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Zolinza

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Zolinza

Zolinza

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Thromboembolism

As pulmonary embolism and deep vein thrombosis have been reported as adverse reactions, physicians should be alert to the signs and symptoms of these events, particularly in patients with a prior history of thromboembolic events [see ADVERSE REACTIONS].

Hematologic

Treatment with ZOLINZA can cause dose-related thrombocytopenia and anemia. If platelet counts and/or hemoglobin are reduced during treatment with ZOLINZA, the dose should be modified or therapy discontinued. [See DOSAGE AND ADMINISTRATION and ADVERSE REACTIONS.]

Gastrointestinal

Gastrointestinal disturbances, including nausea, vomiting and diarrhea, have been reported [see ADVERSE REACTIONS] and may require the use of antiemetic and antidiarrheal medications. Fluid and electrolytes should be replaced to prevent dehydration [see ADVERSE REACTIONS]. Pre-existing nausea, vomiting, and diarrhea should be adequately controlled before beginning therapy with ZOLINZA.

Hepatic

ZOLINZA was studied in a limited number of patients with hepatic impairment. Based on these results, patients with mild and moderate hepatic impairment should be treated with caution. [See CONTRAINDICATIONS, Use In Specific Populations and CLINICAL PHARMACOLOGY.]

Hyperglycemia

Hyperglycemia has been observed in patients receiving ZOLINZA [see ADVERSE REACTIONS]. Serum glucose should be monitored, especially in diabetic or potentially diabetic patients. Adjustment of diet and/or therapy for increased glucose may be necessary.

Monitoring: Laboratory Tests

Careful monitoring of blood cell counts and chemistry tests, including electrolytes, glucose and serum creatinine, should be performed every 2 weeks during the first 2 months of therapy and monthly thereafter. Electrolyte monitoring should include potassium, magnesium and calcium. Hypokalemia or hypomagnesemia should be corrected prior to administration of ZOLINZA, and consideration should be given to monitoring potassium and magnesium in symptomatic patients (e.g., patients with nausea, vomiting, diarrhea, fluid imbalance or cardiac symptoms).

Other Histone Deacetylase (HDAC) Inhibitors

Severe thrombocytopenia and gastrointestinal bleeding have been reported with concomitant use of ZOLINZA and other HDAC inhibitors (e.g., valproic acid). Monitor platelet count every 2 weeks during the first 2 months. [See DRUG INTERACTIONS].

Pregnancy

Pregnancy Category D

ZOLINZA can cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies of ZOLINZA in pregnant women. Results of animal studies indicate that vorinostat crosses the placenta and is found in fetal plasma at levels up to 50% of maternal concentrations. Doses up to 50 and 150 mg/kg/day were tested in rats and rabbits, respectively (~0.5 times the human exposure based on AUC0-24 hours). Treatment-related developmental effects including decreased mean live fetal weights, incomplete ossifications of the skull, thoracic vertebra, sternebra, and skeletal variations (cervical ribs, supernumerary ribs, vertebral count and sacral arch variations) in rats at the highest dose of vorinostat tested. Reductions in mean live fetal weight and an elevated incidence of incomplete ossification of the metacarpals were seen in rabbits dosed at 150 mg/kg/day. The no observed effect levels (NOELs) for these findings were 15 and 50 mg/kg/day ( < 0.1 times the human exposure based on AUC) in rats and rabbits, respectively. A dose-related increase in the incidence of malformations of the gall bladder was noted in all drug treatment groups in rabbits versus the concurrent control. 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.

Patient Counseling Information

[See FDA-Approved Patient Labeling]

Instructions

Patients should be instructed to drink at least 2 L/day of fluid to prevent dehydration and should promptly report excessive vomiting or diarrhea to their physician. Patients should be instructed about the signs of deep vein thrombosis and should consult their physician should any evidence of deep vein thrombosis develop. Patients receiving ZOLINZA should seek immediate medical attention if unusual bleeding occurs. ZOLINZA capsules should not be opened or crushed.

Patients should be instructed to read the patient insert carefully.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies have not been performed with vorinostat.

Vorinostat was mutagenic in vitro in the bacterial reverse mutation assays (Ames test), caused chromosomal aberrations in vitro in Chinese hamster ovary (CHO) cells and increased the incidence of micro-nucleated erythrocytes when administered to mice (Mouse Micronucleus Assay).

Effects on the female reproductive system were identified in the oral fertility study when females were dosed for 14 days prior to mating through gestational day 7. Doses of 15, 50 and 150 mg/kg/day to rats resulted in approximate exposures of 0.15, 0.36 and 0.70 times the expected clinical exposure based on AUC. Dose dependent increases in corpora lutea were noted at ≥ 15 mg/kg/day, which resulted in increased peri-implantation losses were noted at ≥ 50 mg/kg/day. At 150 mg/kg/day, there were increases in the incidences of dead fetuses and in resorptions.

No effects on reproductive performance were observed in male rats dosed (20, 50, 150 mg/kg/day; approximate exposures of 0.15, 0.36 and 0.70 times the expected clinical exposure based on AUC), for 70 days prior to mating with untreated females. [See WARNINGS AND PRECAUTIONS.]

Use In Specific Populations

Pregnancy

Pregnancy Category D [See WARNINGS AND PRECAUTIONS]

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from ZOLINZA, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The safety and effectiveness of ZOLINZA in pediatric patients have not been established.

Geriatric Use

Of the total number of patients with CTCL in trials (N=107), 46 percent were 65 years of age and over, while 15 percent were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Use in Patients with Hepatic Impairment

ZOLINZA was studied in a limited number of patients with hepatic impairment. Based on these limited data, ZOLINZA is contraindicated in patients with severe hepatic impairment and should be used with caution in patients with mild and moderate hepatic impairment. [See CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY.]

Use in Patients with Renal Impairment

Vorinostat was not evaluated in patients with renal impairment. However, renal excretion does not play a role in the elimination of vorinostat. Patients with pre-existing renal impairment should be treated with caution. [See CLINICAL PHARMACOLOGY.]

Last reviewed on RxList: 11/29/2011
This monograph has been modified to include the generic and brand name in many instances.

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