"Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
Akman pleaded guilty in the U.S. District Court"...
(romidepsin) for Injection
Romidepsin, a histone deacetylase (HDAC) inhibitor, is a bicyclic depsipeptide. At room temperature, romidepsin is a white powder and is described chemically as (1S,4S,7Z,10S,16E,21R)-7-ethylidene-4,21-bis(1-methylethyl)-2-oxa-12,13-dithia-5,8,20,23-tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone. The empirical formula is C24H36N4O6S2.
The molecular weight is 540.71 and the structural formula is:
ISTODAX (romidepsin) for injection is intended for intravenous infusion only after reconstitution with the supplied diluent and after further dilution with 0.9% Sodium Chloride, USP.
ISTODAX is supplied as a kit containing 2 vials.
ISTODAX (romidepsin) for injection is a sterile lyophilized white powder and is supplied in a single-use vial containing 10 mg romidepsin and 20 mg povidone, USP.
Diluent for ISTODAX is a sterile clear solution and is supplied in a single-use vial containing a 2-mL deliverable volume. Diluent for ISTODAX contains 80% (v/v) propylene glycol, USP and 20% (v/v) dehydrated alcohol, USP.
What are the possible side effects of romidepsin (Istodax)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- severe nausea or vomiting;
- chest pain, fast or uneven heartbeats, feeling short of breath;
- fever, chills, body aches, flu symptoms, sores in your mouth and throat;
- pale skin, feeling light-headed, rapid heart rate, trouble concentrating;
- easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or...
What are the precautions when taking romidepsin for injection (Istodax)?
Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease (such as hepatitis B), heart disease (such as chest pain, heart attack), current/recent infection.
This drug may cause tiredness. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Romidepsin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can...
Last reviewed on RxList: 11/3/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Istodax Information
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