zycubo
Zycubo (Copper Histidinate) is a medication used to treat Menkes Kinky Hair Syndrome.
Copper Histidinate · by Sentynl Theraps Inc
Key facts
- Active ingredient
- Copper Histidinate
- Form
- Injectable
- Strength
- Copper Histidinate 2.9MG/VIAL
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- menkes kinky hair syndrome
- Manufacturer
- Sentynl Theraps Inc
- FDA application
- NDA211241
What is Zycubo?
From the FDA label:ZYCUBO (copper histidinate) for injection is a copper replacement product. The chemical name is copper, (L-histidinato-ϰ N ,ϰ N 3,ϰO)(L-histidinato-ϰ N ,ϰO)-, ( SP -5-14-C)-. The molecular formula is C 12 H 16 CuN 6 O 4 , and the molecular weight is 371.84 g/mol. Copper histidinate is soluble in water. The chemical structure is: ZYCUBO is a sterile, preservative-free, blue lyophilized powder or cake for subcutaneous injection after reconstitution with 1 mL sterile 0.9% Sodium Chloride Injection, USP. Each single-dose vial contains 2.9 mg of copper histidinate (equivalent to 0.5 mg elemental copper). The resultant solution has a concentration of 2.9 mg/mL and a pH of 7.4. Chemical Structure
How to use
Before initiating ZYCUBO, obtain baseline serum copper and ceruloplasmin levels, serum electrolytes, kidney and liver function, and complete blood count. ( 2.1 ) The recommended dosage of ZYCUBO in pediatric patients: Less than 1 year of age is 1.45 mg twice daily (8-12 hours between injections). ( 2.2 ) 1 year of age to less than 17 years of age is 1.45 mg once daily. ( 2.2 ) Monitor serum copper and ceruloplasmin levels, serum electrolytes, kidney and liver function, and complete blood count (CBC). ( 2.3 ) Reconstitute ZYCUBO and administer subcutaneously. ( 2.4 , 2.6 ) See Full Prescribing Information for additional preparation, storage, and administration instructions. ( 2.4 , 2.5 , 2.6 ) 2.1 Recommended Testing Before Initiating ZYCUBO Before initiating ZYCUBO, obtain baseline serum copper and ceruloplasmin levels, serum electrolytes, kidney and liver function, and complete blood count (CBC) [see Warnings and Precautions ( 5.1 )] . 2.2 Recommended Dosage and Administration The recommended dosage of ZYCUBO in pediatric patients: Less than 1 year of age is 1.45 mg administered subcutaneously twice daily (8-12 hours between injections). 1 year of age to less than 17 years of age is 1.45 mg administered subcutaneously once daily. 2.3 Dosage and Administration Modifications and Monitoring Monitor serum copper and ceruloplasmin levels, serum electrolytes, kidney and liver…
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Copper Accumulation and Risk of Toxicity: Drug-Induced Kidney Injury, Liver Dysfunction, Hematological Abnormalities [see Warnings and Precautions ( 5.1 )] Most common adverse reactions (incidence ≥7%) were pneumonia, viral infection, respiratory failure, seizure, bacterial infection, hemorrhage, hypotension, vomiting, tachycardia, pyrexia, volume depletion, fracture, dyspnea, transaminases elevation, diarrhea, fungal infection, anemia, and local administration reaction. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sentynl Therapeutics, Inc. at 1-888-507-5206 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. The pooled safety analysis from 2 open-label, single-arm clinical trials included a total of 129 ZYCUBO-treated patients with an age range from 0 to 48 months. Patients less than 1 year of age received ZYCUBO 1.45 mg twice daily, and patients 1 year of age and older received ZYCUBO 1.45 mg once daily. The median exposure duration was 24 months (range: 1 to 39 months) [see…
Warnings
Important safety information
Copper Accumulation and Risk of Toxicity : Exogenous administration of copper with ZYCUBO may lead to further copper accumulation and has the potential to result in drug-induced kidney injury, liver dysfunction, and hematological abnormalities. Monitor patients during ZYCUBO treatment. Adjust dosage if necessary. ( 2.2 , 5.1 , 6.1 ) 5.1 Copper Accumulation and Risk of Toxicity Impaired copper transport in patients with Menkes disease can lead to copper accumulation and organ impairment in the kidneys, liver, and hematopoietic system. Treatment with ZYCUBO may lead to further copper accumulation and related toxicity, especially in the first two years of life given renal and hepatic immaturity. Obtain baseline serum copper and ceruloplasmin levels, serum electrolytes, kidney and liver function, and complete blood count (CBC). After initiating ZYCUBO, monitor laboratory values every 6 weeks for the first 6 months, then every 3 months for 18 months, and then every 6 months thereafter during ZYCUBO treatment. If laboratory abnormalities are detected, consider reducing the frequency of ZYCUBO administration or temporarily withholding or permanently discontinuing ZYCUBO. Return to increased frequency of laboratory monitoring when resuming a dosage as clinically indicated. Drug-Induced Kidney Injury Copper accumulation with ZYCUBO use has the potential to result in renal tubular toxicity in patients with Menkes disease. Routinely monitor patients starting or re-starting ZYCUBO for signs and symptoms of renal tubular toxicity. New-onset or worsening non-anion gap metabolic acidosis may be a sign of drug-related renal tubular acidosis. Increased urinary beta-2 microglobulin and/or new-onset hypophosphatemia, hyponatremia, or hypokalemia may be signs of drug-related proximal renal tubular toxicity. Provide supportive care with electrolyte repletion and supplementation as clinically indicated. Copper accumulation with ZYCUBO use has the potential to result in glomerular injury, leading to decreased kidney function or new-onset proteinuria. Liver Dysfunction Copper accumulation with ZYCUBO can result in liver dysfunction. Elevations of liver transaminases have been reported in patients taking ZYCUBO for Menkes disease [see Adverse Reactions ( 6.1 )] . Single cell necrosis, inflammation, and fibrosis, along with increased liver transaminases and bilirubin were observed in studies conducted over 13-weeks in juvenile rats with normal baseline copper levels [see Use in Specific Populations ( 8.4 )]. Hematological Abnormalities Copper accumulation with ZYCUBO can result in spleen and bone marrow dysfunction as well as interference with iron metabolism. Anemia has been reported in patients taking ZYCUBO for Menkes disease [see Adverse Reactions ( 6.1 )] . Increased cellularity and pigmented macrophages in the spleen and increased hematological values were observed in studies conducted over 13-weeks in normal juvenile rats [see Use in Specific Populations ( 8.4 )].
Who should not take Zycubo
None. None ( 4 )
May treat (source: NIH RxClass)
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Zycubo treat?
- Zycubo (Copper Histidinate) may be used to treat menkes kinky hair syndrome, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Zycubo?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Zycubo. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Zycubo?
- Zycubo is marketed by Sentynl Theraps Inc. You can see Sentynl Theraps Inc's full profile, rating, and other products on pharmaranks.
- Is Zycubo a brand-name or generic drug?
- Zycubo is a brand-name product with the active ingredient Copper Histidinate.
- Is Zycubo available over the counter?
- No. Zycubo is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Zycubo come in?
- Zycubo is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Zycubo FDA-registered?
- Zycubo is on record with the U.S. FDA under application number NDA211241. You can verify this on its official FDA label.
- Is Zycubo safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Zycubo. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Zycubo?
- Zycubo's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described elsewhere in the labeling: Copper Accumulation and Risk of Toxicity: Drug-Induced Kidney Injury, Liver Dysfunction,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
Reviews
No reviews yet. Be the first to write one.
People also viewed
abiraterone acetate
Abiraterone Acetate
acular
Ketorolac Tromethamine
acular ls
Ketorolac Tromethamine
aimovig
Erenumab-Aooe
albendazole
Albendazole
alphagan p
Brimonidine Tartrate
Compare Zycubo head-to-head
Browse medications A–Z
Research products from A to Z, compare independent ratings, and find alternatives.
zycubo
New