ZELVYSIA 500 mg/1

sapropterin dihydrochloride · POWDER, FOR SOLUTION · Aucta Pharmaceuticals, Inc.

No Recall History

Plain English

ZELVYSIA is a powder, for solution containing sapropterin dihydrochloride at 500 mg/1, taken oral. Manufactured by Aucta Pharmaceuticals, Inc..

Key Facts

Brand Name: ZELVYSIA
Generic Name: sapropterin dihydrochloride
NDC Code (Product): 73289-0071
Manufacturer: Aucta Pharmaceuticals, Inc.
Strength: 500 mg/1
Dosage Form: POWDER, FOR SOLUTION
Route: ORAL
Marketing Status
Application #: ANDA218645
Marketing Start: 04/29/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

product dose omission issue41 reports

diarrhoea24 reports

headache22 reports

drug ineffective20 reports

exposure during pregnancy18 reports

vomiting18 reports

amino acid level increased17 reports

abdominal discomfort15 reports

decreased appetite15 reports

nausea15 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Zelvysia is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Zelvysia is to be used in conjunction with a Phe-restricted diet. Zelvysia is a phenylalanine hydroxylase activator indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin‑ (BH4‑) responsive Phenylketonuria (PKU). Zelvysia is to be used in conjunction with a Phe‑restricted diet. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION All patients with PKU who are being treated with Zelvysia should also be treated with a Phe-restricted diet, including dietary protein and Phe restriction. ( 2.1 ) Starting Dosage Pediatric patients 1 month to 6 years: The recommended starting dosage of Zelvysia is 10 mg/kg administered orally once daily. ( 2.2 ) Patients 7 years and older : The recommended starting dosage of Zelvysia is 10 to 20 mg/kg administered orally once daily. ( 2.2 ) Dosage Adjustment Doses of Zelvysia may be adjusted in the range of 5 to 20 mg/kg taken once daily. ( 2.2 ) Monitor blood Phe regularly, especially in pediatric patients. ( 2.2 , 5.3 ) Preparation and Administration See the full prescribing information for preparation and administration instructions. ( 2.3 ) 2.1Recommendations Prior to Zelvysia Treatment Treatment with Zelvysia should be directed by physicians knowledgeable in the management of PKU. All patients with PKU who are being treated with Zelvysia should also be treated with a Phe-restricted diet, including dietary protein and Phe restriction. 2.2 Recommended Dosage and Administration The recommended starting dosage of Zelvysia is: Pediatric Patients 1 month…

Contraindications

4 CONTRAINDICATIONS None. None. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Table 4 includes drugs with clinically important drug interactions when administered with sapropterin dihydrochloride and instructions for preventing or managing them. Table 4: Clinically Relevant Drug Interactions Levodopa Clinical Impact Sapropterin dihydrochloride may increase the availability of tyrosine, a precursor of levodopa. Neurologic events were reported postmarketing in patients receiving sapropterin and levodopa concomitantly for a non-PKU indication [see Warnings and Precautions ( 5.5 )] . Intervention Monitor patients for a change in neurologic status. Inhibitors of Folate Synthesis (e.g., methotrexate, valproic acid, phenobarbital, trimethoprim) Clinical Impact In vitro and in vivo nonclinical data suggest that drugs that inhibit folate synthesis may decrease the bioavailability of endogenous BH4 by inhibiting the enzyme dihydrofolate reductase, which is involved in the recycling (regeneration) of BH4. This reduction in net BH4 levels may increase Phe levels. Intervention Consider monitoring blood Phe levels more frequently during concomitant administration. An increased dosage of sapropterin dihydrochloride may be necessary to achieve a biochemi…

Adverse Reactions

6 ADVERSE REACTIONS Most common adverse reactions (≥4%) are: headache, rhinorrhea, pharyngolaryngeal pain, diarrhea, vomiting, cough, and nasal congestion. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact contact Aucta Pharmaceuticals, Inc. at 1-800-655-9902 , or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. PKU Clinical Studies The safety of sapropterin dihydrochloride was evaluated in 7 clinical studies in patients with PKU (aged 1 month to 50 years) [see Clinical Studies ( 14 )] . In Studies 1-4 (controlled and uncontrolled studies), 579 patients with PKU aged 4 to 49 years received sapropterin dihydrochloride in doses ranging from 5 to 20 mg/kg per day for lengths of treatment ranging from 1 to 164 weeks. The patient population was evenly distributed in gender, and approximately 95% of patients were Caucasian. The most common adverse reactions (≥4% of patients) were h…

Frequently Asked Questions

What is ZELVYSIA used for?

ZELVYSIA contains sapropterin dihydrochloride. It is a powder, for solution taken oral. Consult your doctor for specific uses.

Is ZELVYSIA a controlled substance?

ZELVYSIA is not classified as a controlled substance by the DEA.

What is the generic name for ZELVYSIA?

The generic name for ZELVYSIA is sapropterin dihydrochloride. There are 11 other brand versions of sapropterin dihydrochloride.

What is the NDC code for ZELVYSIA 500 mg/1?

The NDC (National Drug Code) for ZELVYSIA 500 mg/1 is 73289-0071, listed by Aucta Pharmaceuticals, Inc..

Product NDC

73289-0071

Package NDC

73289-0071-2

Other Sapropterin Brands

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