Lemtrada 12 mg concentrado para solucion para perfusion

Patient Information Leaflet

LEMTRADA12mg concentrate for solution for infusion

alemtuzumab

This medicine is subject to additional monitoring, which will speed up the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this leaflet carefully before you receive this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor.
• If you experience any adverse effects, consult your doctor, even if they are not listed in this leaflet. See section 4.

LEMTRADA contains the active ingredient alemtuzumab whichis used to treat a form of multiple sclerosis (MS) in adults, known as relapsing-remitting multiple sclerosis (RRMS).LEMTRADAdoes not cure MS but may reduce the number of relapses.It may also slow down or reverse some of the symptoms and signs of MS.In clinical trials, patients treated with LEMTRADA experienced fewer relapses and it was less likely that they would experience a worsening of disability compared to patients who were treated with an interferon beta injected several times a week.

LEMTRADA is used if your MS is very active despite having been treated with at least another MS medication, or if your MS is evolving rapidly.

What is multiple sclerosis?

MS is an autoimmune disease that affects the central nervous system (brain and spinal cord). In MS, the immune system mistakenly attacks the protective layer (myelin) that covers nerve fibers, causing inflammation. When inflammation causes symptoms, it is usually referred to as an "attack" or "relapse". In RRMS patients experience relapses followed by periods of recovery.

The symptoms experienced depend on the part of the central nervous system that is affected. The damage caused to nerves during this inflammation may be reversible but, as the disease progresses,the damage can accumulateand become permanent.

How LEMTRADA worksLEMTRADA

LEMTRADAregulates the immune system to limit its attacks on the nervous system.

Do not use LEMTRADA:

• if you are allergic to alemtuzumab or any of the other components of this medicine (listed in section6)
• if you are a carrier of the human immunodeficiency virus (HIV)
• if you have a severe infection
• if you have any of the following conditions:

• another autoimmune disease in addition to multiple sclerosis
• uncontrolled high blood pressure
• history of bleeding in the blood vessels that supply the brain
• history of stroke (cerebral infarction)
• history of heart attack or chest pain
• history of bleeding disorder.

Warnings and precautions

Consult your doctor before you are given LEMTRADA. After completing a cycle of treatment with LEMTRADA, you may be at a higher risk of developing other autoimmune diseases or experiencing severe infections. It is essential that you understand these risks and know how to detect them. You will be provided with a Patient Card and a Patient Guide with more information. It is essential that you have the Patient Card with you during treatment and for up to 4 years after the last infusion of LEMTRADA, as adverse effects may occur years after treatment. When you are receiving medical treatment, although not for MS, show the Patient Card to your doctor.

Your doctor will perform blood tests before starting treatment with LEMTRADA. These tests are done to determine if you can take LEMTRADA. Your doctor will also ensure that you do not have certain medical conditions or disorders before starting treatment with LEMTRADA.

• Autoimmune diseases

Treatment with LEMTRADA may increase the risk of autoimmune diseases. These diseases are characterized by the immune system attacking the body by mistake. The following information is provided on some specific diseases that have been observed in patients with MS who have been treated with LEMTRADA.

Autoimmune diseases may occur many years after treatment with LEMTRADA. Therefore, blood and urine tests are necessary until 4 years after the last infusion. The tests are necessary, even if you are well and the MS symptoms are under control. There are certain signs and symptoms that you should monitor yourself. Additionally, these diseases may occur beyond 4 years, so you should be aware of the signs and symptoms, even after you no longer need to have monthly blood and urine tests. In sections 2 and 4 –autoimmune diseasesmore details are given on the signs and symptoms, tests, and actions you should take.

For more information on these autoimmune diseases (and associated tests), see the LEMTRADA Patient Guide.

• Acquired hemophilia A

Rarely, patients developed ableeding disordercaused by antibodies that act against factor VIII (a protein necessary for normal blood clotting), called acquired hemophilia A. This disease should be diagnosed and treated immediately. The symptoms of acquired hemophilia A are described in section 4.

Often, patients have developed ableeding disordercaused by low platelet levels, called immune thrombocytopenic purpura (ITP). This disorder should be detected and treated quickly, as otherwise, its effects can besevere or even fatal. The signs and symptoms of ITP are described in section 4.

Rarely, patients have experienced problems related to autoimmune disorders in thekidneys, such as, for example, anti-membrane basal glomerular disease (anti-MBG disease). The signs and symptoms of renal disease are described in section 4. If left untreated, it can cause kidney failure with the need for dialysis or transplantation and could be fatal.

Very frequently, patients have experienced an autoimmune disorder of thethyroid glandthat affects their ability to generate or control important hormones for metabolism.

LEMTRADA may cause different types of thyroid disorders, including:

• Hyperactive thyroid gland(hyperthyroidism) when the thyroid gland produces too much hormone
• Hypoactive thyroid gland(hypothyroidism) when the thyroid gland does not produce enough hormone

The signs and symptoms of thyroid disorders are described in section 4.

If you develop a thyroid disorder, in most cases, you will need to take medication to control the disorder for the rest of your life, and in some cases, the thyroid gland may need to be removed.

It is very important to follow the appropriate treatment for the thyroid disorder, especially if you become pregnant after taking LEMTRADA. An untreated thyroid disorder could harm the fetus or the baby after birth.

Some patients have developed liver inflammation after receiving LEMTRADA. Liver inflammation can be diagnosed from blood tests that will be performed regularly after treatment with LEMTRADA. Inform your doctor if you experience one or more of the following symptoms: nausea, vomiting, abdominal pain, fatigue, loss of appetite, yellow skin or eyes, dark urine, or easy bruising or bleeding.

With LEMTRADA, you may experience a blood clotting disorder called purpura thrombocytopenic thrombocytopenia (PTT). Blood clots form in the blood vessels and can occur throughout the body. Seek immediate medical attention if you experience any of the following symptoms: skin or mouth bruises that appear as red spots, with or without extreme fatigue, fever, confusion, changes in speech, yellow skin or eyes (jaundice), low urine output, or dark urine. It is recommended to seek urgent medical attention as prolonged PTT duration can be fatal (see section 4 “Possible side effects”).

• Sarcoidosis

A systemic immune disorder (sarcoidosis) has been reported in patients treated with LEMTRADA. Symptoms may include persistent dry cough, shortness of breath, chest pain, fever, swollen lymph nodes, weight loss, skin rashes, and blurred vision.

• Autoimmune encephalitis

Autoimmune encephalitis (a brain disorder mediated by the immune system) may occur after receiving LEMTRADA. This condition may include symptoms such as changes in behavior and/or psychiatric symptoms, short-term memory loss, or seizures. Symptoms may resemble a relapse of MS. If you develop one or more of these symptoms, contact your doctor.

Rarely, some patients have experienced autoimmune diseases related tored blood cells or white blood cells. These diseases can be diagnosed from regular blood tests after treatment with LEMTRADA. If you develop one of these diseases, your doctor will inform you and take the necessary measures to treat it.

• Reactions to infusion

Most patients treated with LEMTRADA will experience adverse effects at the time of infusion or within 24 hours. To try to reduce infusion reactions, your doctor will treat you with other medications (see section 4 –infusion reactions).

• Other severe reactions occur shortly after LEMTRADA infusion

Some patients have had severe or potentially fatal reactions after LEMTRADA infusion, including pulmonary hemorrhage, heart attack, stroke (cerebral infarction), or bleeding in the blood vessels that supply the brain. Reactions can occur after any dose during the treatment cycle.Most reactions occurred within days 1-3 of infusion.Your doctor will monitor vital signs, including blood pressure, before and during infusion. Seek immediate help if you experience any of the following symptoms: difficulty breathing, coughing up blood, chest pain, facial drooping, sudden and severe headache, weakness on one side of the body, difficulty speaking, or neck pain.

• Lymphohistiocytosis hemophagocytosis

Treatment with LEMTRADA may increase the risk of excessive activation of white blood cells associated with inflammation (lymphohistiocytosis hemophagocytosis), which can be fatal if not diagnosed and treated promptly. If you experience multiple symptoms such as fever, swollen lymph nodes, bruises, or skin rash, contact your doctor immediately.

• Adult-onset Still's disease (ESIA)

ESIA is a rare condition that has the potential to cause inflammation in multiple organs with various symptoms such as fever >39 °C or 102.2 °F that lasts more than 1 week, pain, stiffness with or without inflammation in multiple joints, and/or skin rash. If you experience a combination of these symptoms, contact your doctor immediately.

• Infections

Patients treated with LEMTRADA have a higher risk of developing asevere infection(see section 4 –infections). In general, infections can be treated with standard medications.

To reduce the possibility of developing an infection, your doctor will check if other medications you are taking may be affecting your immune system. For this reason,it is essential to inform your doctor of all medications you are taking.

Also, inform your doctor if you have a severe infection before starting treatment with LEMTRADA, as your doctor must delay treatment until the infection resolves.

Patients treated with LEMTRADA have a higher risk of developing herpes (for example,mouth ulcers). In general, once a patient has had a herpes infection, they have a higher risk of developing another. It is also possible to develop a herpes infection for the first time. Your doctor will prescribe an appropriate treatment to reduce the risk of developing a herpes infection, which should be taken during the days when you are given LEMTRADA treatment and for the month following treatment.

Additionally, other infections that may causeabnormalities of the cervixmay occur. Therefore, it is recommended that all patients undergo an annual examination, including a cervical smear. Your doctor will inform you of any necessary tests.

There have been reports of infections caused by a virus calledcytomegalovirusin patients treated with LEMTRADA. Most cases occurred in the two months following alemtuzumab administration. Inform your doctor immediately if you experience symptoms of infection, such as fever or swollen lymph nodes.

Patients treated with LEMTRADA have had infections due to a virus calledEpstein-Barr virus (EBV), including cases of severe liver inflammation and sometimes fatal. Inform your doctor immediately if you experience symptoms of infection such as fever, swollen lymph nodes, or fatigue.

Patients treated with LEMTRADA have a high risk of developinglisteria infection(a bacterial infection caused by consuming contaminated food). Listeria infection can cause a severe disease, including meningitis, but can be treated with appropriate medications.To reduce this risk, avoid eating raw or undercooked meat, fresh cheeses, and unpasteurized dairy products two weeks before treatment, during treatment, and for at least 1 month after treatment with LEMTRADA.

If you live in an area wheretuberculosisis common, you may be at a higher risk of developing it. Your doctor will schedule tests for tuberculosis detection.

If you are a carrier of thehepatitis B or hepatitis C virus(which affects the liver), you need to take extra precautions before receiving LEMTRADA, as it is unknown whether treatment may lead to the activation of the infection, which could subsequently damage the liver.

There have been cases of a rare brain infection called LMP (leucoencephalopathy multifocal progressive) in patients who received Lemtrada. LMP has been reported in patients with other risk factors, specifically previous treatment with MS medications associated with LMP.

LMP may cause severe disability for weeks or months and can be fatal.

Symptoms may be similar to a relapse of MS and include progressive weakness or clumsy movements of the limbs, visual disturbances, speech difficulties, changes in thought, memory, and orientation, which cause confusion and changes in personality. It is essential to inform your family members or caregivers about your treatment, as they may notice symptoms of which you are not aware. Inform your doctor immediately if you experience any symptoms suggestive of LMP.

• Pneumonitis and pericarditis

Pneumonitis (inflammation of lung tissue) has been reported in patients treated with LEMTRADA. Most cases occurred in the first month after treatment with LEMTRADA. Pericarditis (inflammation of the membrane surrounding the heart) and pericardial effusion (fluid accumulation around the heart) have also been reported in patients treated with LEMTRADA. Inform your doctor if you experience symptoms such as difficulty breathing, coughing, wheezing, chest pain, coughing up blood, as these symptoms may be caused by pneumonitis, pericardial effusion, or pericarditis.

• Bile duct inflammation

LEMTRADA may increase the risk of bile duct inflammation. This can be a serious medical condition that can be potentially fatal. Inform your doctor if you experience symptoms such as abdominal pain or discomfort, fever, nausea, or vomiting.

• Previous cancer diagnosis

If you were previously diagnosed with cancer, inform your doctor.

• Vaccinations

It is unknown whether LEMTRADA affects the response to vaccines. If you have not completed the necessary standard vaccinations, your doctor will assess whether you should receive them before starting treatment with LEMTRADA. In particular, your doctor will consider vaccinating you against varicella if you have not had it. Any vaccination should be administered at least 6 weeks before starting a treatment cycle with LEMTRADA.

You should not receive certain types of vaccines (live virus vaccines) if you have recently received LEMTRADA.

Children and adolescents

LEMTRADA should not be used in children and adolescents under 18 years old, as it has not been studied in patients with MS under that age.

Other medications and LEMTRADA

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication (including vaccinations or herbal medications).

Aside from LEMTRADA, there are other treatments (including those for MS or to treat other diseases) that may affect the immune system and, therefore, affect your ability to fight infections. If you are using any of these medications, your doctor may ask you to stop taking them before starting treatment with LEMTRADA.

Pregnancy

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before you are given this medicine.

Women of childbearing age should use effective contraceptive methods during each treatment cycle with LEMTRADA and for 4 months after each cycle.

You should take special care if you become pregnant after treatment with LEMTRADA and experience a thyroid disorder during pregnancy. Thyroid disorders can cause harm to the fetus (see section 2Warnings and precautions – autoimmune diseases).

Lactation

It is unknown whether LEMTRADA passes into breast milk, but there is a possibility that it may. It is recommended to stop breastfeeding during each treatment cycle with LEMTRADA and for 4 months after each cycle. However, breast milk may be beneficial (it may protect the baby from infections), so consult your doctor if you plan to breastfeed your baby and they will advise you on what is best for you and your baby.

Fertility

LEMTRADA may remain in your body during the treatment cycle and for up to 4 months after. It is unknown whether LEMTRADA affects fertility during this period. Consult your doctor if you are planning to have children. There is no evidence that LEMTRADA has an impact on male fertility.

Driving and operating machinery

Many patientsexperience adverse effects at the time of LEMTRADA infusion or within 24 hours, and some of these effects, for example, dizziness, may makedriving or operating machinery unsafe. If you experience this, stop these activities until you feel better.

LEMTRADA contains potassium and sodium

This medicine contains less than 1mmol ofpotassium(39mg) per infusion; it is essentially “potassium-free.”

This medicine contains less than 1mmol ofsodium(23mg) per infusion; it is essentially “sodium-free.”

Your doctor will explain how to administer LEMTRADA. If you have any doubts, ask your doctor.

The initial treatment you will receive will consist of an infusion per day for 5 days (cycle 1) and one year later, an infusion per day for 3 days (cycle 2).You will not receive treatment with LEMTRADA between the two cycles. Two treatment cycles can reduce EM activity for up to 6 years.

Some patients, if they have symptoms or signs of EM disease after the initial two cycles, may receive additional one or two treatment cycles consisting of an infusion per day for 3 days. These additional treatment cycles can be administered 12 months or more after the previous treatment.

The maximum daily dose is one infusion.

LEMTRADA will be administered to you through a vein infusion. Each infusion lasts approximately 4 hours. The monitoring to detect adverse effects and periodic tests must continue for 4 years after the last infusion.

To help you better understand the duration of treatment effects and the necessary follow-up, please refer to the following diagram.

Follow-up after LEMTRADA Treatment

Once you have received LEMTRADA, you must undergo periodic tests so that any possible adverse effect can be diagnosed and treated quickly. These tests must continue until 4 years after the last infusion and are described in section 4, most important adverse effects.

If You Receive More LEMTRADA Than You Shouldthan you should

Patients who, accidentally, have been administered too much LEMTRADA in an infusion have experienced severe reactions, such as headache, rash, low blood pressure, or increased heart rate. Doses higher than recommended may cause more severe or prolonged infusion reactions (see section 4) or a greater effect on the immune system. Treatment consists of interrupting LEMTRADA administration and treating symptoms.

If You Forget to Use LEMTRADA

It is unlikely that you will forget your dose since it is administered by a healthcare professional. However, note that if you miss a dose, it should not be administered on the same day as a scheduled dose.

If you have any other questions about the use of this medication, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Themost important side effectsare theautoimmune diseasesdescribed in section 2, including:

• Acquired hemophilia A (a type of bleeding disorder),(rare, may affect up to 1 in 100 people): may show spontaneous bruises, nosebleeds, joint pain or inflammation, other types of bleeding or bleeding in case of a cut that may take longer than usual to stop.PTI (bleeding disorder),(common – may affect up to 1 in 10 people): may present as small red, pink or purple spots scattered over the skin; propensity to bruising; bleeding in case of a cut that may be harder to stop; heavier, longer or more frequent menstrual periods than usual; bleeding between menstrual periods; bleeding of the gums or nose that is longer than usual or of new onset; or coughing up blood.

• Purpura thrombocytopenic thrombocytopenia (PTT), (rare – may affect up to 1 in 1,000 people): may show as bruises on the skin or in the mouth, which may appear as red spots, with or without extreme fatigue, fever, confusion, changes in speech, yellowing of the skin or eyes (jaundice), low urine output, dark-colored urine.
• Kidney disorders, (rare – may affect up to 1 in 1,000 people): may present as blood in the urine (the urine may be red or tea-colored) or as swelling of the legs or feet. It may also cause damage to the lungs and cause coughing up blood.

If you experience any of these signs or symptoms related to kidney or bleeding disorders, inform your doctor immediately. If you cannot contact your doctor, seek immediate medical attention.

• Thyroid disorders(very common – may affect more than 1 in 10 people): may present as excessive sweating; unexplained weight gain or loss; eye swelling; nervousness; rapid heart rate; feeling cold; worsening fatigue; or new onset constipation.
• Disorders of red blood cells and white blood cells(rare – may affect up to 1 in 100 people) diagnosed from blood tests.sarcoidosis(rare - may affect 1 in 100 people): symptoms may include persistent dry cough, shortness of breath, chest pain, fever, swollen lymph nodes, weight loss, skin rashes, and blurred vision.
• Autoimmune encephalitis(rare – may affect 1 in 100 people): may include symptoms such as changes in behavior and/or psychiatric, short-term memory loss or seizures. The symptoms may resemble a relapse of EM.

All these serious side effects may appear years after the administration of LEMTRADA.If you experience any of these signs or symptoms, inform your doctor immediately.Also, you will have blood and urine tests, periodically, to ensure that if you develop any of these diseases, you are treated quickly.

Summary of tests that will be performed to control the appearance of autoimmune conditions:

After this period, if you experience symptoms of PTI, acquired hemophilia A, PTT, thyroid or kidney disorders, your doctor will perform more tests. You should remain vigilant for signs and symptoms of side effects beyond four years as indicated in the Patient Guide, and also carry the Patient Card with you.

Anotherimportant side effectis anincreased risk of developing infections(see below for information on how often patients experience infections). In most cases, these infections are mild, but they may causeserious infections.

To help you reduce the risk of some infections, your doctor may consider administering vaccination against chickenpox and/or other vaccinations that they think you may need (see section 2:What you need to know before starting to use LEMTRADA- Vaccinations). Your doctor may also prescribe a medication for mouth ulcers (see section 2:What you need to know before starting to use LEMTRADA– Infections).

Themost common side effectsareinfusion reactions(see below for information on how often patients experience them), which may occur at the time of infusion or within 24 hours after it. In most cases, these reactions are mild but may cause serious reactions. In some cases, they may cause allergic reactions.

To try to reduce infusion reactions, your doctor will administer medications (corticosteroids) before each of the first three infusions of a LEMTRADA cycle. To limit these reactions, other treatments may be administered before the infusion or when symptoms occur. You will also be monitored during the infusion and for up to 2 hours after it has ended. In case of serious reactions, the infusion may be slowed down or even stopped.

See theLEMTRADA patient guidefor more information on these events.

These are theside effectsyou may experience:

Very common(may affect more than 1 in 10 people):

• Infusion reactionsthat may occur at the time of infusion or within 24 hours after it: changes in heart rate, headache, rash, body rash, fever, urticaria, chills, pruritus, redness of the face and neck, feeling of fatigue, nausea
• Infections: respiratory tract infections such as colds and sinusitis, urinary tract infections, herpes infections
• Decrease in white blood cell count (lymphocytes, leukocytes, neutrophils)
• Thyroid disorders such as hyperactive or hypoactive thyroid gland

Common(may affect up to 1 in 10 people):

• Infusion reactionsthat may occur at the time of infusion or within 24 hours after it: indigestion, chest discomfort, pain, dizziness, altered taste, difficulty sleeping, difficulty breathing or shortness of breath, low blood pressure, pain at the infusion site
• Infections: cough, ear infection, flu-like illness, bronchitis,pneumonia, genital herpes, mouth ulcers, swollen lymph nodes, flu, herpes zoster infection, dental infection
• increase in white blood cell count such as neutrophils, eosinophils (different types of white blood cells), anemia, decrease in red blood cell percentage, easy or excessive bruising or bleeding, swollen lymph nodes
• exaggerated immune response
• back pain, neck pain, arm or leg pain, muscle pain, muscle spasms, joint pain,mouth or throat pain
• inflammation of the mouth/teeth/tongue
• general feeling of illness, weakness, vomiting, diarrhea, abdominal pain, flu-like illness, hiccups
• abnormal liver function
• heartburn
• anomalies that may be found during examination: blood or protein in the urine, decreased heart rate, irregular or abnormal heart rhythm, high blood pressure, altered kidney function, white blood cells in urine
• bruising
• relapse of EM
• shaking, loss of sensation, burning or tingling sensation
• hyperactive or hypoactive thyroid gland of autoimmune type, thyroid antibodies or goiter (inflammation of the thyroid gland in the neck)
• numbness of arms and/or legs
• vision problems, conjunctivitis, eye disease associated with thyroid disease
• feeling of dizziness or loss of balance, migraine
• feeling of anxiety, depression
• irregular or prolonged menstrual periods
• acne, skin redness, excessive sweating, skin discoloration, skin lesions, dermatitis
• nosebleeds, petechiae
• hair loss
• asthma
• muscle and bone pain, chest discomfort

Rare(may affect up to 1 in 100 people)

• Infections: flu-like illness, gum inflammation, fungal infections of the nails, tonsillitis, acute sinusitis, bacterial skin infections, cytomegalovirus infections
• bronchitis
• athlete's foot
• abnormal vaginal discharge
• increased sensitivity, sensory alterations such as numbness, tingling and pain, tension headache
• double vision
• ear pain
• difficulty swallowing, throat irritation, productive cough
• weight loss, weight gain, decrease in red blood cells, increase in blood glucose, increase in red blood cell size
• constipation, acid reflux, dry mouth
• rectal bleeding
• gum bleeding
• loss of appetite
• boils, night sweats, facial swelling, eczema
• stiffness, discomfort in arms and legs
• kidney stones, ketones in urine, kidney disease
• weakened immune system
• tuberculosis
• inflammation of the gallbladder with or without gallstones
• warts
• autoimmune disorder characterized by bleeding (acquired hemophilia A)
• sarcoidosis
• autoimmune brain disorder (autoimmune encephalitis)
• skin patches with loss of color (vitiligo)
• autoimmune hair loss (alopecia areata)

Rare (may affect up to 1 in 1,000 people)

• excessive activation of white blood cells associated with inflammation (hemophagocytic lymphohistiocytosis)
• autoimmune disorder of blood coagulation (purpura thrombocytopenic thrombocytopenia, PTT)

Unknown frequency (cannot be estimated from available data)

• listeriosis/meningitis caused by listeria
• bleeding in the lungs
• heart attack
• stroke
• rupture of vertebral or carotid arteries (blood vessels that supply blood to the brain)
• infection caused by a virus known as Epstein-Barr virus
• inflammatory disease affecting multiple organs, adult-onset Still's disease (ESIA)

Show the Patient Card and this leaflet to any doctor related to your treatment and not just the neurologist.

You will also find this information in the Patient Card and the patient guide that your doctor has provided.

Reporting of side effects

If you experience any type of side effect, consult your doctor, even if it is possible side effects that do not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and vial label after CAD. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2°C and 8°C).

Do not freeze.

Store in the original packaging to protect it from light.

It is recommended to use the product immediately after dilution due to the possible risk of microbial contamination. If not used immediately, the storage conditions and times used before use are the responsibility of the user and should not exceed 8 hours at a temperature of 2°C to 8°C, protected from light.

Composition of LEMTRADA

Theactive principleis alemtuzumab.

Each vial contains 12mg of alemtuzumab in 1.2ml.

The other components are:

• sodium dihydrogen phosphate (E339)
• disodium edetate
• potassium chloride (E508)
• potassium dihydrogen phosphate (E340)
• polysorbate 80 (E433)
• sodium chloride
• water for injection

Appearance ofLEMTRADAand contents of the container

LEMTRADA is a concentrate for solution for infusion (sterile concentrate) transparent and colourless or slightly yellowish that is included in a glass vial with a stopper.

There is 1 vial in each box.

Marketing authorisation holder

Sanofi Belgium

Leonardo Da Vincilaan 19

B-1831 Diegem

Belgium

Responsible for manufacturing

Genzyme Ireland Limited

IDA Industrial Park

Old Kilmeaden Road

Waterford

Ireland

For more information about this medicinal product, please contact the local representative of the marketing authorisation holder:

Last update of this leaflet: .

Other sources of information

To help patients form an understanding of the possible side effects and instructions on what to do in case of certain side effects, the following risk minimisation materials are available:

1 Patient Card:For the patient to present to other healthcare professionals to warn them of the use of LEMTRADA in the patient.

2 Patient Guide:For more information on autoimmune reactions, infections and other types of information.

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

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This information is intended solely for healthcare professionals:

Information on risk minimisation – autoimmune conditions

• It is extremely important that the patient understands the commitment to undergo regular tests (during the 4 years following the last infusion) even if they do not have symptoms and the disease is well controlled.

• Together with the patient, you need to plan and manage the regular checks.

• Patients who are non-compliant may need additional advice to highlight the risks of missing scheduled regular checks.

• You should monitor the test results and remain alert for any symptoms of adverse reactions.

• Review the LEMTRADA leaflet and patient guide with your patient. Remind the patient to be alert for any symptoms related to autoimmune conditions and to seek medical help if in doubt.

There are also educational materials available for healthcare professionals:

• LEMTRADA Guide for Healthcare Professionals
• LEMTRADA Training Module
• LEMTRADA Prescriber Checklist

Read the SmPC (available on the EMA website mentioned above) for more information.

Information to prepare the administration of LEMTRADAand supervise the patient

• Patients should be medicated with corticosteroids immediately before the LEMTRADA infusion during the first 3 days of any treatment cycle. Pre-treatment with antihistamines and/or antipyretics before administration of LEMTRADA may also be considered.

• During treatment and for 1 month after, oral antiviral medication should be administered to all patients. In clinical trials, 200 mg of aciclovir twice a day or equivalent was administered to patients.

• Baseline complete blood counts and screening tests are described in Section 4 of the SmPC.

• The contents of the vial should be visually inspected before each administration to exclude the presence of particles or discoloration. If the concentrate contains particles or shows discoloration, it should not be used.
  DO NOT SHAKE THE VIALS BEFORE USING THEM.

• Follow aseptic techniques to extract 1.2ml of LEMTRADA from the vial and inject into 100ml of a 9mg/ml (0.9%) sodium chloride solution or a glucose solution (5%). The bag should be gently inverted to mix the solution. Care should be taken to ensure the sterility of the prepared solution.

• Administer the LEMTRADA infusion solution intravenously over a period of approximately 4 hours.

• No other medications should be added to the LEMTRADA infusion solution or infused simultaneously through the same intravenous route.

• It is recommended to use the product immediately after dilution, due to the possible risk of microbial contamination. If not used immediately, the conditions and storage times employed before use are the responsibility of the user and should not exceed 8 hours at a temperature of 2oC to 8oC, protected from light.

• Proper handling and disposal procedures should be followed. Disposal of any residue or waste material should be in accordance with local regulations.

After each infusion, the patient should be observed for 2 hours to detect any possible reactions associated with the infusion. Treatment may be initiated if necessary – see SmPC. Continue to perform regular blood tests on the patient every month to detect autoimmune diseases, up to 4 years after the last infusion. Consult the LEMTRADA guide for healthcare professionals for more information, or read the SmPC available on the EMA website mentioned above.