Effective October 1, 2026, VYKOURA from AVYXA Pharma will receive a permanent HCPCS code: J0644. This new code will replace VYKOURA's temporary HCPCS code, C9310, which will be discontinued effective the same date. VYKOURA was approved under the 505(b)(2) pathway and is therefore assigned its own HCPCS code. It should not be billed using the existing leucovorin calcium HCPCS code, J0640.

AVYXA Pharma requests your partnership in updating all systems and locations with the correct HCPCS and NDC information for J0644 to ensure accurate billing and reimbursement.

HCPCS Information

*The above 11-digit NDC codes for AVYXA's VYKOURA are used for claims processing and reimbursement. The 10-digit NDC codes are 83831-147-05, 83831-148-35, and 83831-149-50.

NDC Information

*The above 11-digit NDC codes for AVYXA's VYKOURA are used for claims processing and reimbursement. The 10-digit NDC codes are 83831-147-05, 83831-148-35, and 83831-149-50. Billing units are based on the J0644 descriptor of 1 mg per unit and reflect the full contents of one vial; report units based on the amount administered in accordance with payer policy.

INDICATIONS

VYKOURA^™ (leucovorin calcium) injection is indicated for:

Limitations of Use

VYKOURA is not indicated for pernicious anemia and megaloblastic anemia secondary to the lack of vitamin B₁₂, because of the risk of progression of neurologic manifestations despite hematologic remission.

IMPORTANT SAFETY INFORMATION

Contraindications

VYKOURA is contraindicated in patients who have had a severe hypersensitivity reaction to leucovorin (folinic acid), levoleucovorin, or folic acid. Reactions have included anaphylactic reactions.

Warnings and Precautions

Hypersensitivity

Hypersensitivity reactions, including anaphylactic reactions and urticaria, have been reported following the administration of leucovorin. VYKOURA is contraindicated in patients who have had a severe hypersensitivity reaction to leucovorin, levoleucovorin, or folic acid. Withhold or permanently discontinue VYKOURA based on the severity of hypersensitivity.

Hypercalcemia

Because of the calcium content of the VYKOURA, do not administer more than 160 mg of VYKOURA intravenously per minute.

Risk of Administration Errors

In the treatment of accidental overdosages of intrathecally administered folic acid antagonists, do not administer VYKOURA intrathecally. VYKOURA MAY BE HARMFUL OR FATAL IF GIVEN INTRATHECALLY.

Adverse Reactions

The most common adverse reactions (≥20%) in patients receiving high-dose methotrexate therapy with leucovorin rescue are stomatitis and vomiting.

The most common adverse reactions (>50%) in patients receiving leucovorin in combination with fluorouracil for metastatic colorectal cancer are stomatitis, diarrhea, and nausea.

Drug Interactions

Effects of Other Drugs on VYKOURA

Glucarpidase

Administer VYKOURA at least 2 hours before or 2 hours after the glucarpidase dose when administering concomitantly.

Glucarpidase can decrease leucovorin concentrations, which may decrease the effect of leucovorin rescue.

Effects of VYKOURA on Other Drugs

Certain Antiepileptic Drugs

Increase monitoring for seizure activity in patients taking certain concomitant antiepileptic drugs.

Folic acid in high doses may reduce the effectiveness of certain antiepileptic drugs (e.g., phenobarbital, phenytoin, and primidone) and thereby increase the frequency of seizures.

Trimethoprim-Sulfamethoxazole

Avoid concomitant use of VYKOURA with trimethoprim-sulfamethoxazole. The effectiveness of trimethoprim-sulfamethoxazole can be decreased if used concomitantly with VYKOURA which was associated with increased rates of treatment failure and mortality in patients with HIV infection who receive trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis jirovecii pneumonia.

Use in Specific Populations

Pregnancy

Agents administered in combination with VYKOURA may cause fetal harm. Refer to the Prescribing Information for agents administered in combination with VYKOURA for additional information.

Lactation

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for VYKOURA and any potential adverse effects on the breastfed infant from VYKOURA or from the underlying maternal condition.

Refer to the Prescribing Information for agents administered in combination with VYKOURA for breastfeeding recommendations.

Pediatric Use

VYKOURA is indicated to reduce the toxicity of MTX in pediatric patients with impaired MTX elimination, and folic acid antagonists or dihydrofolate reductase (DHFR) inhibitors following an overdose.

Geriatric Use

Clinical studies of leucovorin calcium did not show differences in safety or effectiveness between subjects over 65 and younger subjects. Other clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older patients cannot be ruled out. This drug is known to be excreted by the kidney and the risk of toxic reactions to the drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in this patient population.

Dosage and Administration Guidelines

Please see full Prescribing Information of VYKOURA.