Get ready to
start patients

Dosing information  

Resources & support  

SUPPLY INFORMATION  

Who may be right for ALYGLO™?

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

Recently
diagnosed
with PI

Consider ALYGLO for adult patients aged 17 and older.

SEEKING
A CLEAN IVIG
TREATMENT

Consider ALYGLO for patients who are seeking IVIG with reduced coagulation factor XIa (FXIa).

LOOKING FOR
GREATER 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

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

After the initial infusion, the maintenance infusion rate of ALYGLO can be every 15 minutes to reach the maximum rate in 30 minutes. This can help shorten the overall infusion time for your patients.1

Robust clinical and support services
are available with ALYGLO

For patients

  • Co-pay assistance is available to help eligible patients address out-of-pocket expenses for ALYGLO. When you prescribe ALYGLO, co-pay assistance helps patients avoid treatment delays of lengthy approval processes.a

For specialty
pharmacies

  • Medical benefits portal—quickly access co-pay assistance for patients with medical benefit coverage, streamline therapy initiation, and ensure uninterrupted treatment
  • Reimbursement support—we understand that benefits verification and prior authorization processes can be complex and time-consuming, so we offer dedicated help to navigate these essential steps effectively

For healthcare
providers

  • Clinical support and education for infusion nurses

For pharmacies,
providers, and
payers

  • Medical Affairs team available for clinical inquiries
  • Access to our medical experts in immunology

SUPPORT AND EDUCATION

Patient Brochure

download

ALYGLO Clinical
Study Publication

download

CEX Chromatography
Publication

download

ALYGLO supply information

ALYGLO is available through the following specialty pharmacies. Please contact your rep if you have any questions about accessing ALYGLO for your patients.

Accredo®

accredoivig.com
1-866-820-4844

Advanced Infusion Care

aiscaregroup.com
877-443-4006

AOM Infusion

aominfusionrx.com
800-746-9089

BioPlus Infusion

bioplusinfusion.com
1-800-829-3975

CSI Pharmacy

csipharmacy.com
833- 569-1005

KabaFusion

kabafusion.com
1-877-577-4844

NuFactor®

www.nufactor.com/
1-800-323-6832

Option Care Health®

optioncarehealth.com
1-877-974-4844

Optum Infusion Pharmacy

specialty.optumrx.com/
1-855-427-4682

Soleo Health®

www.soleohealth.com
1-866-765-3648

Vital Care® Infusion Services

vitalcare.com
1-601-482-7420

aClick here to see terms, conditions, and eligibility criteria.

Reference:

  1. ALYGLO Prescribing Information. GC Biopharma; 2023.
+
INDICATION

ALYGLO™ is indicated for the treatment of primary humoral immunodeficiency (PI) in adults aged 17 years and older. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency (CVID), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

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.

  • Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with the administration of IGIV products in predisposed patients.

  • 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 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).
  • 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.
  • It is recommended that ALYGLO be administered separately from other drugs or medications.

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