Starting patients

Who may be right for ALYGLO?

Recently
diagnosed
with PI

Consider ALYGLO for adult patients aged 17 and older.

PI, primary immunodeficiency.

SEEKING An
extra-purified
IVIG TREATMENT

Consider ALYGLO for patients who are seeking intravenous immunoglobulin (IVIG) with undetectable levels of coagulation factor XI (FXIa).

LOOKING FOR
INFUSION SUPPORT

Consider ALYGLO for patients who are looking for IVIG treatment administered by a nurse at home or in an infusion clinic.

The ALYGLO experience: dosing and infusion¹

ALYGLO is infused every 3-4 weeks administered by a nurse in the patient’s home or at an infusion clinic.

Allow ALYGLO to reach room temperature prior to administration.

After the initial infusion, the maintenance infusion rate of ALYGLO can be doubled every 15 minutes to reach the maximum rate if well tolerated. This can help shorten the overall infusion time for your patients.

	1st infusion	Subsequent infusions
Dose	300-800 mg/kg every 21 or 28 days	300-800 mg/kg every 21 or 28 days
Initial infusion rate	1 mg/kg/min (0.01 mL/kg/min)	2 mg/kg/min (0.02 mL/kg/min)
Maintenance infusion rate	Double the infusion rate every 30 minutes up to 8 mg/kg/min (0.08 mL/kg/min)	Double the infusion rate every 15 minutes up to 8 mg/kg/min (0.08 mL/kg/min)

TIME TO MAXIMUM RATE

For more detailed clinical information on product administration, please contact 1-833-426-6426 or email medicalinfo@gcbiopharmausa.com

Packaging and storage

Available in 3 sizes

5, 10, and 20-gram recyclable vials

Storage instructions¹:

Keep ALYGLO in its original carton to protect it from light
Store ALYGLO in the refrigerator or at room temperature
Refrigeration: 2-8 °C (36-46 °F) for up to 36 months. Do not return to refrigeration after ALYGLO has been stored at room temperature
Room Temperature: 8-25 °C (46-77 °F) for up to 24 months
Do not freeze

Looking for billing and
coding information?

References:

INDICATION

ALYGLO® is indicated for the treatment of primary humoral immunodeficiency (PI) in adults aged 17 years and older.

IMPORTANT SAFETY INFORMATION

WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE

Thrombosis may occur with immune globulin intravenous (IGIV) products, including ALYGLO. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.
Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of IGIV products in predisposed patients. Patients predisposed to renal dysfunction include those with any degree of pre-existing renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients receiving known nephrotoxic drugs.
Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. ALYGLO does not contain sucrose.
For patients at risk of thrombosis, renal dysfunction or acute renal failure, administer ALYGLO at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

Contraindications: ALYGLO is contraindicated in patients who have a history of anaphylactic or severe systemic reaction to the administration of human immune globulin and in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity.
Hypersensitivity: In case of hypersensitivity, discontinue infusion immediately and institute appropriate treatment. Epinephrine should be available for immediate treatment of severe acute hypersensitivity reactions.
Hyperproteinemia, Increased Serum Viscosity, and Hyponatremia: Hyperproteinemia, increased serum viscosity, and hyponatremia may occur.
Aseptic Meningitis Syndrome (AMS): Aseptic meningitis syndrome (AMS) may occur, especially with high doses or rapid infusion. AMS usually begins within several hours to 2 days following ALYGLO treatment. Discontinuation of treatment has resulted in remission of AMS within several days without sequelae.
Hemolysis: Delayed hemolytic anemia due to enhanced red blood cell (RBC) sequestration and acute hemolysis consistent with intravascular hemolysis have been reported. Cases of severe hemolysis-related renal dysfunction/failure or disseminated intravascular coagulation have occurred following infusion of IGIV. Closely monitor patients for clinical signs and symptoms of hemolysis, particularly patients with risk factors.
Transfusion-Related Acute Lung Injury: Noncardiogenic pulmonary edema (transfusion-related acute lung injury [TRALI]) may occur. TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. Patients with TRALI may be managed using oxygen therapy with adequate ventilator support. Monitor patients for pulmonary adverse reactions.
Transmissible Infectious Agents: Because ALYGLO is made from human blood, it may carry a risk of transmitting infectious agents (eg, viruses, the variant Creutzfeldt-Jakob disease [vCJD] agent and, theoretically, the Creutzfeldt-Jakob disease [CJD] agent).
Monitoring Laboratory Tests: Assess blood urea nitrogen (BUN), serum creatinine, renal function, and urine output before and during ALYGLO treatment in patients at risk of acute renal failure. Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity. Evaluate suspected hemolysis with confirmatory laboratory testing, including baseline and 36–96 hours post-infusion hemoglobin and/or hematocrit in higher-risk patients. If TRALI is suspected, test the product and patient serum for anti-neutrophil antibodies.
Interference with Laboratory Tests: After infusion of immunoglobulin, the transitory rise of the various passively transferred antibodies in the patient’s blood may yield positive serological testing results, with the potential for a misleading interpretation.
Adverse Reactions (observed in ≥ 5% of study subjects) were headache, nausea/vomiting, fatigue, nasal/sinus congestion, rash, arthralgia, diarrhea, muscle pain/aches, infusion site pain/swelling, abdominal pain/discomfort, cough, and dizziness.
Drug Interactions: It is recommended that ALYGLO be administered separately from other drugs or medications. The passive transfer of antibodies with IGIV administration may interfere with the response to live virus vaccines.

For more information about ALYGLO, please see full Prescribing Information.

Get ready tostart patients

Who may be right for ALYGLO?

Recentlydiagnosedwith PI

SEEKING Anextra-purifiedIVIG TREATMENT

LOOKING FORINFUSION SUPPORT

The ALYGLO experience: dosing and infusion1