Givinostat

Givinostat is a prescription medication indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients aged six years or older.

• Givinostat is available under the following different brand names: Duvyzat.

Common side effects of Givinostat include:

• diarrhea
• abdominal pain 
• decreased platelet count
• nausea
• vomiting
• increased fat levels in the blood
• fever

Serious side effects of Givinostat include:

• thrombocytopenia
• increased triglycerides
• myalgia
• gastrointestinal disturbances (diarrhea and vomiting)

Rare side effects of Givinostat include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Oral suspension

• 8.86 mg/mL

Duchenne muscular dystrophy

Adult and pediatric dosage

• More than or equal to 60 kg: 53.2 mg orally two times a day
• 40 to less than 60 kg: 44.3 mg orally two times a day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Givinostat has severe interactions with no other drugs
• Givinostat has serious interactions with no other drugs
• Givinostat has moderate interactions with no other drugs
• Givinostat has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Givinostat?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Givinostat?”

Cautions

• Hematologic changes
  • Can cause dose-related thrombocytopenia and other signs of myelosuppression, including decreased hemoglobin and neutropenia
  • Monitor blood cell counts every 2 Weeks for the first 2 months of treatment, then monthly for 3 months, and every 3 Months after that
• Modify dosage for confirmed thrombocytopenia
  • Permanently discontinue if abnormalities worsen despite dose modification
  • Obtain a platelet count if signs or symptoms of thrombocytopenia develop; hold dosing until the platelet count is confirmed
• Increased triglycerides
  • Can cause elevations in triglycerides
  • Monitor triglycerides at 1, 3, and 6 months, and then every 6 Months thereafter
  • Modify dosage if fasting triglycerides above 300 mg/dL
  • Discontinue if triglycerides remain elevated despite adequate dietary intervention and dosage adjustment
• Gastrointestinal disturbances
  • Gastrointestinal disturbances, including diarrhea, nausea/vomiting, and abdominal pain commonly reported
  • Diarrhea may occur within the first few weeks and vomiting within 2 months of initiating treatment
  • Consider treatment with antiemetics or antidiarrheals
  • Replace fluid and electrolytes to prevent dehydration
  • Modify dosage with moderate or severe diarrhea
  • Discontinue if significant symptoms persist
• QTc Prolongation
  • Can cause QTc interval prolongation
  • Avoid in patients with increased risk for ventricular arrhythmias (including Torsades de pointes), such as those with congenital long QT syndrome, coronary artery disease, electrolyte disturbance, and concomitant use of other drugs known to prolong QT
• Obtain ECGs before initiating
  • If unavoidable, obtain ECGs when initiating, during concomitant use, and as clinically indicated
  • Withhold if the QTc interval above 500 ms or a change from baseline above 60 ms
  • Instruct patients to notify a healthcare provider if experiencing symptoms of significant QTc prolongation (eg, dizziness, lightheadedness, syncope) or new cardiac issues and before taking over-the-counter (eg, diphenhydramine), herbal (eg, echinacea), or prescription medications (eg, antibiotics)
• Drug interaction overview
• Weak inhibitor of CYP3A4 and OCT2
  • CYP3A4 sensitive substrates
  • Monitor
    • Closely monitor if coadministered with orally administered CYP3A4 sensitive substrates for which a small change in substrate plasma concentration may lead to serious toxicities
  • OCT2 sensitive substrates
  • Monitor
    • Closely monitor if coadministered with orally administered OCT2-sensitive substrates for which a small change in substrate plasma concentration may lead to serious toxicities
• Drugs prolonging QTc interval
  • Avoid
    • Avoid coadministration with other drugs that prolong QTc interval
    • If unable to avoid, obtain ECGs when initiating, during concomitant use, and as clinically indicated
    • Withhold if the QTc interval is above 500 ms or a change from baseline above 60 ms

Pregnancy and Lactation

• Indicated for treatment of DMD, which is a disease of predominantly young male patients
• Therefore, there is no adequate data available to assess use in pregnant women
• Lactation
  • There are no human or animal data to assess the effect of Givinostat on milk production, its presence in milk, or its effects on breastfed infants