Sapropterin Dihydrochloride 100 mg/1
Sapropterin Dihydrochloride · TABLET · Aurobindo Pharma Limited
Sapropterin Dihydrochloride is a tablet containing sapropterin dihydrochloride at 100 mg/1, taken oral. Manufactured by Aurobindo Pharma Limited.
Key Facts
- Brand Name
- Sapropterin Dihydrochloride
- Generic Name
- Sapropterin Dihydrochloride
- NDC Code (Product)
59651-574- Manufacturer
- Aurobindo Pharma Limited
- Strength
- 100 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA216797
- Marketing Start
- 06/09/2025
Recall History
Dr. Reddy's Laboratories, Inc.
Sub-potent Drug; powder discoloration associated with decreased potency
Dr. Reddy's Laboratories, Inc.
Sub-potent Drug; powder discoloration associated with decreased potency
Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications
Dr. Reddy's Laboratories, Inc.
Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Sapropterin dihydrochloride tablets are 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). Sapropterin dihydrochloride tablets are to be used in conjunction with a Phe-restricted diet. Sapropterin dihydrochloride tablets are 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). Sapropterin dihydrochloride tablets are 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 sapropterin dihydrochloride tablets 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 sapropterin dihydrochloride tablets is 10 mg/kg administered orally once daily. ( 2.2 ) Patients 7 years and older : The recommended starting dosage of sapropterin dihydrochloride tablets is 10 to 20 mg/kg administered orally once daily. ( 2.2 ) Dosage Adjustment Doses of sapropterin dihydrochloride tablets 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 ) 2.1 Recommendations Prior to Sapropterin Dihydrochloride Tablets Treatment Treatment with sapropterin dihydrochloride tablets should be directed by physicians knowledgeable in the management of PKU. All patients with PKU who are being treated with sapropterin dihydrochloride tablets should also be treated …
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 biochemic…
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 Aurobindo Pharma USA, Inc. at 1-866-850-2876, 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 to 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 headache, …
Frequently Asked Questions
What is Sapropterin Dihydrochloride used for?
Sapropterin Dihydrochloride contains Sapropterin Dihydrochloride. It is a tablet taken oral. Consult your doctor for specific uses.
Is Sapropterin Dihydrochloride a controlled substance?
Sapropterin Dihydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Sapropterin Dihydrochloride?
The generic name for Sapropterin Dihydrochloride is Sapropterin Dihydrochloride. There are 9 other brand versions of Sapropterin Dihydrochloride.
What is the NDC code for Sapropterin Dihydrochloride 100 mg/1?
The NDC (National Drug Code) for Sapropterin Dihydrochloride 100 mg/1 is 59651-574, listed by Aurobindo Pharma Limited.
Other Sapropterin Dihydrochloride Dosages
Other Sapropterin Brands
See all →- ZELVYSIA500 mg/173289-0071
- SAPROPTERIN DIHYDROCHLORIDE500 mg/149884-873
- Sapropterin dihydrochloride500 mg/131722-048
- Sapropterin dihydrochloride500 mg/172603-194
- Sapropterin dihydrochloride100 mg/131722-047
- Kuvan500 mg/168135-482
- JAVYGTOR100 mg/143598-097
- JAVYGTOR500 mg/143598-162
- sapropterin dihydrochloride100 mg/149884-720
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)