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Dubyzat (Generic Givinostat)

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Why is this medication prescribed?

Givinostat is a drug primarily prescribed for the treatment of Duchenne muscular dystrophy (DMD), a genetic disorder characterized by progressive muscle degeneration and weakness. It belongs to a class of medications called histone deacetylase (HDAC) inhibitors, which work by modifying gene expression and potentially slowing down disease progression.

How should this medicine be used?

The specific dosage and administration instructions for Givinostat may vary depending on factors such as the patient’s age, weight, and the severity of their condition. Typically, it is taken orally in the form of tablets or liquid suspension. Patients should follow their healthcare provider’s instructions carefully and adhere to the prescribed dosage schedule.

It’s crucial to consult a healthcare professional for personalized advice on the use of Givinostat, including dosing, potential side effects, and any other relevant considerations.

Other uses for this medicine

While Givinostat is primarily being researched for its use in treating certain cancers and inflammatory conditions, other potential uses include:

  • Myeloproliferative Disorders: Conditions like polycythemia vera.
  • Muscular Dystrophy: Research is ongoing to explore its potential in treating Duchenne muscular dystrophy (DMD).
  • Rheumatoid Arthritis: Investigational use for its anti-inflammatory properties.

What special precautions should I follow?

As for special precautions when using Givinostat, here are some important considerations:

  • Pregnancy and Breastfeeding: Givinostat may cause harm to a developing fetus, so it’s crucial to avoid pregnancy while taking this medication. If you are pregnant or planning to become pregnant, discuss the risks and benefits with your healthcare provider. Similarly, it’s not recommended to breastfeed while using Givinostat, as it may pass into breast milk and harm the nursing infant.
  • Liver Function: Givinostat may affect liver function, so regular monitoring of liver enzymes may be necessary during treatment. Your healthcare provider will likely perform liver function tests before starting Givinostat and periodically throughout treatment.
  • Interactions with Other Medications: Inform your healthcare provider about all medications, supplements, and herbal products you are taking, as they may interact with Givinostat. Certain medications, such as those metabolized by the liver, may have their levels altered when taken concomitantly with Givinostat.
  • Side Effects: Be aware of potential side effects of Givinostat, including gastrointestinal issues (such as nausea, vomiting, diarrhea), fatigue, decreased appetite, and hematological abnormalities. If you experience any concerning symptoms while taking Givinostat, contact your healthcare provider.

Always follow your healthcare provider’s instructions and guidance when taking Givinostat or any other medication. They can provide personalized advice based on your medical history and individual circumstances.

What special dietary instructions should I follow?

Regarding special dietary instructions for Givinostat, there are no specific dietary restrictions associated with its use. However, maintaining a healthy and balanced diet is generally recommended for overall well-being, especially for individuals with muscular dystrophy or other chronic conditions.

What should I do if I forget a dose?

If you forget to take a dose of Givinostat, take it as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you have any concerns or questions about missed doses, consult your healthcare provider or pharmacist for guidance.

What side effects can this medication cause?

Givinostat, like any medication, can cause side effects. Some common side effects associated with Givinostat may include:

  • Gastrointestinal Issues: Nausea, vomiting, diarrhea, and abdominal pain are among the most commonly reported side effects. These symptoms are usually mild to moderate in severity and may improve over time.
  • Fatigue: Some individuals may experience fatigue or weakness while taking Givinostat. This side effect can affect daily activities, so it’s essential to communicate any significant fatigue to your healthcare provider.
  • Decreased Appetite: Givinostat may cause a decreased appetite in some people, leading to weight loss or difficulty maintaining adequate nutrition.
  • Hematological Abnormalities: Changes in blood cell counts, such as decreased white blood cell count (leukopenia) or decreased platelet count (thrombocytopenia), can occur with Givinostat treatment. Regular monitoring of blood counts may be necessary.
  • Liver Function Abnormalities: Givinostat may affect liver function, leading to elevated liver enzymes (transaminases) in some individuals. Regular monitoring of liver function tests is typically recommended during treatment.
  • Musculoskeletal Pain: Some patients may experience muscle or joint pain while taking Givinostat. This side effect should be reported to your healthcare provider if it becomes bothersome or persistent.
  • Headache: Headaches are another common side effect reported with Givinostat use. These headaches may range from mild to moderate in intensity.
  • Respiratory Tract Infections: Upper respiratory tract infections, such as the common cold, may occur more frequently in individuals taking Givinostat.

It’s essential to communicate any side effects or concerns to your healthcare provider promptly. They can offer guidance on managing side effects and may adjust your treatment regimen if necessary. Additionally, not all individuals will experience these side effects, and some may experience side effects not listed here. Always consult your healthcare provider for personalized medical advice.

What should I know about storage and disposal of this medication?

When it comes to storage and disposal of Givinostat:

  • Storage: Store Givinostat tablets or oral suspension at room temperature, away from light and moisture. Follow the specific storage instructions provided by your pharmacist or healthcare provider. Keep the medication out of reach of children and pets.
  • Disposal: Dispose of any unused or expired Givinostat medication properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your healthcare provider or pharmacist. Instead, consult your local pharmacy or healthcare facility for guidance on safe disposal methods, such as using a drug take-back program.

In case of emergency/overdose

  • Seek Medical Attention: If you suspect an overdose of Givinostat or experience severe symptoms such as severe nausea, vomiting, dizziness, confusion, or difficulty breathing, seek immediate medical attention by calling emergency services or visiting the nearest emergency room.
  • Poison Control: Contact your local poison control center or emergency medical services for guidance on managing the overdose and receiving appropriate treatment.

What other information should I know?

  • Regular Monitoring: Your healthcare provider may recommend regular monitoring of liver function tests, blood cell counts, and other parameters while you are taking Givinostat. Attend all scheduled appointments and laboratory tests as directed.
  • Follow-up Visits: Attend follow-up visits with your healthcare provider to assess your response to treatment, monitor for side effects, and make any necessary adjustments to your treatment plan.
  • Patient Assistance Programs: Some pharmaceutical companies offer patient assistance programs that provide financial assistance or access to medication for individuals who have difficulty affording their prescribed medication. Ask your healthcare provider or pharmacist about any available assistance programs for Givinostat.
  • Travel Considerations: If you plan to travel while taking Givinostat, ensure you have an adequate supply of medication for the duration of your trip. Pack your medication in its original packaging, and carry a copy of your prescription with you. If traveling internationally, be aware of any regulations or restrictions regarding the importation of prescription medications.
  • Avoid Alcohol: Avoid consuming alcohol while taking Givinostat, as it may exacerbate certain side effects and could potentially interact with the medication.

Always follow your healthcare provider’s instructions and guidance when taking Givinostat or any other medication. If you have any questions or concerns about your treatment, don’t hesitate to discuss them with your healthcare provider.

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