alemtuzumab

High Alert

Relapsing forms of multiple sclerosis (MS), including relapsing-remitting disease and active secondary progressive disease; should be reserved for patients who have had an inadequate response to ≥2 drugs.

Contraindicated in:

Hypersensitivity;
Active infection;
HIV;
OB: Pregnancy.

Use Cautiously in:

Malignancy;
Lactation: Safety not established in breastfeeding;
Rep: Women of reproductive potential and men with female sexual partners of reproductive potential;
Pedi: Safety and effectiveness not established in children.

CV: hypertension, hypotension, MYOCARDIAL ISCHEMIA, tachycardia, vasculitis

Derm: MELANOMA, rash, sweating

Endo: hyperthyroidism, hypothyroidism, THYROID CANCER

F and E: edema

GI: abdominal pain, ACALCULOUS CHOLECYSTITIS, anorexia, AUTOIMMUNE HEPATITIS, constipation, IMMUNE-MEDIATED COLITIS, stomatitis

GU: ↓fertility, glomerular nephropathy

Hemat: anemia, lymphopenia, thrombocytopenia, HEMOLYTIC ANEMIA, HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS, HEMOPHILIA A, NEUTROPENIA, PANCYTOPENIA/BONE MARROW HYPOPLASIA, THROMBOTIC THROMBOCYTOPENIC PURPURA

MS: back pain, skeletal pain

Neuro: Guillain-Barré syndrome, autoimmune encephalitis (AIE), depression, dizziness, drowsiness, fatigue, headache, PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML), STROKE, weakness

Resp: bronchospasm, cough, dyspnea, pneumonitis, PULMONARY ALVEOLAR HEMORRHAGE

Misc: infusion reactions, ADULT-ONSET STILL'S DISEASE, INFECTION, LYMPHOMA, SEPSIS

Drug-drug:

Additive bone marrow depression with other antineoplastics or radiation therapy.
May ↓ antibody response to and ↑ the risk of adverse reactions to live-virus vaccines; do not administer concurrently.

Solution for injection : 10 mg/mL

IV (Adults ): 12 mg once daily for 5 consecutive days followed 12 mo later by 12 mg once daily for 3 consecutive days.

Lemtrada

Binds to the CD52 antigen found on the surface of B- and T-lymphocytes and other white blood cells; resulting in lysis.

Therapeutic effects:

Reduce incidence of relapse and slow progression of physical disability.

Therapeutic Classification: anti-multiple sclerosis agents

Pharmacologic Classification: monoclonal antibodies

Absorption: IV administration results in complete bioavailability.

Distribution: Confined to blood and interstitial space.

Metabolism/Excretion: Unknown.

Half-Life: 2 wk.

MabCampath

ROUTE	ONSET	PEAK	DURATION
IV	unknown	unknown	unknown

Inform patient and family of purpose of alemtuzumab. Advise patient to read Medication Guide before starting and periodically during therapy in case of changes.
REMS: Explain Lemtrada REMS requirements to patient. Patient and health care professionals must be enrolled in program. Patients must comply with ongoing monitoring requirements. Patients must report any symptoms of side effects to health care professional.
Advise patient to notify health care professional if sign and symptoms of neutropenia (bleeding, easy bruising, petechiae, purpura, pallor, weakness, fatigue), colitis, or infections occur. Advise patients to also notify health care professional if signs and symptoms of infusion reactions (swelling in mouth or throat, difficulty breathing, weakness, abnormal heart rate [fast, slow, or irregular], chest pain, rash), thyroid cancer (new lump or swelling in neck, pain in front of neck, persistent hoarseness or other voice changes, trouble swallowing or breathing, or a constant cough not due to upper respiratory tract infection), thyroid disorder (unexplained weight loss or gain, fast heartbeat or palpitations, eye swelling, constipation, feeling cold), stroke, PML, depression, suicide ideation, kidney problems (blood in urine [red or tea-colored urine], swelling in legs or feet, coughing up blood), or acquired hemophilia A (spontaneous bruising, nose bleeds, painful or swollen joints, other types of bleeding, or bleeding from a cut that may take longer than usual to stop) occur.
Inform patient of risk of Listeria monocytogenes infections (meningitis, encephalitis, sepsis, gastroenteritis). Advise to avoid or adequately heat foods that are potential sources of listeria (deli meat; dairy products made with unpasteurized milk; soft cheeses; or undercooked meat, seafood, or poultry). Instruct patient to notify health care professional immediately if signs and symptoms of infection (fever, chills, diarrhea, nausea, vomiting, headache, pain in joints and muscles, neck stiffness, difficulty walking, mental status changes, coma, other neurological changes) occur.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Caution patient to avoid immunizations with a live virus due to immunosuppression. Complete immunizations at least 6 wk before beginning alemtuzumab therapy.
Advise female patients to obtain annual cervical human papilloma virus infection screening.
Rep: May cause fetal harm. Advise females of reproductive potential to use effective contraception during and for at least 4 mo following therapy. Advise patient to notify health care professional if pregnancy is suspected or if breastfeeding. Inform patient of pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Lemtrada during pregnancy. Health care professionals and patients are encouraged to report pregnancies by calling 1-800-745-4447, option 2. Inform patient that alemtuzumab may cause infertility in male and female patients.
Encourage patients of the need for monthly blood and urine tests, and yearly skin exams.

a-lem-TOO-zoo-mab

NDC Code

58468- Genzyme Corporation
- 58468-0200- LEMTRADA
  - 58468-0200-1- 1 VIAL, SINGLE-USE in 1 CARTON (58468-0200-1) > 2 mL in 1 VIAL, SINGLE-USE

58468- Genzyme Corporation
- 58468-0357- Campath
  - 58468-0357-1- 1 VIAL, SINGLE-USE in 1 CARTON (58468-0357-1) > 1 mL in 1 VIAL, SINGLE-USE

58468- Genzyme Corporation
- 58468-0357- Campath
  - 58468-0357-3- 3 VIAL, SINGLE-USE in 1 CARTON (58468-0357-3) > 1 mL in 1 VIAL, SINGLE-USE

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