Gamunex-C
(Redirected from Flebogamma)
What is Gamunex-C?[edit | edit source]
- GAMUNEX-C is an immune globulin injection (human), 10% liquid used to treat primary immune deficiency (PI),Idiopathic Thrombocytopenic Purpura(ITP) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
What are the uses of this medicine?[edit | edit source]
GAMUNEX-C is an immune globulin injection (human), 10% liquid used for treatment of:
- Primary Humoral Immunodeficiency (PI) in patients 2 years of age and older
- Idiopathic Thrombocytopenic Purpura (ITP) in adults and children
- Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in adults
- Immunoglobulin is another name for the purified antibodies from human plasma that defend the body against infections such as viruses and bacteria.
- People with PI lack the healthy antibodies needed to fight off these infections.
- GAMUNEX-C provides those healthy antibodies and will help lower the number and severity of infections you could get.
How does this medicine work?[edit | edit source]
- Primary Humoral Immunodeficiency(PI):
GAMUNEX-C supplies a broad spectrum of opsonic and neutralizing IgG antibodies against bacterial, viral, parasitic, and mycoplasmal agents, and their toxins. The mechanism of action in PI has not been fully elucidated.
- Idiopathic Thrombocytopenic Purpura(ITP):
The mechanism of action of high doses of immunoglobulins in the treatment of ITP has not been fully elucidated.
- Chronic Inflammatory Demyelinating Polyneuropathy(CIDP):
The precise mechanism of action in CIDP has not been fully elucidated.
Who Should Not Use this medicine ?[edit | edit source]
This medicine cannot be used in patients who:
- have had an anaphylactic or severe systemic reaction to the administration of human immune globulin.
- IgA deficient patients with antibodies against IgA and history of hypersensitivity.
What drug interactions can this medicine cause?[edit | edit source]
- The passive transfer of antibodies may transiently interfere with the response to live virus vaccines, such as measles, mumps and rubella.
- GAMUNEX-C with other drugs and intravenous solutions have not been evaluated. It is recommended that GAMUNEX-C be administered separately from other drugs or medications which the patient may be receiving.
- Avoid simultaneous administration of GAMUNEX-C and Heparin through a single lumen delivery device due to GAMUNEX-C, Heparin incompatibilities.
Is this medicine FDA approved?[edit | edit source]
- Initial U.S. Approval: 2003
How should this medicine be used?[edit | edit source]
Recommended dosage:
- Intravenous Administration Only: ITP and CIDP
Indication | Dose | Initial Infusion Rate | Maintenance Infusion Rate (if tolerated) |
---|---|---|---|
ITP | 2 g/kg | 1 mg/kg/min | 8 mg/kg/min |
CIDP | loading dose 2 g/kg maintenance dose 1 g/kg | 2 mg/kg/min | 8 mg/kg/min Every 3 weeks |
- Intravenous or Subcutaneous Administration: PI
Route of Administration | Dose | Initial Infusion Rate | Maintenance Infusion Rate(if tolerated) |
---|---|---|---|
Intravenous (IV) | 300 – 600 mg/kg | 1 mg/kg/min | 8 mg/kg/min Every 3 to 4 weeks |
Subcutaneous (SC) | 1.37 x current IV dose in grams/IV dose interval in weeks | Adult:†20 mL/hr/site;Pediatric:†10 mL/hr/site (< 25 kg)
15 mL/hr/site (≥ 25 kg) ||Adult:†20 mL/hr/site ;Pediatric†:10 mL/hr/site (< 25 kg) 20 mL/hr/site (≥ 25 kg) Weekly |
- Do not administer GAMUNEX-C subcutaneously in patients with ITP
Administration:
- You will take GAMUNEX-C through infusions given just below the skin (in the subcutaneous tissue).
- As directed by your physician, one or more injection sites on your body will be selected.
- The number and location of the injection sites depends on the amount you need to receive.
- Typically, adults may use 1 to 4 needles in different locations at one time. You may use up to 8 needles as directed by your doctor.
- For children, use up to 6 infusion sites simultaneously. For patients of all ages ensure that the infusion sites are at least 2 inches (5 cm) apart.
- The needles are attached with a tube to the pump. You will need to have infusions once a week.
What are the dosage forms and brand names of this medicine?[edit | edit source]
This medicine is available in fallowing doasage form:
- As a sterile solution for injection supplied in 1 g (10 mL), 2.5 g (25 mL), 5 g (50 mL), 10 g (100 mL), 20 g (200 mL), or 40 g (400 mL) single use vials.
This medicine is available in fallowing brand namesː
- GAMUNEX-C
What side effects can this medication cause?[edit | edit source]
The most common side effects of this medicine include:
- Redness, swelling, and itching at the injection site
- Fatigue
- Headache
- Pain (including pain in the joints, arms, legs)
- Diarrhea
- Nausea
- Migraine
- Fever
GAMUNEX-C may cause serious side effects include:
- renal failure
- thrombosis
- aseptic meningitis
- hemolytic anemia
- transfusion-related acute lung injury
- Fever over 100°F (37.8oC)
What special precautions should I follow?[edit | edit source]
- Severe hypersensitivity reactions may occur with IGIV products, including GAMUNEX-C. IgA deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions. Have epinephrine available immediately to treat any acute severe hypersensitivity reactions.
- Hyperproteinemia, with resultant changes in serum viscosity and electrolyte imbalances may occur in patients receiving IGIV therapy.
- Aseptic Meningitis Syndrome (AMS) may occur, especially with high doses or rapid infusion.
- Hemolysis, either intravascular or due to enhanced RBC sequestration, can develop subsequent to GAMUNEX-C treatments. Risk factors include high doses and non-O blood group. Closely monitor patients for hemolysis and hemolytic anemia, especially in patients with pre-existing anemia and/or cardiovascular or pulmonary compromise.
- Noncardiogenic pulmonary edema may occur in patients following treatment with IGIV products, including GAMUNEX-C. Monitor patients for pulmonary adverse reactions. If TRALI is suspected, perform appropriate tests for the presence of anti-neutrophil and anti-HLA antibodies in both the product and patient serum. TRALI may be managed using oxygen therapy with adequate ventilatory support.
- GAMUNEX-C is made from human plasma and may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
- GAMUNEX-C is not approved for subcutaneous use in ITP patients. Due to a potential risk of hematoma formation, do not administer GAMUNEX-C subcutaneously in patients with ITP.
- Passive transfer of antibodies may confound serologic testing.
What to do in case of emergency/overdose?[edit | edit source]
Symptoms of overdosage may include:
Can this medicine be used in pregnancy?[edit | edit source]
- There are no data with GAMUNEX-C use in pregnant women to inform a drug-associated risk.
- It is not known whether GAMUNEX-C can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
- GAMUNEX-C should be given to a pregnant woman only if clearly needed.
Can this medicine be used in children?[edit | edit source]
PI:
- GAMUNEX-C was evaluated in 18 pediatric subjects (age range 0-16 years).
- Efficacy and safety in pediatric patients under 2 years of age using the Subcutaneous route of administration have not been established.
ITP:
- For treatment of ITP, GAMUNEX-C must be administered by the intravenous route.
- GAMUNEX-C was evaluated in 12 pediatric subjects with acute ITP.
CIDP:
- The safety and effectiveness of GAMUNEX-C have not been established in pediatric subjects with CIDP.
What are the active and inactive ingredients in this medicine?[edit | edit source]
Active Ingredients:
- Human Immunoglobulin G
Inactive ingredients:
- Glycine
- Water
Who manufactures and distributes this medicine?[edit | edit source]
Manufactured by:
- Grifols Therapeutics LLC
- Research Triangle Park, NC USA
What should I know about storage and disposal of this medication?[edit | edit source]
- DO NOT FREEZE
- Keep the vial in the carton to protect from light.
- GAMUNEX-C may be stored for 36 months at 2-8°C (36-46°F) from the date of manufacture, AND product may be stored at temperatures not to exceed 25°C (77°F) for up to 6 months anytime during the 36 month shelf life, after which the product must be immediately used or discarded.
- Do not use after expiration date.
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Gamunex-C Resources | ||
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Translate to: East Asian
中文,
日本,
한국어,
South Asian
हिन्दी,
Urdu,
বাংলা,
తెలుగు,
தமிழ்,
ಕನ್ನಡ,
Southeast Asian
Indonesian,
Vietnamese,
Thai,
မြန်မာဘာသာ,
European
español,
Deutsch,
français,
русский,
português do Brasil,
Italian,
polski
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