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|Immune Globulin IV

Immune Globulin IV

Trade Names:
Carimune NF
- Powder for Injection, lyophilized 1, 3, 6, 12 g immune globulin (human)

Trade Names:
Flebogamma 5%
- Injection 5% immune globulin (human) (50 mg/mL)

Trade Names:
Gammar-P I.V.
- Powder for Injection, lyophilized 5% IgG, 3% human albumin

Trade Names:
Gamunex
- Injection 10% immune globulin (human)

Trade Names:
Octagam
- Injection 5% immune globulin (human) (50 mg/mL)

Trade Names:
Panglobulin
- Powder for Injection, lyophilized 6, 12 g

Trade Names:
Panglobulin NF
- Powder for Injection 1, 3, 6, 12 g immune globulin (human)

Trade Names:
Polygam S/D
- Powder for Injection 5% immune globulin (human) (at least 90% gamma globulin)

Trade Names:
Venoglobulin-S
- Injection 5% immune globulin IV (human)
- Injection 10% immune globulin IV (human)

Mechanism of Action

Pharmacology

Replaces normal human IgG antibodies. Promotes opsonization, fixes complement, and neutralizes bacteria, viruses, fungi, and parasites, and their toxins.

Pharmacokinetics

Elimination

Mean t _½ is at least 21 days.

Indications and Usage

Treatment of primary immunodeficiency states in patients unable to produce sufficient amounts of IgG antibodies.

Idiopathic thrombocytopenic purpura (ITP). Consider use in situations that require a rapid, temporary rise in platelet count (eg, prior to surgery).

Maintenance treatment of patients with primary immunodeficiencies (eg, common variable immunodeficiency).

Primary (inherited) humoral immunodeficiency disorders (eg, variable immunodeficiency, X-linked agammaglobulinemia, severe combined immunodeficiency, Wiskott-Aldrich Syndrome).

Primary defective antibody synthesis (eg, agammaglobulinemia) in patients at increased risk of infection.

Decrease risk of septicemia, interstitial pneumonia of infectious and idiopathic etiologies and acute graft vs host disease in patients 20 yr of age and older in the first 100 days post-bone marrow transplant. Decrease frequency of minor and serious bacterial infections and the frequency of hospitalization and to increase time free of serious bacterial infections.

Treatment of primary immune deficient diseases (eg, congenital agammaglobulinemia and hypogammaglobulinemia, Wiskott-Aldrich syndrome).

Prevention of bacterial infections in patients with hypogammaglobulinemia or recurrent bacterial infections associated with B-cell chronic lymphocytic leukemia (CLL).

Prevention of coronary artery abnormalities associated with Kawasaki disease in conjunction with high-dose aspirin (ie, 100 mg/kg/day).

Chronic ITP to maintain platelet counts above 30,000/mm ³ in children and above 20,000/mm ³ in adults.

Unlabeled Uses

Posttransfusion purpura, Guillain-Barré syndrome and chronic inflammatory demyelinating polyneuropathy (as an alternative to plasma exchange). Prevention or treatment of autoimmune diseases (eg, rhesus hemolytic disease, rheumatoid arthritis), IgG4 subclass deficiencies, intractable epilepsy, cystic fibrosis, trauma, thermal injury (eg, severe burns), cytomegalovirus infection, neuromuscular disorders, prophylaxis of infections associated with bone marrow transplantation, and GI protection.

Contraindications

Immediate hypersensitivity to human antibody product; selective IgA deficiency and circulating anti-IgA antibodies; possible aseptic meningitis syndrome; hypersensitivity or intolerance to any component of the product.

Dosage and Administration

IV 400 mg/kg q 3 to 4 wk.

IV 500 mg/kg beginning on days 7 and 2 pretransplant or at time conditioning therapy for transplantation is started, then weekly through the 90-day posttransplant period.

IV 100 mg/kg/month. An initial dose of 200 to 400 mg/kg may be administered.

IV 0.2 g/kg once a month. (If clinical response is inadequate, increase dose to 0.3 g/kg or repeat infusion more frequently than once a month.).

IV 100 to 200 mg/kg/month. (If clinical response is inadequate or level of IgG is insufficient, give the dose more frequently or increase the dose as high as 400 mg/kg.).

IV 200 mg/kg/month. (If clinical response is inadequate or level of serum IgG achieved is insufficient, the dose may be increased to 300 to 400 mg/kg/month or the infusion may be repeated more frequently than once a month.).

IV Start with 200 to 400 mg/kg every 3 to 4 wk. Individualize treatment.

For induction therapy, 0.4 g/kg on 2 to 5 consecutive days.

IV 400 mg/kg for 5 consecutive days or 1,000 mg/kg/day for 1 day or 2 consecutive days.

IV 2 doses of 1 g/kg given on 2 consecutive days or 5 doses of 0.4 mg/kg given on 5 consecutive days.

IV 1 g/kg (Additional doses can be determined based on clinical response and platelet count. Give no more than 3 separate doses on alternate days if required.

IV For induction therapy, 2,000 mg/kg over 5 days or less.

IV A single 1 g/kg dose or 400 mg/kg for 4 consecutive days beginning within 7 days of the onset of fever, coadministered with aspirin therapy (80 to 100 mg/kg/day in 4 divided doses).

IV Start treatment within 10 days of onset of symptoms. Give a single 2 g/kg dose over a 10- to 12-hr period. Treatment should include aspirin (100 mg/kg/day) until patient becomes afebrile or through the 14th day after symptom onset. Administer 3 to 10 mg/kg/day of aspirin for the following 5 wk. Retreatment with same dose may be useful if symptoms persist or recur due to active Kawasaki disease.

IV 400 mg/kg q 28 days.

IV Individualize dose. 300 to 600 mg/kg q 3 to 4 wk.

IV 300 to 600 mg/kg administered q 3 to 4 wk. Adjust dose over time to achieve desired trough levels and clinical response.

General Advice

• For administration by IV infusion only. Not for intradermal, subcutaneous, IM, IV bolus, or intra-arterial administration.
• Reconstitute powder for injection immediately before use following manufacturer"s guidelines for reconstitution. Do not shake during reconstitution process to avoid foaming.
• Contents of individual vials may be pooled under aseptic conditions into sterile infusion containers.
• Carefully follow recommended infusion rates to reduce risk of infusion-related adverse reactions (eg, flushing, changes in BP and pulse). Generally, infusions are started at low rates and then increased as tolerated. If side effects occur, the infusion rate may be reduced, or the infusion interrupted until symptoms subside, and then resumed at the rate which is comfortable for the patient.
• Ensure that IGIV solutions that have been refrigerated are allowed to come to room temperature before infusing.
• Infuse IGIV through separate IV line. Do not add any other medications or IV fluids to IGIV infusion container. If other medications or IV fluids will be sequentially administered, flush IV line with 5% dextrose in water (or 0.9% sodium chloride injection for Gamar-P I.V. ) before and after infusion of IGIV. Gamunex may be diluted with 5% dextrose in water if dilution required.
• In line filtration is acceptable but not required. Pore sizes of 15 microns or greater will be less likely to slow infusion.
• Do not mix IGIV products of different formulations or from different manufacturers.
• Do not administer if solution is discolored, cloudy, turbid, or if particulate matter is noted.

Storage/Stability

• Protect IGIV solutions from freezing. Do not use any IGIV solution that has been frozen.
• Store Gamimune N vials in refrigerator. Promptly use the contents of any vial that has been entered. Discard partially used vials. Do not keep partially used vials for future use.
• Store Panglobulin , Panglobulin NF , and Carimune NF vials at controlled room temperature (less than 86°F). Administer Carimune or Panglobulin NF immediately after reconstitution if reconstitution occurs outside of sterile laminar air flow conditions, or within 24 hr if reconstitution is performed in sterile laminar flow hood using aseptic technique and solution is stored in refrigerator (36° to 46°F) during that time.
• Store Gammar-P I.V. , Polygam S/D , and Venoglobulin-S at controlled room temperature (at or below 77°F). Protect Gamar-P I.V. vial packages from freezing which could damage container for diluent. Promptly use the contents of any vial of Venoglobulin-S that has been entered; discard partially used vial; do not keep partially used vials for future use. Administration of Polygam S/D should begin 2 hr of less following reconstitution if reconstitution occurs outside of sterile laminar air flow conditions, or within 24 hr if reconstitution is performed in sterile laminar flow hood using aseptic technique and solution is stored in refrigerator (36° to 46°F) during that time. Discard any unused solution.
• Store Octagam for up to 24 mo in refrigerator or for up to 18 mo at controlled room temperature from date of manufacture. Promptly use the contents of any vial that has been entered. Discard partially used vials. Do not keep partially used vials for future use.
• Store Gamunex for up to 36 mo in refrigerator. Gamunex may also be stored for up to 5 mo at controlled room temperature during the first 18 mo from date of manufacture, after which the product must be immediately used or discarded. Protect from freezing. Promptly use the contents of any vial that has been entered. Discard partially used vials. Do not keep partially used vials for future use.
• Store Flebogamma in refrigerator or at controlled room temperature. Protect from freezing. Promptly use the contents of any vial that has been entered. Discard partially used vials. Do not keep partially used vials for future use.

Drug Interactions

To avoid inactivating vaccines containing live viruses or bacteria, give live vaccines 2 to 4 wk before or 3 to 11 mo after IGIV depending on dose.

Incompatibility

Do not mix IGIV with other medications.

Laboratory Test Interactions

Blood-group antibodies may be transferred to IGIV recipients, causing confusion regarding recipient"s blood type.

Adverse Reactions

Cardiovascular

Hypotension; cardiac arrest, thromboembolism, vascular collapse (postmarketing).

CNS

Asthenia; dizziness; headache; coma, loss of consciousness, seizures, tremor (postmarketing).

Dermatologic

Diaphoresis; ecchymosis; flushing; petechiae; pruritus; purpura; rash; urticaria; bullous dermatitis, epidermolysis, erythema multiforme, Stevens-Johnson Syndrome (postmarketing).

EENT

Ear pain; epistaxis; nasal congestion; rhinorrhea; sore throat.

GI

Abdominal pain; diarrhea; nausea; vomiting.

Genitourinary

Acute renal failure; acute tubular necrosis; osmotic nephrosis; proximal tubular nephropathy.

Hematologic-Lymphatic

Hemolysis; thrombocytopenia; leukopenia, pancytopenia, positive direct antiglobulin ( Coomb"s ) test (postmarketing).

Hepatic

Hepatic dysfunction (postmarketing).

Lab Tests

Increased BUN and creatinine.

Local

Injection site reaction.

Musculoskeletal

Arthralgia; back pain; leg cramps; neck pain; rigors (postmarketing).

Respiratory

Asthma; bronchitis, bronchospasm, increased cough; pharyngitis; rhinitis; sinusitis; upper respiratory tract infection; wheezing; acute respiratory distress syndrome, apnea, cyanosis, dyspnea, hypoxemia, pulmonary edema, transfusion-related acute lung injury (postmarketing).

Miscellaneous

Accidental injury; chills; fever; tightness in chest.

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Hypersensitivity

Hypersensitivity, including anaphylaxis, may occur.

Renal Function

Use with caution in patients with preexisting renal insufficiency and in patients judged to be at risk of developing renal insufficiency. Has been associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Ensure that IGIV is administered at the minimum concentration available and at the minimum rate of infusion practical in patient predisposed to acute renal failure. Ensure that renal function (BUN, SCr) is evaluated before starting therapy and periodically thereafter in patient determined to be at risk for acute renal failure. Monitor urine output during infusion of IGIV. Notify health care provider if renal function deteriorates and be prepared to discontinue therapy.

Aseptic meningitis

Aseptic meningitis syndrome (including severe headache, rigidity at nape of neck, drowsiness, fever, photophobia, painful eye movements, nausea, and vomiting) may occur.

Hemolysis

Positive direct antiglobulin reaction and hemolysis may occur. Monitor patient for signs and symptoms of hemolysis (eg, unexplained fatigue, jaundice, splenomegaly). Notify health care provider if suspected.

Infection transmission

Immune globulin IV is made from human plasma and may contain infectious agents, such as viruses, than can cause disease.

Thrombotic events

May occur.

Transfusion-related acute lung injury (TRALI)

Noncardiogenic pulmonary edema (TRALI) may occur. Monitor patient for adverse pulmonary reactions. If patient develops signs or symptoms of TRALI (eg, severe respiratory distress, pulmonary edema, hypoxemia, fever), notify health care provider immediately. Ensure that tests for antineutrophil antibodies in the IGIV and patient are performed and evaluated.

Patient Information

• Explain names, actions, and potential side effects of the treatment regimen. Review the treatment regimen, including duration of treatment and monitoring that will be required.
• Review benefits of therapy and risks, including potential to transmit disease and unknown infectious agents.
• Advise patient or caregiver that medication will be prepared and administered by a health care professional in a health care setting.
• Instruct patient to immediately report any of the following to health care provider: decreased urine output, sudden weight gain, fluid retention or swelling, unexplained shortness of breath, fever, severe headache, stiff neck, unexplained drowsiness or fatigue, painful eye movements, sensitivity to bright light, persistent or worsening nausea and vomiting.
• Advise women to notify health care provider if pregnant, planning to become pregnant, or are breastfeeding.
• Caution patient not to take any prescription or OTC medications, herbal preparations, or dietary supplements unless advised by health care provider.
• Advise patient that follow-up visits and laboratory tests will be required to monitor therapy and to keep appointments.