Synagis

DRUG DESCRIPTION

Synagis (palivizumab) is a humanized monoclonal antibody (IgG1?) produced by recombinant DNA technology, directed to an epitope in the A antigenic site of the F protein of respiratory syncytial virus (RSV). Synagis (palivizumab) is a composite of human (95%) and murine (5%) antibody sequences. The human heavy chain sequence was derived from the constant domains of human IgG1 and the variable framework regions of the VHgenes Cor (1) and Cess (2). The human light chain sequence was derived from the constant domain of C?and the variable framework regions of the VLgene K104 with J?-4 (3). The murine sequences were derived from a murine monoclonal antibody, Mab 1129 (4), in a process that involved the grafting of the murine complementarity determining regions into the human antibody frameworks. Synagis (palivizumab) is composed of two heavy chains and two light chains and has a molecular weight of approximately 148,000 Daltons.

Synagis (palivizumab) is supplied as a sterile, preservative-free liquid solution at 100 mg/mL to be administered by intramuscular injection (IM). Thimerosal or other mercury containing salts are not used in the production of Synagis (palivizumab) . The solution has a pH of 6.0 and should appear clear or slightly opalescent.

Each 100 mg single-dose vial of Synagis (palivizumab) liquid solution contains 100 mg of Synagis (palivizumab) , 3.9 mg of histidine, 0.1 mg of glycine, and 0.5 mg of chloride in a volume of 1 mL.

Each 50 mg single-dose vial of Synagis (palivizumab) liquid solution contains 50 mg of Synagis (palivizumab) , 1.9 mg of histidine, 0.06 mg of glycine, and 0.2 mg of chloride in a volume of 0.5 mL.

What are the possible side effects of palivizumab (Synagis)?

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficult breathing; swelling of the face, lips, tongue, or throat.

Call your doctor at once if your child has a serious side effect such as:

  • high fever, ear pain or drainage, tugging at the ear;
  • warmth or swelling of the ear;
  • crying or fussiness, especially while lying down;
  • change in sleeping patterns;
  • poor feeding or loss of appetite;
  • easy bruising or bleeding;...

Read All Potential Side Effects and See Pictures of Synagis »

What are the precautions when taking palivizumab (Synagis)?

Before using palivizumab, tell your child's doctor or pharmacist if your child is allergic to it; or to mouse proteins; or if your child has any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Tell the doctor your child's medical history, especially of: bleeding/blood clotting problems (e.g., thrombocytopenia, coagulation disorder), recent heart bypass...

Read All Potential Precautions of Synagis »

What are the possible side effects of palivizumab (Synagis)?

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficult breathing; swelling of the face, lips, tongue, or throat.

Call your doctor at once if your child has a serious side effect such as:

  • high fever, ear pain or drainage, tugging at the ear;
  • warmth or swelling of the ear;
  • crying or fussiness, especially while lying down;
  • change in sleeping patterns;
  • poor feeding or loss of appetite;
  • easy bruising or bleeding;...

Read All Potential Side Effects and See Pictures of Synagis »

What are the precautions when taking palivizumab (Synagis)?

Before using palivizumab, tell your child's doctor or pharmacist if your child is allergic to it; or to mouse proteins; or if your child has any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Tell the doctor your child's medical history, especially of: bleeding/blood clotting problems (e.g., thrombocytopenia, coagulation disorder), recent heart bypass...

Read All Potential Precautions of Synagis »

What are the possible side effects of palivizumab (Synagis)?

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficult breathing; swelling of the face, lips, tongue, or throat.

Call your doctor at once if your child has a serious side effect such as:

  • high fever, ear pain or drainage, tugging at the ear;
  • warmth or swelling of the ear;
  • crying or fussiness, especially while lying down;
  • change in sleeping patterns;
  • poor feeding or loss of appetite;
  • easy bruising or bleeding;...

Read All Potential Side Effects and See Pictures of Synagis »

What are the precautions when taking palivizumab (Synagis)?

Before using palivizumab, tell your child's doctor or pharmacist if your child is allergic to it; or to mouse proteins; or if your child has any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Tell the doctor your child's medical history, especially of: bleeding/blood clotting problems (e.g., thrombocytopenia, coagulation disorder), recent heart bypass...

Read All Potential Precautions of Synagis »

What are the possible side effects of palivizumab (Synagis)?

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficult breathing; swelling of the face, lips, tongue, or throat.

Call your doctor at once if your child has a serious side effect such as:

  • high fever, ear pain or drainage, tugging at the ear;
  • warmth or swelling of the ear;
  • crying or fussiness, especially while lying down;
  • change in sleeping patterns;
  • poor feeding or loss of appetite;
  • easy bruising or bleeding;...

Read All Potential Side Effects and See Pictures of Synagis »

What are the precautions when taking palivizumab (Synagis)?

Before using palivizumab, tell your child's doctor or pharmacist if your child is allergic to it; or to mouse proteins; or if your child has any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Tell the doctor your child's medical history, especially of: bleeding/blood clotting problems (e.g., thrombocytopenia, coagulation disorder), recent heart bypass...

Read All Potential Precautions of Synagis »

What are the possible side effects of palivizumab (Synagis)?

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficult breathing; swelling of the face, lips, tongue, or throat.

Call your doctor at once if your child has a serious side effect such as:

  • high fever, ear pain or drainage, tugging at the ear;
  • warmth or swelling of the ear;
  • crying or fussiness, especially while lying down;
  • change in sleeping patterns;
  • poor feeding or loss of appetite;
  • easy bruising or bleeding;...

Read All Potential Side Effects and See Pictures of Synagis »

What are the precautions when taking palivizumab (Synagis)?

Before using palivizumab, tell your child's doctor or pharmacist if your child is allergic to it; or to mouse proteins; or if your child has any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Tell the doctor your child's medical history, especially of: bleeding/blood clotting problems (e.g., thrombocytopenia, coagulation disorder), recent heart bypass...

Read All Potential Precautions of Synagis »

What are the possible side effects of palivizumab (Synagis)?

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficult breathing; swelling of the face, lips, tongue, or throat.

Call your doctor at once if your child has a serious side effect such as:

  • high fever, ear pain or drainage, tugging at the ear;
  • warmth or swelling of the ear;
  • crying or fussiness, especially while lying down;
  • change in sleeping patterns;
  • poor feeding or loss of appetite;
  • easy bruising or bleeding;...

Read All Potential Side Effects and See Pictures of Synagis »

What are the precautions when taking palivizumab (Synagis)?

Before using palivizumab, tell your child's doctor or pharmacist if your child is allergic to it; or to mouse proteins; or if your child has any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Tell the doctor your child's medical history, especially of: bleeding/blood clotting problems (e.g., thrombocytopenia, coagulation disorder), recent heart bypass...

Read All Potential Precautions of Synagis »


Synagis Consumer (continued)

SIDE EFFECTS: Diarrhea, fever, cough, earache, runny nose, or pain/redness/swelling at the injection site may occur. If any of these effects persist or worsen, contact the doctor or pharmacist promptly.

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

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.

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 palivizumab, tell your child's doctor or pharmacist if your child is allergic to it; or to mouse proteins; or if your child has any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Tell the doctor your child's medical history, especially of: bleeding/blood clotting problems (e.g., thrombocytopenia, coagulation disorder), recent heart bypass surgery.


Synagis Patient Information Including Side Effects

Brand Names: Synagis

Generic Name: palivizumab (Pronunciation: PAL i VIZ oo mab)

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

What is palivizumab (Synagis)?

Palivizumab is a man-made antibody to respiratory syncytial (sin-SISH-ul) virus (RSV). RSV can cause serious illness in children. Palivizumab helps keep RSV cells from multiplying in the body.

Palivizumab is used to prevent serious lung disease caused by respiratory syncytial virus in premature infants, and infants born with certain lung disorders or heart disease.

Palivizumab will not treat a child who is already sick with RSV disease.

Palivizumab may also be used for other purposes not listed in this medication guide.

What are the possible side effects of palivizumab (Synagis)?

Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficult breathing; swelling of the face, lips, tongue, or throat.

Call your doctor at once if your child has a serious side effect such as:

  • high fever, ear pain or drainage, tugging at the ear;
  • warmth or swelling of the ear;
  • crying or fussiness, especially while lying down;
  • change in sleeping patterns;
  • poor feeding or loss of appetite;
  • easy bruising or bleeding; or
  • trouble breathing.

Less serious side effects may include:

  • low fever;
  • cold symptoms such as stuffy nose, sneezing, cough;
  • vomiting, diarrhea; or
  • pain, redness, or swelling where the shot was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about palivizumab (Synagis)?

Palivizumab should not be given to a child who has had a severe allergic reaction to it.

Before your child receives a palivizumab injection, tell your doctor if the child has a bleeding or blood-clotting disorder; or a low level of platelets in the blood.

Do not use this medicine at home if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Call your doctor at once if your child has a serious side effect such as high fever, ear pain or drainage, warmth or swelling of the ear; crying or fussiness, change in appetite or sleeping patterns, easy bruising or bleeding, or trouble breathing.

Call your doctor for instructions if you miss an appointment for your child's palivizumab injection.

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