Alemtuzumab (Multiple Sclerosis) (Monograph)

Drug class: Monoclonal Antibodies

Medically reviewed by Drugs.com on May 10, 2024. Written by ASHP.

Introduction

Immunomodulatory agent; recombinant DNA-derived humanized anti-CD52 monoclonal antibody.

Uses for Alemtuzumab (Multiple Sclerosis)

Multiple Sclerosis

Management of relapsing forms of multiple sclerosis (MS), including relapsing-remitting disease and active secondary progressive disease, in adults.

Because of substantial risks associated with the drug (e.g., autoimmunity, infusion reactions, malignancy), generally reserve use for patients with inadequate response to ≥2 drugs indicated for the treatment of MS. Not recommended in patients with clinically isolated syndrome due to safety profile.

Alemtuzumab is one of several disease-modifying therapies used in the management of relapsing forms of MS. Although not curative, these therapies have all been shown to modify several measures of disease activity, including relapse rates, new or enhancing MRI lesions, and disability progression.

American Academy of Neurology (AAN) recommends that disease-modifying therapy be offered to patients with relapsing forms of MS who have had recent relapses and/or MRI activity. Clinicians should consider adverse effects, tolerability, method of administration, safety, efficacy, and cost of the drugs in addition to patient preferences when selecting an appropriate therapy.

Alemtuzumab (Multiple Sclerosis) Dosage and Administration

General

Pretreatment Screening

• Test patients without a history of varicella infection or varicella vaccination for antibodies to varicella zoster virus; consider vaccinating antibody-negative patients prior to initiating alemtuzumab therapy.

• Complete any necessary immunizations, including varicella vaccination, at least 6 weeks prior to alemtuzumab therapy.

• Screen patients for tuberculosis according to local guidelines.

• Obtain CBC with differential, S_crconcentration, and urinalysis with urine cell counts prior to initiation.

• Measure urine protein-to-creatinine ratio at baseline.

• Conduct thyroid function tests prior to initiating therapy.

• Determine serum aminotransferase and total bilirubin concentrations prior to initiating therapy.

• Perform dermatologic examination to monitor for melanoma.

Patient Monitoring

• Because alemtuzumab can cause potentially serious adverse effects, perform appropriate laboratory tests and clinical evaluations (e.g., dermatologic examinations) prior to, during, and following a course of alemtuzumab therapy at recommended intervals.

• Obtain CBC with differential, S_cr concentration, and urinalysis with cell counts at monthly intervals until 48 months after last infusion.

• Conduct thyroid function tests every 3 months during therapy.

• Determine serum aminotransferase and total bilirubin concentrations periodically during therapy.

• Monitor for infusion reactions during and for at least 2 hours after each infusion. Longer periods of observation may be considered if clinically indicated.

• Monitor vital signs prior to and periodically during infusion.

• Perform annual dermatologic examinations to monitor for melanoma.

• Screen female patients annually for human papillomavirus (HPV).

Premedication and Prophylaxis

• To reduce incidence and/or severity of infusion-related reactions, premedicate patients with a high-dose corticosteroid (e.g., methylprednisolone 1 g or equivalent) immediately prior to infusion for the first 3 days of each treatment course. In addition, consider premedication with antihistamines and/or antipyretics.

• Because alemtuzumab therapy has been associated with the development of herpes virus infections, antiviral prophylaxis is recommended; initiate prophylactic regimen on the first day of each alemtuzumab treatment course and continue for at least 2 months following completion of the course or until CD4⁺ lymphocyte count is at least 200/mm³, whichever occurs later.

REMS

• Because of the risks of autoimmunity, infusion reactions, and malignancies, alemtuzumab (Lemtrada) is available only through a restricted distribution program called the Lemtrada Risk Evaluation and Mitigation Strategy (REMS) Program.

• Additional information about the Lemtrada REMS Program is available at 855-676-6326 or [Web]

Other General Considerations

• Administer alemtuzumab only in settings where adequate monitoring can be performed and appropriate medical support is available for the management of anaphylaxis or serious infusion reactions.

Administration

Administer by IV infusion. Do not administer by rapid IV injection (e.g., IV push or bolus).

Must be diluted prior to IV infusion.

Dilution

Withdraw 1.2 mL of alemtuzumab 10 mg/mL from vial and add to a 100 mL bag of 0.9% sodium chloride or 5% dextrose injection. Gently invert bag to mix.

Each vial is for single use only.

Rate of Administration

Administer IV infusion over 4 hours (or longer if clinically indicated).

Dosage

Adults

Multiple Sclerosis

IV

Initial treatment course: 12 mg daily for 5 consecutive days (total dose 60 mg), followed 12 months later by second treatment course of 12 mg daily for 3 consecutive days (total dose 36 mg).

Subsequent treatment course: If needed, 12 mg daily on 3 consecutive days (total dose 36 mg) at least 12 months after last infusion of any prior treatment course.

Special Populations

Hepatic Impairment

Manufacturer makes no dosage adjustment recommendations.

Renal Impairment

Manufacturer makes no dosage adjustment recommendations.

Geriatric Patients

Manufacturer makes no dosage adjustment recommendations.

Cautions for Alemtuzumab (Multiple Sclerosis)

Contraindications

• Patients with known hypersensitivity or anaphylactic reactions to alemtuzumab or any excipients in the formulation.

• Patients with HIV infection.

• Patients with active infection.

Warnings/Precautions

Warnings

Autoimmunity

May cause formation of autoantibodies, which can increase risk of serious, and sometimes fatal, autoimmune disorders. (See Boxed Warning.)

Thyroid disorders, immune thrombocytopenia, and anti-glomerular basement membrane disease are among the serious autoimmune conditions that have occurred.

Other autoimmune conditions reported include autoimmune hemolytic anemia, autoimmune pancytopenia, undifferentiated connective tissue disorders, acquired hemophilia A (anti-factor VIII antibodies), rheumatoid arthritis, type 1 diabetes mellitus, vitiligo, and retinal pigment epitheliopathy.

Vasculitis, autoimmune hepatitis, Guillain-Barré syndrome, thrombotic thrombocytopenic purpura, and autoimmune encephalitis also reported during postmarketing experience.

Careful monitoring, including appropriate laboratory testing, is required during and following completion of therapy. Long-term monitoring also recommended because these events can occur months or years after drug is discontinued.

Measure urine protein-to-creatinine ratio prior to initiation of treatment. Monitor CBC with differential, S_cr, and urinalysis with urine cell counts before starting treatment and then at monthly intervals until 48 months after last dose; after 48 months, perform testing based on clinical findings.

Immune Thrombocytopenia

Immune thrombocytopenia (ITP) reported.

Monitor CBC with differential before starting treatment and then at monthly intervals until 48 months after last dose; after 48 months, perform testing based on clinical findings.

Clinical manifestations include easy bruising, petechiae, spontaneous mucocutaneous bleeding (e.g., epistaxis, hemoptysis), and heavier than normal or irregular menstrual bleeding.

If ITP is suspected, obtain CBC immediately; if confirmed, promptly initiate appropriate medical therapy.

Other Autoimmune Cytopenias

Other autoimmune cytopenias such as neutropenia, hemolytic anemia, and pancytopenia reported.

Manifestations of autoimmune hemolytic anemia include weakness, chest pain, jaundice, dark urine, and tachycardia.

Monitor patients closely with routine CBC and clinical observation. If cytopenia confirmed, promptly initiate appropriate medical treatment.

Autoimmune Hepatitis

Autoimmune hepatitis resulting in serious liver injury reported during postmarketing experience.

Monitor serum aminotransferase (ALT and AST) and total bilirubin concentrations routinely (i.e., at baseline and periodically thereafter until 48 months after last dose).

If patient develops any manifestations suggestive of hepatic dysfunction (e.g., nausea, vomiting, abdominal pain, fatigue, anorexia, jaundice, dark urine), promptly measure serum aminotransferase and total bilirubin concentrations; interrupt or discontinue therapy as necessary.

Glomerular Nephropathy

Autoimmune renal conditions, such as membranous glomerulonephritis and anti-glomerular basement membrane disease, reported. Some cases occurred up to 40 months after discontinuance of the drug.

Clinical manifestations of nephropathy may include edema, hematuria, change in urine color, decreased urine output, fatigue, dyspnea, and hemoptysis.

Measure urine protein-to-creatinine ratio prior to initiating therapy. Perform S_cr and urinalysis with urine cell counts prior to initiation of therapy and monthly thereafter until at least 48 months after last infusion.

If there is any evidence of nephropathy based on changes in urine protein-to-creatinine ratio, S_cr, or clinical symptoms (e.g., unexplained hematuria, proteinuria), further evaluate patient. Early detection and treatment may decrease risk of poor outcomes.

Thyroid Disorders

Autoimmune thyroid disorders (e.g., Graves' disease, Graves' ophthalmopathy, hyperthyroidism, hypothyroidism, autoimmune thyroiditis, goiter) reported. In some cases, delayed onset (more than 7 years after initiation of therapy) observed.

Perform thyroid function tests prior to initiation of therapy and every 3 months thereafter until 48 months after last infusion; after 48 months, continue monitoring if clinically indicated or in the case of pregnancy.

Use in patients with ongoing thyroid disorders only if potential benefits outweigh potential risks.

Infusion Reactions

Cytokine release syndrome can occur, causing serious, sometimes fatal, infusion reactions. Such reactions have included anaphylaxis, angioedema, bronchospasm, hypotension, chest pain, bradycardia, tachycardia, atrial fibrillation, transient neurologic symptoms, hypertension, headache, pyrexia, and rash. (See Boxed Warning.) Other possible manifestations include nausea, urticaria, pruritus, insomnia, chills, flushing, fatigue, dyspnea, pulmonary infiltrates, dysgeusia, dyspepsia, dizziness, and pain.

In some cases, infusion reactions occurred more than 24 hours after the drug was administered.

Administer appropriate premedications (i.e., corticosteroids, antihistamines, antipyretics).

Administer only in a setting with appropriate equipment and personnel to manage serious infusion reactions, including anaphylaxis. Monitor for infusion reactions during and for at least 2 hours after each infusion.

Malignancy

Malignancies, including thyroid cancer, melanoma, lymphoproliferative disorders, and lymphoma (e.g., mucosa-associated lymphoid tissue [MALT] lymphoma, Castleman's disease, fatal non-Epstein Barr virus-associated Burkitt's lymphoma, Epstein Barr virus-associated lymphoproliferative disorders) have occurred. (See Boxed Warning.)

Caution advised when initiating therapy in patients with preexisting or ongoing malignancy.

Monitor for symptoms of thyroid cancer and perform baseline and annual dermatologic evaluations.

Cerebrovascular Events

Serious and life-threatening stroke (ischemic and hemorrhagic) reported within 3 days in MS patients receiving alemtuzumab during postmarketing experience. (See Boxed Warning.) Most cases occurred within 1 day of receiving the drug.

Postmarketing cases of cervicocephalic (e.g., carotid, vertebral) arterial dissection also reported.

Instruct patients to monitor for symptoms of stroke and cervicocephalic arterial dissection and seek immediately medical attention if any symptoms occur.

Other Warnings and Precautions

Hemophagocytic Lymphohistiocytosis

Hemophagocytic lymphohistiocytosis (HLH), a life-threatening condition involving pathologic activation of the immune system, reported.

Common manifestations include fever, hepatosplenomegaly, rash, lymphadenopathy, neurologic symptoms (e.g., mental status changes, ataxia, or seizures), cytopenias, high serum ferritin, hypertriglyceridemia, and liver function and coagulation abnormalities. Hemophagocytosis may be present on histologic examination.

Evaluate patients with early manifestations of pathologic immune activation and consider diagnosis of HLH; discontinue therapy if an alternate etiology cannot be established.

Adult Onset Still's Disease

Adult onset Still's disease (AOSD), a rare inflammatory condition, reported. Associated with high mortality rate if not recognized early and treated.

Patients may present with a combination of signs and symptoms (e.g., fever, arthritis, rash, and leukocytosis in the absence of infections, malignancies, and other rheumatic conditions).

Immediately evaluate patients with manifestations of AOSD. Discontinue therapy if an alternate etiology cannot be established.

Thrombotic Thrombocytopenic Purpura

Thrombotic thrombocytopenic purpura (TTP) reported.

Characterized by thrombocytopenia, microangiopathic hemolytic anemia, neurological sequelae, fever, and renal impairment. Associated with high morbidity and mortality if not recognized and treated early.

Discontinue therapy if TTP is confirmed or an alternate etiology cannot be established.

Autoimmune Encephalitis

Autoimmune encephalitis reported.

Symptoms include subacute onset of memory impairment, altered mental status, psychiatric symptoms, neurological findings, and seizures.

Discontinue therapy if autoimmune encephalitis is confirmed by presence of neural autoantibodies or an alternate etiology cannot be established.

Acquired Hemophilia A

Acquired hemophilia A (anti-Factor VIII antibodies) reported.

Patients typically present with spontaneous subcutaneous hematomas and extensive bruising, although hematuria, epistaxis, GI, or other types of bleeding may occur.

Obtain a coagulopathy panel including aPTT in patients who present with symptoms of acquired hemophilia A.

Advise patients to seek immediate medical attention if any symptoms occur.

Infectious Complications

Risk of serious (sometimes fatal) bacterial, viral, fungal, or protozoan infections reported. Reported infections have included nasopharyngitis, urinary tract infection, upper respiratory tract infection, sinusitis, herpes infection, human papillomavirus (HPV) infection, influenza, and bronchitis. Opportunistic infections,(e.g., CMV infection, Pneumocystis jiroveci pneumonia) and other serious infections, such as tuberculosis and Listeria meningitis, also reported.

Administer antiviral prophylaxis for herpes infection during and for at least 2 months after a course of therapy.

Screen for HPV annually in female patients.

Screen and treat (if necessary) patients for tuberculosis prior to therapy.

Avoid or adequately heat foods that are potential sources of Listeria monocytogenes.

Consider screening patients at high risk of HBV or HCV infection prior to initiating therapy and use caution in those identified as carriers of these viruses.

Do not administer live viral vaccinations following administration due to increased risk of infection following live vaccines.

Do not administer in patients with active infection.

Progressive Multifocal Leukoencephalopathy

Progressive multifocal leukoencephalopathy (PML), an opportunistic infection of the brain caused by the JC virus, reported in at least 1 patient receiving alemtuzumab for MS.

Immunocompromised patients are at increased risk.

MRI signs may be apparent before clinical manifestations develop. Further investigation of any suspicious MRI findings may allow for an early diagnosis of PML.

Symptoms typically associated with PML are diverse, progress over a period of days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, vision disturbances, and changes in thinking, memory, orientation, or personality.

At the first sign or symptom suggestive of PML, withhold alemtuzumab therapy and perform appropriate diagnostic evaluation.

Acute Acalculous Cholecystitis

Acute acalculous cholecystitis reported. Onset of symptoms ranged from <24 hours to 2 months after administration of the drug. Cholecystectomy was required in some cases.

Signs and symptoms include abdominal pain or tenderness, fever, nausea, vomiting, leukocytosis, and liver enzyme abnormalities; promptly evaluate and treat to avoid substantial morbidity and mortality.

Pneumonitis

Pneumonitis, including hypersensitivity pneumonitis and pneumonitis with fibrosis, reported. Manifestations include dyspnea, cough, wheezing, chest pain or tightness, and hemoptysis.

Other Alemtuzumab Preparations

Alemtuzumab (Lemtrada) for treatment of MS contains same active ingredient as alemtuzumab (Campath) for treatment of B-cell chronic lymphocytic leukemia (B-CLL); increased monitoring for additive, long-term effects may be necessary in patients currently receiving Lemtrada who have previously received Campath.

Immunogenicity

Development of antibodies (including neutralizing antibodies) to alemtuzumab reported.

Specific Populations

Pregnancy

No adequate data in pregnant women to determine whether there are any developmental risks associated with alemtuzumab. Animal reproductive studies have not shown any evidence of teratogenicity; however, embryolethality was observed.

May induce autoimmune thyroid disorders, which can increase the risk of complications in pregnant women.

Because autoantibodies can cross placenta, placental transfer of antithyrotropin receptor antibodies may occur in pregnant women who develop Graves' disease following alemtuzumab therapy.

A pregnancy surveillance program has been established; if alemtuzumab exposure occurs during pregnancy, clinicians and patients are encouraged to report the pregnancy by calling 800-745-4447, option 2.

Lactation

Distributed into milk in animals; not known whether the drug is distributed into human milk. Effects on nursing infants or on milk production also not known.

Consider known benefits of breast-feeding along with the woman's clinical need for alemtuzumab and any potential adverse effects of the drug or disease on the breast-fed infant.

Females and Males of Reproductive Potential

Women of childbearing potential should use effective contraceptive measures during and for 4 months following a course of alemtuzumab therapy.

Pediatric Use

Safety and efficacy not established in pediatric patients <17 years of age.

Geriatric Use

Clinical studies did not include sufficient numbers of patients ≥65 years of age to determine whether they respond differently than younger patients.

Hepatic Impairment

Pharmacokinetics of alemtuzumab not studied in patients with hepatic impairment.

Renal Impairment

Pharmacokinetics of alemtuzumab not studied in patients with renal impairment.

Common Adverse Effects

Common adverse effects (≥10%): rash, headache, pyrexia, nasopharyngitis, nausea, urinary tract infection, fatigue, insomnia, upper respiratory tract infection, herpes virus infection, urticaria, pruritus, thyroid disorders, fungal infection, arthralgia, extremity pain, back pain, diarrhea, sinusitis, oropharyngeal pain, paresthesia, dizziness, abdominal pain, flushing, vomiting.

Drug Interactions

Antineoplastic Agents

Potential for increased immunosuppression and risk of infection with concomitant use of antineoplastic agents.

Immunosuppressive Agents

Potential for increased immunosuppression and risk of infection with concomitant use of immunosuppressive agents.

Vaccines

Live virus vaccines should not be administered following a course of alemtuzumab therapy.

Alemtuzumab (Multiple Sclerosis) Pharmacokinetics

Absorption

Bioavailability

Following administration of recommended 2-course regimen, serum concentrations increase with each consecutive dose within a treatment course.

Distribution

Extent

Not known whether distributes into human milk.

Elimination

Metabolism

Metabolism thought to be mediated by proteolytic degradation.

Half-life

Elimination half-life approximately 2 weeks.

Stability

Storage

Parenteral

Injection Concentrate for IV infusion

2–8ºC in original carton; protect from light. Do not freeze or shake.

Following dilution, may store at room temperature (15–25°C) or under refrigeration (2–8°C) for up to 8 hours; protect from light.

Actions

• A recombinant DNA-derived humanized monoclonal antibody that binds specifically to antigen CD52, a glycoprotein expressed at high levels on the surface of B and T cells, and at lower levels on monocytes, macrophages, and natural killer (NK) cells.

• Binding to CD52 triggers a host immune response consisting of antibody-dependent cell-mediated cytolysis (ADCC) and complement-dependent cytolysis (CDC), ultimately resulting in depletion of circulating B and T cells.

• Although exact mechanism in MS not fully elucidated, the depletion and repopulation of B and T cells is thought to result in the drug's immunomodulatory effects.

Advice to Patients

• Advise patients to read the manufacturer's patient information (medication guide).

• Inform patients of the risk of developing autoimmune diseases. Advise patients of the importance of monthly blood and urine tests until 48 months after the last dose; monitoring may be needed past 48 months if they have signs or symptoms of autoimmunity. Advise patients to immediately report any manifestations of potential autoimmunity (e.g., bleeding, easy bruising, petechiae, purpura, hematuria, edema, jaundice, hemoptysis) to their clinician.

• Inform patients of the risk of autoimmune hepatitis; instruct patients to immediately contact their clinician if they develop any signs or symptoms of possible hepatic dysfunction (e.g., unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, jaundice, dark urine, easy bruising or bleeding).

• Inform patients of the risk of thyroid disorders (e.g., hyperthyroidism, hypothyroidism). Advise patients to inform their clinician if they experience any manifestations of potential thyroid problems (e.g., unexplained weight loss or gain, rapid heart rate or palpitations, eye swelling, constipation, feeling cold).

• Advise patients to contact their healthcare provider if they experience symptoms of acquired hemophilia A such as 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.

• Advise patients that cases of autoimmune encephalitis can occur after receiving alemtuzumab. This condition may include symptoms such as behavior and psychiatric changes, movement disorders, short-term memory loss or seizures, as well as other symptoms that may resemble an MS relapse.

• Inform patients of the risk of infusion-related reactions; advise patients that they will need to be monitored at the healthcare facility (e.g., infusion center) for 2 hours after each infusion. Advise patients that symptoms of infusion reactions may occur after they leave the infusion center and to report these symptoms to their healthcare provider.

• Advise patients that their healthcare provider will monitor vital signs, including BP, before and during the infusion and to contact their healthcare provider promptly if they experience infusion reactions, which include swelling in the mouth or throat, difficulty breathing, weakness, abnormal heart rate (fast, slow, or irregular), chest pain, rash, facial drooping, sudden severe headache, weakness on one side of the body, difficulty with speech, or neck pain.

• Instruct patients that there have also been reports of rare but serious infusion reactions, including bleeding in the lung, chest tightness/pain or discomfort, heart attack, and stroke or tears in blood vessels supplying the brain, which should be reported to your healthcare provider. These reactions can occur following any of the doses during the treatment course, but in the majority of cases, reactions occurred within 1–3 days of the infusion.

• Instruct patients to seek immediate medical attention if symptoms of stroke or cervicocephalic arterial dissection occur (e.g., neck pain, weakness on one side, facial droop, difficulty with speech, sudden severe headache).

• Advise patients that alemtuzumab may increase their risk of malignancies, including thyroid cancer and melanoma, and to report any symptoms including a new lump or swelling in the neck, pain in the front of the neck, hoarseness or other voice changes that do not go away, trouble swallowing or breathing, or a constant cough not due to a cold. Advise patients to have baseline and yearly skin examinations.

• Inform patients of the risk of a type of excessive immune activation (hemophagocytic lymphohistiocytosis), which can be fatal, particularly if not diagnosed and treated early. Advise patients to contact their healthcare provider immediately if they experience symptoms such as fever, swollen glands, skin rash, or new neurologic symptoms such as mental status changes, ataxia, or seizures.

• Inform patients of the risk of Adult onset Still's disease (AOSD), a rare condition that has the potential to cause multi-organ inflammation with several symptoms such as fever >39°C lasting more than 1 week, pain, stiffness with or without swelling in multiple joints, and/or a skin rash. Instruct patients if they experience a combination of these symptoms to contact their healthcare provider immediately.

• Inform patients that there have been reports of thrombotic thrombocytopenic purpura, a potentially life-threatening condition, in patients treated with alemtuzumab. Instruct patients to seek prompt medical attention if they experience symptoms such as fever, fatigue, pallor, purpura, jaundice, tachycardia, dyspnea, hematuria, dark-colored urine, decreased urine volume, abdominal pain, nausea, vomiting, or new neurological symptoms such as confusion, altered mental status, vision or speech changes, or seizures.

• Advise patients to contact their healthcare provider if they develop symptoms of serious infection such as fatigue, fever, or swollen glands.

• Advise patients to complete any necessary immunizations at least 6 weeks prior to treatment with alemtuzumab.

• Advise patients to avoid or adequately heat foods that are potential sources of Listeria monocytogenes prior to receiving alemtuzumab and if they have received a recent course of alemtuzumab. The duration of increased risk for Listeria infection after alemtuzumab administration is not known. Inform patients that Listeria infection can lead to significant complications or death.

• Advise patients that yearly HPV screening is recommended in female patients.

• Inform patients that progressive multifocal leukoencephalopathy (PML) has occurred in a patient who received alemtuzumab. PML is characterized by a progression of deficits and usually leads to death or severe disability over weeks or months. Instruct patients to contact their doctor if they develop any symptoms suggestive of PML. Inform patients that typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.

• Advise patients to report symptoms (e.g., abdominal pain, abdominal tenderness, fever, nausea, vomiting) of acute acalculous cholecystitis.

• Advise patients that pneumonitis has been reported in patients treated with alemtuzumab and to report symptoms such as shortness of breath, cough, wheezing, chest pain or tightness, and hemoptysis.

• Advise patients that alemtuzumab is the same drug as Campath for use in B-CLL. Patients should inform their healthcare provider if they have received Campath.

• Advise patients to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.

• Advise women to inform their clinician if they are or plan to become pregnant or plan to breastfeed. Advise pregnant women of the potential fetal risk. Advise females of reproductive potential to use effective contraception during treatment and for 4 months after a treatment course of alemtuzumab. Advise patients exposed to alemtuzumab during pregnancy that there is a pregnancy safety surveillance program that monitors pregnancy outcomes. If exposure occurs during pregnancy, healthcare providers and patients are encouraged to report pregnancies by calling 800-745-4447, option 2.

• Inform patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Alemtuzumab (Lemtrada) is available only through a restricted distribution program (Lemtrada REMS Program).

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