cancidas
Pharmaranks rates Cancidas 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Cancidas (Caspofungin Acetate) is an echinocandin antifungal used to treat Aspergillosis, Candidemia.
Caspofungin Acetate · by Merck
Available as a generic: Caspofungin Acetate
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Caspofungin Acetate
- Drug class
- Echinocandin Antifungal
- Form
- Injectable
- Strength
- Caspofungin Acetate 50MG/VIAL **Federal Register Determination That Product was not Discontinued or Withdrawn for Safety or Effectiveness reasons** · Caspofungin Acetate 70MG/VIAL **Federal Register Determination That Product was not Discontinued or Withdrawn for Safety or Effectiveness reasons**
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- aspergillosis, candidemia
- Manufacturer
- Merck
- FDA application
- NDA021227
- Availability
- Discontinued (per FDA)
What is Cancidas?
From the FDA label:CANCIDAS is a sterile, lyophilized product for intravenous (IV) infusion that contains a semisynthetic lipopeptide (echinocandin) compound synthesized from a fermentation product of Glarea lozoyensis. CANCIDAS is an echinocandin antifungal that inhibits the synthesis of β (1,3)-D-glucan, an integral component of the fungal cell wall. CANCIDAS (caspofungin acetate) is 1-[(4 R ,5 S )-5-[(2-aminoethyl)amino]- N 2 -(10,12-dimethyl-1-oxotetradecyl)-4-hydroxy-L-ornithine]-5-[(3 R )-3-hydroxy-L-ornithine] pneumocandin B 0 diacetate (salt). CANCIDAS 50 mg contains 50 mg of caspofungin equivalent to 55.5 mg of caspofungin acetate. CANCIDAS 50 mg also contains: 39 mg sucrose, 26 mg mannitol, 2 mg glacial acetic acid added as a buffering agent, and sodium hydroxide added as a pH adjuster ingredient. CANCIDAS 70 mg contains 70 mg of caspofungin equivalent to 77.7 mg of caspofungin acetate. CANCIDAS 70 mg also contains 54 mg sucrose, 36 mg mannitol, 2.7 mg glacial acetic acid added as a buffering agent, and sodium hydroxide added as a pH adjuster ingredient. Caspofungin acetate is a hygroscopic, white to off-white powder. It is freely soluble in water and methanol, and slightly soluble in ethanol. The pH of a saturated aqueous solution of caspofungin acetate is approximately 6.6. The empirical formula is C 52 H 88 N 10 O 15 ∙2C 2 H 4 O 2 and the formula weight is 1213.42. The structural…
How to use
Important Administration Instructions for All Patients ( 2.1 ): Administer by slow intravenous (IV) infusion over approximately 1 hour. Do not administer by IV bolus administration. Do not mix or co-infuse CANCIDAS with other medications. Do not use diluents containing dextrose (α–D-glucose). Dosage in Adults [18 years of age and older] ( 2.2 ): Administer a single 70-mg loading dose on Day 1, followed by 50 mg once daily for all indications except esophageal candidiasis. For esophageal candidiasis, use 50 mg once daily with no loading dose. Dosage in Pediatric Patients [3 months to 17 years of age] ( 2.3 ): Dosing should be based on the patient's body surface area. For all indications, administer a single 70-mg/m 2 loading dose on Day 1, followed by 50 mg/m 2 once daily thereafter. Maximum loading dose and daily maintenance dose should not exceed 70 mg, regardless of the patient's calculated dose. Dosage Adjustments in Patients with Hepatic Impairment ( 2.4 ): Reduce dosage for adult patients with moderate hepatic impairment (35 mg once daily, with a 70 mg loading dose on Day 1 where appropriate). Dosage Adjustment in Patients Receiving Concomitant Inducers of Hepatic CYP Enzymes ( 2.5 ): Use 70-mg once daily dose for adult patients on rifampin. Consider dose increase to 70 mg once daily for adult patients on nevirapine, efavirenz, carbamazepine, dexamethasone, or phenytoin.…
Side effects
The following serious adverse reactions are discussed in detail in another section of the labeling: Hypersensitivity [see Warnings and Precautions (5.1) ] Hepatic Effects [see Warnings and Precautions (5.2) ] Elevated Liver Enzymes During Concomitant Use With Cyclosporine [see Warnings and Precautions (5.3) ] Adults: Most common adverse reactions (incidence 10% or greater) are diarrhea, pyrexia, ALT/AST increased, blood alkaline phosphatase increased, and blood potassium decreased. ( 6.1 ) Pediatric Patients: Most common adverse reactions (incidence ≥10%) are pyrexia, diarrhea, rash, ALT/AST increased, blood potassium decreased, hypotension, and chills. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme LLC at 1-877-888-4231 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 clinical trials of CANCIDAS cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials Experience in Adults The overall safety of CANCIDAS was assessed in 1865 adult individuals who received single or multiple doses of CANCIDAS: 564 febrile, neutropenic patients (empirical therapy study); 382 patients with candidemia and/or intra-abdominal abscesses, peritonitis, or…
Warnings
Important safety information
Hypersensitivity : Anaphylaxis, possible histamine-mediated adverse reactions, including rash, facial swelling, angioedema, pruritus, sensation of warmth or bronchospasm, and cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with use of CANCIDAS. Discontinue CANCIDAS at the first sign or symptom of a hypersensitivity reaction and administer appropriate treatment. ( 5.1 ) Hepatic Effects: Can cause abnormalities in liver enzymes. Isolated cases of hepatic dysfunction, hepatitis, or hepatic failure have been reported. Monitor patients who develop abnormal liver enzymes for evidence of worsening hepatic function, and evaluate risk/benefit of continuing CANCIDAS. ( 5.2 ) Elevated Liver Enzymes During Concomitant Use with Cyclosporine : Limit use to patients for whom potential benefit outweighs potential risk. Monitor patients who develop abnormal liver function tests (LFTs) during concomitant use with CANCIDAS. ( 5.3 ) 5.1 Hypersensitivity Anaphylaxis and other hypersensitivity reactions have been reported during administration of CANCIDAS. Possible histamine-mediated adverse reactions, including rash, facial swelling, angioedema, pruritus, sensation of warmth or bronchospasm have been reported. Cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some with a fatal outcome, have been reported with use of CANCIDAS [see Adverse Reactions (6.2) ] . Discontinue CANCIDAS at the first sign or symptom of a hypersensitivity reaction and administer appropriate treatment. 5.2 Hepatic Effects Laboratory abnormalities in liver function tests have been seen in healthy volunteers and in adult and pediatric patients treated with CANCIDAS. In some adult and pediatric patients with serious underlying conditions who were receiving multiple concomitant medications with CANCIDAS, isolated cases of clinically significant hepatic dysfunction, hepatitis, and hepatic failure have been reported; a causal relationship to CANCIDAS has not been established. Monitor patients who develop abnormal liver function tests during CANCIDAS therapy for evidence of worsening hepatic function and evaluated for risk/benefit of continuing CANCIDAS therapy. 5.3 Elevated Liver Enzymes During Concomitant Use With Cyclosporine Elevated liver enzymes have occurred in patients receiving CANCIDAS and cyclosporine concomitantly. Only use CANCIDAS and cyclosporine in those patients for whom the potential benefit outweighs the potential risk. Patients who develop abnormal liver enzymes during concomitant therapy should be monitored and the risk/benefit of continuing therapy should be evaluated.
Who should not take Cancidas
CANCIDAS is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to any component of this product [see Adverse Reactions (6) ] . CANCIDAS is contraindicated in patients with known hypersensitivity to any component of this product. ( 4 )
Overdose — what happens if you take too much
In 6 healthy subjects who received a single 210-mg dose, no significant adverse reactions were reported. Multiple doses above 150 mg daily have not been studied. Caspofungin is not dialyzable. In clinical trials, one pediatric patient (16 years of age) unintentionally received a single dose of caspofungin of 113 mg (on Day 1), followed by 80 mg daily for an additional 7 days. No clinically significant adverse reactions were reported.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Cyclosporine: In two adult clinical studies, cyclosporine (one 4 mg/kg dose or two 3 mg/kg doses) increased the AUC of CANCIDAS. CANCIDAS did not increase the plasma levels of cyclosporine. There were transient increases in liver ALT and AST when CANCIDAS and cyclosporine were co-administered . Monitor patients who develop abnormal liver enzymes during concomitant therapy and evaluate the risk/benefit of continuing therapy [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3) ]. Tacrolimus: For patients receiving CANCIDAS and tacrolimus, standard monitoring of tacrolimus trough whole blood concentrations and appropriate tacrolimus dosage adjustments are recommended. Inducers of Hepatic CYP Enzymes Rifampin: Rifampin is a potent CYP3A4 inducer and concomitant administration with CANCIDAS is expected to reduce the plasma concentrations of CANCIDAS. Therefore, adult patients on rifampin should receive 70 mg of CANCIDAS daily and pediatric patients on rifampin should receive 70 mg/m 2 of CANCIDAS daily (not to exceed an actual daily dose of 70 mg) [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3) ] . Other Inducers of Hepatic CYP Enzymes Adults: When CANCIDAS is co-administered to adult patients with other inducers of hepatic CYP enzymes, such as efavirenz, nevirapine, phenytoin, dexamethasone, or carbamazepine, administration of a daily dose of 70 mg of CANCIDAS should be considered [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3) ] . Pediatric Patients: When CANCIDAS is co-administered to pediatric patients with other inducers of hepatic CYP enzymes, such as efavirenz, nevirapine, phenytoin, dexamethasone, or carbamazepine, administration of a daily dose of 70 mg/m 2 CANCIDAS (not to exceed an actual daily dose of 70 mg) should be considered [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3) ] .
Drug class
May treat (source: NIH RxClass)
See how Cancidas ranks — best-rated echinocandin antifungal for:
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- What does Cancidas treat?
- Cancidas (Caspofungin Acetate) may be used to treat aspergillosis, candidemia, 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.
- How is Cancidas rated?
- pharmaranks gives Cancidas a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Cancidas?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Cancidas. 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 Cancidas?
- Cancidas is marketed by Merck. You can see Merck's full profile, rating, and other products on pharmaranks.
- Is Cancidas a brand-name or generic drug?
- Cancidas is a brand-name product with the active ingredient Caspofungin Acetate. Lower-cost generic equivalents containing Caspofungin Acetate are available — ask your pharmacist.
- Is Cancidas available over the counter?
- No. Cancidas 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 Cancidas come in?
- Cancidas is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Cancidas?
- Cancidas is classified as echinocandin antifungal, per the FDA's Established Pharmacologic Class.
- Is Cancidas FDA-registered?
- Cancidas is on record with the U.S. FDA under application number NDA021227. You can verify this on its official FDA label.
- Has Cancidas been recalled by the FDA?
- Cancidas has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Cancidas safe?
- There's no single safe-or-not verdict. pharmaranks gives Cancidas a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Cancidas?
- Cancidas's side effects are taken directly from its FDA label. From the label: The following serious adverse reactions are discussed in detail in another section of the labeling: Hypersensitivity [see Warnings and Precautions (5.1) ] Hepatic Effects [see Warnings and Precautions (5.2) ] Elevated Liver Enzymes During Concomitant Use With Cyclosporine [see Warnings and Precautio… 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.
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cancidas
70/100