Version May 2024
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Zinc acetate: Drug information")
Wilson disease: Note: Dose expressed in mg elemental zinc:
Usual dosage: Oral: 50 mg 3 times daily. Note: In patients who are able to consistently separate administration from food and strictly adhere to the dosing schedule, may administer 25 mg 3 times daily or 50 mg twice daily (minimum effective dose: 75 mg/day in 2 or 3 divided doses); increase dose to 50 mg 3 times daily if inadequate response to lower dose (Ref).
Pregnant patients: Oral: 25 mg 3 times daily; may increase to 50 mg 3 times daily if inadequate response to lower dose.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Frequency not defined:
Central nervous system: Neurological deterioration (uncommon)
Gastrointestinal: Gastric irritation, increased serum amylase, increased serum lipase
Hepatic: Increased serum alkaline phosphatase
<1%, postmarketing, and/or case reports: Hepatic insufficiency
Hypersensitivity to zinc acetate or any component of the formulation.
Concerns related to adverse effects:
• Central nervous system: Neurological deterioration may occur with initial therapy as copper stores are mobilized; effects are less common when compared to chelation therapy.
• GI effects: Gastric irritation/upset may occur with use and particularly with the morning dose.
Other warnings/precautions:
• Appropriate use: Not recommended for initial treatment of Wilson disease in symptomatic patients; may be used as maintenance therapy after patient has been stabilized on initial chelation therapy.
• Therapy management: Hepatic copper levels should not be used to manage therapy as they do not differentiate between potentially toxic free copper and safely bound copper.
Strength of Galzin capsule is expressed as elemental zinc.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Capsule, Oral:
Galzin: 25 mg, 50 mg
Wilzin: 25 mg [DSC] [contains corn starch, fd&c blue #1 (brilliant blue)]
No
Capsules (Galzin Oral)
25 mg (per each): $2.72
50 mg (per each): $4.54
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Oral: Administer on empty stomach at least 1 hour before or 2 to 3 hours after meals, and 1 hour away from beverages other than water. Gastric irritation most commonly associated with morning dose; may administer 1 hour after breakfast if gastric irritation occurs. Swallow capsule whole; do not chew or open.
Oral: Administer on empty stomach at least 1 hour before or 2 to 3 hours after meals, and at least 1 hour separated from beverages other than water. Gastric irritation is most commonly associated with morning dose; may administer morning dose between breakfast and lunch if gastric irritation occurs. Swallow capsule whole; do not chew or open.
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light.
Maintenance treatment of Wilson disease following initial chelation therapy (Galzin: FDA approved in ages ≥10 years and adults)
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Baloxavir Marboxil: Polyvalent Cation Containing Products may decrease the serum concentration of Baloxavir Marboxil. Risk X: Avoid combination
Bictegravir: Polyvalent Cation Containing Products may decrease the serum concentration of Bictegravir. Management: Administer bictegravir under fasting conditions at least 2 hours before or 6 hours after polyvalent cation containing products. Coadministration of bictegravir with or 2 hours after most polyvalent cation products is not recommended. Risk D: Consider therapy modification
Bisphosphonate Derivatives: Polyvalent Cation Containing Products may decrease the serum concentration of Bisphosphonate Derivatives. Management: Avoid administration of oral medications containing polyvalent cations within: 2 hours before or after tiludronate/clodronate/etidronate; 60 minutes after oral ibandronate; or 30 minutes after alendronate/risedronate. Risk D: Consider therapy modification
Cabotegravir: Polyvalent Cation Containing Products may decrease the serum concentration of Cabotegravir. Management: Administer polyvalent cation containing products at least 2 hours before or 4 hours after oral cabotegravir. Risk D: Consider therapy modification
Deferiprone: Polyvalent Cation Containing Products may decrease the serum concentration of Deferiprone. Management: Separate administration of deferiprone and oral medications or supplements that contain polyvalent cations by at least 4 hours. Risk D: Consider therapy modification
Dolutegravir: Zinc Salts may decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after oral zinc salts. Administer the dolutegravir/rilpivirine combination product at least 4 hours before or 6 hours after oral zinc salts. Risk D: Consider therapy modification
Eltrombopag: Polyvalent Cation Containing Products may decrease the serum concentration of Eltrombopag. Management: Administer eltrombopag at least 2 hours before or 4 hours after oral administration of any polyvalent cation containing product. Risk D: Consider therapy modification
Elvitegravir: Polyvalent Cation Containing Products may decrease the serum concentration of Elvitegravir. Management: Administer elvitegravir 2 hours before or 6 hours after the administration of polyvalent cation containing products. Risk D: Consider therapy modification
Levonadifloxacin: Zinc Salts may decrease the serum concentration of Levonadifloxacin. Risk X: Avoid combination
PenicillAMINE: Polyvalent Cation Containing Products may decrease the serum concentration of PenicillAMINE. Management: Separate the administration of penicillamine and oral polyvalent cation containing products by at least 1 hour. Risk D: Consider therapy modification
Quinolones: Zinc Salts may decrease the serum concentration of Quinolones. Management: Give oral quinolones at several hours before (4 h for moxi- and sparfloxacin, 2 h for others) or after (8 h for moxi-, 6 h for cipro/dela-, 4 h for lome-, 3 h for gemi-, and 2 h for enox-, levo-, nor-, pe- or ofloxacin or nalidixic acid) oral zinc salts. Risk D: Consider therapy modification
Raltegravir: Polyvalent Cation Containing Products may decrease the serum concentration of Raltegravir. Management: Administer raltegravir 2 hours before or 6 hours after administration of the polyvalent cations. Dose separation may not adequately minimize the significance of this interaction. Risk D: Consider therapy modification
Roxadustat: Polyvalent Cation Containing Products may decrease the serum concentration of Roxadustat. Management: Administer roxadustat at least 1 hour after the administration of oral polyvalent cation containing products. Risk D: Consider therapy modification
Tetracyclines: Zinc Salts may decrease the absorption of Tetracyclines. Only a concern when both products are administered orally. Management: Separate administration of oral tetracycline derivatives and oral zinc salts by at least 2 hours to minimize this interaction. Risk D: Consider therapy modification
Trientine: Polyvalent Cation Containing Products may decrease the serum concentration of Trientine. Management: Avoid concomitant use of trientine and polyvalent cations. If oral iron supplements are required, separate the administration by 2 hours. For other oral polyvalent cations, give trientine 1 hour before, or 1 to 2 hours after the polyvalent cation. Risk D: Consider therapy modification
Unithiol: May diminish the therapeutic effect of Polyvalent Cation Containing Products. Risk X: Avoid combination
Food and beverages other than water may interfere with zinc absorption. Management: Administer on empty stomach at least 1 hour before or 2 to 3 hours after meals and at least 1 hour separated from beverages other than water. Gastric irritation is most commonly associated with morning dose; may administer morning dose between breakfast and lunch if GI irritation occurs.
Dietary reference intakes for elemental zinc:
≥19 years of age: 11 mg/day (males); 8 mg/day (females).
Pregnant patients: 11 mg/day.
Breastfeeding patients: 12 mg/day.
Menstrual irregularities and infertility are associated with Wilson disease. Patients treated for Wilson disease are able to conceive and therapy should be optimized prior to pregnancy (AASLD [Schilsky 2022]).
Outcome data following maternal use of zinc acetate for the treatment of Wilson disease during pregnancy are available (Brewer 2000; Mussi 2021; Pfeiffenberger 2018). Continued treatment of Wilson disease during pregnancy improves pregnancy outcomes. Appropriate doses of zinc acetate can be maintained during pregnancy. Close monitoring is recommended (AASLD [Schilsky 2022]; EASL 2012).
Serum non-ceruloplasmin bound copper, 24-hour urinary copper excretion, 24-hour urinary zinc levels, LFTs, iron and/or other trace minerals, neurologic evaluation including speech, periodic ophthalmic exam
Target ranges for patients with Wilson disease on zinc acetate therapy:
24-hour urinary copper excretion: ≤75 mcg/24 hours (patients on chelation therapy will have increased urinary copper due to chelated copper)
Non-ceruloplasmin plasma copper (free copper): <20 mcg/dL
Zinc induces production of the copper binding protein metallothionein in enterocytes. Copper binding within enterocytes results in an impairment of the intestinal absorption of dietary copper and reabsorption of endogenously secreted copper in saliva, bile, gastric acid. Following enterocyte desquamation, bound copper is eliminated in the feces.
Absorption: Small intestine (IOM 2001); impaired with food and beverages (other than water).
Distribution: Stored primarily in skeletal muscle and bone (IOM 2001).
Protein binding: Albumin and alpha 1-macroglobulin (Foote 1984).
Excretion: Feces and urine (IOM 2001).
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