"The U.S. Food and Drug Administration today approved Beleodaq (belinostat) for the treatment of patients with peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL). The action was taken under the agency&rsq"...
Zolinza Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
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. 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).
The recommended dose of Zolinza is 400 mg orally once daily with food. Zolinza may interact with valproic acid, or blood thinners. Tell your doctor all medications and supplements you use. 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.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Zolinza in Detail - Patient Information: Side Effects
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.
Stop using vorinostat and call your doctor at once if you have a serious side effect such as:
- chest pain, sudden cough, wheezing, rapid breathing;
- pain, swelling, warmth, or redness in one or both legs;
- fever, chills, body aches, flu symptoms, sores in your mouth and throat;
- pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;
- easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
- severe or ongoing vomiting or diarrhea;
- bloody, black, or tarry stools;
- coughing up blood or vomit that looks like coffee grounds;
- feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin; or
- high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision).
Less serious side effects may include:
- nausea, constipation, diarrhea;
- loss of appetite, weight loss;
- headache, tired feeling;
- itching, chills;
- dry mouth;
- hair loss;
- altered sense of taste;
- muscle spasms; or
- cold symptoms such as stuffy nose, sneezing, cough, sore throat.
Read the entire detailed patient monograph for Zolinza (Vorinostat)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Zolinza Overview - Patient Information: Side Effects
Nausea, vomiting, and diarrhea can also occur and may be severe. Tell your doctor right away if these effects occur. In some cases, your doctor may prescribe medication to prevent or relieve them. Eating several small meals, not eating before treatment, or limiting activity may help to lessen the nausea and vomiting.
Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.
Persistent vomiting/diarrhea may result in a serious loss of body water (dehydration). Contact your doctor promptly if you notice any symptoms of dehydration, such as unusual decreased urination, unusual dry mouth/thirst, fast heartbeat, or dizziness/lightheadedness.
This medication may infrequently make your blood sugar level rise, which can cause or worsen diabetes. Tell your doctor immediately if you develop symptoms of high blood sugar, such as increased thirst and urination. If you already have diabetes, be sure to check your blood sugars regularly. Your doctor may need to adjust your diabetes medication, exercise program, or diet.
This medication decreases bone marrow function, an effect that may lead to a low number of blood cells such as red cells, white cells, and platelets. This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. You may be at an increased risk for stomach/intestine bleeding if you are taking certain medications (see also Drug Interaction section). Tell your doctor right away if you develop any of the following unlikely symptoms: unusual tiredness, pale skin, signs of infection (such as fever, chills, persistent sore throat), easy bruising/bleeding, signs of stomach/intestine bleeding (such as black/bloody stools, vomit that contains blood or looks like coffee grounds, dizziness).
Tell your doctor right away if you have any serious side effects, including: signs of low levels of magnesium/potassium/calcium in the blood (such as severe muscle spasms/cramps, irregular heartbeat, mental/mood changes, seizures).
This medication may rarely cause blood clots (such as pulmonary embolism and deep vein thrombosis). You may be at increased risk for blood clots if you have a history of blood clots. Get medical help right away if any of these side effects occur: chest pain, pain/redness/swelling usually in the leg, trouble breathing.
Get medical help right away if any of these rare but serious side effects occur: fast/irregular heartbeat, severe dizziness, fainting.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Zolinza (Vorinostat)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Zolinza FDA Prescribing 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 [see WARNINGS AND PRECAUTIONS].
Myelosuppression [see WARNINGS AND PRECAUTIONS]
Gastrointestinal Toxicity [see WARNINGS AND PRECAUTIONS]
Clinical Chemistry Abnormalities [see WARNINGS AND PRECAUTIONS]
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.
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
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 Reactions||ZOLINZA 400 mg once daily (N=86)|
|All Grades||Grades 3-5*|
|Blood Creatinine Increased||14||16.3||0||0.0|
|Upper Respiratory Infection||9||10.5||0||0.0|
|* No Grade 5 reactions were reported.|
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.
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.
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 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.
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. Drug-related 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)
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