Synribo Lyophilisate For Solution For Injection 3.5Mg Drug Medication Dosage Information
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SYNRIBO: Lyophilisate for solution for injection (3.5mg)

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What is this Medicine?

OMACETAXINE (OH ma se TAX een) is a chemotherapy drug. This medicine is used to treat chronic myelogenous leukemia.

In-Depth Information

SYNRIBO 3.5mg Powder for Injection

NDC: 634590177
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Chronic Myelogenous Leukemia (CML)

Storage Information
Protect from light
Store in carton until time of use
Discard unused portion. Do not store for later use.
Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
SYNRIBO 3.5mg Powder for Injection

Reported Side Effects for SYNRIBO 3.5mg Powder for Injection

Headache Incidence:
<1.0%*
Severity: SEVERE
Onset: EARLY
Vomiting Incidence:
<2.0%*
Severity: SEVERE
Onset: EARLY
Cough Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Bruise Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Hoarseness Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Metallic Taste Incidence:
1.0-10.0%*
Severity: MILD
Onset: EARLY
Lightheadedness Incidence:
1.0-10.0%*
Severity: MILD
Onset: EARLY
Double Vision Incidence:
1.0-10.0%*
Severity: MILD
Onset: EARLY
Conjunctivitis Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Confusion Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: EARLY
Chest Pain Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: EARLY
Blurred Vision Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: EARLY
Weakness Incidence:
1.0-2.0%*
Severity: SEVERE
Onset: DELAYED
Convulsions Incidence:
1.0-10.0%*
Severity: SEVERE
Onset: DELAYED
Flu Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Difficulty Swallowing Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Cataracts Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Dry Mouth Incidence:
1.0-10.0%*
Severity: MILD
Onset: EARLY
Dry Skin Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Dry Eyes Incidence:
1.0-10.0%*
Severity: MILD
Onset: EARLY
Shaking Incidence:
1.0-10.0%*
Severity: MILD
Onset: EARLY
Upset Stomach Incidence:
1.0-4.0%*
Severity: SEVERE
Onset: EARLY
Night Sweats Incidence:
1.0-10.0%*
Severity: MILD
Onset: EARLY
Weakness Incidence:
1.0-10.0%*
Severity: MILD
Onset: EARLY
Skin Ulcer Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Darkened Skin Patches Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Rapid Heart Rate Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: RAPID
Bruises Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Red Spotted Rash Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Paresthesias Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Rapid Heart Rate Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: EARLY
Mouth Sores Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Bleeding Within The Eye Incidence:
1.0-10.0%*
Severity: SEVERE
Onset: DELAYED
Muscle And/Or Bone Pain Incidence:
1.0-10.0%*
Severity: MILD
Onset: EARLY
Feeling Sick Incidence:
1.0-10.0%*
Severity: MILD
Onset: EARLY
Tiredness Incidence:
1.0-10.0%*
Severity: MILD
Onset: EARLY
Secretion Of Tears Incidence:
1.0-10.0%*
Severity: MILD
Onset: EARLY
Hypoesthesia Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
High Body Temperature Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Coughing Up Blood Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Bruise Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: EARLY
Heartburn Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Skin Redness Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: EARLY
High Blood Pressure Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: EARLY
Excessive Sweating Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Hot Flashes Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: EARLY
Hemorrhoids Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Gout Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Gum Inflammation Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Inflamed Stomach Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Fever Incidence:
1.0-2.0%*
Severity: SEVERE
Onset: EARLY
Nose Bleed Incidence:
1.0-2.0%*
Severity: SEVERE
Onset: DELAYED
Swelling Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Painful Urination Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: EARLY
Upset Stomach Incidence:
1.0-10.0%*
Severity: MILD
Onset: EARLY
Loose Stools Incidence:
1.0-7.0%*
Severity: SEVERE
Onset: EARLY
Diabetes Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Depression Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Dehydration Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Slow Heart Beat Incidence:
1.0-10.0%*
Severity: SEVERE
Onset: RAPID
Bone Pain Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Joint Pain Incidence:
1.0%*
Severity: SEVERE
Onset: DELAYED
Nervousness Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Chest Pain Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: EARLY
Distressed Incidence:
1.0-10.0%*
Severity: MILD
Onset: EARLY
Eye Pain Incidence:
1.0-10.0%*
Severity: MILD
Onset: EARLY
Itching Incidence:
1.0-10.0%*
Severity: MILD
Onset: RAPID
Stuffy Nose Incidence:
1.0-10.0%*
Severity: MILD
Onset: EARLY
Runny Nose Incidence:
1.0-10.0%*
Severity: MILD
Onset: EARLY
Muscle Pain Incidence:
1.0-10.0%*
Severity: MILD
Onset: EARLY
Mouth Ulcers Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: DELAYED
Low Blood Pressure Incidence:
1.0-10.0%*
Severity: MODERATE
Onset: RAPID
Ringing In Ears Incidence:
1.0-10.0%*
Severity: MILD
Onset: DELAYED
Elevated Hepatic Enzymes Incidence:
2.0-6.0%*
Severity: SEVERE
Onset: DELAYED
Back Pain Incidence:
2.0%*
Severity: SEVERE
Onset: DELAYED
Intestinal Bleeding Incidence:
2.0%*
Severity: SEVERE
Onset: DELAYED
Bleeding In The Brain Incidence:
2.0%*
Severity: SEVERE
Onset: DELAYED
Decreased Appetite Incidence:
2.0%*
Severity: SEVERE
Onset: DELAYED
Shortness Of Breath Incidence:
2.0%*
Severity: SEVERE
Onset: EARLY
Tired Incidence:
5.0-9.0%*
Severity: SEVERE
Onset: EARLY
High Bilirubin Level Incidence:
6.0-9.0%*
Severity: SEVERE
Onset: DELAYED
Low Blood Sugar Incidence:
6.0-8.0%*
Severity: SEVERE
Onset: EARLY
Increased Blood Sugar Incidence:
10.0-15.0%*
Severity: SEVERE
Onset: DELAYED
Skin Rash Incidence:
10.0%*
Severity: MILD
Onset: EARLY
Inability To Sleep Incidence:
10.0%*
Severity: MILD
Onset: EARLY
Infection Incidence:
11.0-20.0%*
Severity: SEVERE
Onset: DELAYED
Stomach Pain Incidence:
13.0-14.0%*
Severity: MILD
Onset: EARLY
Fluid Retention Incidence:
13.0%*
Severity: MODERATE
Onset: DELAYED
Chills Incidence:
13.0%*
Severity: MILD
Onset: RAPID
Constipation Incidence:
15.0%*
Severity: MODERATE
Onset: DELAYED
Hair Loss Incidence:
15.0%*
Severity: MILD
Onset: DELAYED
Low Lymphocytes Incidence:
16.0%*
Severity: SEVERE
Onset: DELAYED
Low White Blood Cells Incidence:
18.0-81.0%*
Severity: SEVERE
Onset: DELAYED
Injection Site Reaction Incidence:
22.0-34.0%*
Severity: MILD
Onset: RAPID
Infusion-related Reactions Incidence:
22.0-34.0%*
Severity: MODERATE
Onset: RAPID
Anemia Incidence:
36.0-80.0%*
Severity: SEVERE
Onset: DELAYED
Low Platelet Count Incidence:
49.0-88.0%*
Severity: SEVERE
Onset: DELAYED
High Uric Acid Level Incidence:
56.0-57.0%*
Severity: SEVERE
Onset: DELAYED
Low White Blood Cell Counts Incidence:
61.0-72.0%*
Severity: SEVERE
Onset: DELAYED
*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.


Learning More About
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  • Find other class related drugs
  • Find additional patient usage statistics
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Patient Experiences with SYNRIBO

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