Belinostat Injection

WHY is this medicine prescribed?

Belinostat is used to treat peripheral T-cell lymphoma (PTCL; a form of cancer that begins in a certain type of cells in the immune system) that has not improved or that has come back after treatment with other medications. Belinostat is in a class of medications called histone deacetylase inhibitors. It works by killing cancer cells.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Belinostat comes as a powder to be mixed with liquid to be injected intravenously (into a vein) by a doctor or nurse in a hospital or clinic. It is usually given over a period of 30 minutes once daily on days 1 to 5 of a 21-day cycle. The length of your treatment depends on how well your body responds to the medication and the side effects that you experience.

Your doctor may need to adjust your dose or stop your treatment if you experience certain side effects. Be sure to tell your doctor how you are feeling during your treatment with belinostat injection.

What SPECIAL PRECAUTIONS should I follow?

Before receiving belinostat injection,

• tell your doctor and pharmacist if you are allergic to belinostat injection, any other medications, or any of the ingredients in belinostat injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take or use while receiving belinostat injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have previously received treatment with other chemotherapy medications, if you have or think you may have any type of infection now, or if you have nausea, vomiting, or diarrhea. Also tell your doctor if you have or have ever had kidney or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or if you plan on fathering a child. You should not become pregnant while you are receiving belinostat injection. If you are female, you will need to take a pregnancy test before you start treatment and use birth control to prevent pregnancy during your treatment and for 6 months after your final dose. If you are a male, you and your partner should use birth control during your treatment with belinostat and for 3 months after your final dose. Talk to your doctor about birth control methods that you can use during your treatment. If you or your partner become pregnant while receiving belinostat injection, call your doctor immediately. Belinostat injection may harm the fetus.

• tell your doctor if you are breastfeeding. You should not breastfeed while you are receiving belinostat injection and for 2 weeks after the final dose.

• you should know that this medication may decrease fertility in men. Talk to your doctor about the risks of receiving belinostat injection.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Belinostat injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• diarrhea
• vomiting
• constipation
• headache
• tiredness
• decreased appetite
• pain at the injection site
• swelling of the hands, feet, or ankles
• rash

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• fever, cough, chills, muscle aches, worsening skin problems, flu-like symptoms, or other signs of infection
• painful, frequent, burning or difficult urination
• unusual bleeding or bruising
• dizziness, weakness, excessive tiredness, pale skin, or shortness of breath
• yellowing of the skin or eyes, pain in the right upper stomach area, dark urine, or itching

Belinostat injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to belinostat injection.

Ask your doctor or pharmacist any questions you have about your medication.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.