Tapcom/Tapcom-S Adverse Reactions

Tapcom: Adverse drug reactions (including abnormal change in laboratory test values) were reported in 94 of 379 patients (24.8%) in clinical studies in Japan. The major adverse drug reactions were abnormality in eyelashes in 35 patients (9.2%), conjunctival injection in 32 patients (8.4%), corneal epithelium disorder including punctate keratitis in 21 patients (5.5%), blepharal pigmentation in 9 patients (2.4%), eye irritation in 8 patients (2.1%), etc.
Clinically significant adverse reaction: Iris pigmentation (incidence unknown)*: Iris pigmentation may occur. Patients should be examined periodically, and administration should be discontinued depending on clinical status when iris pigmentation is observed.
Ocular pemphigoid (incidence unknown)*: Ocular pemphigoid may occur. Discontinue administration and treat the patient appropriately when symptoms including conjunctival injection, corneal epithelium disorder, keratoconjunctivitis sicca, conjunctival atrophy, ciliary entropion or symblepharon are observed.
Bronchospasm, dyspnea, respiratory failure (incidence unknown)*: Bronchospasm, dyspnea or respiratory failure may occur. Discontinue administration and treat the patient appropriately if such symptoms are observed.
Heart block, congestive heart failure, cerebral ischemia, cardiac arrest, cerebrovascular disorder (incidence unknown)*: Heart block, congestive heart failure, cerebral ischemia, cardiac arrest or cerebrovascular disorder may occur. Discontinue administration and treat the patient appropriately if such symptoms are observed.
Systemic lupus erythematosus (incidence unknown)*: Systemic lupus erythematosus may occur. Discontinue administration and treat the patient appropriately if such symptom is observed.
*Adverse drug reactions which have been reported in use of tafluprost or timolol maleate.
Other adverse drug reactions: If an adverse drug reaction is observed, appropriate measures including discontinuing administration should be taken. (See Table 4.)

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Tapcom-S: In clinical studies, over 484 patients have been treated with TAPCOM-S. The most frequently reported treatment-related adverse event was conjunctival/ocular hyperaemia. It occurred in approximately 7% of the patients participating in the clinical studies in Europe, was mild in most cases, and was associated with discontinuation of treatment in 1.2% of patients.
The adverse reactions reported in the clinical studies using TAPCOM-S were limited to those earlier reported for either of the single active substances Tafluprost or Timolol. No new adverse reactions specific for TAPCOM-S were observed in the clinical studies. The majority of adverse reactions reported were ocular, mild or moderate in severity and none were serious.
Like other topically applied ophthalmic agents, Tafluprost and Timolol are absorbed systemically. This may cause similar undesirable effects as seen with systemic beta-blocking agents. Incidence of systemic adverse reactions after topical ophthalmic administration is lower than for systemic administration. Listed adverse reactions include reactions seen within the class of ophthalmic beta-blockers.
The following adverse reactions have been reported with TAPCOM-S during clinical trials (within each frequency grouping, adverse reactions are presented in order of decreasing frequency). The frequency of possible adverse reactions listed below is defined using the following convention: See Table 5.

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Additional adverse reactions that have been seen with either of the active substances (Tafluprost or Timolol), and may potentially occur also with TAPCOM-S are listed as follows: See Tables 6 and 7.

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Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.