Campath

1 What is Campath?

Brand: Campath, Lemtrada

Generic: Alemtuzumab

Alemtuzumab injection is used to treat the relapsing forms of multiple sclerosis (MS). This medication will not cure MS, but may slow down some of the disabling effects and decrease the number of relapses of the disease.

This medication is only available through a restricted access program.

Doctor’s who are enrolled in the restricted program can write a prescription for this medication.

This product is available in the following forms:

  • Solution

2 What to Know Before Using

As with all medicines, the risks must be compared to how much a medication will help you. This is a decision that you and your doctor will make together. For this medication, there are many things that need to be considered:

Allergies

Inform your doctor if you have ever had an allergic reaction to doxorubicin or to any other medications. It is also important to inform your doctor of any non-medicine allergies such as foods, dyes, preservatives or animals.

Pediatric

No appropriate studies have been performed on the relationship of age to the effects of this medication in children. Safety and efficacy have not been established.

Geriatric

No appropriate studies have been performed on the relationship of age to the effects of this medication in the elderly. However, geriatric-specific complications that would limit the usefulness of this medication in the elderly are not expected.

Pregnancy

This medication is listed as Pregnancy Category C. This means that animal studies have shown an adverse effect and no studies have been performed on pregnant women OR there are no adequate studies on pregnant animals and pregnant women.

Breastfeeding

There are no up-to-date studies in women for determining infant risk when using this medication while breastfeeding. Weigh the potential risks with the benefits before taking this medication while breastfeeding.

Drug Interactions

Certain medications should not be used together. However, in certain cases, two medications may be used together, even if an interaction might occur.

In these cases, your doctor may want to change your dose or take other precautions. When taking this medication, it is important that you inform your doctor if you are taking any of the medications listed below.

The following interactions were selected on the basis of potential significance and are not all-inclusive.

Using this medication with any of the following medication is not recommended, but may be unavoidable in some cases. Your doctor may make the decision not to treat you with this medication or change some of the other medications you take:

Other Interactions

Certain medications should not be used while eating, or while eating certain foods in case of negative interactions. Using alcohol or tobacco with certain mediations may also cause negative interactions. Talk with your doctor about the use of your medication with food, alcohol or tobacco.

Other Medical Problems

Pre-existing medical problems may affect the use of this medication. Be sure to tell your doctor if you have any other medical problems, especially:

  • Autoimmune diseases
  • Bleeding problems
  • Kidney disease
  • Lung disease
  • Thyroid disease - Use with caution. May make these conditions worse.
  • HIV infection - Should not be used in patients with this condition.
  • Infection - May decrease your body’s ability to fight infection.

3 Proper Usage

A nurse or other trained health professional will give you this medication. This medication is given through a needle placed in one of your veins (intravenously).

This medication is usually given for 2 treatment couses. You will receive this medication for 5 consecutive days for the first treatment course and for 3 consecutive days for about 1 year later for you second treatment course. Each treatment usually takes about 4 hours per day.

You will receive medications to prevent allergic reactions before you start treatment with this medication.

You must enroll in the prescribing program called Lemtrada REMS program in order to begin receiving this medication. Your doctor will explain the program and have you sign an enrollment form.

Ask your doctor if you have any questions about this program.

It is important that you understand and follow all instructions of this program.

This medication should come with a Medication Guide. Read and follow the instructions carefully. Ask you doctor if you have any questions.

4 Precautions to Take

It is very important that your doctor checks in with the you often while you are receiving this medication to make sure that it is working properly. Blood and urine tests may be needed to check of any unwanted effects. It is important that your doctor check your skin for melanoma yearly.

Do not use this medication if you are also receiving Campath.

This medication may cause a rare, but serious, allergic reaction called an infusion reaction. This can be life-threatening and requires immediate medical attention.

Inform your doctor immediately if you develop

while receiving this medication.

This medication may increase risk of cancer, including thyroid, skin or lymph nodes.

Inform you doctor immediately if you have

  • a new lump or swelling in the neck,
  • cough,
  • hoarseness or voice changes,
  • neck pain,
  • trouble breathing or swallowing.

This medication may cause autoimmune disorders, including immune thrombocytopenia (ITP).

Inform your doctor immediately if you have

  • a bloody nose,
  • coughing or spitting up blood,
  • small red or purple spots on the skin
  • heavier than normal or irregular monthly periods.

This medication may cause a serious kidney problem called anti-glomerular basement membrane disease.

Inform your doctor immediately if you have

  • blood in the urine,
  • coughing up blood
  • swelling in the legs or feet.

While being treated with this medication and after you stop treatment, do not have any vaccines without your doctor’s approval. You should not receive live vaccines for at least 6 weeks before starting treatment with this medication, as it can lower your body’s resistance and there is a chance you may get the infection that the vaccine is meant to prevent.

Additionally, other people living in your household should not take the oral polio vaccine, as there is a chance they could pass the polio vaccine on to you. Avoid people who have taken the oral polio vaccine within the last several months. Do not get close to them and do not stay in the same room with them for very long. If you cannot take these precautions, you may want to consider wearing a protective face mask that covers the nose and mouth.

This medication can temporarily lower the number of white blood cells in the blood, which will increase the risk of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this happens, be aware of these precautions you can take to reduce the risk of infection or bleeding:

  • When possible, avoid people with infections. Inform your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Inform your doctor immediately if you notice any unusual bleeding or bruising, black stool, blood in the urine or stool or red spots on the skin.
  • Take care when using a regular toothbrush, dental floss or toothpick. Your doctor or dentist may recommend other ways to clean your teeth and gums. Ask you doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Take care not to cut yourself when using sharp objects such as shaving razors or fingernail clippers.
  • Avoid contact sports or other situations where bruising or injury may occur.

This medication may increase your risk of developing an infection. Avoid being near people who are sick or have infections while you use this medication. Wash your hands often and inform your doctor if you have any infections before you begin using this medication. Inform you doctor i you ever had a recurring infection.

Inform your doctor immediately if you have been exposed to someone with chickenpox.

If you are female, you should have the HPV screening every year to avoid getting a cervical HPV infection.

You will need to have a skin test for tuberculosis before you being this medication. Inform you doctor if you or anyone in your home has ever had a positive tuberculosis skin test or has been exposed to tuberculosis.

Do not eat foods that may contain the bacteria called listeria, such as

  • deli milk,
  • unpasteurized milk and cheese products,
  • improperly cooked meat, seafood or chicken.

Make sure that the food you eat is heated well when you receive this medication.

Inform your doctor if you are pregnant, planning to become pregnant or breastfeeding. Use an effective form of birth control to keep from becoming pregnant while receiving this medication and for 4 months after your treatment ends.

Inform your doctor immediately if you have

  • unexplained weight gain or loss,
  • constipation,
  • fast, pounding or uneven heartbeat (tachycardia, palpitations),
  • feeling cold,
  • swelling of the eye.

These may be symptoms of a thyroid problem.

5 Potential Side Effects

A medication may produce unwanted affects along with the intended effects. Although not all of these side-effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if you experience any of the following side-effects:

More common:

Less common:

  • Bloating or swelling of the face, hands, lower legs, or feet
  • Chest pain
  • Hoarseness
  • Lower back or side pain
  • Muscle weakness
  • Pounding, or irregular heartbeat or pulse (palpitations, arrhythmias)
  • Rapid weight gain
  • Red or purple spots on the skin, varying in size and remaining after pushing the skin surface

Rare:

  • Flushing of the face or neck
  • Swelling of the eyelids, face or lips
  • White patches on the tongue, in the mouth or in folds of the skin, including the genitals

Some side effects that may occur do not normally need medical attention. These may leave as your body becomes accustomed to treatment.

Ask your doctor about ways to prevent or reduce some of these side effects

Talk to your doctor if any of the following side effects continue or are bothersome, or if you have questions:

More common:

  • Fear or nervousness
  • Trouble sleeping (insomnia)

Less common:

  • Acid or sour stomach
  • Belching
  • Bone pain
  • Burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
  • Heartburn
  • Indigestion
  • Lack or loss of strength
  • Loss of appetite
  • Painful cold sores or blisters on the lips, nose, eyes, or genitals
  • Stomach discomfort, upset, or pain
  • Swelling or inflammation of the mouth
  • Weight loss

Rare:

  • Bloody nose
  • Constipation
  • Sensation of temperature change
  • Sleepiness
  • Stuffy nose
  • Tremors
  • Unexplained nosebleeds

Some patients may experience other side effects that are not listed.

Check with your doctor if you notice any other side effects.

Ask your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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