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Cedazuridine-Decitabine: Side Effects, Uses, Dosage, Interactions, Warnings

Cedazuridine-Decitabine

Reviewed on 6/22/2023

What Is Cedazuridine-Decitabine and How Does It Work?

Cedazuridine-Decitabine is a combination medication used for the treatment of myelodysplastic syndrome.

  • Cedazuridine-Decitabine is available under the following different brand names: Inqovi

What Are Side Effects Associated with Using Cedazuridine-Decitabine?

Common side effects of Cedazuridine-Decitabine include:

  • fatigue
  • constipation
  • bleeding
  • muscle pain
  • inflammation of mucus membranes
  • joint pain
  • nausea
  • shortness of breath
  • diarrhea
  • rash
  • dizziness
  • febrile neutropenia
  • fluid retention (edema)
  • headache
  • cough
  • decreased appetite
  • upper respiratory tract infection
  • pneumonia
  • increased transaminase
  • decreased leukocytes
  • decreased platelet count
  • decreased neutrophil count
  • decreased hemoglobin

Serious side effects of Cedazuridine-Decitabine include:

  • low blood cell counts
  • fever
  • chills
  • body aches
  • bruising more easily than usual

Rare side effects of Cedazuridine-Decitabine 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, light-headedness, 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.

What Are the Dosages of Cedazuridine-Decitabine?

Adult dosage

Tablet

  • 100 mg/35 mg

Myelodysplastic syndrome

Adult dosage

  • Each cycle is 28 days
  • Days 1-5: 1 tablet (100 mg cedazuridine/35 mg decitabine) orally once a day of each cycle.
  • Continue for a minimum of 4 cycles until disease progression or unacceptable toxicity.
  • A complete or partial response may take longer than 4 cycles.

Dosage Considerations – Should be Given as Follows:

  • See “Dosages”

What Other Drugs Interact with Cedazuridine-Decitabine?

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, healthcare provider, or pharmacist first.

  • Cedazuridine-Decitabine has severe interactions with no other drugs.
  • Cedazuridine-Decitabine has serious interactions with the following drugs:
    • azacitidine
    • capecitabine
    • cytarabine
    • gemcitabine
    • palifermin
  • Cedazuridine-Decitabine has moderate interactions with the following drugs:
    • acalabrutinib
    • cholera vaccine
    • dengue vaccine
    • dichlorphenamide
    • ethotoin
    • fingolimod
    • hydroxyurea
    • ponesimod
    • siponimod
    • sipuleucel-T
  • Cedazuridine-Decitabine has minor interactions with the following 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.

What Are Warnings and Precautions for Cedazuridine-Decitabine?

Contraindications

  • None

Effects of drug abuse

  • None

Short-Term Effects

  • See “What Are Side Effects Associated with Using Cedazuridine-Decitabine?”

Long-Term Effects

  • See “What Are Side Effects Associated with Using Cedazuridine-Decitabine?”

Cautions

  • May cause fetal harm when administered to pregnant women
  • Myelosuppression
    • Fatal and serious myelosuppression (ie, thrombocytopenia, neutropenia, anemia, febrile neutropenia) can occur
    • Myelosuppression and worsening neutropenia may occur more frequently in the first or second treatment cycle and may not necessarily indicate the progression of underlying MDS
    • Obtain CBC count before initiation and monitor before each cycle and as clinically indicated
    • Administer growth factors and anti-infective therapies for treatment or prophylaxis as appropriate
  • Drug interaction overview
  • Drugs metabolized by cytidine deaminase (CDA)
  • Cedazuridine is an inhibitor of the CDA enzyme
  • Avoid coadministration with drugs metabolized by CDA; this may result in increased systemic exposure and toxicity of these drugs

Pregnancy and Lactation

  • Based on findings from human data, animal studies, and its mechanism of action, may cause fetal harm when administered to pregnant women
  • No data available on use in pregnant women
  • Verify pregnancy status in women of reproductive potential before initiation
  • A single published case report of IV decitabine use throughout the first trimester of pregnancy describes adverse developmental outcomes, including major birth defects (structural abnormalities)
  • Contraception
    • Women of reproductive potential: Use effective contraception during treatment and for 6 months after the last dose
    • Men with female partners of reproductive potential: Use effective contraception during treatment and for 3 months after the last dose
  • Infertility
    • Based on findings of decitabine and cedazuridine in animals, men’s fertility may be impaired
    • The reversibility of the effect on fertility is unknown
  • Lactation
    • There are no data on the presence of cedazuridine, decitabine, or their metabolites in human milk or on their effects on the breastfeeding child or milk production
    • Advise women not to breastfeed during treatment and for at least 2 weeks after the last dose
References
https://reference.medscape.com/drug/inqovi-cedazuridine-decitabine-4000080#0