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Alemtuzumab Injection (Multiple Sclerosis)

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WARNING

Alemtuzumab injection may result in serious or fatal autoimmune disorders, including thrombocytopenia (a low number of platelets [a type of blood cell necessary for blood clotting]) and kidney issues. Autoimmune disorders are those in which the immune system attacks healthy parts of the body and causes pain, swelling, and damage. If you experience bleeding issues or kidney disease, let your doctor know. Call your doctor right away if you have any of the following symptoms: unusual bleeding, swelling of your legs or feet, blood in your cough, difficult-to-stop bleeding from cuts, heavy or irregular menstrual bleeding, red, pink, or purple spots on your skin, bleeding from your nose or gums, blood in your urine, chest pain, a decrease in the amount of urine, and fatigue.

During or up to 3 days after receiving an alemtuzumab injection dose, you could have a serious or fatal infusion reaction. Each dose of medication will be administered to you in a medical setting, and your doctor will closely monitor you both before and after the infusion. You must remain at the infusion facility for at least 2 hours after your infusion is finished. Inform your doctor right once if you suffer any of the following symptoms during or following your infusion: Heartburn, dizziness, shortness of breath, difficulty breathing or swallowing, delayed breathing, tightening of the throat, swelling of the eyes, face, mouth, lips, tongue, or throat; fever; chills; nausea; headache; vomiting; hives; rash; itching; flushing; hoarseness, lightheadedness, dizziness, fainting, an erratic or rapid heartbeat, or chest pain.

Alemtuzumab injection, particularly in the first three days following treatment, may result in a stroke or rips in the arteries supplying blood to your brain. Inform your doctor right once if you suffer any of the following symptoms during or following your infusion: difficulty speaking or understanding, a sagging of the face on one side, a strong headache, neck pain, a sudden paralysis or numbness of an arm or leg, especially on one side of the body.

Your chance of developing certain malignancies, such as thyroid cancer, melanoma (a form of skin cancer), and some blood cancers, may increase if you have an alemtuzumab injection. Before starting therapy and then once a year after that, you should have a doctor examine your skin for any indications of cancer. If you have any of the following symptoms, which could be a sign of thyroid cancer: A small lesion with an irregular border and areas that appear red, white, blue, or blue-black; a new lump or swelling in your neck; pain in front of your neck; unexplained weight loss; bone or joint pain; lumps or swellings in your skin, neck, head, groyne, or stomach; changes in mole shape, size, or colour; bleeding; a persistent raspy voice or other vocal modifications; breathing, coughing, or difficulty swallowing.

Alemtuzumab injection is only accessible through a unique restricted distribution programme due to the hazards associated with this drug. Lemtrada Risk Evaluation and Mitigation Strategy (REMS) Program is a programme with such name. If you have any concerns about receiving your medication, speak with your doctor.

Keep all of your appointments with your physician and the lab. Before, during, and for four years following your final dose of alemtuzumab injection, your doctor will request certain tests to monitor your body’s response.

Discuss the dangers of receiving an injection of alemtuzumab with your doctor.

Why is this medication prescribed?

Adults with multiple sclerosis (MS; a condition in which the nerves malfunction and patients may experience weakness, numbness, loss of muscular coordination, and issues with vision, speech, and bladder control) who have not improved with at least two or more MS drugs, such as:

  • Therapy for relapsing-remitting (course of disease where symptoms flare up from time to time) or
  • Further developing forms (course of disease where relapses occur more often).

Alemtuzumab belongs to the group of drugs known as monoclonal antibodies. It functions by reducing immune cell activity that could harm nerves.

Injection form of alemtuzumab known as Campath is also offered for use in the treatment of chronic lymphocytic leukaemia (a slowly developing cancer in which too many of a certain type of white blood cell accumulates in the body). Only alemtuzumab injection (Lemtrada) for multiple sclerosis is discussed in this monograph. Read the monograph titled Alemtuzumab Injection if you are getting alemtuzumab for chronic lymphocytic leukaemia (Chronic Lymphocytic Leukemia).

How should this medicine be used?

Alemtuzumab injection is administered intravenously (into a vein) over a period of four hours by a physician or nurse in a hospital or medical facility. For the first treatment cycle, it is typically administered once daily for 5 days. Twelve months following the initial treatment cycle, a second treatment cycle is typically administered once daily for three days. At least 12 months after the initial therapy, your doctor can recommend another 3-day treatment cycle.

Although it does not treat multiple sclerosis, alemtuzumab injection aids in its management.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before receiving alemtuzumab injection,

  • If you have an allergy to alemtuzumab, any other drugs, or any of the chemicals in alemtuzumab injection, notify your doctor right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, or dietary supplements you are currently taking or intend to take. Include the following information: Cancer drugs, immunosuppressive drugs such cyclosporine (Gengraf, Neoral, Sandimmune), mycophenolate (Cellcept), prednisone, and tacrolimus, or the drug used to treat leukaemia known as alemtuzumab (Campath) (Astagraf, Envarsus, Prograf). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • If you have an infection or the human immunodeficiency virus, let your doctor know (HIV). Most likely, your doctor will advise against getting an injection of alemtuzumab.
  • Inform your doctor if you have or have ever had varicella (chicken pox), genital herpes (a herpes virus infection that occasionally causes sores to form around the genitals and rectum), tuberculosis (TB), herpes zoster, shingles, thyroid, heart, lung, or gallbladder disease.
  • Inform your physician if you are nursing a baby, intend to get pregnant, or are already pregnant. You must perform a pregnancy test before beginning therapy if you are a female, and you must use birth control both during treatment and for four months after your last dose. Consult your doctor about the many birth control methods you might use to avoid getting pregnant at this time. Call your doctor right away if you fall pregnant while receiving alemtuzumab injectable. The foetus could be harmed by alemtuzumab.
  • If you require any immunisations prior to receiving alemtuzumab, ask your doctor. If you have had a vaccination within the last six weeks, let your doctor know. During your therapy, avoid getting any immunisations without first consulting your doctor.

What special dietary instructions should I follow?

When receiving alemtuzumab and for at least a month afterward, stay away from the following foods that could spread infection: Soft cheeses, unpasteurized dairy items, deli meat, and undercooked meat, poultry, or shellfish.

What side effects can this medication cause?

Side effects from alemtuzumab injection are possible. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Having trouble falling or staying asleep
  • Legs, arms, toes, and hands hurt
  • Neck, back, or joint pain
  • Skin tingling, prickling, freezing, burning, or numbness
  • Scaly, itchy, or red skin
  • Heartburn
  • Swelling of the throat and nose

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you develop any of these signs or any of the ones detailed in the IMPORTANT WARNING section:

  • Wheezing, chest tightness or pain, cough, blood in the cough, or shortness of breath
  • Fever, chills, diarrhoea, nauseous, vomiting, headache, stiff neck, joint or muscle discomfort, or changes in mental status
  • Bruising or bleeding easily, nasal bleeding, bloody vomit, painful or swollen joints, or blood in the pee or stool
  • Heavy perspiration, swollen eyes, loss of weight, agitation, or rapid heartbeat
  • Unjustified weight gain, fatigue, a chilly feeling, or constipation
  • Depression
  • Considering, planning, or attempting to injure or kill oneself
  • Genital sores, a feeling of being pinched, or a rash on the penis or in the vaginal region
  • Fever blisters or cold sores on or near the mouth
  • A severe rash with blisters, discomfort, itching, or tingling on one side of the face or body
  • Vaginal odour, white or yellowish vaginal discharge that may be lumpy or resemble cottage cheese, or vaginal irritation are all common in women
  • Whitish lesions on the inside cheeks or tongue
  • Fever, nausea, or vomiting, as well as stomach pain or sensitivity
  • Nausea, vomiting, abdominal pain, excessive fatigue, weight loss, yellow eyes or skin, black urine, or bleeding or bruising more frequently than usual
  • A long-lasting weakness on one side of the body; clumsiness in the arms or legs; changes that last several days in your thinking, memory, walking, balance, speaking, eyesight, or strength; migraines, seizures, disorientation, or alterations in personality
  • Changes in thinking or alertness, a fever, swollen glands, rash, seizures, new or worsening unsteadiness, or difficulties walking

Other negative effects from alemtuzumab injection are possible. If you have any strange side effects while taking this medicine, call your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

  • Headache
  • Rash
  • Dizziness

What other information should I know?

Ask your pharmacist any queries you may have regarding the injection of alemtuzumab.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Lemtrada®
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