Carbaglu

Indicated For

NAGS deficiency, propionic acidemia, methylmalonic acidemia

About This Medication

# Recordati Rare Diseases CARBAGLU Patient Assistance Program Patient Guide: How to Get Carbaglu (carglumic acid) at Low or No Cost Carbaglu (carglumic acid) is a vital medication for treating hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency, and the **Recordati Rare Diseases CARBAGLU Patient Assistance Program** helps **uninsured or underinsured patients** access it for free if they qualify based on financial need.[1][2][8] ## About Carbaglu (carglumic acid) **Carbaglu** is an FDA-approved tablet for oral suspension that acts as a Carbamoyl Phosphate Synthetase 1 (CPS1) activator. It is used as adjunctive therapy for **acute hyperammonemia** in pediatric and adult patients with NAGS deficiency, often alongside ammonia-lowering therapies like hemodialysis, dietary protein restriction, or alternate pathway medications. For chronic management, it treats ongoing hyperammonemia due to the same condition.[8] NAGS deficiency is a rare urea cycle disorder where the body struggles to process ammonia, leading to dangerous buildup in the blood. Carbaglu helps by mimicking N-acetylglutamate, kickstarting the urea cycle to safely eliminate ammonia.[1][8] Dosing starts based on patient weight—typically 100-250 mg/kg/day divided into doses for acute episodes, adjusted by your doctor. Tablets must be suspended in water right before use. Always follow your healthcare provider's instructions, as this guide does not replace medical advice.[8] Recordati Rare Diseases, the manufacturer, commits to affordability through support programs administered by Accredo Specialty Pharmacy.[2][8] ## Who Qualifies for the Program? This **Patient Assistance Program (PAP)** targets **qualified uninsured and underinsured patients** facing financial hardship who cannot afford Carbaglu.[1][2][8] It's separate from the $0 copay program for commercially insured patients.[1][2] ### Income Eligibility Breakdown Specific income thresholds (e.g., Federal Poverty Level percentages) are **not publicly detailed**; eligibility is determined case-by-case based on proof of income and financial need.[2] Contact the program for personalized assessment. | Household Size | Income Threshold | Notes | |---------------|------------------|-------| | Individual | Not specified | Case-by-case review required | | Couple | Not specified | Proof of total household income needed | | Family of 3 | Not specified | Includes all dependents | | Family of 4 | Not specified | Specific FPL % not listed; call for details | **Key Tip**: Even if near thresholds, apply—exceptions may apply for rare disease patients.[3][9] ## Insurance Requirements The program is for **uninsured or underinsured patients**. 'Underinsured' means high copays, denials, or gaps leave you unable to afford treatment.[2] Commercially insured patients may qualify for the separate **$0 copay program** instead.[1][2] Medicare or government insurance often disqualifies PAP eligibility—check alternatives like Extra Help.[2][5] Benefits investigation helps confirm coverage first.[2][7] ## Step-by-Step Application Process 1. **Get a Prescription**: Ask your doctor for a Carbaglu prescription and discuss NAGS deficiency treatment. 2. **Gather Documents**: Prepare: - **Proof of income** (tax returns, pay stubs, W-2s for all household members) - **Proof of residency** (utility bill, lease) - **Prescription** (from your doctor) - **Insurance status** (denial letter or proof of no coverage) [Provided program details] 3. **Contact the Program**: Call **(888) 991-1330** (Anovo Specialty Pharmacy) or **1-888-454-8860** (Recordati Support). Multiple application methods available (phone, fax, online forms via Accredo).[2][4][5][8] 4. **Submit Application**: Your doctor may need to complete a referral form. Accredo handles prior authorizations if insured.[2][5] 5. **Wait for Approval**: Processing takes **2-4 weeks**.[Provided program details] **Pro Tip**: Start early—acute episodes may qualify for expedited hospital orders via Accredo (1-877-900-9223).[8] ## Timeline and Delivery - **Processing**: 2-4 weeks from complete submission.[Provided program details] - **Delivery**: Shipped free directly to your home via Accredo, with 24/7 support and overnight options.[2][7] - **Refills**: **Reauthorization required** periodically—your doctor resubmits proof.[Provided program details][7] Nurse educators provide adherence check-ins at no cost.[7] ## Alternatives if Denied or Ineligible - **Copay Program**: $0 copay for commercial insurance (call 888-454-8860).[1][4] - **R.A.R.E. Program**: Broader Recordati support for access, appeals, PA help (1-888-855-RARE).[7] - **NORD Assistance**: Free meds, copay help for rare diseases.[9] - **Eton Cares** (if applicable via generics): Similar PAP for uninsured.[5] - **State Programs**: Check Medicaid, specialty pharmacies, or foundations like Patient Access Network. Appeal denials with more financial details.[2] ## Disclaimer This guide is for informational purposes only and based on publicly available data as of 2026. Eligibility, terms, and contacts can change—**always verify directly with Recordati Rare Diseases at (888) 991-1330**.[1][2] Not medical advice; consult your doctor. Recordati Rare Diseases Inc. supports reporting side effects to 1-888-575-8344 or FDA at 1-800-FDA-1088.[8] Word count: 1028.

Program information last verified: March 30, 2026