alemtuzumab (Rx)

Brand and Other Names:Campath, Lemtrada
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

Available only from a restricted distribution program

injectable solution

  • 10mg/mL (Lemtrada; 1.2mL/vial [12mg/1.2mL])
  • 30mg/mL (Campath; 1mL/vial)

Chronic Lymphocytic Leukemia (Campath)

Indicated as a single agent for treatment of B-cell chronic lymphocytic leukemia (B-CLL)

Gradually escalate to maximum recommended single dose of 30 mg (typically over 3-7 days)

Escalation is required at initiation of dosing or if dose is held ≥7 days during treatment

Escalation strategy

  • Administer 3 mg IV qDay until infusion reactions are Grade ≤2, THEN
  • Administer 10 mg IV qDay until infusion reactions are Grade ≤2, THEN
  • Administer 30 mg IV 3x/week (on alternate days [eg, Mon-Wed-Fri])
  • Duration of treatment: 12 weeks (including escalation periods)
  • Not to exceed 30 mg/dose OR 90 mg/week

Multiple Sclerosis (Lemtrada)

Indicated for relapsing forms of multiple sclerosis (MS); owing to its safety profile, reserve for patients who have an inadequate response to ≥2 other drugs for MS

Recommended dose is administered as 2 separate treatment courses

First course: 12 mg/day IV on 5 consecutive days (60 mg total dose)

Second course: 12 mg/day IV on 3 consecutive days (36 mg total dose)

Subsequent courses: Administer 12 mg/day IV on 3 consecutive days (36 mg total dose) as needed, at least 12 months after last dose of any prior treatment courses

Kidney Transplantation (Off-label)

Campath only

In numerous phase 3 clinical trials, use has achieved steroid-sparing effects including improved glycemic stability

Careful patient selection is required

Long-term follow-up results from the 3C trial (NCT01120028) is pending regarding alemtuzumab’s role in reducing calcineurin inhibitor exposure by using a more potent induction regimen

Dosage modifications (Campath)

Withhold therapy during serious infection or other serious adverse reactions until resolution

Discontinue therapy for autoimmune anemia or autoimmune thrombocytopenia

No dosage adjustment necessary for lymphopenia

Delay between doses (≥7 days): Initiate therapy at 3 mg; escalate to 10 mg, and then to 30 mg as tolerated

ANC <250 cells/mcL and/or platelet count ≤25,000 cells/mcL

  • First occurrence: Withhold therapy, resume at 30 mg when ANC ≥500 cells/mcL and platelet count ≥50,000 cells/mcL
  • Second occurrence: Withhold therapy, resume at 10 mg when ANC ≥500 cells/mcL and platelet count ≥50,000 cells/mcL
  • Third occurrence: Discontinue therapy

Patients with ≥50% decrease from baseline (ANC ≤250 cells/mcL and/or a platelet count ≤25,000 cells/mcL)

  • First occurrence: Withhold therapy, resume at 30 mg upon return to baseline
  • Second occurrence: Withhold therapy, resume at 10 mg upon return to baseline
  • Third occurrence: Discontinue therapy

Dosing Considerations

Before initiating

  • Obtain a baseline ECG; monitor vital signs before infusion and periodically during the infusion
  • Complete any necessary immunizations ≥6 weeks
  • Determine whether patients have a history of varicella or were vaccinated for varicella zoster virus (VZV); if not, test for antibodies to VZV and consider vaccination for those who are antibody-negative; postpone initiating treatment until 6 weeks after VZV vaccination
  • Perform tuberculosis screening according to local guidelines
  • Instruct to avoid potential sources of Listeria monocytogenes (see Cautions)

Laboratory testing and monitoring

  • Conduct laboratory tests (ie, CBC with differential, serum creatinine, urinalysis with urine cell counts) at baseline and at periodic intervals for 48 months following the last treatment course
  • Test thyroid function (eg, TSH) before treatment and q3mo thereafter

Safety and efficacy not established

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Adverse Effects

>10% (Campath)

Rigors (86%)

Fever (85%)

Neutropenia (85%)

Anemia (80%)

Thrombocytopenia (72%)

Nausea (54%)

Vomiting (41%)

Rash (40%)

Fatigue (34%)

Dyspnea (26%)

Cough (25%)

Headache (24%)

Pruritus (24%)

Sepsis (24%)

Skeletal pain (24%)

Diarrhea (22%)

Anorexia (20%)

Excessive sweating (19%)

Pneumonia (16%)

Dysthesias (15%)

Stomatitis (14%)

Asthenia (13%)

Edema (13%)

Dizziness (12%)

Abdominal pain (11%)

Herpes simplex (11%)

Hypertension (11%)

Myalgias (11%)

Tachycardia, SVT (11%)

>10% (Lemtrada)

Infusion reactions, all (92%)

Infections, all (71%)

Rash (53%)

Headache (52%)

Pyrexia (29%)

Nasopharyngitis (25%)

Nausea (21%)

Urinary tract infection (19%)

Fatigue (18%)

Insomnia (16%)

Upper respiratory tract infection (16%)

Herpes viral infection (16%)

Urticaria (16%)

Pruritus (14%)

Thyroid gland disorders (13%)

Fungal infection (13%)

Arthralgia (12%)

Pain in extremity (12%)

Back pain (12%)

Diarrhea (12%)

Sinusitis (11%)

Oropharyngeal pain (11%)

1-10% (Campath)

Chest/back pain (10%)

Dyspepsia (10%)

Insomnia (10%)

Bronchospasm (9%)

Constipation (9%)

Depression (7%)

Epistaxis (7%)

Moniliasis (8%)

Pancytopenia (5%)

Somnolence (5%)

1-10% (Lemtrada)

Paresthesia (10%)

Dizziness (10%)

Abdominal pain (10%)

Flushing (10%)

Vomiting (10%)

Cough (9%)

Chills (9%)

Dysgeusia (8%)

Influenza (8%)

Dermatitis (8%)

Dyspepsia (8%)

Blood in urine (8%)

Dyspnea (8%)

Tachycardia (8%)

Anxiety (7%)

Muscular weakness (7%)

Bronchitis (7%)

Chest discomfort (7%)

Muscle spasm (6%)

Myalgia (6%)

Decreased CD4 and CD8 lymphocytes (6%)

Asthenia (5%)

Infusion reactions, serious (3%)

Infections, serious (3%)

Immune thrombocytopenia (2%)

HPV infection (2%)

<1% (Lemtrada)

Pneumonitis (0.5%)

Glomerular nephropathies (0.3%)

Thyroid cancer (0.3%)

Melanoma (0.3%)

Active/latent tuberculosis (0.3%)

Hemolytic anemia (0.2%)

Pancytopenia (0.2%)

Neutropenia (0.1%)

Postmarketing Reports

Campath

  • Fatal infusion reactions
  • Cardiovascular: CHF, cardiomyopathy, decreased ejection fraction (some patients had been previously treated with cardiotoxic agents)
  • Cerebrovascular disorders: Cervicocephalic arterial dissection, stroke, including hemorrhagic and ischemic stroke
  • Gastrointestinal: Acute acalculous cholecystitis
  • Immune disorders: Goodpasture’s syndrome, Graves disease, aplastic anemia, Guillain Barre syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, serum sickness, autoimmune hepatitis, vasculitis, hemophagocytic lymphohistiocytosis, sarcoidosis, fatal transfusion-associated
  • GVHD Infections: Epstein-Barr virus (EBV) including EBV-associated lymphoproliferative disorder, progressive multifocal leukoencephalopathy (PML), reactivation of latent viruses
  • Metabolic: Tumor lysis syndrome
  • Neurologic: Optic neuropathy
  • Renal and urinary disorders: Glomerular nephropathies
  • Endocrine disorders: Hypothyroidism, hyperthyroidism, and thyroiditis

Lemtrada

  • Cerebrovascular disorders: Stroke, including hemorrhagic and ischemic stroke and cervicocephalic arterial dissection
  • Gastrointestinal system disorders: Cholecystitis, including acalculous cholecystitis and acute acalculous cholecystitis
  • Immune system disorders: Guillain-Barre syndrome, hemophagocytic lymphohistiocytosis
  • Pulmonary system disorders: Pulmonary alveolar hemorrhage
  • Thrombotic thrombocytopenia purpura
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Warnings

Black Box Warnings

Infusion reactions

  • Serious infusion reactions, including fatal reactions, can occur
  • Administer in a setting with appropriate equipment and personnel to manage anaphylaxis or serious infusion reactions
  • Monitor during infusions and for 2 hr after each infusion, withhold drug for Grade 3 or 4 infusion reactions
  • Gradually escalate drug to recommended dose at initiation of therapy and after interruption of therapy for ≥7 days

Malignancies

  • May cause an increased risk of malignancies, including thyroid cancer, melanoma, and lymphoproliferative disorders
  • Perform baseline and yearly skin exams

Cytopenias (Campath)

  • Serious cytopenias, including fatal pancytopenia/marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia, can occur
  • Single doses >30 mg or cumulative doses >90 mg/week increase incidence of pancytopenia
  • Monitor CBC with differential, serum creatinine, and urinalysis at periodic intervals for 48 months after last dose

Infections (Campath)

  • Serious infections, including fatal bacterial, viral, fungal, and protozoan infections, reported
  • Administer prophylaxis against Pneumocystis jiroveci pneumonia (PCP) and herpes virus infections

Autoimmunity (Lemtrada)

  • Serious, sometimes fatal, autoimmune conditions (eg, immune thrombocytopenia, antiglomerular basement membrane disease) may occur
  • Monitor complete blood counts with differential, serum creatinine levels, and urinalysis with urine cell counts before starting treatment and then at monthly intervals until 48 months after last dose; after 48 months, testing should be performed based on clinical findings suggestive of autoimmunity

Stroke (Lemtrada)

  • Serious and life-threatening stroke (eg, ischemic, hemorrhagic stroke) reported within 3 days of administration
  • Advise to seek immediate medical attention if symptoms of stroke occur

REMS

  • Campath and Lemtrada are available only through restricted distribution under a Risk Evaluation Mitigation Strategy (REMS) program
  • Prescribers must be certified with the program by enrolling and completing training
  • Patients must enroll in the program and comply with ongoing monitoring requirements
  • Pharmacies must be certified with the program and must only dispense to certified healthcare facilities that are authorized to receive the drug
  • Healthcare facilities must enroll in the program and verify that patients are authorized before infusing drug
  • Healthcare facilities must have on-site access to equipment and personnel trained to manage infusion reactions
  • Campath: 1-877-422-6728
  • Lemtrada: 1-855-676-6326

Contraindications

Campath: None

Lemtrada

  • Patients infected with HIV,
  • Hypersensitivity or anaphylactic reactions to alemtuzumab or excipients
  • Active infection

Cautions

Therapy associated with moderate emetic potential in adults in the oncology setting; may recommend antiemetics to prevent nausea and vomiting

Leukoencephalopathy (PML) reported; withhold therapy immediately for symptoms suggestive of PML

Campath

  • Treatment results in severe and prolonged lymphopenia along with an increased incidence of opportunistic infections
  • Prophylaxis does not eliminate these infections; routinely monitor for CMV infection during treatment and for ≥2 months following completion; withhold treatment for serious infections and during antiviral treatment for CMV infection or confirmed CMV viremia (defined as polymerase chain reaction (PCR) positive CMV in ≥2 consecutive samples obtained 1 week apart)
  • Unless an emergency, administer only irradiated blood products to avoid transfusion-associated graft versus host disease
  • Hemolytic anemia, pure red cell aplasia, bone marrow aplasia, and hypoplasia reported after treatment
  • Safety of immunization with live viral vaccines has not been studied; do not administer live viral vaccines to patients who have recently therapy
  • Serious infusion reactions (pyrexia, chills/rigors, nausea, hypotension, urticaria, dyspnea, rash, emesis, bronchospasm) reported
  • Monitor thyroid-stimulating hormone (TSH) at baseline and every 2-3 months during treatment

Lemtrada

  • Therapy can only be administered in certified healthcare settings that have on-site access to equipment and personnel trained to manage infusion reactions (including anaphylaxis, cerebrovascular, cardiac and respiratory emergencies); therapy causes cytokine release syndrome, resulting in infusion reactions that can be life-threatening; in majority of cases, time to onset may occur within 1 to 3 days of infusion
  • During postmarketing use, cases of vasculitis, autoimmune hepatitis, and Guillain-Barre syndrome reported
  • Autoantibody formation may occur and increase risk of serious autoimmune conditions (eg, thyroid disorders, immune thrombocytopenia, hemolytic anemia, pancytopenia, glomerular nephropathies, connective tissue disorders, and acquired hemophilia A)
  • Thrombotic thrombocytopenia purpura (TTP) reported, characterized by thrombocytopenia, microangiopathic hemolytic anemia, neurological sequelae, fever, and renal impairment; TTP is associated with high morbidity and mortality rates if not recognized and treated early; discontinue treatment if confirmed or alternate etiology for signs and symptoms cannot be established
  • Chronic inflammatory demyelinating polyradiculoneuropathy reported in the treatment of patients with B-cell chronic lymphocytic leukemia (B-CLL), as well as other autoimmune disorders, generally at higher and more frequent doses than recommended in MS
  • Therapy may increase risk of other autoimmune conditions because of the broad range of autoantibody formation with therapy
  • Autoimmune hepatitis causing clinically significant liver injury, including acute liver failure requiring transplant, reported; prior to starting treatment, obtain serum transaminases (ALT and AST) and total bilirubin levels; obtain transaminase levels and total bilirubin levels periodically until 48 months after last dose
  • Infusion reactions are common (92%) and may be serious or life-threatening; premedication with corticosteroids is required and monitoring
  • May increase risk for malignancies, including thyroid cancer, melanoma, lymphoproliferative disorders, and lymphoma; patients and healthcare providers should monitor for symptoms of thyroid cancer including a new lump or swelling in the neck, pain in the front of the neck, persistent hoarseness or other voice changes, trouble swallowing or breathing, or a constant cough not due to an upper respiratory tract infection
  • Obtain thyroid function tests, such as TSH levels, prior to initiation of treatment and every 3 months thereafter until 48 months after the last infusion; continue to test thyroid function after 48 months if clinically indicated or in case of pregnancy
  • Pneumonitis reported; advice patients to contact physician with symptoms of SOB, cough, wheezing, chest pain/tightness, or hemoptysis
  • Cases of pulmonary alveolar hemorrhage, myocardial ischemia, myocardial infarction, stroke (including ischemic and hemorrhagic stroke), and cervicocephalic (eg, vertebral, carotid) arterial dissection reported; reactions may occur following any of the doses during treatment course; patients should be informed about the signs and symptoms and advised to seek immediate medical attention if any of these symptoms occur
  • Cases of severe and fatal neutropenia reported within 2 months of infusion; some cases resolved with receiving granulocyte-colony stimulating factor treatment
  • Increased vigilance and monitoring is warranted in patients previously treated with alemtuzumab (Campath) for CLL who receive Lemtrada for MS; additive and chronic autoimmune effects may occur
  • May increase risk of acute acalculous cholecystitis; symptoms of acute acalculous cholecystitis include abdominal pain, abdominal tenderness, fever, nausea, vomiting; leukocytosis and abnormal liver enzymes are also commonly observed; if acute acalculous cholecystitis is suspected, evaluate and treat promptly
  • In postmarketing setting, cases of cervicocephalic (eg, vertebral, carotid) arterial dissection involving multiple arteries reported within 3 days of administration
  • Monitor TSH at baseline and every 3 months until 48 months after last infusion or longer or at any time during therapy if clinically indicated
  • Concomitant use with antineoplastic or immunosuppressive therapies could increase risk of immunosuppression
  • Hemophagocytic lymphohistiocytosis
    • Patients who develop early manifestations of pathologic immune activation should be evaluated immediately and a diagnosis of hemophagocytic lymphohistiocytosis (HLH) considered; discontinue therapy if alternate etiology for signs and symptoms cannot be established
    • HLH is a life-threatening syndrome of pathologic immune activation characterized by clinical signs and symptoms of extreme systemic inflammation; it is associated with high mortality rates if not recognized early and treated
    • Common findings 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 seen on histologic examination of bone marrow, spleen, or lymph nodes; in cases of HLH reported with therapy, most patients presented with fever, elevated ferritin, transaminitis, hypertriglyceridemia, and all patients required hospitalization
    • Although the small number of cases limits the ability to draw conclusions pertaining to mean or range of latency for HLH, symptoms have been reported to occur within approximately thirteen months to thirty-three months following the initiation of treatment
    • Patients who develop early manifestations of pathologic immune activation should be evaluated immediately, and a diagnosis of HLH should be considered
    • Discontinue therapy if an alternate etiology for signs or symptoms cannot be established
  • Acquired hemophilia A
    • Cases of acquired hemophilia A (anti-Factor VIII antibodies) reported; patients typically present with spontaneous subcutaneous hematomas and extensive bruising, although hematuria, epistaxis, gastrointestinal or other types of bleeding may occur
    • Obtain a coagulopathy panel including aPTT in patients who present with such symptoms; patients should be informed about signs and symptoms of acquired hemophilia A and advised to seek immediate medical attention if any of these symptoms occur
  • Infections
    • Infections reported, including herpes viral infections, HPV, tuberculosis, fungal infections (especially oral and vaginal candidiasis), and listeria meningitis; patients with HBV or HCV were excluded from clinical trials
    • In postmarketing setting, serious, sometimes fatal, opportunistic infections reported, including aspergillosis, coccidioidomycosis, histoplasmosis, Pneumocystis jirovecii pneumonia, nocardiosis, and cytomegalovirus infections
    • Epstein-Barr virus (EBV) infection, including severe and fatal EBV-associated hepatitis, reported; monitor for sign and symptoms of EBV infections; withhold therapy for EBV reactivation or severe infection
    • Avoid or adequately heat foods that are potential sources of Listeria monocytogenes (eg, deli meat, dairy products made with unpasteurized milk, soft cheeses, or undercooked meat, seafood, or poultry)
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Pregnancy & Lactation

Pregnancy

Campath: Unknown whether drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity; administer to a pregnant woman only if clearly needed

Lemtrada

  • Pregnancy exposure registry (1-866-758-2990) monitors pregnancy outcomes of drug exposure during pregnancy
  • No adequate data on developmental risk associated with use in pregnant women
  • When administer during organogenesis, drug was embryolethal in pregnant huCD52 transgenic mice
  • Auto-antibodies may develop after administration; placental transfer of antithyroid antibodies resulting in neonatal Graves’ disease reported
  • Contraception
    • Women of childbearing potential should use effective contraceptive measures during treatment and for 4 months following that course of treatment
  • Infertility
    • In huCD52 transgenic mice, administration 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
  • Clinical considerations
    • Alemtuzumab induces persistent thyroid disorders, 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 may transfer to a developing fetus and can cause neonatal Graves’ disease

Lactation

No data on presence of alemtuzumab in human milk, effects on the breastfed infant, or effects of the drug on milk production

Lemtrada: Alemtuzumab was detected in the milk of lactating huCD52 transgenic mice administered drug

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Recombinant monoclonal antibody against CD52 (lymphocyte antigen); promotes antibody-dependent lysis

Pharmacokinetics

Half-Life: 12 days

Vd: 14.1 L; largely confined to blood and interstitial space

Metabolism: unknown

Excretion: unknown

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Administration

IV Incompatibilities

Do not admix with any other drug; do not administer simultaneously in the same IV line

IV Compatibilities

0.9% NaCl

D5W

Campath: Polyvinylchloride (PVC) bags and PVC or polyethylene-lined PVC administration sets

IV Preparation

Visually inspect for particulate matter and discoloration; if particulate matter is present or solution is discolored, do use vial

Do not shake vial

Withdraw the necessary amount from the vial into a syringe

Campath

  • To prepare 3-mg or 10-mg dose, withdraw calculated amount into a 1-mL syringe calibrated in increments of 0.01 mL
  • To prepare 30-mg dose, withdraw 1 mL in either a 1-mL or 3-mL syringe

Lemtrada

  • Withdraw 1.2 mL from vial into a syringe
  • Inject syringe contents into 100 mL sterile 0.9% NaCl USP or D5W
  • Gently invert bag to mix solution

Premedication and Infection Prophylaxis

Campath

  • Premedicate with diphenhydramine 50 mg and acetaminophen 500-1000 mg PO 30 minutes before first infusion and each dose escalation
  • Administer trimethoprim/sulfamethoxazole DS PO BID 3x/week (or equivalent) for Pneumocystis jiroveci pneumonia (PCP) prophylaxis
  • Administer famciclovir 250 mg PO BID (or equivalent) as herpetic prophylaxis
  • Continue PCP and herpes viral prophylaxis for a minimum of 2 months after treatment completion or until the CD4+ count is ≥200 cells/mcL, whichever occurs later
  • Monitor CBC, platelets, CD4+ counts qWeek

Lemtrada

  • Corticosteroids: Premedication with high-dose corticosteroids (eg, 1,000 mg methylprednisolone) immediately before alemtuzumab IV infusion and for the first 3 days of each treatment course
  • Herpes prophylaxis: Administer antiviral prophylaxis for herpetic viral infections starting on the first day of each treatment course and continue for a minimum of 2 months following or until CD4+ count is ≥200 cells/microL

IV Administration

Administer by IV infusion only, do NOT give as IV push or bolus

Campath: Administer over 2 hr

Lemtrada: Administer over 4 hr; extend duration of infusion if clinically warranted

Do not shake prior to use

Storage

Unopened vials: Refrigerate at 2-8°C (36-46°F)

Diluted solution: Start infusion within 8 hr after dilution (no preservatives); may store at room temperature or refrigerate at 2-8°C (36-46°F)

Do not freeze or shake

Store in original carton to protect from light

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Campath intravenous
-
30 mg/mL vial

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
alemtuzumab intravenous

ALEMTUZUMAB (ANTI-CANCER) - INJECTION

(AL-em-TOOZ-ue-mab)

COMMON BRAND NAME(S): Campath

WARNING: This medication may cause very serious (rarely fatal) blood disorders (decreased bone marrow function leading to low number of blood cells such as red cells, white cells, and platelets). This effect can cause anemia, decrease your body's ability to fight an infection, or cause easy bruising/bleeding. Tell your doctor right away if you develop any of the following symptoms: signs of infection (such as fever, persistent sore throat, swollen lymph nodes), easy bruising/bleeding, coughing up blood, shortness of breath, unusual tiredness, fast/pounding heartbeat.This medication may also cause very serious (rarely fatal) infusion-related reactions. (See also Side Effects section.)

USES: Alemtuzumab is used to treat a certain type of leukemia (B-cell chronic lymphocytic leukemia, also known as B-CLL). This medication works by slowing or stopping the growth of cancer cells.

HOW TO USE: This medication is given by injection into a vein over 2 hours by a health care professional. The dosage is based on your medical condition and response to treatment. Your doctor will increase your dose slowly to decrease the risk of side effects.Before you receive this medication, your doctor will direct you to take other medications (such as acetaminophen, diphenhydramine, corticosteroids) to help prevent side effects. Your doctor should also prescribe other medications (such as antibiotics, antiviral medications) to help prevent infection in your body. Use these additional medications exactly as prescribed by your doctor.

SIDE EFFECTS: See also Warning section.Fever, chills, flushing, dizziness, shortness of breath, nausea, vomiting, or mild rash/itching may occur during or after the infusion. These reactions occur more often during the first week of treatment. Tell your doctor or pharmacist right away if any of these effects occur. Your doctor may prescribe additional medications to help control these symptoms. Diarrhea, stomach/abdominal pain, tiredness, headache, shaking (tremor), trouble sleeping, or mouth sores may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, anxiety), muscle/bone pain, numbness/tingling of arms/legs, fast/slow/irregular heartbeat, unusual weight changes, signs of kidney problems (such as change in the amount of urine, painful urination, pink/bloody urine, swelling ankles/feet), signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, severe stomach/abdominal pain, yellowing eyes/skin).This medication may increase your risk of getting a rare but very serious (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if you have any of these side effects: clumsiness, loss of coordination/balance, weakness, sudden change in your thinking (such as confusion, difficulty concentrating, memory loss), difficulty talking/walking, seizure, vision changes.Get medical help right away if you have any very serious side effects, including: fainting, chest/jaw/left arm pain, neck pain, weakness on one side of the body, sudden severe headache.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before receiving this alemtuzumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: immune system problems (such as HIV), recent/current infections (such as tuberculosis), bleeding/blood problems, high blood pressure, stroke, other cancers, kidney problems, heart problems, blood vessel problems (such as tears in arteries), thyroid problems.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Before receiving a blood transfusion, tell your doctor that you are using this medication.Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).Wash your hands well to prevent the spread of infections.This medication also increases your risk of getting a very serious infection caused by a bacteria called listeria. During treatment and for some time after treatment with this medication, either avoid food that may contain listeria (such as deli meat, unpasteurized milk and cheese products, soft cheeses, undercooked meat/seafood/poultry), or make sure you heat it well. Ask your doctor for more details.To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using alemtuzumab. Alemtuzumab may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for at least 3 months after stopping treatment. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended during treatment and for at least 3 months after stopping treatment. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug are: other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab).

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: trouble breathing.

NOTES: Lab and/or medical tests (such as complete blood count, kidney/liver/thyroid function, blood pressure) should be done before treatment, while you are receiving this medication, and for some time after treatment is completed. Keep all medical and lab appointments. Consult your doctor for more details.

MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

STORAGE: Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.