Beleodaq Vial

GENERIC NAME(S): Belinostat

OTHER NAME(S): Beleodaq Solution, Reconstituted (Recon Soln)

Uses

Uses

Belinostat is used to treat a certain type of cancer: peripheral T-cell lymphoma (PTCL). It is used when other drugs do not work or when the cancer comes back after treatment. Belinostat works by slowing or stopping the growth of cancer cells.

How to use Beleodaq Vial

Read the Patient Information Leaflet if available from your pharmacist before you start using belinostat and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by a health care professional in a clinic or hospital. It is injected into a vein as directed by your doctor, usually once a day on days 1 through 5 of a 21-day treatment cycle. The injection is given slowly, usually over 30 minutes. Tell your doctor or nurse right away if you notice redness, pain, or swelling during your injection. If you have side effects during the injection, your infusion may be given over a longer time, changed, or temporarily stopped.

The dosage is based on your medical condition, body size, laboratory test results, and response to treatment.

To get the most benefit from this medication, do not miss any doses. To help you remember, mark the days when you are scheduled to receive treatment on your calendar.

Side Effects

Side Effects

See also How to Use section.

Tell your doctor if you have nausea, vomiting, or diarrhea. Your doctor may prescribe medications to prevent or relieve these symptoms. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. Tiredness, headache, constipation, decreased appetite, or dizziness may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

People using this medication may 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 ofside effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, swelling hands/ankles/feet, symptoms of anemia (such as severe tiredness, pale skin, shortness of breath).

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as fever, chills, persistent sore throat, cough).

Belinostat may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: persistent nausea/vomiting, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.

Belinostat sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.

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 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Precautions

Before using belinostat, 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: current/recent/past infections (such as flu, tuberculosis), kidney disease, liver problems.

Belinostat can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication is not recommended for use during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is unknown if this drug passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Interactions

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab).

Overdose

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Laboratory and/or medical tests (such as complete blood counts, kidney/liver function tests) should be performed before you start treatment, periodically to monitor your progress, or to check for side effects.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule.

Storage

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.Information last revised November 2016. Copyright(c) 2016 First Databank, Inc.

Images

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.