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Drug overview for GALAFOLD (migalastat hcl):
Generic name: migalastat HCl (mi-GAL-a-stat)
Drug class: Metabolic Disease Enzyme Replacement, Fabry's Disease
Therapeutic class: Metabolic Modifiers
Migalastat hydrochloride is an alpha-galactosidase A (alpha-Gal A) pharmacological chaperone.
No enhanced Uses information available for this drug.
Generic name: migalastat HCl (mi-GAL-a-stat)
Drug class: Metabolic Disease Enzyme Replacement, Fabry's Disease
Therapeutic class: Metabolic Modifiers
Migalastat hydrochloride is an alpha-galactosidase A (alpha-Gal A) pharmacological chaperone.
No enhanced Uses information available for this drug.
DRUG IMAGES
GALAFOLD 123 MG CAPSULE
The following indications for GALAFOLD (migalastat hcl) have been approved by the FDA:
Indications:
Fabry disease
Professional Synonyms:
Alpha-galactosidase A deficiency
Angiokeratoma corporis diffusum universale
Angiokeratoma corporis diffusum
Ceramide trihexosidase deficiency
Diffuse angiokeratoma
Fabry's disease
Glycolipid lipidosis
Indications:
Fabry disease
Professional Synonyms:
Alpha-galactosidase A deficiency
Angiokeratoma corporis diffusum universale
Angiokeratoma corporis diffusum
Ceramide trihexosidase deficiency
Diffuse angiokeratoma
Fabry's disease
Glycolipid lipidosis
The following dosing information is available for GALAFOLD (migalastat hcl):
Dosage of migalastat hydrochloride is expressed in terms of migalastat.
The recommended dosage of migalastat for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data is 123 mg orally once every other day.
The recommended dosage of migalastat for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data is 123 mg orally once every other day.
Administer migalastat hydrochloride orally once every other day at the same time of day, on an empty stomach. The drug is commercially available as an oral capsule. Do not consume food or caffeine at least 2 hours before and after taking migalastat to give a minimum 4 hours fast.
Water (plain, flavored, or sweetened), fruit juices without pulp, and caffeine-free carbonated beverages can be consumed during the fasting period. Do not take migalastat on 2 consecutive days. If a dose is missed entirely for the day, take the missed dose only if it is within 12 hours of the normal time that the dose should have been taken.
If more than 12 hours have passed, resume taking migalastat at the next planned dosing day and time and according to the every-other-day dosing schedule. Swallow capsules whole; do not cut, crush, or chew. Store in the original packaging to protect from moisture at room temperature (20-25degreesC). Excursions are permitted between 15-30degreesC.
Water (plain, flavored, or sweetened), fruit juices without pulp, and caffeine-free carbonated beverages can be consumed during the fasting period. Do not take migalastat on 2 consecutive days. If a dose is missed entirely for the day, take the missed dose only if it is within 12 hours of the normal time that the dose should have been taken.
If more than 12 hours have passed, resume taking migalastat at the next planned dosing day and time and according to the every-other-day dosing schedule. Swallow capsules whole; do not cut, crush, or chew. Store in the original packaging to protect from moisture at room temperature (20-25degreesC). Excursions are permitted between 15-30degreesC.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| GALAFOLD 123 MG CAPSULE | Maintenance | Adults take 1 capsule (123 mg) by oral route every other day at the same time each day |
No generic dosing information available.
The following drug interaction information is available for GALAFOLD (migalastat hcl):
There are 0 contraindications.
There are 0 severe interactions.
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Migalastat/Caffeine-Containing Products SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The mechanism of this interaction is unknown. CLINICAL EFFECTS: Concurrent use of a caffeine-containing product may result in decreased levels and effectiveness of migalastat.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Avoid coadministration of migalastat with caffeine-containing products. Do not administer caffeine-containing products within 2 hours before and 2 hours after taking migalastat.(1) DISCUSSION: Coadministration of migalastat with caffeine 190 mg decreased the migalastat maximum concentration (Cmax) by 60% and area-under-curve (AUC) by 55%.(1) |
ACETAMIN-CAFF-DIHYDROCODEINE, ASA-BUTALB-CAFFEINE-CODEINE, ASCOMP WITH CODEINE, BUTALB-ACETAMINOPH-CAFF-CODEIN, BUTALBITAL-ACETAMINOPHEN-CAFFE, BUTALBITAL-ASPIRIN-CAFFEINE, CAFCIT, CAFFEINE, CAFFEINE AND SODIUM BENZOATE, CAFFEINE CITRATE, ERGOTAMINE-CAFFEINE, FIORICET, MIGERGOT, MORGIDOX, NORGESIC, NORGESIC FORTE, ORPHENADRINE-ASPIRIN-CAFFEINE, ORPHENGESIC FORTE, TREZIX |
The following contraindication information is available for GALAFOLD (migalastat hcl):
Drug contraindication overview.
*None.
*None.
There are 0 contraindications.
There are 0 severe contraindications.
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| No disease contraindications |
The following adverse reaction information is available for GALAFOLD (migalastat hcl):
Adverse reaction overview.
The most common adverse effects of migalastat reported in >=10% of patients are headache, nasopharyngitis, urinary tract infection, nausea, and pyrexia.
The most common adverse effects of migalastat reported in >=10% of patients are headache, nasopharyngitis, urinary tract infection, nausea, and pyrexia.
There are 2 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Hepatocellular damage Hypertension |
There are 38 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Fever Headache disorder Nausea Pharyngitis Urinary tract infection |
Acute abdominal pain Back pain Constipation Cough Depression Diarrhea Dizziness Dyspepsia Dyspnea Epistaxis Fatigue Fecal urgency Hypoesthesia Muscle spasm Myalgia Pain Palpitations Paresthesia Proteinuria Pruritus of skin Skin rash Vertigo Weight gain Xerostomia |
| Rare/Very Rare |
|---|
|
Anorexia Drowsy Erythema Hypercholesterolemia Memory impairment Ocular itching Polyuria Reduced visual acuity Vomiting |
The following precautions are available for GALAFOLD (migalastat hcl):
Safety and effectiveness of migalastat have not been established in pediatric patients.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Available data are not sufficient to assess drug associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. No adverse developmental effects were observed with oral administration of migalastat to pregnant rats and rabbits during organogenesis at doses up to 26 and 54 times, respectively, the recommended dose based on AUC. No effects on post-natal development were observed following oral administration of up to 500 mg/kg migalastat twice daily to pregnant rats (16 times the recommended dose based on AUC) during organogenesis and through lactation.
An ongoing study collects data on pregnant women with Fabry disease, either exposed or unexposed to migalastat. Healthcare providers are encouraged to register patients or obtain additional information by contacting the Pregnancy Coordinating Center at 1-888-239-0758, emailing fabrypregnancy@ubc.com, or visiting https://fabrypregnancyregistry.com/.
An ongoing study collects data on pregnant women with Fabry disease, either exposed or unexposed to migalastat. Healthcare providers are encouraged to register patients or obtain additional information by contacting the Pregnancy Coordinating Center at 1-888-239-0758, emailing fabrypregnancy@ubc.com, or visiting https://fabrypregnancyregistry.com/.
There are no human data available on the presence of migalastat hydrochloride in human milk, the effects on the breastfed infant, or the effects on milk production. Migalastat is present in the milk of lactating rats. When a drug is present in animal milk, it is likely that the drug will be present in human milk.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for migalastat and any potential adverse effects on the breastfed child from migalastat or from the underlying maternal condition. An ongoing study collects data on the effects of migalastat on lactation for women with Fabry disease and their neonates and infants up to 1 year of age who are exposed through breast milk. Healthcare providers are encouraged to register patients or obtain additional information by contacting the Pregnancy Coordinating Center at 1-888-239-0758, emailing fabrypregnancy@ubc.com,
or visiting https://fabrypregnancyregistry.com/.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for migalastat and any potential adverse effects on the breastfed child from migalastat or from the underlying maternal condition. An ongoing study collects data on the effects of migalastat on lactation for women with Fabry disease and their neonates and infants up to 1 year of age who are exposed through breast milk. Healthcare providers are encouraged to register patients or obtain additional information by contacting the Pregnancy Coordinating Center at 1-888-239-0758, emailing fabrypregnancy@ubc.com,
or visiting https://fabrypregnancyregistry.com/.
Experience in patients >=65 years of age is insufficient to determine whether they respond differently to migalastat than younger patients.
The following prioritized warning is available for GALAFOLD (migalastat hcl):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for GALAFOLD (migalastat hcl)'s list of indications:
| Fabry disease | |
| E75.21 | Fabry (-anderson) disease |
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