Sapropterin Dihydrochloride 500 mg Powder, For Solution, 30-count — NDC 52817-851-30 (Billing 52817-0851-30)
This is a package of 30 powders of Sapropterin Dihydrochloride 500 mg Powder, For Solution from TRUPHARMA, LLC, marketed since Jan 2026 and currently FDA-listed.
NDC database record
One package, one record: these facts belong to NDC 52817-851-30 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 52817 labeler · 851 product · 30 package
- Package marketed since
- Jan 30, 2026
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Billing quantity
- 30 EA per package
- Barcode (UPC-A, from the NDC)
- 3 5281785130 7
- FDA record last changed
- Jul 24, 2026
Other active recalls for Sapropterin Dihydrochloride (different manufacturers) — 2 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 074256
- GCN: 38845
- GPI-14 (Medi-Span): 30908565103040
- HICL (First Databank): 035266
- AHFS class code: 44:08.00.00
- RxCUI (RxNorm): 1111018
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Phenylalanine Hydroxylase Activator class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Sapropterin is used along with a restricted diet to control blood phenylalanine levels in adults and children 1 month of age and older who have phenylketonuria (PKU; an inborn condition in which phenylalanine may build up in the blood and causes decreased intelligence and a decreased ability to focus, remember, and organize information). Sapropterin will only work for some people who have PKU, and the only way to tell if sapropterin will help a particular patient is to give the medication for a period of time and see whether his or her phenylalanine level decreases. Sapropterin is in a class o...
Read the full MedlinePlus article ↗- Sapropterin gives your body more of a helper molecule called BH4 that the enzyme responsible for breaking down phenylalanine needs to work. If you have BH4-responsive PKU, this can...
- What exactly does sapropterin do, and why do I still have to follow a special diet?
- Your doctor will check your blood phenylalanine levels regularly after you start the medication. If the drug is working, your levels should start to drop within the first 24 hours,...
- How will I know if sapropterin is actually working for me?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Sapropterin Dihydrochloride — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $24.15 | — |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 52817-0851-01 52817-851-01 Main listing | 1 POWDER, FOR SOLUTION in 1 POUCH | 2026-01-30 | — | Active |
| 52817-0851-30 You're viewing this | 30 POWDER, FOR SOLUTION in 1 CARTON | 2026-01-30 | — | Active |
You're viewing the largest of 2 pack sizes for this product.
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Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Sapropterin dihydrochloride 500 mg 31722-0048-30 | Camber | 30 packets | — | AB | FDA listed | — |
| Sapropterin Dihydrochloride 500 mg 42571-0510-41 | Micro | 30 packets | — | AB | FDA listed | — |
| Javygtor 500 mg 43598-0162-30 | Dr. | 30 packets | — | AB | FDA listed | — |
| Sapropterin Dihydrochloride 500 mg 49884-0873-72 | Par | 30 packets | — | AB | FDA listed | — |
| Sapropterin Dihydrochloride 500 mgthis 52817-0851-30 | TRUPHARMA, | 30 powders | — | AB | FDA listed | — |
| Kuvan 500 mg 68135-0482-11 | BioMarin | 30 packets | — | AB | FDA listed | — |
| Sapropterin dihydrochloride 500 mg 72603-0194-30 | NorthStar | 30 packets | — | AB | FDA listed | — |
| Zelvysia 500 mg 73289-0071-02 | Aucta | 30 packets | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Sapropterin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII PQ6CK8PD0R
Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
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UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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UNII EE90ONI6FF
Potassium citrate is a salt derived from citric acid and potassium. In medicines, it acts as a buffer to adjust and maintain the pH balance of the product, helping keep it stable and palatable.
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UNII 96K6UQ3ZD4
Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
4 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
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Manufacturer & labeler
More NDCs from TRUPHARMA, LLC labeler code 52817
- Levocarnitine 1 g/10mL Solution NDC 52817-830-04
- Dapsone 50 mg/g Gel NDC 52817-831-60
- Dapsone 75 mg/g Gel NDC 52817-832-60
- Nitroglycerin 4 mg/g Ointment NDC 52817-835-30
- Sucralfate 1 g/10mL Suspension NDC 52817-840-16
- Sapropterin Dihydrochloride 100 mg Powder, For Solution NDC 52817-850-01
- Prednisolone 15 mg/5mL Solution NDC 52817-860-08
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Sapropterin dihydrochloride powder for oral solution 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). Sapropterin dihydrochloride powder for oral solution is to be used in conjunction with a Phe- restricted diet. Sapropterin dihydrochloride powder for oral solution 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).
Sapropterin dihydrochloride powder for oral solution is to be used in conjunction with a Phe-restricted diet. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION All patients with PKU who are being treated with sapropterin dihydrochloride powder for oral solution 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 powder for oral solution is 10 mg/kg administered orally once daily. ( 2.2 ) Patients 7 years and older : The recommended starting dose of sapropterin dihydrochloride powder for oral solution is 10 to 20 mg/kg administered orally once daily.
( 2.2 ) Dosage Adjustment Doses of sapropterin dihydrochloride 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)
2.1Recommendations Prior to Sapropterin Dihydrochloride Treatment Treatment with sapropterin dihydrochloride powder for oral solution should be directed by physicians knowledgeable in the management of PKU. All patients with PKU who are being treated with sapropterin dihydrochloride powder for oral solution should also be treated with a Phe- restricted diet, including dietary protein and Phe restriction.
2.2Recommended Dosage and Administration The recommended starting dosage of sapropterin dihydrochloride powder for oral solution is: Pediatric Patients 1 month to 6 years: 10 mg/kg (actual body weight) administered orally once daily. Patients 7 years and older: 10 to 20 mg/kg (actual body weight) administered orally once daily. Administer sapropterin dihydrochloride powder for oral solution with a meal, preferably at the same time each day [see Clinical Pharmacology (12.3 )].
A missed dose should be administered as soon as possible, but two doses should not be administered on the same day. Evaluation Period Existing dietary protein and Phe intake should not be modified during the evaluation period. If a 10 mg/kg per day starting dose is used, then response to therapy is determined by change in blood Phe following treatment with sapropterin dihydrochloride powder for oral solution at 10 mg/kg per day for a period of up to 1 month.
Blood Phe levels should be checked after 1 week of sapropterin dihydrochloride powder for oral solution treatment and periodically for up to a month. If blood Phe does not decrease from baseline at 10 mg/kg per day, the dose may be increased to 20 mg/kg per day. Patients whose blood Phe does not decrease after 1 month of treatment at 20 mg/kg per day do not show a biochemical response and treatment with sapropterin dihydrochloride powder for oral solution should be discontinued in these patients.
If a 20 mg/kg per day starting dose is used, then response to therapy is determined by change in blood Phe following treatment with sapropterin dihydrochloride powder for oral solution at 20 mg/kg per day for a period of 1 month. Blood Phe levels should be checked after 1 week of sapropterin dihydrochloride powder for oral solution treatment and periodically during the first month. Treatment should be discontinued in patients who do not show a biochemical response (blood Phe does not decrease) after 1 month of treatment at 20 mg/kg per day [see Warnings and Precautions ( 5.4 )].
Dosage Adjustment Once responsiveness to sapropterin dihydrochloride powder for oral solution has been established, the dosage may be adjusted within the range of 5 to 20 mg/kg per day according to biochemical response to therapy (blood Phe). Periodic blood Phe monitoring is recommended to assess blood Phe control, especially in pediatric patients [see Warnings and Precautions ( 5.3 )].
2.3Preparation and Administration Instructions Sapropterin dihydrochloride Powder for Oral Solution Patients weighing greater than 10 kg • Sapropterin dihydrochloride powder for oral solution should be dissolved… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Sapropterin dihydrochloride powder for oral solution is available as a unit dose packet containing 100 mg of sapropterin dihydrochloride and as a unit dose packet containing 500 mg of sapropterin dihydrochloride. The powder is off-white to pale yellow in color. Powder for Oral Solution: 100 mg and 500 mg sapropterin dihydrochloride. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions including anaphylaxis : Sapropterin dihydrochloride is not recommended in patients with a history of anaphylaxis to sapropterin dihydrochloride; discontinue treatment in patients who experience anaphylaxis and initate appropriate medical treatment. Continue dietary Phe restrictions. ( 5.1 ) Upper Gastrointestinal Mucosal Inflammation : Monitor patients for signs and symptoms of these conditions including esophagitis and gastritis.
( 5.2 ) Hypophenylalaninemia : Pediatric patients younger than 7 years treated with sapropterin dihydrochloride doses of 20 mg/kg per day are at increased risk for low levels of blood Phe compared with patients 7 years and older. ( 5.3 ) Monitoring Blood Phe Levels During Treatment : Ensure adequate blood Phe control and nutritional balance during treatment with sapropterin dihydrochloride. Frequent blood monitoring is recommended, especially in pediatric patients.
( 5.4 , 2.1 ) Lack of Biochemical Response to sapropterin dihydrochloride Treatment : Response to sapropterin dihydrochloride treatment cannot be pre-determined by laboratory (e.g., molecular) testing and can only be determined by a therapeutic trial of sapropterin dihydrochloride. ( 5.5 , 2.1 ) Interaction with Levodopa : Seizures, over-stimulation or irritability may occur; monitor patients for a change in neurologic status. ( 5.6 , 7 ) Hyperactivity : Monitor patients for hyperactivity.
( 5.7 )
5.1Hypersensitivity Reactions Including Anaphylaxis Sapropterin dihydrochloride is not recommended in patients with a history of anaphylaxis to sapropterin dihydrochloride. Hypersensitivity reactions, including anaphylaxis and rash, have occurred [see Adverse Reactions (6.2) ]. Signs of anaphylaxis include wheezing, dyspnea, coughing, hypotension, flushing, nausea, and rash.
Discontinue treatment with sapropterin dihydrochloride in patients who experience anaphylaxis and initiate appropriate medical treatment. Continue dietary protein and Phe restriction in patients who experience anaphylaxis.
5.2Upper Gastrointestinal Mucosal Inflammation Gastrointestinal (GI) adverse reactions suggestive of upper GI mucosal inflammation have been reported with sapropterin dihydrochloride. Serious adverse reactions included esophagitis and gastritis [see Adverse Reactions (6.2) ] . If left untreated, these could lead to severe sequelae including esophageal stricture, esophageal ulcer, gastric ulcer, and bleeding and such complications have been reported in patients receiving sapropterin dihydrochloride.
Monitor patients for signs and symptoms of upper GI mucosal inflammation.
5.3Hypophenylalaninemia In clinical trials of sapropterin dihydrochloride, some PKU patients experienced hypophenylalaninemia (low blood Phe) during treatment with sapropterin dihydrochloride. In a clinical study of pediatric patients younger than 7 years old treated with sapropterin dihydrochloride 20 mg/kg per day, the incidence of hypophenylalaninemia was higher than in clinical trials of older patients [see Adverse Reactions (6.1) ].
5.4Monitoring Blood Phe Levels During Treatment Prolonged elevations of blood Phe levels in patients with PKU can result in severe neurologic damage, including severe intellectual disability, developmental delay, microcephaly, delayed speech, seizures, and behavioral abnormalities. Conversely, prolonged levels of blood Phe that are too low have been associated with catabolism and endogenous protein breakdown, which has been associated with adverse developmental outcomes. Active management of dietary Phe intake while taking sapropterin dihydrochloride is required to ensure adequate Phe control and nutritional balance.
Monitor blood Phe levels during treatment to ensure adequate blood Phe level control. Frequent blood monitoring is recommended in the pediatric population [see Dosage and Administration (2.1) ] .
5.5Lack of Biochemical Response to Sapropterin Dihydrochloride Some patients with PKU do no… [Excerpted — this section continues on DailyMed.]
🤒 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 TruPharma at 1-877-541-5504 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical 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 headache, rhinorrhea, pharyngolaryngeal pain, diarrhea, vomiting, cough, and nasal congestion. The data described in Table 3 reflect exposure of 74 patients with PKU to sapropterin dihydrochloride at doses of 10 to 20 mg/kg per day for 6 to 10 weeks in two double-blind, placebo-controlled clinical trials (Studies 2 and 4).
Table 3 enumerates adverse reactions occurring in at least 4% of patients treated with sapropterin dihydrochloride in the double-blind, placebo-controlled clinical trials described above. Table 3: Summary of Adverse Reactions Occurring in ≥4% of Patients in Placebo-Controlled Clinical Studies with Sapropterin Dihydrochloride MedDRA Preferred Term Treatment Sapropterin Dihydrochloride (N=74) Placebo (N=59) No. Patients (%) No.
Patients (%) Headache 11 (15) 8 (14) Rhinorrhea 8 (11) 0 Pharyngolaryngeal pain 7(10) 1 (2) Diarrhea 6 (8) 3 (5) Vomiting 6 (8) 4 (7) Cough 5 (7) 3 (5) Nasal congestion 3 (4) 0 In open-label, uncontrolled clinical trials (Studies 1 and 3) all patients received sapropterin dihydrochloride in doses of 5 to 20 mg/kg per day, and adverse reactions were similar in type and frequency to those reported in the double-blind, placebo-controlled clinical trials [see Clinical Studies (14) ] . In Study 5, 65 pediatric patients with PKU aged 1 month to 6 years received sapropterin dihydrochloride 20 mg/kg per day for 6 months.
Adverse reactions in these patients were similar in frequency and type as those seen in other sapropterin dihydrochloride clinical trials except for an increased incidence of low Phe levels. Twenty-five percent (16 out of 65) of patients developed Phe levels below normal for age [see Warnings and Precautions (5.3) , Use In Specific Populations (8.4) , and Clinical Studies (14) ]. . In Study 6, a long term, open-label, extension study of 111 patients aged 4 to 50 years, receiving sapropterin dihydrochloride in doses ranging from 5 to 20 mg/kg per day, adverse reactions were similar in type and frequency to those reported in the previous clinical studies.
Fifty-five patients received sapropterin dihydrochloride both as dissolved and intact tablets. There were no notable differences in the incidence or severity of adverse reactions between the two methods of administration. The mean (± SD) exposure to sapropterin for the entire study population was 659 ± 221 days (maximum 953 days).
In Study 7, 27 pediatric patients with PKU aged 0 to 4 years received sapropterin dihydrochloride 10 mg/kg per day or 20 mg/kg per day. Adverse reactions were similar in type and frequency to those observed in other clinical trials, with the addition of rhinitis, which was reported in 2 subjects (7.4%). Safety Experience from Clinical Studies for Non-PKU Indications Approximately 800 healthy subjects and patients with disorders other than PKU, some of whom… [Excerpted — this section continues on DailyMed.]
🔄 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 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 response. Drugs Affecting Nitric Oxide-Mediated Vasorelaxation (e.g., PDE-5 inhibitors such as sildenafil, vardenafil, or tadalafil) Clinical Impact Both sapropterin dihydrochloride and PDE-5 inhibitors may induce vasorelaxation. A reduction in blood pressure could occur; however, the combined use of these medications has not been evaluated in humans.
Intervention Monitor blood pressure. Inhibitors of Folate Synthesis (e.g., methotrexate, valproic acid, phenobarbital, trimethoprim) : Can decrease endogenous BH4 levels; monitor blood Phe levels more frequently and adjust sapropterin dihydrochloride dosage as needed. ( 7 ) Drugs Affecting Nitric Oxide-Mediated Vasorelaxation (e.g., PDE-5 inhibitors) : Potential for vasorelaxation; monitor blood pressure.
( 7 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Available data from pregnancy safety studies, pharmacovigilance, and published case reports with sapropterin dihydrochloride use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). Uncontrolled blood phenylalanine concentrations before and during pregnancy are associated with an increased risk of adverse pregnancy outcomes and fetal adverse effects (see Clinical Considerations). . An embryo-fetal development study with sapropterin dihydrochloride in rats using oral doses up to 3 times the maximum recommended human dose (MRHD) given during the period of organogenesis showed no effects.
In a rabbit study using oral administration of sapropterin dihydrochloride during the period of organogenesis, a rare defect, holoprosencephaly, was noted at 10 times the MRHD. All pregnancies have a background risk of major birth defects, pregnancy loss, or other adverse pregnancy outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
The estimated background risk of major birth defects and miscarriage in pregnant women with PKU who maintain blood phenylalanine concentrations greater than 600 micromol/L during pregnancy is greater than the corresponding background risk for pregnant women without PKU. Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Uncontrolled blood phenylalanine concentrations before and during pregnancy are associated with an increased risk of adverse pregnancy outcomes and fetal adverse effects. To reduce the risk of hyperphenylalaninemia-induced fetal adverse effects, blood phenylalanine concentrations should be maintained between 120 and 360 micromol/L during pregnancy and during the 3 months before conception [see Dosage and Administration 2.2) ].
Data Human Data Uncontrolled Maternal PKU Available data from the Maternal Phenylketonuria Collaborative Study on 468 pregnancies and 331 live births in PKU-affected women demonstrated that uncontrolled Phe levels above 600 micromol/L are associated with a very high incidence of neurological, cardiac, facial dysmorphism, and growth anomalies. Control of blood phenylalanine during pregnancy is essential to reduce the incidence of Phe-induced teratogenic effects. Animal Data No effects on embryo-fetal development were observed in a reproduction study in rats using oral doses of up to 400 mg/kg per day sapropterin dihydrochloride (about 3 times the MRHD of 20 mg/kg per day, based on body surface area) administered during the period of organogenesis.
However, in a rabbit reproduction study, oral administration of a maximum dose of 600 mg/kg per day (about 10 times the MRHD, based on body surface area) during the period of organogenesis was associated with a non-statistically significant increase in the incidence of holoprosencephaly in two high dose-treated litters (4 fetuses), compared to one control-treated litter (1 fetus).
8.2Lactation Risk Summary There are insufficient data to assess the presence of sapropterin in human milk and no data on the effects on milk production. In postmarketing pregnancy registries, 13 infants were exposed to sapropterin dihydrochloride through breastfeeding. No lactation-related safety concerns were reported in infants of mothers nursing during maternal treatment with sapropterin dihydrochloride.
There are no data on the effects on milk production. Sapropterin is present in the milk of lactating rats following intravenous administration, but not following oral administration. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for sapropterin dihydrochloride and any potential adverse effects on the breastfed child from sapropterin dihydrochloride or from the underlying maternal co… [Excerpted — this section continues on DailyMed.]
🆘 Overdosage ▾
10 OVERDOSAGE Two unintentional overdosages with sapropterin dihydrochloride powder for oral solution have been reported. One adult patient in a sapropterin dihydrochloride clinical trial received a single sapropterin dihydrochloride dose of 4,500 mg (36 mg/kg) instead of 2,600 mg (20 mg/kg). The patient reported mild headache and mild dizziness immediately after taking the dose; both symptoms resolved within 1 hour with no treatment intervention.
There were no associated laboratory test abnormalities. The patient suspended therapy for 24 hours and then restarted sapropterin dihydrochloride with no reports of abnormal signs or symptoms. In postmarketing, one pediatric patient received sapropterin dihydrochloride doses of 45 mg/kg per day instead of 20 mg/kg per day.
The patient reported hyperactivity that began at an unspecified time after overdosage and resolved after the sapropterin dihydrochloride dose was reduced to 20 mg/kg per day. In a clinical study to evaluate the effects of sapropterin dihydrochloride on cardiac repolarization, a single supra- therapeutic dose of 100 mg/kg (5 times the maximum recommended dose) was administered to 54 healthy adults. No serious adverse reactions were reported during the study.
The only adverse reactions reported in more than 1 subject who received the supra-therapeutic dose were upper abdominal pain (6%) and dizziness (4%). A dose-dependent shortening of the QT interval was observed [see Clinical Pharmacology (12.2) ]. Patients should be advised to notify their physicians in cases of overdosage.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Sapropterin dihydrochloride is a synthetic form of BH4, the cofactor for the enzyme phenylalanine hydroxylase (PAH). PAH hydroxylates Phe through an oxidative reaction to form tyrosine. In patients with PKU, PAH activity is absent or deficient. Treatment with BH4 can activate residual PAH enzyme activity, improve the normal oxidative metabolism of Phe, and decrease Phe levels in some patients.
12.2Pharmacodynamics In PKU patients who are responsive to BH4 treatment, blood Phe levels decrease within 24 hours after a single administration of sapropterin dihydrochloride, although maximal effect on Phe level may take up to a month, depending on the patient. A single daily dose of sapropterin dihydrochloride is adequate to maintain stable blood Phe levels over a 24-hour period. Twelve patients with blood Phe levels ranging from 516 to 986 µmol/L (mean 747 ± 153 µmol/L) were assessed with 24-hour blood Phe level monitoring following a daily morning dose of 10 mg/kg per day.
The blood Phe level remained stable during a 24-hour observation period. No substantial increases in blood Phe levels were observed following food intake throughout the 24-hour period. Sapropterin dihydrochloride dose-response relationship was studied in an open-label, forced titration study at doses of 5 mg/kg per day, then 20 mg/kg per day, and then 10 mg/kg per day (Study 3) [see Clinical Studies (14.1) ] .
Individual blood Phe levels were highly variable among patients. The mean blood Phe level observed at the end of each 2-week dosing period decreased as the dose of sapropterin dihydrochloride increased, demonstrating an inverse relationship between the dose of sapropterin dihydrochloride and mean blood Phe levels. Cardiac Electrophysiology A thorough QTc study was performed in 56 healthy adults.
This randomized, placebo and active controlled crossover study was conducted to determine if a single supra-therapeutic (100 mg/kg) dose of sapropterin dihydrochloride or a single therapeutic dose (20 mg/kg) of sapropterin dihydrochloride had an effect on cardiac repolarization. In this study, sapropterin dihydrochloride was administered after dissolving tablets in water under fed condition. This study demonstrated a dose-dependent shortening of the QT interval.
The maximum placebo-subtracted mean change from baseline of the QTc interval was -3.69 and -8.32 ms (lower bound of 90% CI: -5.3 and -10.6 ms) at 20 and 100 mg/kg, respectively.
12.3Pharmacokinetics Studies in healthy subjects have shown comparable absorption of sapropterin when tablets are dissolved in water or orange juice and taken under fasted conditions. Administration of dissolved tablets after a high-fat/high-calorie meal resulted in mean increases in C max of 84% and AUC of 87% (dissolved in water). However, there was extensive variability in individual subject values for C max and AUC across the different modes of administration and meal conditions.
In the clinical trials of sapropterin dihydrochloride, drug was administered in the morning as a dissolved tablet without regard to meals. The mean elimination half-life in PKU patients was approximately 6.7 hours (range 3.9 to 17 hours), comparable with values seen in healthy subjects (range 3.0 to 5.3 hours). A study in healthy adults with 10 mg/kg of sapropterin dihydrochloride demonstrated that the absorption via intact tablet administration was 40% greater than via dissolved tablet administration under fasted conditions based on AUC 0-t .
The administration of intact tablets under fed conditions resulted in an approximately 43% increase in the extent of absorption compared to fasted conditions based on AUC 0-t [see Dosage and Administration (2.3) ] . Population pharmacokinetic analysis of sapropterin including patients from 1 month to 49 years of age showed that body weight is the only covariate substantially affecting clearance or distribution volume (see Table 5). Pharmacokinetics in patients >49… [Excerpted — this section continues on DailyMed.]
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Sapropterin Dihydrochloride Powder for Oral Solution Supplied as a off-white to pale yellow powder supplied in unit dose packets as follows: 100 mg sapropterin dihydrochloride per packet: NDC 52817-850-30 Carton of 30 unit dose packets NDC 52817-850-01 Single unit dose packet 500 mg sapropterin dihydrochloride per packet: NDC 52817-851-30 Carton of 30 unit dose packets NDC 52817-851-01 Single unit dose packet Storage Store Sapropterin dihydrochloride powder for oral solution at 20º to 25ºC (68º to 77ºF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Protect from moisture.
📋 Description ▾
11 DESCRIPTION Sapropterin dihydrochloride is an orally administered Phenylalanine Hydroxylase activator (or PAH activator). Sapropterin dihydrochloride, the active pharmaceutical ingredient in sapropterin dihydrochloride powder for oral solution, is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Sapropterin dihydrochloride is an off-white to pale yellow crystalline powder.
The chemical name of sapropterin dihydrochloride is (6R)-2-amino-6-[(1R,2S)-1,2- dihydroxypropyl]-5,6,7,8-tetrahydro-4(1H)-pteridinone dihydrochloride and the molecular formula is C 9 H 15 N 5 O 3 ·2HCl with a molecular weight of 314.17. Sapropterin dihydrochloride has the following structural formula: Sapropterin dihydrochloride is supplied as powder for oral solution containing 100 mg of sapropterin dihydrochloride (equivalent to 76.8 mg of sapropterin base). Sapropterin dihydrochloride is also supplied as powder for oral solution containing 500 mg of sapropterin dihydrochloride (equivalent to 384 mg of sapropterin base).
Sapropterin dihydrochloride powder for oral solution is off-white to pale yellow in color. Each unit dose packet contains the following inactive ingredients: ascorbic acid, mannitol, potassium citrate and sucralose. image description
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient or caregiver to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Hypersensitivity Reactions Including Anaphylaxis Advise patients and caregivers to discontinue sapropterin dihydrochloride powder for oral solution and contact the patient’s healthcare provider immediately if they experience symptoms of anaphylaxis, including (but not limited to) wheezing, dyspnea, coughing, hypotension, flushing, nausea, and rash. Continue nutritional management including dietary protein and Phe restriction [see Warnings and Precautions (5.1)].
Upper Gastrointestinal Mucosal Inflammation Advise patients and caregivers to contact their healthcare provider if the patient experiences signs and symptoms suggestive of upper GI mucosal inflammation, including nausea, vomiting, dysphagia, dyspepsia, loss of appetite; oropharyngeal, esophageal, or upper abdominal pain [see Warnings and Precautions (5.3)]. Hypophenylalaninemia Advise patients and caregivers that sapropterin dihydrochloride powder for oral solution may cause hypophenylalaninemia (low blood Phe levels), especially in pediatric patients younger than 7 years of age. [see Warnings and Precautions (5.3)] Monitoring of Blood Phe Levels Advise patients and caregivers that frequent blood Phe monitoring is important to ensure blood Phe levels are in the desirable range and that they should maintain dietary protein and Phe restriction while on sapropterin dihydrochloride powder for oral solution. [see Warnings and Precautions (5.4)] Prolonged hyperphenylalaninemia (high blood Phe levels) in patients with PKU can result in severe neurologic damage, including intellectual disability, developmental delay, microcephaly, delayed speech, seizures, and behavioral abnormalities. [see Warnings and Precautions (5.4)] Lack of Biochemical Response to Sapropterin Dihydrochloride Powder for Oral Solution Some patients do not show a biochemical response (blood Phe reduction) when treated with sapropterin dihydrochloride powder for oral solution.
Advise patients and caregivers to discontinue treatment with sapropterin dihydrochloride powder for oral solution if the patient does not show an adequate biochemical response in blood Phe after one month of treatment with sapropterin dihydrochloride powder for oral solution 20 mg/kg per day [see Dosage and Administration (2.2), Warnings and Precautions (5.4)]. Interaction with Levodopa Advise patients and caregivers that patients with underlying neurological disorders taking sapropterin dihydrochloride powder for oral solution in combination with levodopa may experience seizures, exacerbation of seizures, over- stimulation or irritability.
Inform patients and caregivers to contact their healthcare provider if the patient has a change in neurologic status during treatment with sapropterin dihydrochloride powder for oral solution [see Warnings and Precautions (5.5)]. Hyperactivity Advise patients and caregivers that sapropterin dihydrochloride powder for oral solution may cause hyperactivity and to contact their healthcare provider if the patient experiences hyperactivity, restlessness, fidgeting, or excessive talking [see Warnings and Precautions (5.6)].
Dosing and Monitoring [see Dosage and Administration (2.2)] Advise patients and caregivers of the following: •Sapropterin dihydrochloride powder for oral solution should be used in conjunction with a PKU-specific diet, including dietary protein and Phe restriction •Dietary protein and Phe intake should not be modified during the sapropterin dihydrochloride powder for oral solution evaluation period when assessing biochemical response. •The patient must be evaluated for changes in blood Phe after being treated with sapropterin dihydrochloride powder for oral solution at the recommended dose(s) for age to determine if they have a biochemical response and that blood Phe levels and dietary Phe intake should be assessed frequently during… [Excerpted — this section continues on DailyMed.]
🔬 Clinical Studies ▾
14 CLINICAL STUDIES The efficacy of sapropterin dihydrochloride was evaluated in five clinical studies in patients with PKU. Study 1 was a multicenter, open-label, uncontrolled clinical trial of 489 patients with PKU, ages 8 to 48 years (mean 22 years), who had baseline blood Phe levels ≥ 450 µmol/L and who were not on Phe-restricted diets. All patients received treatment with sapropterin dihydrochloride 10 mg/kg per day for 8 days.
For the purposes of this study, response to sapropterin dihydrochloride treatment was defined as a ≥ 30% decrease in blood Phe from baseline. At Day 8, 96 patients (20%) were identified as responders. Study 2 was a multicenter, double-blind, placebo-controlled study of 88 patients with PKU who responded to sapropterin dihydrochloride in Study 1.
After a washout period from Study 1, patients were randomized equally to either sapropterin dihydrochloride 10 mg/kg per day (N=41) or placebo (N=47) for 6 weeks. Efficacy was assessed by the mean change in blood Phe level from baseline to Week 6 in the sapropterin dihydrochloride-treated group as compared to the mean change in the placebo group. The results showed that at baseline, the mean (±SD) blood Phe level was 843 (±300) µmol/L in the sapropterin dihydrochloride-treated group and 888 (±323) µmol/L in the placebo group.
At Week 6, the sapropterin dihydrochloride treated group had a mean (±SD) blood Phe level of 607 (±377) µmol/L, and the placebo group had a mean blood Phe level of 891 (±348) µmol/L. At Week 6, the sapropterin dihydrochloride- and placebo treated groups had mean changes in blood Phe level of –239 and 6 µmol/L, respectively (mean percent changes of –29% (±32) and 3% (±33), respectively). The difference between the groups was statistically significant (p < 0.001) (Table 6).
Table 6: Blood Phe Results in Study 2 Sapropterin (N=41) Placebo (N=47) Baseline Blood Phe Level * (µmol/L) Mean (±SD) 843 (±300) 888 (±323) Percentiles (25 th , 75 th ) 620, 990 618, 1141 Week 6 Blood Phe Level (µmol/L) Mean (±SD) 607 (±377) 891 (±348) Percentiles (25 th , 75 th ) 307, 812 619, 1143 Mean Change in Blood Phe From Baseline to Week 6 (µmol/L) Adjusted Mean (±SE) † -239 (±38) 6 (±36) Percentiles (25 th , 75 th ) -397, -92 -96, 93 Mean Percent Change in Blood Phe From Baseline to Week 6 Mean (±SD) - 29 (±32) 3 (±33) Percentiles (25 th , 75 th ) -61, -11 -13, 12 * The mean baseline levels shown in this table represent the mean of 3 pretreatment levels (Wk -2, Wk -1, and Wk 0).
Treatment with sapropterin dihydrochloride or placebo started at Wk 0. † p-value < 0.001, adjusted mean and standard error from an ANCOVA model with change in blood Phe level from baseline to Week 6 as the response variable, and both treatment group and baseline blood Phe level as covariates. Change in blood Phe was noted in the sapropterin dihydrochloride-treated group at Week 1 and was sustained through Week 6 (Figure 2). Figure 2: Mean Blood Phenylalanine (Phe) Level Over Time* *Error bars indicate 95% confidence interval.
Study 3 was a multicenter, open-label, extension study in which 80 patients who responded to sapropterin dihydrochloride treatment in Study 1 and completed Study 2 underwent 6 weeks of forced dose-titration with 3 different doses of sapropterin dihydrochloride. Treatments consisted of 3 consecutive 2-week courses of sapropterin dihydrochloride at doses of 5, then 20, and then 10 mg/kg per day. Blood Phe level was monitored after 2 weeks of treatment at each dose level.
At baseline, mean (±SD) blood Phe was 844 (±398) µmol/L. At the end of treatment with 5, 10, and 20 mg/kg per day, mean (±SD) blood Phe levels were 744 (±384) µmol/L, 640 (±382) µmol/L, and 581 (±399) µmol/L, respectively (Table 7). Table 7: Blood Phe Results From Forced Dose-Titration in Study 3 Sapropterin dihydrochloride Dose Level (mg/kg per day) No. of Patients Mean ( ± SD) Blood Phe Level ( µ mol/L) Mean Changes ( ± SD) in Blood Phe Level From Week 0 ( µ mol/L) Baseline (No Treatment) 80 844… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility A 2-year carcinogenicity study was conducted in F-344 rats, and a 78-week carcinogenicity study was conducted in CD-1 mice. In the 104-week oral carcinogenicity study in rats, sapropterin dihydrochloride doses of 25, 80, and 250 mg/kg per day (0.2, 0.7, and 2 times the maximum recommended human dose of 20 mg/kg per day, respectively, based on body surface area) were used. In the 78-week oral carcinogenicity study in mice, sapropterin dihydrochloride doses of 25, 80, and 250 mg/kg per day (0.1, 0.3, and 2 times the recommended human dose, respectively, based on body surface area) were used.
In the 2-year rat carcinogenicity study, there was a statistically significant increase in the incidence of benign adrenal pheochromocytoma in male rats treated with the 250 mg/kg per day (about 2 times the maximum recommended human dose, based on body surface area) dose, as compared to vehicle treated rats. The mouse carcinogenicity study showed no evidence of a carcinogenic effect, but the study was not ideal due to its duration of 78 instead of 104 weeks. Sapropterin dihydrochloride was genotoxic in the in vitro Ames test at concentrations of 625 µg (TA98) and 5000 µg (TA100) per plate, without metabolic activation.
However, no genotoxicity was observed in the in vitro Ames test with metabolic activation. Sapropterin dihydrochloride was genotoxic in the in vitro chromosomal aberration assay in Chinese hamster lung cells at concentrations of 0.25 and 0.5 mM. Sapropterin dihydrochloride was not mutagenic in the in vivo micronucleus assay in mice at doses up to 2000 mg/kg per day (about 8 times the maximum recommended human dose of 20 mg/kg per day, based on body surface area).
Sapropterin dihydrochloride, at oral doses up to 400 mg/kg per day (about 3 times the maximum recommended human dose, based on body surface area) was found to have no effect on fertility and reproductive function of male and female rats.
📄 Patient Package Insert ▾
PATIENT INFORMATION Sapropterin Dihydrochloride Powder for Oral Solution (SAP-roe-TER-in dye-HYE-droe-KLOR-ide) What is sapropterin dihydrochloride powder for oral solution? Sapropterin dihydrochloride powder for oral solution is a prescription medicine used to lower blood levels of phenylalanine (Phe), in adults and children one month of age and older with a certain type of Phenylketonuria (PKU). Sapropterin dihydrochloride powder for oral solution is used along with a Phe-restricted diet.
What should I tell my doctor before taking sapropterin dihydrochloride powder for oral solution? Before you take sapropterin dihydrochloride powder for oral solution, tell your doctor about all your medical conditions, including if you: are allergic to sapropterin dihydrochloride or any of the ingredients in sapropterin dihydrochloride powder for oral solution. See the list of ingredients in sapropterin dihydrochloride powder for oral solution at the end of this leaflet. have poor nutrition or have loss of appetite. are pregnant or plan to become pregnant. are breastfeeding or plan to breastfeed.It is not known if sapropterin dihydrochloride powder for oral solution passes into your breast milk.
Talk to your doctor about the best way to feed your baby if you take sapropterin dihydrochloride powder for oral solution. Tell your doctor about all the medicines you take , including prescription and over-the-counter medicines, vitamins, herbal, and dietary supplements. sapropterin dihydrochloride powder for oral solution and other medicines may interact with each other. Especially tell your doctor if you take: a medicine that contains levodopa an antifolate medicine sildenafil (Revatio, Viagra), tadalafil (Adcirca, Cialis), vardenafil (Staxyn, Levitra) Tell your doctor if you are not sure if your medicine is one that is listed above.
Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. How should I take sapropterin dihydrochloride powder for oral solution?
Take sapropterin dihydrochloride powder for oral solution exactly as your doctor tells you. Your doctor should tell you how much sapropterin dihydrochloride powder for oral solution to take and when to take it. Your doctor may change your dose of sapropterin dihydrochloride powder for oral solution depending on how you respond to treatment.
Take sapropterin dihydrochloride powder for oral solution 1 time each day with a meal. It is best to take sapropterin dihydrochloride powder for oral solution at the same time each day. Sapropterin dihydrochloride powder for oral solution comes as a powder for oral solution.
Be sure that you know what dose of sapropterin dihydrochloride powder your doctor prescribed and whether you should use sapropterin dihydrochloride powder for oral solution 100 mg packets, sapropterin dihydrochloride powder for oral solution 500 mg packets, or both types of packets to prepare your dose. Open sapropterin dihydrochloride powder packets only when you are ready to use them. Sapropterin dihydrochloride powder for oral solution should be dissolved in water or apple juice.
You may also mix the powder for oral solution in a small amount of soft food, such as apple sauce or pudding before taking. See the detailed “Instructions for Use” that comes with sapropterin dihydrochloride powder for oral solution for information about the correct way to dissolve and take a dose of sapropterin dihydrochloride powder for oral solution. It is not possible to know if sapropterin dihydrochloride powder for oral solution will work for you until you start taking sapropterin dihydrochloride powder for oral solution.
Your doctor will check your blood Phe levels when you start taking sapropterin dihydrochloride powder for oral solution to see if the medicine is working. During treatment with sapropterin dihydrochloride powder for oral solution: Any change you make to your diet may affect your blood Phe level. Follow your doctor’s instructio… [Excerpted — this section continues on DailyMed.]
📖 Instructions for Use ▾
INSTRUCTIONS FOR USE Instructions for Use Sapropterin Dihydrochloride Powder for Oral Solution (SAP-roe-TER-in dye-HYE-droe-KLOR-ide) Read this Instructions for Use before you start taking sapropterin dihydrochloride powder for oral solution and each time you refill your prescription. There may be new information. This information does not take the place of talking with your healthcare provider about your treatment.
Talk to your doctor if you have any questions about the right dose of sapropterin dihydrochloride powder for oral solution to take or how to mix it. Important information: Sapropterin dihydrochloride powder for oral solution comes in a packet containing powder. Take sapropterin dihydrochloride powder for oral solution exactly as your doctor tells you.
Your doctor should tell you how much Sapropterin dihydrochloride powder for oral solution to take and when to take it. Your doctor may change your dose of sapropterin dihydrochloride powder for oral solution depending on how you respond to treatment, or based on your baby’s weight. If your baby weighs 22 pounds or less, follow the section called “ Instructions for giving sapropterin dihydrochloride powder for oral solution (Sapropterin dihydrochloride powder for oral solution 100 mg packets) to babies who weigh 22 pounds or less ”.
Take sapropterin dihydrochloride powder for oral solution 1 time each day with a meal. It is best to take sapropterin dihydrochloride powder for oral solution at the same time each day. Instructions for taking sapropterin dihydrochloride powder for oral solution: For babies who weigh 22 pounds or less, see the section below called “ Instructions for giving sapropterin dihydrochloride powder for oral solution(sapropterin dihydrochloride 100 mg packets) to babies who weigh 22 pounds or less.” Sapropterin dihydrochloride powder for oral solution should be dissolved in water or apple juice.
The powder for oral solution may also be mixed in a small amount of soft foods, such as apple sauce or pudding. To dissolve Sapropterin dihydrochloride powder for oral solution: Be sure that you know what dose of sapropterin dihydrochloride powder for oral solution your doctor has prescribed and whether you should use sapropterin dihydrochloride 100 mg packets, sapropterin dihydrochloride 500 mg packets, or both types of packets to prepare your dose. Open the packet(s) of sapropterin dihydrochloride powder for oral solution by folding and tearing, or cutting at the dotted line in the upper right corner of the packet.
Open the packet(s) only when you are ready to use them. Empty the contents of the packet(s) into 4 ounces to 8 ounces (1/2 cup to 1 cup) of water or apple juice. Drink within 30 minutes.
Instructions for giving Sapropterin dihydrochloride powder for oral solution (Sapropterin dihydrochloride 100 mg packets) to babies who weigh 22 pounds or less: The dose of sapropterin dihydrochloride powder for oral solution is based on body weight. This will change as your baby grows. Your doctor will tell you: the number of sapropterin dihydrochloride 100 mg packets needed for one dose the amount of water or apple juice needed to mix one dose of sapropterin dihydrochloride powder for oral solution the amount of the mixture (powder and water or apple juice) you will need to give your baby his or her prescribed dose of medicine.
Give your baby the prescribed amount of mixture (powder and water or apple juice) within 30 minutes after mixing. If you are not able to give your baby’s dose within 30 minutes after mixing, pour the unused medicine into the trash. You will need to mix a new dose.
Supplies needed to mix and give your baby’s dose of Sapropterin dihydrochloride powder for oral solution: the number of sapropterin dihydrochloride 100 mg packets needed for one dose a small cup of water or apple juice one 30 mL medicine cup for mixing small spoon or clean utensil for mixing 10 mL oral dosing syringe scissors (optional) Ask your pharmacist for a 30 mL medicine… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL Sapropterin Dihydrochloride Powder for Oral Solution 100 mg* - NDC 52817-850-30 - Carton - Label Sapropterin Dihydrochloride Powder for Oral Solution 100 mg* - NDC 52817-850-01 - Container - Label Sapropterin Dihydrochloride Powder for Oral Solution 500 mg* - NDC 52817-851-30 - Carton - Label Sapropterin Dihydrochloride Powder for Oral Solution 500 mg* - NDC 52817-851-01 - Container - Label image description image description image description image description
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