Xolair Lyophilisate For Solution For Injection 202.5Mg Drug Medication Dosage Information
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Xolair: Lyophilisate for solution for injection (202.5mg)

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What is this Medicine?

OMALIZUMAB (oh mah lye ZOO mab) is used to help treat allergic asthma and other allergies. It may be given with other treatments for these conditions.

In-Depth Information

Xolair 150mg Powder for Injection

NDC: 502420040
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Chronic Idiopathic Urticaria, Asthma

Sometimes used for but not FDA approved for the following conditions:
Allergic Rhinitis

Storage Information
Refrigerate (between 36 and 46 degrees F)
Protect from light
Reconstituted product should be used within 8 hours if stored under refrigeration (36 to 46 degrees F) or within 4 hours if stored at room temperature
Xolair 150mg Powder for Injection

Reported Side Effects for Xolair 150mg Powder for Injection

Antibody Formation Incidence:
<0.1%*
Severity: MODERATE
Onset: DELAYED
Fainting Incidence:
0.1-0.2%*
Severity: MILD
Onset: EARLY
Anaphylactoid Reactions Incidence:
0.1-0.2%*
Severity: SEVERE
Onset: RAPID
Breathing Difficulties Incidence:
0.1-0.2%*
Severity: SEVERE
Onset: RAPID
Shortness Of Breath Incidence:
0.1-0.2%*
Severity: MODERATE
Onset: EARLY
Angioedema Incidence:
0.1-0.2%*
Severity: SEVERE
Onset: RAPID
Infection Incidence:
0.5-23.0%*
Severity: MILD
Onset: DELAYED
Secondary Malignancy Incidence:
0.5%*
Severity: MODERATE
Onset: DELAYED
Injection Site Reaction Incidence:
0.6-45.0%*
Severity: MILD
Onset: RAPID
Sinus Infection Incidence:
1.1-16.0%*
Severity: MILD
Onset: DELAYED
Cough Incidence:
1.1-2.2%*
Severity: MILD
Onset: DELAYED
Upset Stomach Incidence:
1.1-2.7%*
Severity: MILD
Onset: EARLY
Broken Bones Incidence:
2.0%*
Severity: SEVERE
Onset: DELAYED
Muscle And/Or Bone Pain Incidence:
>2.0%*
Severity: MILD
Onset: EARLY
Ear Pain Incidence:
2.0%*
Severity: MILD
Onset: EARLY
Fluid Retention Incidence:
>2.0%*
Severity: MODERATE
Onset: DELAYED
Hives Incidence:
>2.0%*
Severity: MILD
Onset: RAPID
Itching Incidence:
2.0%*
Severity: MILD
Onset: RAPID
Muscle Pain Incidence:
>2.0%*
Severity: MILD
Onset: EARLY
Migraine Incidence:
>2.0%*
Severity: MODERATE
Onset: EARLY
Fever Incidence:
>2.0%*
Severity: MILD
Onset: EARLY
Bladder Infection Incidence:
>2.0%*
Severity: MODERATE
Onset: DELAYED
Nervousness Incidence:
>2.0%*
Severity: MILD
Onset: DELAYED
Hair Loss Incidence:
>2.0%*
Severity: MILD
Onset: DELAYED
Joint Pain Incidence:
2.9-8.0%*
Severity: MILD
Onset: DELAYED
Lightheadedness Incidence:
3.0%*
Severity: MILD
Onset: EARLY
Tired Incidence:
3.0%*
Severity: MILD
Onset: EARLY
Headache Incidence:
6.1-15.0%*
Severity: MILD
Onset: EARLY
Sore Throat Incidence:
6.6-11.0%*
Severity: MILD
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 B - Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

SECOND Trimester

Class B - Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

THIRD Trimester

Class B - Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

Lactation

Caution - Not enough information is available to rule out harm to infants when this drug is taken by nursing mothers.


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