Baygam

DRUG DESCRIPTION

Immune Globulin (Human) — BayGam™ (immune globulin) treated with solvent/detergent is a
sterile solution of immune globulin for intramuscular administration; it contains
no preservative. BayGam is prepared by cold ethanol fractionation from human
plasma. The immune globulin is isolated from solubilized Cohn fraction II. The
fraction II solution is adjusted to a final concentration of 0.3% tri-n-butyl
phosphate (TNBP) and 0.2% sodium cholate. After the addition of solvent (TNBP)
and detergent (sodium cholate), the solution is heated to 30°C and maintained
at that temperature for not less than 6 hours. After the viral inactivation
step, the reactants are removed by precipitation, filtration and finally ultrafiltration
and diafiltra-tion. BayGam (immune globulin) is formulated as a 15–18% protein solution at a pH
of 6.4–7.2 in 0.21–0.32 M glycine. BayGam (immune globulin) is then incubated in the final container
for 21–28 days at 20–27°C.

The removal and inactivation of spiked model enveloped and non-enveloped viruses
during the manufacturing process for BayGam (immune globulin) has been validated in laboratory
studies. Human Immunodeficiency Virus, Type 1 (HIV-1), was chosen as the relevant
virus for blood products; Bovine Viral Diarrhea Virus (BVDV) was chosen to model
Hepatitis C virus; Pseudorabies virus (PRV) was chosen to model Hepatitis B
virus and the Herpes viruses; and Reo virus type 3 (Reo) was chosen to model
non-enveloped viruses and for its resistance to physical and chemical inactivation.
Significant removal of model enveloped and non-enveloped viruses is achieved
at two steps in the Cohn fractionation process leading to the collection of
Cohn Fraction II:the precipitation and removal of Fraction III in the processing
of Fraction II + IIIW suspension to Effluent IIIand the filtration step in the
processing of Effluent III to Filtrate III. Significant inactivation of enveloped
viruses is achieved at the time of treatment of solubilized Cohn Fraction II
with TNBP/sodium cholate.

What are the precautions when taking immune globulin (Baygam)?

Before using this medication, tell your doctor or pharmacist if you have had a bad or allergic reaction to it; or to other immunoglobulin products (e.g., IVIG); 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: a certain immune system problem (immunoglobulin A deficiency), bleeding/blood clotting problems (e.g., low platelets, hemophilia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease.

Tell your doctor of any recent/planned...

Read All Potential Precautions of Baygam »

Baygam Consumer (continued)

SIDE EFFECTS: Muscle stiffness, redness, warmth, pain, and tenderness at the injection site may occur. Fever, chills, headache, and joint pain may also 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 right away if you have any serious side effects, including: unusual tiredness, change in the amount of urine, pink/bloody/frothy urine, sudden weight gain.

Rarely, this product may contain substances that could cause infections because it is made from human blood. Though the risk is very low due to careful screening of blood donors, discuss the risks and benefits with your doctor. Tell your doctor immediately if you develop any signs of infection such as persistent sore throat/fever, yellowing eyes/skin, or dark urine.

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 this medication, tell your doctor or pharmacist if you have had a bad or allergic reaction to it; or to other immunoglobulin products (e.g., IVIG); 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: a certain immune system problem (immunoglobulin A deficiency), bleeding/blood clotting problems (e.g., low platelets, hemophilia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease.

Tell your doctor of any recent/planned vaccinations. This medication may prevent a good response to live virus vaccines (e.g., measles, mumps, rubella). If you are vaccinated less than 14 days before receiving this medication or during the 6 months after receiving this medication, you may need to be vaccinated again or tested to see whether the vaccine was effective.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.