Amevive

DRUG DESCRIPTION

AMEVWE® (alefacept) is a CD2-directed LFA-3/Fc fusion protein that consists of the extracellular CD2-binding portion of the human leukocyte function antigen-3 (LFA-3) linked to the Fc (hinge, CH2 and CH3 domains) portion of human IgGl. Alefacept is produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) mammalian cell expression system. The molecular weight of alefacept is 91.4 kilodaltons.

AMEVIVE® is supplied as a sterile, white-to-off-white, preservative-free, lyophilized powder for intramuscular administration. After reconstitution with 0.6 mL of the supplied Sterile Water for Injection, USP, the solution of AMEVIVE® is clear, with a pH of approximately 6.9.

AMEVIVE® for intramuscular injection contains alefacept (15 mg), citric acid monohydrate (0.06 mg), glycine (5 mg), sodium citrate dehydrate (3.6 mg), and sucrose (12.5 mg) per 0.5 mL of reconstituted solution.

What are the possible side effects of alefacept (Amevive)?

Alefacept reduces levels of certain white blood cells in the body. If the level of these white blood cells falls too low, treatment with alefacept may need to be withheld temporarily or discontinued. Your doctor will monitor your white blood cell levels during treatment.

Alefacept may increase the risk of developing cancer. Do not use alefacept without first talking to your doctor if you have cancer or a history of cancer.

Alefacept reduces certain actions of the immune system and may increase the risk of developing a new infection or...

Read All Potential Side Effects and See Pictures of Amevive »

What are the precautions when taking alefacept (Amevive)?

Before receiving alefacept, tell your doctor or pharmacist if you are allergic 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: cancer, current infection, immune system problems, liver disease, other treatments for psoriasis (including UV light).

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.

Tell your doctor if you are pregnant before using this medication.

It is not known whether this...

Read All Potential Precautions of Amevive »


Amevive Consumer (continued)

SIDE EFFECTS: Mild pain/swelling/bleeding at the injection site and chills may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: symptoms of liver damage (e.g., severe nausea/vomiting, stomach/abdominal pain, dark urine, yellowing eyes/skin).

Rarely, this medication may increase the risk of developing cancer. Tell your doctor immediately if you develop symptoms such as: unusual lumps, swollen glands, skin sores/spots that are new or change appearance.

This medication can lower the body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as fever, muscle aches, or persistent sore throat.

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 alefacept, tell your doctor or pharmacist if you are allergic 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: cancer, current infection, immune system problems, liver disease, other treatments for psoriasis (including UV light).

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.

Tell your doctor if you are pregnant before using this medication.

It is not known whether this drug passes into breast milk. However, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.


Amevive Patient Information Including Side Effects

Brand Names: Amevive

Generic Name: alefacept (Pronunciation: ah LEH fa cept)

  • What is alefacept (Amevive)?
  • What are the possible side effects of alefacept (Amevive)?
  • What is the most important information I should know about alefacept (Amevive)?
  • What should I discuss with my healthcare provider before using alefacept (Amevive)?
  • How should I use alefacept (Amevive)?
  • What happens if I miss a dose (Amevive)?
  • What happens if I overdose (Amevive)?
  • What should I avoid while using alefacept (Amevive)?
  • What other drugs will affect alefacept (Amevive)?
  • Where can I get more information?

What is alefacept (Amevive)?

Alefacept is a protein that reduces specific actions of the immune system that are involved in causing psoriasis.

Alefacept is used for the treatment of moderate to severe chronic plaque psoriasis in people who are candidates for systemic therapy or phototherapy.

Alefacept may also be used for purposes other than those listed here.

What are the possible side effects of alefacept (Amevive)?

Alefacept reduces levels of certain white blood cells in the body. If the level of these white blood cells falls too low, treatment with alefacept may need to be withheld temporarily or discontinued. Your doctor will monitor your white blood cell levels during treatment.

Alefacept may increase the risk of developing cancer. Do not use alefacept without first talking to your doctor if you have cancer or a history of cancer.

Alefacept reduces certain actions of the immune system and may increase the risk of developing a new infection or reactivating a chronic infection that has been latent (inactive). Contact your doctor immediately if you develop symptoms of an infection such as fever or chills, sore throat, coughing, or burning with urination.

Stop using alefacept and seek emergency medical attention if you develop symptoms of an allergic reaction such as difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives.

Other less serious side effects may be more likely to occur. Continue to use alefacept and talk to your doctor if you experience

  • sore throat or cough;
  • dizziness;
  • headache
  • nausea;
  • itching;
  • muscle aches;
  • chills; or
  • pain, discomfort, or inflammation at the injection site.

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 alefacept (Amevive)?

Patients with HIV should not take alefacept. Talk to your doctor before taking alefacept if you are HIV positive.

Alefacept reduces levels of certain white blood cells in the body. If the level of these white blood cells falls too low, treatment with alefacept may need to be withheld temporarily or discontinued. Your doctor will monitor your white blood cell levels during treatment.

Alefacept may increase the risk of developing cancer. Do not use alefacept without first talking to your doctor if you have cancer or a history of cancer.

Alefacept reduces certain actions of the immune system and may increase the risk of developing a new infection or reactivating a chronic infection that has been latent (inactive). Contact your doctor immediately if you develop symptoms of an infection such as fever or chills, sore throat, coughing, or burning with urination.

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