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Belinostat

Generic Name: Belinostat [be-LIN-oh-stat].
The Brand Name: Beleodaq.
Dosage Format: Intravenous powder for injection (500 mg).
The Class of Drugs: Histone deacetylase inhibitors.

What is Belinostat?

Belinostat can be used to treat patients with peripheral lymphoma following various chemotherapy treatments that have had no effect or have been discontinued. Belinostat is approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, a few patients showed an improvement in response to belinostat; however, further research is required. Belinostat can also be employed for other purposes that are not covered in this guideline.

Side effects of Belinostat

See a doctor immediately. Get medical attention immediately if you notice symptoms that indicate an allergic reaction, such as hives, difficulty breathing, or swelling of your lips, face, or tongue. Belinostat can cause serious adverse effects. Consult your physician right away in the event that you experience:

  • Severe ongoing nausea, vomiting, or diarrhea.
  • A fever, chills, muscle aches, flu-like symptoms.
  • Cough with mucus, chest pain, rapid heartbeats, rapid breathing, or breathing problems.
  • Simple bleeding, unusual bruising, or red or purple spots on the skin.
  • Burning or pain during urination.
  • Confusion, severe drowsiness, feeling very ill.
  • Issues with the liver: loss of appetite; stomach discomfort (upper right portion); fatigue; itching; the dark color of urine; stools with clay; jaundice (yellowing of the eyes or skin).
  • Low red blood cells (anemia)—pale skin or a feeling of fatigue that is unusual, faint or lightheaded, cold hands and feet.
  • Signs of tumor cell breakdown—tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, a fast or slow heart rate, tingling in your hands and feet, or around your mouth.

Common adverse effects of belinostat could include:

  • Nausea, vomiting, diarrhea.
  • Anemia.
  • Fever.
  • Tirednesss.

This is not a comprehensive list of possible side effects, and others could happen. Consult your physician for advice regarding medical adverse effects. You can report adverse reactions to the FDA at 1-800-FDA-1088.

Warnings

Belinostat may affect the immune system. It is possible to contract infections more easily, including deadly or life-threatening illnesses. Call your doctor when you experience an increase in temperature, chills, coughs, flu-like symptoms, or unusual bleeding.

Before you take this drug

Speak to your doctor if you are ever diagnosed with:

  • An infection.
  • Intensive or high-dose chemotherapy.
  • Kidney or liver disease.
  • If you're sick and suffering from diarrhea and vomiting.

Belinostat may cause harm to a baby who is not yet born if the father or mother is using it.

  • If you're pregnant, do not use belinostat when you are expecting. It is possible that you will need an unconfirmed pregnancy test prior to taking this medication. Utilize efficient contraception to stop pregnancy while taking this medication, as well as for at least six months following the last dose.
  • If you're male, use effective birth control if you have a partner who can get pregnant. Continue using birth control for at least three months after your last dose.
  • Contact your physician immediately. If you become pregnant during the time that one of the parents or father is taking belinostat.

Avoid breastfeeding while taking this medication and for at least two weeks following the last dose.

How to take belinostat?

Belinostat can be given as an injection into a vein. Your healthcare professional will offer the injection. This medication should be administered slowly, and infusions can take a minimum of 30 minutes before they are completed. Belinostat is administered in a 21-day cycle of treatment. It is possible that you will need to take the medication only for the initial 5 days of every cycle. Your doctor will decide on the duration of treatment with this medication. It is possible to receive medication to help prevent nausea, vomiting, or diarrhea when you receive Belinostat. Belinostat impacts the immune system. You could contract infections more easily, including severe or fatal infections. The blood of your patient will be tested weekly during each cycle of treatment. The treatments for cancer could be delayed based on the results.

Details on dosage

Usual Adult Dose for Lymphoma:

1,000 mg/m2 administered over 30 minutes daily between days 1 and 5 of the 21-day period
The duration of the treatment Recurring cycles every 21 days until progression of the disease or unacceptable toxicity.
Comments: Dose reduction, discontinuation, or even interruption of therapy could be necessary to treat adverse reactions.
Relapsed or resistant peripheral T-cell lymphoma

What happens if I miss a dose?

Contact your doctor for advice in the event that you don't make an appointment for your belinostat shot.

What happens if I overdose?

Because belinostat is administered by a medical expert in a medical environment, it is highly unlikely for an overdose to occur.

What should be avoided?

Beware of being around those who are sick or suffering from infections. Contact your doctor right away when you begin to show symptoms of an infection. Avoid activities that could increase the chance of injury or bleeding. Make sure you take extra precautions to prevent bleeding while shaving or brushing your teeth.

Interaction with other drugs

Other medications can affect belinostat as well, such as medications that are prescribed and available over the counter, vitamins, and herbal products. Discuss with your doctor the medicines you are currently taking as well as any medications you are about to start or stop taking.

DRUG STATUS

Availability

Prescription only

Pregnancy & Lactation

CSA Schedule*

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