Decitabine Lyophilisate For Solution For Injection 50Mg Drug Medication Dosage Information
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Decitabine: Lyophilisate for solution for injection (50mg)

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What is this Medicine?

DECITABINE (dee SYE ta been) is a chemotherapy drug. This medicine reduces the growth of cancer cells. It is used to treat adults with myelodysplastic syndromes.

In-Depth Information

Decitabine 50mg Powder for Injection

NDC: 473350361
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Myelodysplastic Syndrome (MDS)

Sometimes used for but not FDA approved for the following conditions:
Chronic Myelogenous Leukemia (CML)

Storage Information
Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
Decitabine 50mg Powder for Injection

Reported Side Effects for Decitabine 50mg Powder for Injection

Low White Blood Cell Counts Incidence:
<22.0%*
Severity: SEVERE
Onset: DELAYED
Anemia Incidence:
<22.0%*
Severity: SEVERE
Onset: DELAYED
Infection Incidence:
<22.0%*
Severity: MILD
Onset: DELAYED
Sinus Infection Incidence:
5.0-6.0%*
Severity: MILD
Onset: DELAYED
Difficulty Swallowing Incidence:
5.0-6.0%*
Severity: MODERATE
Onset: DELAYED
Stomach Pain Incidence:
5.0-14.0%*
Severity: MILD
Onset: EARLY
Fluid Around The Lungs Incidence:
5.0%*
Severity: SEVERE
Onset: DELAYED
Stuffy Nose Incidence:
5.0%*
Severity: MILD
Onset: EARLY
Muscle Pain Incidence:
5.0-9.0%*
Severity: MILD
Onset: EARLY
Electrolyte Imbalance Incidence:
5.0%*
Severity: MODERATE
Onset: DELAYED
Electrolyte Imbalance Incidence:
5.0%*
Severity: MODERATE
Onset: DELAYED
Skin Redness Incidence:
5.0-14.0%*
Severity: MODERATE
Onset: EARLY
Low Magnesium Levels Incidence:
5.0-24.0%*
Severity: MODERATE
Onset: DELAYED
Heartburn Incidence:
5.0%*
Severity: MILD
Onset: DELAYED
Muscle And/Or Bone Pain Incidence:
5.0-6.0%*
Severity: MILD
Onset: EARLY
Mouth Sores Incidence:
5.0-7.0%*
Severity: MODERATE
Onset: DELAYED
Swelling Incidence:
5.0-18.0%*
Severity: MODERATE
Onset: DELAYED
Pancytopenia Incidence:
5.0%*
Severity: SEVERE
Onset: DELAYED
Feeling Sick Incidence:
5.0%*
Severity: MILD
Onset: EARLY
Injection Site Reaction Incidence:
5.0-8.0%*
Severity: MILD
Onset: RAPID
Increased Urination Incidence:
5.0%*
Severity: MILD
Onset: EARLY
Heart Failure Incidence:
5.0%*
Severity: SEVERE
Onset: DELAYED
Bruise Incidence:
5.0%*
Severity: MODERATE
Onset: EARLY
Weakness Incidence:
5.0%*
Severity: MILD
Onset: EARLY
Night Sweats Incidence:
5.0%*
Severity: MILD
Onset: EARLY
Yeast Infection Incidence:
6.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Dehydration Incidence:
6.0-8.0%*
Severity: MODERATE
Onset: DELAYED
Bone Pain Incidence:
6.0%*
Severity: MODERATE
Onset: DELAYED
Hives Incidence:
6.0%*
Severity: MILD
Onset: RAPID
Increased Blood Sugar Incidence:
6.0-33.0%*
Severity: MODERATE
Onset: DELAYED
Ear Pain Incidence:
6.0%*
Severity: MILD
Onset: EARLY
Fluid In Lungs Incidence:
6.0%*
Severity: SEVERE
Onset: EARLY
Painful Urination Incidence:
6.0%*
Severity: MODERATE
Onset: EARLY
Blurred Vision Incidence:
6.0%*
Severity: MODERATE
Onset: EARLY
Chest Pain Incidence:
6.0%*
Severity: MODERATE
Onset: EARLY
Fever Incidence:
6.0-53.0%*
Severity: MILD
Onset: EARLY
Low Blood Pressure Incidence:
6.0-11.0%*
Severity: MODERATE
Onset: RAPID
High Bilirubin Level Incidence:
6.0-14.0%*
Severity: MODERATE
Onset: DELAYED
Low Chloride Levels Incidence:
6.0%*
Severity: MODERATE
Onset: DELAYED
High Blood Pressure Incidence:
6.0%*
Severity: MODERATE
Onset: EARLY
Low Albumin In Blood Incidence:
7.0-24.0%*
Severity: MODERATE
Onset: DELAYED
Confusion Incidence:
8.0-12.0%*
Severity: MODERATE
Onset: EARLY
Rapid Heart Rate Incidence:
8.0%*
Severity: MODERATE
Onset: RAPID
Dry Skin Incidence:
8.0%*
Severity: MILD
Onset: DELAYED
Hair Loss Incidence:
8.0%*
Severity: MILD
Onset: DELAYED
Hemorrhoids Incidence:
8.0%*
Severity: MODERATE
Onset: DELAYED
Depression Incidence:
9.0%*
Severity: MODERATE
Onset: DELAYED
Itching Incidence:
9.0-11.0%*
Severity: MILD
Onset: RAPID
Nervousness Incidence:
9.0-11.0%*
Severity: MILD
Onset: DELAYED
Weight Loss Incidence:
9.0%*
Severity: MILD
Onset: DELAYED
Bruise Incidence:
9.0-22.0%*
Severity: MILD
Onset: DELAYED
Extra Abdominal Fluid Incidence:
10.0%*
Severity: MODERATE
Onset: DELAYED
Upset Stomach Incidence:
10.0-12.0%*
Severity: MILD
Onset: EARLY
Hypoxia Incidence:
10.0%*
Severity: MODERATE
Onset: EARLY
Elevated Hepatic Enzymes Incidence:
10.0-11.0%*
Severity: MODERATE
Onset: DELAYED
Skin Rash Incidence:
11.0-19.0%*
Severity: MILD
Onset: EARLY
Hypoesthesia Incidence:
11.0%*
Severity: MILD
Onset: DELAYED
Mouth Ulcers Incidence:
11.0-12.0%*
Severity: MODERATE
Onset: DELAYED
Red Spotted Rash Incidence:
12.0-39.0%*
Severity: MILD
Onset: DELAYED
Enlarged Lymph Nodes Incidence:
12.0%*
Severity: MODERATE
Onset: DELAYED
Tiredness Incidence:
12.0%*
Severity: MILD
Onset: EARLY
Low Potassium Levels Incidence:
12.0-22.0%*
Severity: MODERATE
Onset: DELAYED
High Potassium Level Incidence:
13.0%*
Severity: SEVERE
Onset: DELAYED
Nose Bleed Incidence:
13.0%*
Severity: MILD
Onset: DELAYED
Inability To Sleep Incidence:
14.0-28.0%*
Severity: MILD
Onset: EARLY
Weakness Incidence:
15.0%*
Severity: MILD
Onset: DELAYED
Chills Incidence:
16.0-22.0%*
Severity: MILD
Onset: RAPID
Decreased Appetite Incidence:
16.0-23.0%*
Severity: MILD
Onset: DELAYED
Sore Throat Incidence:
16.0%*
Severity: MILD
Onset: DELAYED
Vomiting Incidence:
16.0-25.0%*
Severity: MILD
Onset: EARLY
Joint Pain Incidence:
17.0-20.0%*
Severity: MILD
Onset: DELAYED
Back Pain Incidence:
17.0-18.0%*
Severity: MILD
Onset: DELAYED
Lightheadedness Incidence:
18.0-21.0%*
Severity: MILD
Onset: EARLY
Low Blood Sodium Levels Incidence:
19.0%*
Severity: MODERATE
Onset: DELAYED
Headache Incidence:
23.0-28.0%*
Severity: MILD
Onset: EARLY
Low Platelet Count Incidence:
24.0-85.0%*
Severity: SEVERE
Onset: DELAYED
Cough Incidence:
27.0-40.0%*
Severity: MILD
Onset: DELAYED
Loose Stools Incidence:
28.0-34.0%*
Severity: MILD
Onset: EARLY
Shortness Of Breath Incidence:
29.0%*
Severity: MODERATE
Onset: EARLY
Constipation Incidence:
30.0-35.0%*
Severity: MODERATE
Onset: DELAYED
Low White Blood Cells Incidence:
38.0-87.0%*
Severity: SEVERE
Onset: DELAYED
Upset Stomach Incidence:
40.0-42.0%*
Severity: MILD
Onset: EARLY
Tired Incidence:
46.0%*
Severity: MILD
Onset: EARLY
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Pregnancy & Lactation Information
FIRST Trimester

Class D - Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk. For example, the drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective.

SECOND Trimester

Class D - Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk. For example, the drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective.

THIRD Trimester

Class D - Adequate well-controlled or observational studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risk. For example, the drug may be acceptable if needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective.

Lactation

Avoid - This drug is known to cause harm to infants when taken by nursing mothers.


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