Givinostat Side Effects

Applies to givinostat: oral suspension.

Important warnings This medicine can cause some serious health issues

Givinostat can make it easier for you to bleed, even from a minor injury.

Call your doctor if you have bleeding that will not stop.

Bleeding may also happen inside your body, such as in your stomach or intestines, or in your brain.

Givinostat can cause high triglycerides in your blood, diarrhea, and vomiting.

Tell your doctor if you have diarrhea that is watery.

Ask your doctor about your risk.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Givinostat can make it easier for you to bleed, even from a minor injury. Call your doctor if you have bleeding that will not stop. Bleeding may also happen inside your body, such as in your stomach or intestines, or in your brain.

Call your doctor at once if you have:

• severe or ongoing diarrhea;

• irregular heartbeats;

• long QT syndrome (in you or a family member);

• coronary artery disease (clogged arteries);

• an electrolyte imbalance (such as low blood levels of potassium or magnesium);

• dizziness, fainting; or

• loss of consciousness.

Your treatment with givinostat may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• nausea, vomiting, stomach pain;

• loose stools or diarrhea that is watery;

• fever;

• high cholesterol or triglycerides; or

• low levels of platelets in your blood.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For healthcare professionals

Applies to givinostat: oral suspension.

General

The most common side effects were abdominal pain, diarrhea, hypertriglyceridemia, nausea or vomiting, pyrexia, and thrombocytopenia.^[Ref]

Cardiovascular

• Frequency not reported: QTc prolongation

Dermatologic

• Common (1% to 10%): Rash

Endocrine

• Common (1% to 10%): Hypothyroidism, increased thyroid stimulating hormone

Gastrointestinal

• Very common (10% or more): Abdominal pain (34%), diarrhea (37%), nausea/vomiting (32%)
• Common (1% to 10%): Constipation

Hematologic

• Very common (10% or more): Thrombocytopenia (33%)

Thrombocytopenia included a decreased platelet count and thrombocytopenia.

Metabolic

• Very common (10% or more): Hypertriglyceridemia (23%)
• Common (1% to 10%): Decreased appetite

Musculoskeletal

• Common (1% to 10%): Arthralgia, myalgia

Other

• Very common (10% or more): Pyrexia (13%)
• Common (1% to 10%): Fatigue

Further information

Givinostat side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer