Cresemba Capsules (Hard Gelatin)
Isavuconazonium sulfate (Isavuconazole)
100mg
Al Hikma Pharmaceuticals
| Pack size | 14's (7's Blister x 2) |
|---|---|
| Dispensing mode | POM |
| Source | JORDAN |
| Agent | ALPHAMED DRUG STORE |
| Retail Price | 3906.00 AED |
Available as:
Indications
Cresemba Capsules (Hard Gelatin) is used for:
Invasive Aspergillosis, Invasive Mucormycosis
Adult Dose
Invasive Aspergillosis
Indicated for invasive aspergillosis
Has activity against most strains of the following microorganisms, both in vitro and in clinical infection: Aspergillus flavus, Aspergillus fumigatus, and Aspergillus niger
Initial: 372 mg PO/IV q8hr x6 doses (48 hr)
Maintenance: 372 mg PO/IV qDay
Invasive Mucormycosis
Indicated for invasive mucormycosis caused by Mucorales fungi such as Rhizopus oryzae and Mucormycetes species
Initial: 372 mg PO/IV q8hr x6 doses (48 hr)
Maintenance: 372 mg PO/IV qDay
Hepatic impairment
Mild or moderate: No dose adjustment required
Severe: Not studied
Child Dose
<18 years: Safety and efficacy not established
Renal Dose
Renal impairment
Mild, moderate, or severe (including ESRD): No dose adjustment required
Administration
IV Preparation
Reconstitute lyophilized powder in vial
Reconstitute 1 vial by adding 5 mL sterile water for injection
Gently shake to dissolve the powder completely
Visually inspect the reconstituted solution for particulate matter and discoloration; reconstituted solution should be clear and free of visible particulate
Further dilution
Remove 5 mL of the reconstituted solution from the vial and add it to an infusion bag containing 250 mL (approximately 1.5 mg/mL isavuconazonium sulfate) of compatible diluent
The diluted solution may show visible translucent-to-white particulates of isavuconazole (which will be removed by in-line filtration)
Use gentle mixing or roll bag to minimize the formation of particulates
Avoid unnecessary vibration or vigorous shaking of the solution
Apply in-line filter with a microporous membrane pore size of 0.2 - 1.2 micron and in-line filter reminder sticker to the infusion bag
IV Administration
Do not use a pneumatic transport system
Complete IV administration within 6 hr of dilution at room temperature (or immediately store refrigerated, see Storage)
IV formulation must be administered via an infusion set with an in-line filter (pore size 0.2-1.2 micron)
Infuse over a minimum of 1 hr in 250 mL of a compatible diluent, to reduce the risk for infusion-related reactions
Do not administer as an intravenous bolus injection
Do not infuse with other intravenous medications
Flush IV lines with 0.9% NaCl injection or D5W prior to and after infusion
Oral Administration
Switching between IV and oral formulations is acceptable as bioequivalence has been demonstrated
Loading dose is not required when switching between formulations
Swallow oral capsules whole; do not chew, crush, dissolve, or open the capsules
Can be taken with or without food
Contra Indications
Known hypersensitivity
Strong CYP3A4 inhibitors; coadministration with strong CYP3A4 inhibitors can significantly increase the plasma concentration of isavuconazole
Strong CYP3A4 inducers; coadministration with strong CYP3A4 inducers can significantly decrease the plasma concentration of isavuconazole
Familial short QT syndrome; isavuconazole shortens the QTc interval in a concentration-related manner
Precautions
Hepatic adverse drug reactions (eg, elevated ALT, AST, alkaline phosphatase, total bilirubin) reported; the elevations in liver-related laboratory tests were generally reversible and did not require discontinuation of drug; cases of more severe hepatic adverse drug reactions, including hepatitis, cholestasis, or hepatic failure including death, have been reported in patients with serious underlying medical conditions (eg, hematologic malignancy) during treatment with azole antifungal agents
Infusion-related reactions, including hypotension, dyspnea, chills, dizziness, paresthesia, and hypoesthesia, were reported; discontinue the infusion if these reaction occur
Serious hypersensitivity and severe skin reactions (eg, anaphylaxis, Stevens-Johnson syndrome) have been reported during treatment with other azole antifungal agents
May cause fetal harm when administered to a pregnant woman; should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the fetus
Pregnancy-Lactation
Pregnancy
Based on findings from animal studies, fetal harm may occur when administered to pregnant women
No human data available on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes
Animal studies
In animal reproduction studies, perinatal mortality was increased in the offspring of pregnant rats dosed orally with isavuconazonium sulfate at 90 mg/kg/day during pregnancy through the weaning period
In animal studies when isavuconazonium chloride was administered by oral gavage to pregnant rats and rabbits during organogenesis at exposures corresponding to less than the human maintenance dose, increases in the incidences of multiple skeletal abnormalities, including rudimentary cervical ribs and fused zygomatic arches, were observed
Contraception
Advise female patients of reproductive potential to use effective contraception during treatment and for 28 days after the final dose
Lactation
Isavuconazole was present in the milk of lactating rats following IV administration
Thus, drug may be present in human milk
Therefore, breastfeeding should be discontinued during treatment
Interactions
Adverse Effects
Side effects of Isavuconazonium sulfate (Isavuconazole) :
>10%
Nausea (27.6%)
Vomiting (24.9%)
Diarrhea (23.7%)
Hypokalemia (19.1%)
Elevated liver tests (17.1%)
Dyspnea (17.1%)
Abdominal pain (16.7%)
Headache (16.7%)
Peripheral edema (15.2%)
Constipation (14%)
Fatigue (10.5%)
Insomnia (10.5%)
Back pain (10.1%)
Renal failure (10.1%)
1-10%
Chest pain (8.9%)
Decreased appetite (8.6%)
Delirium (8.6%)
Rash (8.6%)
Pruritus (8.2%)
Hypotension (8.2%)
Anxiety (8.2%)
Acute respiratory failure (7.4%)
Injection site reaction (6.2%)
Dyspepsia (6.2%)
Hypomagnesemia (5.4%)
Cardiac disorders: Atrial fibrillation, atrial flutter, bradycardia, reduced QT interval on electrocardiogram, palpitations, supraventricular extrasystoles, supraventricular tachycardia, ventricular extrasystoles, cardiac arrest (<5%)
Nervous system disorders: Convulsion, dysgeusia, encephalopathy, hypoesthesia, migraine, peripheral neuropathy, paraesthesia, somnolence, stupor, syncope, tremor (<5%)
Psychiatric disorders: Confusion, hallucination, depression (<5%)
Renal and urinary disorders: Hematuria, proteinuria (<5%)
Respiratory, thoracic, and mediastinal disorders: Bronchospasm, tachypnea (<5%)
Mechanism of Action
Triazole antifungal agent; isavuconazole is the active moiety of the prodrug isavuconazonium sulfate
Note
Cresemba 100mg Capsules (Hard Gelatin) manufactured by Al Hikma Pharmaceuticals. Its generic name is Isavuconazonium sulfate (Isavuconazole). Cresemba is availble in United Arab Emirates.
Farmaco UAE drug index information on Cresemba Capsules (Hard Gelatin) is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.