Campath

DRUG DESCRIPTION

Campath (alemtuzumab) is a recombinant DNA-derived humanized monoclonal antibody (Campath (alemtuzumab) -IH) directed against the 21-28 kD cell surface glycoprotein, CD52. Campath (alemtuzumab) -1H is an IgGl kappa antibody with human variable framework and constant regions, and complementarity-determining regions from a murine (rat) monoclonal antibody (Campath (alemtuzumab) -1G). The Campath (alemtuzumab) -1H antibody has an approximate molecular weight of 150 kD. Campath (alemtuzumab) is produced in mammalian cell (Chinese hamster ovary) suspension culture in a medium containing neomycin. Neomycin is not detectable in the final product.

Campath (alemtuzumab) is a sterile, clear, colorless, isotonic solution (pH 6.8-7.4) for injection. Each single use vial of Campath contains 30 mg alemtuzumab, 8.0 mg sodium chloride, 1.44 mg dibasic sodium phosphate, 0.2 mg potassium chloride, 0.2 mg monobasic potassium phosphate, 0.1 mg polysorbate 80, and 0.0187 mg disodium edetate dihydrate. No preservatives are added.

What are the possible side effects of alemtuzumab (Campath)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some people receiving a alemtuzumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, hot or cold, nauseated, light-headed, sweaty, itchy, or have a fast heartbeat, chest tightness, or trouble breathing during the injection.

Call your doctor at once if you have any of these serious side...

Read All Potential Side Effects and See Pictures of Campath

What are the precautions when taking alemtuzumab (Campath)?

Before receiving this medication, tell your doctor or pharmacist if you are allergic to it; or if you have ever had a severe reaction 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: any current infections, immune system problems (e.g., HIV).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems, low blood pressure.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness...

Read All Potential Precautions of Campath


Campath Consumer (continued)

SIDE EFFECTS: See also Warning section.

Fever, chills, dizziness, muscle stiffness, nausea, vomiting, headache, diarrhea, mild rash/itching, tiredness, or trouble breathing may occur during or after the infusion. These reactions occur more often during the first week of treatment. Tell your doctor or pharmacist immediately if any of these effects occur, persist, or worsen. Your doctor may prescribe additional medications to help control these symptoms. Mouth sores, loss of appetite, shaking (tremor), stomach/abdominal pain, constipation, drowsiness, cough, increased sweating, or trouble sleeping may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she 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 immediately if any of these serious side effects occur: shortness of breath, mental/mood changes (e.g., depression, anxiety), bone pain, muscle pain/spasm, unusual weakness, swelling ankles/feet, yellowing skin/eyes, change in the amount of urine, painful urination, numbness/tingling of arms/legs, pain/redness/swelling of arms/legs/injection site.

Seek immediate medical attention if any of these rare but very serious side effects occur: fainting, trouble breathing, chest/jaw/left arm pain, irregular heartbeat, seizures, confusion, vision changes, weakness on one side of the body.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.

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 medication, tell your doctor or pharmacist if you are allergic to it; or if you have ever had a severe reaction 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: any current infections, immune system problems (e.g., HIV).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart problems, low blood pressure.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication.

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, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

Wash your hands well to prevent the spread of infections.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Since the effects of this medication on an unborn baby are unknown, it is recommended that both men and women receiving this medication use at least 2 reliable forms of birth control (e.g., condoms, birth control pills) during treatment with this medication and for at least 6 months afterwards. If you become pregnant or think you may be pregnant, or if your partner becomes pregnant, tell your doctor immediately.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended during treatment with this medication and for at least 3 months afterwards. Consult your doctor before breast-feeding.


Campath Patient Information Including Side Effects

Brand Names: Campath

Generic Name: alemtuzumab (Pronunciation: AL em TOOZ oo mab)

  • What is alemtuzumab (Campath)?
  • What are the possible side effects of alemtuzumab (Campath)?
  • What is the most important information I should know about alemtuzumab (Campath)?
  • What should I discuss with my health care provider before taking alemtuzumab (Campath)?
  • How is alemtuzumab given (Campath)?
  • What happens if I miss a dose (Campath)?
  • What happens if I overdose (Campath)?
  • What should I avoid while taking alemtuzumab (Campath)?
  • What other drugs will affect alemtuzumab (Campath)?
  • Where can I get more information?

What is alemtuzumab (Campath)?

Alemtuzumab is an antibody made from animal DNA.

Alemtuzumab is used to treat chronic lymphocytic leukemia.

Alemtuzumab is usually given after other medications have been tried without successful treatment.

Alemtuzumab may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of alemtuzumab (Campath)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some people receiving a alemtuzumab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, hot or cold, nauseated, light-headed, sweaty, itchy, or have a fast heartbeat, chest tightness, or trouble breathing during the injection.

Call your doctor at once if you have any of these serious side effects:

  • pale skin, easy bruising or bleeding, unusual weakness;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • fever, chills, body aches, flu symptoms;
  • feeling light-headed, fainting;
  • confusion, hallucinations; or
  • white patches or sores inside your mouth or on your lips.

Less serious side effects include:

  • nausea, vomiting, stomach pain;
  • diarrhea, constipation;
  • loss of appetite;
  • headache;
  • back or chest pain;
  • sleep problems (insomnia);
  • tired feeling;
  • runny nose, sore throat; or
  • sweating, mild skin rash or itching;

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about alemtuzumab (Campath)?

You should not receive this medication if you are allergic to alemtuzumab, or if you have HIV or AIDS, any type of active infection, or if you are allergic to mouse or hamster proteins.

Before receiving alemtuzumab, tell your doctor if you have heart disease, a bleeding or blood clotting disorder, diabetes, a stomach or intestinal disorder, or asthma or other breathing problem.

Tell your doctor if you are pregnant or plan to become pregnant during treatment.

If a man fathers a child while using this medication, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment. Continue using condoms for at least 6 months after you stop using alemtuzumab.

Do not breast-feed a baby while you are receiving alemtuzumab and for at least 3 months after your treatment ends.

You may be given other medications together with alemtuzumab to help prevent infection or certain side effects.

Alemtuzumab can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while you are being treated with alemtuzumab, and for at least several weeks after your treatment ends. The live vaccine may not work as well during this time, and may not fully protect you from disease.

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