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Summary of Prescribing Information for Cresemba® (Isavuconazole)

Composition: Each hard capsule contains 100 mg isavuconazole (as 186.3 mg isavuconazonium sulfate). Each vial contains 200 mg isavuconazole (as 372.6 mg isavuconazonium sulfate).

Indications: Isavuconazole is an azole antifungal indicated for patients 18 years of age and older for the treatment of Invasive Aspergillosis and Invasive Mucormycosis.

   

Dosage:

Loading dose (Vial)

The recommended loading dose is one vial after reconstitution and dilution (equivalent to 200 mg of isavuconazole) every 8 hours for the first 48 hours (6 administrations in total).

Maintenance dose

The recommended maintenance dose is one vial after reconstitution and dilution (equivalent to 200 mg of isavuconazole) once daily, starting 12 to 24 hours after the last loading dose.

Method of administration (Vial)

Intravenous use.

Isavuconazole must be reconstituted and then further diluted to a concentration corresponding to approximately 0.8 mg/mL isavuconazole prior to administration by intravenous infusion over a minimum of 1 hour to reduce the risk of infusion-related reactions. The infusion must be administered via an infusion set with an in-line filter with a microporous membrane made of polyethersulfone (PES) and with a pore size of 0.2 μm to 1.2 μm. Isavuconazole must only be given as an intravenous infusion.

Loading dose (Hard capsule)

The recommended loading dose is two capsules (equivalent to 200 mg of isavuconazole) every 8 hours for the first 48 hours (6 administrations in total).

Maintenance dose

The recommended maintenance dose is two capsules (equivalent to 200 mg of isavuconazole) once daily, starting 12 to 24 hours after the last loading dose.

Method of administration (Capsule)

Isavuconazole capsules can be taken with or without food.

Isavuconazole capsules should be swallowed whole. Do not chew, crush, dissolve or open the capsule

Contraindications: Hypersensitivity to the active substance or to any of the excipients; coadministration with ketoconazole; co-administration with high-dose ritonavir (>200 mg every 12 hours); co-administration with strong CYP3A4/5 inducers such as rifampicin, rifabutin, carbamazepine, long acting barbiturates (e.g.phenobarbital), phenytoin and St. John’s wort or with moderate CYP3A4/5 inducers such as efavirenz, nafcillin and etravirine; patients with familial short QT syndrome.

Warning and Precautions: Caution should be used in prescribing isavuconazole to patients with hypersensitivity to other azole antifungal agents. Severe cutaneous adverse reactions, such as Stevens-Johnson syndrome, have been reported during treatment with azole antifungal agents. If a patient develops a severe cutaneous adverse reaction, Isavuconazole should be discontinued. Isavuconazole is contraindicated in patients with familial short QT syndrome. Isavuconazole has not been studied in patients with severe hepatic impairment (Child-Pugh Class C). Use in these patients is not recommended unless the potential benefit is considered to outweigh the risks. Isavuconazole must not be used during pregnancy except in patients with severe or potentially life-threatening fungal infections, in whom isavuconazole may be used if the anticipated benefits outweigh the possible risks to the foetus. Isavuconazole is not recommended for women of childbearing potential who are not using contraception. Breastfeeding should be discontinued during treatment with Isavuconazole.

Adverse Reactions: The frequency of adverse reactions is based on data from 403 patients with invasive fungal infections treated with Isavuconazole in phase 3 studies. The most common treatment-related adverse reactions were elevated liver chemistry tests (7.9%), nausea (7.4%), vomiting (5.5%), dyspnoea (3.2%), abdominal pain (2.7%), diarrhoea (2.7%), injection site reaction (2.2%), headache (2.0%), hypokalaemia (1.7%) and rash (1.7%). The adverse reactions which most often led to permanent discontinuation of Isavuconazole treatment were confusional state (0.7%), acute renal failure (0.7%), increased blood bilirubin (0.5%), convulsion (0.5%), dyspnoea (0.5%), epilepsy (0.5%), respiratory failure (0.5%) and vomiting (0.5%)

Drug Interactions: Co-administration of Isavuconazole with the strong CYP3A4/5 inhibitor ketoconazole is contraindicated, since this medicinal product can significantly increase plasma concentrations of isavuconazole; co-administration of Isavuconazole with potent CYP3A4/5 inducers such as rifampicin, rifabutin, carbamazepine, long-acting barbiturates (e.g., phenobarbital), phenytoin and St. John’s wort, or with moderate CYP3A4/5 inducers such as efavirenz, nafcillin and etravirine, is contraindicated, since these medicinal products can significantly decrease plasma concentrations of isavuconazole; Co-administration with highdose ritonavir (>200 mg twice daily) is contraindicated, as at high doses ritonavir may induce CYP3A4/5 and decrease isavuconazole plasma concentrations.

Overdose:

Symptoms

Symptoms reported more frequently at supratherapeutic doses of Isavuconazole (equivalent to isavuconazole 600 mg/day) evaluated in a QT study than in the therapeutic dose group (equivalent to isavuconazole 200 mg/day dose) included: headache, dizziness, paraesthesia, somnolence, disturbance in attention, dysgeusia, dry mouth, diarrhoea, oral hypoaesthesia, vomiting, hot flush, anxiety, restlessness, palpitations, tachycardia, photophobia and arthralgia.

Management of overdose

Isavuconazole is not removed by haemodialysis. There is no specific antidote for isavuconazole. In the event of an overdose, supportive treatment should be instituted.

Storage Condition:

Vial: Store in a refrigerator (2°C to 8°C).

Hard Capsule: Store below 30°C.

Adapted from Local product document for Cresemba version LPDCRE052021.
®Trademark Proprietor: Basilea Pharmaceutica AG Licensed user Pfizer Products India Private Limited, India.

 

   

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