrile neutropenia, which was fatal in 4 patients (1.1%).

Assess neutrophil count prior to administration of each dose of YONDELIS and periodically throughout the treatment cycle. Withhold YONDELIS for neutrophil counts of less than 1,500 cells/microliter on the day of dosing. Permanently reduce the dose of YONDELIS for life-threatening or prolonged, severe neutropenia in the preceding cycle .

The following adverse reactions are discussed in more detail in other sections of the labeling:

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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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Professional

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. 315.72
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Interactions

Interactions

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