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LEMTRADA: Solution for injection (10mg)

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What is this Medicine?

ALEMTUZUMAB (AL em TOOZ oo mab) is a monoclonal antibody. Campath is used to treat B cell chronic lymphocytic leukemia. Lemtrada is used to treat multiple sclerosis.

In-Depth Information

LEMTRADA 12mg/1.2ml Solution for Injection

NDC: 584680200
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Multiple Sclerosis

Storage Information
Protect from light
Discard product if it contains particulate matter, is cloudy, or discolored
Store in original container
Do not freeze
Store between 36 to 46 degrees F
LEMTRADA 12mg/1.2ml Solution for Injection

Reported Side Effects for LEMTRADA 12mg/1.2ml Solution for Injection

Hemolytic Anemia Incidence:
0.2%*
Severity: SEVERE
Onset: DELAYED
Pancytopenia Incidence:
0.2%*
Severity: SEVERE
Onset: DELAYED
Secondary Malignancy Incidence:
0.3%*
Severity: MODERATE
Onset: DELAYED
Lung Inflammation Incidence:
0.5%*
Severity: MODERATE
Onset: DELAYED
Thoughts Of Suicide Incidence:
0.6%*
Severity: SEVERE
Onset: DELAYED
Skin Rash Incidence:
1.0%*
Severity: SEVERE
Onset: EARLY
Headache Incidence:
1.0%*
Severity: SEVERE
Onset: EARLY
Low Blood Pressure Incidence:
1.0%*
Severity: SEVERE
Onset: RAPID
Loose Stools Incidence:
1.0%*
Severity: SEVERE
Onset: EARLY
Antibody Formation Incidence:
1.9-94.0%*
Severity: MODERATE
Onset: DELAYED
Hives Incidence:
2.0%*
Severity: SEVERE
Onset: RAPID
Shaking Incidence:
3.0%*
Severity: MILD
Onset: EARLY
Chills Incidence:
3.0-35.0%*
Severity: SEVERE
Onset: RAPID
Skin Redness Incidence:
4.0-5.0%*
Severity: MODERATE
Onset: EARLY
Shortness Of Breath Incidence:
4.0%*
Severity: SEVERE
Onset: EARLY
Upset Stomach Incidence:
>5.0%*
Severity: MILD
Onset: EARLY
Decreased Appetite Incidence:
>5.0%*
Severity: MILD
Onset: DELAYED
Muscle And/Or Bone Pain Incidence:
>5.0%*
Severity: MILD
Onset: EARLY
Dysesthesia Incidence:
>5.0%*
Severity: MILD
Onset: DELAYED
Breathing Difficulties Incidence:
>5.0%*
Severity: SEVERE
Onset: RAPID
Weakness Incidence:
5.0%*
Severity: MILD
Onset: DELAYED
Nose Bleed Incidence:
5.0%*
Severity: MILD
Onset: DELAYED
Tired Incidence:
>5.0%*
Severity: MILD
Onset: EARLY
Vomiting Incidence:
>5.0%*
Severity: MILD
Onset: EARLY
High Blood Pressure Incidence:
5.0%*
Severity: SEVERE
Onset: EARLY
Fluid Retention Incidence:
5.0%*
Severity: MODERATE
Onset: DELAYED
Infection Incidence:
5.0-21.0%*
Severity: SEVERE
Onset: DELAYED
Bleeding Incidence:
5.0-8.0%*
Severity: MODERATE
Onset: EARLY
Muscle Pain Incidence:
6.0%*
Severity: MILD
Onset: EARLY
Weakness Incidence:
7.0%*
Severity: MILD
Onset: EARLY
Nervousness Incidence:
7.0-8.0%*
Severity: MILD
Onset: DELAYED
Chest Pain Incidence:
7.0%*
Severity: MODERATE
Onset: EARLY
Rapid Heart Rate Incidence:
8.0-10.0%*
Severity: MODERATE
Onset: RAPID
Upset Stomach Incidence:
8.0%*
Severity: MILD
Onset: EARLY
Flu Incidence:
8.0%*
Severity: MILD
Onset: DELAYED
Metallic Taste Incidence:
8.0%*
Severity: MILD
Onset: EARLY
Cough Incidence:
9.0%*
Severity: MILD
Onset: DELAYED
Paresthesias Incidence:
10.0%*
Severity: MILD
Onset: DELAYED
Flushing Incidence:
10.0%*
Severity: MILD
Onset: RAPID
Stomach Pain Incidence:
10.0%*
Severity: MILD
Onset: EARLY
Lightheadedness Incidence:
10.0%*
Severity: MILD
Onset: EARLY
Infusion-related Reactions Incidence:
10.0-92.0%*
Severity: MODERATE
Onset: RAPID
Inability To Sleep Incidence:
10.0-16.0%*
Severity: MILD
Onset: EARLY
Fever Incidence:
10.0-35.0%*
Severity: SEVERE
Onset: EARLY
Joint Pain Incidence:
12.0%*
Severity: MILD
Onset: DELAYED
Back Pain Incidence:
12.0%*
Severity: MILD
Onset: DELAYED
Low Platelet Count Incidence:
13.0-52.0%*
Severity: SEVERE
Onset: DELAYED
Anemia Incidence:
13.0-38.0%*
Severity: SEVERE
Onset: DELAYED
Itching Incidence:
14.0%*
Severity: MILD
Onset: RAPID
Sore Throat Incidence:
25.0%*
Severity: MILD
Onset: DELAYED
Low White Blood Cells Incidence:
42.0-64.0%*
Severity: SEVERE
Onset: DELAYED
Low Lymphocytes Incidence:
97.0-99.9%*
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

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


Learning More About
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