LEMTRADA- alemtuzumab injection, solution, concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ALEMTUZUMAB (UNII: 3A189DH42V) (ALEMTUZUMAB - UNII:3A189DH42V)

Available from:

Genzyme Corporation

INN (International Name):

ALEMTUZUMAB

Composition:

ALEMTUZUMAB 12 mg in 1.2 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

LEMTRADA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, the use of LEMTRADA should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS [see Warnings and Precautions (5)] . Limitations of Use LEMTRADA is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile [see Warnings and Precautions (5)]. LEMTRADA is contraindicated in patients: - with known hypersensitivity or anaphylactic reactions to alemtuzumab or any of the excipients in LEMTRADA - who are infected with human immunodeficiency virus (HIV) because LEMTRADA causes prolonged reductions of CD4+ lymphocyte counts - with active infection Risk Summary There are no adequate data on the developmental risk associated with the use of LEMTRADA in pregnant women. LEMTRADA was embryolethal in pregnant huCD52 transgenic mice when administered during organogenesis [see Animal data] . Auto-antibodies may develop after administration of LEMTRADA. Placental transfer of anti-thyroid antibodies resulting in neonatal Graves' disease has been reported. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. There is a pregnancy surveillance program for LEMTRADA. If LEMTRADA exposure occurs during pregnancy, healthcare providers and patients are encouraged to report pregnancies by calling 1-800-745-4447, option 2. Clinical Considerations LEMTRADA induces persistent thyroid disorders [see Warnings and Precautions (5.8)] . Untreated hypothyroidism in pregnant women increases the risk for miscarriage and may have effects on the fetus including mental retardation and dwarfism. In mothers with Graves' disease, maternal thyroid stimulating hormone receptor antibodies can be transferred to a developing fetus and can cause neonatal Graves' disease. In a patient who developed Graves' disease after treatment with alemtuzumab, placental transfer of anti-thyrotropin receptor antibodies resulted in neonatal Graves' disease with thyroid storm in her infant who was born 1 year after alemtuzumab dosing [see Warnings and Precautions (5.1)] . Data Animal data When LEMTRADA was administered to pregnant huCD52 transgenic mice during organogenesis (gestation days [GD] 6–10 or GD 11–15) at doses of 3 or 10 mg/kg IV, no teratogenic effects were observed. However, there was an increase in embryolethality (increased postimplantation loss and the number of dams with all fetuses dead or resorbed) in pregnant animals dosed during GD 11–15. In a separate study in pregnant huCD52 transgenic mice, administration of LEMTRADA during organogenesis (GD 6–10 or GD 11–15) at doses of 3 or 10 mg/kg IV, decreases in B- and T-lymphocyte populations were observed in the offspring at both doses tested. In pregnant huCD52 transgenic mice administered LEMTRADA at doses of 3 or 10 mg/kg/day IV throughout gestation and lactation, there was an increase in pup deaths during the lactation period at 10 mg/kg. Decreases in T- and B-lymphocyte populations and in antibody response were observed in offspring at both doses tested. Risk Summary There are no data on the presence of alemtuzumab in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. Alemtuzumab was detected in the milk of lactating huCD52 transgenic mice administered LEMTRADA [see Animal data]. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for LEMTRADA and any potential adverse effects on the breastfed child from LEMTRADA or from the underlying maternal conditions. Data Animal data Alemtuzumab was detected in the milk of lactating huCD52 transgenic mice following intravenous administration of LEMTRADA at a dose of 10 mg/kg on postpartum days 8–12. Serum levels of alemtuzumab were similar in lactating mice and offspring on postpartum Day 13 and were associated with evidence of pharmacological activity (decrease in lymphocyte counts) in the offspring. Contraception Before initiation of LEMTRADA treatment, women of childbearing potential should be counselled on the potential for a serious risk to the fetus. To avoid in utero exposure to LEMTRADA, women of childbearing potential should use effective contraceptive measures when receiving a course of treatment with LEMTRADA and for 4 months following that course of treatment [see Use in Specific Populations (8.1)] . Infertility In huCD52 transgenic mice, administration of LEMTRADA prior to and during the mating period resulted in adverse effects on sperm parameters in males and reduced number of corpora lutea and implantations in females [see Nonclinical Toxicology (13.1)] . Safety and effectiveness in pediatric patients less than 17 years of age have not been established. Use of LEMTRADA is not recommended in pediatric patients due to the risks of autoimmunity, infusion reactions, and stroke, and because it may increase the risk of malignancies (thyroid, melanoma, lymphoproliferative disorders, and lymphoma) [see Warnings and Precautions (5.1, 5.2, 5.3, 5.4)] . Clinical studies of LEMTRADA did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients.

Product summary:

LEMTRADA (alemtuzumab) injection is a sterile, clear and colorless to slightly yellow solution for intravenous infusion, containing no antimicrobial preservatives. Each LEMTRADA carton (NDC: 58468-0200-1) contains one single-dose vial that delivers 12 mg/1.2 mL (10 mg/mL). The vial stopper is not made with natural rubber latex. Store LEMTRADA vials at 2°C to 8°C (36°F to 46°F). Do not freeze or shake. Store in original carton to protect from light.

Authorization status:

Biologic Licensing Application

Patient Information leaflet

Genzyme Corporation
----------
This Medication Guide has been approved by the U.S.
Food and Drug Administration
Revised: February 2024
MEDICATION GUIDE
LEMTRADA® (lem-TRA-da)
(alemtuzumab), injection for intravenous infusion
Read this Medication Guide before you start receiving LEMTRADA and
before you begin each
treatment course. There may be new information. This information does
not take the place of talking to
your healthcare provider about your medical condition or treatment.
What is the most important information I should know about LEMTRADA?
LEMTRADA can cause serious side effects, including:
1.
Serious autoimmune problems. Some people receiving LEMTRADA develop a
condition where
the immune cells in your body attack other cells or organs in the body
(autoimmunity) which can
be serious and may cause death. Serious autoimmune problems may
include:
•
immune thrombocytopenic purpura (ITP). LEMTRADA may cause the number
of platelets in
your blood to be reduced (ITP). ITP can cause severe bleeding that may
cause life-threatening
problems. Call your healthcare provider right away if you have any of
the following symptoms:
•
easy bruising
•
bleeding from a cut that is hard to stop
•
coughing up blood
•
heavier menstrual periods than normal
•
bleeding from your gums or nose that
is new or takes longer than usual to
stop
•
small, scattered spots on your skin that
are red, pink, or purple
•
kidney problems. LEMTRADA may cause a serious kidney problem called
anti-glomerular
basement membrane disease. If this happens and you do not get treated,
anti-glomerular basement
membrane disease can lead to severe kidney damage, kidney failure that
needs dialysis, a kidney
transplant, or death. Call your healthcare provider right away if you
have any of the following
symptoms:
•
swelling of your legs or feet
•
blood in the urine (red or tea-colored urine)
•
decrease in urine
•
fatigue
•
coughing up blood
Side effects may happen while you receive LEMTRADA and for 4 years
after you stop receiving
LEMTRADA

Summary of Product characteristics

LEMTRADA- ALEMTUZUMAB INJECTION, SOLUTION, CONCENTRATE
GENZYME CORPORATION
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEMTRADA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR LEMTRADA.
LEMTRADA (ALEMTUZUMAB) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2001
WARNING: AUTOIMMUNITY, INFUSION REACTIONS, STROKE, AND MALIGNANCIES
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
LEMTRADA CAUSES SERIOUS, SOMETIMES FATAL, AUTOIMMUNE CONDITIONS SUCH
AS IMMUNE THROMBOCYTOPENIA AND
ANTI-GLOMERULAR BASEMENT MEMBRANE DISEASE. MONITOR COMPLETE BLOOD
COUNTS WITH DIFFERENTIAL, SERUM CREATININE
LEVELS, AND URINALYSIS WITH URINE CELL COUNTS MONTHLY UNTIL 48 MONTHS
AFTER THE LAST DOSE. (5.1)
LEMTRADA CAUSES SERIOUS AND LIFE-THREATENING INFUSION REACTIONS.
LEMTRADA MUST BE ADMINISTERED IN A SETTING
WITH APPROPRIATE EQUIPMENT AND PERSONNEL TO MANAGE ANAPHYLAXIS OR
SERIOUS INFUSION REACTIONS. MONITOR
PATIENTS FOR TWO HOURS AFTER EACH INFUSION. MAKE PATIENTS AWARE THAT
SERIOUS INFUSION REACTIONS CAN ALSO OCCUR
AFTER THE 2-HOUR MONITORING PERIOD. (5.2)
SERIOUS AND LIFE-THREATENING STROKE HAS BEEN REPORTED WITHIN 3 DAYS OF
LEMTRADA ADMINISTRATION. INSTRUCT
PATIENTS TO SEEK IMMEDIATE MEDICAL ATTENTION IF SYMPTOMS OF STROKE
OCCUR. (5.3)
LEMTRADA MAY CAUSE AN INCREASED RISK OF MALIGNANCIES, INCLUDING
THYROID CANCER, MELANOMA, AND
LYMPHOPROLIFERATIVE DISORDERS. PERFORM BASELINE AND YEARLY SKIN EXAMS.
(5.4)
LEMTRADA IS AVAILABLE ONLY THROUGH A RESTRICTED DISTRIBUTION PROGRAM.
( 5.5)
INDICATIONS AND USAGE
LEMTRADA is a CD52-directed cytolytic monoclonal antibody indicated
for the treatment of relapsing forms of multiple sclerosis
(MS), to include relapsing-remitting disease and active secondary
progressive disease, in adults. Because of its safety profile, the
use of LEMTRADA should generally be reserved for patients who have had
an inadequate response to two or more drugs indicated
for the treatment of MS. (1.5)
Limitations of Use:
LEMTR