Zolinza

Last updated on RxList: 7/20/2020
Zolinza Side Effects Center

What Is Zolinza?

Zolinza (vorinostat) is an antineoplastic (anti-cancer) agent that works by slowing or stopping the growth of cancer cells and is used to treat skin problems caused by cutaneous T-cell lymphoma. Zolinza is usually given after other treatments have been tried without successful treatment of symptoms.

What Are Side Effects of Zolinza?

Common side effects of Zolinza include nausea, constipation, diarrhea, tiredness, loss of appetite, weight loss, dizziness, dry mouth, change in the sense of taste, hair loss, headache, itching, chills, muscle spasms, or cold symptoms (cough, stuffy nose, sneezing, or sore throat).

Dosage for Zolinza

The recommended dose of Zolinza is 400 mg orally once daily with food.

What Drugs, Substances, or Supplements Interact with Zolinza?

Zolinza may interact with valproic acid, or blood thinners. Tell your doctor all medications and supplements you use.

Zolinza During Pregnancy and Breastfeeding

Zolinza is not recommended for use during pregnancy. It may harm a fetus. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding while using this drug is not recommended.

Additional Information

Our Zolinza (vorinostat) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Zolinza Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • dehydration symptoms--dizziness, drowsiness, feeling very thirsty or hot, being unable to urinate, hot and dry skin;
  • high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;
  • low platelets or red blood cells--pale skin, easy bruising, unusual bleeding, purple or red spots under your skin, unusual tiredness, feeling light-headed, cold hands and feet;
  • signs of a blood clot in the lung--chest pain, fast heartbeats, shortness of breath, sweating, coughing up blood; or
  • signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

Common side effects may include:

  • nausea, vomiting, loss of appetite;
  • diarrhea, constipation;
  • weight loss;
  • swelling in your lower legs;
  • dry mouth;
  • fever, chills, headache, muscle pain;
  • cold symptoms such as stuffy nose, sneezing, cough.
  • dizziness, tiredness;
  • itching, hair loss; or
  • altered sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Zolinza (Vorinostat)

Zolinza Professional Information

SIDE EFFECTS

The following serious adverse reactions have been associated with ZOLINZA in clinical trials and are discussed in greater detail in other sections of the label:

  • Thromboembolism [see WARNINGS AND PRECAUTIONS]
  • Myelosuppression [see WARNINGS AND PRECAUTIONS]
  • Gastrointestinal Toxicity [see WARNINGS AND PRECAUTIONS]
  • Hyperglycemia [see WARNINGS AND PRECAUTIONS]
  • Clinical Chemistry Abnormalities [see WARNINGS AND PRECAUTIONS]
  • Severe thrombocytopenia when combined with other Histone Deacetylase (HDAC) Inhibitors [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of ZOLINZA was evaluated in 107 CTCL patients in two single arm clinical studies in which 86 patients received 400 mg once daily.

The data described below reflect exposure to ZOLINZA 400 mg once daily in the 86 patients for a median number of 97.5 days on therapy (range 2 to 480+ days). Seventeen (19.8%) patients were exposed beyond 24 weeks and 8 (9.3%) patients were exposed beyond 1 year. The population of CTCL patients studied was 37 to 83 years of age, 47.7% female, 52.3% male, and 81.4% white, 16.3% black, and 1.2% Asian or multi-racial.

Common Adverse Reactions

The most common drug-related adverse reactions can be classified into 4 symptom complexes: gastrointestinal symptoms (diarrhea, nausea, anorexia, weight decrease, vomiting, constipation), constitutional symptoms (fatigue, chills), hematologic abnormalities (thrombocytopenia, anemia), and taste disorders (dysgeusia, dry mouth). The most common serious drug-related adverse reactions were pulmonary embolism and anemia.

Table 1 summarizes the frequency of CTCL patients with specific adverse reactions, using the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE, version 3.0).

Table 1: Clinical or Laboratory Adverse Reactions Occurring in CTCL Patients (Incidence ≥10% of patients)

Adverse ReactionsZOLINZA 400 mg once daily (N=86)
All GradesGrades 3-4
n%n%
Fatigue4552.333.5
Diarrhea4552.300.0
Nausea3540.733.5
Dysgeusia2427.900.0
Thrombocytopenia2225.655.8
Anorexia2124.422.3
Weight Decreased1820.911.2
Muscle Spasms1719.822.3
Alopecia1618.600.0
Dry Mouth1416.300.0
Blood Creatinine Increased1416.300.0
Chills1416.311.2
Vomiting1315.111.2
Constipation1315.100.0
Dizziness1315.111.2
Anemia1214.022.3
Decreased Appetite1214.011.2
Peripheral Edema1112.800.0
Headache1011.600.0
Pruritus1011.611.2
Cough910.500.0
Upper Respiratory
Infection
910.511.2

The frequencies of more severe thrombocytopenia, anemia [see WARNINGS AND PRECAUTIONS] and fatigue were increased at doses higher than 400 mg once daily of ZOLINZA.

Serious Adverse Reactions

The most common serious adverse reactions in the 86 CTCL patients in two clinical trials were pulmonary embolism reported in 4.7% (4/86) of patients, squamous cell carcinoma reported in 3.5% (3/86) of patients and anemia reported in 2.3% (2/86) of patients. There were single events of cholecystitis, death (of unknown cause), deep vein thrombosis, enterococcal infection, exfoliative dermatitis, gastrointestinal hemorrhage, infection, lobar pneumonia, myocardial infarction, ischemic stroke, pelviureteric obstruction, sepsis, spinal cord injury, streptococcal bacteremia, syncope, T-cell lymphoma, thrombocytopenia and ureteric obstruction.

Discontinuations

Of the CTCL patients who received the 400-mg once daily dose, 9.3% (8/86) of patients discontinued ZOLINZA due to adverse reactions. These adverse reactions, regardless of causality, included anemia, angioneurotic edema, asthenia, chest pain, exfoliative dermatitis, death, deep vein thrombosis, ischemic stroke, lethargy, pulmonary embolism, and spinal cord injury.

Dose Modifications

Of the CTCL patients who received the 400-mg once daily dose, 10.5% (9/86) of patients required a dose modification of ZOLINZA due to adverse reactions. These adverse reactions included increased serum creatinine, decreased appetite, hypokalemia, leukopenia, nausea, neutropenia, thrombocytopenia and vomiting. The median time to the first adverse reactions resulting in dose reduction was 42 days (range 17 to 263 days).

Laboratory Abnormalities

Laboratory abnormalities were reported in all of the 86 CTCL patients who received the 400-mg once-daily dose.

Increased serum glucose was reported as a laboratory abnormality in 69% (59/86) of CTCL patients who received the 400-mg once daily dose; only 4 of these abnormalities were severe (Grade 3). Increased serum glucose was reported as an adverse reaction in 8.1% (7/86) of CTCL patients who received the 400-mg once daily dose [see WARNINGS AND PRECAUTIONS].

Transient increases in serum creatinine were detected in 46.5% (40/86) of CTCL patients who received the 400- mg once daily dose. Of these laboratory abnormalities, 34 were NCI CTCAE Grade 1, 5 were Grade 2, and 1 was Grade 3.

Proteinuria was detected as a laboratory abnormality (51.4%) in 38 of 74 patients tested. The clinical significance of this finding is unknown.

Dehydration

Based on reports of dehydration as a serious drug-related adverse reaction in clinical trials, patients were instructed to drink at least 2 L/day of fluids for adequate hydration [see WARNINGS AND PRECAUTIONS].

Adverse Reactions In Non-CTCL Patients

The frequencies of individual adverse reactions were substantially higher in the non-CTCL population. Drugrelated serious adverse reactions reported in the non-CTCL population which were not observed in the CTCL population included single events of blurred vision, asthenia, hyponatremia, tumor hemorrhage, Guillain-Barré syndrome, renal failure, urinary retention, cough, hemoptysis, hypertension, and vasculitis.

In patients recovering from bowel surgery and treated perioperatively with ZOLINZA, anastomotic healing complications including fistulas, perforations, and abscess formation have occurred.

Read the entire FDA prescribing information for Zolinza (Vorinostat)

© Zolinza Patient Information is supplied by Cerner Multum, Inc. and Zolinza Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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