Caspofungin

What is Caspofungin?

• Caspofungin (Cancidas) is an echinocandin antifungal used in adults and children 3 months of age and older to treat yeast infections in the blood, stomach, lungs, and esophagus and certain fungal infections that could not be treated successfully with other medications.

Caspofungin

Caspofungin ball-and-stick

Caspofungin chemical structure

What are the uses of this medicine?

Caspofungin (Cancidas) used in adults and pediatric patients (3 months of age and older) for:

• Empirical therapy for presumed fungal infections in febrile, neutropenic patients.
• Treatment of candidemia and the following Candida infections: intra-abdominal abscesses, peritonitis and pleural space infections.
• Treatment of esophageal candidiasis.
• Treatment of invasive aspergillosis in patients who are refractory to or intolerant of other therapies.

How does this medicine work?

• Caspofungin is an echinocandin antifungal drug.
• Caspofungin, an echinocandin, inhibits the synthesis of beta (1,3)-D-glucan, an essential component of the cell wall of susceptible Aspergillus species and Candida species.
• Beta (1,3)-D-glucan is not present in mammalian cells.
• Caspofungin has shown activity against Candida species and in regions of active cell growth of the hyphae of Aspergillus fumigatus.

Caspofungin has been shown to be active against most strains of the following microorganisms:

• Aspergillus flavus
• Aspergillus fumigatus
• Aspergillus terreus
• Candida albicans
• Candida glabrata
• Candida guilliermondii
• Candida krusei
• Candida parapsilosis
• Candida tropicalis

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• with known hypersensitivity (e.g., anaphylaxis) to any component of this product.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• carbamazepine (Carbatrol, Tegretol)
• cyclosporine (Gengraf, Neoral, Sandimmune)
• dexamethasone
• efavirenz (Sustiva, in Atripla)
• nevirapine (Viramune)
• phenytoin (Dilantin, Phenytek)
• rifampin (Rifadin, Rimactane, in Rifamate, in Rifater)
• tacrolimus (Prograf)

Is this medicine FDA approved?

• Caspofungin was the first inhibitor of fungal (1→3)-β-D-glucan synthesis to be approved by the United States Food and Drug Administration in the year of 2001.

How should this medicine be used?

Recommended dosage: Dosage in Adults (18 years of age and older):

• 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):

• Dosing should be based on the patient's body surface area.
• For all indications, administer a single 70-mg/m2 loading dose on Day 1, followed by 50 mg/m2 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:

• 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 Adjustments in Patients Receiving Concomitant Inducers of Hepatic CYP Enzymes.

Adult Patients:

• When Cancidas is co-administered to adult patients with other inducers of hepatic CYP enzymes such as nevirapine, efavirenz, carbamazepine, dexamethasone, or phenytoin, administration of a daily dose of 70 mg of Cancidas should be considered.
• Adult patients on rifampin should receive 70 mg of Cancidas once daily.

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, a Cancidas dose of 70 mg/m2 once daily (not to exceed 70 mg) should be considered.

Administration:

• Caspofungin injection comes as a powder to be mixed with liquid and injected intravenously (into a vein) over approximately 1 hour once a day.
• 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).
• The length of your treatment depends on your general health, the type of infection that you have, and how well you respond to the medication.
• You may receive caspofungin injection in a hospital or you may administer the medication at home.
• If you will be receiving caspofungin injection at home, your healthcare provider will show you how to use the medication.
• Your doctor may start you on a standard dose of caspofungin injection and increase your dose depending on your response to the medication and any side effects you experience.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 50 or 70 mg lyophilized powder (plus allowance for overfill) in a single-dose vial for reconstitution

This medicine is available in fallowing brand namesː

• Cancidas

What side effects can this medication cause?

The most common side effects of this medicine include: In Adults:diarrhea, pyrexia, ALT/AST increased, blood alkaline phosphatase increased, and blood potassium decreased.

In Pediatric Patients:

• pyrexia, diarrhea, rash, ALT/AST increased, blood potassium decreased, hypotension, and chills.

Caspofungin may cause some serious side effects which may include:

• Hypersensitivity
• Hepatic Effects
• Elevated Liver Enzymes During Concomitant Use With Cyclosporine

What special precautions should I follow?

• 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.
• Laboratory abnormalities in liver function tests have been seen in healthy volunteers and in adult and pediatric patients treated with Cancidas. 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.
• Elevated liver enzymes have occurred in patients receiving Cancidas and cyclosporine concomitantly. 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.
• Advise female patients of the potential risks to a fetus. Instruct patients to tell their healthcare provider if they are pregnant, become pregnant, or are thinking about becoming pregnant. Instruct patients to tell their healthcare provider if they plan to breastfeed their infant.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• No clinically significant adverse reactions were reported.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Caspofungin is not dialyzable.

Can this medicine be used in pregnancy?

• Based on animal data, Cancidas may cause fetal harm.
• There are insufficient human data to establish whether there is a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes with Cancidas use in pregnant women.

Can this medicine be used in children?

• The efficacy and safety of Cancidas has not been adequately studied in prospective clinical trials involving neonates and infants under 3 months of age.

What are the active and inactive ingredients in this medicine?

Active Ingredients:

• CASPOFUNGIN ACETATE

Inactive Ingredients:

• ACETIC ACID
• MANNITOL
• SODIUM HYDROXIDE
• SUCROSE

Who manufactures and distributes this medicine?

Distributed by:

• Merck Sharp & Dohme LLC
• Rahway, NJ , USA

What should I know about storage and disposal of this medication?

• The lyophilized vials should be stored refrigerated at 2° to 8°C (36° to 46°F).

• Dailymed label info on Caspofungin
• FDA Caspofungin

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