Duvyzat (givinostat)

Duvyzat generic

Duvyzat is available only as a brand-name medication. It’s not currently available in generic form.

A generic drug is an exact copy of the active ingredient in a brand-name medication. Generics usually cost less than brand-name drugs.

Duvyzat dosage

The Duvyzat dosage your doctor prescribes will depend on several factors. These include:

• your body weight
• whether you have certain side effects with Duvyzat

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Duvyzat comes as an oral liquid suspension. It’s available in one strength: 8.86 milligrams (mg) per milliliter (mL).

Dosage for Duchenne muscular dystrophy

The usual recommended dosage depends on body weight in kilograms (kg), as described in the following table. For reference, 1 kg equals about 2.2 pounds (lb).

Children’s dosage

Duvyzat is approved for children ages 6 years and older. The recommended dosage depends on the child’s body weight. This is described in the table.

About taking Duvyzat

The following information refers to key dosage issues:

• When to take: You should take Duvyzat twice per day (morning and evening). Taking the medication around the same times each day helps keep a steady level of the drug in your body. This helps Duvyzat work effectively.
• If you miss a dose: If you miss a dose, take the missed dose as soon as possible. But if it’s almost time for your next dose, skip the missed dose and just take your next dose as usual. Do not take a double dose or any extra doses to make up for missing a dose.
• Taking Duvyzat with food: You should take Duvyzat with food.
• Length of use: Duvyzat is meant to be a long-term treatment. If you and your doctor determine that Duvyzat is safe and effective for you, you’ll likely take it long term.
• Length of time to work: Duvystat starts working right away, but you might not notice this. This is because the drug helps slow worsening of Duchenne muscular dystrophy rather than improving symptoms.

Overdose

Do not use more Duvyzat than your doctor recommends. For some drugs, doing so may lead to unwanted side effects or overdose.

What to do in case you take too much Duvyzat

If you think you’ve taken too much of this drug, call your doctor. You can also call America’s Poison Centers at 800-222-1222 or use its online tool. However, if your symptoms are severe, call 911 or your local emergency number or go to the nearest emergency room right away.

Duvyzat side effects

Duvyzat can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Duvyzat. These lists do not include all possible side effects.

For more information about the possible side effects of Duvyzat, talk with your doctor or pharmacist. They can give you tips on how to manage any side effects that may be concerning or bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Duvyzat, you can do so through MedWatch.

Mild side effects

Below is a partial list of mild side effects of Duvyzat. To learn about other mild side effects, talk with your doctor or pharmacist or view Duvyzat’s prescribing information.

Mild side effects of Duvyzat can include:

• nausea and vomiting
• diarrhea
• constipation
• abdominal pain
• reduced appetite
• fever
• muscle or joint pain
• skin rash
• fatigue

Most of these side effects may go away within a few days to a couple of weeks. However, if they become more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Duvyzat aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 or your local emergency number if your symptoms feel life threatening or you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• thrombocytopenia (low levels of platelets in the blood), which may include symptoms such as:
  • bruising easily
  • small purple or red spots on the skin
  • unusual bleeding, such as nosebleeds
• QT prolongation (a type of abnormal heart rhythm), which may include symptoms such as:
  • heart palpitations
  • dizziness
  • fainting
• severe diarrhea or vomiting, which may cause symptoms such as:
  • frequently passing loose or watery stools
  • frequent vomiting
  • dehydration
• increased levels of triglycerides in the blood, which doesn’t usually cause symptoms

ALLERGIC REACTION

For some people, Duvyzat oral suspension can cause an allergic reaction. But this side effect wasn’t reported in the drug’s studies.

In general, symptoms of allergic reaction can be mild or serious.

Ways to manage

For mild allergic reaction symptoms, such as a mild rash, call your doctor right away. They may recommend treatments to help manage your symptoms. They’ll also let you know whether you should keep taking the medication.

For severe allergic reaction symptoms, such as swelling or difficulty breathing, call 911 or your local emergency number right away. These symptoms require immediate medical care because they can become life threatening. If you’ve had a serious allergic reaction to Duvyzat oral suspension, your doctor may recommend taking a different medication instead.

Duvyzat uses

The Food and Drug Administration (FDA) approves prescription drugs such as Duvyzat to treat certain conditions.

Duvyzat for Duchenne muscular dystrophy

Duvyzat is FDA approved to treat Duchenne muscular dystrophy (DMD) in people ages 6 years and older.

DMD is a rare genetic disorder that usually only affects young males.* The condition causes muscle fibers to break down and be replaced with fatty or fibrous tissue. This leads to muscle weakness and wasting that worsens over time.

The muscle weakness usually starts in the pelvic and leg muscles and spreads to the shoulders and arm muscles. Eventually, the heart muscle and muscles controlling breathing can also be affected.

Symptoms of DMD can include:

• difficulty walking, getting up from the floor, and climbing stairs
• frequent falls
• calf muscle enlargement
• difficulty lifting objects
• contractures (shortening of muscles and tendons that causes joint stiffness)
• fatigue
• chest pain
• heart palpitations
• difficulty breathing and shortness of breath

Duvyzat helps slow down worsening muscle weakness and wasting in DMD.

For this purpose, Duvyzat may be prescribed by itself or with other drugs for DMD.

Examples of other drugs that may be used with Duvyzat include corticosteroids such as prednisone (Rayos) and deflazacort (Emflaza).

*Sex and gender exist on spectrums. Use of the term “male” in this article refers to sex assigned at birth.

Duvyzat and children

Duvyzat is FDA approved to treat Duchenne muscular dystrophy in children ages 6 years and older. It’s not known whether the drug is safe or effective in children under 6 years old.

Duvyzat interactions

Duvyzat can interact with several other medications.

Before taking Duvyzat, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

Interactions with medications

The following list of medications can interact with Duvyzat. This list does not contain all drugs that may interact with Duvyzat. If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

• antiarrhythmics, such as amiodarone (Pacerone)
• certain antipsychotics, such as chlorpromazine
• certain antidepressants, such as citalopram (Celexa)
• certain antibiotics, such as clarithromycin
• certain oral drugs broken down by the CYP3A4 enzyme, such as midazolam or tacrolimus

Alcohol interaction

Alcohol is not known to interact with Duvyzat. It’s likely safe to consume alcohol while taking Duvyzat. If you have questions about how much alcohol is safe to drink while taking Duvyzat, talk with your doctor or pharmacist.

Duvyzat cost and coupons

As with all medications, the cost of Duvyzat can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Financial and insurance assistance: If you need financial support to pay for Duvyzat, or if you need help understanding your insurance coverage, help is available.

A program called ITF ARC is available for Duvyzat. For more information and to find out if you’re eligible for support, call 855-448-3272 or visit the program website.

Generic version: Duvyzat is not available in a generic form. A generic drug is an exact copy of the active ingredient in a brand-name medication. Generics tend to cost less than brand-name drugs.

Learn more about saving money on prescriptions.

Alternative drugs

Other drugs are available that can treat your condition. Some may be a better fit for you than others. If you’re interested in finding an alternative to Duvyzat, talk with your doctor. They can tell you about other medications that may work well for you.

The following gene therapy drugs are alternatives to Duvyzat:

• casimersen (Amondys 45)
• delandistrogene moxeparvovec (Elevidys)
• eteplirsen (Exondys 51)
• golodirsen (Vyondys 53)
• viltolarsen (Viltepso)

Things to consider when taking Duvyzat

If you can become pregnant, consider the following information about pregnancy, fertility, birth control, and breastfeeding.

Duvyzat and pregnancy

It’s not known whether Duvyzat should be taken during pregnancy. If you’re planning a pregnancy or can become pregnant, talk with your doctor before taking this medication.

Duvyzat and birth control

It’s not known whether Duvyzat is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control options while you’re using Duvyzat.

Duvyzat and breastfeeding

It’s not known whether Duvyzat should be taken while breastfeeding. If you’re currently breastfeeding or planning to do so, talk with your doctor before taking this medication.

How Duvyzat works

Duvyzat is used to treat Duchenne muscular dystrophy (DMD), which is a rare genetic disorder that affects your muscles.

What happens with DMD

With DMD, a genetic mutation (abnormal change in a gene) prevents muscle cells from making dystrophin. Dystrophin is an essential protein that helps hold muscle fibers together.

Without dystrophin, your muscle fibers can easily break apart. As a result, your muscles can become damaged and inflamed with usual wear and tear. Without dystrophin, your muscles can’t repair themselves. Over time, fibrous or fatty tissue replaces the muscle fibers. This causes muscle weakness and muscle loss that worsens over time.

Enzymes called histone deacetylases are involved in causing the muscle inflammation and breakdown, and buildup of fibrous and fatty tissue that occurs with DMD.

What Duvyzat does

Duvyzat is a type of drug called a histone deacetylase inhibitor. It works by reducing the action of histone deacetylases. Doctors don’t fully understand how this action treats DMD. However, it’s thought that it may help reduce the inflammation and buildup of fibrous and fatty tissue in muscles. It may also help increase muscle repair.

These actions can slow down worsening muscle weakness and muscle loss in DMD.