Caspofungin inhibits glucan synthase, an enzyme present in fungal cells but not in mammalian cells. This results in the inhibition of the formation of 1,3-β-D-glucan, an essential component of the fungal cell wall.

Caspofungin is indicated for use in adult and pediatric patients (3 months and older) for:

Empirical therapy for presumed fungal infections (such as Candida or Aspergillus) 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.

Dosage in Adults (18 years 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 loading dose on Day 1, followed by 50 mg once daily thereafter.

The 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 the dosage for adult patients with moderate hepatic impairment to 35 mg once daily, with a 70 mg loading dose on Day 1 where appropriate.

Administer Caspofungin by slow intravenous (IV) infusion over approximately 1 hour.
Do not administer Caspofungin by IV bolus.

Allow the refrigerated vial of Caspofungin to reach room temperature before reconstitution.

Aseptically add 10 mL of one of the following to the vial:

0.9% Sodium Chloride Injection
Sterile Water for Injection
Bacteriostatic Water for Injection with methylparaben and propylparaben
Bacteriostatic Water for Injection with 0.9% benzyl alcohol
Each vial contains an intentional overfill of Caspofungin. The volume of diluent to be added and the resulting drug concentration is listed in the table below.
The white to off-white cake will dissolve completely. Mix gently until a clear solution is obtained.
The reconstituted solution may be stored for up to 24 hours at ≤25 °C before preparation for infusion.

Aseptically transfer the appropriate volume (mL) of the reconstituted Caspofungin solution to an IV bag (or bottle) containing 250 mL of:

0.9% Sodium Chloride Injection
0.45% Sodium Chloride Injection
0.225% Sodium Chloride Injection

Lactated Ringer’s Injection

In six healthy subjects who received a single 210 mg dose, no significant adverse reactions were reported.

Caspofungin is contraindicated in patients with a known hypersensitivity to any component of this product.

Hepatic Effects

Caspofungin may cause abnormalities in liver enzymes.

Isolated cases of hepatic dysfunction, hepatitis, and hepatic failure have been reported.

Monitor patients with abnormal liver enzyme levels for signs of worsening hepatic function and evaluate the risk/benefit of continuing Caspofungin.

Hypersensitivity Reactions

Cases of anaphylaxis and histamine-mediated reactions (such as rash, facial swelling, angioedema, pruritus, sensation of warmth, or bronchospasm) have been reported.
Severe reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been observed.
Discontinue Caspofungin immediately at the first sign of hypersensitivity and administer appropriate treatment.

The most common adverse reactions include:

Gastrointestinal: Nausea, vomiting, diarrhea, abdominal pain
Systemic: Pyrexia (fever), chills, hypotension, peripheral edema
Neurological: Headache
Respiratory: Cough
Dermatological: Skin rash

When Caspofungin is co-administered with hepatic enzyme inducers (such as efavirenz, nevirapine, phenytoin, dexamethasone, or carbamazepine), consider increasing the daily dose to 70 mg.

In patients receiving Caspofungin and tacrolimus, standard monitoring of tacrolimus trough levels and dosage adjustments are recommended.

Pregnancy:

There is no clinical experience in pregnant women.

Caspofungin should only be used during pregnancy if absolutely necessary.

Lactation:

It is unknown whether Caspofungin is excreted in human milk.

Women receiving Caspofungin should not breastfeed.

Unreconstituted vials: Store in a refrigerator (2–8 °C). Do not freeze.

Reconstituted solution in vial: Store at ≤25 °C for up to 24 hours.

Infusion solution:

Store at ≤25 °C for up to 24 hours.

If refrigerated at 2–8 °C, store for up to 48 hours

Keep out of reach of children.