- Approval Id
- 5cf6bdd8dad2432d
- Drug Name
- INTRAGAM P INJECTION 6% w/v
- Product Name
- INTRAGAM P INJECTION 6% w/v
- Approval Number
- SIN12022P
- Approval Date
- 2002-07-15
- Registrant
- BLOOD SERVICES GROUP, HEALTH SCIENCES AUTHORITY
- Licence Holder
- BLOOD SERVICES GROUP, HEALTH SCIENCES AUTHORITY
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION
- Dosage
- **DOSAGE AND ADMINISTRATION**
**Dosage**
Intragam® P may be infused undiluted. Intragam® P may also be infused diluted with up to 2 parts of 0.9% saline or 5% glucose.
The infusion should be commenced at the rate of
1 mL/minute (60 mL/hour). After 15 minutes the rate may be gradually increased to a maximum of 3–4 mL/minute (180 to 240 mL/hour) over a further 15 minutes. Consideration should be given to reducing the rate of infusion in patients naïve to Intragam P, patients switching from alternative IVIg, patients who have not received IVIg for a long time, paediatric and elderly patients and in patients with pre-existing renal disease (see **SPECIAL WARNINGS AND PRECAUTIONS FOR USE** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
A rate of infusion which is too rapid may cause flushing and changes in heart rate and blood pressure.
**REPLACEMENT THERAPY**
Replacement therapy should be commenced and monitored under the supervision of a healthcare professional experienced in the treatment of immunodeficiency.
The optimal dose and frequency of administration of Intragam® P must be determined for each patient. Freedom from recurrent bacterial infections is usually achieved with a serum IgG level above 5 g/litre. Most patients receive a dose of 0.2–0.6 g IgG/kilogram body weight/month, either as a single dose or as two equal doses at fortnightly intervals. Following initial diagnosis, higher doses (0.4 to 0.6 g IgG per kilogram body weight per month) may be required for several months to provide rapid protection against recurrent infections. Adjustment of both dose and infusion interval is empirical and should be based on the patient’s clinical state and the pre-infusion IgG level.
**IMMUNOMODULATORY THERAPY**
**Idiopathic Thrombocytopenic Purpura (ITP)**
The optimal dose and frequency of administration of Intragam® P must be determined for each patient.
Patients may receive a dose of up to a maximum total cumulative dose of 2 g IgG/kilogram body weight, over two to five days. Adjustment of both dose and infusion interval is empirical and should be based on the patient’s clinical state.
**Kawasaki Disease**
The optimal dose and frequency of administration of Intragam® P must be determined for each patient.
Patients should receive 1.6–2.0 g IgG/kilogram body weight, administered in divided doses over two to five days or 2 g IgG/kilogram body weight as a single dose.
Patients should receive concomitant treatment with acetylsalicylic acid.
**Allogeneic bone marrow transplantation**
Treatment with Intragam® P may be used as part of the conditioning regime and after the transplant.
The optimal dose and frequency of administration of Intragam® P should be individualised. A starting dose of 0.5 g IgG per kilogram body weight per week is recommended.
**METHOD OF ADMINISTRATION**
NOTE: Intragam® P contains no antimicrobial preservative. It must, therefore, be used immediately after opening the bottle. Use in one patient on one occasion only. Any unused portion should be discarded appropriately. Do not use if the solution has been frozen. If Intragam® P appears to be turbid or to contain any sediment, it must not be used. The unopened bottle should be returned to the Blood Services Group.
Intragam® P should be administered separately from other intravenous fluids or medications the patient might be receiving.
Intragam® P may be administered through any standard IV infusion giving set. The following procedure is recommended:
1. Allow the preparation to reach room temperature before use.
2. Remove the plastic cover from the seal.
3. Apply a suitable antiseptic to the exposed part of the rubber stopper and allow to dry.
4. Stand the bottle upright and insert the air vent needle vertically in one of the indentations of the stopper. It is preferable to use a long airway needle fitted with a filter. If not available, a short needle attached to a non-wettable filter may be used.
5. Clamp the tubing of the giving set and insert the needle at the upper end of the giving set vertically through another indentation of the stopper. Should the stopper become dislodged, do not use this bottle and discard the solution appropriately.
6. Invert the bottle and attach the hanger to a support approximately one metre above the patient.
7. Allow the tubing to fill by adjusting the clamp. Attach the giving set to the venous access device (cannula) and adjust the rate of flow.
8. When the bottle is empty, clamp the tubing and transfer the needle at the upper end of the giving set to a further bottle of Intragam® P.
9. Should leakage become evident during administration, cease the infusion and discard the solution appropriately. Recommence the infusion with a new bottle and giving set.
- Route Of Administration
- INTRAVENOUS
- Indication Info
- **INDICATIONS**
Intragam® P is indicated for replacement IgG therapy in:
- primary immunodeficiency
- myeloma and chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections
- congenital or acquired immune deficiency syndrome with recurrent infections.
Intragam® P is indicated for immunomodulatory therapy in:
- Idiopathic Thrombocytopenic Purpura (ITP), in adults or children at high risk of bleeding or prior to surgery to correct the platelet count
- allogeneic bone marrow transplantation
- Kawasaki disease.
Comprehensive evidence-based guidelines describing appropriate clinical use of intravenous immunoglobulin in ITP have been published and should be followed wherever possible to avoid the inappropriate utilisation of this blood product1, 2.
* * *
**REFERENCES**
1. George, JN _et al_: Idiopathic Thrombocytopenic Purpura: A Practice Guideline Developed by Explicit Methods for The American Society of Hematology. Blood 88, 3–40, 1996.
2. The American Society of Hematology ITP Guideline Panel: Diagnosis and Treatment of Idiopathic Thrombocytopenic Purpura: Recommendations of The American Society of Hematology. Ann Intern Med 126, 319–326, 1997.
- Contraindications
- **CONTRAINDICATIONS**
Intragam P is contraindicated in patients:
- Who have had a true anaphylactic reaction to a human immunoglobulin preparation
- Who are IgA-deficient with antibodies to IgA and a history of hypersensitivity
- With a history of hypersensitivity to the excipient maltose.
- Atc Code
- J06BA02
- Atc Item Name
- immunoglobulins, normal human, for intravascular adm.
- Pharma Manufacturer Name
- blood services group, health sciences authority
