"The U.S. Food and Drug Administration today granted accelerated approval to Zykadia (ceritinib) for patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC).
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(topotecan hydrochloride) for Injection
BONE MARROW SUPPRESSION
Do not give HYCAMTIN® to patients with baseline neutrophil counts less than 1,500 cells/mm³. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection and death, monitor peripheral blood counts frequently on all patients receiving HYCAMTIN [see WARNINGS AND PRECAUTIONS].
HYCAMTIN (topotecan hydrochloride) is a semi-synthetic derivative of camptothecin and is an anti-tumor drug with topoisomerase I-inhibitory activity.
HYCAMTIN for Injection is supplied as a sterile, lyophilized, buffered, light yellow to greenish powder available in single-dose vials. Each vial contains topotecan hydrochloride equivalent to 4 mg of topotecan as free base. The reconstituted solution ranges in color from yellow to yellow-green and is intended for administration by intravenous infusion.
Inactive ingredients are mannitol, 48 mg, and tartaric acid, 20 mg. Hydrochloric acid and sodium hydroxide may be used to adjust the pH. The solution pH ranges from 2.5 to 3.5.
The chemical name for topotecan hydrochloride is (S)-10-[(dimethylamino)methyl]-4- ethyl-4,9-dihydroxy-1#-pyrano[3',4':6,7] indolizino [1,2-6]quinoline-3,14-(4#,12#)-dione monohydrochloride. It has the molecular formula C23H23N3O5*HCl and a molecular weight of 457.9.
Topotecan hydrochloride has the following structural formula:
It is soluble in water and melts with decomposition at 213° to 218°C.
What are the possible side effects of topotecan (Hycamtin)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- wheezing, feeling short of breath, chest pain, dry cough;
- fever, chills, flu symptoms, mouth and throat ulcers, rapid and shallow breathing, fainting;
- pale skin, feeling light-headed, rapid heart rate, trouble concentrating;
- easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots...
What are the precautions when taking topotecan hydrochloride (Hycamtin)?
Before using topotecan, 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.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain immune system problem (neutropenia).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bone marrow disorders (e.g., low platelet/white blood cell/red blood cell levels), kidney disease, liver disease.
This drug may make you weak or tired. Do not drive, use machinery, or do any activity that requires...
Last reviewed on RxList: 3/18/2014
This monograph has been modified to include the generic and brand name in many instances.
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