JAVYGTOR 100 mg/1
Sapropterin Dihydrochloride · POWDER, FOR SOLUTION · Dr. Reddys Laboratories Inc
JAVYGTOR is a powder, for solution containing sapropterin dihydrochloride at 100 mg/1, taken oral. Manufactured by Dr. Reddys Laboratories Inc.
Key Facts
- Brand Name
- JAVYGTOR
- Generic Name
- Sapropterin Dihydrochloride
- NDC Code (Product)
43598-097- Manufacturer
- Dr. Reddys Laboratories Inc
- Strength
- 100 mg/1
- Dosage Form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA209452
- Marketing Start
- 09/16/2022
Recall History
Dr. Reddy's Laboratories, Inc.
Sub-potent Drug; powder discoloration associated with decreased potency
Dr. Reddy's Laboratories, Inc.
Failed Impurities/Degradation Specifications
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 JAVYGTOR (sapropterin dihydrochloride) 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). JAVYGTOR is to be used in conjunction with a Phe-restricted diet. JAVYGTOR (sapropterin dihydrochloride) 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). JAVYGTOR 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 JAVYGTOR (sapropterin dihydrochloride) 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 dose of JAVYGTOR is 10 mg/kg administered orally once daily. (2.2) Patients 7 years and older: The recommended starting dose of JAVYGTOR is 10 to 20 mg/kg administered orally once daily. (2.2) Dosa g e Adjustment Doses of JAVYGTOR powder for oral solution 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 JAVYGTOR Treatment Treatment with JAVYGTOR should be directed by physicians knowledgeable in the anagement of PKU. All patients with PKU who are being treated with JAVYGTOR should also be treated with a Phe-restricted diet, including dietary protein and Phe restriction. 2.2 Recommended Dosage and Administration The recommended starting dosag…
Contraindications
4 CONTRAINDICATIONS None. None (4).
Drug Interactions
7 DRUG INTERACTIONS Table 4 includes drugs with clinically important drug interactions when administered withsapropterin 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 post-marketing 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 biochemical …
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 Dr. Reddy’s Laboratories, Inc. at 1-888-375-3784 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 Studies1 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 heada…
Frequently Asked Questions
What is JAVYGTOR used for?
JAVYGTOR contains Sapropterin Dihydrochloride. It is a powder, for solution taken oral. Consult your doctor for specific uses.
Is JAVYGTOR a controlled substance?
JAVYGTOR is not classified as a controlled substance by the DEA.
What is the generic name for JAVYGTOR?
The generic name for JAVYGTOR is Sapropterin Dihydrochloride. There are 10 other brand versions of Sapropterin Dihydrochloride.
What is the NDC code for JAVYGTOR 100 mg/1?
The NDC (National Drug Code) for JAVYGTOR 100 mg/1 is 43598-097, listed by Dr. Reddys Laboratories Inc.
Other JAVYGTOR Dosages
Other Sapropterin Brands
See all →- ZELVYSIA500 mg/173289-0071
- SAPROPTERIN DIHYDROCHLORIDE500 mg/149884-873
- Sapropterin Dihydrochloride500 mg/152817-851
- Sapropterin dihydrochloride500 mg/131722-048
- Sapropterin Dihydrochloride500 mg/142571-510
- Sapropterin Dihydrochloride100 mg/159651-574
- Sapropterin dihydrochloride500 mg/172603-194
- Sapropterin dihydrochloride100 mg/131722-047
- Kuvan500 mg/168135-482
- 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)