Duvyzat (Givinostat)

Duvyzat (givinostat) is approved by the FDA only for patients aged 6 years and older with Duchenne Muscular Dystrophy (DMD) who are able to walk. It is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD. Duvyzat is a histone deacetylase (HDAC) inhibitor that works by targeting pathogenic processes to reduce inflammation and loss of muscle.

Recommended Dosage:
The dosage of Duvyzat is based on the patient’s body weight. Administer orally twice daily with food. It should be prescribed and managed under the supervision of a physician experienced in neuromuscular disorders. Dosage modifications may be required for diarrhea, decreased platelet counts, increased triglycerides, or QTc prolongation. Obtain and evaluate baseline platelet counts and triglycerides before initiation of treatment with this medicine. Do not start receiving this treatment in patients with a platelet count less than 150 x 10^9/L.

Clinical Evidence: EPIDYS Phase 3 Trial
Duvyzat’s efficacy was demonstrated in the 18-month, randomized, double-blind, placebo-controlled EPIDYS Phase 3 trial involving ambulant boys with Duchenne Muscular Dystrophy (DMD). The primary endpoint—time to climb four stairs—showed that patients receiving Duvyzat had significantly less functional decline than those on placebo (mean change: 1.25 seconds vs. 3.03 seconds).
A key secondary endpoint, the North Star Ambulatory Assessment (NSAA), also showed that Duvyzat slowed deterioration in motor function compared to placebo. All participants remained on standard steroid therapy during the trial.

• Treatment with Duvyzat 8.86 mg/mL oral suspension may cause hematological abnormalities, including decreased white blood cell (WBC) counts, neutrophils, platelets, and hemoglobin levels. Periodic monitoring of complete blood counts (CBC) is recommended during treatment. Dose interruptions or modifications may be required based on the severity of abnormalities.
• Duvyzat has been associated with hypertriglyceridemia. Fasting lipid profiles should be assessed before initiation and periodically during treatment. If triglyceride levels are markedly elevated, clinical management, including dose adjustment or medical intervention, may be necessary.
• Patients taking Duvyzat may experience nausea, vomiting, diarrhea, and abdominal discomfort. These adverse events are generally manageable but may require dose adjustments, supportive care, or temporary interruption of therapy in some cases.
• Duvyzat has the potential to cause QTc interval prolongation, which can increase the risk of serious cardiac arrhythmias. Baseline and periodic electrocardiograms (ECGs) are recommended, especially in patients with known risk factors or those receiving concomitant medications that affect the QT interval.
• Duvyzat may cause fetal harm when administered during pregnancy. There are no adequate and well-controlled studies in pregnant women. Women of reproductive potential should use effective contraception during treatment and for a period after the last dose. Duvyzat should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.
• It is not known whether Duvyzat is excreted in human breast milk. Because of the potential for serious adverse reactions in breastfed infants, breastfeeding is not recommended during treatment with Duvyzat and for a period following the last dose.

How Can a Patient or Hospital Import DUVYZAT to India?

DUVYZAT (givinostat oral suspension, 8.86 mg/mL) is a prescription medication approved by the U.S. FDA for the treatment of Duchenne Muscular Dystrophy (DMD) in specific patients. However, Duvyzat is not approved for commercial sale in India.
DUVYZAT can only be imported in the name of the patient, either by the patient themselves or a registered hospital, under Indian regulations. The following documents are required to initiate the process:

• A valid prescription from a licensed medical practitioner.
• Relevant diagnostic reports confirming the medical need.
• A government-issued ID proof of the patient (e.g., Aadhaar card, passport).
• Import permit, if applicable (to be applied after prescription submission).

How is the Order Confirmed?

The order is confirmed only after:

• Submission and verification of a valid prescription from a treating doctor.
• Receipt of an import permit (if required by regulatory authorities).

Is DUVYZAT Available in India?

DUVYZAT is not commercially available or approved in India. It is a prescription-only medicine that can only be accessed through legal import channels on a named-patient basis. It is not available over-the-counter and must be prescribed by a registered physician.
Indian Pharma Network (IPN) can facilitate the legal access and import of DUVYZAT for eligible patients in India by:
Providing guidance on availability from genuine global sources (e.g., U.S., Canada, Europe).
Assisting in the documentation and regulatory compliance for Named Patient Import.
Offering complete transparency in sourcing, pricing, and delivery.
Coordinating supply support for patients and hospitals in major cities, including Mumbai, Delhi, Chennai, Bangalore, Hyderabad, Kolkata, Ahmedabad, Pune, and more.

Need Help with DUVYZAT Import?

If you are a patient, caregiver, or doctor seeking to legally access Duvyzat 8.86 mg/mL oral suspension in India, you can reach out to Indian Pharma Network (IPN) for support and guidance.
Call/WhatsApp: +91-9310090915
Toll-Free: 1800-889-1064
Email: info@indianpharmanetwork.in

Note: IPN does not market or sell unapproved medicines. We only facilitate access under authorized legal pathways such as Named Patient Programs

Indian Pharma Network can source the DUVYZAT (Cancer Treatment Medicines) from across the globe and can supply. Indian Pharma offers its customers worldwide access to the best available treatment.

Indian Pharma Network (IPN) can dispense any valid prescription in the shortest possible time. All prescriptions are dispensed and checked by registered pharmacists and dispatched to the Patient’s address only from New Delhi, India.

What is the Generic Name for the trade name drug Duvyzat®?

Givinostat is the Generic Name for the trade name drug Duvyzat®.

What is the Manufacturer’s Name of Duvyzat®?

Duvyzat® is manufactured by Italfarmaco S.A.

Is Duvyzat approved by the FDA?

Yes. Duvyzat is approved by the US FDA. Date of first approval: March 21, 2024.

What is the dosage and form of Duvyzat® supplied?

Duvyzat is supplied in oral suspension: 8.86 mg/mL for oral administration.

What are the side effects of Duvyzat® 8.86 mg/mL oral suspension?

According to the FDA-approved label, the most common side effects observed in clinical trials include:

• Thrombocytopenia (low platelet count)
• Elevated triglyceride levels
• Changes in the electrical activity of your heart, called QT Prolongation
• Gastrointestinal symptoms such as:
• Diarrhea
• Vomiting
• Nausea
• Abdominal pain

Other reported side effects include low platelet counts in the blood, increased fat levels in the blood, and fever.Patients prescribed Duvyzat should be closely monitored with lipid panels, routine blood counts, and liver function tests to manage any emerging side effects effectively. Dose adjustments or treatment interruptions may be necessary based on the severity of side effects.

How much does Duvyzat® 8.86 mg/mL oral suspension cost in India?

Duvyzat® (givinostat) 8.86 mg/mL oral suspension has received FDA approval in the United States. It is not yet approved for use in India. However, under certain regulatory pathways, eligible patients in India may seek access to the medication through compassionate or named patient import channels. Duvyzat price may vary due to availability, sourcing complexities, and regulatory factors.

Can Duvyzat® 8.86 mg/mL oral suspension be available in SAARC countries?

As of now, Duvyzat (givinostat) is approved only by the U.S. FDA and has not received marketing authorization in other countries. Patients outside the United States may consider accessing it through Named Patient Programs (NPP). This program is subject to local regulatory frameworks and medical justification by a licensed treating physician.

Is it safe to buy Duvyzat® 8.86 mg/mL oral suspension online in India?

Duvyzat® (givinostat) 8.86 mg/mL oral suspension is currently approved by the U.S. FDA and may not be authorized for marketing in India. However, Indian patients with a valid prescription may be able to access this medicine through the Named Patient Import Program under the guidance of a registered medical practitioner.

What are the storage conditions of Duvyzat® 8.86 mg/mL oral suspension?

Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Do not freeze it. Store this medicine upright. Discard any unused medicine remaining after 60 days of the first opening of the bottle.

References:

https://www.fda.gov/news-events/press-announcements/fda-approves-nonsteroidal-treatment-duchenne-muscular-dystrophy#:~:text=Today%2C%20the%20U.S.%20Food%20and,all%20genetic%20variants%20of%20DMD
https://itftherapeutics.com/products
https://www.duvyzat.com/
https://www.griffeshield.com