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What is Gamimune
Immune
globulin for intravenous administration (IGIV) is a sterilized
solution obtained from pooled human blood. It contains the
immunoglobulins (or antibodies) to protect against infectious
agents that cause various diseases. Antibodies are substances
in the blood that fight infections.
Gamimune
is used to reduce the risk of infection in individuals with
poorly functioning immune systems such as those with HIV infection,
hereditary immunodeficiency syndromes, chronic lymphocytic
leukemia (CLL), and following bone marrow transplantation.
Gamimune is also used to increase platelet counts in individuals
with idiopathic thrombocytopenic purpura (ITP) and to prevent
coronary artery aneurysms (weakening of the main artery in
the heart) associated with Kawasaki syndrome.
Gamimune
may also be used for purposes other than those listed here.
General medical information about Gamimune
Gamimune is made from human plasma (part of the blood)
and may contain infectious agents (e.g., viruses) that can
cause disease. Although Gamimune is screened, tested, and
treated to reduce the possibility that it carries an infectious
agent, it can still potentially transmit disease. Discuss
with your doctor the risks and benefits of using Gamimune.
Treatment with Gamimune has been associated with
the development of kidney problems, sometimes resulting
in kidney failure and/or death. Notify your doctor immediately
if you develop decreased urination, sudden weight gain,
fluid retention or swelling, or shortness of breath. These
may be signs of kidney problems.
Rare cases of aseptic
meningitis syndrome (AMS) have been associated with the
use of Gamimune. Notify your doctor immediately if you experience
severe headache, neck stiffness, drowsiness, fever, eye
sensitivity to light, painful eye movements, and nausea
or vomiting. These may be signs of AMS. Stopping treatment
with Gamimune has resulted in resolution of AMS without
any lasting problems.
What you should find out before taking
Gamimune
Do not use Gamimune without first talking to your
doctor if you have - kidney disease; - diabetes;
- a history of blood clots, stroke, or heart disease;
- IgA deficiency; or - previously had an allergic
reaction to an immune globulin product.
You may not
be able to use Gamimune, or you may require a dosage adjustment
or special monitoring during treatment.
Gamimune
is in the FDA pregnancy category C. This means that it is
not known whether it will be harmful to an unborn baby.
Do not use Gamimune without first talking to your doctor
if you are pregnant or could become pregnant during treatment.
It is not known whether Gamimune passes into breast
milk. Do not use Gamimune without first talking to your
doctor if you are breast-feeding a baby.
Individuals
over the age of 65 years may have an increased risk of kidney
problems with the use of Gamimune. Your doctor may prescribe
a lower dose of the medication or special monitoring during
treatment.
How should take Gamimune Gamimune will be administered by intravenous (into
a vein) injection by a healthcare provider in a hospital
or clinic setting.
Your doctor may want you to have
blood tests or other forms of monitoring during treatment
with Gamimune to monitor progress and side effects.
Your healthcare provider will store Gamimune as directed
by the manufacturer. If you are storing Gamimune at home,
your healthcare provider will provider storage instructions.
If you miss a dose: Contact your healthcare provider if a dose of Gamimune
is missed.
What happens if you overdose: Seek emergency medical attention or contact your
healthcare provider if an overdose of Gamimune is suspected.
No information is available regarding an overdose
of Gamimune.
Avoid while taking Gamimune Do not receive vaccines that use live strains of
the virus (e.g., measles, mumps, and rubella or MMR) during
and for six months following treatment with Gamimune. These
vaccines may not work properly when Gamimune has been recently
administered.
Possible side effects of Gamimune Gamimune is made from human plasma (part of the blood)
and may contain infectious agents (e.g., viruses) that can
cause disease. Although Gamimune is screened, tested, and
treated to reduce the possibility that it carries an infectious
agent, it can still potentially transmit disease. Discuss
with your doctor the risks and benefits of using Gamimune.
Treatment with Gamimune has been associated with
the development of kidney problems, sometimes resulting
in kidney failure and/or death. Notify your doctor immediately
if you develop decreased urination, sudden weight gain,
fluid retention or swelling, or shortness of breath. These
may be signs of kidney problems.
Rare cases of aseptic
meningitis syndrome (AMS) have been associated with the
use of Gamimune. Notify your doctor immediately if you experience
severe headache, neck stiffness, drowsiness, fever, eye
sensitivity to light, painful eye movements, and nausea
or vomiting. These may be signs of AMS. Stopping treatment
with Gamimune has resulted in resolution of AMS without
any lasting problems.
Notify your doctor immediately
if you experience a rare but serious allergic reaction (difficulty
breathing; closing of the throat; swelling of the lips,
tongue, or face; or hives) to Gamimune.
Other less
serious side effects may also occur. Upon injection of the
medication, some patients experience the following: -
anxiety; - flushing or sweating; - stomach
cramps; - muscle or joint pain; - dizziness;
- nausea or vomiting; - fever or chills; or
- pain, tenderness, or irritation 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.
What other drugs will affect Gamimune Do not receive vaccines that use live strains of
the virus (e.g., measles, mumps, and rubella or MMR) during
and for six months following treatment with Gamimune. These
vaccines may not work properly when Gamimune has been recently
administered.
It
is not known whether other medications will interact with
Gamimune. Talk to your doctor and pharmacist before taking
any prescription or over-the-counter medicines, including
herbal products during treatment with Gamimune. |