Lemtrada

What is Lemtrada?

Lemtrada (Alemtuzumab) is a CD52-directed cytolytic monoclonal antibody used for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults.

Alemtuzumab Fab 1CE1

What are the uses of this medicine?

Lemtrada (Alemtuzumab) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults.

Limitations of use:

• Since treatment with Lemtrada can increase your risk of getting certain conditions and diseases, Lemtrada is generally prescribed for people who have tried 2 or more MS medicines that have not worked well enough.
• Lemtrada is not recommended for use in patients with clinically isolated syndrome (CIS).

How does this medicine work?

• The precise mechanism by which alemtuzumab exerts its therapeutic effects in multiple sclerosis is unknown but is presumed to involve binding to CD52, a cell surface antigen present on T and B lymphocytes, and on natural killer cells, monocytes, and macrophages.
• Following cell surface binding to T and B lymphocytes, alemtuzumab results in antibody-dependent cellular cytolysis and complement-mediated lysis.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to alemtuzumab or to any of the inactive ingredients in Lemtrada.
• are infected with human immunodeficiency virus (HIV)
• have an active infection

What drug interactions can this medicine cause?

• Lemtrada and other medicines may affect each other causing side effects.
• Especially tell your healthcare provider if you take medicines that increase your chance of getting infections, including medicines used to treat cancer or to control your immune system.

Is this medicine FDA approved?

• Alemtuzumab was approved for medical use in the United States in 2001.

How should this medicine be used?

• Premedicate with corticosteroids prior to Lemtrada infusion for the first 3 days of each treatment course.
• Administer antiviral agents for herpetic prophylaxis starting on the first day of Lemtrada dosing and continuing for a minimum of two months after completion of Lemtrada dosing or until CD4+ lymphocyte count is more than 200 cells per microliter, whichever occurs later.

Recommended dosage: The recommended dosage of Lemtrada is 12 mg/day administered by intravenous infusion for 2 treatment courses:

• First Treatment Course: 12 mg/day on 5 consecutive days (60 mg total dose).
• Second Treatment Course: 12 mg/day on 3 consecutive days (36 mg total dose) administered 12 months after the first treatment course.
• Following the second treatment course, subsequent treatment courses of 12 mg per day on 3 consecutive days (36 mg total dose) may be administered, as needed, at least 12 months after the last dose of any prior treatment courses.

Administration:

• Lemtrada is given through a needle placed in your vein (IV infusion).
• It takes about 4 hours to receive a full dose of Lemtrada each day.
• You will receive Lemtrada over 2 or more treatment courses.
• You will receive Lemtrada for 5 days in a row (consecutive) for the first treatment course and then for 3 days in a row (consecutive) about 1 year later for your second treatment course.
• Additional Lemtrada treatment courses, if needed, may be given for 3 days in a row (consecutive) at least 1 year after the prior treatment course.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 12 mg/1.2 mL (10 mg/mL) in a single-dose vial.

This medicine is available in fallowing brand namesː

• Lemtrada

What side effects can this medication cause?

The most common side effects of this medicine include:

• rash
• headache
• thyroid problems
• fever
• swelling of your nose and throat (nasopharyngitis)
• nausea
• urinary tract infection
• feeling tired
• trouble sleeping
• upper respiratory tract infection
• herpes viral infection
• hives
• itching
• fungal infection
• joint pain
• pain in your arms or legs
• back pain
• diarrhea
• sinus infection
• mouth pain or sore throat
• tingling sensation
• dizziness
• stomach pain
• sudden redness in face, neck, or chest
• vomiting

Lemtrada may cause serious side effects including:

• Serious autoimmune problems
• Serious infusion reactions
• Certain cancers
• thyroid problems
• cytopenias
• inflammation of the liver
• hemophagocytic lymphohistiocytosis (HLH)
• Adult Onset Still's Disease (AOSD)
• thrombotic thrombocytopenic purpura (TTP)
• acquired hemophilia A
• serious infections
• Progressive multifocal leukoencephalopathy
• acalculous cholecystitis
• pneumonitis

What special precautions should I follow?

• Treatment with Lemtrada can result in the formation of autoantibodies and increase the risk of serious autoimmune mediated conditions, which may be life threatening. Obtain complete blood counts (CBCs) with differential prior to initiation of treatment and at monthly intervals thereafter until 48 months after the last infusion.
• Glomerular nephropathies occurred in Lemtrada-treated patients in MS. Obtain serum creatinine levels, urinalysis with cell counts and urine protein to creatinine ratio prior to initiation of treatment. Monitor serum creatinine levels and urinalysis with cell counts at monthly intervals thereafter until 48 months after the last infusion.
• Thyroid endocrine disorders, including autoimmune thyroid disorders, occurred in Lemtrada-treated patients in MS. Obtain thyroid function tests prior to initiation of treatment and every 3 months until 48 months after the last infusion.
• Autoimmune cytopenias such as neutropenia, hemolytic anemia, and pancytopenia occurred in Lemtrada-treated patients in MS. Monitor CBCs monthly until 48 months after the last infusion.
• Autoimmune hepatitis causing clinically significant liver injury, including acute liver failure requiring transplant, has been reported in patients treated with Lemtrada. If signs of hepatic dysfunction occur, promptly measure serum transaminases and total bilirubin and interrupt or discontinue treatment.
• Hemophagocytic lymphohistiocytosis (HLH) has occurred in patients taking Lemtrada. Consider this diagnosis and evaluate patients immediately if they develop signs or symptoms of systemic inflammation. Discontinue Lemtrada if an alternative etiology is not established.
• During postmarketing use, Adult Onset Still's Disease (AOSD) has been reported in patients treated with Lemtrada. If a patient develops AOSD, they require prompt evaluation and treatment.
• Thrombotic Thrombocytopenic Purpura (TTP) has been reported in patients treated with Lemtrada. Evaluate patients immediately if they develop clinical symptoms or laboratory findings consistent with TTP. Discontinue Lemtrada if TTP is confirmed or if an alternative etiology is not established.
• Cases of acquired hemophilia A (anti-Factor VIII antibodies) have been reported. Obtain a coagulopathy panel including aPTT in patients who present with signs such as spontaneous subcutaneous hematomas, extensive bruising, hematuria, epistaxis, or gastrointestinal or other types of bleeding.
• Infections occurred in Lemtrada-treated patients. Administration is contraindicated in patients with active infection. Do not administer live viral vaccines following a course of Lemtrada.
• Progressive multifocal leukoencephalopathy (PML) has occurred in a patient with MS treated with Lemtrada. Withhold Lemtrada at the first sign or symptom suggestive of PML.
• Lemtrada causes cytokine release syndrome resulting in infusion reactions, some of which may be serious and life threatening. Premedicate patients with corticosteroids immediately prior to Lemtrada infusion for the first 3 days of each treatment course. Lemtrada can only be administered in certified healthcare settings that have on-site access to equipment and personnel trained to manage infusion reactions.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• headache
• rash
• hypotension
• sinus tachycardia
• increase the intensity and/or duration of infusion reactions or its immune effects

Management of overdosage:

• There is no known antidote for alemtuzumab overdosage.

Can this medicine be used in pregnancy?

• Lemtrada may harm your unborn baby.
• There is a pregnancy registry for females who are exposed to Lemtrada during pregnancy. The purpose of the registry is to collect information about the health of females exposed to Lemtrada and their baby. If you become pregnant while taking Lemtrada, talk to your healthcare provider about registering by calling 1-866-758-2990.
• you should use birth control while receiving Lemtrada and for 4 months after your course of treatment.

Can this medicine be used in children?

• It is not known if Lemtrada is safe and effective for use in children under 17 years of age.

What are the active and inactive ingredients in this medicine?

• Active ingredient: alemtuzumab
• Inactive ingredients: dibasic sodium phosphate, disodium edetate dihydrate, polysorbate 80, potassium chloride, potassium dihydrogen phosphate, sodium chloride, and Water for Injection, USP.

Who manufactures and distributes this medicine?

Manufactured and distributed by:

• Genzyme Corporation
• Cambridge, MA

• Lemtrada and CAMPATH are registered trademarks of Genzyme Corporation.

What should I know about storage and disposal of this medication?

• 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.

• Dailymed label info on Lemtrada
• FDA Lemtrada

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