Janssen-Cilag Ltd

Change to section 4.3 - Contraindications

Addition of Atorvastatin

Women of childbearing potential taking Sporanox-Pulse should use contraceptive precautions. Effective contraception should be continued until the menstrual period following the end of Sporanox-Pulse therapy

Change to section 4.4 - Special warnings and precautions for Use

Cardiac effects

In a healthy volunteer study with Sporanox^® IV, a transient asymptomatic decrease of the left ventricular ejection fraction was observed; this resolved before the next infusion. The clinical relevance of these findings to the oral formulations is unknown.

Sporanox should not be used in patients with congestive heart failure or with a history of congestive heart failure unless the benefit clearly outweighs the risk.  This individual benefit/risk assessment should take into consideration factors such as the severity of the indication, the dose and duration of treatment (e.g. total daily dose), and individual risk factors for congestive heart failure.  These risk factors include cardiac disease, such as ischemic and valvular disease; significant pulmonary disease, such as chronic obstructive pulmonary disease; and renal failure and other edematous disorders. Such patients should be informed of the signs and symptoms of congestive heart failure, should be treated with caution, and should be monitored for signs and symptoms of congestive heart failure during treatment; if such signs or symptoms do occur during treatment, Sporanox should be discontinued

Hepatic impairment

Limited data are available on the use of oral itraconazole in patients with hepatic impairment. Caution should be exercised when the drug is administered in this patient population. (See Section 5.2)

Renal impairment

Limited data are available on the use of oral itraconazole in patients with renal impairment. Caution should be exercised when this drug is administered in this patient population. The oral bioavailability of itraconazole may be lower in patients with renal insufficiency. Dose adaptation may be considered.

Interaction Potential

Sporanox has a potential for clinically important drug interactions.  (See Section 4.5). Itraconazole should not be used within 2 weeks after discontinuation of treatment with CYP 3A4 inducing agents (rifampicin, rifabutin, phenobarbital, phenytoin, carbamazepine, Hypericum perforatum (St. John´s wort). The use of itraconazole with these drugs may lead to subtherapeutic plasma levels of itraconazole and thus treatment failure.

Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Itraconazole is mainly metabolised through the cytochrome CYP3A4.  Interaction studies have been performed with rifampicin, rifabutin and phenytoin, which are potent inducers of CYP3A4.  Since the bioavailability of itraconazole and hydroxy-itraconazole was decreased in these studies to such an extent that efficacy may be largely reduced, the combination of itraconazole with these potent enzyme inducers is not recommended.  No formal study data are available for other enzyme inducers, such as carbamazepine, Hypericum perforatum (St John’s Wort), phenobarbital and isoniazid, but similar effects should be anticipated.

CYP3A4 metabolised HMG-CoA reductase inhibitors such as atorvastatin, lovastatin and simvastatin.

Change to section 4.6 - Pregnancy and Lactation

There is limited information on the use of Sporanox during pregnancy. During post-marketing experience, cases of congenital abnormalities have been reported. These cases included skeletal, genitourinary tract, cardiovascular and ophthalmic malformations as well as chromosomal and multiple malformations. A causal relationship with Sporanox has not been established.

Change to section 4.7 - Effects on Ability to Drive and Use Machines

No studies on the effects on the ability to drive and use machines have been performed. When driving vehicles and operating machinery the possibility of adverse reactions such as dizziness, visual disturbances and hearing loss (see Section 4.8), which may occur in some instances, must be taken into account.

Change to section 4.8 - Undesirable Effects

*see section 4.4

Change to section 10 - Date of revision of the text

01 December 2010

1.             Trade Name of the Medicinal Product

SporanoxPORANOX^® -Pulse

4.4.         Special Warnings and Precautions for Use

Addition of hearing loss warning

4.8.         Undesirable Effects

Complete section has been re-worded 

10.          Date of (Partial) Revision of the Text

Changed from April 2009 to 23 October 2009

Change to section 4.4 Special Warnings and Precautions for Use

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Change to section 10 Date of Revision of the Text

Amended to ‘April 2009’

Change to section 6.4 – Special Precautions for Storage

Store below 30C

X

Change to section 10 – Date of revision of the text

July 2008

Change to section 4.5 –Interaction with other medicinal products and other forms of interaction

Addition of interaction with Fluticasone

Change to section 10 – Date of revision of the text

August 2007