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Flebogamma 5%: Uses, Side Effects and Dosage

Strength:
50 mg
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Source: Health Canada – Drug Product Database (DPD) and product monographs · About this document

Patient Medication Information: uses, side effects, how to take - Flebogamma 5%

What is Flebogamma 5% used for?

Replacement therapy in adults, children and adolescents (2 - 18 years) in:

  • Patients with Primary Immunodeficiency (PID), an inborn lack of antibodies.
  • Hypogammaglobulinaemia (a condition implying low immunoglobulin levels in your blood) and recurrent bacterial infections in patients with chronic lymphocytic leukaemia (cancer of the blood where too many white blood cells are produced), in whom prophylactic antibiotics have failed.
  • Hypogammaglobulinaemia (a condition implying low immunoglobulin levels in your blood) and recurrent bacterial infections in myeloma (tumour composed of cells derived from the bone marrow) patients who failed to respond to pneumococcal immunisation.
  • Hypogammaglobulinaemia (a condition implying low immunoglobulin levels in your blood) in patients after a stem cell transplantation (allogeneic haematopoietic stem cell transplantation), when you are given stem cells from another person.
  • Children and adolescents with the Acquired Immune Deficiency Syndrome (AIDS), it can be used to prevent troublesome infections.

Serious Warnings and Precautions

  • Immune Globulin Intravenous (Human) products have been reported to be associated with kidney failure. You should talk to your healthcare provider if you have some kind of kidney disease, diabetes, are over 65, seriously dehydrated, have other diseases (called sepsis and paraproteinemia), or are taking drugs that you were told could damage your kidneys.
  • Flebogamma 5% and other Immune Globulin Intravenous (Human) products have been reported to be associated with the premature destruction of red blood cells, a condition known as hemolytic anemia. Speak with your healthcare professional if you are taking antibiotics, have received a kidney transplant or blood transfusions, or you have a history of blood disorders.
  • Immune Globulin Intravenous (Human) products have been reported to be associated with heart and blood circulation problems such as heart attack, stroke and blood clots (thrombosis). You should talk to your doctor if you have risk factors for these kinds of conditions. Some of these risk factors include obesity, old age, high blood pressure, diabetes, or a history of heart disease. Thrombosis may occur even in the absence of known risk factor.

Treatment of certain autoimmune disorders (immunomodulation) in adults, children and adolescents (2 - 18 years):

  • Primary immune thrombocytopenia (ITP), a condition where the number of platelets in the blood stream is greatly reduced. Platelets form an important part of the clotting process and a reduction in their numbers may cause unwanted bleeding and bruising. The product is also used in patients at high risk of bleeding or prior to surgery to correct the platelet count.
  • Guillain Barré syndrome, where the immune system damages the nerves and hinders them from working properly.

How does Flebogamma 5% work?

Flebogamma 5% contains human normal immunoglobulin. This medicine belongs to the group of medicines called intravenous immunoglobulins. These are used to treat conditions where the body’s defence system against disease is not working properly.

What are the ingredients in Flebogamma 5%?

Medicinal ingredients: Human normal immunoglobulin

Non-medicinal ingredients: Sorbitol and water for injections

Flebogamma 5% comes in the following dosage forms:

Flebogamma 5% is a 50 mg/mL solution for infusion and comes in the following dosage forms: 0.5 g in 10 mL, 2.5 g in 50 mL, 5 g in 100 mL, 10 g in 200 mL and 20 g in 400 mL pack sizes.

Do not use Flebogamma 5%:

  • If you are allergic to human normal immunoglobulin or any of the other ingredients of this medicine.
  • If you do not have enough immunoglobulins of the type IgA in your blood or have developed antibodies to IgA.

  • If you have fructose intolerance, a quite rare genetic condition where the enzyme for breaking down fructose is not produced. In babies and young children (aged 0 - 2 years) hereditary fructose intolerance may not yet be diagnosed and may be fatal, thus, they must not receive this medicine.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Flebogamma 5%. Talk about any health conditions or problems you may have, including if you:

  • have hypo- or agammaglobulinaemia (a condition implying low immunoglobulin levels in your blood) with or without IgA deficiency.
  • you are having Flebogamma 5% for the first time, or it has been switched from an alternative human normal immunoglobulin (IGIV) product, or it is a long time since your last infusion (e.g. several weeks). You will be watched carefully until an hour after the infusion to detect potential side effects.

Allergic reactions are rare. It may happen particularly if you do not have enough immunoglobulins of the type IgA in your blood or have developed antibodies to IgA.

Certain side effects may occur more frequently in case of high rate of infusion.

Effects on blood tests

After receiving Flebogamma 5%, the results of certain blood tests (serological tests) may be interfered for a certain time. If you have a blood test after receiving Flebogamma 5%, please tell the analyst or your doctor that you have been given this medicine.

Special safety warning

When medicines are made from human blood or plasma, certain measures are put in place to prevent infections being passed on to patients. These include careful selection of blood and plasma donors to make sure those at risk of carrying infections are excluded, and the testing of each donation and pools of plasma for signs of virus/infections. Manufacturers of these products also include steps in the processing of the blood or plasma that can inactivate or remove viruses. Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. This applies to any unknown or emerging viruses or other types of infections.

The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A and parvovirus B19 viruses.

Immunoglobulins have not been associated with hepatitis A or parvovirus B19 infections possibly because the antibodies against these infections, which are contained in the product, are protective.

It is strongly recommended that every time you receive a dose of Flebogamma, the name and batch number of the product are recorded in order to maintain a record of the batches used.

Other warnings you should know about:

Children and adolescents

Vital signs (body temperature, blood pressure, heart rate and respiratory rate) should be observed during the infusion of Flebogamma 5%.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Patients may experience reactions (for example dizziness or nausea) during treatment, which might affect the ability to drive and use machines.

Flebogamma 5% contains sorbitol

Each ml of this medicinal product contains 50 mg of sorbitol. Patients with rare hereditary problems of fructose intolerance (HFI) must not take this medicine.

In other patients, in case of inadvertent administration and suspicion of fructose intolerance the infusion has to be stopped immediately, normal glycaemia has to be re-established and organ function has to be stabilized by means of intensive care.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Flebogamma 5%:

Effects on vaccines: Flebogamma 5% may reduce the effectiveness of certain types of vaccines (live attenuated virus vaccines). In case of rubella, mumps and varicella a period of up to 3 months should elapse after receiving this medicine and before receiving these vaccines. In case of measles, the period is up to 1 year.

How to take Flebogamma 5%:

Flebogamma 5% is given by injection into your veins (intravenous administration).

Usual dose:

The dose that you will be given will depend on your illness and body weight and will be worked out by your doctor.

At the beginning of your infusion you will receive Flebogamma 5% at a slow rate (0.01-0.02 ml/kg/min). Depending on how comfortable you feel, your doctor may then gradually increase the infusion rate (up to 0.1 ml/kg/min).

Overdose:

If you get more Flebogamma 5% than you should, your body may take on too much fluid. This could particularly happen when you are a patient at risk, e.g. an elderly patient or a patient having problems with your kidneys.

In case of drug overdose, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

Not applicable

What are possible side effects from using Flebogamma 5%?

These are not all the possible side effects you may feel when taking Flebogamma 5%. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.

In rare and isolated cases, the following side effects have been reported with immunoglobulin preparations:

  • A sudden fall in blood pressure and, in isolated cases, anaphylactic shock (which symptoms or signs are rash, hypotension, palpitation, wheezing, coughing, sneezing and difficulty breathing among others), even if you have shown no hypersensitivity to previous administration.
  • Cases of temporary meningitis (which symptoms or signs are headache, fear or intolerance of light, stiff neck).
  • Cases of temporary reduction in the number of the red cells in the blood (reversible haemolytic anaemia/haemolysis).
  • Cases of transient cutaneous reactions (side effects on your skin).
  • Increase in serum creatinine level (a test which measures your kidney function) and/or acute renal failure (which symptoms or signs are low back pain, fatigue, decrease in the amount of urine).
  • Thromboembolic reactions such as myocardial infarction (tight band around the chest with feeling like your heart is beating too fast), stroke (muscle weakness in the face, arm, or leg, trouble speaking or understanding others who are speaking), pulmonary embolism (shortness of breath, chest pain and fatigue), deep vein thromboses (pain and swelling in an extremity).
  • There have been reports of transfusion-related acute lung injury (TRALI) in patients administered IGIV. Therefore, patients should be monitored for pulmonary adverse reactions.

Other side effects reported in clinical studies with Flebogamma 5%:

Common (may affect up to 1 in 10 people):

  • headache
  • injection site reaction
  • fever (body temperature increased)

Uncommon (may affect up to 1 in 100 people):

  • Coombs test positive
  • dizziness (motion sickness)
  • blood pressure increased or decreased
  • bronchitis
  • cough
  • wheezing
  • abdominal pain (including abdominal pain upper)
  • diarrhoea
  • vomiting
  • nausea
  • urticaria
  • pruritus (itching)
  • rash (eruption of the skin)
  • dermatitis contact
  • back pain
  • myalgia
  • arthralgia (joint pain)
  • muscle cramp
  • rigors (cold shivering sensation) or chills
  • asthenia
  • pain
  • infusion site inflammation
  • injection site reaction (including injection site oedema, pruritus, swelling and pain)
  • migration of an implant

Frequency not known (cannot be estimated from available data):

  • chest pain
  • flushing (to blush)
  • malaise
  • dyspnoea (difficulty in breathing)

Additional side effects in children and adolescents

It was observed that the proportion of headache, fever, heart rate increased and low blood pressure in children was higher than in adults.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

  • Online at MedEffect;
  • By calling 1-866-234-2345 (toll-free);

  • By completing a Patient Side Effect Reporting Form and sending it by:

    • Fax to 1-866-678-6789 (toll-free), or

    • Mail to: Canada Vigilance Program

      Health Canada, Postal Locator 0701E Ottawa, ON

      K1A 0K9

      Postage paid labels and the Patient Side Effect Reporting Form are available at MedEffect.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Do not use this medicine after the expiry date which is stated on the label and carton after EXP.

Do not store above 30 ºC. Do not freeze.

The solution should be clear or slightly opalescent. Do not use this medicine if you notice that the solution is cloudy or has deposits.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

Keep out of reach and sight of children.

If you want more information about Flebogamma 5%:

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website www.grifols.ca, or by calling 1-800-482-5226.

Instituto Grifols, S.A. (Manufacturer)

Can Guasc, 2 - Parets del Vallès

E-08150 Barcelona

Spain

Grifols Canada Ltd. (Importer and Distributor)

5060 Spectrum Way, Suite 405

Mississauga, Ontario

L4W 5N5

Last Revised:

About this document

Source: Health Canada – Drug Product Database (DPD) and product monographs · DIN (Drug Identification Number): 02467488

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Flebogamma 5%

DIN 02467488
Schedule(s) SCHEDULE D
Active ingredient(s) Immunoglobulin (human) 50 MG
Dosage form(s) Solution
Route(s) of administration Intravenous
Drug class (WHO ATC)
  1. J Antiinfectives for systemic use
    1. J06 Immune sera and immunoglobulins
      1. J06B Immunoglobulins
        1. J06BA Immunoglobulins, normal human
          1. J06BA02 Immunoglobulins, normal human, for intravasc. adm.
Company INSTITUTO GRIFOLS S.A.
Current status Approved
Current status date August 17, 2017

Source: Health Canada – Drug Product Database (DPD) and product monographs, data as of November 1, 2026. Data from the Health Canada Drug Product Database, as published there. Not a substitute for the advice of a doctor or pharmacist.