AHFS Class:

80:04 Antitoxins and Immune Globulins

Immune globulin human products may be formulated for intravenous or subcutaneous infusion or for intramuscular injection; the product labeling must be consulted for details on the specific product, including instructions for preparation, administration, and storage.

Immune globulin human products for intravenous administration include: Bivigam (Biotest); Carimune NF (CSL Behring); Flebogamma DIF (5 or 10%, Grifols); Gammagard S/D (Baxter); Gammagard Liquid (Baxter); Gammaked (Grifols); Gammaplex (BPL); Gamunex-C (Grifols); Octagam (5 or 10%, Octapharma); and Privigen (CSL Behring).³⁰⁵³; ³⁰⁵⁴; ³⁰⁵⁵; ³⁰⁵⁶; ³⁰⁵⁸; ³⁰⁵⁹; ³⁰⁶⁰; ³⁰⁶¹; ³⁰⁶²; ³⁰⁶⁵; ³⁰⁶⁶; ³⁰⁶⁷

Immune globulin human products intended exclusively for subcutaneous infusion include: Cuvitru (Baxalta), Hizentra (CSL Behring) and HyQvia (Baxter).³⁰⁶³; ³⁰⁶⁴; ³²⁴⁰ In addition, several of the intravenous immune globulin human preparations also may be administered by subcutaneous infusion for certain indications; these products include Gammagard Liquid (Baxter); Gammaked (Grifols); and Gamunex-C (Grifols).³⁰⁵⁹; ³⁰⁶⁰; ³⁰⁶²

GamaSTAN S/D (Grifols) immune globulin human is labeled solely for administration by intramuscular injection.³⁰⁵⁷

Immune Globulin Human Products for Intravenous Administration Only

Immune globulin human intravenous is available from a number of manufacturers in both liquid and lyophilized powder forms that are prepared with varying manufacturing processes and excipients, resulting in different physicochemical properties for each formulation.³⁰⁷⁵ Protein concentrations of 5 and 10% are available in liquid forms.³⁰⁷⁵ Lyophilized preparation vial sizes vary by product, but typically contain between 3 and 12 g of protein.³⁰⁵⁴; ³⁰⁵⁸ Lyophilized preparations require reconstitution with the diluents and volumes specified by the manufacturers and typically result in protein concentrations of 3 to 12%.³⁰⁵⁴; ³⁰⁵⁸; ³⁰⁷⁵

Bivigam (Biotest) is available as a 10% solution in 50- and 100-mL single-use vials.³⁰⁵³ The drug also contains sodium chloride 0.1 to 0.14 M (approximately 5.8 to 8.2 mg/mL), glycine 0.2 to 0.29 M (approximately 15 to 21.8 mg/mL), and polysorbate 80 0.15 to 0.25% in water for injection.³⁰⁵³ The concentration of IgA present in the formulation does not exceed 200 mcg/mL.³⁰⁵³

Carimune NF (CSL Behring) is available as a lyophilized powder in single-use vials containing 3, 6, and 12 g of protein.³⁰⁵⁴ The drug should be reconstituted with sodium chloride 0.9%, dextrose 5%, or sterile water for injection in the amounts shown in Table 1.³⁰⁵⁴

Table 1. Reconstitution of Carimune NF³⁰⁵⁴

^a Container not large enough to permit concentration.

Vials of Carimune NF also contain sucrose 1.67 g and less than 20 mg of sodium chloride per gram of protein.³⁰⁵⁴ Trace amounts of IgA and IgM are present.³⁰⁵⁴

Flebogamma DIF (Grifols) is available as a 5% solution in 10-, 50-, 100-, 200-, and 400-mL single-use vials³⁰⁵⁵ and as a 10% solution in 50-, 100-, and 200-mL single-use vials.³⁰⁵⁶ Both strengths contain D-sorbitol 5 g in 100 mL of water for injection, trace amounts of sodium, and no greater than 3 or 6 mg/mL of polyethylene glycol in the 5 or 10% preparations, respectively.³⁰⁵⁵; ³⁰⁵⁶ The 5% solutions typically contain less than 50 mcg/mL of IgA,³⁰⁵⁵ and the 10% solutions typically contain less than 100 mcg/mL.³⁰⁵⁶ Both strengths contain trace amounts of IgM.³⁰⁵⁵; ³⁰⁵⁶

Gammagard S/D (Baxter) is available in a kit containing 5 or 10 g of lyophilized immune globulin human in a single-use bottle, a diluent bottle containing sterile water for injection, a transfer device, and an administration set with an integral airway and a 15-µm filter.³⁰⁵⁸ To produce the desired concentration, the powder must be reconstituted with an appropriate amount of the provided diluent.³⁰⁵⁸ Before the provided transfer device is attached to the diluent vial, however, the amounts of diluent shown in Table 2 must be removed from the vial depending on the target concentration; the amount remaining in the vial is then used to reconstitute the lyophilized immune globulin human using the transfer device.³⁰⁵⁸ The manufacturer’s prescribing information should be consulted for specific instructions.³⁰⁵⁸

Table 2. Reconstitution of Gammagard S/D³⁰⁵⁸

^a Do not remove any diluent from the diluent vial to prepare a 5% solution.

When Gammagard S/D is reconstituted as directed, each mL of the resulting 5% solution also contains sodium chloride 8.5 mg, albumin human 3 mg, glycine 22.5 mg, glucose 20 mg, polyethylene glycol 2 mg, tri-n-butyl phosphate (TNBP) 1 mcg, octoxynol 9 1 mcg, and polysorbate 80 100 mcg.³⁰⁵⁸ (A 10% solution contains twice the concentration of these excipients per mL contained in the 5% solution.³⁰⁵⁸) Less than 1 mcg/mL of IgA is present in the 5% solution and less than 2 mcg/mL is present in the 10% solution.³⁰⁵⁸ Trace amounts of IgM also are present.³⁰⁵⁸

Gammaplex (BPL) is available as a 5% solution in 50-, 100-, 200-, and 400-mL single-use bottles.³⁰⁶¹ The formulation also contains 5 g D-sorbitol in 100 mL of buffer solution, which contains glycine 0.6 g, sodium acetate 0.2 g, sodium chloride 0.3 g, and polysorbate 80 approximately 5 mg.³⁰⁶¹ IgA is present at a concentration of less than 10 mcg/mL.³⁰⁶¹

Octagam (Octapharma) 5 and 10% solutions are available in 20-, 50-, 100-, and 200-mL single-use bottles.³⁰⁶⁵; ³⁰⁶⁶ The 5% solution also is available in 500-mL single-use bottles.³⁰⁶⁵ To prevent coring, needles larger than 16 gauge should not be used with either strength of the drug.³⁰⁶⁵; ³⁰⁶⁶ Each mL of the 5% formulation also contains maltose 100 mg, octoxynol (TRITON X-100) no greater than 5 mcg, TNBP no greater than 1 mcg, and sodium no greater than 0.03 mmol in water for injection.³⁰⁶⁵ Each mL of the 10% formulation also contains maltose 90 mg and sodium no greater than 0.03 mmol.³⁰⁶⁶ No greater than 200 mcg/mL of IgA and 100 mcg/mL of IgM are present in the 5% solution.³⁰⁶⁵ In the 10% formulation, IgA is present at an average concentration of 106 mcg/mL with even lesser amounts of IgM.³⁰⁶⁶

Privigen (CSL Behring) is available as a 10% solution in 50-, 100-, 200-, and 400-mL single-use vials.³⁰⁶⁷ Each mL of the formulation also contains L-proline 0.25 mmol (range: 0.21 to 0.29 mmol) and trace amounts of sodium.³⁰⁶⁷ The concentration of IgA present in the formulation does not exceed 25 mcg/mL.³⁰⁶⁷

Immune Globulin Human Products for Intravenous or Subcutaneous Administration

Several immune globulin human preparations (e.g., Gammagard Liquid, Gammaked, and Gamunex-C) may be administered by intravenous or subcutaneous infusion depending on the specific indication.³⁰⁵⁹; ³⁰⁶⁰; ³⁰⁶²

Gammagard Liquid (Baxter) is available as a 10% solution in 10-, 25-, 50-, 100-, 200-, and 300-mL single-use bottles.³⁰⁵⁹ The formulation also contains glycine 0.25 M (approximately 18.8 mg/mL).³⁰⁵⁹ IgA is present at an average concentration of 37 mcg/mL; trace amounts of IgM are present.³⁰⁵⁹

Gammaked and Gamunex-C (both manufactured by Grifols) are available as 10% solutions in 10-, 25-, 50-, 100-, and 200-mL single-use vials.³⁰⁶⁰; ³⁰⁶² Gamunex-C also is available in 400-mL single-use vials.³⁰⁶² Only 18-gauge needles should be used to penetrate the stopper of Gammaked or Gamunex-C 10-mL vials; for vials containing 25 mL or more, 16-gauge needles or dispensing pins should be used.³⁰⁶⁰; ³⁰⁶² Both products also contain glycine 0.16 to 0.24 M (approximately 12 to 18 mg/mL) and residual caprylate concentrations no greater than 216 mg/mL (1.3 mmol/L).³⁰⁶⁰; ³⁰⁶² IgA is present at an average concentration of 46 mcg/mL; trace amounts of IgM also are present.³⁰⁶⁰; ³⁰⁶²

Immune Globulin Human Products for Subcutaneous Administration

Some immune globulin human products are intended only for administration by subcutaneous infusion.³⁰⁶³; ³⁰⁶⁴; ³²⁴⁰

Cuvitru (Baxalta) is available as a 20% solution in 5-, 10-, 20-, and 40-mL single-use vials for subcutaneous use only.³²⁴⁰ Each vial also contains glycine 0.25 M.³²⁴⁰ IgA is present at an average concentration of 80 mcg/mL.³²⁴⁰

Hizentra (CSL Behring) is available as a 20% solution in 5-, 10-, 20-, and 50-mL single-use vials for subcutaneous use only.³⁰⁶³ Each mL of the formulation also contains L-proline 0.25 mmol (range: 0.21 to 0.29 mmol), polysorbate 80 0.008 to 0.03 mg, and trace amounts of sodium.³⁰⁶³ The concentration of IgA present in the formulation does not exceed 50 mcg/mL.³⁰⁶³

HyQvia (Baxter) is available as a 10% solution in 25-, 50-, 100-, 200-, and 300-mL single-use vials; each vial is packaged with a vial containing recombinant human hyaluronidase 160 units/mL.³⁰⁶⁴ The 2 vials should not be mixed; they are intended for sequential subcutaneous use only.³⁰⁶⁴ The immune globulin human vial also contains glycine 0.25 M (approximately 18.8 mg/mL); IgA is present at an average concentration of less than 37 mcg/mL, and trace amounts of IgM also are present.³⁰⁶⁴ Each mL of the recombinant human hyaluronidase solution also contains sodium chloride 8.5 mg, sodium phosphate dibasic dihydrate 1.78 mg, human albumin 1 mg, edetate disodium dihydrate 1 mg, and calcium chloride dihydrate 0.4 mg; sodium hydroxide 0.17 mg has been added for pH adjustment.³⁰⁶⁴

Immune Globulin Human Products for Intramuscular Administration

GamaSTAN S/D (Grifols) is available as a 15 to 18% solution in 2- and 10-mL single-use vials for intramuscular use only.³⁰⁵⁷ The formulation also contains glycine 0.21 to 0.32 M (approximately 15.8 to 24 mg/mL).³⁰⁵⁷ IgA presence and/or concentration is not specified in the prescribing information.³⁰⁵⁷

Reconstitution of Lyophilized Immune Globulin Human

To reconstitute a lyophilized immune globulin human powder, the diluent specified by the manufacturer should be added and then the vial or bottle should be rotated or swirled to dissolve particles.³⁰⁵⁴; ³⁰⁵⁸ Foaming, which has been noted to be very slow to subside in some products,³⁰⁵⁴ results from shaking and should be avoided³⁰⁵⁴; ³⁰⁵⁸ because it may impede dissolution.¹⁴⁹⁹ In general, liquid and reconstituted immune globulin human products should not be shaken.³⁰⁵³; ³⁰⁵⁴; ³⁰⁵⁸; ³⁰⁵⁹; ³⁰⁶⁰; ³⁰⁶¹; ³⁰⁶²; ³⁰⁶³; ³⁰⁶⁴; ³⁰⁶⁷

Reconstitution of Sandoglobulin (no longer commercially available in the US) with dextrose 5% has resulted in extended dissolution times of 75 and 135 minutes for the 3 and 6% solutions, respectively. With sodium chloride 0.9%, dissolution occurs over a few minutes; exceptional cases take up to 20 minutes.¹⁴⁹⁸

pH

Bivigam: From 4 to 4.6.³⁰⁵³

Carimune NF: From 6.4 to 6.8.³⁰⁵⁴

Cuvitru: From 4.6 to 5.1.³²⁴⁰

Flebogamma DIF: From 5 to 6.³⁰⁵⁵; ³⁰⁵⁶

GamaSTAN: From 6.4 to 7.2.³⁰⁵⁷

Gammagard Liquid: From 4.6 to 5.1.³⁰⁵⁹

Gammagard S/D: From 6.4 to 7.2.³⁰⁵⁸

Gammaked: From 4 to 4.5.³⁰⁶⁰

Gammaplex: From 4.8 to 5.1.³⁰⁶¹

Gamunex-C: From 4 to 4.5.³⁰⁶²

Hizentra: From 4.6 to 5.2.³⁰⁶³

HyQvia: From 4.6 to 5.1.³⁰⁶⁴

Octagam 5%: From 5.1 to 6;³⁰⁶⁵ Octagam 10%: From 4.5 to 5.³⁰⁶⁶

Privigen: From 4.6 to 5.³⁰⁶⁷

Osmolality

Carimune NF: Following reconstitution of the Carimune NF formulation of immune globulin human to targeted concentrations of 3, 6, 9, or 12%, the calculated osmolality of the solution varied with the diluent used.³⁰⁵⁴ (See Table 3.)

Table 3. Calculated Osmolality of Reconstituted Carimune NF (CSL Behring)³⁰⁵⁴

Cuvitru: 280 to 292 mOsm/kg.³²⁴⁰

Flebogamma DIF 5 and 10%: 240 to 370 mOsm/kg.³⁰⁵⁵; ³⁰⁵⁶

Gammagard Liquid: 240 to 300 mOsm/kg.³⁰⁵⁹

Gammaked: 258 mOsm/kg.³⁰⁶⁰

Gammaplex: Typically 420 to 500 mOsm/kg.³⁰⁶¹ Not less than 240 mOsm/kg.³⁰⁶¹

Gamunex-C: 258 mOsm/kg.³⁰⁶²

HyQvia: 240 to 300 mOsm/kg.³⁰⁶⁴

Octagam 5 and 10%: 310 to 380 mOsm/kg.³⁰⁶⁵; ³⁰⁶⁶

Privigen: Approximately 320 mOsm/kg (range: 240 to 440 mOsm/kg).³⁰⁶⁷

Trade Name(s)

Bivigam, Carimune NF, Cuvitru, Flebogamma DIF, GamaSTAN S/D, Gammagard Liquid, Gammagard S/D, Gammaked, Gammaplex, Gamunex-C, Hizentra, HyQvia, Octagam, Privigen

Immune globulin human may be administered by intravenous infusion,³⁰⁵³; ³⁰⁵⁴; ³⁰⁵⁵; ³⁰⁵⁶; ³⁰⁵⁸; ³⁰⁵⁹; ³⁰⁶⁰; ³⁰⁶¹; ³⁰⁶²; ³⁰⁶⁵; ³⁰⁶⁶; ³⁰⁶⁷ subcutaneous infusion using an infusion pump,³⁰⁵⁹; ³⁰⁶⁰; ³⁰⁶²; ³⁰⁶³; ³⁰⁶⁴ or intramuscular injection.³⁰⁵⁷ The route of administration and, where applicable, the rate of infusion depend upon the product selected, the indication for the drug, and patient-specific risk factors.³⁰⁵³; ³⁰⁵⁴; ³⁰⁵⁵; ³⁰⁵⁶; ³⁰⁵⁷; ³⁰⁵⁸; ³⁰⁵⁹; ³⁰⁶⁰; ³⁰⁶¹; ³⁰⁶²; ³⁰⁶³; ³⁰⁶⁴; ³⁰⁶⁵; ³⁰⁶⁶; ³⁰⁶⁷

For intravenous infusion, a slow initial infusion rate is usually maintained for 10 to 30 minutes prior to gradually (e.g., every 15 to 30 minutes) increasing the rate according to patient tolerance and the product-specific maximum rate.³⁰⁵³; ³⁰⁵⁴; ³⁰⁵⁵; ³⁰⁵⁶; ³⁰⁵⁹; ³⁰⁶⁰; ³⁰⁶¹; ³⁰⁶²; ³⁰⁶⁵; ³⁰⁶⁶; ³⁰⁶⁷

For subcutaneous infusion, initial infusion rates range from 5 to 20 mL/hour per site, with product-specific maximum rates and number of infusion sites.³⁰⁵⁹; ³⁰⁶⁰; ³⁰⁶²; ³⁰⁶³; ³⁰⁶⁴; ³²⁴⁰ For subcutaneous infusion of HyQvia, a 24-gauge subcutaneous needle set that is labeled for high flow rates should be used.³⁰⁶⁴

GamaSTAN S/D is administered only by intramuscular injection; the drug should not be administered subcutaneously or intravenously.³⁰⁵⁷

Recommended storage conditions vary among the different immune globulin human products.³⁰⁷⁵; ³⁰⁷⁶ Typically, intact immune globulin human products are stored either at room temperature, under refrigeration, or some combination of both and have a shelf life of about 24³⁰⁵⁵; ³⁰⁵⁶; ³⁰⁵⁸; ³⁰⁵⁹; ³⁰⁶¹; ³⁰⁶⁵; ³⁰⁶⁶ to 36 months³⁰⁵⁹; ³⁰⁶⁰; ³⁰⁶²; ³⁰⁶⁷; ³²⁴⁰ from the date of manufacture.³⁰⁷⁵; ³⁰⁷⁶ Immune globulin human products should not be frozen.³⁰⁵³; ³⁰⁵⁴; ³⁰⁵⁵; ³⁰⁵⁶; ³⁰⁵⁷; ³⁰⁵⁸; ³⁰⁵⁹; ³⁰⁶⁰; ³⁰⁶¹; ³⁰⁶²; ³⁰⁶³; ³⁰⁶⁴; ³⁰⁶⁵; ³⁰⁶⁶; ³⁰⁶⁷; ³²⁴⁰ Manufacturers of certain products state that the drug should be kept in the carton to protect from light.³⁰⁵⁵; ³⁰⁵⁶; ³⁰⁵⁹; ³⁰⁶¹; ³⁰⁶³; ³⁰⁶⁴; ³⁰⁶⁷; ³²⁴⁰ Specific product labeling should be consulted for all storage requirements.

In general, liquid and reconstituted immune globulin human products should not be shaken.³⁰⁵³; ³⁰⁵⁴; ³⁰⁵⁸; ³⁰⁵⁹; ³⁰⁶⁰; ³⁰⁶¹; ³⁰⁶²; ³⁰⁶³; ³⁰⁶⁴; ³⁰⁶⁷; ³²⁴⁰

Containers of immune globulin human are for single use only; partially used containers should be discarded.³⁰⁵³; ³⁰⁵⁴; ³⁰⁵⁵; ³⁰⁵⁶; ³⁰⁵⁷; ³⁰⁵⁸; ³⁰⁵⁹; ³⁰⁶⁰; ³⁰⁶¹; ³⁰⁶²; ³⁰⁶³; ³⁰⁶⁴; ³⁰⁶⁵; ³⁰⁶⁶; ³⁰⁶⁷; ³²⁴⁰

Most immune globulin human solutions are colorless to pale yellow in appearance.³⁰⁵³; ³⁰⁵⁵; ³⁰⁵⁶; ³⁰⁵⁸; ³⁰⁵⁹; ³⁰⁶⁰; ³⁰⁶¹; ³⁰⁶²; ³⁰⁶⁴; ³⁰⁶⁷; ³²⁴⁰ Oxidative reactions may be a cause of yellowish discoloration of intravenous immune globulin human solutions.³⁰⁷⁶

Two immune globulin human products (Gammagard S/D, Baxter and Polygam S/D [no longer commercially available in the US], American Red Cross) for intravenous use were reconstituted with sterile water for injection to concentrations of 50 mg/mL (5%) and 100 mg/mL (10%). Stability of the reconstituted product was evaluated in the original glass vials and also after transfer to PVC bags at 4°C for 48 hours and at 25°C for 12 hours. The visual appearance of the solutions remained acceptable, extremely low amounts of diethylhexyl phthalate (DEHP) plasticizer were leached from the PVC bags, and all tests for protein content and antibody activity indicated that stability was maintained throughout the study under both storage conditions.²⁴³⁵

pH Effects

One study evaluated multiple substances (e.g., sugars, polyalcohols, amino acids) for their ability to stabilize dissolved immune globulin G (IgG) molecules to prevent aggregation, dimerization, and fragmentation across a range of pH conditions when stored at 37°C for 90 days.³⁰⁷⁶ The lowest percentage of aggregates was observed at weakly acidic conditions (pH 5.3) and the highest percentage of aggregates was observed at the lowest pH tested (i.e., 4.8 for L-lysine and L-ornithine; 4.1 for all other stabilizers tested).³⁰⁷⁶ L-Proline, sucrose, and maltose showed good stabilizing effects over the entire pH range tested (4.1 to 6.8); glycine was less effective over this range, and L-lysine and L-ornithine were only marginally stabilizing at pH 6.8.³⁰⁷⁶

In terms of dimerization, L-proline was the most effective stabilizer tested, decreasing the percentage of dimers over the entire pH range tested.³⁰⁷⁶ Sucrose also was effective over the entire pH range tested; however, its effects were less robust than those of L-proline.³⁰⁷⁶ Glycine, L-lysine, and L-ornithine had negligible effects on dimerization, with glycine being the least effective.³⁰⁷⁶ Mannitol and maltose actually increased dimer formation as compared with control solutions of immune globulin not containing a stabilizer.³⁰⁷⁶

The greatest amounts of fragmentation occurred at the lowest pH tested (i.e., 4.1).³⁰⁷⁶ No substantial differences in fragmentation were observed among solutions containing L-proline, glycine, or no stabilizer except at a neutral pH of 6.8, where the formulation without stabilizer contained slightly more fragments.³⁰⁷⁶ These results suggest that glycine and L-proline have a small inhibitory effect on neutral proteases (e.g., serine proteases).³⁰⁷⁶

Sorption

A stability evaluation of immune globulin human for intravenous use in PVC bags found no loss of activity due to sorption when compared to glass containers.²⁴³⁵

Filtration

For details on filtration of immune globulin human products, the product labeling should be consulted; some manufacturers do not make specific recommendations.

Carimune NF (CSL Behring) may be filtered, but filtration is not required.³⁰⁵⁴ Filters with pore sizes of 15 µm or larger will be less likely to slow the infusion, especially at higher concentrations.³⁰⁵⁴ Antibacterial filters (i.e., 0.2-µm filters) may be used.³⁰⁵⁴

Use of an inline filter with Gammagard Liquid (Baxter) is optional.³⁰⁵⁹

The administration set provided with Gammagard S/D (Baxter) contains an integral airway and a 15-µm filter.³⁰⁵⁸ If an alternative administration set is used to administer the drug, an administration set containing a similar filter should be used.³⁰⁵⁸

Inline filtration is not required with Octagam (Octapharma); however, if a filter is used, the pore size should be 0.2 to 200 µm.³⁰⁶⁵; ³⁰⁶⁶

Plasticizer Leaching

Storage of reconstituted immune globulin human for intravenous use in PVC containers for 48 hours at 4°C and 12 hours at 25°C resulted in very low amounts of leached DEHP plasticizer from undetectable amounts up to a maximum of 86 ng/mL.²⁴³⁵

Solution Compatibility

Additive Compatibility

Y-Site Injection Compatibility (1:1 Mixture)

Additional Compatibility Information

Immune globulin human products are manufactured using differing processes and exhibit differing compatibility and stability characteristics.³⁰⁷⁵ All manufacturers recommend using a separate infusion line for administration and not mixing other drugs with immune globulin human.³⁰⁵³; ³⁰⁵⁴; ³⁰⁵⁵; ³⁰⁵⁶; ³⁰⁵⁸; ³⁰⁵⁹; ³⁰⁶⁰; ³⁰⁶¹; ³⁰⁶²; ³⁰⁶³; ³⁰⁶⁴; ³⁰⁶⁵; ³⁰⁶⁶; ³⁰⁶⁷; ³²⁴⁰ Pooling of vials of the same product and strength (and where applicable, the same diluent used for reconstitution) into sterile empty infusion containers is acceptable to facilitate the administration of large doses; however, storage requirements and the maximum duration of time allowed from the time of pooling to infusion vary among products.³⁰⁵³; ³⁰⁵⁴; ³⁰⁵⁵; ³⁰⁵⁶; ³⁰⁵⁸; ³⁰⁵⁹; ³⁰⁶⁰; ³⁰⁶¹; ³⁰⁶²; ³⁰⁶⁴; ³⁰⁶⁵; ³⁰⁶⁶; ³⁰⁶⁷ Specific product labeling should be consulted. Different formulations of immune globulin human from the same or different manufacturers should not be mixed.³⁰⁵³; ³⁰⁵⁴; ³⁰⁵⁵; ³⁰⁵⁶; ³⁰⁵⁸; ³⁰⁵⁹; ³⁰⁶⁰; ³⁰⁶¹; ³⁰⁶²; ³⁰⁶³; ³⁰⁶⁴; ³⁰⁶⁵; ³⁰⁶⁶; ³⁰⁶⁷ The manufacturers make the recommendations cited in Table 4 regarding compatibility with infusion solutions.

Table 4. Immune Globulin Human Products: Compatibility with Infusion Solutions

Heparin Locks

The manufacturer of Gammaked and Gamunex-C immune globulin human products (Grifols) specifically states that heparin locks through which either drug has been administered should be flushed only with dextrose 5% or sodium chloride 0.9%; heparin should not be used to flush the lock.³⁰⁶⁰; ³⁰⁶²

For a list of references cited in the text of this monograph, search the monograph titled References.

ASHP^® Injectable Drug Information^TM. Selected Revisions April 16, 2018. © Copyright, 2024. American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.