Cipaglucosidase Alfa-Atga: uses, dosing, side effects & brands
Cipaglucosidase Alfa-Atga is a medicine sold in the U.S. under one brand, for glycogen storage disease type ii. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Glycogen Storage Disease Type II
- Available as
- Injectable
- Sold as
- Pombiliti
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How cipaglucosidase alfa-atga is dosed
From the FDA label for Pombiliti (application BLA761204). Other cipaglucosidase alfa-atga products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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 ) POMBILITI is administered every two weeks as an intravenous infusion based on the patient’s weight ( 2.2 ): 20 mg/kg for patients weighing ≥40 kg 30 mg/kg for patients weighing ≥10 kg to <40 kg In ERT‑experienced patients, start POMBILITI in combination with Opfolda 2 weeks after the last ERT dose. . For ERT‑naïve pediatric patients, treatment may be initiated immediately. ( 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 Evaluation Prior to Initiating Treatment Verify the pregnancy status of females of…
Cipaglucosidase Alfa-Atga side effects
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-label extension trial where patients switched from a non‑U.S.‑approved alglucosidase alfa product [see Clinical Studies (14) ] to POMBILITI in combination with Opfolda, 29 patients in an open-label trial. The total…
Who shouldn’t take cipaglucosidase alfa-atga
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 )
Every cipaglucosidase alfa-atga product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Pombiliti.
Related calculators
Frequently asked questions
What is cipaglucosidase alfa-atga?
Pombiliti (Cipaglucosidase Alfa-Atga) is a medication used to treat Glycogen Storage Disease Type II.
Can you take cipaglucosidase alfa-atga with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run cipaglucosidase alfa-atga against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does cipaglucosidase alfa-atga come in?
Across the brands we track, cipaglucosidase alfa-atga is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic cipaglucosidase alfa-atga?
We do not currently list a generic-labelled cipaglucosidase alfa-atga product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Cipaglucosidase Alfa-Atga: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/cipaglucosidase-alfa-atga
- MLA
- “Cipaglucosidase Alfa-Atga: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/cipaglucosidase-alfa-atga.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for cipaglucosidase alfa-atga on DailyMed (NIH) ↗ — including its boxed warning in full.