Coverage authorization, billing, coding, reimbursement, and storage and handling of GAMUNEX-C
GAMUNEX-C is indicated for the treatment of CIDP in adults to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse.
This letter is required when the coverage authorization is denied by your patient's health plan.
The purpose of an LMN, if necessary, is to explain the prescribing HCP's rationale when choosing GAMUNEX-C.
A formulary exception is used if GAMUNEX-C is not included on a health plan's formulary.
Coding and reimbursement guidance
Health insurance reimbursement policies can be complex and confusing. Gamunex Connexions can help you by providing easy-to-understand information on coverage, coding, reimbursement, and claims submissions.
For technical support regarding the Copay Assistance Program, call 1-866-ADHERE2 (1-866-234-3732) (available 9 AM to 8 PM ET) or email firstname.lastname@example.org.
If you have any other questions regarding GAMUNEX-C or clinical information, contact a Grifols Sales Representative.
GAMUNEX-C packaging and storage
Convenient packaging and storage offered by GAMUNEX-C1
- Built-in hanger on 5, 10, 20, and 40 g vials
- Long 3-year shelf life at 2-8°C (36-46°F) from the date of manufacture
- Room temperature storage (not to exceed 25°C or 77°F) for up to 6 months at any time during 36-month shelf life
- 6 color-coded package sizes with barcode
- Vials available in 1, 2.5, 5, 10, 20, and 40 g
- Peel-off labels to simplify record keeping
Order it from GAMUNEX-C Customer Service:
Get it shipped to:
Home healthcare/specialty pharmacies
Specialty biological distributors
Directly to the physician or patient
Find an authorized distributor near you
3101 Gaylord Parkway
Frisco, TX 75034
9075 Centre Point Drive, #140
West Chester, OH 45069
2826 South Potter Drive
Tempe, AZ 85282
Cardinal Health SPD
305 Tech Park Drive, Ste 113
LaVergne, TN 37086
Caribe Rx Service, Inc.
PO Box 7514
Ponce, PR 00732
CuraScript Specialty Distribution
255 Technology Park
Lake Mary, FL 32703
1-877-599-7748, option 1
44000 Winchester Road
Temecula, CA 92591
Genesis Biopharma Services (Technomed)
465 Route 17
Ramsey, NJ 07446
8741 Landmark Road
Richmond, VA 23228
McKesson Plasma and Biologics
2615 Medical Center Parkway
Murfreesboro, TN 37129
McKesson Specialty Health
10101 Woodloch Forest Drive
Woodlands, TX 77380
200 Cumberland Bend
Nashville, TN 37228
2811 Horace Shepard Drive
Dothan, AL 36303
Prodigy Health Supplier Corp
9417 Brodie Lane
Austin, TX 78748
Important Safety Information
GAMUNEX®-C (immune globulin injection [human], 10% caprylate/chromatography purified) is indicated for the treatment of primary humoral immunodeficiency disease (PIDD) in patients 2 years of age and older, idiopathic thrombocytopenic purpura (ITP) in adults and children, and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults.
Thrombosis may occur with immune globulin products, including GAMUNEX-C. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors. For patients at risk of thrombosis, administer GAMUNEX-C 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.
Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IVIG) products in predisposed patients. Patients predisposed to renal dysfunction include those with any degree of preexisting 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 IVIG products containing sucrose. GAMUNEX-C does not contain sucrose. For patients at risk of renal dysfunction or failure, administer GAMUNEX-C at the minimum concentration available and the minimum infusion rate practicable.
GAMUNEX-C is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. It is contraindicated in IgA-deficient patients with antibodies against IgA and history of hypersensitivity.
Severe hypersensitivity reactions may occur with IVIG products, including GAMUNEX-C. In case of hypersensitivity, discontinue GAMUNEX-C infusion immediately and institute appropriate treatment.
Monitor renal function, including blood urea nitrogen (BUN), serum creatinine, and urine output in patients at risk of developing acute renal failure.
Hyperproteinemia, increased serum viscosity, and hyponatremia may occur in patients receiving IVIG treatment, including GAMUNEX-C.
There have been reports of aseptic meningitis, hemolytic anemia, and noncardiogenic pulmonary edema (transfusion-related acute lung injury [TRALI]) in patients administered with IVIG, including GAMUNEX-C.
The high-dose regimen (1g/kg x 1-2 days) is not recommended for individuals with expanded fluid volumes or where fluid volume may be a concern.
Because GAMUNEX-C 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.
Do not administer GAMUNEX-C subcutaneously in patients with ITP because of the risk of hematoma formation.
Periodic monitoring of renal function and urine output is particularly important in patients judged to be at increased risk of developing acute renal failure. Assess renal function, including measurement of BUN and serum creatinine, before the initial infusion of GAMUNEX-C and at appropriate intervals thereafter.
Consider baseline assessment of blood viscosity in patients at risk for hyperviscosity, including those with cryoglobulins, fasting chylomicronemia/markedly high triacylglycerols (triglycerides), or monoclonal gammopathies, because of the potentially increased risk of thrombosis.
If signs and/or symptoms of hemolysis are present after an infusion of GAMUNEX-C, perform appropriate laboratory testing for confirmation.
If TRALI is suspected, perform appropriate tests for the presence of antineutrophil antibodies and anti-HLA antibodies in both the product and patient's serum.
After infusion of IgG, the transitory rise of the various passively transferred antibodies in the patient's blood may yield positive serological testing results, with the potential for misleading interpretation.
In clinical studies, the most common adverse reactions with GAMUNEX-C were headache, pyrexia, hypertension, chills, rash, nausea, arthralgia, and asthenia (in CIDP); cough, rhinitis, pharyngitis, headache, asthma, nausea, fever, diarrhea, and sinusitis with intravenous use (in PIDD) and local infusion-site reactions, fatigue, headache, upper respiratory tract infection, arthralgia, diarrhea, nausea, sinusitis, bronchitis, depression, allergic dermatitis, migraine, myalgia, viral infection, and pyrexia with subcutaneous use (in PIDD); and headache, ecchymosis, vomiting, fever, nausea, rash, abdominal pain, back pain, and dyspepsia (in ITP).
The most serious adverse reactions in clinical studies were pulmonary embolism (PE) in 1 subject with a history of PE (in CIDP), an exacerbation of autoimmune pure red cell aplasia in 1 subject (in PIDD), and myocarditis in 1 subject that occurred 50 days post-study drug infusion and was not considered drug related (in ITP).
Please see accompanying full Prescribing Information for GAMUNEX-C.
Terms to know
IG, immune globulin; CIDP, chronic inflammatory demyelinating polyneuropathy; PIDD, primary immunodeficiency disease; ITP, idiopathic thrombocytopenic purpura; Sub Q, subcutaneous; IV, intravenous; ICE, 10% caprylate-chromatography purified immune globulin intravenous (IGIV-C) CIDP efficacy.
- GAMUNEX®-C (immune globulin injection [human], 10% caprylate/chromatography purified) Prescribing Information. Grifols.