POMBILITI ATGA 105 mg/1
cipaglucosidase alfa-atga · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · AMICUS THERAPEUTICS US, LLC
Pombiliti Atga (cipaglucosidase alfa-atga) is an intravenous injection used to treat Pompe disease, a rare genetic disorder that affects muscle function. It works by helping the body break down a type of sugar that accumulates in muscles and other tissues.
Key Facts
- Brand Name
- POMBILITI ATGA
- Generic Name
- cipaglucosidase alfa-atga
- NDC Code (Product)
71904-200- Manufacturer
- AMICUS THERAPEUTICS US, LLC
- Strength
- 105 mg/1
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- BLA761204
- Marketing Start
- 10/11/2023
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE POMBILITI is indicated, in combination with Opfolda, for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency) weighing ≥40 kg and who are not improving on their current enzyme replacement therapy (ERT). POMBILITI is a hydrolytic lysosomal glycogen-specific enzyme indicated, in combination with Opfolda, an enzyme stabilizer, for the treatment of adult patients with late-onset Pompe disease (lysosomal acid alpha-glucosidase [GAA] deficiency) weighing ≥40 kg and who are not improving on their current enzyme replacement therapy (ERT). ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Verify pregnancy status in females of reproductive potential prior to initiating treatment. ( 2.1 ) Administer POMBILITI in combination with Opfolda. ( 2.2 ) Consider administering antihistamines, antipyretics, and/or corticosteroids prior to POMBILITI administration. ( 2.2 ) Recommended POMBILITI dosage is 20 mg/kg (of actual body weight) administered every other week as an intravenous infusion over approximately 4 hours. ( 2.2 ) Start POMBILITI in combination with Opfolda 2 weeks after the last ERT dose. ( 2.2 ) Initiate the POMBILITI infusion approximately 1 hour after oral administration of Opfolda. If the POMBILITI infusion cannot be started within 3 hours of oral administration of Opfolda, reschedule POMBILITI in combination with Opfolda at least 24 hours after Opfolda was last taken. If POMBILITI in combination with Opfolda are both missed, re-start treatment as soon as possible. ( 2.2 ) See the full prescribing information for dosage modifications due to hypersensitivity reactions or IARs. ( 2.3 ) Must be reconstituted and diluted prior to use. ( 2.4 ) See the full prescribing information for administration instructions. ( 2.6 ) 2.1 Pregnancy Eva…
Contraindications
4 CONTRAINDICATIONS POMBILITI in combination with Opfolda is contraindicated in pregnancy [see Warnings and Precautions (5.4) and Use in Specific Populations (8.1) ]. Pregnancy ( 4 , 5.4 , 8.1 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions Including Anaphylaxis [see Warnings and Precautions (5.1) ] Infusion-Associated Reactions [see Warnings and Precautions (5.2) ] Most common adverse reactions ≥ 5% are headache, diarrhea, fatigue, nausea, abdominal pain and pyrexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amicus Therapeutics at 1-877-4AMICUS 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 rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions from the Pooled Clinical Trials Including Trial 1 The pooled safety analysis from 3 clinical trials included 151 adult patients with late-onset Pompe disease (LOPD) treated with POMBILITI in combination with Opfolda including: 85 patients in the randomized, double-blind, active-controlled trial in adults (Trial 1) [see Clinical Studies (14) ] , 37 patients in the open…
Frequently Asked Questions
What is POMBILITI ATGA used for?
Pombiliti Atga (cipaglucosidase alfa-atga) is an intravenous injection used to treat Pompe disease, a rare genetic disorder that affects muscle function. It works by helping the body break down a type of sugar that accumulates in muscles and other tissues.
Is POMBILITI ATGA a controlled substance?
POMBILITI ATGA is not classified as a controlled substance by the DEA.
What is the generic name for POMBILITI ATGA?
The generic name for POMBILITI ATGA is cipaglucosidase alfa-atga. There are no other listed brand versions of cipaglucosidase alfa-atga.
What is the NDC code for POMBILITI ATGA 105 mg/1?
The NDC (National Drug Code) for POMBILITI ATGA 105 mg/1 is 71904-200, listed by AMICUS THERAPEUTICS US, LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)