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Drug Interactions between givinostat and samarium sm 153 lexidronam

This report displays the potential drug interactions for the following 2 drugs:

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Interactions between your drugs

Major

samarium sm 153 lexidronam givinostat

Applies to: samarium sm 153 lexidronam and givinostat

GENERALLY AVOID: Theoretical concerns exist that chemotherapeutic agents and other bone marrow depressants may potentiate the myelosuppressive effects of samarium sm 153 lexidronam. In clinical trials, white blood cell and platelet counts decreased to a nadir of approximately 40% to 50% of baseline in 95% of patients within three to five weeks after administration of samarium sm 153 lexidronam, and tended to return to pretreatment levels by eight weeks. The potential for additive bone marrow toxicity with myelotoxic treatments including chemotherapy or external beam radiation has not been studied.

MANAGEMENT: The manufacturer recommends avoiding concomitant use of samarium sm 153 lexidronam with chemotherapy or external beam radiation therapy unless benefits are anticipated to outweigh the risks. Moreover, samarium sm 153 lexidronam should not be given after either of these treatments until there has been time for adequate marrow recovery. Caution and close monitoring of bone marrow function are advisable if coadministration with other myelotoxic agents is required. Patients should be advised to contact their physician if they develop signs and symptoms of myelosuppression such as pallor, dizziness, fatigue, lethargy, fainting, unusual bleeding or bruising, or signs of infection such as fever, chills, diarrhea, sore throat, muscle aches, shortness of breath, blood in phlegm, weight loss, red or inflamed skin, body sores, and pain or burning during urination.

References (2)
  1. (2001) "Product Information. Quadramet (samarium sm 153 lexidronam)." Berlex Laboratories
  2. EMEA. European Medicines Agency (2007) EPARs. European Union Public Assessment Reports. http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid

Drug and food interactions

Moderate

givinostat food

Applies to: givinostat

ADJUST DOSING INTERVAL: Food increases the systemic exposure of givinostat. An open-label, randomized, crossover, single dose food effect study conducted in 12 healthy males used givinostat liquid filled capsules. Subjects received a single oral dose of givinostat (100 mg) in the fasting state or after a high-fat standard meal, with a washout period of at least 1 week in between. The high-fat standard meal resulted in an increase in systemic exposure (AUC) and maximum plasma concentration (Cmax) of about 40% and 23%, respectively, when compared to the fasted state. Additionally, the time to maximum concentration (Tmax) was delayed slightly from 2 to 3 hours.

MANAGEMENT: Givinostat should be administered with food to increase its absorption. In the case of the oral suspension, this can also help mask its bitter taste.

References (2)
  1. (2024) "Product Information. Duvyzat (givinostat)." ITF Therapeutics, LLC
  2. Italfarmaco Spa (2024) Center for drug evaluation and research. Application number: 217865Orig1s000. Integrated review. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/217865Orig1s000IntegratedR.pdf

Therapeutic duplication warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.


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Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.