(Drug Name) (Drug Form) (Drug Strength)
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Arzerra: Solution for injection (20mg)

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What is this Medicine?

OFATUMUMAB (O fa TOOM ue mab) is a monoclonal antibody. It is used to treat chronic lymphocytic leukemia (CLL).

In-Depth Information
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Arzerra 1000mg/50mL Solution for Injection

NDC: 000780690
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Chronic Lymphocytic Leukemia (CLL)

Storage Information
Refrigerate (between 36 and 46 degrees F)
Protect from light
Do not freeze
Arzerra 1000mg/50mL Solution for Injection

Reported Side Effects for Arzerra 1000mg/50mL Solution for Injection

Infection Incidence:
<29.0%*
Severity: SEVERE
Onset: DELAYED
Flu Incidence:
<6.0%*
Severity: MILD
Onset: DELAYED
Porphyria Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Infusion-related Reactions Incidence:
<10.0%*
Severity: SEVERE
Onset: RAPID
Antibody Formation Incidence:
<1.0%*
Severity: MODERATE
Onset: DELAYED
Weakness Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Back Pain Incidence:
<2.0%*
Severity: SEVERE
Onset: DELAYED
Stevens-Johnson Syndrome Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Sinus Infection Incidence:
<2.0%*
Severity: SEVERE
Onset: DELAYED
Sore Throat Incidence:
<8.0%*
Severity: MILD
Onset: DELAYED
Inability To Sleep Incidence:
<1.0%*
Severity: SEVERE
Onset: EARLY
Joint Pain Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Headache Incidence:
<1.0%*
Severity: SEVERE
Onset: EARLY
Rapid Heart Rate Incidence:
2.0%*
Severity: SEVERE
Onset: RAPID
Skin Rash Incidence:
2.0%*
Severity: SEVERE
Onset: EARLY
Fluid Retention Incidence:
2.0%*
Severity: SEVERE
Onset: DELAYED
Low Blood Pressure Incidence:
3.0%*
Severity: MODERATE
Onset: RAPID
Shortness Of Breath Incidence:
5.0%*
Severity: SEVERE
Onset: EARLY
Fever Incidence:
5.0%*
Severity: SEVERE
Onset: EARLY
Excessive Sweating Incidence:
5.0%*
Severity: MILD
Onset: DELAYED
Hives Incidence:
5.0%*
Severity: MILD
Onset: RAPID
High Blood Pressure Incidence:
8.0%*
Severity: MODERATE
Onset: EARLY
Anemia Incidence:
8.0%*
Severity: SEVERE
Onset: DELAYED
Chills Incidence:
10.0%*
Severity: MILD
Onset: RAPID
Upset Stomach Incidence:
12.0%*
Severity: MILD
Onset: EARLY
Tired Incidence:
15.0%*
Severity: MILD
Onset: EARLY
Loose Stools Incidence:
19.0%*
Severity: MILD
Onset: EARLY
Cough Incidence:
19.0%*
Severity: MILD
Onset: DELAYED
Low White Blood Cells Incidence:
22.0-60.0%*
Severity: SEVERE
Onset: DELAYED
Low White Blood Cell Counts Incidence:
23.0%*
Severity: SEVERE
Onset: DELAYED
Low Lymphocytes Incidence:
29.0%*
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 C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

SECOND Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

THIRD Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

Lactation

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


Learning More About
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