Zenapax

DRUG DESCRIPTION

ZENAPAX (daclizumab) is an immunosuppressive, humanized IgG1 monoclonal antibody produced by recombinant DNA technology that binds specifically to the alpha subunit (p55 alpha, CD25, or Tac subunit) of the human high-affinity interleukin-2 (IL-2) receptor that is expressed on the surface of activated lymphocytes.

Daclizumab is a composite of human (90%) and murine (10%) antibody sequences. The human sequences were derived from the constant domains of human IgG1 and the variable framework regions of the Eu myeloma antibody. The murine sequences were derived from the complementarity-determining regions of a murine anti-Tac antibody. The molecular weight predicted from the DNA sequence is 144 kilodaltons.

ZENAPAX (daclizumab) 25 mg/5 mL is supplied as a clear, sterile, colorless concentrate for further dilution and intravenous administration. Each milliliter of ZENAPAX contains 5 mg of daclizumab and 3.6 mg sodium phosphate monobasic monohydrate, 11 mg sodium phosphate dibasic heptahydrate, 4.6 mg sodium chloride, 0.2 mg polysorbate 80, and may contain hydrochloric acid or sodium hydroxide to adjust the pH to 6.9. No preservatives are added.

What are the possible side effects of daclizumab (Zenapax)?

There may be an increased risk of infection with the use of daclizumab. Contact your doctor immediately if you develop signs of infection such as fever or chills; sore throat, coughing, congestion or other signs of infection; redness, pain, or swelling of a skin wound; or burning or difficult urination.

Treatment with an immunosuppressant such as daclizumab may increase the risk of developing certain types of cancer (e.g., lymphoma). Talk to your doctor about the risks and benefits of using this medication.

If you experience a serious...

Read All Potential Side Effects and See Pictures of Zenapax

What are the precautions when taking daclizumab (Zenapax)?

Before using daclizumab, 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: serious infection, cancer.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received polio vaccine by mouth or flu vaccine inhaled through the nose.

Since this medication can increase your risk of developing serious infections, wash your hands well to prevent the spread of infections. Avoid contact with people who have illnesses that may...

Read All Potential Precautions of Zenapax


Zenapax Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, constipation, or diarrhea may commonly occur during treatment with daclizumab. However, these side effects are probably caused by other drugs you are taking at the same time (e.g., cyclosporine, corticosteroids). 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 right away if you have any serious side effects, including: redness/pain/swelling at the injection site.

This medication can lower your body's ability to fight an infection. Use of drugs that weaken the immune system may also infrequently increase your risk of developing certain types of cancer (e.g., lymphoma) years after treatment. Your doctor should monitor you closely for signs of these problems. Tell your doctor immediately if you develop any of the following signs: signs of infection (e.g., fever, persistent sore throat, cough, painful urination), poor wound healing, unusual growths/lumps, swollen glands (e.g., on the neck, in the armpits), unexplained weight loss, night sweats, easy bruising/bleeding, abdominal pain/swelling, unusual tiredness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, chest pain, slow/fast/irregular heartbeat, increased sweating.

In a heart transplant study, use of daclizumab in combination with cyclosporine, mycophenolate mofetil, and corticosteroids may have infrequently caused an increased risk of serious (sometimes fatal) reactions. Consult your doctor or pharmacist for more details.

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 using daclizumab, 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: serious infection, cancer.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received polio vaccine by mouth or flu vaccine inhaled through the nose.

Since this medication can increase your risk of developing serious infections, wash your hands well to prevent the spread of infections. Avoid contact with people who have illnesses that may spread to others (e.g., flu, chickenpox).

Caution is advised when using this drug in children because they may be more sensitive to its side effects, especially diarrhea, vomiting, infection, and worsening high blood pressure.

Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially infection.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is recommended that women of childbearing age should use effective birth control before, during, and for 4 months after completion of treatment with this medication. Talk to your doctor about reliable forms of birth control.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, consult your doctor before breast-feeding.


Zenapax Patient Information Including Side Effects

Brand Names: Zenapax

Generic Name: daclizumab (Pronunciation: dah KLIH zyoo mab)

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

What is daclizumab (Zenapax)?

Daclizumab is an immunosuppressant. Immunosuppressants decrease the actions of the body's immune system.

Daclizumab is used to prevent the body from rejecting a transplanted kidney. Daclizumab is usually used as part of a treatment regimen including other medications.

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

What are the possible side effects of daclizumab (Zenapax)?

There may be an increased risk of infection with the use of daclizumab. Contact your doctor immediately if you develop signs of infection such as fever or chills; sore throat, coughing, congestion or other signs of infection; redness, pain, or swelling of a skin wound; or burning or difficult urination.

Treatment with an immunosuppressant such as daclizumab may increase the risk of developing certain types of cancer (e.g., lymphoma). Talk to your doctor about the risks and benefits of using this medication.

If you experience a serious allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to daclizumab, seek emergency medical attention.

Other, less serious side effects may also occur. Continue to use daclizumab and notify your doctor if you experience

  • upset stomach, nausea, or vomiting;
  • diarrhea or constipation;
  • tremor or dizziness;
  • headache; or
  • swelling of the hands, feet or legs.

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 daclizumab (Zenapax)?

Because it may cause serious side effects, daclizumab should only be prescribed by a doctor experienced in immunosuppressive therapy and the management of organ transplant patients. Discuss the risks and benefits of using this medication with your doctor.

There may be an increased risk of infection with the use of daclizumab. Contact your doctor immediately if you develop signs of infection such as fever or chills; sore throat, coughing, congestion or other signs of infection; redness, pain, or swelling of a skin wound; or burning or difficult urination.

Treatment with an immunosuppressant such as daclizumab may increase the risk of developing certain types of cancer (e.g., lymphoma). Talk to your doctor about the risks and benefits of using this medication.

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