Belinostat

(be-LIN-oh-stat)

Trade Name(s): Beleodaq®

Belinostat is the generic name for the trade name drug Beleodaq®. In some cases, health care professionals may use the trade name, Beleodaq, when referring to the generic drug name, belinostat.

Drug Type: Belinostat is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. This medication is classified as a "­­­­­­­­­histone deacetylase (HDAC) inhibitor". (For more detail, see “How Belinostat Works” below.)

What Belinostat Is Used For:

• Belinostat is used to treat relapsed or refractory peripheral T-cell lymphoma (PTCL).

Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How Belinostat Is Given:

• Belinostat is given as an intravenous (IV) infusion over 30 minutes for 5 days in a row. This is repeated every 21 days (3 weeks). (Some patients may require infusion to run over 45 minutes.)

The amount of Belinostat that you will receive depends on many factors, including your height and weight, your general health or other health problems, and the type of cancer or condition you have. Your doctor will determine your exact dosage and schedule.

Belinostat Side Effects:

Important things to remember about the side effects of belinostat:

• Most people will not experience all of the belinostat side effects listed.
• Belinostat side effects are often predictable in terms of their onset, duration, and severity.
• Belinostat side effects will improve after therapy is complete.
• Belinostat side effects may be quite manageable. There are many options to minimize or prevent the side effects of belinostat.

The following side effects are common (occurring in greater than 30%) for patients taking belinostat:

• Nausea and vomiting
• Fatigue
• Fever
• Anemia (low red blood cell count)

These are less common side effects for patients receiving belinostat (occurring 10-29%):

• Constipation
• Diarrhea
• Shortness of breath
• Peripheral edema (swelling of the extremities)
• Skin rash
• Cough
• Chills
• Itching
• Thrombocytopenia (low platelet count)
• Increased LDH level (enzyme measured by blood test)
• Headache
• Decreased appetite
• Pain at infusion site or phlebitis (inflammation of a vein)
• Low potassium level
• Abnormal EKG (prolonged Q-T interval)
• Abdominal pain
• Hypotension (low blood pressure)
• Dizziness

Tumor lysis syndrome may occur as a result of lymphoma treatment. Tumor lysis syndrome occurs when large amounts of cancerous cells are rapidly killed by the therapy. These cells release uric acid, potassium and phosphorus into the blood stream. Tumor lysis syndrome can lead to kidney failure. Tumor lysis syndrome usually occurs within 24 – 48 hours of therapy. Care must be taken to prevent the development of tumor lysis syndrome. Your health care provider will prescribe plenty of fluids to keep you hydrated. You may be given a drug called allopurinol that blocks uric acid production. Let your health care provider know immediately if you are unable to urinate. Your health care provider will monitor your progress carefully during therapy.

Not all side effects are listed above. Side effects that are very rare -- occurring in less than about 10 percent of patients -- are not listed here. But you should always inform your health care provider if you experience any unusual symptoms.

When to Contact Your Doctor or Health Care Provider:

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

• Fever of 100.5º F (38º C) or higher, chills (possible signs of infection)

The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:

• Nausea (interferes with ability to eat and unrelieved with prescribed medication)
• Vomiting (vomiting more than 4-5 times in a 24 hour period)
• Constipation unrelieved by laxative use.
• Diarrhea (4-6 episodes in a 24-hour period)
• Swelling of the feet or ankles. Sudden weight gain.
• Unable to urinate for more than 8 hours
• Unusual bleeding or bruising
• Black or tarry stools, or blood in your stools
• Blood in the urine
• Pain or burning with urination
• Extreme fatigue (unable to carry on self-care activities)
• Unable to eat or drink for 24 hours or have signs of dehydration: tiredness, thirst, dry mouth, dark and decrease amount of urine, or dizziness.

Always inform your health care provider if you experience any unusual symptoms.

Precautions:

• Before starting belinostat treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.). Do not take aspirin, products containing aspirin unless your doctor specifically permits this.
• Please inform your doctor and dentist before local anesthetic or vasoconstrictor medications are used (for example, epinephrine, mepivacaine and levonordefrin).
• Do not receive any kind of immunization or vaccination without your doctor’s approval while taking belinostat.
• Inform your doctor if you are aware of having a homozygous UGT1A1*28 allele (a gene variance/mutation) as it may require a dose adjustment of the belinostat.
• Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category D (Belinostat may be hazardous to the fetus. Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus.)
• For both men and women: Use contraceptives, and do not conceive a child (get pregnant) while taking belinostat. Barrier methods of contraception, such as condoms, are recommended.
• Do not breast feed while taking belinostat.

Self-Care Tips:

• Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
• You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.
• Wash your hands often.
• Use an electric razor and a soft toothbrush to minimize bleeding.
• Avoid contact sports or activities that could cause injury.
• To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.
• Avoid sun exposure. Wear SPF 15 (or higher) sunblock and protective clothing.
• In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
• Get plenty of rest.
• Maintain good nutrition.
• Remain active as you are able. Gentle exercise is encouraged such as a daily walk.
• If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing While Taking Belinostat:

You will be checked regularly by your doctor while you are taking belinostat, to monitor side effects and check your response to therapy. Periodic blood work will be obtained to monitor your complete blood count (CBC) as well as the function of other organs (such as your kidneys and liver) will also be ordered by your doctor.

How Belinostat Works:

Cancerous tumors are characterized by increased cell division, which is no longer controlled as it is in normal tissue. "Normal" cells stop dividing when they come into contact with like cells, a mechanism known as contact inhibition. Cancerous cells lose this ability. Cancer cells no longer have the normal checks and balances in place that control and limit cell division. The process of cell division, whether normal or cancerous cells, is through the cell cycle. The cell cycle goes from the resting phase, through active growing phases, and then to mitosis (division).

The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis).

Chemotherapy drugs that affect cells only when they are dividing are called cell-cycle specific. Chemotherapy drugs that affect cells when they are at rest are called cell-cycle non-specific. The scheduling of chemotherapy is set based on the type of cells, rate at which they divide, and the time at which a given drug is likely to be effective. This is why chemotherapy is typically given in cycles.

Chemotherapy is most effective at killing cells that are rapidly dividing. Unfortunately, chemotherapy does not know the difference between the cancerous cells and the normal cells. The "normal" cells will grow back and be healthy but in the meantime, side effects occur.

Belinostat belongs to a class of drugs called histone deacetylase (HDAC) inhibitors. HDACs are enzymes that control histones, which are important proteins in the formulation of DNA. Belinostat blocks HDACs so histones cannot be used properly. This interferes with the genetic make-up of cancer cells, leading to cell death. Belinostat causes more cell death in cancer cells versus normal cells.

Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

Chemocare.com is designed to provide the latest information about chemotherapy to patients and their families, caregivers and friends. For information about the 4th Angel Mentoring Program visit www.4thangel.org